RATACAND 8 мг/12,5 мг Таблетки

Содержание инструкции

1. 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
   1. What is Ratacand Plus 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. Package Contents and Other Information

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

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 may 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 Ratacand Plus is and what it is used for
• 2. What you need to know before you take 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 is Ratacand Plus 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 ingredients: 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 relaxation and dilation of blood vessels. This helps to reduce blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called diuretics (which help you to urinate). This helps the body to eliminate water and salts such as sodium in the urine. This contributes to reducing blood pressure.

The 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 any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to sulfonamide medicines. If you are not sure whether this condition may concern you, consult your doctor.
• if you are pregnant for more than 3 months (it is best to avoid the use of Ratacand Plus even in the early stages of pregnancy - see the section relating to pregnancy).
• if you have severe kidney problems.
• if you have a severe liver disease or obstruction of the bile ducts (a problem with the drainage of bile 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 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 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 problems with your heart, liver or kidneys.
• if you have recently undergone a kidney transplant.
• if you vomit, have recently had severe vomiting or diarrhoea.
• if you have a disease of the adrenal gland, 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.
• tell your doctor if you think you may be pregnant (or if there is a possibility of starting a pregnancy). Ratacand Plus is not recommended in the early stages of pregnancy, and must not be taken if you are pregnant for more than 3 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, etc.), especially if you suffer from kidney problems related to diabetes.
• aliskiren.
• if you have had skin cancer in the past or if you are developing an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use with high doses, may increase the risk of some types of skin cancer and lips (non-melanoma skin cancer). Protect your skin from exposure to the sun and UV rays while taking Ratacand Plus. 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 reported under "Do not take Ratacand Plus". Your doctor may need to see you more often and do tests if you experience any of these conditions.

If you are about to have an operation, tell your doctor or dentist that you are taking Ratacand Plus. This
is because Ratacand Plus, when combined with certain anaesthetics, can cause an excessive drop in
blood pressure.
Ratacand Plus can increase the sensitivity of your skin to the sun.

Children
There is no experience regarding the use of Ratacand Plus in children (under 18 years of age).
Therefore Ratacand Plus should not be given to children.
For athletes
The use of the drug without a therapeutic need constitutes doping and may still
result in positive doping tests.

Other medicines and Ratacand Plus
Tell your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicine. Ratacand Plus can affect the mechanism of action of other medicines, and
some medicines can have an effect on Ratacand Plus. 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 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 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).
• Calcium or vitamin D supplements.
• Medicines for lowering cholesterol, such as colestipol or colestyramine.
• Medicines for diabetes (oral or insulin).
• Medicines to control the heartbeat (antiarrhythmic agents) such as digoxin and beta-blockers.
• Medicines whose action may be affected by blood potassium levels, such as some antipsychotic drugs.
• Heparin (a medicine for thinning the blood).
• Medicines that help you urinate (diuretics).
• Laxatives.
• Penicillin or co-trimoxazole also known as trimethoprim/sulfamethoxazole (antibiotic medicines).
• Amphotericin (for the treatment of fungal infections).
• Lithium (a medicine for mental health problems).
• Steroids, such as prednisolone.
• Pituitary hormone (ACTH).
• Medicines to treat cancer.
• Amantadine (for the treatment of Parkinson's disease or for severe infections caused by viruses).
• Barbiturates (a type of sedative also used for the treatment of epilepsy).
• Carbenoxolone (for the treatment of esophageal disease or oral ulcers).
• Anticholinergic agents such as atropine and biperidene.
• Cyclosporine, a medicine used in organ transplantation to prevent rejection.
• Other medicines that can enhance the antihypertensive effect, such as baclofen (a medicine for relieving spasticity), amifostine (used for the treatment of cancer) and some antipsychotic medicines.
• If you are taking an ACE inhibitor or aliskiren (see also what is reported under: "Do not take Ratacand Plus" and "Warnings and precautions").

Ratacand Plus with food, beverages and alcohol

• You can take Ratacand Plus with or without food.
• When you are prescribed Ratacand Plus, 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 starting
a pregnancy). As a rule, your doctor will advise you to stop taking Ratacand Plus
before starting a pregnancy or as soon as you find out you are pregnant and will advise you to take another medicine instead of Ratacand Plus. Ratacand Plus is not
recommended in the early stages of pregnancy, and must not be taken if you are pregnant for
more than 3 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 about to start breastfeeding. 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 newborn or premature.

Driving and operating machinery
Some people may feel tired or dizzy when taking Ratacand Plus. If this happens to
you, do not drive or use tools or machinery.

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

3. How to take Ratacand Plus

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 Plus every day.
The recommended dose of Ratacand Plus is one tablet once a day.
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 missed tablet. Just take the next
dose as usual.

If you stop taking Ratacand Plus
If you stop taking Ratacand Plus, your blood pressure may increase again.
Therefore, do not stop taking Ratacand Plus 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. 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 in breathing, with or without swelling of the face, lips, tongue and/or throat.
• swelling of the face, lips, tongue and/or throat, which can cause difficulty in swallowing.
• severe itching of the skin (with raised bumps).

Ratacand Plus 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. Your doctor may occasionally perform blood tests to check if
Ratacand Plus has had any effects on your blood (agranulocytosis).
Other possible side effects include:

Common (affects 1 to 10 people in 100)

• Changes in blood test results:
• A reduced amount of sodium in the blood. If this reduction is severe, then you may notice weakness, lack of energy or muscle cramps.
• An increased or reduced amount of potassium in the blood, especially if you already have kidney problems or heart failure. If this increase or reduction is severe, then you may notice fatigue, weakness, an irregular heartbeat or tingling.
• An increased amount of cholesterol, sugar or uric acid in the blood.
• Sugar in the urine.
• Feeling dizzy/lightheaded or weak.
• Headache.
• Respiratory infection.

Uncommon (affects less than 1 in 100 people)

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

Rare (affects less than 1 in 1,000 people)

• Jaundice (yellowing of the skin or the white of the eye). If this happens to you, contact your doctor immediately.
• Effects on the functioning of your kidneys, especially if you already have kidney problems or heart failure.
• Difficulty sleeping, depression, feeling restless.
• Tingling or prickling in the arms or legs.
• Blurred vision for a short period.
• Abnormal heartbeat.
• Difficulty breathing (including inflammation of the lungs and fluid in the lungs).
• High temperature (fever).
• Inflammation of the pancreas. This causes moderate to severe stomach pain.
• Muscle cramps.
• Damage to blood vessels causing the appearance of red or purple spots on the skin.
• A reduction in red blood cells, white blood cells or platelets. You may notice fatigue, infection, fever, easy bruising (bleeding).
• Severe skin rash that develops rapidly, with blistering and peeling of the skin and possible blistering in the mouth.

Very rare (affects less than 1 in 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 the white of the eye 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 myopia.
• Sudden eye pain (acute angle-closure glaucoma).
• Systemic and cutaneous lupus erythematosus (allergic condition that causes fever, joint pain, rash that may include redness, blistering, peeling and swelling).
• Diarrhea.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through
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 particular storage temperature.
• Do not use this medicine after the expiry date which is stated on the packaging, blister or bottle. The expiry date refers to the last day of the month.

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 Plus contains
The active ingredients of 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 ingredients are calcium carmellose, hydroxypropylcellulose, lactose monohydrate, magnesium
stearate, corn 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 package contents
Ratacand Plus 8 mg/12.5 mg tablets are white, oval-shaped tablets, measuring 4.5 mm x

A.
9.5 mm, with a fracture line on both sides and imprinted with CK
Ratacand Plus 16 mg/12.5 mg tablets are peach-colored, oval-shaped tablets, measuring

A.
4.5 mm x 9.5 mm, with a fracture line on both sides and imprinted with CS
Ratacand Plus 32 mg/12.5 mg tablets are yellow-colored, measuring

A
6.5 mm x 11 mm, oval, imprinted with CJ
on one side and with a pressure-sensitive fracture line
on the other side.
The tablet can be divided into two equal parts by breaking it along the fracture line.
Ratacand Plus 32 mg/25 mg tablets are pink-colored, measuring

A
6.5 mm x 11 mm, oval, imprinted with CD
on one side and with a pressure-sensitive fracture line
on the other side.
The tablet can be divided into two equal parts by breaking it along the fracture line.
Ratacand Plus 8 mg/12.5 mg tablets are available in plastic bottles containing 100
tablets or in blisters containing 7, 14, 15, 15x1 (single dose), 28, 30, 30x1 (single dose), 50, 56,
90, 98, 98x1 (single dose), 100 or 300 tablets.
Ratacand Plus 16 mg/12.5 mg tablets are available in plastic bottles containing 100
tablets or in blisters containing 7, 14, 15, 15x1 (single dose), 28, 28x1 (single dose), 30, 30x1
(single dose), 50, 50x1 (single dose), 56, 56x1 (single dose), 90, 98, 98x1 (single dose), 100 or 300
tablets.
Ratacand Plus 32 mg/12.5 mg tablets are available in plastic bottles containing 100
tablets or in blisters containing 7, 14, 15, 15x1 (single dose), 28, 28x1 (single dose) 30, 30x1
(single dose), 50, 50x1 (single dose), 56, 56x1 (single dose), 98, 98x1 (single dose), 100 or 300
tablets.
Ratacand Plus 32 mg/25 mg tablets are available in blisters containing 7, 14, 15, 15x1 (single
dose), 28, 28x1 (single dose), 30, 30x1 (single dose), 50, 50x1 (single dose), 56, 56x1 (single
dose), 98, 98x1 (single 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 SK 10 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 with the
following names:
Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency.