Parapres Comp

Information för alternativet: Parapres Comp 32 Mg/12,5 Mg Tablett, visa andra alternativ

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.


Parapres Comp 32 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.

In this leaflet:

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

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

3. How to take Parapres Comp

4. Possible side effects

5. How to store Parapres Comp

6. Contents of the pack and other information

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

The name of your medicine is Parapres Comp.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.

Your doctor may prescribe Parapres Comp 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

Do not take Parapres Comp:

- 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 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 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.

Warnings and precautions

Talk to your doctor before taking Parapres Comp :

- 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 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), 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:”.

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

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

Use in children

There is no experience with the use of Parapres Comp in children (below the age of 18 years. Therefore Parapres Comp 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 can affect the way some other medicines work and some medicines can have an effect on Parapres Comp. 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:

Parapres Comp with food, drink and alcohol

Pregnancy and breast-feeding


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 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. Parapres Comp 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.


Tell your doctor if you are breast-feeding or about to start breast-feeding. Parapres Comp 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. If this happens to you, do not drive or use any tools or machines.

Parapres Comp 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

Always take Parapres Comp 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 every day.

The recommended dose of Parapres Comp 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 score line is only there to help you break the tablet if you have difficulty swallowing it whole.

If you take more Parapres Comp than you should

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

If you forget to take Parapres Comp

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

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

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

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

Other possible side effects include:

Common (affects 1 to 10 users in 100)

Uncommon (affects less than 1 user in 100)

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

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

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

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

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


What Parapres Comp contains

What Parapres Comp looks like and contents of the pack

Parapres Comp 32 mg/12.5mgtablets are light yellow, oval, flat tabletsapproximately 11 mm by 6.5 mmwith debossing 32│C1 on both sides.

Parapres Comp 32 mg/12.5mg tablets come in blister packs containing 7, 14, 20, 28, 50, 56, 98, 100 and 300 tablets.

Not all pack sizes may be marketed in every country.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Takeda Pharma A/S

Dybendal Alle 10, 2630 Taastrup, Denmark


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:


Member State

Parapres Comp 32 mg/12,5 mg


Parapres Plus 32 mg/12,5 mg


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>.

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