Valgen 40 mg Film-Coated Tablets

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.

VALGEN can be used for three different conditions:

• To treat mild to moderate high blood pressure in adults.
• To treat adult patients after a recent heart attack (myocardial infarction).
• To treat symptomatic heart failure in adult patients.

Do not take VALGEN:

• if you are hypersensitive (allergic) to valsartan or any of the other ingredients of VALGEN (listed in section 6).
• if you have developed swelling of the face, lips, mouth, tongue or throat and giant wheals on your skin when previously taking medicines called angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) – you should never take these medicines again.
• if you suffer from severe liver disease or biliary obstruction (a problem with the drainage of the bile from the gall bladder).
• if you suffer from obstruction of blood vessels to your heart or kidneys.
• if you suffer from severe kidney function impairment.
• if you suffer from porphyria.
• if you have a history of angioedema.
• if you have a heart condition called "hypertrophic obstructive cardiomyopathy" where the cardiac muscle is abnormally thickened and, during the contraction, it obstructs the blood flow in the left lower cavity of the heart.
• if you are currently taking lithium.
• if you are currently taking potassium sparing water tablets containing spironolactone, triamterene or amiloride.
• if you are taking fluoroquinolones (antibiotics to treat infections).
• if you are currently taking aliskiren-containing medicines (especially if you have Type 2 diabetes and/or kidney problems).
• if you are pregnant or breastfeeding.

Warnings and precautions

Take special care with VALGEN:

• if you have liver disease.
• if you have severe kidney disease or if you are undergoing dialysis.
• if you are suffering from a narrowing of the kidney artery.
• if you have recently undergone kidney transplantation (received a new kidney).
• if you are treated after a heart attack or for heart failure, your doctor may check your kidney function.
• if you have severe heart disease other than heart failure or heart attack.
• if you are taking medicines that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. It may be necessary to check the amount of potassium in your blood at regular intervals.
• if you suffer from aldosteronism. This is a disease in which your adrenal glands make too much of the hormone aldosterone. If this applies to you, the use of VALGEN is not recommended.
• if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water pills (diuretics).
• 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 VALGEN, stop taking VALGEN immediately and never take it again. See section 4 ‘Possible side effects’.
• 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 you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or beta-blockers (for example metoprolol).

Do not share medicines prescribed for you with any other person. Always take VALGEN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

High blood pressure: The usual starting dose is 80 mg of VALGEN once daily. In some cases your doctor may prescribe higher doses (the dose can be increased to 160 mg and to a maximum of 320 mg).

VALGEN may also be administered with other medicines for high blood pressure.

Adult patients after a recent heart attack: After a heart attack the treatment is generally started as early as after 12 hours, usually at a low dose of 20 mg twice daily. You obtain the 20 mg dose by dividing the 40 mg tablet. Your doctor will increase this dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate.

VALGEN can be given together with other treatment for heart attack, and your doctor will decide which treatment is suitable for you.

Adult patients with heart failure: Treatment starts generally with 40 mg twice daily. Your doctor will increase the dose gradually over several weeks to a maximum of 160 mg twice daily. The final dose depends on what you as an individual patient can tolerate.

VALGEN can be given together with other treatment for heart failure, and your doctor will decide which treatment is suitable for you.

If you have the impression that VALGEN is too strong or too weak, talk to your doctor or pharmacist.

VALGEN tablets are only for adults and should not be taken by children and adolescents up to 18 years.

If you take more VALGEN than you should If you experience severe dizziness and/or fainting, contact your doctor immediately and lie down. In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take VALGEN 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.

Effects when treatment with VALGEN is stopped: Stopping your treatment with VALGEN may cause your disease to get worse. Do not stop taking your medicine unless your doctor tells you to.

VALGEN can have side effects. Not all side effects reported for VALGEN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking VALGEN, please consult your healthcare provider for advice.

If any of the following happens, stop taking VALGEN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching.

These are all very serious side effects. If you have them, you may have had a serious reaction to VALGEN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• breathlessness, difficulty breathing when lying down, swelling of the feet or legs (signs of cardiac failure);
• severe blistering of the skin (bullous dermatitis).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent:
• viral infections,
• dizziness,
• low blood pressure with or without symptoms such as dizziness and fainting when standing up,
• decreased kidney function (signs of renal impairment).

• Less frequent:
• sudden loss of consciousness (syncope),
• spinning sensation (vertigo),
• severely decreased kidney function (signs of acute renal failure),
• increase of level of serum creatinine (which can indicate abnormal kidney function),
• muscle spasms, abnormal heart rhythm (signs of hyperkalaemia),
• swelling under the skin (angioedema),
• back pain, headache, cough, sore throat, hay fever, inflamed sinuses,
• abdominal pain, nausea, diarrhoea,
• tiredness, weakness,
• sleeplessness,
• low sex drive.

• Unknown frequency:
• allergic reactions with rash, itching and hives; symptoms of fever, swollen joints and joint pain, muscle pain, swollen lymph nodes and/or flu-like symptoms may occur (signs of serum sickness),
• purplish-red spots, fever, itching (signs of inflammation of blood vessels also called vasculitis),
• unusual bleeding or bruising (signs of thrombocytopenia),
• muscle pain (myalgia),
• fever, sore throat or mouth ulcers due to infections (symptoms of low level of white blood cells also called neutropenia),
• decrease of level of haemoglobin and decrease of the percentage of red blood cells in the blood (which can lead to anaemia in severe cases),
• increase of level of potassium in the blood (which can trigger muscle spasms, abnormal heart rhythm in severe cases),
• elevation of liver function values (which can indicate liver damage) including an increase of bilirubin in the blood (which can trigger yellow skin and eyes in severe cases),
• increase of level of blood urea nitrogen (which can indicate abnormal kidney function),
• low level of sodium in the blood (which can trigger tiredness, confusion, muscle twitching and/or convulsions in severe cases).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of VALGEN.

Store all medicines out of reach of children.

• Store at or below 25 ˚C in a dry place.
• Protect from moisture.
• Keep container tightly closed.
• Keep blister in the carton until required for use.
• Do not use after the expiry date stated on the carton/label.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).