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Vivendal Comp

Package leaflet: Information for the user


Vivendal Comp 80mg /12.5 mg film-coated tablets

Vivendal Comp 160 mg /12.5 mg film-coated tablets

Vivendal Comp 160 mg /25 mg film-coated tablets

Vivendal Comp 320 mg /12.5 mg film-coated tablets

Vivendal Comp 320 mg /25 mg film-coated tablets


Valsartan/hydrochlorothiazide


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.


What is in this leaflet

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

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

3. How to take Vivendal Comp

4. Possible side effects

How to store Vivendal Comp

6. Contents of the pack and other information


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


Vivendal Comp film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).



Vivendal 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 youtake Vivendal Comp


Do not take Vivendal Comp

if you are allergic to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide) or to any of the other ingredients of this medicine (listed in section 6).

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 before taking Vivendal Comp

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

- aliskiren.


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 Vivendal Comp”


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


Children and adolescents

The use of Vivendal Comp in children and adolescents (below the age of 18 years) is not recommended.


Other medicines and Vivendal 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 Vivendal Comp is taken together with certain other medicines. Your doctor may need to change your dose and/or take other precautions, or in some cases to stop taking one of the medicines. This especially applies to the following medicines:



Vivendal Comp with food, drink and alcohol

You can take Vivendal Comp with 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

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this 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 Vivendal Comp before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Vivendal Comp. Vivendal 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 it is used after the third month of pregnancy.


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

Vivendal 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 Vivendal Comp affects you. Like many other medicines used to treat high blood pressure, Vivendal Comp may occasionally cause dizziness and affect the ability to concentrate.


3. How to take Vivendal Comp


Always take this medicineexactly as your doctor has told you. This will help you to get the best results and lower the risk of side effects. 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 Vivendal Comp to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.



If you take more Vivendal Comp than 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 Vivendal 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 Vivendal Comp

Stopping your treatment with Vivendal Comp may 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 medicinecan 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:

If you get any of these symptoms, stop taking Vivendal Comp and contact your doctor straight away (see also section 2 “Warnings and precautions”).


Other side effects include:


Uncommon, affects 1 to 10 per 1,000 users


Very rare, affects less than 1 per 10,000 users


Frequency not known, according tothe available data


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


Valsartan


Uncommon, affects 1 to 10 per 1,000 users


Frequency not known, according tothe available data

blistering skin (sign of dermatitis bullous)


Hydrochlorothiazide


Very common, affects more than 1 per 10 users


Common, affects 1 to 10 per 100 users


Rare, affects 1 to 10 per 10,000 users

swelling and blistering of the skin (due to increased sensitivity to sun)


Very rare, affects less than 1 per 10,000 users


Frequency not known, according tothe 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; to be completed nationally]. By reporting side effects you can help provide more information on the safety of this medicine.


5. How to store Vivendal Comp



1Contents of the pack and other information


What Vivendal Comp contains

The active substances are valsartan and hydrochlorothiazide.

Each tablet contains 80 mg of valsartan and 12.5 mg of hydrochlorothiazide

Each tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide

Each tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide

Each tablet contains 320 mg of valsartan and 12.5 mg of hydrochlorothiazide.

Each tablet contains 320 mg of valsartan and 25 mg of hydrochlorothiazide.


The other ingredients are:


Tablet core:

microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica

Coating:

hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide.


Tablet core:

microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica

Coating:

hypromellose, macrogol 8000, talc, titanium dioxide (E171), red iron oxide (E172).


Tablet core:

microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica

Coating:

hypromellose, macrogol 4000, talc, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172).


Tablet core:

microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica

Coating:

hypromellose, macrogol 4000, talc, titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172).


Tablet core:

microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica

Coating:

hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).


What Vivendal Comp looks like and contents of the pack

Vivendal Comp 80 mg/12.5 mg film-coated tablets

Film-coated tablet, light orange, ovaloid, slightly convex faces, imprinted (debossed) with “HGH” on one side and “CG" on the reverse side


Vivendal Comp 160 mg/12.5 mg film-coated tablets

Film-coated tablet, dark red, ovaloid, slightly convex faces, imprinted (debossed) with “HHH” on one side and “CG" on the reverse side.


Vivendal Comp 160 mg/25 mg film-coated tablets

Film-coated tablet, brown orange, ovaloid, slightly convex faces, imprinted (debossed) with “HXH” on one side and “NVR" on the reverse side


Vivendal Comp 320 mg/12.5 mg film-coated tablets

Film-coated tablet , pink, ovaloid shaped, beveled edge, imprinted (debossed) with “NVR” on one side and “HIL” on the reverse side


Vivendal Comp 320 mg/25 mg film-coated tablets

Yellow, ovaloid shaped, beveled edge, film coated tablet, imprinted (debossed) with “NVR” on one side and “CTI” on the reverse side


Pack sizes: one pack contains 7, 10, 14, 15, 20, 28, 30, 50, 50x1, 56, 60, 84, 90, 98, 100 or 280 film-coated tablets.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


[To be completed nationally]


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

[To be completed nationally]


This leaflet was last revised in 2015-02-12