Product Details

Product Information of Exforge HCT 10mg/160mg/12.5mg Tablets

Do not take Exforge HCT:

if you are more than 3 months pregnant (It is also better to avoid Exforge HCT in early pregnancy

if you are allergic (hypersensitive) to amlodipine, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of Exforge HCT

If you think you may be allergic, do not take Exforge HCT and talk to your doctor.

if you have liver problems, such as liver disorders and jaundice (cholestasis).

if you have severe kidney problems or if you are having dialysis.

if you are suffering from an inability to produce urine.

if the level of potassium or sodium in your blood is too low despite treatment.

if the level of calcium in your blood is too high despite treatment.

if you have gout (uric acid crystals in the joints). If any of the above applies to you, do not take Exforge HCT and talk to your doctor.

Take special care with Exforge HCT

if you have a low level of potassium, sodium or magnesium in your blood.

if you have a high level of calcium in your blood.

• if you are taking medicines or substances 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 have kidney problems, have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries.
• if you have liver problems.
• if you have or have had heart failure or coronary arterydisease, particularly if you are taking the maximum dose of Exforge HCT (10 mg/320 mg/25 mg)
• if your doctor has told you that you have a narrowing of the valves in your heart
• if you suffer from aldosteronism. This is a disease in which the adrenal glands make too much of the hormone aldosterone If this applies to you, the use of Exforge HCT is not recommended.
• if you suffer from a disease called systemic lupus erythematosus
• if you have diabetes (high blood sugar).
• if you have high levels of cholesterol or triglycerides in your blood.
• if you experience skin reactions such as rash after sun exposure
• if you had an allergic reaction to other high blood pressure medicines or diuretics (a type of medicine also known as
• if you have been sick (vomiting or diarrhoea).
• if you experience dizziness and/or fainting during treatment with Exforge HCT, tell your doctor as soon as possible. If any of these apply to you, talk to your doctor.

You must tell your doctor if you think that you are ( or might become) pregnant. Exforge HCT 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 this stage

The use of Exforge HCT in children and adolescents under 18 years of age is not recommended.

Exforge HCT and older people (age 65 years and older)

Exforge HCT can be used by people aged 65 years and over at the same dose as for other adults and in the same way as they have already taken the three substances called amlodipine, valsartan and hydrochlorothiazide. Elderly patients, particularly those taking the maximum dose of Exforge HCT (10 mg/320 mg/25 mg), should have their blood pressure checked regularly.

Using other medicines

Please tell your doctor or pharmacist if you are using or have recently used any other medicine, including medicines obtained without a prescription. Your doctor may need to change the dose or take other precautions. In some cases you may have to stop using one of the medicines. This is especially important if you are using any of the medicines listed below:

Do not take together with:

• lithium (a medicine used to treat some types of depression);
• medicines or substances that increase the amount of potassium in your blood. These include potassium supplements or salt substitutes containing potassium, potassium-sparing medicines and heparin. Caution should be used with:
• alcohol, sleeping pills and anaesthetics (medicines allowing patients to undergo surgery and other procedures);
• allopurinol (anti-gout treatment);
• amantadine (anti-Parkinson therapy, also used for influenza treatment);
• anticholinergic agents (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);
• anticonvulsant medicines and mood-stabilising medicines used to treat epilepsy and bipolar disorder (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine and colestipol (substances used mainly to treat high levels of lipids in the blood);
• ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g: rheumatoid arthritis or atopic dermatitis);
• cortisone-like medicines, steroids;
• curare derivatives (a medicine to relax the muscles which is used during operations);
• cytotoxic medicines (used to treat cancer);
• digoxin (a heart medicine);
• medicines for the treatment of diabetes (oral agents such as metformin or insulins);
• medicines to increase blood pressure (adrenaline, noradrenaline);
• medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g. ketoconazole);
• medicines used for oesophageal ulceration and inflammation (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory agents;
• nitroglycerin and other nitrates, or other substances called ?vasodilators?;
• other medicines to treat high blood pressure (beta blockers, diazoxides, methyldopa);
• rifampicin (used, for example, to treat tuberculosis);
• some medicines used to treat infections such as amphotericin, penicillin G, tetracycline;
• St. John?s wort;
• vitamin D and calcium salts. Talk to your doctor before drinking alcohol. Alcohol may make your blood pressure fall too much and/or increase the possibility of dizziness or fainting.

Taking Exforge HCT with food and drink

You can take Exforge HCT with or without food.

Pregnancy and breast-feeding

Pregnancy
You must tell your doctor if you think you are ( or might become) pregnant. Your doctor will normally advise you to stop taking Exforge HCT before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Exforge HCT. Exforge HCT 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 it is used after the third month of pregnancy.

Breast-feedingTell your doctor if you are breast-feeding or about to start breast-feeding. Exforge HCT 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 a newborn, or was born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

As with many other medicines used to treat high blood pressure, this medicine may make you feel dizzy. If you experience this symptom, do not drive or use tools or machines.

How should it be stored?