GRANPIDAM 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Granpidam 20 mg film-coated tablets EFG

sildenafil

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Granpidam and what is it used for

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

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

2. What you need to know before you take 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 that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medicines are often given to relieve chest pain (or angina). Granpidam can increase the effects of these medicines. You should tell your doctor if you are taking any of these medicines. If you are not sure, 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 shown that they increase the hypotensive effect of this medicine. If you are taking riociguat or are not sure, consult your doctor.
• if you have recently had a stroke, a heart attack, 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 that contain ritonavir (for HIV).
• if you have previously experienced a loss of vision due to a problem with blood flow to the nerve of the eye called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting Granpidam if

• you have a disease due to a blockage or narrowing of a vein in the lungs rather than a blockage or narrowing of an artery.
• you have a serious heart problem.
• 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 resting blood pressure.
• you lose a large amount of body fluids (dehydration) that can occur when you sweat a lot or do not drink enough fluids. This can happen if you are ill with fever, vomiting, or diarrhea.
• you have a rare inherited eye disease (retinitis pigmentosa).
• you have an abnormality of the red blood cells (sickle cell anemia), blood cell cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis.
• you currently have stomach ulcers or 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 an unknown frequency: decrease or loss of vision, sudden, temporary, or permanent, in one or both eyes. If you experience a 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 that lasts for 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 should inform your doctor if you have kidney or liver problems, as a dose adjustment may be necessary.

Children

Granpidam should not be administered 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 use any other medicines.

• Medicines that contain nitrates or nitric oxide donors such as amyl nitrite (“poppers”). These medicines are often given to relieve chest pain or angina (see section 2. Do not take Granpidam).
• Tell your doctor or pharmacist if you are taking riociguat.
• Treatments for pulmonary hypertension (e.g., bosentan, iloprost).
• Medicines that contain St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy).
• Medicines that inhibit blood clotting (e.g., warfarin), although they have not caused any adverse effects.

• Medicines that contain erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for depression), as a dose adjustment may be necessary.
• Alpha-blocker therapy (e.g., doxazosin) for the treatment of hypertension or prostate problems, as the combination of the two medicines can cause symptoms of reduced blood pressure (e.g., dizziness, fainting).
• Medicines that contain sacubitril/valsartan, used to treat heart failure.

Taking Granpidam with food and drinks

Do not take grapefruit juice when being treated with Granpidam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Granpidam should not be used during pregnancy unless absolutely necessary. Granpidam should not be administered to women of childbearing age 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 vehicles or using machines.

Granpidam contains lactose

Before taking this medicine, consult your doctor if you have been told you have an intolerance to some sugars.

Granpidam contains sodium

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

3. How to take Granpidam

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

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

Use in children and adolescents

For children and adolescents from 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 in children and adolescents > 20 kg, administered with or without food. In children, doses higher than those recommended should not be used.

This medicine should only be used for cases where 20 mg three times a day should be administered. For administration in patients ≤ 20 kg and in other younger patients who cannot swallow tablets, other pharmaceutical forms more suitable for their needs 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 you should, consult your doctor immediately. Taking more Granpidam than you should can increase the risk of known side effects.

If you forget to take Granpidam

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

If you stop taking Granpidam

Sudden interruption of treatment with Granpidam may lead to worsening of your symptoms. Do not stop taking Granpidam unless your doctor tells you to. Your doctor will tell you how to reduce the dose over a few days before stopping it completely.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Adults

The very common side effects (may affect more than 1 in 10 people) were headache or facial flushing, indigestion, diarrhea, and pain in arms and legs.

The common side effects (may affect up to 1 in 10 people) are: skin infection, flu-like symptoms, nasal congestion, reduction in red blood cell count (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding in the back of the eye, changes in vision, blurred vision, and sensitivity to light, effects on color perception, eye irritation, red eyes, dizziness, bronchitis, nosebleeds, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, hemorrhoids, abdominal distension, dry mouth, hair loss, skin flushing, night sweats, muscle pain, back pain, and increased body temperature.

The uncommon side effects (may affect up to 1 in 100 people) included: reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, presence of blood in semen and/or urine, and gynecomastia in men.

Also, skin rash, sudden loss of hearing, and decreased blood pressure have been reported with an unknown frequency (the frequency cannot be estimated from the available data).

Children and adolescents

The following serious side effects have been reported frequently (may affect up to 1 in 10 people): pneumonia, right heart failure, cardiac arrest, high blood pressure in the lungs, chest pain, dizziness, respiratory infections, bronchitis, viral gastroenteritis, urinary tract infections, and tooth abscesses.

The following serious side effects were considered related to treatment and reported infrequently (may affect up to 1 in 100 people): allergic reaction (such as skin rash, facial swelling, lip and tongue swelling, sneezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing disorders, shortness of breath, gastrointestinal inflammation, and sneezing due to airway disorders.

The very common side effects (may affect more than 1 in 10 people) were headache, vomiting, throat infection, fever, diarrhea, flu, and nosebleeds.

The common side effects (may affect up to 1 in 10 people) were nausea, increased erections, pneumonia, and runny nose.

Reporting of side effects

If you experience 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.

5. Storage of Granpidam

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 the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Granpidam

• The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
• The other ingredients are: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, sodium croscarmellose (see Section 2: “Granpidam 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, approximately 6.6 mm in diameter, biconvex, film-coated tablets, marked with "20" on one side and plain 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 unit-dose blister packs of PVC/Alu containing 15x1, 90x1, and 300x1 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Accord Healthcare S.L.U.

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

Edifici Est 6ª planta,

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 last revision of this leaflet:

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