20 mg film-coated tablets
tadalafil
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.
Talmanco belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors, which improve blood flow to the lungs by causing the blood vessels around the lungs to relax. The result is improved capacity during physical exertion.
What you need to know before you take Talmanco
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 medicines containing nitrates such as amyl nitrite, which are used to treat chest pain. Talmanco has been shown to increase the effect of these drugs. If you take any form of nitrate or are unsure, talk to your doctor.
- if you have ever lost your sight – a condition called ‘stroke in 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 take riociguat. This medicine is used to treat pulmonary arterial hypertension (ie high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (ie high blood pressure in the lungs due to blood clots). PDE5 inhibitors, such as Talmanco, have been shown to increase the blood pressure-lowering effect of this drug. If you are taking riociguat or if you are not sure, talk to your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine if you have:
- heart problems other than your high blood pressure in the lungs
- problems with your blood pressure
- any hereditary eye disease
- abnormal red blood cells (sickle cell anemia)
- bone marrow cancer (multiple myeloma )
- blood cell cancer ( leukemia )
- a deformed penis, or unwanted or persistent erection lasting more than 4 hours
- severe liver disease
- severe kidney disease.
If you experience a sudden decrease or loss of vision, contact your doctor immediately.
Impaired hearing or sudden hearing loss has been noted in some patients taking tadalafil. Although it is not known whether the events are related to tadalafil, you should contact your doctor immediately if you develop hearing impairment or sudden hearing loss.
Children and young people
This medicine should not be given to children or adolescents under 18 years of age.
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 this medicine if you are already taking nitrates.
Some medicines can be affected by Talmanco or they can affect Talmanco’s effect. Tell your doctor or pharmacist if you are already taking:
- bosentan (another drug used to treat pulmonary arterial hypertension )
- nitrates (for chest pain)
- alpha-blockers are 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
Alcohol intake can temporarily lower your blood pressure. Avoid consuming large amounts of alcohol (over 5 alcohol units) when you have taken or plan to take Talmanco as this may increase the risk of dizziness when standing up.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. Do not use this medicine during pregnancy, unless it is necessary and you have discussed it with your doctor.
Do not breastfeed while taking these tablets, as it is not known whether the drug passes into human breast milk. Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.
Treated dogs had reduced sperm development in the testes. A reduced sperm concentration has been demonstrated in some men. Its effects are unlikely to impair male fertility.
Driving ability and use of machinery
Dizziness has been reported. Feel how you react to the medicine before driving or using machines.
Talmanco contains lactose and sodium
If you have an intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is almost ‘sodium-free’.
How to take Talmanco
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
Talmanco is supplied as a 20 mg tablet. The usual dose is two 20 mg tablets once daily. You should take both tablets at the same time, one after the other. Your doctor may have prescribed just one 20 mg tablet daily if you have mild to moderate liver or kidney problems.
Swallow the tablets with a little water. You can take the tablets regardless of a meal.
If you have taken too much Talmanco
If you or someone else takes more tablets than they should, contact your doctor or go to the hospital immediately, and take the medicine pack with you. You may experience some of the side effects described in section 4.
If you forget to take Talmanco
Take dose one 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 missed dose.
If you stop taking Talmanco
Do not stop taking your tablets unless your doctor tells you to.
If you have any further questions about this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are usually mild or moderate.
If you experience any of the following side effects, stop using the medicine and see a doctor immediately:
Common (may affect up to 1 in 10 users)
- allergic reactions with rash
- chest pain – do not use nitrates but see a doctor immediately
Uncommon (may affect up to 1 in 100 users)
- priapism, prolonged and possibly painful erection after taking this medicine. If you get an erection that lasts continuously for more than 4 hours, consult a doctor immediately.
Rare (may affect up to 1 in 1,000 users)
- sudden loss of vision
Other side effects have been reported:
Very common (may affect more than 1 in 10 users)
- headache
- redness, nasal congestion, and blocked sinuses
- nausea, indigestion (including stomach pain)
- muscle pain, back pain, and pain or discomfort in the arms and legs
Common (may affect up to 1 in 10 users)
- blurred vision
- low blood pressure
- nosebleed
- vomiting
- increased or abnormal vaginal bleeding, facial swelling
- acid reflux
- migraine
- irregular heartbeats
- fainting
Uncommon (may affect up to 1 in 100 users)
- convulsions
- temporary memory loss
- hives
- profuse sweating
- bleeding from the penis
- presence of blood in semen and/or urine
- Hypertension
- palpitation
- sudden cardiac death
- tinnitus (sound in the ears without an external sound source)
PDE5 inhibitors are also used to treat erectile dysfunction in men. Some side effects that are reported rarely (may affect up to 1 in 1,000 users):
- Partial, temporary, or permanent visual impairment or loss of vision in one or both eyes and severe allergic reaction causing swelling of the face and throat. Sudden deterioration or loss of hearing has also been reported.
Some side effects have been reported by men taking tadalafil for the treatment of erectile dysfunction. These side effects have not occurred in clinical trials of pulmonary arterial hypertension and therefore the frequency is not known (cannot be estimated from the available data):
- swollen eyelids, eye pain, red eyes, heart attack, and stroke
Most, but not all, of the men who reported palpitations, irregular heartbeats, heart attack, stroke, and sudden cardiac death had known heart problems before taking the drug. It is not possible to determine whether these reactions were directly related to tadalafil.
How to store Talmanco
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton or blister card after the Expiration date. or EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is tadalafil. One tablet contains 20 mg of tadalafil.
- Other ingredients in the tablet core are povidone, sodium lauryl sulfate, poloxamer 188, and anhydrous lactose (see section 2 “Talmanco contains lactose and sodium”), microcrystalline cellulose ( PH 101), croscarmellose sodium, colloidal anhydrous silicon dioxide, and magnesium stearate. The film coating contains lactose monohydrate (see section 2 “Talmanco contains lactose and sodium”), hypromellose (E464), titanium dioxide (E171), and triacetin.
Appearance and package sizes of the medicine
This medicine is a white, film-coated, round, biconvex tablet with a beveled edge, marked with “M” on one side and “TA20” on the other. The medicine is supplied in blister packs containing 28 or 56 tablets and in perforated single-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
Manufacturer
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 vd Hoehe, Benzstrasse 1
Bad Homburg CEO Hoehe
Hesse, 61352,
Germany