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Valsartan/Hydroclothiazide

Valsartan and Hydrochlorothiazide film-coated tablets contain two active substances called valsartan and hydrochlorothiazide.


Generic Name

Valsartan/Hydroclothiazide


Packing

30, 100, 500


Therapeutic Category

Antihypertensive


Storage

Store below 30°C.


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adobe-pdf-logoPrescribing Information(SPC)


Product Description

Product Overview


What Valsartan and Hydrochlorothiazide is and what it is used for

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

• Valsartan belongs to a class of medicines known as “angiotensin II receptor antagonists”, which help to control high blood pressure. Angiotensin II is a substance in the body that causes vessels to tighten, thus causing your blood pressure to increase. Valsartan works by blocking the effect of angiotensin II. As a result, blood vessels relax and blood pressure is lowered.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as “water tablets”). Hydrochlorothiazide increases urine output, which also lowers blood pressure.

Valsartan and Hydrochlorothiazide 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 and Hydrochlorothiazide

Do not take Valsartan and Hydrochlorothiazide:

•if you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide) or any of the other ingredients of this medicine listed in section 6.
•if you are more than 3 months pregnant (it is also better to avoid Valsartan and Hydrochlorothiazide in early pregnancy – see pregnancy section).
•if you have severe liver disease.
•if you have severe kidney disease.
•if you are unable to urinate.
•if you are treated with an artificial kidney.
•if the level of potassium or sodium in your blood is lower than normal, or of the level of calcium in your blood is higher than normal despite treatment.
•if you have gout.

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 using Valsartan and Hydrochlorothiazide

Take special care with Valsartan and Hydrochlorothiazide
• if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium or other medicines that increase the amount of potassium in your blood such as heparin. Your doctor may need to check the amount of potassium in your blood regularly.
• if you have low levels of potassium in your blood.
• if you have diarrhoea or severe vomiting.
• if you are taking high doses of water tablets (diuretics).
• if you have severe heart disease.
• if you suffer from a narrowing of the kidney artery.
• if you have recently received a new kidney.
• if you suffer from hyperaldosteronism. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you, the use of Valsartan and Hydrochlorothiazide is not recommended.

Children and adolescents

The use of Valsartan and Hydrochlorothiazide 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 and Hydrochlorothiazide 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 and Hydrochlorothiazide

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 and Hydrochlorothiazide 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:

•lithium, a medicine used to treat some types of psychiatric illness
•medicines that affect or can be affected by potassium blood levels, such as digoxin, a medicine to control the heart rhythm, some antipsychotic medicines
•medicines that may increase the amount of potassium in your blood, such as potassium supplements, potassium-containing salt substitutes, potassium-sparing medicines, heparin
•medicines that may reduce the amount of potassium in your blood, such as corticosteroids, some laxatives
•diuretics (water tablets), medicines for the treatment of gout, such as allopurinol, therapeutic vitamin D and calcium supplements, medicines for the treatment of diabetes (oral agents or insulins)
•other medicines to lower your blood pressure, such as beta blockers or methyldopa, or medicines that tighten your blood vessels or stimulate your heart, such as noradrenaline or adrenaline
•medicines to increase blood sugar levels, such as diazoxide
•medicines to treat cancer, such as methotrexate or cyclophosphamide
•pain killers

Valsartan and Hydrochlorothiazide with food, drink and alcohol
You can take Valsartan and Hydrochlorothiazide 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 Valsartan and Hydrochlorothiazide before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan and Hydrochlorothiazide. Valsartan and Hydrochlorothiazide 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 and Hydrochlorothiazide 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 and Hydrochlorothiazide affects you. Like many other medicines used to treat high blood pressure, this medicine may occasionally cause dizziness and affect the ability to concentrate.

Valsartan and Hydrochlorothiazide contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Valsartan and Hydrochlorothiazide

Always take this medicine exactly as your doctor or pharmacist 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 and Hydrochlorothiazide to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

•The recommended dose of Valsartan and Hydrochlorothiazide is one tablet per day.
•Do not change the dose or stop taking the tablets without consulting your doctor.
•The medicine should be taken at the same time each day, usually in the morning.
•You can take Valsartan and Hydrochlorothiazide with or without food.
•Swallow the tablet with a glass of water.

If you take more Valsartan and Hydrochlorothiazide 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 and Hydrochlorothiazide

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 and Hydrochlorothiazide

Stopping your treatment with Valsartan and Hydrochlorothiazide 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.

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:
• swollen face, tongue or pharynx
• difficulty in swallowing
• hives and difficulties in breathing

Other side effects include:

Uncommon: may affect up to 1 in 100 people
•cough
•low blood pressure
•light-headedness
•dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark colored urine, dry skin)
•muscle pain
•tiredness
•tingling or numbness
•blurred vision
•noises (e.g. hissing, buzzing) in ears

Very rare: may affect up to 1 in 10,000 people
• dizziness
• diarrhoea
• joint pain

Not known: frequency cannot be estimated from the available data
•breathing difficulty
•severely decreased urine output
•low level of sodium in the blood (sometimes with nausea, tiredness, confusion, malaise, convulsions)
•low level of potassium in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm)
•low level of white cells in the blood (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness)
•the level of bilirubin increased in blood (which can, in severe cases, trigger yellow skin and eyes)
•the level of blood urea nitrogen and creatinine increased in blood (which can indicate abnormal kidney function)
•the level of uric acid in blood increased (which can, in severe cases, trigger gout)
•syncope (fainting)

Side effects reported with valsartan or hydrochlorothiazide alone, but not observed with Valsartan and Hydrochlorothiazide:

Valsartan

Uncommon: may affect up to 1 in 100 people
•spinning sensation
•abdominal pain

Not known: frequency cannot be estimated from the available data
•skin rash with or without itching together with some of the following signs or symptoms: fever, joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms
•rash, purplished-red spots, fever, itching (symptoms of inflammation of blood vessels)
•low level of blood platelets (sometimes with unusual bleeding or bruising)
•high level of potassium in the blood (sometimes with muscle spasms, abnormal heart rhythm)
•allergic reactions (with symptoms such as rash, itching, hives, difficulty breathing or swallowing, dizziness)
•swelling mainly of the face and throat; rash; itching

Hydrochlorothiazide

Common: may affect up to 1 in 10 people
•itchy rash and other types of rash
•reduced appetite
•mild nausea and vomiting
•faintness, fainting on standing up
•impotence

Rare: may affect up to 1 in 1,000 people
•swelling and blistering of the skin (due to increased sensitivity to sun)
•constipation, discomfort of the stomach or bowels, liver disorders (yellow skin or eyes)
•irregular heart beat
•headache
•sleep disturbances
•sad mood (depression)
•low level of blood platelets (sometimes with bleeding or bruising underneath the skin)

Very rare: may affect up to 1 in 10,000 people
•inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever
•itching or red skin
•blistering of the lips, eyes or mouth
•skin peeling
•fever
•facial rash associated with joint pain
•muscle disorder

How to store Valsartan and Hydrochlorothiazide

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton/ label. The expiry date refers to the last day of that month.
Store below 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment Valsartan/Hydroclothiazide – Taj Dearob Pharma | Valsartan and Hydrochlorothiazide film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control high blood pressure (hypertension).

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