Atacand (Candesartan) 28 Tablets

Please read the INSTRUCTIONS carefully before you start using this medicine because it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have additional questions, please ask your doctor or pharmacist.

• This medicine has been prescribed to you personally, please do not give it to others. Even if the symptoms of others are the same as yours, the medicine may harm those people.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions given to you about your medication. Do not use high or low doses other than the dose given to you.

In these Instructions for Use:

1. What is ATACAND® PLUS and what is it used for? 2. Things to consider before using ATACAND® PLUS 3. How to use ATACAND® PLUS? 4. What are the possible side effects? 5. ATACAND® PLUS storage

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1. What is ATACAND® PLUS and what is it used for?

The name of your medicine is ATACAND® PLUS. Available in 28 and 84 tablets. The tablets are peach colored and oval and can be divided into two equal parts along the line.

ATACAND® PLUS is used to treat high blood pressure (in the treatment of hypertension). It contains two active ingredients: Candesartan cilexetil and hydrochlorothiazide. These two agents are involved in reducing your blood pressure.

• Candesartan cilexetil belongs to a group of drugs called an angiotensin II receptor antagonist. It relaxes and dilates your blood vessels. This helps to lower your blood pressure.

• Hydrochlorothiazide belongs to a group of drugs called 'diuretics' (diuretics). It helps to remove water and salts like sodium from your body with urine. This will decrease your blood pressure.

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Your doctor may prescribe ATACAND® PLUS in cases where your blood pressure cannot be reduced by candesartan cilexetil or hydrochlorothiazide alone.

2. Things to consider before using ATACAND® PLUS, douse ATACAND® PLUS, please be aware that

If you are pregnantnotyou are pregnant or are pregnant. You should tell your doctor if you are pregnant or if you are in doubt. Use of ATACAND® PLUS during pregnancy can cause serious damage to your baby and even death (see section on pregnancy and breastfeeding).

DO NOT use ATACAND® PLUS in the following cases

If you

•are allergic to any of Kandesartan cilexetil and hydrochlorothiazide or any of the substances contained in ATACAND® PLUS,

• If you are allergic to sulfonamide drugs (To be sure, Please consult)

• you severe liver disease or biliary tract If you have any obstruction (a problem with the disposal of bile from the gall bladder)

• if you have severe kidney problems,

• if you have gout,

• potassium level in your blood constantly low,

• calcium levels in your blood constant If you are,

breastfeeding• If you are breastfeeding,

• If you have diabetes (diabetes mellitus) or renal failure, do not use ARB and ACE inhibitors, which include ATACAND® PLUS, as the blood pressure lowering group, together with ğ aliskiren itus, another blood pressure lowering drug.

If you are unsure whether the above conditions apply to you, consult your doctor before using ATACAND® PLUS.

Instructions for appropriate use and dose / frequency of administration: General dose is 1 tablet per day.

Method and method of administration:

• Swallow the tablets as a whole with a glass of water.

• Try taking the tablets at the same time every day. This will help you remember to take your tablet.

Different age groups::

Use in childrenThere is no experience in the use of ATACAND® PLUS in children (under 18 years). Therefore ATACAND® PLUS should not be used in children.

Use in the elderly: Dose adjustment is not required in elderly patients.

Specific Use Cases: Renal insufficiency and hepatic failure: In patients with mild to moderate renal impairment, the recommended initial dose of candesartan cilexetil is 4 mg. If you have severe renal failure, you should not use ATACAND® PLUS.

If you have mild to moderate hepatic impairment, your doctor will determine the appropriate dose for you. In this case, the recommended starting dose is 4 mg. You should not use ATACAND® PLUS if you have severe liver failure or cholestasis (blockage of bile ducts).

If you have an impression that the effect of ATACAND® PLUS is too strong or too weak, talk to your doctor or pharmacist.

If you have used more than ATACAND® PLUS: If you have used ATACAND® PLUS more than you should, talk to your doctor or pharmacist immediately.

If you forget to use ATACAND® PLUS: Do not take a double dose to compensate for the missed dose. Just take your next dose when it's time.

Effects after termination of treatment with ATACAND® PLUS:

If you stop using ATACAND® PLUS, your blood pressure may increase again. Therefore, do not stop using ATACAND® PLUS before talking to your doctor.

If you have further questions regarding the use of this product, ask your doctor or pharmacist.

4. What are the possible side effects?

Like all medicines, ATACAND® PLUS may have side effects in people who are sensitive to the substances contained in its contents.

It is important to know that these side effects may occur. Some side effects of ATACAND® PLUS come from candesartan cilexetil and some from hydrochlorothiazide.

If you have one of the following allergic reactions, cut to take Atacand® PLUS you get medical help immediately:

• your face, your lips, your tongue and / or your throat swelling with or difficulties alone in breathing

• your face, your lips your language and / or difficulty in swallowing as a result of your throat swelling

• Severe itching on your skin (with bubbles)

These are all very serious side effects. If you have one of these, you have a serious allergy to ATACAND® PLUS. You may need urgent medical attention or hospitalization.

Side effects are classified as follows: Common (seen in 1 to 10 patients from 100 patients) Uncommon (less than 1 in 100 patients) Sparse (less than 1 in 1000 patients) Very rare (less than 1 in 10 000 patients) seen)

Candesartan effects seen with possible side are as follows:

Common side effects

• dizziness / vertigo, headache

• Respiratory tract infections,

side effects Very rare

• decrease in your platelet your or red or white blood cells. This may cause fatigue, an infection, a fever, or an easy bruise.

• Reduction of sodium in your blood. If this is a serious reduction you may feel fatigue, energy deprivation or muscle cramps.

• If you have kidney problems or heart failure, increase or decrease in the amount of potassium in your blood (if this is a serious effect, you may feel fatigue, weakness, irregular heartbeat.)

• Cough

• Nausea

• Including inflammation in your liver (hepatitis) changes. You can see signs of fatigue, flu-like symptoms, yellowing of your skin and eyes.

• Rapidly developing, scaling or peeling of the skin, severe rash in the mouth, possible rash in the mouth, lumpy itchy rash (urticaria), itching

• Back pain, pain in the joints and muscles

• If you have kidney problems and heart failure, especially for your kidneys to work .

Side effects in doses of 25 mg and higher in monotherapy with hydrochlorothiazide.

Common side effects:

• Change in blood test values ​​- Decrease in the amount of sodium in your blood. If this is a serious reductionfatigue, energy

you may feeldeprivation or muscle cramps. - Decrease in the amount of potassium in your blood, especially if you have kidney problems or heart failure. .)

• Sugar in your urine

• Dizziness, dizziness, weakness

• Headache

• Respiratory infection

Uncommon side effects:

• Decrease in blood pressure. This may cause a sense of dizziness and faintness.

• Loss of appetite, diarrhea, constipation, stomach irritation

• Skin rash, lumpy rash (urticaria), rash caused by sunlight sensitivity

Rare side effects:

• Jaundice (yellowing of your skin color or white parts of your eyes) If

this occurs, IMMEDIATELY inform your doctor.

• If you have kidney problems and heart failure, it affects your kidneys.

• Difficulty sleeping, depression, restlessness

• Tingling or pinching in your arms or legs

• Short blurred vision

• Abnormal heartbeat

• Difficulty in breathing (Lung inflammation and fluid in lungs)

• High fever

• Inflammation of the pancreas. This situation causes moderate to severe pain in the stomach.

• Muscle cramps

• Red or pink spots on the skin caused by damage to your blood vessels

• Reduction of your platelets or red or white blood cells. This may cause fatigue, an infection, a fever, or an easy bruise.

• There is Lupus Erythematosus as worsening reactions to be seen or different skin reactions

• Face, lips, tongue and / or throat swelling

• increase in the amount of creatinine, blood urea nitrogen and your blood (in this case are examined.)

Also sudden myopia (sighted) or sudden eye pain can be seen.

ATACAND® PLUS may cause a decrease in the number of white blood cells. Your resistance to infections may decrease and you may experience infection and fever with fatigue. In this case, consult your doctor. Your doctor may ask you from time to time to take blood tests to determine if ATACAND® PLUS has any effect on your blood (agronulocytosis).

Report side effectsside effects that are

If you experience anyincluded in the instructions for use or not, talk to your doctor, pharmacist or nurse. Also located on the side effects www.titck.gov.t site you encounter "Drug Side Impact Statement" by clicking on the icon or 0800314 00 08 number of side effects by calling the notification line Turkey Pharmacovigilance Center (TÜFAM) 'What do you notice. By informing you of any side effects, you will contribute to further information on the safety of the drug you are using.

5. Storage of ATACAND® PLUS Keep ATACAND® PLUS in a place where children cannot see, reach, and pack.

Store at room temperature below 30 ° C. Keep in original packaging.

Use in accordance with the expiration date. Do not use ATACAND® PLUS after it has passed the expiry date on the label or packaging. The expiry date is the last day of the month.

Do not throw away any expired or unused medicines! Give to the collection system determined by the Ministry of Environment and Urbanization.

Registration holder: AstraZeneca İlaç San. and Tic. Ltd. Sti. Buyukdere Cad. Yapı Kredi Plaza, B Block Floor 3-4, Levent - İstanbul

Production site: AstraZeneca AB Södertalje, Sweden

This instructions for use is approved on 23/12/2016.