BALCOGA 20 mg FILM-COATED TABLETS

Introduction

Leaflet:information for the patient

Balcoga 20 mg film-coated tablets EFG

Sildenafil

Read the entire leaflet carefully before starting to take this medication,as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

• This medication has been prescribed to you only, 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Balcoga and what is it used for
2. What you need to know before taking Balcoga
3. How to take Balcoga
4. Possible side effects

5 Conservation of Balcoga

1. Package contents and additional information

1. What is Balcoga and what is it used for

Balcoga contains the active ingredient sildenafil, which belongs to a group of medications called phosphodiesterase type 5 inhibitors (PDE5).

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

2. What you need to know before taking Balcoga

Do not take Balcoga:

• if you are allergic to sildenafil or any of the other components of this medication (listed in section 6),
• if you are taking medications that contain nitrates or nitric oxide donors, such as amyl nitrite ("poppers").

These medications are often administered to relieve chest pain (or angina pectoris). Balcoga may produce a significant increase in the effects of these medications. You should inform your doctor if you are taking any of these medications. If you are unsure, consult your doctor or pharmacist,

• if you are taking riociguat. This medication 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 blood clots). PDE5 inhibitors, such as Balcoga, have shown that they increase the hypotensive effect of this medication. 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 (<90/50 mmHg),
• if you are taking a medication to treat fungal infections such as ketoconazole or itraconazole or medications that contain ritonavir (for AIDS),
• if you have previously experienced vision loss due to a problem with blood flow to the optic nerve called non-arteritic anterior ischemic optic neuropathy (NAION).

Warnings and precautions

Consult your doctor before starting to take Balcoga 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 fluids. This can happen if you are sick with fever, vomiting, or diarrhea,
• you suffer from a rare inherited eye disease (retinitis pigmentosa),
• you suffer from a disorder of red blood cells (sickle cell anemia), blood cell cancer (leukemia), bone marrow cancer (multiple myeloma), or any disease or deformity of the penis,
• you currently have a stomach ulcer or bleeding disorders (such as hemophilia) or nosebleeds,
• you use medications for erectile dysfunction.

When using PDE5 inhibitors, including sildenafil, to treat erectile dysfunction (ED), the following visual side effects have been reported with unknown frequency: decrease or loss of vision, sudden, temporary, or permanent, in one or both eyes.

If you experience a reduction or sudden loss of vision, stop takingthis medicationand consult your doctor immediately(see also section 4).

Prolonged and sometimes painful erections have been observed in men taking sildenafil. If you have an erection that lasts for more than 4 hours, stop takingthis medicationand consult your doctor immediately(see also section 4).

Special precautions in patients with kidney or liver problems

You should inform your doctor if you have kidney or liver problems, as a dose adjustment may be necessary.

Children

Balcoga should not be administered to children under 1 year of age.

Other medications and Balcoga

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

• medications that contain nitrates or nitric oxide donors, such as amyl nitrite ("poppers"). These medications are often administered to relieve chest pain or angina pectoris (see section 2. What you need to know before taking Balcoga),
• inform your doctor or pharmacist if you are taking riociguat,
• treatments for pulmonary hypertension (e.g., bosentan, iloprost),
• medications that contain St. John's Wort (herbal medicine), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin, and phenobarbital (used, among others, to treat epilepsy),
• medications that inhibit blood coagulation (e.g., warfarin), although they have not caused any side effects,
• medications that contain erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for 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 medications can cause symptoms of reduced blood pressure (e.g., dizziness, fainting),
• medications that contain sacubitril/valsartan, used to treat heart failure.

Taking Balcoga with food and drinks

You should not drink grapefruit juice when being treated with Balcoga.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Sildenafil should not be used during pregnancy unless absolutely necessary.

Sildenafil should not be administered to women of childbearing age unless adequate contraceptive methods are used.

Balcoga passes into breast milk at very low levels and is not expected to harm your baby.

Driving and using machines

Balcoga may cause dizziness and affect vision. You should know how you react to this medication before driving vehicles or using machinery.

Balcoga contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per film-coated tablet; this is, essentially, "sodium-free".

3. How to take Balcoga

Follow the administration instructions of this medication 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) taken 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 in 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 is to be administered.

For administration in patients weighing ≤ 20 kg and in other younger patients who cannot swallow tablets, other pharmaceutical forms more suitable for their needs may be used.

If you take more Balcoga than you should

You should not take more medication than your doctor indicates.

If you have taken more Balcoga than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

Taking more than you should may increase the risk of known side effects.

If you forget to take Balcoga

If you have forgotten to take Balcoga, take the dose as soon as you remember and continue taking your medication at the usual times. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Balcoga

Sudden interruption of treatment with Balcoga may lead to worsening of your symptoms.

Do not stop taking this medication unless your doctor tells you to. Your doctor will indicate how to reduce the dose over a few days before stopping it completely.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

If you suffer from any of the following side effects, stop taking Balcoga and inform your doctor immediately (see section 2):

• if you experience a sudden loss of vision (unknown frequency),
• if you have an erection that lasts continuously for more than 4 hours. Prolonged and sometimes painful erections have been reported in men taking sildenafil (unknown frequency).

Adults

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

The common side effects (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, vision changes, blurred vision, and sensitivity to light, effects on color perception, eye irritation, red eyes, dizziness, bronchitis, nosebleeds, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, hemorrhoids, abdominal distension, dry mouth, hair loss, skin flushing, night sweats, muscle pain, back pain, and increased body temperature.

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

Also, skin rashes, sudden loss of hearing, and decreased blood pressure have been reported with unknown frequency (cannot be estimated from available data).

Children and adolescents

The following serious side effects have been reported frequently (may affect up to 1 in 10 patients): pneumonia, heart failure, right heart failure, cardiac shock, high blood pressure in the lungs, chest pain, dizziness, respiratory infections, bronchitis, viral gastroenteritis, urinary tract infections, and tooth perforations.

The following serious side effects were considered related to treatment and were reported infrequently (may affect up to 1 in 100 patients): allergic reaction (such as skin rash, facial swelling, lip and tongue swelling, sneezing, difficulty breathing or swallowing), seizures, irregular heartbeat, hearing changes, shortness of breath, digestive tract inflammation, and sneezing due to changes in air flow.

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Balcoga

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and blister after CAD/EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Balcoga

• The active ingredient is sildenafil. Each film-coated tablet contains sildenafil citrate equivalent to 20 mg of sildenafil.
• The other components are:

Core of the tablet: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, sodium croscarmellose, copovidone, magnesium stearate.

Coating: hypromellose, titanium dioxide (E171), macrogol 4000.

Appearance of the product and package contents

Balcoga is a white, round (diameter 7.1 mm), biconvex film-coated tablet, marked with "20" on one side, packaged in PVC/Aclar/Aluminum blisters.

Package sizes: 30, 90, 100, 150, 300, and multiple package of 300 (2 packages of 150 and 3 packages of 100) film-coated tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

D - 39179 Barleben,

Germany

Date of the last revision of this leaflet:December 2023.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/