Blopress

Patient Information Leaflet: Information for the patient

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

candesartan cilexetil
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to 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 taking 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 relaxation and dilation of blood vessels. This helps lower blood pressure. It also allows the heart to pump blood more easily throughout the body.

This medicine is used for:

• treating high blood pressure (hypertension) in adult patients and in children and adolescents aged 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 as an add-on to ACE inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you should 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 more than three months pregnant (it is also advisable to avoid Blopress during early pregnancy - see section Pregnancy).
• if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder).
• if the patient is a child under 1 year of age.
• if you are being treated with a blood pressure-lowering medicine containing aliskiren and have diabetes or impaired kidney function.

If you are unsure whether 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 heart, liver or kidney problems or are on dialysis.
• if you have recently undergone 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.
• inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Blopress is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn 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" (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
• aliskiren. if you are taking an ACE inhibitor together with a medicine belonging to a class of medicines known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see "Other medicines and Blopress"). Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also the section “Do not take Blopress”.
Your doctor may need to examine you more frequently and carry out tests if any of these conditions occur.
If you are about to undergo surgery, tell your doctor or dentist that you are taking Blopress. This is because Blopress, when combined with certain anaesthetics, may cause a drop in blood pressure.
Children and adolescents
Blopress has been studied in children. For further information, consult your doctor. Blopress must not be given to children under 1 year of age due to the potential risk to developing kidneys.
Other medicines and Blopress
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Blopress may affect how other medicines work, and some medicines may affect Blopress. If you are taking certain medicines, your doctor may need to carry out 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 your dose and/or take other precautions:

• other medicines that 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 used to relieve pain and inflammation)
• acetylsalicylic acid (if you are taking more than 3 g per day) (a medicine used to relieve pain and inflammation)
• potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood)
• heparin (a medicine used to thin the blood)
• tablets that help you pass urine (diuretics)
• lithium (a medicine used for mental health conditions)
• 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 certain medicines used to treat heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

Blopress with food, drinks and alcohol

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

Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you think you are pregnant (or if there is a possibility of becoming pregnant). Normally, your doctor will advise you to stop taking Blopress before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead of Blopress. Blopress is not recommended during early pregnancy, and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Blopress is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.
Driving and using machines
Some people may feel tired or dizzy while taking Blopress. If this happens to you, do not drive or operate tools or machinery.
Blopress contains lactose. Lactose is a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. How to take Blopress

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. It is important to continue taking Blopress every day. Blopress may 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 remember to take it.
Blopress 4 mg, 8 mg, 16 mg and 32 mg tablets: the tablet may be divided into equal doses.

High blood pressure:

• The recommended dose of Blopress is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily, and further up to 32 mg once daily, depending on your blood pressure response.
• In some patients, such as those with liver problems, kidney problems, or who have recently lost fluids (for example due to vomiting, diarrhoea, or taking tablets that increase urine production), your doctor may prescribe a lower starting dose.
• Some black patients may have a reduced response to this medicine when used as monotherapy, and may require 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 daily.
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 daily.
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 daily, and further to 16 mg once daily.

Heart failure in adults:

• The recommended starting dose of Blopress is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least 2 weeks, up to a maximum of 32 mg once daily. Blopress may be taken together with other medicines for heart failure, and your doctor will decide which treatment is most suitable 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 the forgotten tablet. Take only the next dose as usual.

If you stop taking Blopress
If you stop treatment with Blopress, your blood pressure may rise again. Therefore, do not stop treatment with Blopress without first talking to your doctor.

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.
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 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 swallowing
• Severe itching of the skin (with raised bumps)

Blopress may cause a reduction 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 occurs, contact your
doctor. Your doctor may occasionally perform blood tests to monitor whether Blopress has affected
your blood (agranulocytosis).
Possible side effects include:
Common (may affect from 1 to 10 users in 100)

• Dizziness/spinning sensation
• Headache
• Respiratory infection
• Low blood pressure. This may make you feel weak or dizzy
• Changes in blood test results:
• Increased potassium levels 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 kidney function, especially if you already have kidney problems or heart failure. In very rare cases, kidney failure may occur.

Very rare (may affect less than 1 user in 10,000)

• Swelling of the face, lips, tongue and/or throat
• Reduction 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 liver inflammation (hepatitis). You may notice fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms
• Cough
• Nausea
• Changes in blood test results:
• Reduced sodium levels 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 due to 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
rhinorrhoea (runny nose), fever and increased heart rate are common in children.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or
pharmacist. You can also report side effects directly via 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 stated on the carton or blister after Exp./EXP.. The expiry date refers to the last day of that month.
• Do not store above 30 °C.

Do not dispose of any medicine via 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 Blopress contains

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

Description of the appearance of Blopress and package contents

• 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, one side convex with "16" engraved, and the other side flat with a score line.
• The 32 mg tablets are light pink, round tablets, both sides convex, with "32" engraved 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 available in blister packs containing 7, 14, 20, 28, 30, 50, 56, 84, 90, 91, 98, 98x1 (unit dose single pack), 100, 140, 280, or 300 tablets.
Blopress 32 mg tablets are available in blister 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 Authorization Holder and Manufacturer
The marketing authorization 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 authorized in the European Economic Area Member States under the following names: