62.5 mg and 125 mg film-coated tablets 
bosentan

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 may harm them, even if they show symptoms 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: 
1. What Bosentan Accord is and what it is used for 
2. What you need to know before you take Bosentan Accord 
3. How to take Bosentan Accord 
4. Possible side effects 
5. How to store Bosentan Accord 
6. Contents of the packaging and other information 

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

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

Bosentan Accord 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. Bosentan Accord dilates the pulmonary arteries and makes it easier for the heart to pump blood through them. This lowers blood pressure and relieves symptoms.

Bosentan Accord 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 symptoms. The class shows the severity of the disease, where class III means that physical activity is markedly limited. Class II means that physical activity is easily limited. PAHs for which Bosentan Accord is used can 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.
  • Finger and toe ulcers in adult patients with a condition called scleroderma. Bosentan Accord reduces the number of new wounds on fingers and toes that occur.

Bosentan contained in the Bosentan Accord may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before taking Bosentan Accord

Do not take Bosentan Accord

  • 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 Accord”,
  • if you are taking ciclosporin A (a medicine used after a transplant 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 Accord.

Checks that your doctor will do before treatment:

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

Some patients who have used bosentan 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 Accord.

For all these tests, see also the patient care (in the package with Bosentan Accord). It is important that these regular blood tests are taken throughout the time you are taking Bosentan Accord. 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 will be taken once a month throughout the treatment with Bosentan Accord. After an increase in dose one, an extra sample will be taken after 2 weeks.

Blood tests for anemia ( anemia )

This will be done once a month during the first 4 months of treatment and then once every 3 months, as patients taking Bosentan Accord may develop anemia.

If the results are abnormal, your doctor may decide to reduce the dose one or stop treatment with Bosentan Accord and do further research to investigate the cause.

Children and young people

There is only limited clinical experience in children under 2 years of age with pulmonary arterial hypertension. Bosentan Accord is not recommended for children with systemic sclerosis and ongoing illness with digital wounds. See also section 3, “How to take Bosentan Accord”.

Other medicines and Bosentan Accord

Tell your doctor or pharmacist if you are taking or have recently taken or might take 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 Accord,
  • sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended for use with Bosentan Accord,
  • glibenclamide (for diabetes ), rifampicin (for the treatment of tuberculosis ), fluconazole and ketoconazole (for the treatment of fungal infections), nevirapine (for the treatment of HIV ) as these medicines are not recommended for use with Bosentan Accord,
  • other drugs for the treatment of HIV – infection that can be checked particularly if used in combination with bosentan Accord
  • hormonal contraceptives, which are not effective as the only method of contraception when taking Bosentan Accord. Inside your Bosentan Accord packaging is patient care for patients that you should read carefully. Your doctor and/or gynecologist will determine which contraceptives are right for you.
  • other medicines used to treat pulmonary hypertension: sildenafil and tadalafil.
  • warfarin (a blood thinner)
  • simvastatin (used to treat hypercholesterolemia )

Driving and using machines

Bosentan Accord has no or negligible influence on the ability to drive and use machines. Bosentan Accord may 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 BosentanAccord, 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.

Pregnancy, breastfeeding, and fertility

Pregnancy

Women of childbearing age

Do NOT take Bosentan Accord if you are pregnant or planning to become pregnant.

Pregnancy tests

Bosentan Accord can harm unborn babies born before or during treatment. If you are a woman and could become pregnant, your doctor will ask you to undergo a pregnancy test before you start taking Bosentan Accord, and regularly during the time you are taking Bosentan Accord.

Contraceptive

If it is possible that you may become pregnant, use a safe method of contraception when taking Bosentan Accord. Your doctor or gynecologist can advise you on reliable contraceptive methods while using Bosentan Accord. Since Bosentan Accord can make hormonal contraception (e.g., oral, injectable, implantable, or p- patches ) ineffective, this alone no sure method. Therefore, if you use hormonal contraceptives, you must also use a barrier method (eg condoms for women, diapers, contraceptive pillows or your partner must also use a condom). Inside the BosentanAccord packaging includes a patient card. You should complete this card and take it with you to your doctor at your next visit so that your doctor or gynecologist can evaluate whether you need additional or alternative reliable contraceptive methods. Pregnancy tests are recommended every month while you are taking Bosentan Accord if you are of childbearing potential.

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.

Breast-feeding

Tell your doctor immediately if you are breast-feeding.  It is recommended that you stop breastfeeding if you are prescribed Bosentan Accord. It is not known whether this medicine is passed on to breast milk.

Fertility

In infertility studies in animals, no effects on sperm or fertility parameters were seen.

If you are a man and use the Bosentan Accord, it is possible that the medicine may reduce the number of sperm. It can not be ruled out that this may affect your ability to have children. Talk to your doctor if you have any questions or concerns about this.

How to take Bosentan Accord

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

Bosentan Accord with food and drink

Bosentan Accord 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 Accord.

Use for children and adolescents

The dose recommended for children only applies to PAHs. In children 2 years of age and older, treatment is usually started at 2 mg/kg body weight twice daily (morning and evening). Your doctor will tell you how to dose.

Note that there are other formulations of bosentan that may facilitate the correct dosing for children and patients with low body weight or patients who have difficulty swallowing film-coated tablets.

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

How to take Bosentan Accord

The tablets should be taken twice daily (morning and evening), should be swallowed with water, and can be taken with or without food.

If you forget to take Bosentan Accord

If you forget to take Bosentan Accord, 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 taking Bosentan Accord

If you suddenly stop taking Bosentan Accord, your symptoms may get worse. Do not stop taking Bosentan Accord unless instructed to do so by your doctor. 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 of the Bosentan Accord are:

  • abnormal liver function, which may occur in more than 1 in 10 people,
  • anemia (low blood count), which can occur in up to 1 in 10 people. Anemia can sometimes require blood transfusions.

Your liver and blood levels will be monitored during your treatment with BosentanAccord (see section 2). It is important that you take these 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
  • 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 are

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

  • headache
  • edema (swelling of the legs and ankles or other symptoms of fluid retention).

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

  • sudden flushing or reddening of the skin
  • hypersensitivity reaction (with skin inflammation, itching, and rash)
  • gastroesophageal reflux disease (acid reflux)
  • diarrhea
  • short-term loss of consciousness (fainting)
  • palpitations (fast or irregular heartbeat)
  • low blood pressure
  • nasal congestion.

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

  • thrombocytopenia (lack of platelets )
  • neutropenia/leukopenia (low white blood cell count )elevated liver enzyme levels 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) in the liver, liver failure (a severe disorder of liver function).

Blurred vision has been reported (may occur in an unknown number of users).

Side effects in children and adolescents

Children treated with Bosentan Accord 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 Accord

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.

Aluminum-aluminum blister card

No special storage instructions.

PVC / PE / PVDC aluminum blister card

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 will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • Bosentan Accord 62.5 mg film-coated tablets: the active substance is bosentan as monohydrate. Each tablet contains 62.5 mg bosentan (as monohydrate).
  • Bosentan Accord 125 mg film-coated tablets: the active substance is bosentan as monohydrate. Each tablet contains 125 mg bosentan (as monohydrate).
  • The other excipients in the tablet are maize starch, pregelatinized starch(maize), sodium starch glycolate (type A), povidone, and magnesium stearate. The film coating contains hypromellose, triacetin, talc, titanium dioxide (E171), yellow iron oxide (E172), and red iron oxide (E172).

What the medicine looks like and the contents of the pack

Bosentan Accord 62.5 mg film-coated tablets are light orange, round, approximately 6.20 mm in diameter, biconvex, film-coated tablets with “IB1” embossed on one side and the other side is completely smooth.

Bosentan Accord 125 mg film-coated tablets are light orange, oval, approximately 11.00 mm long, 5.00 mm wide, biconvex, film-coated tablets with “IB2” embossed on one side and the other side completely smooth.

Bosentan Accord 62.5 mg film-coated tablets are packaged in aluminum-aluminum blister cards and in PVC / PE / PVDC / aluminum blister cards containing 14 film-coated tablets. The cartons contain 14, 56, or 112 film-coated tablets.

Bosentan Accord 125 mg film-coated tablets are packaged in aluminum-aluminum blister cards and in PVC / PE / PVDC / aluminum blister cards containing 14 film-coated tablets. The cartons contain 56 or 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Accord Healthcare BV

Winthontlaan 200

3526 kV Utrecht

Netherlands

Manufacturer:

Accord Healthcare Ltd

Sage House

319, Pinner Road

North Harrow

Middlesex HA1 4 HF

UK

Accord Healthcare Polska Sp.z oo,

ul. Lutomierska 50,95-200 Pabianice, Poland

Accord Healthcare BV

Winthontlaan 200

3526 KV Utrecht

The Netherlands

Muhammad Nadeem

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