Talmanco

Patient Information Leaflet

Talmanco 20 mg film-coated tablets

tadalafil
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Talmanco is and what it is used for
2. What you need to know before taking Talmanco
3. How to take Talmanco
4. Possible side effects
5. How to store Talmanco
6. Contents of the pack and other information

1. What Talmanco is and what it is used for

Talmanco contains the active substance tadalafil.
Talmanco is a treatment for pulmonary arterial hypertension in adults and children aged 2 years and older.
It belongs to a class of medicines called phosphodiesterase type 5 (PDE5) inhibitors, which help relax the blood vessels in the lungs, improving blood flow to the lungs. This results in improved exercise capacity.

2. What you need to know before taking Talmanco

Do not take Talmanco

• if you are allergic to tadalafil or to 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 to treat chest pain. It has been shown that tadalafil increases the effect of these medicines. If you are taking any form of nitrate or have any doubts, inform your doctor
• if you have previously experienced loss of vision – a condition described as "eye stroke" (non-arteritic anterior ischemic optic neuropathy - NAION)
• if you have had a heart attack within 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 due to blood clots). Phosphodiesterase-5 (PDE5) inhibitors such as Talmanco have been shown to increase the blood pressure-lowering effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you have:

• any heart problems other than pulmonary arterial hypertension
• blood pressure problems
• any inherited eye diseases
• a red blood cell disorder (sickle cell anemia)
• bone marrow cancer (multiple myeloma)
• blood cell cancer (leukemia)
• any deformity of the penis or involuntary or prolonged erections lasting more than 4 hours
• severe liver problems
• severe kidney problems

If you experience a sudden decrease or loss of vision, or if your vision becomes distorted or blurred while taking Talmanco, stop taking Talmanco and contact your doctor immediately.
Sudden decrease or loss of hearing has been observed in some patients taking tadalafil. Although it is not known whether this is directly related to tadalafil, if you experience sudden hearing decrease or loss, contact your doctor immediately.
Children and adolescents
This medicine is not recommended for the treatment of pulmonary arterial hypertension in children under 2 years of age, as it has not been studied in this age group.
Other medicines and Talmanco
Inform 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 may affect how Talmanco works. Inform 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 the treatment of HIV)
• tablets for erectile dysfunction (PDE5 inhibitors)

Talmanco and alcohol
Drinking alcohol may temporarily lower your blood pressure. If you have taken or plan to take Talmanco, avoid excessive alcohol consumption (more than 5 units of alcohol), as this may increase the risk of dizziness when standing up.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Do not take this medicine during pregnancy unless absolutely necessary and discussed with your doctor.
Do not breastfeed while taking these tablets, as it is not known whether the medicine passes into breast milk. Consult your doctor or pharmacist before taking any medicine if you are pregnant or breastfeeding.
In dogs treated with tadalafil, reduced sperm development in the testes has been observed. In some men, reduced sperm count has been observed. It is unlikely that these effects would lead to infertility.
Driving and using machines
Dizziness has been reported. Carefully assess how you react to this medicine before driving or operating machinery.
Talmanco contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Talmanco

Take this medicine exactly as your doctor has told you. If you are in doubt, consult your doctor or pharmacist.
Talmanco is available as 20 mg tablets. Swallow the tablets whole with water. The tablets may be taken with or without food.

Pulmonary arterial hypertension in adults
The usual dose is two 20 mg tablets taken once daily. You should take the tablets at the same time, one after the other. If you have mild or moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet daily.

Pulmonary arterial hypertension in children (aged 2 years and above) weighing at least 40 kg
The recommended dose is two 20 mg tablets taken once daily. Both tablets should be taken at the same time, one after the other. If you have mild or moderate liver or kidney problems, your doctor may advise you to take only one 20 mg tablet daily.

Pulmonary arterial hypertension in children (aged 2 years and above) weighing less than 40 kg
The recommended dose is one 20 mg tablet once daily. If you have mild or moderate liver or kidney problems, your doctor may advise you to take 10 mg once daily.
Other forms of this medicine may be more suitable for children; please consult your doctor or pharmacist.

If you take more Talmanco than you should
If you or someone else takes more tablets than prescribed, inform your doctor or go immediately to hospital, taking the medicine or its packaging with you. It is possible that the side effects described in section 4 may occur.

If you forget to take Talmanco
Take the missed dose as soon as you remember, provided it is within 8 hours of when you should have taken it. Do not take a double dose to make up for a forgotten dose.

If you stop taking Talmanco
Do not stop treatment unless instructed by your doctor.

If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. These side effects are usually mild to moderate in severity.
If you experience any of the following side effects, stop taking the medicine and
seek immediate medical help:
Common (may affect up to 1 in 10 people)

• allergic reactions, including skin rashes.
• chest pain – do not use nitrates, but seek immediate medical help.

Uncommon (may affect up to 1 in 100 people)

• priapism, a prolonged and sometimes painful erection after taking this medicine. If you have an erection lasting more than 4 hours in a row, you must 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, blurred, fuzzy vision or sudden decrease in central vision.

Other side effects have been reported:
Very common (may affect more than 1 in 10 people)

• headache.
• flushing, nasal and sinus congestion (sensation of a blocked nose).
• nausea, indigestion (including abdominal pain or discomfort).
• muscle pain, back and limb pain (including limb discomfort).

Common (may affect up to 1 in 10 people)

• blurred vision,
• low blood pressure,
• nosebleeds,
• vomiting,
• increased or abnormal uterine bleeding,
• facial swelling,
• acid reflux,
• migraine,
• irregular heartbeat,
• fainting.

Uncommon (may affect up to 1 in 100 people)

• seizures,
• transient memory loss,
• hives,
• excessive sweating,
• penile bleeding,
• blood in semen and/or urine,
• high blood pressure,
• rapid heartbeat,
• sudden cardiac death,
• ringing in the ears.

PDE5 inhibitors are also used to treat erectile dysfunction in men.
Some side effects have been reported rarely (may affect up to 1 in 1,000 people):

• Partial, temporary or permanent decrease or loss of vision in one or both eyes and severe allergic reaction causing facial or throat swelling. 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 observed in clinical studies for pulmonary arterial hypertension and therefore the frequency is not known (frequency cannot be estimated from the available data):

• eyelid swelling, eye discomfort, red eyes, heart attack and stroke. Some additional rare side effects not observed during clinical trials have been reported in men taking tadalafil. These include:
• distorted, blurred, fuzzy vision or sudden decrease in central vision (frequency not known).

Most, but not all, men who experienced rapid heartbeat, irregular heartbeat, heart attack, stroke and sudden cardiac death had pre-existing heart conditions before taking tadalafil. It is not possible to determine whether these events were directly associated with tadalafil.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly through the national reporting system at the website www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Talmanco

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Scad./EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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 lauryl sulfate, poloxamer 188, anhydrous lactose (see section 2 'Talmanco contains lactose and sodium'), microcrystalline cellulose (PH 101), sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate. The film coating contains monohydrate lactose (see section 2 'Talmanco contains lactose and sodium'), hypromellose (E464), titanium dioxide (E171), and triacetin.

Description of the appearance of Talmanco and contents of the pack
This medicine is a white, film-coated, round, biconvex tablet with bevelled edges, marked with 'M' on one side and 'TA20' on the other.
This medicine is available in blisters containing 28 or 56 tablets, and in perforated unit dose blisters 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 13
Ireland
Mylan Hungary Kft
Mylan 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 further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: +32 (0)2 658 61 00 Tel: +370 5 205 1288

Luxembourg/Luxemburg
Viatris
Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
Viatris CZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: +36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: +356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Viatris AS
Tel: +372 6363 052 Tlf: +47 66 75 33 00
(Sverige)

Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Tel: +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: +34 900 102 712 Tel.: +48 22 546 64 00

France Portugal
Substipharm Mylan, Lda.
Tél: +33 1 43181300 Tel: +351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: +386 1 236 31 80

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: +39 (0)2 612 46921 Puh/Tel: +358 20 720 9555

Sverige
GPA Pharmaceuticals Ltd Viatris AB
Tel: +357 22863100 Tel: +46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 1 8711600

This Patient Information Leaflet was last updated on
More detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu