Information för alternativet: Atacand Plus 32 Mg/25 Mg Tablett, Atacand Plus 32 Mg/12,5 Mg Tablett, visar 2 alternativ

Välj alternativ:

1. Atacand Plus 32 Mg/25 Mg Tablett Atacand Plus 32 Mg/12,5 Mg Tablett
2. Atacand Plus 16 Mg/12,5 Mg Tablett Atacand Plus 8 Mg/12,5 Mg Tablett
3. Atacand Plus 16 Mg / 12,5 Mg Tablett Atacand Plus 16 Mg/12,5 Mg Tablett Atacand Plus 16 Mg / 12,5 Mg Tablett

Document: Atacand Plus tablet ENG PL change

• Atacand Plus tablet PL
• Atacand Plus tablet ENG PL

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Package leaflet: Information for the user

Atacand Plus 8 mg/12.5 mg tablets

Atacand Plus 16 mg/12.5 mg tablets

Atacand Plus 32 mg/12.5 mg tablets

Atacand Plus 32 mg/25 mg tablets

candesartan cilexetil/hydrochlorothiazide

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 further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet

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

2. What you need to know before you take Atacand Plus

3. How to take Atacand Plus

4. Possible side effects

6. Contents of the pack and other information

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

• Candesartan cilexetil belongs to a group of medicines called angiotensin II receptor antagonists. It makes your blood vessels relax and widen. This helps to lower your blood pressure.

• Hydrochlorothiazide belongs to a group of medicines called diuretics (water tablets). It helps your body to get rid of water and salts like sodium in your urine. This helps to lower your blood pressure.

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

Do not take Atacand 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 sulphonamide medicines. If you are not sure if this applies to you, please ask your doctor.

- if you are more than 3 months pregnant (it is also better to avoid Atacand Plus in early pregnancy – see pregnancy section).

- if you have severe kidney problems.

- if you have severe liver disease or biliary obstruction (a problem with the drainage of bile from the gall bladder).

- 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 ever had gout.

- if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Atacand Plus.

Warnings and precautions

Talk to your doctor or pharmacist before taking Atacand Plus:

- if you have diabetes.

- if you have heart, liver or kidney problems.

- 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 called Conn’s syndrome (also called primary hyperaldosteronism).

- if you have ever had a disease called systemic lupus erythaematosus (SLE).

- if you have low blood pressure.

- if you have ever had a stroke.

- if you have ever had allergy or asthma.

• you must tell your doctor if you think you are (or might become) pregnant. Atacand Plus is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

• if you are taking any of the following medicines used to treat high blood pressure:

  • an ACE‑inhibitor (for example enalapril, lisinopril, ramipril, etc.), in particular if you have diabetes‑related kidney problems.

  • aliskiren.

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 information under the heading “Do not take Atacand Plus:”.

Your doctor may want to see you more often and do some tests if you have any of these conditions.

If you are going to have an operation, tell your doctor or dentist that you are taking Atacand Plus. This is because Atacand Plus, when combined with some anaesthetics, may cause an excessive drop in blood pressure.

Atacand Plus may cause increased sensitivity of the skin to sun.

Children

There is no experience with the use of Atacand Plus in children (below the age of 18 years). Therefore Atacand Plus should not be given to children.

Other medicines and Atacand Plus

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Atacand Plus can affect the way some other medicines work and some medicines can have an effect on Atacand Plus. If you are using certain medicines, your doctor may need to do blood tests from time to time.

In particular, tell your doctor if you are using any of the following medicines as your doctor may need to change your dose and/or take other precautions:

• Other medicines to help lower your blood pressure, including beta-blockers, aliskiren- containing medicines, diazoxide and Angiotensin Converting Enzyme (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 you are taking more than 3 g each day) (medicine to relieve pain and inflammation).

• Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).

• Calcium or Vitamin D supplements.

• Medicines to lower your cholesterol, such as colestipol or cholestyramine.

• Medicines for diabetes (tablets or insulin).

• Medicines to control your heart beat (antiarrhythmic agents) such as digoxin and beta‑blockers.

• Medicines that can be affected by potassium blood levels such as some antipsychotic medicines.

• Heparin (a medicine for thinning the blood).

• Water tablets (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 serious infections caused by viruses).

• Barbiturates (a type of sedative also used to treat epilepsy).

• Carbenoxolone (for treatment of oesophageal disease, or oral ulcers).

• Anticholinergic agents such as atropine and biperiden.

• Cyclosporine, a medicine used for organ transplant to avoid organ rejection.

• Other medicines that may lead to enhancement of the antihypertensive effect such as baclofen (a medicine for relief of spasticity), amifostin (used in cancer treatment) and some antipsychotic medicines.

• If you are taking an ACE‑inhibitor or aliskiren (see also information under the headings “Do not take Atacand Plus” and “Warnings and precautions”).

Atacand Plus with food and drink and alcohol

• You can take Atacand Plus with or without food.

• When you are prescribed Atacand Plus, discuss with your doctor before drinking alcohol. Alcohol may make you feel faint or dizzy.

Pregnancy and breast-feeding

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Atacand Plus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Atacand Plus. Atacand Plus is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Atacand Plus is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Driving and using machines

Some people may feel tired or dizzy when taking Atacand Plus. If this happens to you, do not drive or use any tools or machines.

Atacand Plus contains lactose

Atacand Plus contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. It is important to keep taking Atacand Plus every day.

The recommended dose of Atacand Plus is one tablet once a day.

Swallow the tablet with a drink of water.

Try to take the tablet at the same time each day. This will help you to remember to take it.

If you take more Atacand Plus than you should

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

If you forget to take Atacand Plus

Do not take a double dose to make up for a forgotten tablet. Just take the next dose as normal.

If you stop taking Atacand Plus

If you stop taking Atacand Plus, your blood pressure may increase again. Therefore do not stop taking Atacand 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 Atacand Plus are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.

Stop taking Atacand Plus and seek medical help immediately if you have any of the following allergic reactions:

• difficulties 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 difficulties in swallowing.

• severe itching of the skin (with raised lumps).

Atacand Plus may cause a reduction in number of white blood cells. Your resistance to infection may be decreased and you may notice tiredness, an infection or a fever. If this happens contact your doctor. Your doctor may occasionally do blood tests to check whether Atacand Plus has had any effect on your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

• • An increased or reduced amount of potassium in your blood, especially if you already have kidney problems or heart failure. If this is severe, you may notice tiredness, weakness, irregular heartbeat or pins and needles.

  • An increased amount of cholesterol, sugar or uric acid in your blood.

• Sugar in your urine.

• Feeling dizzy/spinning sensation or weak.

• Headache.

• Respiratory infection.

Uncommon (affects less than 1 user in 100)

• Low blood pressure. This may make you feel faint or dizzy.

• Loss of appetite, diarrhoea, constipation, stomach irritation.

• Skin rash, lumpy rash (hives), rash caused by sensitivity to sunlight.

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

• Jaundice (yellowing of the skin or the whites of your eyes). If this happens to you, contact your doctor immediately.

• Effects on how your kidneys work, especially if you have kidney problems or heart failure.

• Difficulty in sleeping, depression, being restless.

• Tingling or prickling in your arms or legs.

• Blurred vision for a short time.

• Abnormal heart beat.

• Breathing difficulties (including lung inflammation and fluid in the lungs).

• High temperature (fever).

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

• Muscle cramps.

• Damage to blood vessels causing red or purple dots in the skin.

• A reduction in your red or white blood cells or platelets. You may notice tiredness, an infection, fever or easy bruising.

• A severe rash, that develops quickly, with blistering or peeling of the skin and possibly blistering in the mouth.

Very rare (affects less than 1 user in 10,000)

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

• Itching.

• Back pain, pain in joints and muscles.

• Changes in how your liver is working, including inflammation of the liver (hepatitis).You may notice tiredness, yellowing of your skin and the whites of your eyes and flu like symptoms.

• Cough.

• Nausea.

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

• Sudden short-sightedness.

• Sudden eye pain (acute angle-closure glaucoma).

• Systemic and cutaneous lupus erythematosus (allergic condition which causes fever, joint pain, skin rashes which may include redness, blistering, peeling and lumps).

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Atacand Plus

• Keep this medicine out of the sight and reach of children.

• This medicinal product does not require any special temperature storage conditions.

• Do not use this medicine after the expiry date which is stated on the carton, blister pack or bottle. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Atacand Plus contains

The active ingredients in Atacand Plus are candesartan cilexetil and hydrochlorothiazide. The tablets contain either 8 mg,16 mg or 32 mg of candesartan cilexetil and either 12.5 mg or 25 mg of hydrochlorothiazide.

The other ingredients are carmellose calcium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, maize starch and macrogol. Atacand Plus 16 mg/12.5 mg and Atacand Plus 32 mg/25 mg also contains iron oxide red (E172). Atacand Plus 16 mg/12.5, Atacand Plus 32 mg/12.5 mg and Atacand Plus 32 mg/25 mg also contains iron oxide yellow (E172).

What Atacand Plus looks like and contents of the pack

Atacand Plus 8/12.5 mg tablets are white, oval tablets with a score line on both sides and marked
.

Atacand Plus 16/12.5 mg tablets are peach, oval tablets with a score line on both sides and marked

Atacand Plus 32 mg/12.5 mg tablets are yellow, oval tablets with a score and marked on one side and a pressure sensitive score on the other side. The tablet can be divided into equal halves by breaking along the score line.

Atacand Plus 32 mg /25 mg tablets are pink, oval tablets with a score and marked on one side and a pressure sensitive score on the other side. The tablet can be divided into equal halves by breaking along the score line.

Atacand Plus 8 mg/12.5 mg tablets come in a plastic bottle containing 100 tablets or a blister pack containing 7, 14, 15, 15x1 (single dose unit), 28, 30, 30x1 (single dose unit), 50, 56, 90, 98, 98x1 (single dose unit), 100 or 300 tablets.

Atacand Plus 16 mg/12.5 mg tablets come in a plastic bottle containing 100 tablets or a blister pack containing 7, 14, 15, 15x1 (single dose unit), 28, 28x1 (single dose unit) 30, 30x1 (single dose unit), 50, 50x1 (single dose unit), 56, 56x1 (single dose unit), 90, 98, 98x1 (single dose unit), 100 or 300 tablets.

Atacand Plus 32 mg/12.5 mg tablets come in a plastic bottle containing 100 tablets or a blister pack containing 7, 14, 15, 15x1 (single dose unit), 28, 28x1 (single dose unit), 30, 30x1 (single dose unit), 50, 50x1 (single dose unit), 56, 56x1 (single dose unit), 98, 98x1 (single dose unit), 100 or 300 tablets.

Atacand Plus 32 mg/25 mg tablets come in a blister pack containing 7, 14, 15, 15x1 (single dose unit), 28, 28x1 (single dose unit), 30, 30x1 (single dose unit), 50, 50x1 (single dose unit), 56, 56x1 (single dose unit) 98, 98x1 (single dose unit), 100 or 300 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

{Name and address}

<{tel}>

<{fax}>

<{e-mail}>

This medicinal product is authorised in the Member States of the EEA under the following names:

Name	Member State
Atacand Plus	Austria, Belgium, Cyprus, Estonia, Germany, Greece, Finland, Iceland, Ireland, Latvia, Luxembourg, Malta, The Netherlands, Norway, Romania, Slovakia, Slovenia, Spain, Sweden
Hytacand	France, Portugal
Atacand Zid	Denmark
Ratacand Plus	Italy

[To be completed nationally]

This leaflet was last revised in 13 May 2016

Other sources of information

Detailed information on this medicinal product is available on the website of {name of MS Agency (link)}