Tadalafil 20 Mg Film-Coated Tablets
Package leaflet: Information for the patient
Tadalafil 20 mg film-coated tablets (tadalafil)
Read all of this leaflet carefully before you start using 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 Tadalafil 20 mg film-coated tablets are and what they are used for
2. What you need to know before you use Tadalafil 20 mg film-coated tablets
3. How to use Tadalafil 20 mg film-coated tablets
4. Possible side effects
5. How to store Tadalafil 20 mg film-coated tablets
6. Contents of the pack and other information
1. What Tadalafil 20 mg film-coated tablets are and what they are used for
Tadalafil 20 mg film-coated tablets are 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 20 mg film-coated tablets contain the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil 20 mg film-coated tablets work 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 20 mg film-coated tablets 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 use Tadalafil 20 mg film-coated tablets Do not use Tadalafil 20 mg film-coated tablets 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 sometimes 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 20 mg film-coated tablets.
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 nonnerve-sparing prostatectomy).
If you experience sudden decrease or loss of vision, stop taking Tadalafil 20 mg film-coated tablets and contact your doctor immediately.
Tadalafil 20 mg film-coated tablets are not intended for use by women.
Children and adolescents
Tadalafil 20 mg film-coated tablets are not intended for use by children and adolescents under the age of 18.
Other medicines and Tadalafil 20 mg film-coated tablets
Tell your doctor if you are taking, have recently taken or might take any other medicines
Do not take Tadalafil 20 mg film-coated tablets if you are already taking nitrates.
Some medicines may be affected by Tadalafil 20 mg film-coated tablets or they may affect how well Tadalafil 20 mg film-coated tablets 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 20 mg film-coated tablets with drink and alcohol
Information on the effect of alcohol is in section 3. Grapefruit juice may affect how well Tadalafil 20 mg film-coated tablets 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 20 mg film-coated tablets contains lactose
If you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to use Tadalafil 20 mg film-coated tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Tadalafil 20 mg film-coated 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. If the effect of this dose is too weak your doctor may increase the dose to 20 mg. Tadalafil 20 mg film-coated tablets are for oral use.
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 20 mg film-coated tablets more than once a day. Tadalafil 10 mg and 20 mg film-coated tablets are intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
It is important to note that Tadalafil 20 mg film-coated tablets do 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 20 mg film-coated tablets, avoid excessive drinking (blood alcohol level of 0.08 % or greater), since this may increase the risk of dizziness when standing up.
For doses not realisable/practicable with this medicinal product other strengths and medicinal products are available. Tadalafil is available as 2.5, 5, 10 and 20mg film coated tablets.
If you use more Tadalafil 20 mg film-coated tablets 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).
• 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 (may affect up to 1 in 10 people)
• headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion, and indigestion.
Uncommon (may affect up to 1 in 100 people)
• dizziness, stomach ache, feeling sick, being sick (vomiting), blurred vision, eye pain, difficulty in breathing, presence of blood in semen and/or urine, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds and ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Rare (may affect up to 1 in 1,000 people)
• fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and 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.
Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
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 effects diarrhoea have 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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Tadalafil 20 mg film-coated tablets
This medicinal product does not require any special storage conditions.
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 after EXP. The expiry date refers to the last day of that month.
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 Tadalafil 20 mg film-coated tablets contain
The active substance is tadalafil.
1 film-coated tablet contains 20 mg tadalafil.
The other ingredients are:
Tablet core: lactose monohydrate, croscarmellose sodium (E468), microcrystalline cellulose (E460), sodium lauryl sulfate, poloxamer 407, magnesium stearate (E572) Film-coating: hypromellose (E464), hydroxypropylcellulose (E463), macrogol 8000, titanium dioxide (E171), iron oxide yellow (E172),
What Tadalafil 20 mg film-coated tablets looks like and contents of the pack
Yellow, almond shaped, biconvex film coated tablets. Engraved “APO” on one side, “T20” on the other side
The film-coated tablets are packaged in:
PVC/PVdC/Al or PVC/Aclar/Al blisters in carton boxes of 2, 4, 8 or 12 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Apotex Europe B.V.
Darwinweg 20, 2333 CR Leiden The Netherlands
Apotex Nederland B.V Archimedesweg 2, 2333 CN Leiden The Netherlands
This leaflet was last revised in November 2016
7