Candesartan Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

CANDESARTAN DOC Generici 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets

Equivalent medicine
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 others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CANDESARTAN DOC Generici is and what it is used for

The name of the medicine is CANDESARTAN DOC Generici. 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 enables the heart to pump blood more easily throughout the body.

This medicine is used for:

• treating high blood pressure (hypertension) in adults and in children and adolescents aged 6 to 18 years.
• CANDESARTAN DOC Generici can be used to treat 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 MRAs are medicines used to treat heart failure.)

2. What you need to know before taking CANDESARTAN DOC Generici

Do not take CANDESARTAN DOC Generici if:

• you are allergic to candesartan cilexetil or to any of the other ingredients of this medicine (listed in section 6);
• you are more than three months pregnant (it is best to avoid CANDESARTAN DOC Generici even in the early stages of pregnancy – see section Pregnancy);
• you have severe liver disease or biliary obstruction (a condition affecting bile drainage from the gallbladder);
• the patient is a child under 1 year of age;
• you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor or pharmacist before taking CANDESARTAN DOC Generici:

• if you have heart, liver or kidney problems 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;
• inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). CANDESARTAN DOC Generici is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child 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 the class of drugs known as mineralocorticoid receptor antagonists (MRAs). These medicines are used to treat heart failure (see “Other medicines and CANDESARTAN DOC Generici”). Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.

See also the section "Do not take CANDESARTAN DOC Generici if"
Your doctor may need to examine you more frequently and carry out tests if you have any of these conditions.
If you are about to undergo surgery, tell your doctor or dentist that you are taking CANDESARTAN DOC Generici. This is because CANDESARTAN DOC Generici, when combined with certain anaesthetics, may cause a drop in blood pressure.

Children and adolescents
Candesartan has been studied in children. For further information, speak with your doctor.
CANDESARTAN DOC Generici must not be given to children under 1 year of age due to the potential risk to kidney development.

Other medicines and CANDESARTAN DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. CANDESARTAN DOC Generici may affect how other medicines work, and some medicines may affect CANDESARTAN DOC Generici. 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:

• other medicines that help 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 increase urine production (diuretics);
• lithium (a medicine used for mental health conditions).

Your doctor may consider it necessary to adjust your dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also section: "Do not take CANDESARTAN DOC Generici if" and "Warnings and precautions");
• If you are being treated with an ACE inhibitor together with other medicines used for heart failure, known as mineralocorticoid receptor antagonists (MRAs) (e.g. spironolactone, eplerenone).

CANDESARTAN DOC Generici with food, drinks and alcohol

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

Pregnancy, breast-feeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking CANDESARTAN DOC Generici before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. CANDESARTAN DOC Generici is not recommended during early pregnancy, and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.

Breast-feeding
Inform your doctor if you are breast-feeding or plan to start breast-feeding. CANDESARTAN DOC Generici is not recommended for women who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
Some people may feel tired or dizzy while taking CANDESARTAN DOC Generici. If this happens to you, do not drive or operate tools or machines.

CANDESARTAN DOC Generici contains lactose
CANDESARTAN DOC Generici contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

CANDESARTAN DOC Generici contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘sodium-free’.

3. How to take CANDESARTAN DOC Generici

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. It is important to continue taking CANDESARTAN DOC Generici every day. CANDESARTAN DOC Generici 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 remember to take it.

High blood pressure:

• • The usual dose of CANDESARTAN DOC Generici is 8 mg once daily. Your doctor may increase this dose to 16 mg once daily and further increase it 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 due to, for example, vomiting, diarrhoea, or taking tablets that help you urinate, 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.

Heart failure:

• The usual starting dose of CANDESARTAN DOC Generici is 4 mg once daily. Your doctor may increase this dose by doubling it at intervals of at least two weeks, up to a maximum of 32 mg once daily. CANDESARTAN DOC Generici may be taken together with other medicines for heart failure, and your doctor will decide which treatment is most suitable for you.

Use in children and adolescents with high blood pressure
Children aged between 6 and 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, your doctor may decide that 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, your doctor may decide that the dose should be increased to 8 mg once daily and further to 16 mg once daily.

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

If you forget to take CANDESARTAN DOC Generici
Do not take a double dose to make up for the missed tablet. Take only the next dose as usual.

If you stop taking CANDESARTAN DOC Generici
If you stop treatment with CANDESARTAN DOC Generici, your blood pressure may rise again. Therefore, do not stop treatment with CANDESARTAN DOC Generici 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 might be.
Stop taking CANDESARTAN DOC Generici 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, itchy bumps)

CANDESARTAN DOC Generici 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 check whether CANDESARTAN DOC Generici has affected your blood (agranulocytosis).

Possible side effects include:
Common (may affect from 1 to 10 users in 100)

• Dizziness/lightheadedness
• Headache
• Respiratory infection
• Low blood pressure. This may make you feel weak or dizzy.
• Changes in blood test results:
• Increased levels 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 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 inflammation of the liver (hepatitis). You may notice fatigue, yellowing of the skin and whites of the eyes, and flu-like symptoms.
• Nausea.
• Changes in blood test results:
• Reduced levels of sodium in the blood. If this is severe, you may also notice weakness, lack of energy or muscle cramps.
• Cough

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

• Diarrhoea

In children treated for high blood pressure, side effects appear similar to those seen in adults, but occur more frequently. Sore throat is a very common side effect in children but not reported in adults, and runny nose, fever and increased heart rate are common in children but not reported in adults.

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 the website: http://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 CANDESARTAN DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or on the
blister. The expiry date refers to the last day of the month.
This medicine does not require any special storage temperature.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What CANDESARTAN DOC Generici contains
The active substance is candesartan cilexetil.
Each CANDESARTAN DOC Generici 4 mg tablet contains 4 mg of candesartan cilexetil.
Each CANDESARTAN DOC Generici 8 mg tablet contains 8 mg of candesartan cilexetil.
Each CANDESARTAN DOC Generici 16 mg tablet contains 16 mg of candesartan cilexetil.
Each CANDESARTAN DOC Generici 32 mg tablet contains 32 mg of candesartan cilexetil.
The excipients are monohydrate lactose, maize starch, hydroxypropylcellulose, sodium croscarmellose, magnesium stearate and triethyl citrate.

Description of the appearance of CANDESARTAN DOC Generici and contents of the pack
CANDESARTAN DOC Generici 4 mg tablets are white, biconvex tablets with a score line on one side and engraved with "C4" on the same side.
CANDESARTAN DOC Generici 8 mg tablets are white, biconvex tablets with a score line on one side and engraved with "C8" on the same side.
CANDESARTAN DOC Generici 16 mg tablets are white, biconvex tablets with a score line on one side and engraved with "C16" on the same side.
CANDESARTAN DOC Generici 32 mg tablets are white, biconvex tablets with a score line on one side and engraved with "C32" on the same side.
The score line on the tablet is intended to facilitate breaking the tablet for easier swallowing and is not intended to divide the tablet into equal doses.
Packs: 7, 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Manufacturer
Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate
P.O. box 14
Hal Far BBG 3000
Malta

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