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Valtensin Plus 160 mg / 25 mg. 28 tablets

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Valtensin plus film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both substances help control high blood pressure (hypertension).

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What Valtensin Plus is and what it is used for

Valtensin plus film-coated tablets contain two active substances called valsartan and hydrochlorothiazide. Both substances help control high blood pressure (hypertension).

Valsartan belongs to a group of medicines called 'angiotensin II receptor blockers' and is used to lower high blood pressure. Angiotensin II is a substance that causes blood vessels to constrict, which is found in the body and can cause high blood pressure. Valsartan works by blocking angiotensin II. This causes the blood vessels to dilate and the blood pressure to drop.

Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (also known as 'water tablets'). Hydrochlorothiazide increases the amount of urine excreted, which also lowers blood pressure.

Valtensin Plus is used to treat high blood pressure in patients whose blood pressure is not adequately controlled on individual substances.

High blood pressure increases the load on the heart and arteries. If left untreated, it can damage the blood vessels of the brain, heart and kidneys, and cause 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 Valtensin Plus

Do not take Valtensin Plus:

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

if you are 3 months pregnant (Valtensin Plus should also be avoided in early pregnancy - see Pregnancy section).

if you have severe liver disease, destruction of the small bile ducts in the liver (biliary cirrhosis), leading to the accumulation of bile in the liver (cholestasis).

if you have severe kidney disease.

if you cannot pass urine (anuria).

if you are on dialysis.

if you have lower than normal levels of potassium or sodium in your blood, or if you have too high levels of calcium in your blood despite treatment.

if you have gout.

if you have diabetes or impaired kidney function and are being treated with a blood pressure lowering medicine containing aliskiren.

If any of the above apply to you, do not take this medicine and talk to your doctor.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Valtensin Plus

if you are taking potassium-sparing medicines, potassium supplements, salt substitutes containing potassium, or other medicines that increase the levels of potassium in the blood, such as heparin. Your doctor needs to monitor your blood potassium levels 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 water tablets (diuretics);

if you have severe heart disease;

if you suffer from heart failure or have had a heart attack. Follow your doctor's instructions for the starting dose carefully. Your doctor may also check your kidney function.

if you suffer from narrowing of the renal artery;

if you have recently had a new kidney;

if you suffer from hyperaldosteronism - a disease in which your adrenal glands produce too much of the hormone aldosterone. In this case, the use of Valtensin Plus is not recommended.

if you have liver or kidney disease;

If you have ever had swelling of the tongue and face due to an allergic reaction called angioedema when taking another medicine (including ACE inhibitors), tell your doctor. If these symptoms occur while you are taking Valtensin Plus, stop taking Valtensin Plus immediately and never take it again. See also point 4.

if you have a fever, rash and joint pain that may be symptoms of systemic lupus erythematosus (SLE, which is an autoimmune disease);

if you have diabetes, gout, high cholesterol or triglycerides in your blood;

if you have had allergic reactions to other medicines that lower blood pressure in this class (angiotensin II receptor blockers) or if you have allergies or asthma;

if you get reduced vision or eye pain. These can be symptoms of high pressure in the eye and can occur within hours to a week of taking Valtensin Plus. This can lead to permanent vision loss if left untreated. You may be at higher risk of getting this if you have had an allergy to penicillin or a sulphonamide in the past.

may cause hypersensitivity of the skin to sun exposure;

if you are taking any of the following medicines used to treat high blood pressure

Other drugs and Valtensin Plus

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

The effect of treatment may be affected by taking other medicines at the same time as Valtensin Plus. It may be necessary to change the dosage, take other precautions or, in some cases, stop treatment with some medicines. This is especially true for the following drugs:

lithium - a drug used to treat certain mental illnesses;

medicines or substances that may increase the amount of potassium in the blood. These include potassium supplements, salt substitutes containing potassium, potassium-sparing drugs and heparin.

medicines that can lower the amount of potassium in the blood (hypokalaemia), such as diuretics (water tablets), corticosteroids (eg prednisone), laxatives (such as castor oil), adrenocorticotropic hormone (ACTH), carbenoxolone (used treatment of canker sores in the mouth), amphotericin (antifungal agent), penicillin G (antibiotic), salicylic acid and its derivatives;

certain antibiotics (from the rifampicin group), a medicine used to prevent organ transplant rejection (cyclosporine) or antiretroviral medicines used to treat HIV infection / AIDS (ritonavir). These medicines may increase the effect of Valtensin Plus.

medicines that can cause 'torsades de pointes' (irregular heartbeat), such as antiarrhythmic medicines (medicines used to treat heart problems) and some antipsychotics;

medicines that can lower the amount of sodium in your blood, such as antidepressants, antipsychotics, antiepileptics;

drugs for the treatment of gout, such as allopurinol, probenecid, sulfinpyrazone;

vitamin D and calcium supplements;

medicines to treat diabetes (oral agents such as metformin or insulin);

other medicines to lower blood pressure, including methyldopa, ACE inhibitors (such as enalapril, lisinopril, etc.) or aliskiren (see also the information in the sections 'Do not take Valtensin Plus' and 'Warnings and precautions');

medicines to increase blood pressure, such as norepinephrine or adrenaline;

digoxin or other digitalis glycosides (medicines used to treat heart problems);

medicines that can raise blood sugar, such as diazoxide or beta-blockers;

cytotoxic drugs (used to treat cancer), such as methotrexate or cyclophosphamide;

painkillers and drugs for the treatment of arthritis, such as non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 inhibitors (COX-2 inhibitors) and acetylsalicylic acid> 3 g;

muscle relaxants, such as tubocurarine;

anticholinergic drugs (drugs used to treat various diseases, such as gastrointestinal spasms, bladder spasms, asthma, seasickness, muscle spasms, Parkinson's disease and as an adjunct to anesthesia), such as atropine and biperiden;

amantadine (a medicine used to treat Parkinson's disease and also used to treat or prevent certain diseases caused by viruses);

cholestyramine and colestipol (drugs mainly used to treat high blood fat levels);

cyclosporine - a drug used in organ transplantation to prevent organ rejection;

alcohol, hypnotics and anesthetics (drugs with a hypnotic or analgesic effect, used during surgery);

iodine-contrast agents (substances used for imaging).

Valtensin Plus with food and alcohol

You can take Valtensin Plus with or without food.

Avoid alcohol until you have consulted your doctor. Alcohol may cause your blood pressure to drop further and / or increase your risk of feeling dizzy or nauseous.

Pregnancy and lactation

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 should tell your doctor if you think you are (or might become) pregnant.

Your doctor will usually advise you to stop taking Valtensin Plus before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Valtensin Plus. Valtensin Plus is not recommended in early pregnancy, and must not be taken when more than 3 months old, as it may cause serious harm to your baby if used after the 3rd month of pregnancy.

Tell your doctor if you are breast-feeding or intend to breast-feed.

Valtensin plus is not recommended for breast-feeding mothers and your doctor may prescribe another treatment if you wish to breast-feed, especially if your baby is newborn or born prematurely.

Driving and using machines

Before driving, operating machinery or other activities requiring

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

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 require immediate medical attention:

Tell your doctor immediately if you experience symptoms of angioneurotic edema, such as:

swelling of the face, tongue or pharynx;

difficulty swallowing;

hives and difficulty breathing.

If you get any of these symptoms, stop taking Valtensin Plus and contact your doctor immediately (see also section 2 “Warnings and precautions”).

Other side effects are:

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

cough;

low blood pressure;

fainting;

dehydration (with symptoms of thirst, dry mouth and tongue, infrequent urination, dark urine, dry skin);

muscle pain;

fatigue;

tingling or tingling;

blurred vision;

noise (eg whistling, buzzing) in the ears.

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

dizziness;

diarrhea;

joint pain.

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

difficulty breathing;

severe reduction in the amount of urine excreted;

low levels of sodium in the blood (which can cause fatigue, confusion, muscle twitching and / or severe convulsions);

low levels of potassium in the blood (sometimes with muscle weakness, muscle spasms, abnormal heart rhythm);

low white blood cell count (with symptoms such as fever, skin infections, sore throat or mouth ulcers due to infections, weakness);

increase in bilirubin levels in the blood (which in severe cases can lead to yellowing of the skin and eyes);

elevated levels of urea and creatinine in the blood (which may be a sign of impaired renal function);

elevated levels of uric acid in the blood (which in severe cases can cause gout);

syncope (loss of consciousness).

The following adverse reactions have been reported with valsartan and hydrochlorothiazide alone.

Valsartan

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

dizziness;

abdominal pain.

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

blistering of the skin (a sign of bullous dermatitis);

skin rash with or without itching, combined with any of the following signs and symptoms: fever, joint pain, muscle aches, swollen lymph nodes and / or flu-like symptoms;

rash, purple-red spots, fever, itching (symptoms of inflammation of the blood vessels);

low platelet count (sometimes with abnormal bleeding or bruising);

high levels 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 in the face and throat; rash; itching;

increased liver function tests;

decrease in hemoglobin and red blood cell count (which in combination, in severe cases, can lead to anemia);

kidney failure;

low levels of sodium in the blood (which can cause fatigue, confusion, muscle twitching and / or seizures in severe cases).

Hydrochlorothiazide

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

low levels of potassium in the blood;

increase in blood lipids.

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

low levels of sodium in the blood;

low levels of magnesium in the blood;

high levels of uric acid in the blood;

itchy rash and other types of rash;

decreased appetite;

moderate nausea and vomiting;

dizziness, dizziness on standing up;

inability to achieve or maintain an erection.

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

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

high levels of calcium in the blood;

high blood sugar;

sugar in the urine;

worsening of diabetic metabolic status;

constipation, diarrhea, stomach or intestinal discomfort, liver disorders that may occur simultaneously with yellowing of the skin and eyes;

irregular heart rhythm;

headache;

sleep disorders;

bad mood (depression);

decreased number of platelets in the blood (sometimes with bleeding or subcutaneous bruising);

dizziness;

tingling or tingling;

visual impairment.

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

inflammation of blood vessels with symptoms such as rash, red-violet spots, fever (vasculitis);

rash, itching, hives, difficulty breathing or swallowing, dizziness (hypersensitivity reactions);

severe skin disease that causes a rash, reddening of the skin, blistering of the lips, eyes or mouth, peeling of the skin, fever (toxic epidermal

How to store Valtensin Plus

Keep out of reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister and tablet pack after EXP. The expiry date refers to the last day of that month.

[For blister packs only]: Store below 30 ° C.

Do not use this medicine if you notice that the package is damaged or its integrity is compromised.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the package and additional information

What Valtensin Plus contains

The active substances are: valsartan and hydrochlorothiazide.

Each film-coated tablet contains 80 mg valsartan and 12.5 mg hydrochlorothiazide

Each film-coated tablet contains 160 mg of valsartan and 12.5 mg of hydrochlorothiazide

Each film-coated tablet contains 160 mg of valsartan and 25 mg of hydrochlorothiazide

The other ingredients are: tablet core: cellulose, microcrystalline, lactose monohydrate, croscarmellose sodium, povidone K29-32, talc, magnesium stearate, silica, colloidal anhydrous; film coating:

[80 mg / 12.5 mg] polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, lecithin (contains soybean oil) (E322), red iron oxide (E172), yellow iron oxide (E 172), black iron oxide (E 172).

[160 mg / 12.5 mg] polyvinyl alcohol, talc, macrogol 3350, titanium dioxide (E171), red iron oxide (E172), sunset yellow FCF (E110), lecithin (contains soybean oil) (E322).

[160 mg / 25 mg] polyvinyl alcohol, talc, titanium dioxide (E171), macrogol 3350, yellow iron oxide (E 172), lecithin (contains soybean oil) (E322), red iron oxide (E 172), black iron oxide (E 172).

What Valtensin Plus looks like:

Valtensin Plus 80 mg / 12.5 mg: pink, oval, biconvex film-coated tablets, 11 x 5.8 mm, marked "V" on one side and "H" on the other.

Valtensin Plus 160 mg / 12.5 mg: red, oval, biconvex film-coated tablets, 15 x 6 mm, marked "V" on one side and "H" on the other.

Valtensin Plus 160 mg / 25 mg: orange, oval, biconvex film-coated tablets, 15 x 6 mm, marked "V" on one side and "H" on the other.

Package contents:

Blister:

7, 14, 28, 30, 56, 98 and 280 tablets

Pack for tablets:

7, 14, 28, 30, 56, 98 and 280 tablets

Not all pack sizes may be marketed.

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