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.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or 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.

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).

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.

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 you are more than 3 months pregnant (it is also better to avoid Vivendal Comp 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 containing 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 before taking Vivendal Comp

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 Vivendal Comp 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 medicine (including ACE-inhibitors), tell your doctor. If these symptoms occur when you are taking Vivendal Comp, stop taking Vivendal Comp 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 an increase of pressure in your eye and can happen within hours to a week of taking Vivendal Comp. 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.
if you are taking any of the following medicines used to treat high blood pressure:

- 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:

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 include 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 medicine used to protect against transplant rejection (ciclosporin) or an antiretroviral medicine used to treat HIV/AIDS infection (ritonavir). These medicines may increase the effect of Vivendal Comp.
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 (see also information under the headings “Do not take Vivendal Comp” and “Warnings and precautions”)
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 more than 3 grams of acetylsalicylic acid per day
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).

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.

The recommended dose of Vivendal Comp 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 Vivendal Comp with or without food
Swallow the tablet with a glass of water.

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:

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

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

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, affects less than 1 per 10,000 users

dizziness
diarrhoea
joint pain

Frequency not known, according tothe 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 sideeffects have been reported with products containing valsartan or hydrochlorothiazide alone:

Valsartan

Uncommon, affects 1 to 10 per 1,000 users

spinning sensation
abdominal pain

Frequency not known, according tothe 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, 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
low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases)

Hydrochlorothiazide

Very common, affects more than 1 per 10 users

low level of potassium in the blood
increase of lipids in the blood

Common, affects 1 to 10 per 100 users

low level of sodium in the blood
low 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, affects 1 to 10 per 10,000 users

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 heart beat
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, affects less than 1 per 10,000 users

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)

Frequency not known, according tothe 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 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)

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

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 blister and carton. The expiry date refers to the last day of that month.
Do not store above 30 °C. Store in the original package in order to protect from moisture.
Do not use any Vivendal Comp pack that is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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: