VALSARTAN HYDROCHLOROTHIAZIDE 80 MG / 12.5 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - VALSARTAN HYDROCHLOROTHIAZIDE 80 MG / 12.5 MG FILM-COATED TABLETS

Valsartan-Hydrochlorothiazide 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, Film-coated Tablets

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

Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or your 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)
1. What Valsartan-Hydrochlorothiazide Film-coated tablet is and what it is used for.
2. What you need to know before you take Valsartan-Hydrochlorothiazide Film-coated tablet.
3. How to take Valsartan-Hydrochlorothiazide Film-coated tablet.
4. Possible side effects.
5. How to store Valsartan-Hydrochlorothiazide Film-coated tablet.
6. Contents of the pack and other information.

1. What Valsartan-Hydrochlorothiazide Film-coated tablet is and what it is used for

Valsartan-Hydrochlorothiazide film-coated tablet 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 receptorantagonists”, 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-Hydrochlorothiazide Film-coated tablet 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 take valsartan-hydrochlorothiazide film-coated tablet

Do not take Valsartan-Hydrochlorothiazide Film-coated tablet

If you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide) or to any of the other ingredients of Valsartan-Hydrochlorothiazide Film-coated tablet (listed in Section 6).
If you are allergic to peanut, arachis oil, soya lecithin or related substances.
If you are more than 3 months pregnant (it is also better to avoid Valsartan-Hydrochlorothiazide Film-coated tablet in early pregnancy – see pregnancy section).
If you have severe liver disease, destruction of the small bile ducts within the liver(biliary cirrhosis) leading to the build up of bile in the liver (cholestasis).
If you have severe kidney disease.
If you are unable to produce urine (anuria).
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.
If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine called aliskiren.

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 Valsartan-Hydrochlorothiazide Film-coated tablet

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 are suffering from heart failure or have experienced a heart attack. Follow your doctor’s instruction for the starting dose carefully. Your doctor may also check your kidney function.
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-Hydrochlorothiazide Film-coated tablet is not recommended.
If you have liver or kidney disease.
If you have ever experienced swelling of the tongue and face caused by an allergic reaction called angioedema when taking another drug (including ACE inhibitors), tell your doctor. If these symptoms occur when you are taking Valsartan-Hydrochlorothiazide Film-coated tablet, stop taking Valsartan-Hydrochlorothiazide Film-coated tablet immediately and never take it again. See also section 4, “Possible side effects”.
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 triglycerides 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.
If you experience a decrease in vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or an increase of pressure in your eye and can happen within hours to a week of taking Valsartan-Hydrochlorothiazide Film-coated tablet. This can lead to permanent vision loss, if not treated. If you earlier have had a penicillin or sulphonamide allergy you can be at higher risk of developing this.
It may cause increased sensitivity of the skin to sun.
The use of Valsartan-Hydrochlorothiazide Film-coated tablet 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-Hydrochlorothiazide Film-coated tablet 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).
If you are taking any of the following medicines used to treat high blood pressure:
■ An ACE inhibitors (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
■ Aliskiren.
If you have had skin cancer or if you develop an unexpected skin lesion during the treatment. Treatment with hydrochlorothiazide, particularly long term use with high doses, may increase the risk of some types of skin and lip cancer (non-melanoma skin cancer). Protect your skin from sun exposure and UV rays while taking Valsartan-Hydrochlorothiazide Film-coated tablet.
If you experienced breathing or lung problems (including inflammation or fluid in the lungs) following hydrochlorothiazide intake in the past. If you develop any severe shortness of breath or difficulty breathing after taking Valsartan-Hydrochlorothiazide Film-coated tablet, seek medical attention immediately.

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-Hydrochlorothiazide Film-coated tablet”

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

Children and adolescents

The use of Valsartan and Hydrochlorothiazide Tablets in children and adolescents (below the age of 18 years) is not recommended.

Other medicines and Valsartan-Hydrochlorothiazide Film-coated tablet

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

The effect of the treatment can be influenced if Valsartan-Hydrochlorothiazide Film-coated tablet 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 diseases.
Medicines or substances that may increase the amount of potassium in your blood. These includes potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin.
Medicines that may reduce the amount of potassium in your blood, such as diuretics (water tablets), corticosteroids, laxatives, carbenoxolone, amphotericin or penicillin G.
Some antibiotics (rifamycin group), a drug used to protect against transplant rejection (ciclosporin) or an antiretroviral drug used to treat HIV/AIDS infection (ritonavir). These drugs may increase the effect of Valsartan-Hydrochlorothiazide Film-coated tablet.
Medicines that may induce “torsades de pointes” (irregular heart beat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics.
Medicines that may reduce the amount of sodium in your blood, such as antidepressants, antipsychotics, antiepileptics.
Medicines for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone
Therapeutic vitamin D and calcium supplements.
Medicines for the treatment of diabetes (oral agents such as metformin or insulins).
Other medicines to lower your blood pressure including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren.
Medicines to increase blood pressure, such as noradrenaline or adrenaline.
Digoxin or other digitalis glycosides (medicines used to treat heart problems).
Medicines that may increase blood sugar levels, such as diazoxide or beta blockers.
Cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide.
Pain killers such as non-steroidal anti-inflammatory agents (NSAIDs), including selective cyclooxygenase-2 inhibitors (Cox-2 inhibitors) and acetylsalicylic acid > 3 g.
Muscle relaxing medicines, such as tubocurarine.
Anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia).
Amantadine (medicine used to treat Parkinson’s disease and also used to treat or prevent certain illnesses caused by viruses).
Cholestyramine and colestipol (medicines used mainly to treat high levels of lipids in the blood).
Ciclosporin, a medicine used for organ transplant to avoid organ rejection.
Alcohol, sleeping pills and anaesthetics (medicines with sleeping or painkilling effect used for example during surgery).
Iodine contrast media (agents used for imaging examinations).

Taking Valsartan-Hydrochlorothiazide Film-coated tablet with food and drink

You can take Valsartan-Hydrochlorothiazide Film-coated tablet 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-Hydrochlorothiazide Film-coated tablet before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valsartan-Hydrochlorothiazide Film-coated tablet. Valsartan-Hydrochlorothiazide Film-coated tablet 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-Hydrochlorothiazide Film-coated tablet 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 new born, 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-Hydrochlorothiazide Film-coated tablet affects you. Like many other medicines used to treat high blood pressure, Valsartan-Hydrochlorothiazide Film-coated tablet may occasionally cause dizziness and affect the ability to concentrate.

Important information about some of the ingredients if Valsartan-Hydrochlorothiazide Film-coated tablet

Valsartan-Hydrochlorothiazide Film-coated tablet contains soya lecithin. If you are allergic to peanut, soya or arachis oil do not use Valsartan-Hydrochlorothiazide Film-coated tablet.

3. how to take valsartan-hydrochlorothiazide film-coated tablet

Always take Valsartan-Hydrochlorothiazide Film-coated tablet exactly 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 Valsartan-Hydrochlorothiazide Film-coated tablet to take. Depending on how you respond to the treatment, your doctor may suggest a higher or lower dose.

The usual dose of Valsartan-Hydrochlorothiazide Film-coated tablet 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-Hydrochlorothiazide Film-coated tablet with or without food.
Swallow the tablet with a glass of water.

If you take more Valsartan-Hydrochlorothiazide film-coated tablet than you should

If you experience severe dizziness and/or fainting, lie 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-Hydrochlorothiazide Film-coated tablet

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-Hydrochlorothiazide Film-coated tablet

Stopping your treatment with Valsartan-Hydrochlorothiazide Film-coated tablet 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 product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Valsartan-Hydrochlorothiazide Film-coated tablet 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.
Severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling fever (toxic epidermal necrolysis).

If you get any of these symptoms, stop taking Valsartan-Hydrochlorothiazide Film-coated tablet 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) :

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 available data) :

Breathing difficulty
Severely decreased urine output
Low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and /or convulsions in severe cases)
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)

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

Valsartan

Uncommon ( may affect up to 1 in 100 people) :

Spinning sensation
Abdominal pain

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

Blistering skin (sign of dermatitis bullous)
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, purplish-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, abnormalheart 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
Low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)

Hydrochlorothiazide

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

Low level of potassium in the blood
Increase of lipids in the blood

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

Low level of sodium in the blood,
loL level of magnesium in the blood
High level of uric acid in the blood
Itchy rash and other types of rash
Reduced appetite
Mild nausea and vomiting,
Dizziness, fainting on standing up
Inability to achieve or maintain erection.

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

Swelling and blistering of the skin (due to increased sensitivity to sun)
High level of calcium in the blood
High level of sugar in the blood
Sugar in the urine
Worsening of diabetic metabolic state
Constipation, diarrhoea, discomfort of the stomach or bowels, liver disorders which can occur together with yellow skin and eyes
Irregular heartbeat
Headache
Sleep disturbances
Sad mood (depression)
Low level of blood platelets (sometimes with bleeding or bruising underneath the skin)
Dizziness
Tingling or numbness
Vision disorder

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

Inflammation of blood vessels with symptoms such as rash, purplish-red spots, fever (vasculitis),
Rash, itching, hives, difficulty breathing or swallowing, dizziness, (hypersensitivity reactions),
Severe skin disease that causes rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis),
Facial rash, joint pain, muscle disorder, fever (lupus erythematosus)
Severe upper stomach pain (pancreatitis),
Difficulty breathing with fever, coughing, wheezing, breathlessness (respiratory distress including pneumonitis and pulmonary oedema),
Fever, sore throat, more frequent infections (agranulocytosis),
Pale skin, tiredness, breathlessness, dark urine (haemolytic anaemia)
Fever, sore throat or mouth ulcers due to infections (leucopenia)
Confusion, tiredness, muscle twitching and spasm, rapid breathing (hypochloraemic alkalosis).
Acute respiratory distress (signs include severe shortness of breath, fever, weakness, and confusion).

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

Weakness, bruising and frequent infections (aplastic anemia)
severely decreased urine output (possible signs of renal disorder or renal failure)
Decrease in vision or pain in your eyes due to high pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
Rash, red skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme)
Muscle spasm
Fever (pyrexia)
Weakness (asthenia)
Skin and lip cancer (Non melanoma skin cancer).

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 by Yellow Card Scheme at r search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store valsartan-hydrochlorothiazide film-coated tablet

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. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Do not use any Valsartan-Hydrochlorothiazide Film-coated tablet pack that 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 to protect the environment.

6. contents of the pack and other information

What Valsartan-Hydrochlorothiazide Film-coated tablet contains

The medicinal product contains two active substances called valsartan and hydrochlorothiazide.

What Valsartan-Hydrochlorothiazide Film-coated tablet looks like and contents of the pack

Valsartan-Hydrochlorothiazide 80/12.5 mg Film-coated tablets are pink, biconvex, oval shaped film-coated tablets of 9.7~10.7 mm length, 4.8~5.8 mm width and 3.6~4.6 mm height and is supplied in packs of 28 tablets (2×14).

Valsartan-Hydrochlorothiazide 160/12.5 mg Film-coated tablets are dark red, biconvex, oval shaped film coated tablets of 14.7~15.7 mm length, 5.7~6.7 mm width and 4.0~5.0 mm height and is supplied in packs of 28 tablets (2×14).

Valsartan-Hydrochlorothiazide 160/25 mg Film-coated tablets are yellow, biconvex, oval shaped film coated tablets of 14.7~15.7 mm length, 5.7~6.7 mm width and 4.0~5.0 mm height, with a break line on one side. The tablet can be divided into equal halves and is supplied in packs of 28 tablets (2×14).

Marketing Authorisation Holder

DAWA Limited

5 Sandridge Close, Harrow,

Middlesex, HA1 1XD,

United Kingdom

This leaflet was last revised in November 2021