Talmanco (previously Tadalafil Generics) - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Talmanco 20 mg film-coated tablets tadalafil

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 Talmanco is and what it is used for

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

• 3. How to take Talmanco

• 4. Possible side effects

• 5. How to store Talmanco

• 6. Contents of the pack and other information

1. What Talmanco is and what it is used for

Talmanco contains the active substance tadalafil.

Talmanco is a treatment for pulmonary arterial hypertension in adults.

It belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity.

2. What you need to know before you take Talmanco

Do not take Talmanco:

• – if you are allergic to tadalafil or any of the other ingredients of this medicine (listed in

section 6).

• – if you are taking any form of nitrates such as amyl nitrite, used in the treatment of chest pain.

Tadalafil has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.

• – if you have ever had loss of vision – a condition described as “stroke of the eye” (non-arteritic

anterior ischemic optic neuropathy – NAION)

• – if you have had a heart attack in the last 3 months

• – if you have low blood pressure

• – 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, such as Talmanco, have been shown to increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine if you have:

• – any heart problems other than your pulmonary hypertension

• – problems with your blood pressure

• – any hereditary eye disease

• – an abnormality of red blood cells (sickle cell anaemia)

• – cancer of the bone marrow (multiple myeloma)

• – cancer of the blood cells (leukaemia)

• – any deformation of your penis, or unwanted or persistent erections lasting more than 4 hours

• – a serious liver problem

• – a serious kidney problem

If you experience sudden decrease or loss of vision, contact your doctor immediately.

Decreased or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, contact your doctor immediately.

Children and adolescents

This medicine is not indicated for use by children and adolescents under the age of 18.

Other medicines and Talmanco

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do NOT take these tablets if you are already taking nitrates.

Some medicines may be affected by Talmanco or they may affect how well Talmanco will work. Tell your doctor or pharmacist if you are already taking:

• – bosentan (another treatment for pulmonary arterial hypertension)

• – nitrates (for chest pain)

• – alpha blockers used to treat high blood pressure or prostate problems

• – riociguat

• – rifampicin (to treat bacterial infections)

• – ketoconazole tablets (to treat fungal infections)

• – ritonavir (for HIV treatment)

• – tablets for erectile dysfunction (PDE5 inhibitors)

Talmanco with alcohol

Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Talmanco, avoid excessive drinking (over 5 units of alcohol), since this may increase the risk of dizziness when standing up.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Do not take this medicine when pregnant, unless it is strictly necessary and you have discussed this with your doctor.

Do not breast-feed while taking these tablets as it is not known if the medicine passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine while pregnant or breast-feeding.

When dogs were treated there was reduced sperm development in the testes. A reduction in sperm was seen in some men. These effects are unlikely to lead to a lack of fertility.

Driving and using machines

Dizziness has been reported. Check carefully how you react to the medicines before driving or using any machinery.

Talmanco contains lactose and sodium

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. How to take Talmanco

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

Talmanco is supplied as a 20 mg tablet. The usual dose is two 20 mg tablets taken once a day. You should take both tablets at the same time, one after the other. If you have a mild or moderate liver or kidney problem, your doctor may advise you to take only one 20 mg tablet per day.

Swallow the tablets whole with a drink of water. The tablets can be taken with or without food.

If you take more Talmanco than you should

If you or anyone else takes more tablets than they should, tell your doctor or go to a hospital immediately, taking the medicine or pack with you. You may experience any of the side effects described in section 4.

If you forget to take Talmanco

Take your dose as soon as you remember if it is within 8 hours of when you should have taken your dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Talmanco

Do not stop taking your tablets, unless advised otherwise by your doctor.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.

If you experience any of the following side effects stop using the medicine and seek medical help immediately:

Common (may affect up to 1 in 10 people)

• – allergic reactions including skin rashes.

• – chest pain – do not use nitrates, but seek immediate medical assistance.

Uncommon (may affect up to 1 in 100 people)

• – priapism, a prolonged and possibly painful erection after taking this medicine. If you have such

an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.

Rare (may affect up to 1 in 1,000 people) – sudden loss of vision.

Other side effects have been reported:

Very Common (may affect more than 1 in 10 people)

• – headache.

• – flushing, nasal and sinus congestion (blocked nose).

• – nausea, indigestion (including abdominal pain or discomfort).

• – muscle aches, back pain and pain in the extremity (including limb discomfort).

Common (may affect up to 1 in 10 people)

• – blurred vision.

• – low blood pressure.

• – nosebleed.

• – vomiting.

• – increased or abnormal uterine bleeding.

• – swelling of the face.

• – acid reflux.

• – migraine.

• – irregular heartbeat.

• – fainting.

Uncommon (may affect up to 1 in 100 people)

• – seizures.

• – passing memory loss.

• – hives.

• – excessive sweating.

• – penile bleeding.

• – presence of blood in semen and/or urine.

• – high blood pressure.

• – fast heart rate.

• – sudden cardiac death.

• – ringing in the ears.

PDE5 inhibitors are also used for the treatment of erectile dysfunction in men. Some side effects have been rarely (may affect up to 1 in 1,000 people) reported:

• – Partial, temporary or permanent decrease or loss of vision in one or both eyes and serious

allergic reaction which causes swelling of the face or throat. Sudden decrease or loss of hearing has also been reported.

Some side effects have been reported in men taking tadalafil for the treatment of erectile dysfunction. These events were not seen in clinical studies for pulmonary arterial hypertension and therefore frequency is not known (frequency cannot be estimated from the available data):

• – swelling of the eyelids, eye pain, red eyes, heart attack and stroke.

Most but not all of those men reporting fast heart rate, irregular heartbeat, heart attack, stroke and sudden cardiac death had known heart problems before taking tadalafil. It is not possible to determine whether these events were related directly to tadalafil.

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. You 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 Talmanco

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 carton and blister after “EXP”.

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

This medicine does not require any special storage conditions.

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 Talmanco contains

• – The active substance is tadalafil. Each tablet contains 20 mg of tadalafil.

• – The other ingredients in the tablet core are povidone, sodium laurilsulfate, poloxamer 188,

What Talmanco looks like and contents of the pack

This medicine is a white, film-coated, round, biconvex, bevelled edge tablet marked with ‘M’ on one side of the tablet and ‘TA20’ on the other side.

This medicine is available in blister packs containing 28 or 56 tablets and in perforated unit dose blister packs containing 28 × 1 or 56 × 1 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Viatris Limited

Damastown Industrial Park,

Mulhuddart, Dublin 15,

DUBLIN

Ireland

Manufacturers

McDermott Laboratories Limited t/a Gerard Laboratories t/a Mylan Dublin

35/36 Baldoyle Industrial Estate

Grange Road, Dublin 13

Ireland

Mylan Hungary Kft

Mylan utca 1

Komarom, 2900

Hungary

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352,

Germany

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

Belgie/Belgiqu­e/Belgien Mylan bvba/sprl Tél/Tel: +32( 0)2 658 61 00	Lietuva Mylan Healthcare UAB Tel: +370 5 205 1288
Etnrapua Maw.iaH EOO4 Ten.: +359 2 44 55400	Luxembourg/Lu­xemburg Mylan bvba/sprl Tel: +32 (0)2 658 61 00 (Belgique/Belgien)
Česká republika Mylan Healthcare CZ s.r.o. Tel: +420 222 004 400	Magyarország Mylan EPD Kft Tel: +36 1 465 2100
Danmark Viatris ApS Tlf: +45 28 11 69 32	Malta V.J. Salomone Pharma Ltd Tel: +356 21 22 01 74
Deutschland Mylan Healthcare GmbH Tel: +49 800 0700 800	Nederland Mylan BV Tel: +31 (0)20 426 3300
Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: +372 6363 052	Norge Mylan Healthcare Norge AS Tel: +47 66 75 33 00
EZZáSa Generics Pharma Hellas EnE Tql: +30 210 993 6410	Österreich Arcana Arzneimittel GmbH Tel: +43 1 416 2418
España Mylan Pharmaceuticals, S.L Tel: +34 900 102 712	Polska Mylan Healthcare Sp. z.o.o. Tel: +48 22 546 64 00
France Substipharm Tél: +33 1 43181300	Portugal Mylan, Lda. Tel: +351 21 412 72 56
Hrvatska Mylan Hrvatska d.o.o. Tel: +385 1 23 50 599	Romania BGP Products SRL Tel: +40 372 579 000
Ireland Mylan Ireland Limited Tel: +353 1 8711600	Slovenija Mylan Healthcare d.o.o. Tel: +386 1 236 31 80
Ísland Icepharma hf Símí: +354 540 8000	Slovenská republika Mylan s.r.o. Tel: +421 2 32 199 100
Italia Mylan Italia S.r.l Tel: +39 02 612 46921	Suomi/Finland Mylan Finland OY Puh/Tel: +358 20 720 9555

Kùnpoç

Varnavas Hadjipanayis Ltd

Tql: +357 222 077 00

United Kingdom (Northern Ireland)

Mylan IRE Healthcare Limited

Tel: +353 18711600

This leaflet was last revised in {MM/YYYY}.

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

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