Balcoga

Patient Information Leaflet: Information for the User

Balcoga 20 mg Film-coated Tablets

Sildenafil
Generic Medicine
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 only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Balcoga is and what it is used for
2. What you need to know before taking Balcoga
3. How to take Balcoga
4. Possible side effects
5. How to store Balcoga
6. Package contents and other information

1. What Balcoga is and what it is used for

Balcoga contains the active substance sildenafil, which belongs to a class of medicines called
phosphodiesterase type 5 (PDE5) inhibitors.
Balcoga reduces blood pressure by dilating the blood vessels in the lungs.
Balcoga is used to treat adults and children and adolescents from 1 to 17 years of age with high
blood pressure in the lung blood vessels (pulmonary arterial hypertension).

2. What you need to know before taking Balcoga

Do not take Balcoga if:

• you are allergic to sildenafil or any of the other ingredients of this medicine (listed in section 6).
• 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"). Balcoga can significantly 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.
• 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 due to blood clots). PDE5 inhibitors such as Balcoga have been shown to enhance the blood pressure-lowering effect of this medicine. If you are taking riociguat or have any doubts, inform your doctor.
• you have recently had a stroke or heart attack, or if you have severe liver disease or very low blood pressure (< 90/50 mmHg).
• you are taking a medicine to treat fungal infections, such as ketoconazole or itraconazole, or medicines containing ritonavir (for HIV).
• you have previously experienced vision loss caused by a blood flow problem to the optic nerve known as non-arteritic anterior ischemic optic neuropathy (NAION).

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

• you have a disease caused by 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 sweating excessively or not drinking enough fluids. This may 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 cancer (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 been associated with the following visual side effects, the frequency of which is unknown: partial, sudden, temporary or permanent reduction or loss of vision in one or both eyes.
If you experience sudden decrease or loss of vision, stop taking Balcoga
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 Balcoga
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, inform your doctor, as a dose adjustment may be necessary.

Children
Balcoga must not be given to children under 1 year of age.

Other medicines and Balcoga
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• Medicines containing nitrates or substances that release nitric oxide, such as amyl nitrate ("poppers") or nicorandil (a vasodilator used to treat angina). These medicines are often used to relieve angina pectoris or "chest pain" attacks (see section 2. What you need to know before taking Balcoga).
• Inform your doctor or pharmacist if you are already taking riociguat.
• Treatments for pulmonary arterial hypertension (e.g., bosentan, iloprost).
• 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 clotting (e.g., warfarin), although no adverse effects have been observed.
• Medicines containing 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 treating high blood pressure or prostate problems, as combining these medicines may cause symptoms leading to low blood pressure (e.g., dizziness, lightheadedness).

Balcoga with food and drinks
You must not drink grapefruit juice while being treated with Balcoga.

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

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

3. How to take Balcoga

You must take this medicine exactly as instructed by your doctor. If you have any doubts,
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 administered at a dose of 20 mg three times daily.
Other pharmaceutical forms may be more suitable for administration to patients with body weight ≤ 20 kg and to younger patients who are unable to swallow tablets.
If you take more Balcoga than you should
Do not take more medicine than prescribed by your doctor.
If you take more medicine than prescribed, contact your doctor immediately. Taking more Balcoga than recommended may increase the risk of known adverse effects.
If you forget to take Balcoga
If you forget to take Balcoga, 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 missed dose.
If you stop taking Balcoga
Stopping treatment with Balcoga suddenly may cause worsening of symptoms. Do not stop treatment with Balcoga 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, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following side effects, you must stop taking Balcoga and contact your doctor immediately (see also section 2):

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

Adults
The side effects reported very commonly (may affect more than 1 in 10 people) were:
headache, facial flushing, indigestion, diarrhoea, and pain in arms or legs.
The side effects reported commonly (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, 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.
The side effects reported uncommonly (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 breast development in males.
Skin rash, sudden decrease or loss of hearing, and low 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 reported commonly (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 infection of the stomach and intestine, 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 side effects reported very commonly (may affect more than 1 in 10 people) were:
headache, vomiting, sore throat, fever, diarrhoea, influenza, and nosebleeds.
The side effects reported commonly (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 at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Balcoga

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after
Exp. The expiry date refers to the last day of the month indicated.
Do not dispose of medicines 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 Balcoga contains

• The active substance is sildenafil. Each tablet contains sildenafil citrate equivalent to 20 mg of sildenafil.
• The other components are:
  Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, copovidone, magnesium stearate
  Tablet coating: hypromellose, titanium dioxide (E171), macrogol 4000

Description of the appearance of Balcoga and contents of the pack
Balcoga are white, round, film-coated tablets (diameter: 7.1 mm), biconvex, with "20" engraved on one side, packed in PVC/Aclar/aluminium blisters.
Pack sizes: 30, 90, 100, 150 and 300 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Sandoz GmbH, Biochemiestraße 10, 6250 Kundl, Austria
Legal representative in Italy: Sandoz S.p.A., L.go U. Boccioni 1, 21040 Origgio (VA), Italy

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1, D - 39179 Barleben, Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria Balcoga 20 mg - Filmtabletten
Belgium Balcoga 20 mg filmomhulde tabletten
Bulgaria Balcoga, 20 mg film-coated tablets
Finland Balcoga 20 mg tabletti, kalvopäällysteinen
France Balcoga 20 mg, comprimé pelliculé
Germany Balcoga 20 mg Filmtabletten
Ireland Balcoga 20 mg Film-coated tablets
Italy Balcoga
Luxembourg Balcoga 20 mg comprimés pelliculés
Netherlands Balcoga 20 mg, filmomhulde tabletten
Czech Republic Balcoga 20 mg
Slovakia Balcoga 20 mg filmom obalené tablety
Romania Balcoga 20 mg comprimate filmate
Slovenia Balcoga 20 mg filmsko obložene tablete
Spain Balcoga 20 mg comprimidos recubiertos con película EFG
Sweden Balcoga 20 mg filmdragerade tabletter