Valsartan/hydrochlorothiazide film-coated tablets

Pharmaceutical Group: Angiotensin II receptor antagonists

Therapeutic indications: Control high blood pressure

Dosage Form(s): Film coated tablet

Pregnancy Category: D

Valtizide® 80 mg /12.5 mg film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both of these substances help to control  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. Hydrochlorothiazide increases urine output, which also lowers blood pressure.

Valtizide® 80 mg /12.5 mg 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.

Dosage and direction

 The recommended dose of Valtizide 80 mg/12.5 mg is one tablet per day.  

•  The medicine should be taken at the same time each day, usually in the morning. 
•  You can take Valtizide 80 mg/12.5 mg with or without food. 
•  Swallow the tablet with a glass of water.

If you take more Valtizide® 80 mg /12.5 mg 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 Valtizide® 80 mg /12.5 mg
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 Valtizide® 80 mg /12.5 mg
Stopping your treatment with Valtizide® 80 mg /12.5 mg may cause your high blood pressure to get worse. Do not stop taking your medicine unless your doctor tells you to.

Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

These side effects may occur with certain frequencies, which are defined as follows:

very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data

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
- 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
- dizziness
- diarrhoea
- joint pain

Not known
- 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 Valtizide® 80 mg /12.5 mg

Valsartan

Uncommon
- spinning sensation
- abdominal pain

Not known
- 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
- elevation of liver function values
- the level of haemoglobin decreased and the percentage of red cells decreased in the blood (which both can, in severe cases, trigger an anaemia).
- kidney failure

Hydrochlorothiazide

Common
- itchy rash and other types of rash
- reduced appetite
- mild nausea and vomiting
- faintness, fainting on standing up
- impotence

Rare
- 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
- 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
- fever (cutaneous lupus erythematosus)
- severe upper stomach pain; lack or low levels of different blood cells
- severe allergic reactions
- difficulty breathing
- lung infection; breathlessness

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Contraindications

Do not take Valtizide® 80 mg /12.5 mg:

•  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 you are more than 3 months pregnant. (It is also better to avoid Valtizide 80 mg/12.5 mg 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 if the level of calcium in your blood is higher than normal despite treatment. 
•  if you have gout.

precautions

• 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.
• Respond to the treatment, your doctor may suggest a higher or lower dose.
•  Do not change the dose or stop taking the tablets without consulting your doctor.
• 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. 
• Talk to your doctor, pharmacist or nurse before taking Valtizide® 80 mg /12.5 mg:

- 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 diarrhea or severe vomiting.
- if you are taking high doses of 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 Valtizide® 80 mg /12.5 mg is not recommended.
- if you have liver or kidney disease.
- if you have fever, rash and joint pain, which may be signs of systemic lupus erythematosus (SLE, a so-called autoimmune disease).
- if you have diabetes, gout, high levels of cholesterol or fats in your blood.
- if you have had allergic reactions with the use of other blood pressure-lowering agents of this class (angiotensin II receptor antagonists) or if you have allergy or asthma.
- it may cause increased sensitivity of the skin to sun.

Children and adolescents
The use of Valtizide® 80 mg /12.5 mg in children and adolescents (below the age of 18 years) is not recommended.

Interaction with other medicinal products and other forms of interaction

• 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 Valtizide® 80 mg /12.5 mg 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, 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
- arthritis medicines
- muscle relaxing medicines, such as tubocurarine
- anti-cholinergic medicines, such as atropine or biperiden
- amantadine (a medicine used to prevent influenza)
- cholestyramine and colestipol (medicines used to treat high levels of fats in the blood)
- ciclosporin, a medicine used for organ transplant to avoid organ rejection
- some antibiotics (tetracyclines), anaesthetics and sedatives
- carbamazepine, a medicine used to treat seizure conditions

Valtizide® 80 mg /12.5 mg with food, drink and alcohol

• You can take Valtizide 80 mg/12.5 mg 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 Valtizide® 80 mg /12.5 mg before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine. Valtizide 80 mg/12.5 mg 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. 
• Valtizide® 80 mg /12.5 mg is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.

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 Valtizide® 80 mg /12.5 mg affects you. Like many other medicines used to treat high blood pressure, Valtizide 80 mg/12.5 mg may occasionally cause dizziness and affect the ability to concentrate.

How to store Valtizide® 80 mg /12.5 mg

• 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 pack. The expiry date refers to the last day of that month. 
• Do not store above 30C.
• Do not use this medicine if you notice that the pack is damaged or shows signs of tampering. 
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Valtizide® 80 mg /12.5 mg contains? 

- The active substances are valsartan 80 mg and hydrochlorothiazide 12.5 mg.
- The other ingredients (excipients) are: Microcrystalline cellulose, cros povidone and magnesium stearate
- Coat ingredients: Hypromellose, talc, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

What Valtizide® 80 mg /12.5 mg looks like and contents of the pack
Valtizide® 80 mg /12.5 mg film-coated tablets are pink, oblong and convex film-coated tablets.

Valtizide® 80 mg /12.5 mg is available in Box of 30 film coated tablets.

Packaging Authorization Holder: Behshadpharma

Manufacturer: West Pharma –Portugal