20 mg film-coated tablets 
sildenafil

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
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. Contents of the packaging and other information 

1. What Balcoga is and what it is used for

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


Balcoga lowers blood pressure in the lungs 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 blood vessels of the lungs (pulmonary arterial hypertension ).

Sildenafil found in Balcoga may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you take Balcoga

Do not take Balcoga:

  • 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. These medications are often given to relieve angina (or angina pectoris). Balcoga can cause a sharp 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 Balcoga, 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 Balcoga if you:

  • have a disease 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 number 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 on vision 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 Balcoga 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 Balcoga 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.

Children

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

Other medicines and Balcoga

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 or nicorandil (drugs that dilate the blood vessels used in the treatment of angina). These medicines are often given to relieve angina pectoris or angina (see section 2. What you need to know before you take Balcoga).
  • 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 thinners (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 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).

Balcoga with food and drink

You should not drink grapefruit juice while you are being treated with Balcoga.

Pregnancy and breastfeeding

If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Balcoga should be used during pregnancy only when clearly needed.

Balcoga should not be given to women of childbearing potential unless appropriate contraception is used. Balcoga passes into breast milk in very small amounts and is not expected to harm the baby.

Driving and using machines

Balcoga can cause dizziness and affect vision. You should be aware of how you react to the medicine before driving or using machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Balcoga contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.

3. How to take Balcoga

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. There are other forms of medicine that are more suitable for the treatment of patients weighing less than 20 kg, as well as for younger patients who can not swallow tablets.

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

If you forget to take Balcoga

If you forget to take Balcoga, 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 Balcoga

Sudden discontinuation of Balcoga can lead to worsening of your symptoms. Do not stop taking Balcoga 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 Balcoga 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).

Adults

The side effects 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 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, the effect on color vision, eye irritation, bloodshot eyes / red eyes, dizziness, tracheal cataracts, nosebleeds, runny nose, cough, nasal congestion, gastritis, gastrointestinal inflammation, heartburn, hemorrhoids, distended abdomen, dry mouth, hair loss, reddening of the skin, night sweats, muscle aches, back pain, and increased body temperature.

Adverse reactions reported as uncommon (may affect up to 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 (may affect up to 1 in 10 people): pneumonia, heart failure, right ventricular failure, heart-related shock, high blood pressure in the lungs, chest pain, fainting, respiratory tract infection, tracheal inflammation, gastrointestinal and intestinal viral infection caries.

The following serious side effects were considered treatment-related and have been reported as uncommon (may affect up to 1 in 100 people): allergic reactions (such as rash, swelling of the face, lips, and tongue, wheezing, difficulty breathing and swallowing), convulsions, irregular heartbeat, hearing loss, shortness of breath, inflammation of the stomach and intestines, wheezing due to obstructed airflow.

Side effects reported as very common (may affect more than 1 in 10 people) were headache, vomiting, throat infection, fever, diarrhea, flu, and nosebleeds.

Adverse reactions reported as common (may affect up to 1 in 10 people) were 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 includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How to store Balcoga

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

Content declaration

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

What the medicine looks like and the contents of the pack

Balcoga tablets are white, round (7.1 mm in diameter), biconvex film-coated tablets. They are marked “20” on one side. The tablets are packaged in PVC / Aclar / Aluminum pressure packs.

Pack sizes: 30, 90, 100, 150 and 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

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

Muhammad Nadeem

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