Ratacand

Package leaflet: Information for the patient

Ratacand 4 mg tablets, 8 mg tablets, 16 mg tablets, 32 mg tablets

candesartan cilexetil
Please read all of this leaflet carefully before you start 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, because it may be harmful. If any adverse reaction occurs, including those not listed in this leaflet, contact 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 taking 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 Ratacand is and what it is used for

The name of the medicine is Ratacand. 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.
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 (MRAs) cannot be used. (ACE inhibitors and MRAs are medicines used to treat heart failure).

2. What you should 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 more than three months pregnant (it is better to avoid Ratacand even in the early stages of 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 suffer from diabetes or have impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If you are unsure whether 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 undergone a kidney transplant.
• if you are vomiting, have recently experienced 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 any chance you could become pregnant). Ratacand 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 "Taking other medicines"). 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 Ratacand 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 Ratacand. This is because Ratacand, when combined with certain anaesthetics, may cause a drop in blood pressure.
Children and adolescents
Ratacand has been studied in children. For further information, consult your doctor. Ratacand must not be given to children under 1 year of age due to the potential risk to developing kidneys.
Other medicines and Ratacand
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Ratacand may affect how other medicines work, and some medicines may affect Ratacand. 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 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).
• cotrimoxazole (an antibiotic), also known as trimethoprim/sulfamethoxazole.
• tablets that help you urinate (diuretics).
• lithium (a medicine used for mental health conditions).
• if you are taking an ACE inhibitor or aliskiren (see also "Do not take Ratacand if" and "Take 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 (MRAs) (e.g. spironolactone, eplerenone).

Ratacand with food, drinks and alcohol

• You may take Ratacand with or without food.
• When Ratacand is prescribed for you, 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 may be pregnant (or if there is any chance of becoming pregnant). Your doctor will usually advise you to stop taking Ratacand before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Ratacand 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.

Breast-feeding
Inform your doctor if you are breast-feeding or planning to start breast-feeding. Ratacand is not recommended for women who are breast-feeding, and your doctor may choose an alternative treatment 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 Ratacand. If this happens to you, do not drive or operate tools or machinery.
Ratacand contains lactose. Lactose is a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Ratacand

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 Ratacand every day. Ratacand 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.

High blood pressure:

• The usual dose of Ratacand is 8 mg once daily. Your doctor may increase this dose up 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 due to, for example, 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, your doctor may decide to increase the dose 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 to increase the dose to 8 mg once daily and then to 16 mg once daily.

Heart failure in adults:

• The recommended starting dose of Ratacand 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. Ratacand 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 Ratacand than you should
If you take more Ratacand than prescribed, contact a doctor or pharmacist immediately for advice.

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

If you stop taking Ratacand
If you stop treatment with Ratacand, your blood pressure may rise again. Therefore, do not stop treatment with Ratacand 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.
Stop taking Ratacand 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 rashes)

Ratacand 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 Ratacand has affected your blood (agranulocytosis).

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

• Dizziness
• 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 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 sodium levels 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

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 is a very common side effect in children but not reported in adults, and rhinorrhoea (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, pharmacist, or nurse. 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 Ratacand

• 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 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 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 Ratacand 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 (excipients) are calcium carmellose, hydroxypropylcellulose, monohydrate lactose, magnesium stearate, maize starch, and polyethylene glycol (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 marked A/CF on one side and 004 on the other.
• The 8 mg tablets are pale pink, round, with a score line and marked A/CG on one side and 008 on the other.
• The 16 mg tablets are pink, round, with a score line and marked A/CH on one side and 016 on the other.
• The 32 mg tablets are pink, round, with a score line and marked A/CL on one side and 032 on the other.

The tablet may be divided into two equal parts by breaking it along the score line.
The tablets are supplied 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 European Economic Area countries under the following names:
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, United Kingdom: 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