RATACAND 4 mg Tablets

Зміст інструкції

1. Ratacand 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets
   1. What is Ratacand and what it is used for
   2. What you need to know before taking Ratacand
   3. How to take Ratacand
   4. Possible side effects
   5. How to store Ratacand
   6. Package Contents and Other Information

Ratacand 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 they have the same symptoms as you, as it could 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 Ratacand is and what it is used for
• 2. What you need to know before you take Ratacand
• 3. How to take Ratacand
• 4. Possible side effects
• 5. How to store Ratacand
• 6. Contents of the pack and other information

1. What is Ratacand and what it is used for

The name of the medicine is Ratacand. 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. Furthermore, it ensures
that the heart pumps blood more easily throughout the body.
Ratacand can be 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 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 Ratacand

Do not take Ratacand:

• if you are allergic 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 Ratacand 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 suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.

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

Warnings and precautions
Talk to your doctor before taking Ratacand:

• 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). Ratacand is not recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than three months, 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 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 (MRA). These medicines are used for the treatment of heart failure (see “Taking other medicines”) 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 Ratacand 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 Ratacand. This
is because Ratacand, when combined with some anaesthetics, can cause a drop in blood
pressure.

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

Other medicines and Ratacand
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Ratacand can affect the mechanism of action of other medicines, and some
medicines can have an effect on Ratacand. 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 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)
• co-trimoxazole (an antibiotic) also known as trimethoprim/sulfamethoxazole.
• 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 Ratacand if" and "Special care with Ratacand")
• if you are being treated with an ACE inhibitor together with other medicines used for heart failure, known as mineralocorticoid receptor antagonists (MRA) (for example spironolactone, eplerenone).

Ratacand with food, beverages and alcohol

• You can take Ratacand with or without food.
• When you are prescribed Ratacand, 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 may be pregnant (or if there is a possibility of becoming pregnant). As a rule, your doctor will advise you to stop taking Ratacand before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Ratacand. Ratacand is not recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than three months, 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 are planning to start breastfeeding. Ratacand 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 operating machinery
Some people may feel tired or dizzy when taking Ratacand. If this happens to
you do not drive or use tools or machinery.

Ratacand contains lactose.Lactose is a type of sugar. If your doctor has diagnosed you with
lactose intolerance, contact them before taking this medicine.

3. How to take Ratacand

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist. It is important to continue taking Ratacand every day. Ratacand can
be taken with or without food.
Swallow the tablet with a sip 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 Ratacand 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 with urination, the doctor may prescribe a lower starting dose.
• Some patients of Black ethnicity may respond to this medicine in a reduced manner when 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 Ratacand is 4 mg once a day. The doctor may increase this dosage by doubling the dose at intervals of at least 2 weeks up to 32 mg once a day. Ratacand can be taken together with other medicines for heart failure, and the doctor will decide which treatment is most suitable for you.

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

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

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

Ratacand 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. The doctor may occasionally perform blood tests to check if Ratacand 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, an 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 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.

Additional side effects in children
In children treated for high blood pressure, side effects appear to be
similar to those observed in adults, but occur more frequently. Sore throat in children is a very
common side effect 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, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system 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 Ratacand

• 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 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 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 Ratacand 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 iron oxide (E172).

Description of the appearance of Ratacand and package contents

• The 4 mg tablets are white, round with a score line and imprinted with A/CF on one side and 004 on the other.
• The 8 mg tablets are pale pink, round with a score line and imprinted with A/CG on one side and 008 on the other.
• The 16 mg tablets are pink, round with a score line and imprinted with A/CH on one side and 016 on the other.
• The 32 mg tablets are pink, round with a score line and imprinted with A/CL on one side and 032 on the other.

The tablet can be divided into two equal parts by cutting along the score line.
The tablets are presented in plastic bottles containing 100 or 250 tablets or in blisters
containing 7, 14, 15, 15x1, 20, 28, 30, 30x1, 50, 50x1, 56, 90, 98, 98x1, 100 or 300 tablets.
Not all pack sizes may be marketed in every country.

Marketing Authorisation Holder and Manufacturer
CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
The tablets are manufactured by:
AstraZeneca AB, Gärtunavägen, S-151 85 Södertälje, Sweden
AstraZeneca GmbH, Tinsdaler Weg 183, 22880 Wedel, Germany.
AstraZeneca UK Limited Silk Road Business Park Macclesfield Cheshire SK10 2NA
United Kingdom
AstraZeneca Dunkerque Production Astrazeneca Reims Production, Parc industriel de la Pompelle,
Chemin de Vrilly, 51100 Reims France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations::
Austria, Belgium, Bulgaria, Cyprus, Denmark,
Estonia, Finland, France, Germany, Greece,
Iceland, Ireland, Latvia, Lithuania, Luxembourg,
Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden,
England
Atacand
Italy Ratacand

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency
AIFA: http://www.agenziafarmaco.gov.it