Amlodipine/Valsartan Teva

Amlodipine besilate, valsartan.

The active substances of Amlodipine/Valsartan Teva Tablets are amlodipine (as amlodipine besilate) and valsartan.
5/80 mg tab: Each tablet contains 5 mg amlodipine and 80 mg valsartan.
5/160 mg tab: Each tablet contains 5 mg amlodipine and 160 mg valsartan.
10/160 mg tab: Each tablet contains 10 mg amlodipine and 160 mg valsartan.
Excipients/Inactive Ingredients: The other ingredients are cellulose microcrystalline (Type 101 & Type 102), povidone, croscarmellose, talc, magnesium stearate, hypromellose, titanium dioxide (E171), iron oxide yellow (E172) (for 5/80 mg and 5/160 mg tab) & macrogol/PEG (400).

Amlodipine/Valsartan Teva Tablets contain two substances called amlodipine and valsartan. Both of these substances help to control high blood pressure.
Amlodipine belongs to a group of substances called "calcium channel blockers". Amlodipine stops calcium from moving into the blood vessel wall which stops the blood vessels from tightening.
Valsartan belongs to a group of substances called "angiotensin-II receptor antagonists".
Angiotensin II is produced by the body and makes the blood vessels tighten, thus increasing the blood pressure. Valsartan works by blocking the effect of angiotensin II.
This means that both of these substances help to stop the blood vessels tightening. As a result, the blood vessels relax and blood pressure is lowered.

Amlodipine/Valsartan Teva Tablets is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.

The usual dose of Amlodipine/Valsartan Teva Tablets is one tablet per day.
It is preferable to take the medicine at the same time each day.
Swallow the tablets with a glass of water.
Amlodipine/Valsartan Teva Tablets can be taken with or without food. Do not take Amlodipine/Valsartan Teva Tablets with grapefruit or grapefruit juice.
Depending on the response to treatment, the doctor may suggest a higher or lower dose. Do not exceed the prescribed dose.
Amlodipine/Valsartan Teva Tablets and older people (age 65 years or over): The doctor should exercise caution when increasing the dose.
If the patient has any further questions on the use of this medicine, ask the doctor or pharmacist.
If the patient forgets to take Amlodipine/Valsartan Teva Tablets: If the patient forgets to take this medicine, take it as soon as remembered. Then take the next dose at its usual time. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten tablet.
If the patient stops taking Amlodipine/Valsartan Teva Tablets: Stopping the treatment with Amlodipine/Valsartan Teva Tablets may cause the disease to get worse. Do not stop taking the medicine unless told by the doctor.

If the patient has taken too many tablets of Amlodipine/Valsartan Teva Tablets, or if someone else has taken the tablets, consult a doctor immediately.

Do not take Amlodipine/Valsartan Teva Tablets: If allergic to amlodipine or to any other calcium channel blockers. This may involve itching, reddening of the skin or difficulty in breathing.
If allergic to valsartan or any of the other ingredients of this medicine (listed in Description). If the patient thinks he/she may be allergic, talk to the doctor before taking Amlodipine/Valsartan Teva Tablets.
If the patient has severe liver problems or bile problems such as biliary cirrhosis or cholestasis.
If the patient is more than 3 months pregnant. (It is also better to avoid Amlodipine/Valsartan Teva Tablets in early pregnancy, see Use in Pregnancy & Lactation).
If the patient has severe low blood pressure (hypotension).
If the patient has narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body).
If the patient suffers from heart failure after a heart attack.
If the patient has diabetes or impaired kidney function and being treated with a blood pressure lowering medicine containing aliskiren.
Contraindication: The concomitant use of Amlodipine/Valsartan Teva Tablets with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²).
If any of the above applies to the patient, do not take Amlodipine/Valsartan Teva Tablets and talk to the doctor.

Talk to the doctor before taking Amlodipine/Valsartan Teva Tablets: If the patient has been sick (vomiting or diarrhoea).
If the patient has liver or kidney problems.
If the patient has had a kidney transplant or if he/she has been told that he/she has narrowing of the kidney arteries.
If the patient has a condition affecting the renal glands called "primary hyperaldosteronism".
If the patient has had heart failure or has experienced a heart attack. Follow the doctor's instructions for starting the dose carefully. The doctor may also check the kidney function.
If the patient has narrowing of the valves in the heart (called "aortic or mitral stenosis") or if thickness of the heart muscle is abnormally increased (called "obstructive hypertrophic cardiomyopathy").
If the patient has experienced swelling, particularly of the face and throat while taking other medicines (including angiotensin converting enzyme inhibitors). If the patient gets these symptoms, stop taking Amlodipine/Valsartan Teva Tablets and contact the doctor straight away. The patient should never take Amlodipine/Valsartan Teva Tablets again.
If the patient is taking any of the following medicines used to treat high blood pressure: an ACE inhibitor (for example enalapril, lisinopril, ramipril), in particular if the patient has diabetes-related kidney problems; aliskiren.
Dual blockade of the renin-angiotensin-aldosterone system (RAAS): There is evidence that the concomitant use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended.
If dual blockade therapy is considered absolutely necessary, this should only occur under specialist supervision and subject to frequent close monitoring of renal function, electrolytes and blood pressure.
ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
The doctor may check the kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in the blood at regular intervals.
See also information under Contraindications.
If any of these apply, tell the doctor before taking Amlodipine/Valsartan Teva Tablets.
Driving and using machines: This medicine may make the patient feel dizzy. This can affect how well he/she can concentrate. If not sure how this medicine will affect the patient, do not drive, use machinery, or do other activities that need concentration.
Use in children: The use of Amlodipine/Valsartan Teva Tablets in children and adolescents is not recommended (aged below 18 years old).

Pregnancy: Tell the doctor if the patient thinks she is (or might become) pregnant. The doctor will normally advise the patient to stop taking Amlodipine/Valsartan Teva Tablets before becoming pregnant or as soon as pregnancy is known and will advise to take another medicine instead of Amlodipine/Valsartan Teva Tablets. Amlodipine/Valsartan Teva Tablets is not recommended in early pregnancy (first 3 months), and must not be taken when more than 3 months pregnant, as it may cause serious harm to the baby if used after the third month of pregnancy.
Breast-feeding: Tell the doctor if the patient is breast-feeding or about to start breast-feeding. Amlodipine has been shown to pass into breast milk in small amounts. Amlodipine/Valsartan Teva Tablets is not recommended for mothers who are breast-feeding, and the doctor may choose another treatment if the mother wishes to breast-feed, especially if the baby is newborn, or was born prematurely.
Ask the doctor or pharmacist for advice before taking any medicine.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and need immediate medical attention: Few patients have experienced these serious side effects (may affect up to 1 in 1,000 people). If any of the following happen, tell the doctor straight away: Allergic reaction with symptoms such as rash, itching, swelling of face or lips or tongue, difficulty breathing, low blood pressure (feeling of faintness, lightheadedness).
Other possible side effects of Amlodipine/Valsartan Teva Tablets: Common (may affect up to 1 in 10 people): Influenza (flu); blocked nose, sore throat and discomfort when swallowing; headache; swelling of arms, hands, legs, ankles or feet; tiredness; asthenia (weakness); redness and warm feeling of the face and/or neck.
Uncommon (may affect up to 1 in 100 people): Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling or numbness of the hands or feet; vertigo; fast heart beat including palpitations; dizziness on standing up; cough; diarrhoea; constipation; skin rash, redness of the skin; joint swelling, back pain; pain in joints.
Rare (may affect up to 1 in 1,000 people): Feeling anxious; ringing in the ears (tinnitus); fainting; passing more urine than normal or feeling more of an urge to pass urine; inability to get or maintain an erection; sensation of heaviness; low blood pressure with symptoms such as dizziness, light-headedness; excessive sweating; skin rash all over the body; itching; muscle spasm.
If any of these affect the patient severely, tell the doctor.
Side effects reported with amlodipine or valsartan alone and either not observed with Amlodipine/Valsartan Teva Tablets or observed with a higher frequency than with Amlodipine/Valsartan Teva Tablets: Amlodipine: Consult a doctor immediately if the patient experiences any of the following very rare, severe side effects after taking this medicine: Sudden wheeziness, chest pain, shortness of breath or difficulty in breathing; Swelling of eyelids, face or lips; Swelling of the tongue and throat which causes great difficulty breathing; Severe skin reactions including intense skin rash, hives, reddening of the skin over the whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson Syndrome, toxic epidermal necrolysis) or other allergic reactions; Heart attack, abnormal heart beat; Inflamed pancreas, which may cause severe abdominal and back pain accompanied with feeling of being very unwell.
The following side effects have been reported. If any of these cause problems or if they last for more than one week, contact the doctor.
Common (may affect up to 1 in 10 people): Dizziness, sleepiness; palpitations (awareness of the heart beat); flushing, ankle swelling (oedema); abdominal pain, feeling sick (nausea).
Uncommon (may affect up to 1 in 100 people): Mood changes, anxiety, depression, sleeplessness, trembling, taste abnormalities, fainting, loss of pain sensation; visual disturbances, visual impairment, ringing in the ears; low blood pressure; sneezing/runny nose caused by inflammation of the lining of the nose (rhinitis); indigestion, vomiting (being sick); hair loss, increased sweating, itchy skin, skin discolouration; disorder in passing urine, increased need to urinate at night, increased number of times of passing urine; inability to obtain an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight increase or decrease.
Rare (may affect up to 1 in 1,000 people): Confusion.
Very rare (may affect up to 1 in 10,000 people): Decreased number of white blood cells, decrease in blood platelets which may result in unusual bruising or easy bleeding (red blood cell damage); excess sugar in blood (hyperglycaemia); swelling of the gums, abdominal bloating (gastritis); abnormal liver function, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), liver enzyme increase which may have an effect on some medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, sensitivity to light; disorders combining rigidity, tremor and/or movement disorders.
Valsartan: Not known (frequency cannot be estimated from the available data): Decrease in red blood cells, fever, sore throat or mouth sores due to infections; spontaneous bleeding or bruising; high level of potassium in the blood; abnormal liver test results; decreased renal functions and severely decreased renal functions; swelling mainly of the face and the throat; muscle pain; rash, purplish-red spots; fever; itching; allergic reaction; blistering skin (sign of a condition called dermatitis bullous).
If the patient experiences any of these, tell the doctor straight away.
Reporting of side effects: If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in the monograph. By reporting side effects the patient can help provide more information on the safety of this medicine.

Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. The doctor may need to change the dose and/or to take other precautions. In some cases the patient may have to stop taking one of the medicines. This applies especially to the medicines listed as follows.
ACE inhibitors, other RAAS-acting agent or aliskiren: Clinical trial data has shown that dual blockade of the RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see also Contraindications and Precautions).
Diuretics (a type of medicine also called "water tablets" which increases the amount of urine produced).
Lithium (a medicine used to treat some types of depression).
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels.
Certain types of painkillers called non-steroidal anti-inflammatory medicines (NSAIDs) or selective cyclooxygenase-2 inhibitors (COX-2 inhibitors). The doctor may also check the kidney function.
Anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone).
St. John's wort.
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).
Medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin).
Verapamil, diltiazem (heart medicines).
Simvastatin (a medicine used to control high cholesterol levels).
Dantrolene (infusion for severe body temperature abnormalities).
Medicines used to protect against transplant rejection (ciclosporin).
Amlodipine/Valsartan Teva Tablets with food and drink: Grapefruit and grapefruit juice should not be consumed by people who are taking Amlodipine/Valsartan Teva Tablets. 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 Amlodipine/Valsartan Teva Tablets.

Do not store above 30°C.
Store in the original package in order to protect from moisture.

Angiotensin II Antagonists / Calcium Antagonists

C09DB01 - valsartan and amlodipine ; Belongs to the class of angiotensin II receptor blockers (ARBs) and calcium channel blockers. Used in the treatment of cardiovascular disease.

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