Granpidam 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Granpidam 20 mg film-coated tablets EFG

sildenafil

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Granpidam is and what it is used for

Granpidam contains the active substance sildenafil, which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.

Granpidam reduces blood pressure in the lungs by dilating the pulmonary blood vessels. Granpidam is used to treat high blood pressure in the blood vessels of the lung (pulmonary arterial hypertension) in adults and children and adolescents aged 1 to 17 years.

2. What you need to know before taking Granpidam

Do not take Granpidam

• if you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines containing nitrates or nitric oxide donors such as amyl nitrite ("poppers"). These medicines are often used to relieve chest pain (or angina). Granpidam may significantly increase the effects of these medicines. You must inform your doctor if you are taking any of these medicines. If you are unsure, consult your doctor or pharmacist.
• 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 caused by blood clots). PDE5 inhibitors, such as sildenafil, have been shown to increase the hypotensive effect of this medicine. If you are taking riociguat or are unsure, consult your doctor.
• if you have recently had a stroke or myocardial infarction, or if you have severe liver disease or very low blood pressure (<90/50 mmHg).
• if you are taking a medicine for fungal infections such as ketoconazole or itraconazole, or medicines containing ritonavir (for AIDS).
• if you have previously experienced vision loss due to a blood flow problem in a nerve of the eye called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before taking Granpidam if:

• you have a condition caused by blockage or narrowing of a vein in the lungs rather than blockage or narrowing of an artery.
• you have a serious heart condition.
• you have a problem with the pumping chambers of the heart.
• you have high blood pressure in the blood vessels of the lungs.
• you have low blood pressure at rest.
• you are losing large amounts of body fluids (dehydration), which may occur when you sweat excessively or do not drink enough fluids. This may happen if you are ill with fever, vomiting, or diarrhea.
• you suffer from a rare inherited eye disease (retinitis pigmentosa).
• you have an abnormality of red blood cells (sickle cell anemia), cancer of the blood cells (leukemia), cancer of the bone marrow (multiple myeloma), or any disease or deformity of the penis.
• you currently have a stomach ulcer, bleeding disorders (such as hemophilia), or nosebleeds.
• you use medicines for erectile dysfunction.

When PDE5 inhibitors, including sildenafil, are used to treat erectile dysfunction (ED), the following visual adverse effects have been reported with unknown frequency: decrease or partial, sudden, temporary or permanent vision loss in one or both eyes. If you experience sudden reduction or loss of vision, stop taking Granpidam and inform your doctor immediately (see also section 4).

Prolonged and sometimes painful erections have been observed in men taking sildenafil. If you have an erection lasting more than 4 hours, stop taking Granpidam and consult your doctor immediately (see also section 4).

Special precautions in patients with kidney or liver problems

You must inform your doctor if you have kidney or liver problems, as dose adjustment may be necessary.

Children

Granpidam must not be given to children under 1 year of age.

Other medicines and Granpidam

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

• Medicines containing nitrates or nitric oxide donors such as amyl nitrite ("poppers"). These medicines are often used to relieve chest pain or angina (see section 2. Do not take Granpidam).
• Inform your doctor or pharmacist if you are taking riociguat.
• Treatments for pulmonary hypertension (e.g., bosentan, iloprost).
• Medicines containing St. John's wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).
• Medicines that inhibit blood coagulation (e.g., warfarin), although no adverse effects have been reported.
• Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for AIDS), or nefazodone (for depression), as dose adjustment may be necessary.
• Alpha-blocker therapy (e.g., doxazosin) for the treatment of high blood pressure or prostate problems, as the combination of both medicines may cause symptoms of low blood pressure (e.g., dizziness, fainting).
• Medicines containing sacubitril/valsartan, used to treat heart failure.

Taking Granpidam with food and drinks

You should not drink grapefruit juice while being treated with Granpidam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Granpidam must not be used during pregnancy unless absolutely necessary. Granpidam must not be given to women of childbearing potential unless adequate contraceptive methods are used.

Granpidam passes into breast milk at very low levels and is not expected to harm your baby.

Driving and using machines

Granpidam may cause dizziness and affect vision. You should know how you react to this medicine before driving or operating machinery.

Granpidam contains lactose

Before taking this medicine, consult your doctor if you have been diagnosed with an intolerance to certain sugars.

Granpidam contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet. This means it is essentially "sodium-free".

3. How to take Granpidam

Follow exactly the instructions for use of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

For adults, the recommended dose is 20 mg three times a day (taken at 6 to 8 hour intervals), taken with or without food.

Use in children and adolescents

For children and adolescents aged 1 to 17 years, the recommended dose is 10 mg three times a day for children and adolescents ≤ 20 kg, or 20 mg three times a day for children and adolescents > 20 kg, administered with or without food. In children, doses higher than those recommended must not be used.

This medicine should only be used in cases where a dose of 20 mg three times a day is required. For administration in patients ≤ 20 kg and in younger patients who cannot swallow tablets, other more suitable pharmaceutical forms may be used.

If you take more Granpidam than you should

Do not take more medicine than your doctor has prescribed.

If you have taken more medicine than recommended, consult your doctor immediately. Taking more Granpidam than you should may increase the risk of known adverse effects.

If you forget to take Granpidam

If you forget to take Granpidam, take the dose as soon as you remember and then continue taking your medicine at your usual times. Do not take a double dose to make up for forgotten doses.

If you stop taking Granpidam

Stopping treatment with Granpidam suddenly may lead to worsening of your symptoms. Do not stop taking Granpidam unless instructed by your doctor. Your doctor will advise you on how to gradually reduce the dose over a few days before stopping completely.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following adverse effects, stop taking Granpidam and inform your doctor immediately (see also section 2):

• if you experience a sudden reduction or loss of vision (frequency not known).
• if you have an erection lasting continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (frequency not known).

Adults

Very commonly reported adverse effects (may affect more than 1 in 10 patients) were headache or facial flushing, indigestion, diarrhoea, and pain in arms and legs.

Commonly reported adverse effects (may affect up to 1 in 10 patients) are: skin infection, flu-like symptoms, nasal sinus inflammation, reduction in the number of red blood cells (anaemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding from the back of the eye, vision disturbances, blurred vision and light sensitivity, effects on colour perception, eye irritation, red eyes, dizziness, bronchitis, nosebleed, rhinorrhoea, cough, nasal congestion, stomach inflammation, gastroenteritis, heartburn, haemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.

Uncommonly reported adverse effects (may affect up to 1 in 100 patients) included: reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, blood in semen and/or urine, and breast enlargement in men.

Skin rashes, sudden decrease or loss of hearing, and reduction in blood pressure have also been reported with unknown frequency (frequency cannot be estimated from the available data).

Children and adolescents

The following serious adverse effects have been frequently reported (may affect up to 1 in 10 patients): pneumonia, right heart failure, cardiogenic shock, high blood pressure in the lungs, chest pain, dizziness, respiratory infections, bronchitis, viral infection of the stomach and intestine, urinary tract infections, and dental perforations.

The following serious adverse effects considered related to treatment have been reported uncommonly (may affect up to 1 in 100 patients): allergic reaction (such as skin rash, swelling of face, lips and tongue, sneezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disturbances, shortness of breath, inflammation of the gastrointestinal tract, and sneezing due to airflow disturbances.

Very commonly reported adverse effects (may affect more than 1 in 10 people) were headache, vomiting, throat infection, fever, diarrhoea, flu, and nosebleed.

Commonly reported adverse effects (may affect up to 1 in 10 patients) were nausea, increased erections, pneumonia, and runny nose.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Granpidam

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Granpidam

• The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
• The other components are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose (see Section 2: "Grandipam contains sodium"), hypromellose 2910 (E464), magnesium stearate. Coating: hypromellose 2910 (E464), titanium dioxide (E171), lactose monohydrate, triacetin.

Appearance of Granpidam and contents of the pack

White to off-white, round, film-coated tablets approximately 6.6 mm in diameter, biconvex, marked with "20" on one side and smooth on the other.

Granpidam 20 mg film-coated tablets are available in PVC/Alu blister packs containing 90 and 300 tablets.

Granpidam 20 mg film-coated tablets are also available in single-dose perforated PVC/Alu blister packs containing 15x1, 90x1 and 300x1 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Accord Healthcare S.L.U.

World Trade Center, Moll de Barcelona, s/n,

Edifici Est, 6th floor,

08039 Barcelona,

Spain

Manufacturer:

Wessling Hungary Kft

Fòti ùt 56., Budapest 1047,

Hungary

or

Laboratori Fundació DAU

C/ C, 12-14 Pol. Ind. Zona Franca, 08040 Barcelona,

Spain

or

Accord Healthcare Polska Sp.z o.o.,

ul. Lutomierska 50, 95-200 Pabianice,

Poland

Date of the most recent revision of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.