Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - tadalafil

Document Subject

Generated Narrative: MedicinalProductDefinition mpd115286718a651dcd06cf9dfb35e2ceb

identifier: http://ema.europa.eu/identifier/EU/1/14/961/008

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Tadalafil Mylan 2.5 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d115286718a651dcd06cf9dfb35e2ceb

identifier: http://ema.europa.eu/identifier/EU/1/14/961/008

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - tadalafil

Attesters

What is in this leaflet

1. What Tadalafil Mylan is and what it is used for
2. What you need to know before you take Tadalafil Mylan
3. How to take Tadalafil Mylan
4. Possible side effects
5. How to store Tadalafil Mylan
6. 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.

Do not take Tadalafil Mylan

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. Warnings and precautions 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. Children and adolescents Tadalafil Mylan is not intended for use by children and adolescents under the age of 18. Other medicines and Tadalafil Mylan 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. Tadalafil Mylan with drink and alcohol 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. 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 Mylan contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. Tadalafil Mylan contains sodium 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. If you take more Tadalafil Mylan than you should Contact your doctor. You may experience side effects described in section 4. If you forget to take Tadalafil Mylan 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. 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 (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), 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 (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, 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 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. 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 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.

What Tadalafil Mylan contains

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. What Tadalafil Mylan looks like and contents of the pack 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. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN Ireland Manufacturer McDermott Laboratories Ltd. t/a Gerard Laboratories 35/36 Baldoyle Industrial Estate, Grange Road Dublin Ireland Mylan Hungary Kft. Mylan utca 1 Kom rom, 2Hungary 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. Belgi /Belgique/Belgien Mylan bvba/sprl T l/Tel: + 32 (0)2 658 61 Lietuva (Lithuania) Mylan Healthcare UAB Tel: + 370 5 205 1 (Bulgaria)

: + 359 2 44 55 Luxembourg/Luxemburg Mylan bvba/sprl Tel: + 32 (0)2 658 61 (Belgique/Belgien) esk republika Mylan Healthcare CZ s.r.o. Tel: + 420 222 004 Magyarorsz g (Hungary) Mylan EPD Kft. Tel: + 36 1 465 2Danmark Viatris ApS Tlf: + 45 28 11 69 Malta V.J. Salomone Pharma Ltd Tel: + 356 21 22 01 Deutschland Mylan Healthcare GmbH Tel: + 49 800 0700 Nederland Mylan BV Tel: + 31 (0)20 426 3Eesti (Estonia) BGP Products Switzerland GmbH Eesti filiaal Tel: + 372 6363 Norge Mylan Healthcare Norge AS Tel: + 47 66 75 33 (Greece) Generics Pharma Hellas
: + 30 210 993 6 sterreich Arcana Arzneimittel GmbH Tel: + 43 1 416 2Espa a Mylan Pharmaceuticals, S.L. Tel: + 34 900 102 Polska Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 France Mylan S.A.S Tel: + 33 4 37 25 75 Portugal Mylan, Lda. Tel: + 351 21 412 72 Hrvatska (Croatia) Mylan Hrvatska d.o.o.
Tel: + 385 1 23 50 Rom nia BGP Products SRL Tel: + 40 372 579 Ireland Mylan Ireland Limited Tel: +353 1 8711Slovenija Mylan Healthcare d.o.o. Tel: + 386 1 23 63 sland Icepharma hf S m : + 354 540 8Slovensk republika Mylan s.r.o. Tel: + 421 2 32 199 Italia Mylan Italia S.r.l. Tel: + 39 02 612 46Suomi/Finland Mylan Finland OY Puh/Tel: + 358 20 720 9 (Cyprus) Varnavas Hadjipanayis Ltd : +357 2220 7Sverige Mylan AB Tel: + 46 855 522 Latvija Mylan Healthcare SIA Tel: + 371 676 05United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: