BLOPRESS 4 мг Коированная таблетка

Содержание инструкции

1. Blopress 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets
   1. What Blopress is and what it is used for
   2. What you need to know before taking Blopress
   3. How to take Blopress
   4. Possible side effects
   5. How to store Blopress
   6. Contents of the pack and other information

Blopress 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets

candesartan cilexetil

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 their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

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

1. What Blopress is and what it is used for

The name of the medicine is Blopress. The active substance is candesartan cilexetil. It belongs to a group
of medicines called angiotensin II receptor antagonists. It works by causing the relaxation
and dilation of blood vessels. This helps to reduce blood pressure. It also ensures that
the heart pumps blood more easily throughout the body.
This medicine is used for:

• treating high blood pressure (hypertension) in adult and in children and adolescents aged from 6 to 18 years.
• treating heart failure in adult patients with reduced heart muscle function, when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used or in addition to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used (ACE inhibitors and MRA are medicines used to treat heart failure).

2. What you need to know before taking Blopress

Do not take Blopress:

• if you are allergic (hypersensitive) to candesartan cilexetil or to any of the other ingredients of this medicine listed in section 6.
• if you are pregnant for more than three months (it is best to avoid Blopress even in the early stages of pregnancy - see section Pregnancy).
• if you have a severe liver disease or obstruction of the bile ducts (a problem with the drainage of bile from the gallbladder).
• if the patient is a child under 1 year of age.
• if you are being treated with a medicine that lowers blood pressure containing aliskiren and you have diabetes or impaired kidney function.

If you are not sure if any of these conditions apply to you, consult your doctor or pharmacist before
taking Blopress.

Warnings and precautions
Talk to your doctor before taking Blopress:

• if you have problems with your heart, liver or kidneys or are on dialysis.
• if you have recently had a kidney transplant.
• if you are vomiting, have recently had severe vomiting or have diarrhoea.
• if you have a disease of the adrenal gland, known as Conn's syndrome (also called primary hyperaldosteronism).
• if you have low blood pressure.
• if you have ever had a stroke.
• tell your doctor if you think you might be pregnant (or if there is a possibility of becoming pregnant). Blopress is not recommended in the early stages of pregnancy, and must not be taken if you are more than three months pregnant, as it can cause serious harm to the baby if taken during this period (see section Pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes
• aliskiren. If you are taking an ACE inhibitor together with a medicine that belongs to the class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used for the treatment of heart failure (see “Other medicines and Blopress”). Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also the section “Do not take Blopress”.
Your doctor may need to see you more often and perform tests if you experience any of these
conditions.
If you are going to have an operation, tell your doctor or dentist that you are taking Blopress. This
is because Blopress, when combined with some anaesthetics, can cause a drop in blood
pressure.

Children and adolescents
Blopress has been studied in children. For more information, ask your doctor. Blopress should not
be given to children under 1 year of age due to the potential risk to developing kidneys.

Other medicines and Blopress
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Blopress can affect the mechanism of action of other medicines, and some medicines can have
an effect on Blopress. If you are taking certain medicines, your doctor may need to perform
blood tests from time to time.
In particular, tell your doctor if you are taking any of the following medicines as your doctor may
need to adjust the dose and/or take other precautions:

• other medicines that help to lower blood pressure, including beta-blockers, diazoxide and ACE inhibitors such as enalapril, captopril, lisinopril or ramipril
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, naproxen, diclofenac, celecoxib, or etoricoxib (medicines for relieving pain and inflammation)
• acetylsalicylic acid (if you are taking more than 3 g per day) (medicine for relieving pain and inflammation)
• potassium supplements or salt substitutes containing potassium (medicines that increase the level of potassium in the blood)
• heparin (a medicine for thinning the blood)
• tablets that help you to urinate (diuretics)
• lithium (a medicine for mental health problems)
• if you are taking an ACE inhibitor or aliskiren (see also the sections: “Do not take Blopress” and “Warnings and precautions”)
• if you are being treated with an ACE inhibitor together with some medicines for the treatment of heart failure, known as mineralocorticoid receptor antagonists (MRAs) (for example spironolactone, eplerenone).

Blopress with food, drinks and alcohol

• You can take Blopress with or without food.
• When you are prescribed Blopress, talk to your doctor before drinking alcohol. Alcohol can make you feel weak or dizzy.

Pregnancy and breastfeeding
Pregnancy
You must tell your doctor if you think you might be pregnant (or if there is a possibility of becoming
pregnant). Usually your doctor will advise you to stop taking Blopress before
becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Blopress. Blopress is not recommended
in the early stages of pregnancy, and must not be taken if you are more than three months pregnant,
as it can cause serious harm to the baby if taken after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or planning to start breastfeeding. Blopress is not recommended
for women who are breastfeeding and your doctor may choose another treatment for you if you wish
to breastfeed, especially if your baby is newborn or premature.

Driving and using machines
Some people may feel tired or dizzy when taking Blopress. If this happens to you do not
drive or use tools or machines.

Blopress contains lactose.Lactose is a type of sugar. If you have been diagnosed with
intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Blopress

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist. It is important to continue taking Blopress every day. Blopress can
be taken with or without food.
Swallow the tablet with a glass of water.
Try to take the tablet at the same time each day. This will help you to remember to take it.
Blopress 4 mg, 8 mg, 16 mg and 32 mg tablets: the tablet can be divided into equal doses.
High blood pressure:

• the recommended dose of Blopress is 8 mg once a day. Your doctor may increase this dosage up to 16 mg once a day and further up to 32 mg once a day depending on the blood pressure response.
• In some patients, such as those with liver problems, kidney problems or who have recently lost fluids due to for example: vomiting, diarrhea or taking tablets that help to urinate, the doctor may prescribe a lower starting dose.
• Some patients of Black ethnicity may respond to this medicine in a reduced manner, when it is administered as a single treatment, and may need a higher dose. Use in children and adolescents with high blood pressure:

Children aged 6 to 18 years:
The recommended starting dose is 4 mg once a day.
For patients weighing less than 50 kg: in some patients whose blood pressure is not
adequately controlled, the doctor may decide whether the dose should be increased up to a
maximum of 8 mg once a day.
For patients weighing 50 kg or more: in some patients whose blood pressure is not
adequately controlled, the doctor may decide whether the dose should be increased to 8 mg once
a day and to 16 mg once a day.
Heart failure in adults:

• the recommended starting dose of Blopress is 4 mg once a day. Your doctor may increase this dosage by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Blopress can be taken together with other medicines for heart failure, and your doctor will decide what is the most suitable treatment for you.

If you take more Blopress than you should
If you take more Blopress than prescribed by your doctor, contact a doctor or
pharmacist immediately for advice.

If you forget to take Blopress
Do not take a double dose to make up for a missed tablet. Just take the next
dose as usual.

If you stop taking Blopress
If you stop taking Blopress, your blood pressure may increase again. So
do not stop taking Blopress without first talking to your doctor.
If you have any further questions on 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.
It is important that you are aware of what these side effects may be.

Stop taking Blopress and seek immediate medical help if you experience any of the
following allergic reactions:

• difficulty in breathing, with or without swelling of the face, lips, tongue and/or throat
• swelling of the face, lips, tongue and/or throat, which may cause difficulty in swallowing
• severe itching of the skin (with raised blisters)

Blopress can cause a decrease in the number of white blood cells in the blood. Your resistance to
infections may decrease and you may notice fatigue, infection or fever. If this happens, contact your
doctor. Your doctor may occasionally perform blood tests to check if Blopress has
had any effects on your blood (agranulocytosis).
Possible side effects include:

Common (may affect up to 1 in 10 people)

• Feeling dizzy/lightheaded
• Headache
• Respiratory infection
• Low blood pressure. This may make you feel weak or dizzy
• Changes in blood test results:
• An increased amount of potassium in the blood, especially if you already have kidney problems or heart failure. If this is severe, you may also notice fatigue, weakness, irregular heartbeat or tingling
• Effects on the function of your kidneys, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (may affect up to 1 in 10,000 people)

• Swelling of the face, lips, tongue and/or throat
• A decrease in red or white blood cells. You may notice fatigue, infection or fever
• Skin rash, rash with swelling (urticaria)
• Itching
• Back pain, joint and muscle pain
• Changes in liver function, including inflammation of the liver (hepatitis). You may notice fatigue, yellowing of the skin and whites of the eyes and flu-like symptoms
• Tosse (Cough)
• Nausea
• Changes in blood test results:
• A reduced amount of sodium in the blood. If this is severe, you may also notice weakness, lack of energy or muscle cramps.

Not known (frequency cannot be estimated from the available data)

• Diarrhoea.

In children treated for high blood pressure, side effects appear to be
similar to those observed in adults, but occur more frequently. In addition, sore throat is a very common side effect in children and runny nose (nasal congestion), fever and increased
heart rate are common in children.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the
safety of this medicine.

5. How to store Blopress

• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the package or blister after Scad./EXP. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30 °C.

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. Contents of the pack and other information

What Blopress contains

• The active ingredient is candesartan cilexetil. The tablets contain 4 mg, 8 mg, 16 mg or 32 mg of candesartan cilexetil.
• The excipients are calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, corn starch, macrogol. The 8 mg, 16 mg and 32 mg tablets also contain red iron oxide (E172).

Description of the appearance of Blopress and contents of the pack

• The 4 mg tablets are white, round tablets, with a score line on each side.
• The 8 mg tablets are pale pink, round tablets, with a score line on each side.
• The 16 mg tablets are light pink, round tablets, with one convex side imprinted with “16” and one flat side with a score line.
• The 32 mg tablets are light pink, round tablets, with both sides convex imprinted with “32” on one side and a score line on the other.

Blopress tablets are packaged in blisters made of Polypropylene or PVC/PVDC/Alu.
Blopress 4 mg, 8 mg and 16 mg tablets are presented in blisters, in packs containing 7, 14,
20, 28, 30, 50, 56, 84, 90, 91, 98, 98x1 (single unit dose), 100, 140, 280 or 300 tablets.
Blopress 32 mg tablets are presented in blisters, in packs containing 7, 14, 20, 28, 30, 50,
56, 84, 90, 91 98, 100, 140, 280 or 300 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
The marketing authorisation holder for Blopress is CHEPLAPHARM Arzneimittel GmbH, Ziegelhof 24 - 17489 Greifswald,
Germany
The tablets are manufactured by Delpharm Novara S.r.l., Via Crosa 86 – 28065 Cerano (NO), Italy.

This medicinal product is authorised in the Member States of the European Economic Area with the following
names: