20 mg film-coated tablets
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 lowers blood pressure in the lungs by dilating the blood vessels in the lungs.
Granpidam is used to treat adults and children and adolescents from 1 to 17 years of age with high blood pressure in the blood vessels of the lungs ( pulmonary arterial hypertension ).
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 medications are often given to relieve angina (or angina pectoris ). Granpidam can cause a severe increase in the effect of these medicines. Tell your doctor if you are taking any of these medicines. If you are not sure, ask your doctor or pharmacist.
- 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 sildenafil, have been shown to increase the antihypertensive effect of this medicine. If you are taking riociguat or if you are not sure, talk to your doctor.
- if you have recently had a stroke , a heart attack, severe liver disease or very low blood pressure (<90/50 mmHg).
- if you are taking medicines containing ketoconazole or itraconazole to treat fungal infections or medicines containing ritonavir (for HIV ).
- if you have ever lost your sight due to a problem with the blood flow to the nerve in the eye called non-arteritic anterior ischemic optic infarction / neuropathy (NAION).
Warnings and cautions
Talk to your doctor before taking Granpidam if you:
- have a disease that is due to a blocked or narrowed vein in the lung, rather than a blocked or narrowed artery .
- have severe heart problems.
- have problems with the chambers of the heart.
- have high blood pressure in the blood vessels of the lungs.
- have low blood pressure at rest.
- loses a large amount of body fluids ( dehydration ) which can occur if you sweat a lot or do not drink enough fluid. This can happen if you are sick with fever, vomiting or diarrhea.
- have a rare inherited eye disease (retinitis pigmentosa).
- have abnormal red blood cells (sickle cell anemia), blood cell cancer ( leukemia ), bone marrow cancer (multiple myeloma ), any disease of the penis or deformed penis.
- right now have stomach ulcers or a bleeding disorder (such as hemophilia ) or problems with nosebleeds.
- uses drugs for erectile dysfunction .
When used to treat male erectile dysfunction (ED), the following side effects have been reported with PDE5 inhibitors, including sildenafil, at an unknown frequency: partial, sudden, temporary, or permanent visual impairment or loss of vision in one or both eyes.
If you experience sudden visual impairment or loss of vision, stop taking Granpidam and contact your doctor immediately (see also section 4).
Prolonged and sometimes painful erections have been reported in men after using sildenafil. If you get an erection that lasts longer than 4 hours, stop taking Granpidam and contact your doctor immediately (see also section 4).
Especially to take into account for patients with kidney or liver problems:
You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.
Granpidam should not be given to children under 1 year of age.
Other medicines and Granpidam
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:
- Drugs containing nitrates, or nitric oxide donors such as amyl nitrite (“poppers”). These medicines are often given to relieve angina pectoris or angina (see section 2. Do not take Granpidam).
- Tell your doctor or pharmacist if you are already taking riociguat.
- Treatment for pulmonary hypertension (eg bosentan , iloprost). Medicines containing St. John’s wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy ).
- Blood-thinning drugs (eg warfarin ) even if they do not show any side effects.
- Medicines containing erythromycin, clarithromycin, telithromycin ( antibiotics for the treatment of specific bacterial infections ), saquinavir (for the treatment of HIV ) or nefazodone (for depression), as your dose may need to be adjusted.
- Alpha-receptor blockers (eg doxazosin ) for the treatment of high blood pressure or prostate problems, as the combination of the two drugs can cause symptoms that lead to a decrease in your blood pressure (eg dizziness and dizziness).
Granpidam with food and drink
You should not drink grapefruit juice while you are 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 be used during pregnancy only when needed.
Granpidam should not be given to women of childbearing potential unless appropriate contraception is used.
Granpidam passes into breast milk in very small amounts and is not expected to harm the baby.
Driving and using machines
Granpidam can cause dizziness and affect vision. You should be aware of how you react to the medicine before driving or using machines.
Granpidam contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Granpidam contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free.
How to take Granpidam
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
For adults, the recommended dose is one 20 mg three times daily (taken at 6 to 8-hour intervals) with or without food.
Use in children and adolescents
For children and adolescents between 1 and 17 years of age, the recommended dose is either 10 mg three times daily for children and adolescents weighing 20 kg or less, or 20 mg three times daily for children and adolescents weighing over 20 kg. Taken with or without food. Higher doses should not be used in children. This medicine should only be used when administering 20 mg 3 times daily. Other forms of medicine are more suitable for the treatment of patients weighing less than 20 kg, as well as for younger patients who can not swallow tablets.
If you take more Granpidam than you should
Do not take more medicines than your doctor tells you to do. If you take more medicines than you have been told to take, contact your doctor immediately. Taking more Granpidam than you should increase the risk of known side effects.
If you forget to take Granpidam
If you forget to take Granpidam, take a dose as soon as you remember. Then continue to take your medicine at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Granpidam
Sudden discontinuation of Granpidam may make your symptoms worse. Do not stop taking Granpidam unless your doctor tells you to. Your doctor may ask you to reduce your dose for a few days before stopping completely.
If you have any further questions on the use of this product, 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 contact your doctor immediately (see also section 2):
- if you experience a sudden deterioration or loss of vision (no known frequency).
- if you have an erection that lasts longer than 4 hours. Prolonged and sometimes painful erections have been reported in men after taking sildenafil (no known frequency).
The side effects that were reported as very common (may affect more than 1 in 10 people) were: headache, flushing, digestive problems, diarrhea, and pain in the arms and legs.
Side effects that were reported as common (may affect up to 1 in 10 people) were: subcutaneous infection, flu-like symptoms, sinusitis, decreased red blood cell count ( anemia ), fluid retention in the body, difficulty sleeping, anxiety, migraines, tremors, numbness and tingling, burning sensation, decreased sensitivity of the skin, bleeding in the back of the eye, effects on vision, blurred vision and light shading, effect on color vision, eye irritation, bloodshot eyes / red eyes, dizziness, tracheal cataracts, nosebleeds, runny nose, cough, nasal congestion, stomach intestinal inflammation, heartburn, hemorrhoids, distended abdomen, dry mouth, hair loss, reddening of the skin, night sweats, muscle aches, back pain, and increased body temperature.
Side effects that were reported as uncommon (may affect 1 in 100 people) were: decreased visual acuity, double vision, abnormal sensation in the eyes, bleeding in the penis, the presence of blood in semen and/or urine, and breast enlargement in men.
Skin rash and sudden loss or loss of hearing and decreased blood pressure have also been reported with an unknown frequency (frequency cannot be calculated from the available data).
Children and young people
The following serious side effects have been reported commonly (occurring in up to 1 user in 10): pneumonia, heart failure, right ventricular failure, heart-related shock, high blood pressure in the lungs, chest pain, fainting, respiratory tract infection, tracheal, and urinary tract infections, gastrointestinal.
The following serious side effects were considered treatment-related and have been reported as uncommon (occurring in up to 1 user in 100): allergic reactions (such as rash, swelling of the face, lips, and tongue, wheezing, difficulty breathing and swallowing), convulsions, irregularities heartbeat, hearing loss, shortness of breath, inflammation of the stomach and intestines, wheezing due to obstructed airflow.
Side effects reported as very common (affects more than 1 user in 10) were: headache, vomiting, throat infection, fever, diarrhea, flu, and nosebleeds.
Side effects reported as common (affects up to 1 user in 10) include nausea, increased erection, pneumonia, and runny nose.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
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 which is stated on the carton and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 to protect the environment.
6. Contents of the packaging and other information
The active substance is sildenafil. Each tablet contains 20 mg of sildenafil (citrate).
- Other ingredients are:Tablet core: microcrystalline cellulose, calcium phosphate, croscarmellose sodium (see section 2, Granpidam contains sodium ), hypromellose 2910 (E464), magnesium stearate.
Film coating: hypromellose 2910 (E464), titanium dioxide (E171), lactose monohydrate , triacetin.
What the medicine looks like and contents of the pack
White to off-white, round, biconvex, film-coated tablets approximately 6.6 mm in diameter, embossed with “20” on one side and smooth on the other side.
Granpidam 20 mg film-coated tablets are available in blisters of PVC / Alu containing 90 tablets and 300 tablets.
Granpidam 20 mg film-coated tablets are also available in PVC / Alu perforated unit dose blisters containing 15×1, 90×1, and 300×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF
Laboratori Fundació DAU
C / C, 12-14 Pol. Ind. Zona Franca,
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland
Accord Healthcare BV,
3526 KV Utrecht,