Please note that section 2-3 and 6 in the SPC and related section in package leaflet and labelling show the approved information in RMS.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Parapres Comp Forte 16 mg/12.5 mgtablets

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. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Parapres Comp Forte is and what it is used for

2. What you need to know before you take Parapres Comp Forte

3. How to take Parapres Comp Forte

4. Possible side effects

5. How to store Parapres Comp Forte

6. Contents of the pack and other information

1. What Parapres Comp Forteis and what it is used for

The name of your medicine is Parapres Comp Forte.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 Parapres Comp Forte if your blood pressure has not been properly controlled by candesartan cilexetil or hydrochlorothiazide alone.

2. WHAT YOU NEED TO KNOW Before you take Parapres Comp Forte

Do not take Parapres Comp Forte if:

- if you are allergic to candesartan cilexetil or hydrochlorothiazide or any of the other ingredients of this medicine (listed in section 6).

- if youare 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 Parapres Comp Fortein 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 the 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 Parapres Comp Forte.

Warnings and precautions

Talk to your doctor before taking Parapres Comp Forte:

- 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. Parapres Comp Forteis 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), 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 Parapres Comp Forte:”

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 Parapres Comp Forte. This is because Parapres Comp Forte, when combined with some anaesthetics, may cause a drop in blood pressure.

Parapres Comp Forte may cause increased sensitivity of the skin to sun.

Use in children

There is no experience with the use of Parapres Comp Forte in children (below the age of 18 years. Therefore Parapres Comp Forte should not be given to children.

Other medicines and Parapres Comp

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Parapres Comp Forte can affect the way some other medicines work and some medicines can have an effect on Parapres Comp Forte. 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, 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 3g 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 (an antibiotic).

• 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 heading “Do not take Parapres Comp Forte:” and “Warnings and precautions”).

Parapres Comp Forte with food, drink and alcohol

• You can take Parapres Comp Forte with or without food.

• When you are prescribed Parapres Comp Forte, 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 Parapres Comp Forte before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Parapres Comp Forte. Parapres Comp Forte 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. Parapres Comp Forte 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 Parapres Comp Forte. If this happens to you, do not drive or use any tools or machines.

Parapres Comp Forte contains lactose. Lactose 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.

3. How to take PARAPRES COMP FORTE

Always take Parapres Comp Forte exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. It is important to keep taking Parapres Comp Forte every day.

The recommended dose of Parapres Comp Forte 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.

The tablet can be divided into equal doses.

If you take more Parapres Comp Forte than you should

If you take more Parapres Comp Forte than prescribed by your doctor, contact a doctor or pharmacist immediately for advice.

If you forget to take Parapres Comp Forte

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

If you stop taking Parapres Comp Forte

If you stop taking Parapres Comp Forte, your blood pressure may increase again. Therefore do not stop taking Parapres Comp Forte without first talking to your doctor.

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

4. Possible side effects

Like all medicines, Parapres Comp Forte 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 Parapres Comp Forte are caused by candesartan cilexetil and some are caused by hydrochlorothiazide.

Stop taking Parapres Comp Forte 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)

Parapres Comp Forte 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 Parapres Comp Forte has had any effect on your blood (agranulocytosis).

Other possible side effects include:

Common (affects 1 to 10 users in 100)

• Changes in blood test results:

  • A reduced amount of sodium in your blood. If this is severe then you may notice weakness, lack of energy, or muscle cramps.

  • 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.

• Worsening of existing lupus erythaematosus-like reactions or appearance of unusual skin reactions.

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 shortsightedness

• Sudden eye pain (acute angle-closure glaucoma)

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via <tobe completed nationally>.By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store PARAPRES COMP FORTE

• Keep out of the sight and reach of children.

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

• Do not use Parapres Comp Forte after the expiry date which is stated on the carton label and blister foil after (EXP). The expiry date refers to the last day of that month.

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

6. CONTENTS OF THE PACK AND OTHER information

What Parapres Comp Forte contains

• The active substances are candesartan cilexetil and hydrochlorothiazide. Each tablet contains 16 mg of candesartan cilexetil and 12,5 mg of hydrochlorothiazide.

• The other ingredients are carmellose calcium, hydroxypropylcellulose, lactose monohydrate, magnesium stearate, maize starch, macrogol and red iron oxide (E172).

What Parapres Comp Forte looks like and contents of the pack

Parapres Comp Forte tablets come in blister packs containing 7, 14, 20, 28, 50, 56, 98, 100 or 300 tablets.

Not all pack sizes may be marketed in every country.

Marketing Authorisation Holder and Manufacturer

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Denmark

Manufacturer

Takeda Ireland Ltd., Bray Business Park, Kilruddery, Co. Wicklow, Ireland, or by

Takeda Italia, Via Crosa 86, 28065 Cerano (No), Italy, or by Industrias Farmacéuticas Almirall, S.A., Ctra. Nacional II, km 593 E-08740 Sant Andreu de La Barca, Barcelona, Spain.

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

Name	Member State
Parapres Comp Forte 16 mg/12,5 mg	Sweden
Parapres Plus 16 mg/12,5 mg	Spain

This leaflet was last revised in 2016-08-02

Other sources of information

Detailed information on this medicine is available on the website of <tobe completed nationally>.