Tadalafil Mylan
tadalafil
tadalafil
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 Tadalafil Mylan is and what it is used for
What you need to know before you take Tadalafil Mylan
How to take Tadalafil Mylan
Possible side effects
How to store Tadalafil Mylan
Contents of the pack and other information
Tadalafil Mylan 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 Mylan contains the active substance tadalafil which belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Following sexual stimulation Tadalafil Mylan 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 Mylan 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.
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 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.
if you have serious heart disease or recently had a heart attack within the last 90 days.
if you had a stroke within the last 6 months.
if you have low blood pressure or uncontrolled high blood pressure.
if you ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
if you 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 Mylan, have been shown to
increase the hypotensive effects of this medicine. If you are taking riociguat or are unsure tell your doctor.
Talk to your doctor before taking Tadalafil Mylan.
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 Mylan 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 Mylan and contact your doctor immediately.
Tadalafil Mylan is not intended for use by women.
Tadalafil Mylan is not intended for use by children and adolescents under the age of 18.
Tell your doctor if you are taking, have recently taken or might take any other medicines. Do not take Tadalafil Mylan if you are already taking nitrates.
Some medicines may be affected by Tadalafil Mylan or they may affect how well Tadalafil Mylan 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.
Grapefruit juice may affect how well Tadalafil Mylan will work and should be taken with caution. Talk to your doctor for further information.
Drinking alcohol may temporarily lower your blood pressure. If you have taken or are planning to take Tadalafil Mylan, avoid excessive drinking (blood alcohol level of 0.08% or greater), since this may increase the risk of dizziness when standing up.
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.
Some men taking tadalafil in clinical studies have reported dizziness. Check carefully how you react to the tablets before driving or using machines.
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’.
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 one 5 mg tablet taken once a day at approximately the same time of the day. Your doctor may adjust the dose to 2.5 mg based on your response to Tadalafil Mylan. This will be given as a
2.5 mg tablet.
Do not take Tadalafil Mylan more than once a day.
Tadalafil Mylan tablets are for oral use in men only. Swallow the tablet whole with some water. The tablets can be taken with or without food.
Once a day dosing of Tadalafil Mylan may be useful to men who anticipate having sexual activity two or more times per week.
When taken once a day Tadalafil Mylan allows you to obtain an erection, when sexually stimulated, at any time point during the 24 hours of the day.
Contact your doctor. You may experience side effects described in section 4.
Take your dose as soon as you remember but do not take a double dose to make up for a forgotten tablet. You should not take Tadalafil Mylan more than once a day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. These effects are normally mild to moderate in nature.
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:
headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
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.
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.
Partial, temporary, or permanent decrease or loss of vision in one or both eyes has been rarely reported.
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 the age of 65 taking tadalafil.
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 Appendix
V. By reporting side affects you can help provide more information on the safety of this medicine.
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.
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.
The active substance is tadalafil. Each tablet contains 2.5 mg of tadalafil.
The other ingredients are:
Tablet core: lactose anhydrous (see section 2 ‘Tadalafil Mylan contains lactose’), poloxamer 188, cellulose microcrystalline (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, sodium laurilsulfate, silica colloidal anhydrous.
Film-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172), triacetin.
Tadalafil Mylan 2.5 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M’ on one side of the tablet and ‘TL over 1’ on the other side.
Tadalafil Mylan 2.5 mg is available in blister packs containing 28 and 56 tablets. Not all pack sizes may be marketed.
Mylan Pharmaceuticals Limited
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN
Ireland
McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road Dublin 13
Ireland
Mylan Mylan | Hungary Kft. | |||
utca | 1 | |||
Komárom, | 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.
Mylan bvba/sprl
Tél/Tel: + 32 (0)2 658 61 00
Майлан ЕООД
Тел: + 359 2 44 55 400
Mylan bvba/sprl
Tel: + 32 (0)2 658 61 00
(Belgique/Belgien)
Mylan Healthcare CZ s.r.o. Tel: + 420 222 004 400
Mylan EPD Kft.
Tel: + 36 1 465 2100
Viatris ApS
Tlf: + 45 28 11 69 32
V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 74
Mylan Healthcare GmbH Tel: + 49 800 0700 800
Mylan BV
Tel: + 31 (0)20 426 3300
BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 052
Mylan Healthcare Norge AS Tel: + 47 66 75 33 00
Generics Pharma Hellas ΕΠΕ Τηλ: + 30 210 993 6410
Arcana Arzneimittel GmbH Tel: + 43 1 416 2418
Mylan Pharmaceuticals, S.L. Tel: + 34 900 102 712
Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 00
Mylan S.A.S
Tel: + 33 4 37 25 75 00
Mylan, Lda.
Tel: + 351 21 412 72 56
BGP Products SRL Tel: + 40 372 579 000
Mylan Ireland Limited Tel: +353 1 8711600
Mylan Healthcare d.o.o. Tel: + 386 1 23 63 180
Icepharma hf
Símí: + 354 540 8000
Mylan s.r.o.
Tel: + 421 2 32 199 100
Mylan Italia S.r.l.
Tel: + 39 02 612 46921
Mylan Finland OY
Puh/Tel: + 358 20 720 9555
Mylan AB
Tel: + 46 855 522 750
Mylan Healthcare SIA Tel: + 371 676 05580
Mylan IRE Healthcare Limited Tel: +353 18711600