B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Spedra 50 mg tablets avanafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Spedra is and what it is used for

• 2. What you need to know before you take Spedra

• 3. How to take Spedra

• 4. Possible side effects

• 5. How to store Spedra

• 6. Contents of the pack and other information

1. What Spedra is and what it is used for

Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence). This is when you cannot get, or keep a hard, erect penis suitable for sexual activity.

Spedra works by helping the blood vessels in your penis to relax. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Spedra does not cure your condition.

It is important to note that Spedra only works if you are sexually stimulated. You and your partner will still need to use foreplay to get ready for sex – just as you would if you were not taking a medicine to help you.

Spedra will not help you if you do not have erectile dysfunction. Spedra is not for women.

2. What you need to know before you take Spedra

Do not take Spedra:

• If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
• If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl

trinitrate. Spedra can increase the effects of these medicines and severely lower your blood pressure

• If you are taking s for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
• If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
• If you have a serious cardiac problem
• If you have had a stroke or heart attack in the last 6 months
• If you have low blood pressure or high blood pressure not controlled by medicines
• If you have chest pain (angina) or you get chest pain during sexual intercourse
• If you have a serious liver or kidney problem
• If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic

ischemic optic neuropathy [NAION])

• If certain serious eye problems run in your family (such as retinitis pigmentosa).
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Do not take Spedra if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Spedra.

Warnings and precautions

Talk to your doctor or pharmacist before taking Spedra:

• If you have heart trouble. It may be risky for you to have sexual intercourse
• If you suffer from priapism, that is a persistent erection lasting 4 hours or more. This can

happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.

• If you have a physical condition that affects the shape of your penis (such as angulation, Peyronie’s disease or cavernosal fibrosis)
• If you have any bleeding disorder or active peptic ulceration.

If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Problems with your sight or hearing

Some men taking medicines like Spedra have had problems with their sight and hearing – see “Serious side effects” in section 4 for more details. It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors.

Children and adolescents

Spedra should not be taken by children and adolescents under 18 years of age.

Other medicines and Spedra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Spedra can affect the way some other medicines work. Also some other medicines can affect the way Spedra works.

In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate. Spedra has been shown to increase the effects of these medicines and severely lower your blood pressure. Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra’).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• so called “alpha-blockers” – for prostate problems or for lowering your high blood pressure
• medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide,

amiodarone or sotalol

• antibiotics for infections such as erythromycin
• phenobarbital or primidone – for epilepsy
• carbamazepine – for epilepsy, to stabilise your mood or for certain types of pain
• other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4

inhibitors’) including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.

• riociguat

Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil.

If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Spedra with drink and alcohol

Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra.

Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure. You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations). Drinking alcohol may also decrease your ability to get an erection.

Fertility

There was no effect on sperm movement or structure after single 200 mg oral doses of avanafil in healthy volunteers.

The repeated oral administration of avanafil 100 mg over a period of 26 weeks to healthy volunteers and adult males with mild erectile dysfunction was not associated with any untoward effects on sperm concentration, count, motility, or morphology.

Driving and using machines

Spedra can make you feel dizzy or affect your vision. If this happens, do not drive, cycle, use tools or machines.

3. How to take Spedra

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is a 100 mg tablet, as needed. You should not take Spedra more than once a day. You could have been given the dose of one 200 mg tablet if your doctor has decided that the 100 mg dose was too weak for you, or the dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet was too strong for you. Dose adjustments can also be required if Spedra is used together with certain other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil (‘moderate CYP3A4 inhibitors’) the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.

You should take Spedra about 30 minutes before you have sexual intercourse. Remember that Spedra will only help you to get an erection if you are sexually stimulated.

Spedra can be taken with or without food; if taken with food, it may take longer to work.

If you take more Spedra than you should

If you take too much Spedra, you should tell your doctor straight away. You may get more side effects than usual and they may be worse.

If you have any further questions on the use of Spedra, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

• an erection that will not go away (“priapism”). If you get an erection that lasts more than

4 hours, this must be treated as soon as possible or lasting damage can happen to your penis (including not being able to get erections).

• blurred vision.
• sudden decrease or loss of vision in one or both eyes.
• sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your ears).

Stop taking Spedra and see a doctor straight away, if you notice any of the serious side effects above.

Other side effects include:

Common (may affect up to 1 in 10 people)

• headache
• flushing
• nasal congestion

Uncommon (may affect up to 1 in 100 people)

• feeling dizzy
• feeling sleepy or very tired
• sinus congestion
• back pain
• hot flush
• feeling out of breath when you exert yourself
• heartbeat changes seen on a heart tracing (ECG)
• increased heart beat
• feeling your heartbeat in your chest (palpitations)
• indigestion, feeling or being sick to your stomach
• blurry vision
• raised liver enzymes

Rare (may affect up to 1 in 1,000 people)

• influenza
• influenza-like illness
• stuffy or runny nose
• hayfever
• congestion in the nose, sinuses or upper part of the airway bringing air into the lungs
• gout
• trouble sleeping (insomnia)

premature ejaculation

feeling strange

feeling unable to keep still

chest pain

serious chest pain

fast heart beat

high blood pressure

dry mouth

stomach ache or heartburn

pain or discomfort in the lower abdomen diarrhoea

rash

pain in the lower back or side of lower chest muscle aches or pains

muscle spasms

frequent urination

penile disorder

spontaneous erection without sexual stimulation

itching in the genital area

feeling weak or tired all the time

swelling in the feet or ankles

increased blood pressure

pink or red urine, blood in the urine abnormal extra sound from the heart

an abnormal blood test result for a prostate test called ‘PSA’

an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of red blood cells

an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function

weight gain

fever

nosebleed

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Spedra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.

The expiry date refers to the last day of that month.

This medicine does not require any special storage condition.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Spedra contains

• The active substance is avanafil. Each tablet contains 50 mg of avanafil.
• The other ingredients are mannitol, fumaric acid, hydroxypropyl­cellulose, hydroxypropyl­cellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).

What Spedra looks like and contents of the pack

Spedra is a pale yellow oval tablet, marked “50”on one side. The tablets are provided in perforated

unit dose blister packs containing 4×1, 8×1, or 12×1 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder :

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.,

1, Avenue de la Gare,

L-1611 Luxembourg, Luxembourg.

Manufacturer :

Menarini – Von Heyden GmbH

Leipziger Straße 7–13

01097 Dresden

Germany or

Sanofi Winthrop Industrie

1, rue de la Vierge Ambares et Lagrave

33565 Carbon-Blanc-Cedex

France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgiqu­e/Belgien

Menarini Benelux NV/SA

Tél/Tel: + 32 (0)2 721 4545

Btarapuu

EepauH-XeMu/A. MeHapuHu Etarapua EOOfl mea.: +359 2 454 0950

Česká republika

Berlin-Chemie/A.Menarini Ceska republika

s.r.o.

Tel: +420 267 199 333

Danmark Pharmaprim AB Tlf: +46 8355933	Malta Menarini International Operations Luxembourg S.A. Tel: +352 264976
Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67070	Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4545
Eesti OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001	Norge Pharmaprim AB Tlf: +46 8355933
EMáSa MENARINI HELLAS AE Tql: +30 210 8316111–13	Österreich A. Menarini Pharma GmbH Tel: +43 1 879 95 85–0
España Laboratorios Menarini S.A. Tel: +34–93 462 88 00	Polska Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 00
France MENARINI France Tél: +33 (0)1 45 60 77 20	Portugal A. Menarini Portugal – Farmacéutica, S.A. Tel: +351 210 935 500
Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 361	Romania Berlin-Chemie A. Menarini S.R.L. Tel: +40 21 232 34 32
Ireland A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744	Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2160
Ísland Pharmaprim AB Sími: +46 8355933	Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.Tel: +421 2 544 30 730
Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39–055 56801	Suomi/Finland Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760

Kùnpoç MENARINI HELLAS AE Tql: +30 210 8316111–13	Sverige Pharmaprim AB Tel: +46 8355933
Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210	United Kingdom (Northern Ireland) A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856400

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient Spedra 100 mg tablets

avanafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Spedra is and what it is used for

• 2. What you need to know before you take Spedra

• 3. How to take Spedra

• 4. Possible side effects

• 5. How to store Spedra

• 6. Contents of the pack and other information

1. What Spedra is and what it is used for

Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence). This is when you cannot get, or keep a hard, erect penis suitable for sexual activity.

Spedra works by helping the blood vessels in your penis to relax. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Spedra does not cure your condition.

It is important to note that Spedra only works if you are sexually stimulated. You and your partner will still need to use foreplay to get ready for sex – just as you would if you were not taking a medicine to help you.

Spedra will not help you if you do not have erectile dysfunction. Spedra is not for women.

2. What you need to know before you take Spedra

Do not take Spedra:

• If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
• If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl

trinitrate. Spedra can increase the effects of these medicines and severely lower your blood pressure

• If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
• If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
• If you have a serious cardiac problem
• If you have had a stroke or heart attack in the last 6 months
• If you have low blood pressure or high blood pressure not controlled by medicines
• If you have chest pain (angina) or you get chest pain during sexual intercourse
• If you have a serious liver or kidney problem
• If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic

ischemic optic neuropathy [NAION])

• If certain serious eye problems run in your family (such as retinitis pigmentosa).
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Do not take Spedra if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Spedra.

Warnings and precautions

Talk to your doctor or pharmacist before taking Spedra:

• If you have heart trouble. It may be risky for you to have sexual intercourse
• If you suffer from priapism, that is a persistent erection lasting 4 hours or more. This can

happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.

• If you have a physical condition that affects the shape of your penis (such as angulation, Peyronie’s disease or cavernosal fibrosis)
• If you have any bleeding disorder or active peptic ulceration.

If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Problems with your sight or hearing

Some men taking medicines like Spedra have had problems with their sight and hearing – see “Serious side effects” in section 4 for more details. It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors.

Children and adolescents

Spedra should not be taken by children and adolescents under 18 years of age.

Other medicines and Spedra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Spedra can affect the way some other medicines work. Also some other medicines can affect the way Spedra works.

In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate. Spedra has been shown to increase the effects of these medicines and severely lower your blood pressure. Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra’).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• so called “alpha-blockers” – for prostate problems or for lowering your high blood pressure
• medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide,

amiodarone or sotalol

• antibiotics for infections such as erythromycin
• phenobarbital or primidone – for epilepsy
• carbamazepine – for epilepsy, to stabilise your mood or for certain types of pain
• other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4

inhibitors’) including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.

• riociguat

Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil.

If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Spedra with drink and alcohol

Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra.

Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure. You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations). Drinking alcohol may also decrease your ability to get an erection.

Fertility

There was no effect on sperm movement or structure after single 200 mg oral doses of avanafil in healthy volunteers.

The repeated oral administration of avanafil 100 mg over a period of 26 weeks to healthy volunteers and adult males with mild erectile dysfunction was not associated with any untoward effects on sperm concentration, count, motility, or morphology.

Driving and using machines

Spedra can make you feel dizzy or affect your vision. If this happens, do not drive, cycle, use tools or machines.

3. How to take Spedra

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is a 100 mg tablet, as needed. You should not take Spedra more than once a day. You could have been given the dose of one 200 mg tablet if your doctor has decided that the 100 mg dose was too weak for you, or the dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet was too strong for you. Dose adjustments can also be required if Spedra is used together with certain other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil (‘moderate CYP3A4 inhibitors’) the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.

You should take Spedra approximately 15 to 30 minutes before you have sexual intercourse. Remember that Spedra will only help you to get an erection if you are sexually stimulated. Spedra can be taken with or without food; if taken with food, it may take longer to work.

If you take more Spedra than you should

If you take too much Spedra, you should tell your doctor straight away. You may get more side effects than usual and they may be worse.

If you have any further questions on the use of Spedra, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

• an erection that will not go away (“priapism”). If you get an erection that lasts more than

4 hours, this must be treated as soon as possible or lasting damage can happen to your penis (including not being able to get erections).

• blurred vision.
• sudden decrease or loss of vision in one or both eyes.
• sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your

ears).

Stop taking Spedra and see a doctor straight away, if you notice any of the serious side effects above.

Other side effects include:

Common (may affect up to 1 in 10 people)

• headache
• flushing
• nasal congestion

Uncommon (may affect up to 1 in 100 people)

• feeling dizzy
• feeling sleepy or very tired
• sinus congestion
• back pain
• hot flush
• feeling out of breath when you exert yourself
• heartbeat changes seen on a heart tracing (ECG)
• increased heart beat
• feeling your heartbeat in your chest (palpitations)
• indigestion, feeling or being sick to your stomach
• blurry vision
• raised liver enzymes

Rare (may affect up to 1 in 1,000 people)

• influenza
• influenza-like illness
• stuffy or runny nose
• hayfever
• congestion in the nose, sinuses or upper part of the airway bringing air into the lungs
• gout
• trouble sleeping (insomnia)
• premature ejaculation
• feeling strange
• feeling unable to keep still
• chest pain
• serious chest pain
• fast heart beat
• high blood pressure
• dry mouth
• stomach ache or heartburn
• pain or discomfort in the lower abdomen
• diarrhoea
• rash
• pain in the lower back or side of lower chest
• muscle aches or pains
• muscle spasms
• frequent urination
• penile disorder
• spontaneous erection without sexual stimulation
• itching in the genital area
• feeling weak or tired all the time
• swelling in the feet or ankles
• increased blood pressure
• pink or red urine, blood in the urine
• abnormal extra sound from the heart
• an abnormal blood test result for a prostate test called ‘PSA’
• an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of

red blood cells

• an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function
• weight gain
• fever
• nosebleed

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Spedra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.

The expiry date refers to the last day of that month.

This medicine does not require any special storage condition.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Spedra contains

• The active substance is avanafil. Each tablet contains 100 mg of avanafil.
• The other ingredients are mannitol, fumaric acid, hydroxypropyl­cellulose, hydroxypropyl­cellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).

What Spedra looks like and contents of the pack

Spedra is a pale yellow oval tablet, marked “100” on one side. The tablets are provided in perforated unit dose blister packs containing 2×1, 4×1, 8×1, or 12×1 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder:

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.,

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Manufacturer:

Menarini – Von Heyden GmbH

Leipziger Straße 7–13

01097 Dresden

Germany

or

Sanofi Winthrop Industrie

1, rue de la Vierge

Ambares et Lagrave

33565 Carbon-Blanc-Cedex

France

For any information about this medicine l product, please contact the local representative of the Marketing Authorisation Holder.

Belgie/Belgiqu­e/Belgien Menarini Benelux NV/SA Tél/Tel: + 32 (0)2 721 4545 Btnrapuu EepauH-XeMu/A. MeHapuHu Etnrapua EOOfl mea.: +359 2 454 0950 Česká republika Berlin-Chemie/A.Menarini Ceska republika s.r.o. Tel: +420 267 199 333 Danmark Pharmaprim AB Tlf: +46 8355933

Lietuva UAB “BERLIN-CHEMIE MENARINI BALTIC” Tel: +370 52 691 947 Luxembourg/Lu­xemburg Menarini Benelux NV/SA Tel/Tel: + 32 (0)2 721 4545 Magyarorszag Berlin-Chemie/A. Menarini Kft. Tel.: +36 23501301 Malta Menarini International Operations Luxembourg S.A. Tel: +352 264976

Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67070	Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4545
Eesti OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001	Norge Pharmaprim AB Tlf: +46 8355933
EXXáSa MENARINI HELLAS AE Tql: +30 210 8316111–13	Österreich A. Menarini Pharma GmbH Tel: +43 1 879 95 85–0
España Laboratorios Menarini S.A. Tel: +34–93 462 88 00	Polska Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 00
France MENARINI France Tél: +33 (0)1 45 60 77 20	Portugal A. Menarini Portugal – Farmacéutica, S.A. Tel: +351 210 935 500
Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 361	Romania Berlin-Chemie A. Menarini S.R.L. Tel: +40 21 232 34 32
Ireland A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744	Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2160
Ísland Pharmaprim AB Sími: +46 8355933	Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 730
Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39–055 56801	Suomi/Finland Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760

Kùnpoç MENARINI HELLAS AE Tql: +30 210 8316111–13	Sverige Pharmaprim AB Tel: +46 8355933
Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210	United Kingdom (Northern Ireland) A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856400

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Spedra 200 mg tablets

avanafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Spedra is and what it is used for

• 2. What you need to know before you take Spedra

• 3. How to take Spedra

• 4. Possible side effects

• 5. How to store Spedra

• 6. Contents of the pack and other information

1. What Spedra is and what it is used for

Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence). This is when you cannot get, or keep a hard, erect penis suitable for sexual activity.

Spedra works by helping the blood vessels in your penis to relax. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Spedra does not cure your condition.

It is important to note that Spedra only works if you are sexually stimulated. You and your partner will still need to use foreplay to get ready for sex – just as you would if you were not taking a medicine to help you.

Spedra will not help you if you do not have erectile dysfunction. Spedra is not for women.

2. What you need to know before you take Spedra

Do not take Spedra:

• If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
• If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl

trinitrate. Spedra can increase the effects of these medicines and severely lower your blood pressure

• If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
• If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
• If you have a serious cardiac problem
• If you have had a stroke or heart attack in the last 6 months
• If you have low blood pressure or high blood pressure not controlled by medicines
• If you have chest pain (angina) or you get chest pain during sexual intercourse
• If you have a serious liver or kidney problem
• If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic

ischemic optic neuropathy [NAION])

• If certain serious eye problems run in your family (such as retinitis pigmentosa).
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Do not take Spedra if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Spedra.

Warnings and precautions

Talk to your doctor or pharmacist before taking Spedra:

• If you have heart trouble. It may be risky for you to have sexual intercourse
• If you suffer from priapism, that is a persistent erection lasting 4 hours or more. This can

happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.

• If you have a physical condition that affects the shape of your penis (such as angulation, Peyronie’s disease or cavernosal fibrosis)
• If you have any bleeding disorder or active peptic ulceration.

If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Problems with your sight or hearing

Some men taking medicines like Spedra have had problems with their sight and hearing – see “Serious side effects” in section 4 for more details. It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors.

Children and adolescents

Spedra should not be taken by children and adolescents under 18 years of age.

Other medicines and Spedra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Spedra can affect the way some other medicines work. Also some other medicines can affect the way Spedra works.

In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate. Spedra has been shown to increase the effects of these medicines and severely lower your blood pressure. Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra’).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• so called “alpha-blockers” – for prostate problems or for lowering your high blood pressure
• medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide,

amiodarone or sotalol

• antibiotics for infections such as erythromycin
• phenobarbital or primidone – for epilepsy
• carbamazepine – for epilepsy, to stabilise your mood or for certain types of pain
• other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4

inhibitors’) including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.

• riociguat

Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil.

If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Spedra with drink and alcohol

Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra.

Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure. You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations). Drinking alcohol may also decrease your ability to get an erection.

Fertility

There was no effect on sperm movement or structure after single 200 mg oral doses of avanafil in healthy volunteers.

The repeated oral administration of avanafil 100 mg over a period of 26 weeks to healthy volunteers and adult males with mild erectile dysfunction was not associated with any untoward effects on sperm concentration, count, motility, or morphology.

Driving and using machines

Spedra can make you feel dizzy or affect your vision. If this happens, do not drive, cycle, use tools or machines.

3. How to take Spedra

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is a 100 mg tablet, as needed. You should not take Spedra more than once a day. You could have been given the dose of one 200 mg tablet if your doctor has decided that the 100 mg dose was too weak for you, or the dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet was too strong for you.

Dose adjustments can also be required if Spedra is used together with certain other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil (‘moderate CYP3A4 inhibitors’) the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.

You should take Spedra approximately 15 to 30 minutes before you have sexual intercourse. Remember that Spedra will only help you to get an erection if you are sexually stimulated. Spedra can be taken with or without food; if taken with food, it may take longer to work.

If you take more Spedra than you should

If you take too much Spedra, you should tell your doctor straight away. You may get more side effects than usual and they may be worse.

If you have any further questions on the use of Spedra, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

• an erection that will not go away (“priapism”). If you get an erection that lasts more than

4 hours, this must be treated as soon as possible or lasting damage can happen to your penis (including not being able to get erections).

• blurred vision.
• sudden decrease or loss of vision in one or both eyes.
• sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your

ears).

Stop taking Spedra and see a doctor straight away, if you notice any of the serious side effects above.

Other side effects include:

Common (may affect up to 1 in 10 people)

• headache
• flushing
• nasal congestion

Uncommon (may affect up to 1 in 100 people)

• feeling dizzy
• feeling sleepy or very tired
• sinus congestion
• back pain
• hot flush
• feeling out of breath when you exert yourself
• heartbeat changes seen on a heart tracing (ECG)
• increased heart beat
• feeling your heartbeat in your chest (palpitations)
• indigestion, feeling or being sick to your stomach
• blurry vision
• raised liver enzymes

Rare (may affect up to 1 in 1,000 people)

• influenza
• influenza-like illness
• stuffy or runny nose
• hayfever
• congestion in the nose, sinuses or upper part of the airway bringing air into the lungs
• gout
• trouble sleeping (insomnia)
• premature ejaculation
• feeling strange
• feeling unable to keep still
• chest pain
• serious chest pain
• fast heart beat
• high blood pressure
• dry mouth
• stomach ache or heartburn
• pain or discomfort in the lower abdomen
• diarrhoea
• rash
• pain in the lower back or side of lower chest
• muscle aches or pains
• muscle spasms
• frequent urination
• penile disorder
• spontaneous erection without sexual stimulation
• itching in the genital area
• feeling weak or tired all the time
• swelling in the feet or ankles
• increased blood pressure
• pink or red urine, blood in the urine
• abnormal extra sound from the heart
• an abnormal blood test result for a prostate test called ‘PSA’
• an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of

red blood cells

• an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function
• weight gain
• fever
• nosebleed

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Spedra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage condition.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Spedra contains

• The active substance is avanafil. Each tablet contains 200 mg of avanafil.
• The other ingredients are mannitol, fumaric acid, hydroxypropyl­cellulose, hydroxypropyl­cellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).

What Spedra looks like and contents of the pack

Spedra is a pale yellow oval tablet, marked “50”on one side. The tablets are provided in perforated

unit dose blister packs containing 4×1, 8×1, or 12×1 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder :

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.,

1, Avenue de la Gare,

L-1611 Luxembourg, Luxembourg.

Manufacturer :

Menarini – Von Heyden GmbH

Leipziger Straße 7–13

01097 Dresden

Germany or

Sanofi Winthrop Industrie

1, rue de la Vierge Ambares et Lagrave

33565 Carbon-Blanc-Cedex

France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

België/Belgiqu­e/Belgien

Menarini Benelux NV/SA

Tél/Tel: + 32 (0)2 721 4545

Btarapuu

EepauH-XeMu/A. MeHapuHu Etarapua EOOfl mea.: +359 2 454 0950

Česká republika

Berlin-Chemie/A.Menarini Ceska republika

s.r.o.

Tel: +420 267 199 333

Danmark Pharmaprim AB Tlf: +46 8355933	Malta Menarini International Operations Luxembourg S.A. Tel: +352 264976
Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67070	Nederland Menarini Benelux NV/SA Tel: +32 (0)2 721 4545
Eesti OÜ Berlin-Chemie Menarini Eesti Tel: +372 667 5001	Norge Pharmaprim AB Tlf: +46 8355933
EMáSa MENARINI HELLAS AE Tql: +30 210 8316111–13	Österreich A. Menarini Pharma GmbH Tel: +43 1 879 95 85–0
España Laboratorios Menarini S.A. Tel: +34–93 462 88 00	Polska Berlin-Chemie/Menarini Polska Sp. z o.o. Tel.: +48 22 566 21 00
France MENARINI France Tél: +33 (0)1 45 60 77 20	Portugal A. Menarini Portugal – Farmacéutica, S.A. Tel: +351 210 935 500
Hrvatska Berlin-Chemie Menarini Hrvatska d.o.o. Tel: + 385 1 4821 361	Romania Berlin-Chemie A. Menarini S.R.L. Tel: +40 21 232 34 32
Ireland A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744	Slovenija Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2160
Ísland Pharmaprim AB Sími: +46 8355933	Slovenská republika Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o.Tel: +421 2 544 30 730
Italia A. Menarini Industrie Farmaceutiche Riunite s.r.l. Tel: +39–055 56801	Suomi/Finland Berlin-Chemie/A.Menarini Suomi OY Puh/Tel: +358 403 000 760

Kùnpoç MENARINI HELLAS AE Tql: +30 210 8316111–13	Sverige Pharmaprim AB Tel: +46 8355933
Latvija SIA Berlin-Chemie/Menarini Baltic Tel: +371 67103210	United Kingdom (Northern Ireland) A. Menarini Farmaceutica Internazionale S.R.L. Tel: +44 (0)1628 856400

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient Spedra 100 mg tablets

avanafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Spedra is and what it is used for

• 2. What you need to know before you take Spedra

• 3. How to take Spedra

• 4. Possible side effects

• 5. How to store Spedra

• 6. Contents of the pack and other information

1. What Spedra is and what it is used for

Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence). This is when you cannot get, or keep a hard, erect penis suitable for sexual activity.

Spedra works by helping the blood vessels in your penis to relax. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Spedra does not cure your condition.

It is important to note that Spedra only works if you are sexually stimulated. You and your partner will still need to use foreplay to get ready for sex – just as you would if you were not taking a medicine to help you.

Spedra will not help you if you do not have erectile dysfunction. Spedra is not for women.

2. What you need to know before you take Spedra

Do not take Spedra:

• If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
• If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl

trinitrate. Spedra can increase the effects of these medicines and severely lower your blood pressure

• If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
• If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
• If you have a serious cardiac problem
• If you have had a stroke or heart attack in the last 6 months
• If you have low blood pressure or high blood pressure not controlled by medicines
• If you have chest pain (angina) or you get chest pain during sexual intercourse
• If you have a serious liver or kidney problem
• If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic

ischemic optic neuropathy [NAION])

• If certain serious eye problems run in your family (such as retinitis pigmentosa).
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Do not take Spedra if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Spedra.

Warnings and precautions

Talk to your doctor or pharmacist before taking Spedra:

• If you have heart trouble. It may be risky for you to have sexual intercourse
• If you suffer from priapism, that is a persistent erection lasting 4 hours or more. This can

happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.

• If you have a physical condition that affects the shape of your penis (such as angulation, Peyronie’s disease or cavernosal fibrosis)
• If you have any bleeding disorder or active peptic ulceration.

If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Problems with your sight or hearing

Some men taking medicines like Spedra have had problems with their sight and hearing – see “Serious side effects” in section 4 for more details. It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors.

Children and adolescents

Spedra should not be taken by children and adolescents under 18 years of age.

Other medicines and Spedra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Spedra can affect the way some other medicines work. Also some other medicines can affect the way Spedra works.

In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate. Spedra has been shown to increase the effects of these medicines and severely lower your blood pressure. Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra’).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• so called “alpha-blockers” – for prostate problems or for lowering your high blood pressure
• medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide,

amiodarone or sotalol

• antibiotics for infections such as erythromycin
• phenobarbital or primidone – for epilepsy
• carbamazepine – for epilepsy, to stabilise your mood or for certain types of pain
• other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4

inhibitors’) including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.

• riociguat

Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil.

If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Spedra with drink and alcohol

Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra.

Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure. You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations). Drinking alcohol may also decrease your ability to get an erection.

Fertility

There was no effect on sperm movement or structure after single 200 mg oral doses of avanafil in healthy volunteers.

The repeated oral administration of avanafil 100 mg over a period of 26 weeks to healthy volunteers and adult males with mild erectile dysfunction was not associated with any untoward effects on sperm concentration, count, motility, or morphology.

Driving and using machines

Spedra can make you feel dizzy or affect your vision. If this happens, do not drive, cycle, use tools or machines.

3. How to take Spedra

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is a 100 mg tablet, as needed. You should not take Spedra more than once a day. You could have been given the dose of one 200 mg tablet if your doctor has decided that the 100 mg dose was too weak for you, or the dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet was too strong for you. Dose adjustments can also be required if Spedra is used together with certain other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil (‘moderate CYP3A4 inhibitors’) the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.

You should take Spedra approximately 15 to 30 minutes before you have sexual intercourse. Remember that Spedra will only help you to get an erection if you are sexually stimulated. Spedra can be taken with or without food; if taken with food, it may take longer to work.

If you take more Spedra than you should

If you take too much Spedra, you should tell your doctor straight away. You may get more side effects than usual and they may be worse.

If you have any further questions on the use of Spedra, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

• an erection that will not go away (“priapism”). If you get an erection that lasts more than

4 hours, this must be treated as soon as possible or lasting damage can happen to your penis (including not being able to get erections).

• blurred vision.
• sudden decrease or loss of vision in one or both eyes.
• sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your

ears).

Stop taking Spedra and see a doctor straight away, if you notice any of the serious side effects above.

Other side effects include:

Common (may affect up to 1 in 10 people)

• headache
• flushing
• nasal congestion

Uncommon (may affect up to 1 in 100 people)

• feeling dizzy
• feeling sleepy or very tired
• sinus congestion
• back pain
• hot flush
• feeling out of breath when you exert yourself
• heartbeat changes seen on a heart tracing (ECG)
• increased heart beat
• feeling your heartbeat in your chest (palpitations)
• indigestion, feeling or being sick to your stomach
• blurry vision
• raised liver enzymes

Rare (may affect up to 1 in 1,000 people)

• influenza
• influenza-like illness
• stuffy or runny nose
• hayfever
• congestion in the nose, sinuses or upper part of the airway bringing air into the lungs
• gout
• trouble sleeping (insomnia)
• premature ejaculation
• feeling strange
• feeling unable to keep still
• chest pain
• serious chest pain
• fast heart beat
• high blood pressure
• dry mouth
• stomach ache or heartburn
• pain or discomfort in the lower abdomen
• diarrhoea
• rash
• pain in the lower back or side of lower chest
• muscle aches or pains
• muscle spasms
• frequent urination
• penile disorder
• spontaneous erection without sexual stimulation
• itching in the genital area
• feeling weak or tired all the time
• swelling in the feet or ankles
• increased blood pressure
• pink or red urine, blood in the urine
• abnormal extra sound from the heart
• an abnormal blood test result for a prostate test called ‘PSA’
• an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of

red blood cells

• an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function
• weight gain
• fever
• nosebleed

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Spedra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.

The expiry date refers to the last day of that month.

This medicine does not require any special storage condition.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Spedra contains

• The active substance is avanafil. Each tablet contains 100 mg of avanafil.
• The other ingredients are mannitol, fumaric acid, hydroxypropyl­cellulose, hydroxypropyl­cellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).

What Spedra looks like and contents of the pack

Spedra is a pale yellow oval tablet, marked “100” on one side. The tablets are provided in perforated unit dose blister packs containing 2×1, 4×1, 8×1, or 12×1 tablets.

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder:

MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.,

1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg

Manufacturer:

Menarini – Von Heyden GmbH

Leipziger Straße 7–13

01097 Dresden

Germany

or

Sanofi Winthrop Industrie

1, rue de la Vierge

Ambares et Lagrave

33565 Carbon-Blanc-Cedex

France

For any information about this medicine l product, please contact the local representative of the Marketing Authorisation Holder.

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This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

Package leaflet: Information for the patient

Spedra 200 mg tablets

avanafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Spedra is and what it is used for

• 2. What you need to know before you take Spedra

• 3. How to take Spedra

• 4. Possible side effects

• 5. How to store Spedra

• 6. Contents of the pack and other information

1. What Spedra is and what it is used for

Spedra contains the active substance avanafil. It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors. Spedra is a treatment for adult men suffering from erectile dysfunction (also known as impotence). This is when you cannot get, or keep a hard, erect penis suitable for sexual activity.

Spedra works by helping the blood vessels in your penis to relax. This increases the blood flow into your penis, helping it stay hard and erect when you get sexually excited. Spedra does not cure your condition.

It is important to note that Spedra only works if you are sexually stimulated. You and your partner will still need to use foreplay to get ready for sex – just as you would if you were not taking a medicine to help you.

Spedra will not help you if you do not have erectile dysfunction. Spedra is not for women.

2. What you need to know before you take Spedra

Do not take Spedra:

• If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
• If you are taking “nitrate” medicines for chest pain (angina), such as amyl nitrite or glyceryl

trinitrate. Spedra can increase the effects of these medicines and severely lower your blood pressure

• If you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir
• If you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin
• If you have a serious cardiac problem
• If you have had a stroke or heart attack in the last 6 months
• If you have low blood pressure or high blood pressure not controlled by medicines
• If you have chest pain (angina) or you get chest pain during sexual intercourse
• If you have a serious liver or kidney problem
• If you have loss of vision in one eye due to not enough blood getting to your eye (non-arteritic

ischemic optic neuropathy [NAION])

• If certain serious eye problems run in your family (such as retinitis pigmentosa).
• If you are taking riociguat. This medicine is used to treat pulmonary arterial hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs secondary to blood clots). PDE5 inhibitors have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Do not take Spedra if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Spedra.

Warnings and precautions

Talk to your doctor or pharmacist before taking Spedra:

• If you have heart trouble. It may be risky for you to have sexual intercourse
• If you suffer from priapism, that is a persistent erection lasting 4 hours or more. This can

happen in men with conditions like sickle cell disease, multiple myeloma or leukaemia.

• If you have a physical condition that affects the shape of your penis (such as angulation, Peyronie’s disease or cavernosal fibrosis)
• If you have any bleeding disorder or active peptic ulceration.

If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Problems with your sight or hearing

Some men taking medicines like Spedra have had problems with their sight and hearing – see “Serious side effects” in section 4 for more details. It is not known if these problems are related directly to Spedra, other diseases that you may have or a combination of factors.

Children and adolescents

Spedra should not be taken by children and adolescents under 18 years of age.

Other medicines and Spedra

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Spedra can affect the way some other medicines work. Also some other medicines can affect the way Spedra works.

In particular, tell your doctor and do not take Spedra if you are taking “nitrate” medicines for chest pain (angina) such as amyl nitrite or glyceryl trinitrate. Spedra has been shown to increase the effects of these medicines and severely lower your blood pressure. Also do not take Spedra if you are taking medicines for HIV or AIDS such as ritonavir, indinavir, saquinavir, nelfinavir or atazanavir or if you are taking medicines for fungal infections such as ketoconazole, itraconazole or voriconazole or certain antibiotics for bacterial infections, such as clarithromycin or telithromycin (see beginning of section 2 under ‘Do not take Spedra’).

Tell your doctor or pharmacist if you are taking any of the following medicines:

• so called “alpha-blockers” – for prostate problems or for lowering your high blood pressure
• medicines for an irregular heartbeat (“arrhythmia”) such as quinidine, procainamide,

amiodarone or sotalol

• antibiotics for infections such as erythromycin
• phenobarbital or primidone – for epilepsy
• carbamazepine – for epilepsy, to stabilise your mood or for certain types of pain
• other medicines that may reduce the breakdown of Spedra in the body (‘moderate CYP3A4

inhibitors’) including amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir, and verapamil.

• riociguat

Do not use Spedra together with other treatments for erectile dysfunction such as sildenafil, tadalafil or vardenafil.

If any of the above apply to you talk to your doctor or pharmacist before taking Spedra. Check with your doctor or pharmacist if you are not sure.

Spedra with drink and alcohol

Grapefruit juice can increase exposure to the medicine and should be avoided within 24 hours prior to taking Spedra.

Drinking alcohol at the same time as taking Spedra may increase your heart rate and lower your blood pressure. You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations). Drinking alcohol may also decrease your ability to get an erection.

Fertility

There was no effect on sperm movement or structure after single 200 mg oral doses of avanafil in healthy volunteers.

The repeated oral administration of avanafil 100 mg over a period of 26 weeks to healthy volunteers and adult males with mild erectile dysfunction was not associated with any untoward effects on sperm concentration, count, motility, or morphology.

Driving and using machines

Spedra can make you feel dizzy or affect your vision. If this happens, do not drive, cycle, use tools or machines.

3. How to take Spedra

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is a 100 mg tablet, as needed. You should not take Spedra more than once a day. You could have been given the dose of one 200 mg tablet if your doctor has decided that the 100 mg dose was too weak for you, or the dose of one 50 mg tablet if your doctor has decided that the 100 mg tablet was too strong for you.

Dose adjustments can also be required if Spedra is used together with certain other medicines. If you are taking a medicine such as erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir or verapamil (‘moderate CYP3A4 inhibitors’) the recommended dose of Spedra is a 100 mg tablet, with an interval of at least 2 days between doses.

You should take Spedra approximately 15 to 30 minutes before you have sexual intercourse. Remember that Spedra will only help you to get an erection if you are sexually stimulated. Spedra can be taken with or without food; if taken with food, it may take longer to work.

If you take more Spedra than you should

If you take too much Spedra, you should tell your doctor straight away. You may get more side effects than usual and they may be worse.

If you have any further questions on the use of Spedra, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

Stop taking Spedra and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

• an erection that will not go away (“priapism”). If you get an erection that lasts more than

4 hours, this must be treated as soon as possible or lasting damage can happen to your penis (including not being able to get erections).

• blurred vision.
• sudden decrease or loss of vision in one or both eyes.
• sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your

ears).

Stop taking Spedra and see a doctor straight away, if you notice any of the serious side effects above.

Other side effects include:

Common (may affect up to 1 in 10 people)

• headache
• flushing
• nasal congestion

Uncommon (may affect up to 1 in 100 people)

• feeling dizzy
• feeling sleepy or very tired
• sinus congestion
• back pain
• hot flush
• feeling out of breath when you exert yourself
• heartbeat changes seen on a heart tracing (ECG)
• increased heart beat
• feeling your heartbeat in your chest (palpitations)
• indigestion, feeling or being sick to your stomach
• blurry vision
• raised liver enzymes

Rare (may affect up to 1 in 1,000 people)

• influenza
• influenza-like illness
• stuffy or runny nose
• hayfever
• congestion in the nose, sinuses or upper part of the airway bringing air into the lungs
• gout
• trouble sleeping (insomnia)
• premature ejaculation
• feeling strange
• feeling unable to keep still
• chest pain
• serious chest pain
• fast heart beat
• high blood pressure
• dry mouth
• stomach ache or heartburn
• pain or discomfort in the lower abdomen
• diarrhoea
• rash
• pain in the lower back or side of lower chest
• muscle aches or pains
• muscle spasms
• frequent urination
• penile disorder
• spontaneous erection without sexual stimulation
• itching in the genital area
• feeling weak or tired all the time
• swelling in the feet or ankles
• increased blood pressure
• pink or red urine, blood in the urine
• abnormal extra sound from the heart
• an abnormal blood test result for a prostate test called ‘PSA’
• an abnormal blood test result for bilirubin, a chemical produced from the normal breakdown of

red blood cells

• an abnormal blood test result for creatinine, a chemical excreted in the urine, and a measure of kidney function
• weight gain
• fever
• nosebleed

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Spedra

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiry date refers to the last day of that month.

This medicine does not require any special storage condition.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Spedra contains

• The active substance is avanafil. Each tablet contains 200 mg of avanafil.
• The other ingredients are mannitol, fumaric acid, hydroxypropyl­cellulose, hydroxypropyl­cellulose low substituted, calcium carbonate, magnesium stearate and ferric oxide yellow (E172).