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Valtsu Comp

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Document: Valtsu comp 320 mg_12.5 mg 320 mg_25 mg film-coated tablet ENG PL change


PACKAGE LEAFLET: INFORMATION FOR THE USER


Valtsu comp 320 mg/12.5 mg film-coated tablets

Valtsu comp 320 mg/25 mg film-coated tablets


Valsartan/hydrochlorothiazide


Read all of this leaflet carefully before you start taking this medicinebecause 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 Valtsu compis and what it is used for

2. What you need to know before you take Valtsu comp

3. How to take Valtsu comp

4. Possible side effects

5. How to store Valtsu comp

6. Contents of the pack and other information

1. What Valtsu comp is and what it is used for


Valtsu comp contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).


Valtsu comp is used to treat high blood pressure which is not adequately controlled by a single substance alone.


High blood pressure increases the workload of the heart and arteries. If not treated, it can damage the blood vessels of the brain, heart, and kidneys, and may result in a stroke, heart failure or kidney failure. High blood pressure increases the risk of heart attacks. Lowering your blood pressure to normal reduces the risk of developing these disorders.

2. What you need to know before you takeValtsu comp

Do not take Valtsu comp


If any of the above apply to you, do not take this medicine and speak to your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before taking Valtsu comp,

If any of these apply to you, talk to your doctor.


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 Valtsu comp


You must tell your doctor if you think you are (or might become) pregnant. Valtsu compis 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).


Children and adolescents

The use of Valtsu compin children and adolescents (below the age of 18 years) is not recommended.

Other medicines and Valtsu comp

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.


The effect of the treatment can be influenced if Valtsu comp is taken together with certain other medicines. It may be necessary to change the dose, to take other precautions, or in some cases to stop taking one of the medicines. This especially applies to the following medicines:



Valtsu compwith food, drink and alcohol

You can take Valtsu compwith or without food.

Avoid taking alcohol until you have talked to your doctor. Alcohol may make your blood pressure fall more and/or increase the risk of you becoming dizzy or feeling faint.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.


You must tell your doctor if you think that you are (or might become) pregnant

Your doctor will normally advise you to stop taking Valtsu comp before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valtsu comp. Valtsu compis 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 it is used after the third month of pregnancy.


Tell your doctor if you are breast-feeding or about to start breast-feeding

Valtsu 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

Before you drive a vehicle, use tools or operate machines or carry out other activities that require concentration, make sure you know how Valtsu comp affects you. Like many other medicines used to treat high blood pressure, Valtsu comp may occasionally cause dizziness and affect the ability to concentrate.

3. How to take Valtsu comp

Always take Valtsu compexactly as your doctor has told you. This will help you to get the best results and lower the risk of side effects. You should check with your doctor or pharmacist if you are not sure.


People with high blood pressure often do not notice any signs of this problem. Many may feel quite normal. This makes it all the more important for you to keep your appointments with your doctor even if you are feeling well.


Your doctor will tell you exactly how many tablets of Valtsu comp to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.


If you take more Valtsu compthan you should

If you experience severe dizziness and/or fainting, lay down and contact your doctor immediately.

If you have accidentally taken too many tablets, contact your doctor, pharmacist or hospital.

If you forget to take Valtsu comp

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Valtsu comp

Stopping your treatment with Valtsu compmay cause your high blood pressure to get worse. Do not stop taking your medicine unless your doctor tells you to.


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.


Some side effects can be serious and need immediate medical attention:


You should see your doctor immediately if you experience symptoms of angioedema such as:


These side effects are very rare or of frequency not known.


Other side effects include:


Uncommon (may affect up to 1 in 100 people)


Very rare (may affect up to 1 in 10,000 people)


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


The following side effects have been reported with products containing valsartan or hydrochlorothiazide alone:


Valsartan


Uncommon (may affect up to 1 in 100 people)


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


Hydrochlorothiazide


Very common (may affect more than 1 in 10 people)


Common (may affect up to 1 in 10 people)


Rare (may affect up to 1 in 1,000 people)


Very rare (may affect up to 1 in 10,000 people)


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


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Valtsu comp

Do not store above 30 °C.

Store in the original package in order to protect from moisture.

Bottle

This medicinal product does not require any special storage conditions.

6. Contents of the pack and other information

What Valtsu compcontains

The active substances are valsartan and hydrochlorothiazide.

Each tablet contains 320 mg valsartan and 12.5 mg hydrochlorothiazide.

Each tablet contains 320 mg valsartan and 25 mg hydrochlorothiazide.


The other ingredients are

Tablet core:

Cellulose, microcrystalline; croscarmellose sodium; povidone; magnesium stearate.

Film-coating:

Opadry II pink containing polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172), iron oxide red (E172).

Opadry II yellow containing polyvinyl alcohol (partially hydrolyzed), titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172).

What Valtsu complooks like and contents of the pack

Valtsu comp 320/1.,5 mg film-coated tablet is a pink, modified capsule-shaped, film-coated tablet.

Valtsu comp 320/25 mg film-coated tablet is a yellow, modified capsule-shaped, scored film-coated tablet.


Blisters:

Packs of 14, 28, 30, 50, 56, 60, 84, 90, 98, 100 film-coated tablets.

Bottles:

100, 500 film-coated tablets.


Not all pack sizes may be marketed.


Marketing Authorisation Holder

[To be completed nationally]


Manufacturer

[To be completed nationally]



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

<{Name of the Member State}> <{Name of the medicinal product}>

[To be completed nationally]


This leaflet was last revised in 2015-06-17


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