Package Insert: Patient Information

Granpidam 20 mg Film-Coated Tablets EFG

sildenafil

Read this package insert carefully before starting to take this medication, because

it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if
• they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this package insert. See section 4.

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

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

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 used to relieve chest pain (or angina). Granpidam may increase the effects of these medicines. 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 clots). Phosphodiesterase type 5 inhibitors, such as sildenafil, have 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, a heart attack, or if you have severe liver disease or very low blood pressure (<90)
• if you are taking a medicine to treat fungal infections such as ketoconazole or itraconazole or medicines that contain ritonavir (for HIV/AIDS).
• if you have previously experienced vision loss due to a problem with blood flow to an eye nerve called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Granpidam if

• you have a disease due to a blockage or narrowing of a vein in the lungs instead of a blockage or narrowing of an artery.
• you have a serious heart problem.
• you have a problem with the heart's pumping chambers.
• you have high blood pressure in the blood vessels of the lungs.
• you have low blood pressure at rest.
• you lose a large amount of body fluids (dehydration) that can occur when you sweat a lot or do not drink enough liquids. This can happen if you are sick with fever, vomiting, or diarrhea.
• you have a rare inherited eye disease (retinitis pigmentosa).
• you have an abnormality of red blood cells (sickle cell anemia), leukemia, multiple myeloma, or any disease or deformity of the penis.
• you have an active stomach ulcer or bleeding disorders (such as hemophilia) or nosebleeds.
• you are taking medicines for erectile dysfunction.

When phosphodiesterase type 5 inhibitors, including sildenafil, are used to treat erectile dysfunction (ED), the following visual adverse effects have been reported with an unknown frequency: sudden, temporary, or permanent partial or complete loss of vision in one or both eyes. If you experience a sudden loss of vision, stop taking Granpidam and inform your doctor immediately (see also section 4).

Sudden, prolonged, and sometimes painful erections have been observed in men taking sildenafil. If you have an erection that lasts 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

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.

Other medicines and Granpidam

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

• Medicines that contain 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 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 coagulation (e.g., warfarin) although no adverse effects have been reported.

• Medicines that contain erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV/AIDS), 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 may cause symptoms of reduced blood pressure (e.g., dizziness, fainting).
• Medicines that contain sacubitril/valsartan, used to treat heart failure.

Granpidam with food and drinks

Do not take grapefruit juice while being treated with Granpidam.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using 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 operating machinery

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

Granpidam contains lactose

Before taking this medicine, consult your doctor if they have told you that 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”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

For adults, the recommended dose is 20 mg three times a day (taken at intervals of 6 to 8 hours) 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 for children and adolescents > 20 kg, administered with or without food. In children, doses higher than those recommended should not be used.

This medication 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 the tablets, other more suitable pharmaceutical forms may be used.

If you take more Granpidam than you should

You should not take more medication than your doctor tells you to.

If you have taken more medication than advised, consult your doctor immediately. Taking more Granpidam than you should may increase the risk of known side effects.

If you forgot to take Granpidam

If you have forgotten to take Granpidam, take the dose as soon as you remember and continue taking your medication at regular hours. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Granpidam

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

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience 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 sudden loss or reduction of vision (unknown frequency).
• if you have an erection that lasts for more than 4 hours. Prolonged and sometimes painful erections have been reported after taking sildenafilo in men (unknown frequency).

Adults

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

The side effects reported frequently (may affect up to 1 in 10 patients) 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, visual disturbances, blurred vision, and light sensitivity, color perception effects, eye irritation, red or bloodshot eyes, dizziness, bronchitis, nasal bleeding, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, burning, hemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.

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

Also, skin eruptions, sudden loss or reduction of hearing, and reduced blood pressure have been reported with an unknown frequency (the frequency cannot be estimated with the available data).

Children and adolescents

Frequent side effects (may affect up to 1 in 10 patients) reported in children and adolescents included: pneumonia, right heart failure, cardiac shock, high blood pressure in the lungs, chest pain, dizziness, respiratory infections, bronchitis, viral infections in the stomach and intestines, urinary tract infections, and tooth perforations.

Severe side effects considered related to treatment and reported infrequently (may affect up to 1 in 100 patients) included: allergic reaction (such as skin rash, facial inflammation, lips and tongue inflammation, sneezing, difficulty breathing or swallowing), convulsions, irregular heartbeat, hearing disturbances, shortness of breath, digestive tract inflammation, and sneezing due to airway obstruction.

The side effects reported very frequently (may affect more than 1 in 10 patients) were headache, vomiting, throat infection, fever, diarrhea, flu, and nasal bleeding.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require any special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to properly dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Granpidam

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

Appearance of Granpidam and content of the container

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

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

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

Only some container sizes may be commercially marketed.

Marketing authorization holder and responsible 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 út 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

Last review date of this leaflet:

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