GRANPIDAM 20 mg Film-Coated Tablets

Зміст інструкції

1. Granpidam 20 mg film-coated tablets
   1. What is Granpidam and what is it 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. Package contents and other information What Granpidam contains

Granpidam 20 mg film-coated tablets

Sildenafil

Read this leaflet carefully before taking this medicine as 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 could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is Granpidam and what is it used for

Granpidam contains the active substance sildenafil which belongs to the 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 for the treatment of adults and children and adolescents from 1 to 17 years with high
blood pressure in the blood vessels of the lungs (pulmonary arterial hypertension).

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 that contain nitrates or if you are taking substances that release nitric oxide, such as amyl nitrate (“poppers”). These medicines are often used to relieve chest pain (or “angina pectoris”). Granpidam may cause a considerable increase in the effects of these medicines. Tell 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). It has been shown that PDE5 inhibitors, such as sildenafil, increase the hypotensive effect of this medicine. If you are taking riociguat or if you have any doubts, tell your doctor.
• if you have recently had a stroke, a heart attack or if you have a severe liver disease or very low blood pressure (< 90/50 mmHg).
• if you are taking a medicine to treat fungal infections, such as ketoconazole

or itraconazole or medicines containing ritonavir (for HIV).

• if you have previously experienced loss of vision caused by a problem with blood flow to the optic nerve called non-arteritic anterior ischemic optic neuropathy (NAION).

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

• the condition is due to obstruction or narrowing of a pulmonary vein rather than an artery.
• you have a serious heart problem.
• you have problems with the cardiac 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 can occur when you sweat a lot or when you don’t drink enough fluids. 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 the red blood cells (sickle cell anemia), a cancer of the blood cells (leukemia), a cancer of the bone marrow (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 it has been used for the treatment of erectile dysfunction (ED), with PDE5 inhibitors,
including sildenafil, the following adverse effects on vision have been reported, with unknown frequency: 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).
Prolonged and sometimes painful erections have been reported after taking sildenafil in men.
If you have an erection that lasts 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 should tell your doctor because a
dose adjustment may be necessary.

Children
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.

• Medicines that contain 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).
• Tell your doctor or pharmacist if you are already taking riociguat.
• Therapies for pulmonary arterial hypertension (for example bosentan, iloprost) ask your doctor or pharmacist for advice before taking Granpidam.
• Medicines containing St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (also used for epilepsy).
• Medicines that inhibit blood clotting (for example warfarin), although no adverse effects have been reported.
• Medicines containing erythromycin, clarithromycin, telithromycin (are antibiotics used to treat some 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 the two medicines may 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 drink
Do not drink grapefruit juice while being treated with Granpidam.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect or are planning a pregnancy, ask
your doctor or pharmacist for advice before taking this medicine. Granpidam should not be
taken during pregnancy unless absolutely necessary.
Granpidam should not be given to women of childbearing potential unless they are using adequate
contraceptive methods.
Granpidam passes into breast milk in small amounts and is not believed to be harmful to
the baby.

Driving and using machines
Granpidam can cause dizziness and can alter vision. Before driving and using machines
you should be aware of how you react to this medicine.

Granpidam contains lactose
If you have been diagnosed by your doctor as intolerant to some 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 following exactly the instructions of your doctor. If you have any doubts, ask your
doctor or pharmacist.
For adults, the recommended dose is 20 mg three times a day (to be taken at intervals of 6-8 hours) with or
without food.

Use in children and adolescents
For children and adolescents from 1 to 17 years of age, 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, to be taken with or without food. Higher doses should not be used in children. This
medicine should only be used if administration of 20 mg three times a day is required. Other pharmaceutical
forms may be more appropriate for administration to patients weighing ≤ 20 kg and to
other younger patients who are unable to swallow the tablets.

If you take more Granpidam than you should
Do not take a quantity of medicine greater than that prescribed by your doctor.
If you take a quantity of medicine greater than that prescribed, contact your doctor
immediately. Taking more Granpidam than you should may increase the risk of known
side effects.

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

If you stop taking Granpidam
Suddenly stopping treatment with Granpidam may cause a worsening of
symptoms. Do not stop treatment with Granpidam unless your doctor tells you to. Your doctor
may tell you to reduce the dose over a few days before stopping treatment completely.
If you have any doubts about 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, you must stop taking
Granpidam and contact your doctor immediately (see also section 2):

• if you experience sudden vision impairment or loss of vision (frequency not known)
• if you experience 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
Very common side effects (may affect more than 1 in 10 people) have been headache, facial flushing, indigestion, diarrhoea and pain in the arms or legs.
Common side effects (may affect up to 1 in 10 people) include:
skin infections, flu-like symptoms, sinusitis, reduced number of red blood cells (anaemia),
fluid retention, sleep disorders, anxiety, headache, tremor, pins and needles sensation,
burning sensation, reduced sense of touch, bleeding in the back of the eye, effects on
vision, blurred vision and sensitivity to light, effects on colour perception,
eye irritation, eye inflammation/redness, dizziness, bronchitis, nosebleeds,
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.
Uncommon side effects (may affect up to 1 in 100 people) reported include: reduced visual acuity, double vision, abnormal sensation in the eye, bleeding
of the penis, blood in the semen and/or urine, and excessive development of male breast tissue.
Skin rash, a sudden decrease or loss of hearing and
decreased blood pressure have also been reported, with frequency not known (frequency cannot be established on the basis of the available data).
Children and adolescents
The following serious adverse events have been reported commonly (may affect up to 1 in 10): pneumonia, heart failure, right-sided heart failure, heart-related shock,
high blood pressure in the lungs, chest pain, fainting, respiratory infection, bronchitis,
viral infection of the stomach and intestines, urinary tract infection and tooth decay.
The following serious adverse events have been considered related to treatment and have been reported uncommon (may affect up to 1 in 100): allergic reactions (such as rash, swelling of the face, lips and tongue, wheezing, difficulty breathing or swallowing), convulsions,
irregular heartbeat, hearing loss, shortness of breath, inflammation of the digestive tract,
wheezing due to breathing problems.
Very common side effects (may affect more than 1 in 10 people) have been:
headache, vomiting, sore throat, fever, diarrhoea, influenza and nosebleeds.
Common side effects (may occur in up to 1 in 10 people) have been:
nausea, increased erections, pneumonia and runny nose.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through the national reporting system indicated 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 blister, after Scad.
The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in 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 ingredient is sildenafil. Each tablet contains 20 mg of sildenafil (as citrate).
• The excipients are: 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 contents of the pack
Film-coated tablets of white to off-white color, round in shape, with a diameter of approximately 6.6
mm, biconvex, with “20” imprinted on one side and smooth on the other.
Granpidam 20 mg film-coated tablets are available in PVC/All blister packs containing 90
tablets and 300 tablets.
Granpidam 20 mg film-coated tablets are also provided in unit dose blister packs in
PVC / aluminum 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,
Netherlands
More detailed information on this medicine is available on the website of the European Medicines
Agency (EMA): http://www.ema.europa.eu .