Prospecto:information for the patient

Balcoga 20 mg film-coated tablets EFG

Sildenafil

Read this prospectus carefully before starting to take this medication,because it contains important information for you.

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

-This medication has been prescribedonlyto you, and you should not give it to other people even iftheyhave the same symptomsas you,as it may harm them.

• If you experience any adverse effects,consult your doctor or pharmacist,evenifthey are not listed in this prospectus. See section 4.

1.What is Balcoga and what is it used for

2.What you need to knowbeforestarting totake Balcoga

3.How to take Balcoga

4.Possible adverse effects

5Storage of Balcoga

6.Contents of the package and additional information

Balcogacontains the active ingredient sildenafilo which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.

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 lung (pulmonary arterial hypertension) in adults and children and adolescents between 1 to 17 years.

Do not take Balcoga:

• if you are allergic to sildenafil or any of the other ingredients 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). Balcoga may cause a significant increase in the effects of these medications. Inform your doctor if you are taking any of these medications. If you are unsure, consult with your doctor or pharmacist,

• if you are taking riociguat. This medication is used to treat pulmonary hypertension (i.e., high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e., high blood pressure in the lungs caused by clots). PDE5 inhibitors, such as Balcoga, have shown to 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),
• if you are taking a medication to treat fungal infections such as ketoconazole or itraconazole or medications that contain ritonavir (for HIV/AIDS),
• if you have previously experienced vision loss due to a problem with blood flow to an eye 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 caused by 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 liquids. This can happen if you are sick with fever, vomiting, or diarrhea,
• you have a rare inherited eye disease (retinitis pigmentosa),
• you have a blood disorder (sickle cell anemia), leukemia, multiple myeloma, or any disease or deformity of the penis,
• you have an active stomach ulcer or bleeding disorders (such as hemophilia) or nosebleeds,
• you are taking medications for erectile dysfunction.

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

If you experience a sudden loss of vision, stop taking this medication and 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 more than 4 hours, stop taking this medication and consult your doctor immediately (see also section 4).

Special precautions in patients with kidney or liver problems

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.

Other medications and Balcoga

Inform your doctor or pharmacist if you are taking, have taken recently, 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 (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),
• blood-thinning medications (e.g., warfarin) although no adverse effects have been reported,
• medications that contain erythromycin, clarithromycin, telithromycin (antibiotics used to treat certain bacterial infections), saquinavir (for HIV/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 may cause symptoms of low blood pressure (e.g., dizziness, fainting),
• medications that contain sacubitril/valsartan, used to treat heart failure.

Taking Balcoga with food and drinks

Do not take orange juice while being treated with Balcoga.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 operating machinery

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

Balcoga contains sodium

This medication contains less than 1mmol of sodium (23 mg) per coated tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor.This medication should be taken exactly as directed 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) 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 for 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 necessary.

For administration in patients weighing 20 kg or less and in other younger patients who cannot swallow the tablets, other more suitable pharmaceutical forms may be used.

If you take moreBalcogathan 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 Toxicological 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 forgot to takeBalcoga

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

If you interrupt treatment withBalcoga

Stopping treatment with Balcoga abruptly may lead to worsening of your symptoms.

Do not stop taking this medication unless your doctor tells you to. Your doctor will instruct you on 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following side effects, stop takingBalcogaand inform your doctor immediately (see section 2):

• if you experience sudden loss or reduction 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 after taking sildenafil in men (unknown frequency).

Adults

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

The side effects reported frequently (may affect up to 1 in 10 patients) are: skin infection, flu-like symptoms, nasal sinus inflammation, reduction in red blood cell count (anemia), fluid retention, difficulty sleeping, anxiety, migraine, tremor, tingling sensation, burning sensation, reduced sense of touch, bleeding from the back of the eye, visual disturbances, blurred vision, and light sensitivity, color perception effects, eye irritation, red or bloodshot eyes, dizziness, bronchitis, nasal bleeding, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, burning sensation, hemorrhoids, abdominal distension, dry mouth, hair loss, skin redness, night sweats, muscle pain, back pain, and increased body temperature.

The side effects reported infrequently (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 eruptions, sudden loss or reduction of hearing, and reduced blood pressure have been reported with an unknown frequency (cannot be estimated from available data).

Children and adolescents

Frequently reported (may affect up to 1 in 10 patients) severe side effects in children and adolescents were: pneumonia, heart failure, right heart failure, cardiac shock, high blood pressure in the lungs, chest pain, dizziness, respiratory infections, bronchitis, viral infections in the stomach and intestines, urinary tract infections, and tooth perforations.

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

The side effects reported very frequently (may affect more than 1 in 10 people) were headache, vomiting, throat infection, fever, diarrhea, flu, and nasal bleeding.

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

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears on thecontainer and blister pack 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 drains or in the trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Balcoga

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

Tablet core: microcrystalline cellulose, anhydrous calcium hydrogen phosphate, croscarmellose sodium, copovidone, magnesium stearate.

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

Appearance of the product and content of the container

Balcogais a white, round (diameter 7.1 mm), biconvex film-coated tablet, marked with “20” on one face, packaged in PVC/Aclar/Aluminum blisters.

Container sizes: 30, 90, 100, 150, 300, and a multiple container of 300 (2 containers of 150 and 3 containers of 100) film-coated tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

D - 39179 Barleben,

Germany

Last review date of thisleaflet:December 2023.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/