RATACAND PLUS

Patient Information Leaflet: Information for the User

Ratacand Plus 8 mg/12.5 mg tablets, 16 mg/12.5 mg tablets, 32 mg/12.5 mg tablets, 32 mg/25 mg tablets

candesartan cilexetil/hydrochlorothiazide
Please read all of 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 give it to other people, 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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ratacand Plus is and what it is used for

The name of your medicine is Ratacand Plus. It is used to treat high blood pressure (hypertension) in adult patients. It contains two active substances: candesartan cilexetil and hydrochlorothiazide. These work together to lower blood pressure.

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It causes the blood vessels to relax and widen. This helps reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (medicines that help you pass urine). It helps the body eliminate water and salts such as sodium through the urine. This contributes to lowering blood pressure.

Your doctor may prescribe Ratacand Plus if your blood pressure has not been adequately controlled by candesartan cilexetil or hydrochlorothiazide alone.

2. What you need to know before taking Ratacand Plus

Do not take Ratacand Plus:

• if you are allergic to candesartan cilexetil or hydrochlorothiazide or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamide medicines. If you are unsure whether this applies to you, consult your doctor.
• if you are more than 3 months pregnant. (It is better to avoid using Ratacand Plus even in the early stages of pregnancy – see the section on pregnancy.)
• if you have severe kidney problems.
• if you have severe liver disease or biliary obstruction (a problem with bile drainage from the gallbladder).
• if you have persistently low levels of potassium in your blood.
• if you have persistently high levels of calcium in your blood.
• if you have had gout.
• if you have diabetes or 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 Plus.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ratacand Plus:

• if you have diabetes.
• if you have heart, liver, or kidney problems.
• if you have recently undergone a kidney transplant.
• if you are vomiting, or have recently experienced severe vomiting or diarrhea.
• if you have an adrenal gland disorder known as Conn's syndrome (also called primary hyperaldosteronism).
• if you have had a disease called systemic lupus erythematosus (SLE).
• if you have low blood pressure.
• if you have ever had a stroke.
• if you have had allergies or asthma.
• inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Ratacand Plus is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section on Pregnancy).
• if you are taking any of the following medicines used to treat high blood pressure:
• an "ACE inhibitor" (e.g., enalapril, lisinopril, ramipril, etc.), particularly if you have kidney problems related to diabetes.
• aliskiren.
• if you have previously had skin cancer or if you develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from exposure to sunlight and UV rays during treatment with Ratacand Plus. Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals. See also the section "Do not take Ratacand Plus". Your doctor may need to see you more frequently and perform tests if you develop any of these conditions.

If you are about to undergo surgery, tell your doctor or dentist that you are taking Ratacand Plus. This is because Ratacand Plus, when combined with certain anesthetics, may cause excessive lowering of blood pressure.
Ratacand Plus may increase your skin's sensitivity to sunlight.
Children
There is no experience with the use of Ratacand Plus in children (under 18 years of age). Therefore, Ratacand Plus must not be given to children.
For those engaged in sports
Using the medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Other medicines and Ratacand Plus
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Ratacand Plus may affect how other medicines work, and some medicines may affect Ratacand Plus. If you are taking certain medicines, your doctor may need to perform 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 lower blood pressure, including beta-blockers, medicines containing aliskiren, 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 to relieve pain and inflammation).
• Acetylsalicylic acid (if taking more than 3 g per day) (a medicine to relieve pain and inflammation).
• Potassium supplements or potassium-containing salt substitutes (medicines that increase potassium levels in the blood).
• Calcium or vitamin D supplements.
• Medicines to lower cholesterol, such as colestipol or cholestyramine.
• Medicines for diabetes (oral or insulin).
• Medicines to control heart rhythm (antiarrhythmics) such as digoxin and beta-blockers.
• Medicines whose action may be affected by blood potassium levels, such as certain antipsychotics.
• Heparin (a medicine to thin the blood).
• Medicines that help you urinate (diuretics).
• Laxatives.
• Penicillin or co-trimoxazole (also known as trimethoprim/sulfamethoxazole) (antibiotic medicines).
• Amphotericin (for treating fungal infections).
• Lithium (a medicine for mental health conditions).
• Steroids, such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines for treating cancer.
• Amantadine (for treating Parkinson's disease or severe viral infections).
• Barbiturates (a type of sedative also used to treat epilepsy).
• Carbenoxolone (for treating esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperiden.
• Cyclosporine, a medicine used in organ transplants to prevent rejection.
• Other medicines that may enhance the antihypertensive effect, such as baclofen (a medicine to relieve spasticity), amifostine (used in cancer treatment), and certain antipsychotics.
• If you are taking an ACE inhibitor or aliskiren (see also the sections: "Do not take Ratacand Plus" and "Warnings and precautions").

Ratacand Plus with food, drinks, and alcohol

• You may take Ratacand Plus with or without food.
• When Ratacand Plus 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 a possibility of becoming pregnant). Your doctor will normally advise you to stop taking Ratacand Plus before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Ratacand Plus. Ratacand Plus is not recommended during early pregnancy, and must not be taken if you are more than 3 months pregnant, 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. Ratacand Plus is not recommended for women who are breastfeeding, and your doctor may choose another treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Some people may feel tired or dizzy while taking Ratacand Plus. If this happens to you, do not drive or operate tools or machinery.
Ratacand Plus contains lactose
Ratacand Plus contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Ratacand Plus

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
It is important to continue taking Ratacand Plus every day.
The recommended dose of Ratacand Plus is one tablet once daily.
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.

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

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

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

If you have any doubts about how to use this medicine, consult 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.
Some of the side effects of Ratacand Plus are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.
Stop taking Ratacand Plus 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 lumps).

Ratacand Plus 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 carry out blood tests to check whether Ratacand Plus has affected your blood (agranulocytosis).
Other possible side effects include:
Common (occurs in 1 to 10 out of 100 people)

• Changes in blood test results:
• Reduced sodium levels in the blood. If this reduction is severe, you may notice weakness, lack of energy or muscle cramps.
• Increased or decreased potassium levels in the blood, especially if you already have kidney problems or heart failure. If this increase or decrease is severe, you may notice fatigue, weakness, irregular heartbeat or tingling.
• Increased levels of cholesterol, glucose or uric acid in the blood.
• Glucose in the urine.
• Dizziness, lightheadedness or weakness.
• Headache.
• Respiratory infection.

Uncommon (occurs in fewer than 1 out of 100 people)

• Low blood pressure. This may make you feel weak or dizzy.
• Loss of appetite, diarrhoea, constipation, stomach irritation.
• Skin rash, rash with swelling (urticaria), skin rash caused by sensitivity to sunlight.

Rare (occurs in fewer than 1 out of 1,000 people)

• Jaundice (yellowing of the skin or whites of the eyes). If this occurs, contact your doctor immediately.
• Effects on kidney function, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, feeling restless.
• Tingling or prickling sensations in the arms or legs.
• Brief episodes of blurred vision.
• Abnormal heartbeat.
• Breathing difficulties (including lung inflammation and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes mild to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing the appearance of small red or purple spots on the skin.
• Reduction in red blood cells, white blood cells or platelets. You may notice fatigue, infection, fever, or easy bruising.
• Severe skin rash developing rapidly, with blistering and peeling of the skin, and possible blistering in the mouth.

Very rare (occurs in fewer than 1 out of 10,000 people)

• Swelling of the face, lips, tongue and/or throat.
• 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.
• Cough.
• Nausea.

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

• Skin and lip cancer (non-melanoma skin cancer)
• Sudden onset of myopia.
• Sudden eye pain (acute angle-closure glaucoma).
• Systemic and cutaneous lupus erythematosus (an allergic condition causing fever, joint pain, skin rash which may include redness, blistering, peeling and swelling).
• Diarrhoea.

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 Ratacand Plus

• Keep this medicine out of the sight and reach of children.
• This medicine does not require any special storage temperature.
• Do not use this medicine after the expiry date stated on the packaging, blister, or bottle. The expiry date refers to the last day of the month.

Do not dispose of medicines 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 Plus contains
The active substances in Ratacand Plus are candesartan cilexetil and hydrochlorothiazide. The tablets contain 8 mg, 16 mg, 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide.
The other components are calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, maize starch and macrogol. Ratacand Plus 16 mg/12.5 mg and Ratacand Plus 32 mg/25 mg also contain red iron oxide (E172). Ratacand Plus 16 mg/12.5 mg, Ratacand Plus 32 mg/12.5 mg and Ratacand Plus 32 mg/25 mg also contain yellow iron oxide (E172).

Description of the appearance of Ratacand Plus and contents of the pack
Ratacand Plus 8 mg/12.5 mg tablets are white, 4.5 mm x 9.5 mm, oval tablets, with a breakline on both sides and engraved with CK on one side.
Ratacand Plus 16 mg/12.5 mg tablets are peach-coloured, 4.5 mm x 9.5 mm, oval tablets, with a breakline on both sides and engraved with CS on one side.
Ratacand Plus 32 mg/12.5 mg tablets are yellow, 6.5 mm x 11 mm, oval tablets, engraved with CJ on one side and with a pressure-sensitive breakline on the other side.
The tablet can be divided into two equal parts by breaking it along the breakline.
Ratacand Plus 32 mg/25 mg tablets are pink, 6.5 mm x 11 mm, oval tablets, engraved with CD on one side and with a pressure-sensitive breakline on the other side.
The tablet can be divided into two equal parts by breaking it along the breakline.

Ratacand Plus 8 mg/12.5 mg tablets are supplied in plastic bottles containing 100 tablets or in blisters containing 7, 14, 15, 15x1 (unit dose), 28, 30, 30x1 (unit dose), 50, 56, 90, 98, 98x1 (unit dose), 100 or 300 tablets.
Ratacand Plus 16 mg/12.5 mg tablets are supplied in plastic bottles containing 100 tablets or in blisters containing 7, 14, 15, 15x1 (unit dose), 28, 28x1 (unit dose), 30, 30x1 (unit dose), 50, 50x1 (unit dose), 56, 56x1 (unit dose), 90, 98, 98x1 (unit dose), 100 or 300 tablets.
Ratacand Plus 32 mg/12.5 mg tablets are supplied in plastic bottles containing 100 tablets or in blisters containing 7, 14, 15, 15x1 (unit dose), 28, 28x1 (unit dose), 30, 30x1 (unit dose), 50, 50x1 (unit dose), 56, 56x1 (unit dose), 98, 98x1 (unit dose), 100 or 300 tablets.
Ratacand Plus 32 mg/25 mg tablets are supplied in blisters containing 7, 14, 15, 15x1 (unit dose), 28, 28x1 (unit dose), 30, 30x1 (unit dose), 50, 50x1 (unit dose), 56, 56x1 (unit dose), 98, 98x1 (unit dose), 100 or 300 tablets.
Not all pack sizes may be marketed.

CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24
17489 Greifswald
Germany
The tablets are manufactured by AstraZeneca AB, AstraZeneca Sweden, Gärtunavägen, S-151 85 Södertälje, Sweden and released by: AstraZeneca AB, AstraZeneca Sweden, Gärtunavägen, S-151 85 Södertälje, Sweden or AstraZeneca GmbH, Tinsdaler Weg 183, 22880 Wedel, Germany.
The 8 mg/12.5 mg and 16 mg/12.5 mg tablets are also released by: AstraZeneca UK Limited, Silk Road Business Park, Macclesfield, Cheshire SK10 2NA, United Kingdom or 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 under the following names:

Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency.