Do not take FORGEVASC:
- If you are hypersensitive (allergic) to amlodipine or any other calcium channel blockers, valsartan or to any of the other ingredients of FORGEVASC (listed in section 6)
- If you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors) (see “Warnings and precautions”)
- If you have recurrent episodes of severe swelling without a known cause
- Your doctor has diagnosed that you are suffering from a narrowing of valves in your heart (called aortic or mitral stenosis), or abnormally increased thickness of your heart muscle with narrowing (called obstructive hypertrophic cardiomyopathy)
- If you have received a kidney transplant or if you had been diagnosed to suffer from a narrowing of your kidney artery or if you are suffering from severe kidney problems
- If you are taking other medicine or substances, which increase the potassium levels in your blood (such as certain types of diuretics, potassium supplements, etc.) (see “Other medicines and FORGEVASC”)
- If you have porphyria
- If you are taking a medicine called lithium (see “Other medicines and FORGEVASC”)
- If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren
- If you have severe liver impairment
- If you have severe low blood pressure (hypotension)
- If you have cardiogenic shock (a condition where your heart is unable to supply enough blood to the body)
- If you suffer from heart failure after a heart attack
- If you are pregnant or breastfeeding.
Warnings and precautions
Take special care with FORGEVASC:
- if you are taking aliskiren (see “Do not take” and “Other medicines and FORGEVASC”)
- if you have been sick (vomiting or diarrhoea)
- if you have had a kidney transplant or if you had been told that you have a narrowing of your kidney arteries
- if you have liver or kidney problems
- if you have a condition affecting the renal glands called “primary hyperaldosteronism”
- if you have experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors). If you get these symptoms, stop taking FORGEVASC and contact your doctor straight away. You should never take FORGEVASC again (see “Do not take”)
- If you have had heart failure or have experienced a heart attack. Follow your doctor’s instructions for the starting dose carefully. Your doctor may also check your kidney function.
Contact your doctor to re-evaluate your treatment if you are treated with ACE-Inhibitors/Angiotensin receptor blockers together with a fluoroquinolone antibiotic.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.
Children and adolescents
The use of FORGEVASC in children and adolescents is not recommended (aged below 18 years old).
Other medicines and FORGEVASC
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)
Tell your doctor if you are taking:
- ACE-inhibitors or aliskiren (medicines used to treat high blood pressure) (see also information under the headings “Do not take” and “Warnings and precautions”)
- diuretics (a type of medicine also called “water tablets” which increases the amount of urine you produce)
- potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels (see “Do not take”)
- nitroglycerin and other nitrates, or other substances called “vasodilators”
- medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir)
- medicines used to treat fungal infections (e.g. ketoconazole, itraconazole)
- clarithromycin (for infections caused by bacteria)
- verapamil, diltiazem (heart medicines)
- medicines used to treat bacterial infections (such as rifampicin, erythromycin, telithromycin)
- anticonvulsant medicines (e.g. carbamazepine, phenobarbitone, phenytoin, fosphenytoin, primidone)
- St. John’s wort
- simvastatin (a medicine used to control high cholesterol levels)
- dantrolene (infusion for severe body temperature abnormalities)
- tacrolimus (used to control your body’s immune response, enabling your body to accept the transplanted organ)
- medicines used to protect against transplant rejection (ciclosporin)
- lithium (a medicine used to treat some types of depression) (see also information under the headings “Do not take”)
- certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors).
Your doctor may also check your kidney function.
FORGEVASC with food and drink
Grapefruit and grapefruit juice should not be consumed by people who are taking FORGEVASC. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active substance amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of FORGEVASC.
Pregnancy, breast-feeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking FORGEVASC. Safety of FORGEVASC in pregnant and breastfeeding women has not been established. You should not use FORGEVASC if you are pregnant, trying to become pregnant or breastfeeding your baby. If you are a woman of childbearing age, you should ensure that you use an effective contraception.
Driving and using machines
This medicine may make you feel dizzy. This can affect how well you can concentrate. It is not always possible to predict to what extent FORGEVASC may interfere with your daily activities. You should ensure that you do not engage in driving a vehicle or operate machines until you are aware of the measure to which FORGEVASC affects you.
