Granpidam

Package leaflet: Information for the patient

Granpidam 20 mg film-coated tablets

Sildenafil
Please read this leaflet carefully before taking this medicine because 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this 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 class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. Granpidam reduces blood pressure in the blood vessels of the lungs by dilating the pulmonary blood vessels.
Granpidam is used to treat adults, children and adolescents aged 1 to 17 years with high blood pressure in the blood vessels of the lungs (pulmonary arterial hypertension).

2. What you should know before taking Granpidam

Do not take Granpidam

• if you are allergic to sildenafil or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking medicines containing nitrates or if you are using substances that release nitric oxide, such as amyl nitrate ("poppers"). These medicines are often used to relieve chest pain attacks (or "angina pectoris"). Granpidam can cause a significant increase in the effects of these medicines. Inform your doctor if you are taking any of these medicines. If you have any doubts, 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 secondary to blood clots). PDE5 inhibitors, such as sildenafil, have been shown to enhance the hypotensive effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.
• if you have recently had a stroke or 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 containing ritonavir (for HIV).
• if you have previously experienced vision loss caused by a problem with blood flow to the optic nerve known as non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions
Talk to your doctor before taking Granpidam if:

• your condition is due to obstruction or narrowing of a pulmonary vein rather than an artery.
• you have a serious heart condition.
• you have problems with the heart ventricles.
• you have high blood pressure in the blood vessels of the lungs.
• you have low blood pressure while 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 can happen if you are ill with fever, vomiting, or diarrhea.
• you have a rare inherited eye disease (retinitis pigmentosa).
• you have a red blood cell disorder (sickle cell anemia), a blood cell cancer (leukemia), a bone marrow tumor (multiple myeloma), or any disease or deformity of the penis.
• you currently have a stomach ulcer, a bleeding disorder (such as hemophilia), or nosebleeds.
• you are taking medicines for erectile dysfunction.

When used to treat erectile dysfunction (ED), PDE5 inhibitors, including sildenafil, have reported, with unknown frequency, the following adverse effects related to vision: partial, sudden, temporary or permanent reduction or loss of vision in one or both eyes.
If you experience a sudden decrease or loss of vision, stop taking Granpidam and contact your doctor immediately (see also section 4).
After taking sildenafil, prolonged and sometimes painful erections have been reported in men.
If you have an erection lasting continuously for more than 4 hours, stop taking Granpidam and contact your doctor immediately (see also section 4).

Special precautions for patients with kidney or liver problems
If you have kidney or liver problems, you must inform your doctor, as a 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 taking, have recently taken, or might take any other medicine.

• Medicines containing nitrates or substances that release nitric oxide, such as amyl nitrate ("poppers"). These medicines are often used to relieve angina pectoris or "chest pain" (see section 2. Do not take Granpidam).
• Inform your doctor or pharmacist if you are already taking riociguat.
• Therapies for pulmonary arterial hypertension (e.g., bosentan, iloprost): consult your doctor or pharmacist before taking Granpidam.
• Medicines containing St. John's Wort (herbal remedy), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (also used for epilepsy).
• Medicines that inhibit blood coagulation (e.g., warfarin), even though no adverse effect has been observed.
• Medicines containing erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV), or nefazodone (for depression), because a 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 these two medicines could cause symptoms leading to low blood pressure (e.g., dizziness, lightheadedness).
• Medicines containing sacubitril/valsartan, used for the treatment of heart failure.

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

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Granpidam must not be taken during pregnancy unless absolutely necessary.
Granpidam must not be administered to women of childbearing age unless they are using adequate contraceptive methods.
Granpidam passes into breast milk in small amounts and is not considered harmful to the infant.

Driving and using machines
Granpidam may cause dizziness and may affect vision. Before driving or operating machinery, you should be aware of how you react to this medicine.

Granpidam contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

Granpidam contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take Granpidam

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
For adults, the recommended dose is 20 mg three times daily (taken 6–8 hours apart), 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 daily for children and adolescents ≤ 20 kg, or 20 mg three times daily for children and adolescents > 20 kg, taken with or without food. Higher doses must not be used in children. This medicine should only be used when administering 20 mg three times daily. Other pharmaceutical forms may be more suitable for patients weighing ≤ 20 kg and for younger patients who are unable to swallow tablets.

If you take more Granpidam than you should
Do not take more medicine than your doctor has prescribed. If you take more medicine than prescribed, contact your doctor immediately. Taking more Granpidam than recommended may increase the risk of known side effects.

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

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

If you have any questions 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 everybody will experience them.
If you experience any of the following side effects, you must stop taking Granpidam and contact your doctor immediately (see also section 2):

• sudden decrease or loss of vision (frequency not known)
• an erection that persists continuously for more than 4 hours. After taking sildenafil, prolonged and sometimes painful erections have been reported, with frequency not known.

Adults
The very commonly reported side effects (may affect more than 1 in 10 people) were: headache, facial flushing, indigestion, diarrhoea, and pain in arms or legs.
The commonly reported side effects (may affect up to 1 in 10 people) include:
subcutaneous infections, flu-like symptoms, sinusitis, reduced number of red blood cells (anaemia), fluid retention, sleep disorders, anxiety, headache, tremor, prickling sensation, burning sensation, reduced sense of touch, bleeding in the back of the eye, visual disturbances, blurred vision, light sensitivity, disturbances in colour perception, eye irritation, eye inflammation/redness, dizziness, bronchitis, nasal bleeding, increased nasal secretions, 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.
The uncommonly reported side effects (may affect up to 1 in 100 people) include: reduced visual acuity, double vision, abnormal sensation in the eye, penile bleeding, blood in semen and/or urine, and excessive development of male breast tissue.
Skin rash, sudden decrease or loss of hearing, and decrease in blood pressure have also been reported, with frequency not known (frequency cannot be estimated from the available data).

Children and adolescents
The following serious adverse events have been commonly reported (may affect up to 1 in 10 people): pneumonia, heart failure, right-sided heart failure, cardiac shock, high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis, viral stomach and intestinal infection, urinary tract infection, and dental caries.
The following serious adverse events considered related to treatment have been reported uncommonly (may affect up to 1 in 100 people): allergic reactions (such as skin rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing impairment, shortness of breath, inflammation of the digestive tract, wheezing due to breathing problems.
The very commonly reported side effects (may affect more than 1 in 10 people) were: headache, vomiting, sore throat, fever, diarrhoea, influenza, and nosebleed.
The commonly reported 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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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.
This medicine does not require any special storage conditions.
Do not dispose of any medicine 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 Granpidam contains

• The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
• The excipients are:
  Inner core: microcrystalline cellulose, anhydrous 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.

Description of the appearance of Granpidam and pack contents
Film-coated tablets, white to off-white in colour, round-shaped, 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/Al blisters in packs of 90 tablets and 300 tablets.
Granpidam 20 mg film-coated tablets are also supplied in unit-dose blister packs in PVC/aluminium 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:
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
or
Accord Healthcare B.V.,
Winthontlaan 200,
3526 KV Utrecht,
The Netherlands

More detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA): http://www.ema.europa.eu.