62.5 mg film-coated tablets 
bosentan

1. What Bosentan Actavis is and what it is used for

Bosentan Actavis tablets contain bosentan , which blocks a naturally occurring hormone called endothelin-1 (ET-1) which causes the blood vessels to become narrow. Bosentan Actavis, therefore, causes the blood vessels to dilate and belongs to a group of medicines called ‘endothelin receptor antagonists’.

Bosentan Actavis is used to treat:

  • Pulmonary arterial hypertension (PAH): PAH is a disease that leads to severe narrowing of the blood vessels in the lungs. As a result, high blood pressure occurs in the blood vessels in the lungs (pulmonary arteries) that transport blood from the heart to the lungs. This pressure reduces the amount of oxygen that can enter the blood in the lungs, making physical activity more difficult. BosentanActavis dilates the pulmonary arteries and makes it easier for the heart to pump blood through them. This lowers blood pressure and relieves symptoms.

Bosentan Actavis is used for treating patients with pulmonary arterial hypertension(PAH) class III to improve their ability to work (the ability to perform physical activity) and their symptoms. The class shows the severity of the disease, where class III means that physical activity is markedly limited. Some improvements have also been shown in patients with PAH class II. Class II means that physical activity is easily limited. PAHs for which Bosentan Actavis is used may be:

  • primary (without identified cause or hereditary)
  • caused by scleroderma (also called systemic sclerosis, a disease with abnormal growth of connective tissue that supports the skin and other organs)
  • caused by congenital (congenital) heart defects where shunts (abnormal connections) cause an abnormal blood flow through the heart and lungs.
  • Digital sores (sores on the fingers and toes) in adult patients with a condition called scleroderma. Bosentan Actavis reduces the number of new wounds on fingers and toes that occur.

Bosentan contained in Bosentan Actavis 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.

What you need to know before using Bosentan Actavis

Do not use Bosentan Actavis

  • if you are allergic to bosentan or any of the other ingredients of this medicine (listed in section 6).
  • if you have liver problems (ask your doctor)
  • if you are pregnant or may become pregnant because you are not using reliable contraception. Read the information under “Contraceptives” and “Other medicines and Bosentan Actavis”.
  • if you are taking ciclosporin A (a medicine used after transplantation or to treat psoriasis )

If any of these apply to you, talk to your doctor.

Warnings and cautions

Talk to your doctor or pharmacist before taking Bosentan Actavis

Checks that your doctor will do before treatment

  • blood tests to check liver function
  • blood tests to check anemia ( anemia, low hemoglobin )
  • pregnancy test if you are a woman of childbearing age

Some patients who have used Bosentan Actavis have had abnormal liver function tests and anemia (low hemoglobin ).

Checks that your doctor will do during treatment

Your doctor will arrange regular blood tests to check for changes in liver function and hemoglobin levels during treatment with Bosentan Actavis.

For all these tests, see also the patient card (in the package with Bosentan Actavis). It is important that these regular blood tests are taken throughout the time you take Bosentan Actavis. We suggest that you write down the date of the last test and also the next test (ask your doctor about the date) on the patient card, as help to remember when the next test is to be taken.

Blood tests for liver function

These samples will be taken once a month throughout the treatment with BosentanActavis. After an increase in dose one, an extra sample will be taken after two weeks.

Blood tests for anemia ( anemia )

These will be taken once a month during the first four months of treatment and then once every three months thereafter, as patients taking Bosentan Actavis may develop anemia .

If the results are abnormal, your doctor may decide to reduce the dose one or stop treatment with Bosentan Actavis and make further tests to find out the cause.

Children and young people

Bosentan Actavis is not recommended for children with systemic sclerosis and ongoing disease with digital ulcers. Bosentan Actavis should not be used in children weighing less than 31 kg and in certain weight ranges associated with pulmonary arterial hypertension. See also section 3. How to use Bosentan Actavis.

Other medicines and Bosentan Actavis

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important that you tell your doctor if you are taking:

  • ciclosporin A (a medicine used after transplants and to treat psoriasis ), not to be used with Bosentan Actavis
  • sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended for use with Bosentan Actavis
  • glibenclamide (for diabetes ), rifampicin (for the treatment of tuberculosis ), fluconazole and ketoconazole (for the treatment of Cushing’s syndrome) or nevirapine (for the treatment of HIV ) as these medicines are not recommended for use with Bosentan Actavis.
  • other medicines for the treatment of HIV – infection that may need to be controlled especially if used with Bosentan Actavis
  • hormonal contraceptives, which are not effective as the only method of contraception when taking Bosentan Actavis. The package of Bosentan Actavis tablets contains a patient card that you must read carefully. Your doctor and/or gynecologist will determine which contraceptives are right for you.
  • other medicines for the treatment of pulmonary hypertension: sildenafil and tadalafil
  • warfarin (a blood thinner)
  • simvastatin (used to treat hypercholesterolemia ).

Driving and using machines

Bosentan Actavis has no or negligible influence on the ability to drive and use machines. Bosentan Actavis can cause hypotension (low blood pressure ), which may make you feel dizzy, affect your vision and your ability to drive and use machines. Therefore, if you feel dizzy or if your vision is impaired when you take BosentanActavis, do not drive or use any tools or 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.

Bosentan Actavis contains sodium

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

How to use Bosentan Actavis

Treatment with Bosentan Actavis should only be started and followed up by a doctor who has experience in the treatment of PAH or systemic sclerosis. Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Bosentan Actavis with food and drink

Bosentan Actavis can be taken with or without food.

Recommended dose

Adults

Treatment is usually started with 62.5 mg twice daily (morning and evening) for the first 4 weeks. Thereafter, your doctor will usually prescribe a 125 mg tablet twice daily, depending on how you react to Bosentan Actavis.

Children and young people

The recommended dose for children is for PAH only. In children 1 year of age and older, treatment with Bosentan Actavis is usually started at 2 mg/kg body weight twice daily (morning and evening). Some doses can not be given to children weighing less than 31 kg and in some other weight ranges, as they need a bosentan tablet with lower strength. Your doctor will tell you how to dose.

If you have the impression that the effect of bosentan is too strong or too weak, talk to your doctor as your dose may need to be changed.

How to use Bosentan Actavis

The tablets should be taken morning and evening and should be swallowed with water. The tablets can be taken with or without food.

If you forget to take Bosentan Actavis

If you forget to take Bosentan Actavis, take a dose as soon as you remember and then continue to take your tablets at the usual times. Do not take a double dose to make up for a forgotten tablet.

If you stop using Bosentan Actavis

If you suddenly stop taking Bosentan Actavis treatment, your symptoms may get worse. Do not stop taking Bosentan Actavis unless your doctor tells you to. Your doctor may instruct 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.

The most serious side effects with Bosentan Actavis are

  • abnormal liver function that may occur in more than 1 in 10 users
  • anemia (low blood count) that may affect up to 1 in 10 people. Anemia can sometimes require a blood transfusion.

Your liver and blood counts will be monitored during treatment with BosentanActavis (see section 2). It is important that you take the samples as prescribed by your doctor.

Symptoms that indicate that your liver is not functioning normally include:

  • nausea (feeling the need to vomit)
  • vomiting
  • fever (elevated body temperature)
  • stomach ache
  • jaundice (yellowing of the skin or whites of the eyes)
  • dark-colored urine
  • skin itching
  • listlessness or fatigue (unusual tiredness or fatigue)
  • flu-like symptoms (muscle and joint pain with fever)

Tell your doctor immediately if you experience any of these side effects.

Other side effects:

Very common (may affect more than 1 user in 10 ):

  • Headache
  • Edema (swelling of the legs and ankles or other symptoms of fluid retention)

Common (may affect up to 1 in 10 people):

  • Sudden reddening of the face or redness of the skin
  • Hypersensitivity reaction (with skin inflammation, itching, and rash)
  • Nasal congestion
  • Gastroesophageal reflux disease (acid reflux)
  • Diarrhea
  • Short-term loss of consciousness (fainting)
  • Palpitations (fast or irregular heartbeat)
  • Low blood pressure

Uncommon (may affect up to 1 in 100 people):

  • Thrombocytopenia (lack of platelets )
  • Neutropenia/leukopenia (low white blood cell count )
  • Elevated liver function values ​​with hepatitis ( inflammation of the liver) including possible worsening of underlying hepatitis and/or jaundice (yellowing of the skin or whites of the eyes)

Rare (may affect up to 1 in 1,000 people ):

  • Anaphylactic reactions (general allergic reaction ), angioedema (swelling, usually around the eyes, lips, tongue, or throat)
  • Cirrhosis (scarring) of the liver, liver failure (severe hepatic impairment)

Has been reported (occurs in an unknown number of users)

– Dimsyn

Side effects are in children and adolescents

Children treated with Bosentan Actavis have the same reported side effects as adults.

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 Bosentan Actavis

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 expiry date will be the last day of that month.

Do not store above 30 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures are necessary to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is bosentan in the form of monohydrate. Each tablet contains 62.5 mg bosentan (monohydrate).

Other ingredients:

Tablet core: 

corn starch, pregelatinized starch, sodium starch glycolate, povidone, glycerol behenate, magnesium stearate.

Film coating:

poly (vinyl alcohol) (E1203), macrogol (E1521), talc (E553b), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

What the medicine looks like and the contents of the pack

Bosentan Actavis 62.5 mg film-coated tablets are pale yellow, (6 mm) round, biconvex and debossed with “111” on one side and “A” on the other side.

The blister pack contains 10, 14, 30, 56, 60, and 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Actavis Group PTC ehf

Reykjavíkurvegur 76-78

220 Hafnarfjörður

Iceland

Manufacturer:

Balkanpharma – Dupnitsa AD 
3, Samokovsko Shose Str. 
2600 Dupnitsa 
Bulgaria

Muhammad Nadeem

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