Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - talmanco

Document Subject

Generated Narrative: MedicinalProductDefinition mp7d70fe375a5923a60727e1f723f93cda

identifier: http://ema.europa.eu/identifier/EU/1/16/1153/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Talmanco 20 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-7d70fe375a5923a60727e1f723f93cda

identifier: http://ema.europa.eu/identifier/EU/1/16/1153/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - talmanco

Attesters

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

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.

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 or your vision is distorted, dimmed while you are taking Talmanco, stop taking Talmanco 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, 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 .

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.

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.

Not known (frequency cannot be estimated from the available data)

• distorted, dimmed, blurred central vision or sudden decrease 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.

Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials. These include:

• distorted, dimmed, blurred central vision or sudden decrease of vision (frequency not known).

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 Appendix V. By reporting side effects 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 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.

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, anhydrous lactose (see section 2 Talmanco contains lactose and sodium ), microcrystalline cellulose (PH 101), croscarmellose sodium, colloidal anhydrous silica and magnesium stearate. The film-coating contains lactose monohydrate (see section 2 Talmanco contains lactose and sodium ), hypromellose (E464), titanium dioxide (E171) and triacetin.

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 x 1 or 56 x 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 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 Viatris T l/Tel: +32(0)2 658 61 Lietuva Mylan Healthcare UAB Tel: +370 5 205 1

Te .: +359 2 44 55Luxembourg/Luxemburg Viatris T l/Tel: +32 (0)2 658 61 (Belgique/Belgien)

esk republika Viatris CZ s.r.o. Tel: +420 222 004 Magyarorsz g Viatris Healthcare 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 Viatris Healthcare GmbH Tel: +49 800 0700 Nederland Mylan BV Tel: +31 (0)20 426 3Eesti BGP Products Switzerland GmbH Eesti filiaal Tel: +372 6363 Norge Viatris AS Tlf: +47 66 75 33
Viatris Hellas Ltd : +30 2100 100 sterreich Arcana Arzneimittel GmbH Tel: +43 1 416 2Espa a Viatris Pharmaceuticals, S.L.U. Tel: +34 900 102 Polska Mylan Healthcare Sp. z.o.o. Tel.: +48 22 546 64 France Substipharm T l: +33 1 43181Portugal Mylan, Lda. Tel: +351 21 412 72 Hrvatska Viatris 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 Viatris d.o.o. Tel: +386 1 236 31 sland Icepharma hf. S mi: +354 540 8Slovensk republika Viatris Slovakia s.r.o. Tel: +421 2 32 199 Italia Viatris Italia S.r.l. Tel: +39 (0) 2 612 46Suomi/Finland Viatris Oy Puh/Tel: +358 20 720 9
Varnavas Hadjipanayis Ltd : +357 222 077 Sverige Viatris AB Tel: +46 (0) 8 630 19 Latvija Mylan Healthcare SIA Tel: +371 676 055 United Kingdom (Northern Ireland) Mylan IRE Healthcare Limited Tel: +353 18711This leaflet was last revised in {MM/YYYY}.

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