CANDESARTAN 4 mg Tablet

Зміст інструкції

1. CANDESARTAN DOC Generici 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets
   1. What is CANDESARTAN DOC Generici and what it is used for
   2. What you need to know before taking CANDESARTAN DOC Generici
2. CANDESARTAN DOC Generici contains lactose CANDESARTAN DOC Generici contains
   1. How to take CANDESARTAN DOC Generici
   2. Possible side effects
   3. How to store CANDESARTAN DOC Generici
   4. Package Contents and Other Information
3. CANDESARTAN DOC Generici 16 mg tablets are white, biconvex tablets with a
4. CANDESARTAN DOC Generici 32 mg tablets are white, biconvex tablets with a

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

Generic medicine

Read this leaflet carefully before 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 could 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 CANDESARTAN DOC Generici is and what it is used for
• 2. What you need to know before you take 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 is CANDESARTAN DOC Generici and what it is used for

The name of the medicine is CANDESARTAN DOC Generici. The active ingredient 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 patients and in children and adolescents between the ages of 6 and 18 years.
• CANDESARTAN DOC Generici can be used to treat heart failure in adult patients with reduced heart muscle function when 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 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 CANDESARTAN DOC Generici even in the early stages of pregnancy - see section Pregnancy).
• - 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 suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

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

• 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 may be pregnant (or if there is a possibility of becoming pregnant). CANDESARTAN DOC Generici is not recommended in early pregnancy, and must not be taken if you are pregnant for more than three months, as it may 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 have 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 to treat heart failure (see “Other medicines and CANDESARTAN DOC Generici”).” 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 what is stated in the section "Do not take CANDESARTAN DOC Generici if"
The doctor may need to see you more often and do 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 CANDESARTAN
DOC Generici. This is because CANDESARTAN DOC Generici, when combined with some
anaesthetics, can cause a drop in blood pressure.

Children and adolescents.
Candesartan has been studied in children. For further information, talk to your doctor.
CANDESARTAN DOC Generici cannot be given to children under 1 year of age due to the possible 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 can affect the way other medicines work, and some medicines can have an effect on CANDESARTAN DOC
Generici. If you are taking certain medicines, your doctor may need to do blood tests from time to time.
In particular, tell your doctor if you are taking any of the following medicines:

• 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 pass water (diuretics)
• lithium (a medicine for mental health problems).

Your doctor may need to adjust your dose and/or take other precautions:

• If you are taking an ACE inhibitor or aliskiren (see also what is stated in the 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) (for example spironolactone, eplerenone)

CANDESARTAN DOC Generici with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility
If you are pregnant, if you suspect you are pregnant or if you are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
You must tell your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Usually your doctor will advise you to stop taking CANDESARTAN DOC Generici before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of CANDESARTAN DOC Generici. CANDESARTAN DOC Generici is not recommended in early pregnancy, and must not be taken if you are pregnant for more than three months, as it may cause serious harm to the baby if taken after the third month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. CANDESARTAN DOC
Generici 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 was born
prematurely.

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

CANDESARTAN DOC Generici contains lactose CANDESARTAN DOC Generici contains

lactose, which is a type of sugar. If your doctor has diagnosed you with an intolerance to some
sugars, contact them 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 your doctor has told you. 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 to remember to
take it.
High blood pressure:

• - the usual dose of CANDESARTAN DOC Generici is 8 mg once a day. Your doctor may increase this dose to 16 mg once a day and further 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, diarrhoea or taking tablets that help to urinate, your doctor may prescribe a lower starting dose.
• Some patients of Black race may respond to this medicine in a reduced manner, when administered as single treatment, and may need a higher dose.

Heart failure:

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

Use in children and adolescents with high blood pressure
Children aged between 6 and 18 years
The recommended starting dose is 4mg once a day.
For patients weighing less than 50 kg: in some patients whose blood pressure is not
adequately controlled, the doctor may decide that it is necessary to increase the dose 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 that it is necessary to increase the dose to 8 mg
once a day and to 16 mg once a day.

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

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

If you stop taking CANDESARTAN DOC Generici
If you stop taking CANDESARTAN DOC Generici, your blood pressure may
increase again. Therefore, do not stop taking CANDESARTAN DOC Generici
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 CANDESARTAN DOC Generici 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)

CANDESARTAN DOC Generici can cause a decrease in the number of white blood cells in
your 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 CANDESARTAN DOC Generici has had any effects on your blood
(agranulocytosis).
Possible side effects include:

Common (affects 1 to 10 users out of 100)

• 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 (affects less than 1 user out of 10,000)

• Swelling of the face, lips, tongue and/or throat.
• A decrease in red blood cells 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:
• A reduced amount 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 available data)

• Diarrhoea

In children treated for high blood pressure, side effects appear to be 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 get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the national reporting system
at 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 which is stated on the packaging or on the
blister. The expiry date refers to the last day of the month.
The medicine does not require any particular storage temperature.
Do not dispose of any medicine in waste water 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 CANDESARTAN DOC Generici contains
The active ingredient 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 lactose monohydrate, corn starch, hydroxypropylcellulose, croscarmellose
sodium, magnesium stearate and triethyl citrate.

Description of the appearance of CANDESARTAN DOC Generici and package contents
CANDESARTAN DOC Generici 4 mg tablets are white, biconvex tablets with a
score line on one side and with C4 inscribed on the same side.
CANDESARTAN DOC Generici 8 mg tablets are white, biconvex tablets with a
score line on one side and with C8 inscribed on the same side.

CANDESARTAN DOC Generici 16 mg tablets are white, biconvex tablets with a

notch on one side and inscribed with C16 on the same side.

CANDESARTAN DOC Generici 32 mg tablets are white, biconvex tablets with a

notch on one side and inscribed with C32 on the same side.
The notch on the tablet is designed to facilitate breaking it to make swallowing easier and not to divide it into equal doses.
Pack sizes: 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
20121Milan
Italy

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

This leaflet was last updated on