BOSENTAN 62.5 mg Фильм-coated таблетки

Содержание инструкции

1. Bosentan Mylan 62.5 mg film-coated tablets, 125 mg film-coated tablets
   1. What is Bosentan Mylan and what it is used for
   2. What you need to know before taking Bosentan Mylan
   3. How to take Bosentan Mylan
   4. Possible side effects
   5. How to store Bosentan Mylan
   6. Package Contents and Other Information

Bosentan Mylan 62.5 mg film-coated tablets, 125 mg film-coated tablets

bosentan

Generic Medicine
Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Bosentan Mylan is and what it is used for
• 2. What you need to know before you take Bosentan Mylan
• 3. How to take Bosentan Mylan
• 4. Possible side effects
• 5. How to store Bosentan Mylan
• 6. Contents of the pack and other information

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

The film-coated tablets of Bosentan Mylan 62.5 mg or 125 mg contain bosentan which blocks a
natural hormone called endothelin-1 (ET-1) causing the constriction of blood vessels. Bosentan
therefore expands blood vessels and belongs to the class of medicines called “endothelin receptor
antagonists”.
Bosentan Mylan is used to treat:

• Pulmonary arterial hypertension (PAH): PAH is a disease characterized by severe narrowing of the blood vessels in the lungs leading to increased pressure in the arterial blood vessels (pulmonary arteries) that carry blood from the heart to the lungs. This pressure reduces the amount of oxygen that can pass into the blood through the lungs, making physical activity more difficult. Bosentan widens the pulmonary arteries, making it easier for the heart to pump blood through them. This results in a reduction in blood pressure and a reduction in symptoms.

Bosentan Mylan is used for the treatment of patients with pulmonary arterial hypertension (PAH) in
class III to improve the ability to perform physical activity and its symptoms. “Class” indicates the severity
of the disease: “class III” means a marked limitation of physical activity. Some improvements
have also been observed in patients with PAH of class II. “Class II” means a mild limitation
of physical activity.
The PAH for which Bosentan Mylan is indicated may be:

• primary (without an identified cause or a family history of);
• caused by scleroderma (also called systemic sclerosis, a condition characterized by abnormal growth of connective tissue that supports the skin and other organs);
• caused by congenital heart defect (from birth) with shunts (abnormal connections) that cause abnormal blood flow between the heart and the lungs. Bosentan Mylan is also used for the treatment of digital ulcers (sores on the fingers of hands and feet) in adult patients with scleroderma. Bosentan prevents the formation of new ulcers on the fingers and toes.

If you do not feel well or if your symptoms worsen after taking Bosentan Mylan, you should inform your
doctor.

2. What you need to know before taking Bosentan Mylan

Do not take Bosentan Mylan:

• if you are allergic to bosentan or any of the other ingredients of this medicine (listed in section 6)
• if you have liver problems
• if you are being treated with Cyclosporine A (a medicine used after an organ transplant or for the treatment of psoriasis)
• if you are pregnant or could become pregnant as you are not using reliable contraceptive methods. Read the information provided in “Contraceptives” and in “Other medicines and Bosentan Mylan”.

If any of these conditions apply to you, consult your doctor.

Warnings and precautions
Tests required by the doctor before starting treatment

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

It has been found that some patients undergoing treatment with bosentan have shown abnormal results
in blood tests for liver function and anemia (low hemoglobin levels).

Tests that your doctor will prescribe during treatment
During treatment with Bosentan Mylan, your doctor will regularly request blood tests
to monitor any changes in liver function and hemoglobin levels.
For all these tests, also refer to the Patient Alert Card (contained in your
pack of Bosentan Mylan tablets). It is important that the patient undergoes these blood tests at regular intervals during the entire period of Bosentan Mylan administration. It is recommended
to note the date of the most recent test and also the date of the next scheduled test (ask your doctor) on the Patient Alert Card, so as not to forget the date of the next test.

Blood tests for liver function
Will be performed every month for the entire duration of treatment with Bosentan Mylan. Following an
increase in the dose, an additional test will be performed after 2 weeks.

Blood tests for anemia
Will be performed every month for the first 4 months of treatment and subsequently every 3 months,
as patients taking bosentan may develop anemic conditions.
If these results are abnormal, your doctor may decide to reduce the dose or stop treatment with
Bosentan Mylan and perform further tests to determine the cause.

Children and adolescents
Bosentan is not recommended in pediatric patients with systemic sclerosis and ongoing digital ulcers. Please
also see section 3. “How to take Bosentan Mylan”.

Other medicines and Bosentan Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including those available without a prescription. It is especially important to tell your doctor if you are taking:

• Cyclosporine A (a medicine used after organ transplants and for the treatment of psoriasis), see paragraph “Do not take Bosentan Mylan”
• hormonal contraceptives (which are not effective as the sole method of contraception when you are taking Bosentan Mylan). Inside the pack of Bosentan Mylan tablets you will find a Patient Alert Card that you should read carefully. Your doctor and/or gynecologist will determine the appropriate contraceptive method for you
• glibenclamide (for the treatment of diabetes - as this combination may increase the risk of side effects)
• tacrolimus, sirolimus or any other medicine used to prevent organ rejection (as these medicines may increase the concentrations of bosentan in the blood)
• fluconazole, ketoconazole, itraconazole and voriconazole (for the treatment of fungal infections - as these medicines may increase the concentrations of bosentan in the blood)
• simvastatin (used for the treatment of hypercholesterolemia, high cholesterol levels - as bosentan may reduce the concentrations of this medicine in the blood)
• warfarin (an anticoagulant - as bosentan may reduce the concentrations of this medicine in the blood)
• other medicines for the treatment of pulmonary hypertension: sildenafil and tadalafil (also used to treat erectile dysfunction - as bosentan may reduce the concentration of this medicine in the blood)
• rifampicin (for the treatment of tuberculosis - as this medicine may reduce the effectiveness of bosentan)
• carbamazepine, phenobarbital, phenytoin (medicines normally used for the treatment of epilepsy) or St. John's Wort (used to treat depression) - as these medicines may reduce the effectiveness of bosentan
• ritonavir and lopinavir, nevirapine or other medicines for the treatment of HIV infection.

Pregnancy, breastfeeding and fertility
Women of childbearing potential
DO NOT take Bosentan Mylan if you are pregnant or planning a pregnancy.

Pregnancy test
Bosentan can harm the unborn child conceived before or during treatment. The doctor will ask women
of childbearing potential to take a pregnancy test before starting to take Bosentan Mylan and then
every month during treatment with Bosentan Mylan.

Contraceptives
If you could become pregnant, use a reliable method of birth control (contraception) during
taking Bosentan Mylan. Your doctor or gynecologist will advise you on reliable contraceptives to
use during therapy with Bosentan Mylan. Because bosentan may render hormonal contraception ineffective (e.g. oral contraceptives, injectables, implants or skin patches), this
method alone is not reliable. Therefore, if you are using hormonal contraceptives, you must also use a barrier method (e.g. female condom, diaphragm, contraceptive sponge or your partner must
also use a condom). Inside your pack of Bosentan Mylan tablets you will find a
Patient Alert Card. You must fill out this card and bring it to your doctor at your next
visit, so that your doctor or gynecologist can assess whether you need reliable
additional or alternative contraceptive methods. It is recommended to take a pregnancy test every month
during treatment with Bosentan Mylan if you are of childbearing potential.
Tell your doctor immediately if you become pregnant during treatment with Bosentan
Mylan and if you plan to become pregnant in the near future.

Breastfeeding
Tell your doctor immediately if you are breastfeeding. It is recommended to stop breastfeeding in
case Bosentan Mylan is prescribed as it is not known whether this medicine is excreted in breast milk.

Fertility
If you are a man taking bosentan, it is possible that this medicine may reduce sperm count.
It cannot be ruled out that this could compromise your ability to conceive a child. Talk to
your doctor if you have questions about this.

Driving and operating machinery
Bosentan does not alter or negligibly alters the ability to drive vehicles and operate machinery.
However, bosentan may cause hypotension (low blood pressure), which may cause
dizziness, visual impairment and affect the ability to drive and operate machinery. Therefore, if you experience dizziness or blurred vision while taking bosentan,
do not drive vehicles and do not use tools or machinery.

3. How to take Bosentan Mylan

Treatment with Bosentan Mylan must be initiated and monitored only by a doctor experienced in the
treatment of PAH or systemic sclerosis. Take this medicine following exactly the instructions of your
doctor or pharmacist. If you have doubts, consult your doctor or pharmacist.
If you feel that the effect of Bosentan Mylan is too strong or too weak, contact your doctor
to find out if the dose needs to be changed.

Recommended dose
Use in adults
In adults, treatment usually begins with taking a recommended dose of 62.5 mg
twice a day (morning and evening) for the first 4 weeks; afterwards, your doctor will usually advise you to
take one 125 mg tablet twice a day depending on the response to Bosentan Mylan
observed.
Use in children and adolescents
The recommended dose in children is only for the treatment of pulmonary arterial hypertension. For
children aged 1 year and over, the recommended dose for treatment with bosentan usually begins
with 2 mg per kg of body weight twice a day (morning and evening). Your doctor will advise you on the
exact dose to give to your child.
Other formulations of this medicine may be more suitable for children, for people with low
body weight or who have difficulty swallowing; consult your doctor or pharmacist.

How to take Bosentan Mylan
Take the tablets (morning and evening) by swallowing them with water. The tablets can be taken with
or without food.

If you take more Bosentan Mylan than you should
If you have taken more tablets than prescribed, consult your doctor immediately.
You may experience symptoms such as headache, feeling or state of unwellness, low blood pressure (which may
make you feel weak or dizzy), sweating and blurred vision.

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

If you stop taking Bosentan Mylan
Suddenly stopping treatment with Bosentan Mylan may lead to a worsening of
symptoms. Do not stop treatment with Bosentan unless this is requested by your doctor. Your
doctor may advise you to reduce the dose over a few days before stopping
treatment definitively.
If you have any questions about the use of this medicine, 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 observed with bosentan are:

• impaired liver function that can affect more than 1 in 10 people
• anemia (low number of red blood cells), which can affect up to 1 in 10 people. Anemia may occasionally require a blood transfusion.

Your liver and blood values will be monitored during treatment with bosentan (see
section 2). It is important to have these tests performed as ordered by your doctor.
Possible signs of impaired liver function are:

• nausea (feeling sick)
• vomiting
• fever (high temperature)
• stomach pain (abdomen)
• jaundice (yellowing of the skin or the white of the eye)
• dark urine
• skin itching
• lethargy or fatigue (unusual tiredness or weakness)
• flu-like syndrome (joint and muscle pain with fever).

If you experience any of these signs consult your doctor immediately.
Other side effects:

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

• Headache
• Edema (swelling of the legs and ankles or other signs due to fluid retention)

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

• Flushed skin or redness
• Hypersensitivity reactions (including skin inflammation, itching and rash)
• Gastroesophageal reflux (acid reflux)
• Diarrhea
• Nasal congestion
• Syncope (fainting)
• Palpitations (fast or irregular heartbeat)
• Low blood pressure

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

• Thrombocytopenia (low number of platelets in the blood)
• Neutropenia/leukopenia (low number of white blood cells)
• Abnormalities in liver function tests associated with hepatitis (inflammation of the liver including

a possible worsening of pre-existing hepatitis) and/or jaundice (yellowing of the skin or the
white of the eye)

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

• Anaphylaxis (generalized allergic reaction), angioedema (swelling, most commonly around the eyes, lips, tongue or throat)
• Cirrhosis, liver failure (severe impairment of liver function)

Not known(frequency cannot be estimated from available data)

• Blurred vision

Side effects in children and adolescents
The side effects that have been reported in children treated with bosentan have been the same as those reported
in adults.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-
reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Bosentan Mylan

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the package and on the blister after “Exp.”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Bosentan Mylan contains
The active ingredient is bosentan.
Each tablet contains 62.5 mg or 125 mg of bosentan (as monohydrate).
The other ingredients are: corn starch, pregelatinized corn starch, sodium starch glycolate, povidone,
sodium lauryl sulfate, glycerin dibehenate and magnesium stearate. The film coating contains hypromellose
(E464), titanium dioxide (E171), triacetin, talc, yellow iron oxide (E172) and red iron oxide (E172).

Description of the appearance of Bosentan Mylan and package contents
[62.5 mg] – Film-coated tablet, orange-white in colour, round, biconvex, with beveled edge
with imprinted “M” on one side of the tablet and “BN1” on the other side.
[125 mg] – Film-coated tablet, orange-white in colour, oval, biconvex, with beveled edge
with imprinted “M” on one side of the tablet and “BN2” on the other side.
The tablets are available in blisters in packs of 14, 14 x 1 (unit dose blisters), 28 x 1 (unit dose blisters), 56, 56 x 1 (unit dose blisters), 112, 112 x 1 (unit dose blisters).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan

Manufacturers responsible for batch release
McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange
Road, Dublin 13, Ireland.
Mylan Hungary Kft, Mylan útca 1, Komárom H-2900 Hungary.

This medicinal product is authorised in the Member States of the European Economic Area under the following
names:
Belgium & Luxembourg:Bosentan Mylan 62.5 mg and 125 mg film-coated tablets

Czech Republic:Bosentan Mylan 125 mg

France:Bosentan Mylan 62.5mg & 125mg film-coated tablet

Germany:Bosentan Mylan 62.5 mg & 125 mg Film-coated tablets

Greece:Bosentan Mylan 62.5 mg & 125 mg film-coated tablets

Italy:Bosentan Mylan

Portugal:Bosentano Mylan

Slovakia:Bosentan Mylan 62.5 mg and 125 mg

Spain:Bosentán MYLAN 62.5 mg & 125 mg film-coated tablets EFG

United Kingdom:Bosentan 62.5 mg & 125 mg Film-coated Tablets