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Valsartan/Hydroklortiazid Novartis

Information för alternativet: Valsartan/Hydroklortiazid Novartis 160 Mg/25 Mg Filmdragerad Tablett, visar 4 alternativ

Package leaflet: Information for the user


Valsartan/Hydroklortiazid Novartis 80 mg/12.5 mg film-coated tablets

Valsartan/Hydroklortiazid Novartis 160 mg/12.5 mg film-coated tablets

Valsartan/Hydroklortiazid Novartis 160 mg/25 mg film-coated tablets

Valsartan/Hydroklortiazid Novartis 320 mg/12.5 mg film-coated tablets

Valsartan/Hydroklortiazid Novartis 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 Valsartan/Hydroklortiazid Novartis is and what it is used for

2. What you need to know before you take Valsartan/Hydroklortiazid Novartis

3. How to take Valsartan/Hydroklortiazid Novartis

4. Possible side effects

5. How to store Valsartan/Hydroklortiazid Novartis

6. Contents of the pack and otherinformation


What Valsartan/Hydroklortiazid Novartis is and what it is used for


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


Valsartan/Hydroklortiazid Novartis 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.


What you need to know before you take Valsartan/Hydroklortiazid Novartis


Do not take Valsartan/Hydroklortiazid Novartis:

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

lowering medicine containing aliskiren.


If any of the above apply to you, tell your doctor and do not take Valsartan/Hydroklortiazid Novartis.


Warnings and precautions

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 Valsartan/Hydroklortiazid Novartis”


Valsartan/Hydroklortiazid Novartis may cause increased sensitivity of the skin to sun.


The use of Valsartan/Hydroklortiazid Novartis in children and adolescents (below the age of 18 years) is not recommended.


You must tell your doctor if you think you are (or might become) pregnant. Valsartan/Hydroklortiazid Novartis 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).


Other medicines and Valsartan/Hydroklortiazid Novartis

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 Valsartan/Hydroklortiazid Novartis 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:


Valsartan/Hydroklortiazid Novartis with food, drink and alcohol

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


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

Your doctor will normally advise you to stop taking Valsartan/Hydroklortiazid Novartis before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan/Hydroklortiazid Novartis. Valsartan/Hydroklortiazid Novartis 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

Valsartan/Hydroklortiazid Novartis 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 Valsartan/Hydroklortiazid Novartis affects you. Like many other medicines used to treat high blood pressure, Valsartan/Hydroklortiazid Novartis may occasionally cause dizziness and affect the ability to concentrate.


How to take Valsartan/Hydroklortiazid Novartis


Always take this medicine exactly 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 Valsartan/Hydroklortiazid Novartisto take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.



If you take more Valsartan/Hydroklortiazid Novartis 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 Valsartan/Hydroklortiazid Novartis

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 Valsartan/Hydroklortiazid Novartis

Stopping your treatment with Valsartan/Hydroklortiazid Novartis 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 medicine can cause side effects, although not everybody gets them.

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



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


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


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 affectmore than 1 in 10 people):


Common (may affect up to 1 in 10 people):


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

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


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


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


Reportingof side effects

If you getany side effects, talk toyour 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 Valsartan/Hydroklortiazid Novartis



6. Contents of the pack and other information


What Valsartan/Hydroklortiazid Novartis contains



What Valsartan/Hydroklortiazid Novartis looks like and contents of the pack


Valsartan/Hydroklortiazid Novartis 80 mg/12.5 mg film-coated tablets are light orange, ovaloid tablets imprinted with HGH on one side and CG on the other side.

Valsartan/Hydroklortiazid Novartis 160 mg/12.5 mg film-coated tablets are dark red, ovaloid tablets imprinted with HHH on one side and CG on the other side.

Valsartan/Hydroklortiazid Novartis 160 mg/25 mg film-coated tablets are brown, ovaloid tablets imprinted with HXH on one side and NVR on the other side.

Valsartan/Hydroklortiazid Novartis 320 mg/12.5 mg film-coated tablets are pink, ovaloid shaped, beveled edge tablets, imprinted with NVR on one side and HIL on the other side.

Valsartan/Hydroklortiazid Novartis 320 mg/25 mg film-coated tablets are yellow, ovaloid shaped, beveled edge tablet, imprinted with NVR on one side and CTI on the other side.


The tablets are supplied in blister packs of 7 tablets (only for Valsartan/Hydroklortiazid Novartis 320 mg/12.5 mg and 320 mg/25 mg), 14 tablets, 28 tablets as calendar pack, 30 tablets (only for Valsartan/Hydroklortiazid Novartis 80 mg/12.5 mg), 56 tablets, 98 tablets as calendar pack or 280 tablets. Perforated unit dose blister packs of 56x1, 98x1 or 280x1 tablets are also available.


Not all pack sizes may be marketed.


Marketing Authorisation Holder and Manufacturer


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


Sweden

Valsartan/Hydroklortiazid Novartis

Portugal, Spain

Co-Novasan

Portugal, Spain

Co-Novasan Forte

Belgium

Co-Novacard

Germany

Provas comp

Germany

Provas maxx


This leaflet was last revised in 2015-04-09