Arbaval Plus®

Arbaval Plus<sup>®</sup>

Arbaval Plus®

Valsartan/ Hydrochlorothiazide

Arbaval Plus® 

Valsartan/ Hydrochlorothiazide

(160/12.5 mg), (160/25 mg), (320/25 mg)

Film coated tablet for oral use

Product leaflet summary

Therapeutic Indications

  • Arbaval Plus is used to treat high blood pressure which is not adequately controlled by a single substance alone.

 

Dosage and Administration

  • The usual dose of Arbaval Plus 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 Arbaval Plus with or without food.
  • Swallow the tablet with a glass of water.

 

Contraindications

  • If you are allergic (hypersensitive) to valsartan, hydrochlorothiazide, sulphonamide derivatives (substances chemically related to hydrochlorothiazide) or to any of the other ingredients of Arbaval Plus.
  • If you are more than 3 months pregnant (it is also better to avoid Arbaval Plus in early pregnancy – see pregnancy section).
  • Arbaval Plus HCT should not be co-administered with aliskiren in patients with diabetes mellitus or renal impairment
  • If you have severe liver disease, destruction of the small bile ducts within the liver (biliary cirrhosis) leading to the buildup 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. Take special care with Arbaval Plus
  • Dual Blockade of the Renin-Angiotensin-aldosterone System (RAAS):
  • Combination of Cardioval HCT with ACE inhibitors, or aliskiren may cause increased risks of hyperkalemia, worsening of kidney function and hypotension. Therefore, this combination should not be used, especially in patients with kidney problems.
  • 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 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 Arbaval Plus 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 Arbaval Plus, stop taking Arbaval Plus 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 Arbaval Plus.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 Arbaval Plus 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. Arbaval Plus 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:
  • “ACE inhibitors” such as enalapril, lisinopril, Aliskiren, etc.

 

Pregnancy and Lactation

Pregnancy:

  • You must tell your doctor If you think that you are (or might become) pregnant
  • Your doctor will normally advise you to stop taking Arbaval Plus before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead of Arbaval Plus. Arbaval Plus 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.

Lactation:

  • Tell your doctor If you are breast feeding or about to start breast feeding
  • Arbaval Plus 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.

 

Ability to Drive and Use Machinery

Before you drive a vehicle, use tools or operate machines or carry out other activities that require concentration, make sure you know how Arbaval Plus affects you. Like many other medicines used to treat high blood pressure, Arbaval Plus may occasionally cause dizziness and affect the ability to concentrate.

 

Package Presentation:

Arbaval Plus Packs contain 28 film-coated tablets