62.5 mg, 125 mg film-coated tablets 
bosentan

Read all of this leaflet carefully before you start using 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 Bosentan Aurobindo is and what it is used for 
2. What you need to know before you use Bosentan Aurobindo 
3. How to use Bosentan Aurobindo 
4. Possible side effects 
5. How to store Bosentan Aurobindo 6. Contents of the pack 
and other information

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

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

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

Bosentan Aurobindo is used to treat 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. Class II means that physical activity is easily limited. PAHs for which Bosentan Aurobindo 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 Aurobindo reduces the number of new wounds on fingers and toes that occur.

Bosentan contained in Bosentan Aurobindo 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 further questions and always follow their instructions.

What you need to know before you use Bosentan Aurobindo

Do not use Bosentan Aurobindo

Do not take Bosentan Aurobindo:

  • 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 drugs and Bosentan Aurobindo”
  • 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 using Bosentan Aurobindo.

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 taking Bosentan Aurobindo 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 Aurobindo.

For all these tests, see also the patient care (in the package of Bosentan Aurobindo tablets). It is important that these regular blood tests are taken throughout the time you take Bosentan Aurobindo. 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 treatment with Bosentan Aurobindo. 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 Aurobindo may develop anemia.

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

Children and young people

Bosentan Aurobindo is not recommended for children with systemic sclerosis and ongoing disease with digital ulcers. See also section 3, How to take BosentanAurobindo.

Other medicines and Bosentan Aurobindo

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. It is especially important that you tell your doctor if you are taking:

  • ciclosporin A (a medicine used after transplants and to treat psoriasis ), which should not be used with Bosentan Aurobindo.
  • sirolimus or tacrolimus, which are medicines used after transplants, as these are not recommended for use with Bosentan Aurobindo
  • 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 Aurobindo
  • other medications for treating HIV – infection that can be checked particularly if used in combination with bosentan Aurobindo
  • hormonal contraceptives, which are not effective as the only method of contraception when taking Bosentan Aurobindo. Inside your Bosentan Aurobindo 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 for the treatment of pulmonary hypertension: sildenafil and tadalafil
  • warfarin (a blood thinner)
  • simvastatin (used to treat hypercholesterolemia ).

Bosentan Aurobindo with food, drink, and alcohol

Bosentan Aurobindo can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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.

Women of childbearing age

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

Pregnancy test

Bosentan Aurobindo 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 Aurobindo, and regularly during the time you are taking Bosentan Aurobindo.

Contraceptive

If it is possible that you may become pregnant, use a safe method of contraception when taking Bosentan Aurobindo. Your doctor or gynecologist can advise you on reliable contraceptive methods while using Bosentan Aurobindo. Since BosentanAurobindo may 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 BosentanAurobindo packaging is 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 Aurobindo if you are of childbearing potential.

Breast-feeding

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

Fertility

If you are a man and use Bosentan Aurobindo, 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.

Driving and using machines

Bosentan Aurobindo has no or negligible influence on the ability to drive and use machines. Bosentan Aurobindo 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 while taking Bosentan Aurobindo, 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 increased 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.

How to use Bosentan Aurobindo

Treatment with Bosentan Aurobindo 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.

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.

How to take Bosentan Aurobindo

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

Use for children and adolescents

The dose recommended for children only applies to PAHs. In children 1 year 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.

Please note that other preparations of bosentan are also available, which 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 Aurobindo is too strong or too weak, talk to your doctor as your dose may need to be changed.

If you forget to use Bosentan Aurobindo

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

If you stop using Bosentan Aurobindo

If you suddenly stop taking Bosentan Aurobindo treatment, your symptoms may getworse. Do not stop taking Bosentan Aurobindo 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 Aurobindo 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 BosentanAurobindo (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:

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 reddening of the face or redness 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 also been reported with an unknown frequency (frequency cannot be calculated from available data).

Additional side effects in children and adolescents

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

Reporting of side effects ar

If you get any side effects , talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effectsdirectly via

The Medical Products Agency

Box 26

751 03 Uppsala

Website: www.lakemedelsverket.se

By reporting side effects , you can help increase drug safety information.

5. How to store Bosentan Aurobindo

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 label and carton 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 bosentan in the form of the monohydrate. 
    Each film-coated tablet contains 62.5 mg bosentan (monohydrate). 
    Each film-coated tablet contains 125 mg bosentan (monohydrate).
  • The other ingredients are Tablet core:  Pregelatinized starch, maize starch, sodium starch glycolate (Type-A), crospovidone (Type-B), povidone (k-90), glycerol dibehanate, magnesium stearate. Tablet coating: Hypromellose (E464), ethylcellulose, triacetin, titanium dioxide (E171), yellow iron oxide, red iron oxide. 

What the medicine looks like and contents of the pack

Film-coated tablet. 

Bosentan Aurobindo 62.5 mg film-coated tablets

Orange-white colored, round [Diameter: 6.1mm], biconvex, film-coated tablets debossed with “K” on one side and “21” on the other side.

Bosentan Aurobindo 125 mg film-coated tablets

Orange-white colored, oval, biconvex, film-coated tablets debossed with “K” on one side and “22” on the other side, separated by the notch. The tablet can be divided into two equal doses . The size is 11.2 mm x 5.2 mm.

Bosentan Aurobindo film-coated tablets are available in triple-laminated, white, opaque PVC / PE / PVdC-Aluminum blister pack and HDPE jar with polypropylene lid.

Blister pack:

62.5 mg : 14, 28, 30, 50, 56, 60, 90, 98 and 112 film-coated tablets

125 mg : 10, 14, 28, 30, 50, 56, 60, 90, 98, 100 and 112 film-coated tablets.

HDPE jar: 30, 100, and 1000 film-coated tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Aurobindo Pharma (Malta) Limited

Vault 14, Level 2, Valletta Waterfront

Floriana FRN 1913

Malta

Manufacturer

Milpharm Limited

Ares Block, Odyssey Business Park

West End Road

Ruislip HA4 6QD

UK

or

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Orion Corporation

Orion Pharma

Orionintie 1

02200 Espoo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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