Patient leaflet - CIALIS 20 MG FILM-COATED TABLETS, TADALAFIL 20 MG FILM-COATED TABLETS
Cialis® 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.
-
– The name of your medicine is Cialis 20 mg film-coated tablets but it will be referred to as Cialis throughout the remainder of this leaflet.
What is in this leaflet:
-
1. What Cialis is and what it is used for
-
2. What you need to know before you take Cialis
-
3. How to take Cialis
-
4. Possible side effects
-
5. How to store Cialis
-
6. Contents of the pack and other information
1. what cialis is and what it is used for
Cialis is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Cialis has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Cialis contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Cialis works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Cialis will not help you if you do not have erectile dysfunction.
It is important to note that Cialis does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
2. what you need to know before you take cialisdo not take cialis if you:- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
-
– are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“chest pain”). Cialis has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure tell your doctor.
-
– have serious heart disease or recently had a heart attack within the last 90 days.
-
– recently had a stroke within the last 6 months.
-
– have low blood pressure or uncontrolled high blood pressure.
-
– ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
-
– are taking riociguat. This drug 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 Cialis, 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 before taking Cialis.
Before taking the tablets, tell your doctor if you have:
-
– sickle cell anaemia (an abnormality of red blood cells).
-
– multiple myeloma (cancer of the bone marrow).
-
– leukaemia (cancer of the blood cells).
-
– any deformation of your penis.
-
– a serious liver problem.
-
– a severe kidney problem.
It is not known if Cialis is effective in patients who have had:
-
– pelvic surgery.
-
– removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve-sparing prostatectomy).
If you experience sudden decrease or loss of vision, stop taking Cialis and 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, stop taking Cialis and contact your doctor immediately.
Cialis is not intended for use by women.
Children and adolescents
Cialis is not intended for use by children and adolescents under the age of 18.
Other medicines and Cialis
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Cialis if you are already taking nitrates.
Some medicines may be affected by Cialis or they may affect how well Cialis will work. Tell your doctor or pharmacist if you are already taking:
-
– an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
-
– other medicines to treat high blood pressure.
-
– riociguat.
-
– a 5– alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
-
– medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
-
– phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
-
– rifampicin, erythromycin, clarithromycin or itraconazole.
-
– other treatments for erectile dysfunction.
Cialis with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Cialis will work and should be taken with caution. Talk to your doctor for further information.
Fertility
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
Some men taking Cialis in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.
Cialis contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Cialis contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.
3. how to take cialis
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Cialis tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.
The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is too weak.
You may take a Cialis tablet at least 30 minutes before sexual activity. Cialis may still be effective up to 36 hours after taking the tablet.
Do not take Cialis more than once a day. Cialis 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Cialis does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Cialis, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.
If you take more Cialis than you should
Contact your doctor. You may experience side effects described in section 4.
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:
-
– allergic reactions including rashes (frequency uncommon).
-
– chest pain – do not use nitrates but seek immediate medical assistance (frequency uncommon).
-
– priapism, a prolonged and possibly painful erection after taking Cialis (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
-
– sudden loss of vision (frequency rare).
Other side effects have been reported:
Common (seen in 1 to 10 in every 100 patients)
-
– headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
Uncommon (seen in 1 to 10 in every 1,000 patients)
-
– dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Rare (seen in 1 to 10 in every 10,000 patients)
-
– fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.
Heart attack and stroke have also been reported rarely in men taking Cialis. Most of these men had known heart problems before taking this medicine.
Some additional rare side effects have been reported in men taking Cialis that were not seen in clinical trials. These include:
-
– migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
The side effect dizziness has been reported more frequently in men over 75 years of age taking Cialis. Diarrhoea has been reported more frequently in men over 65 years of age taking Cialis.
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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store cialis keep out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the blister and on the carton after ‘exp’. the expiry date refers to the last day of that month.
- Store in the original package in order to protect from moisture.
- Do not store above 30°C.
- If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other informationwhat cialis containsthe active substance is tadalafil. each tablet contains 20 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see section 2 “Cialis contains lactose”. Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
What Cialis looks like and contents of the pack
Cialis 20 mg tablets are yellow, film-coated tablets in the shape of an almond and has “C 20” marked on one side and plain on the reverse.
Cialis is available in blister packs containing 4, 8 or 12 tablets.
Manufactured by
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PLGB: 33532/1376
POM
Leaflet dated 23rd February 2022
Leaflet coded xxxxxxxxxxxxxx
Cialis® is a registered trademark of Eli Lilly and Company.
To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.
Tadalafil 20 mg film-coated tablets
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.
-
– The name of your medicine is Tadalafil 20 mg film-coated tablets but it will be referred to as Tadalafil throughout the remainder of this leaflet.
What is in this leaflet:
-
1. What Tadalafil is and what it is used for
-
2. What you need to know before you take Tadalafil
-
3. How to take Tadalafil
-
4. Possible side effects
-
5. How to store Tadalafil
-
6. Contents of the pack and other information
1. what tadalafil is and what it is used for
Tadalafil is a treatment for adult men with erectile dysfunction. This is when a man cannot get, or keep a hard, erect penis suitable for sexual activity. Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Tadalafil contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil works by helping the blood vessels in your penis to relax, allowing the flow of blood into your penis. The result of this is improved erectile function. Tadalafil will not help you if you do not have erectile dysfunction.
It is important to note that Tadalafil does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
2. what you need to know before you take tadalafildo not take tadalafil if you:- are allergic to tadalafil or any of the other ingredients of this medicine (listed in section 6).
-
– are taking any form of organic nitrate or nitric oxide donors such as amyl nitrite. This is a group of medicines (“nitrates”) used in the treatment of angina pectoris (“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.
-
– have serious heart disease or recently had a heart attack within the last 90 days.
-
– recently had a stroke within the last 6 months.
-
– have low blood pressure or uncontrolled high blood pressure.
-
– ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
-
– are taking riociguat. This drug 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 Tadalafil, 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 before taking Tadalafil.
Be aware that sexual activity carries a possible risk to patients with heart disease because it puts an extra strain on your heart. If you have a heart problem you should tell your doctor.
Before taking the tablets, tell your doctor if you have:
-
– sickle cell anaemia (an abnormality of red blood cells).
-
– multiple myeloma (cancer of the bone marrow).
-
– leukaemia (cancer of the blood cells).
-
– any deformation of your penis.
-
– a serious liver problem.
-
– a severe kidney problem.
It is not known if Tadalafil is effective in patients who have had:
-
– pelvic surgery.
-
– removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non-nerve-sparing prostatectomy).
If you experience sudden decrease or loss of vision, stop taking Tadalafil and 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, stop taking Tadalafil and contact your doctor immediately.
Tadalafil is not intended for use by women.
Children and adolescents
Tadalafil is not intended for use by children and adolescents under the age of 18.
Other medicines and Tadalafil
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Do not take Tadalafil if you are already taking nitrates.
Some medicines may be affected by Tadalafil or they may affect how well Tadalafil will work. Tell your doctor or pharmacist if you are already taking:
-
– an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
-
– other medicines to treat high blood pressure.
-
– riociguat.
-
– a 5– alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
-
– medicines such as ketoconazole tablets (to treat fungal infections) and protease inhibitors for treatment of AIDS or HIV infection.
-
– phenobarbital, phenytoin and carbamazepine (anticonvulsant medicines).
-
– rifampicin, erythromycin, clarithromycin or itraconazole.
-
– other treatments for erectile dysfunction.
Tadalafil with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil will work and should be taken with caution. Talk to your doctor for further information.
Fertility
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
Some men taking Tadalafil in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.
Tadalafil contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Tadalafil contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. how to take tadalafil
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tadalafil tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.
The recommended starting dose is one 10 mg tablet before sexual activity. However, you have been given the dose of one 20 mg tablet as your doctor has decided that the recommended dose of 10 mg is too weak.
You may take a Tadalafil tablet at least 30 minutes before sexual activity. Tadalafil may still be effective up to 36 hours after taking the tablet.
Do not take Tadalafil more than once a day. Tadalafil 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil does not work if there is no sexual stimulation. You and your partner will need to engage in foreplay, just as you would if you were not taking a medicine for erectile dysfunction.
Drinking alcohol may affect your ability to get an erection and may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.
If you take more Tadalafil than you should
Contact your doctor. You may experience side effects described in section 4.
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:
-
– allergic reactions including rashes (frequency uncommon).
-
– chest pain – do not use nitrates but seek immediate medical assistance (frequency uncommon).
-
– priapism, a prolonged and possibly painful erection after taking Tadalafil (frequency rare). If you have such an erection, which lasts continuously for more than 4 hours you should contact a doctor immediately.
-
– sudden loss of vision (frequency rare).
Other side effects have been reported:
Common (seen in 1 to 10 in every 100 patients)
-
– headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
Uncommon (seen in 1 to 10 in every 1,000 patients)
-
– dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Rare (seen in 1 to 10 in every 10,000 patients)
-
– fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing, hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in semen and increased sweating.
Heart attack and stroke have also been reported rarely in men taking Tadalafil. Most of these men had known heart problems before taking this medicine.
Some additional rare side effects have been reported in men taking Tadalafil that were not seen in clinical trials. These include:
-
– migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat, serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
The side effect dizziness has been reported more frequently in men over 75 years of age taking Tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking 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 Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store tadalafil keep out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the blister and on the carton after ‘exp’. the expiry date refers to the last day of that month.
- Store in the original package in order to protect from moisture.
- Do not store above 30°C.
- If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other informationwhat tadalafil containsthe active substance is tadalafil. each tablet contains 20 mg of tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate (see end of section 2), croscarmellose sodium, hydroxypropylcellulose, microcrystalline cellulose, sodium laurilsulfate, magnesium stearate, see section 2 “Tadalafil contains lactose”.
Film-coat: lactose monohydrate, hypromellose, triacetin, titanium dioxide (E171), iron oxide yellow (E172), talc.
What Tadalafil looks like and contents of the pack
Tadalafil 20 mg tablets are yellow, film-coated tablets in the shape of an almond and has “C 20” marked on one side and plain on the reverse.
Tadalafil is available in blister packs containing 4 or 8 tablets.
Manufactured by
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5–7 Tintagel Way, Aldridge, Walsall, WS9 8ER.
Repackaged by MPT Pharma Ltd.
PLGB: 33532/1376
POM
Leaflet dated 23rd February 2022
Leaflet coded xxxxxxxxxxxxxx
To request a copy of this leaflet in Braille, large print or audio please call 01922 745645 and ask for the Regulatory Department.
Partial, temporary, or permanent decrease or loss of vision in one or both
eyes has been rarely reported.