Wamlox

Amlodipine, valsartan.

5 mg/80 mg tablet: Each 5 mg/80 mg film-coated tablet contains 5 mg amlodipine (as amlodipine besilate) and 80 mg valsartan.
5 mg/160 mg tablet: Each 5 mg/160 mg film-coated tablet contains 5 mg amlodipine (as amlodipine besilate) and 160 mg valsartan.
10 mg/160 mg tablet: Each 10 mg/160 mg film-coated tablet contains 10 mg amlodipine (as amlodipine besilate) and 160 mg valsartan.
Excipients/Inactive Ingredients: The other ingredients are microcrystalline cellulose, magnesium stearate, croscarmellose sodium, povidone K25, sodium laurilsulfate, mannitol and colloidal anhydrous silica in the tablet core and poly(vinyl alcohol), titanium dioxide (E171), macrogol 3000, talc and yellow iron oxide (E172) in the film coating. See Wamlox contains sodium under Precautions.

Wamlox 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.

Wamlox is used to treat high blood pressure in adults whose blood pressure is not controlled enough with either amlodipine or valsartan on its own.

Always take this medicine exactly as told by the doctor. Check with the doctor if unsure. This will help to get the best results and lower the risk of side effects.
The usual dose of Wamlox 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.
Wamlox can be taken with or without food. Do not take Wamlox with grapefruit or grapefruit juice.
Depending on the patient's treatment response, the doctor may suggest a higher or lower dose. Do not exceed the prescribed dose.
Wamlox and older people (aged 65 years or over): The doctor should exercise caution when increasing the dose.
If the patient forgets to take Wamlox: If forgotten to take this medicine, take it as soon as it is 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 Wamlox: Stopping the treatment with Wamlox may cause the disease to get worse. Do not stop taking the medicine unless told by the doctor.
If there are any further questions on the use of this medicine, ask the doctor or pharmacist.

If too many tablets of Wamlox have been taken, or if someone else has taken the tablets, consult a doctor immediately.

The patient should not take Wamlox: if he/she is allergic to amlodipine or to any other calcium channel blockers [may involve itching, reddening of the skin or difficulty in breathing]; if he/she is allergic to valsartan or any of the other ingredients of this medicine (listed in Description) [if the patient thinks he/she may be allergic, he/she should talk to the doctor before taking Wamlox]; if he/she has severe liver problems or bile problems such as biliary cirrhosis or cholestasis; if she is more than 3 months pregnant [also better to avoid Wamlox in early pregnancy] (see Use in Pregnancy & Lactation); if he/she has severe low blood pressure (hypotension); if he/she 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 he/she suffers from heart failure after a heart attack; if he/she has diabetes or impaired kidney function and is treated with a blood pressure lowering medicine containing aliskiren [concomitant use of Wamlox 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 previously mentioned apply to the patient, he/she should not take Wamlox and should talk to the doctor.

The patient should talk to the doctor before taking Wamlox: if he/she has been sick (vomiting or diarrhoea); if he/she has liver or kidney problems; if he/she has had a kidney transplant or had been told that he/she has a narrowing of the kidney arteries; if he/she has a condition affecting the renal glands called "primary hyperaldosteronism"; if he/she has had heart failure or has experienced a heart attack [doctor's instructions for the starting dose should be followed carefully; kidney function may also be checked by the doctor]; if the doctor has told the patient that he/she has a narrowing of the valves in the heart (called "aortic or mitral stenosis") or that the thickness of the heart muscle is abnormally increased (called "obstructive hypertrophic cardiomyopathy"); if he/she has experienced swelling, particularly of the face and throat, while taking other medicines (including angiotensin converting enzyme inhibitors) [if these symptoms occur, the patient should stop taking Wamlox and should contact the doctor straight away; Wamlox should never be taken again]; if he/she 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.
The doctor may check the kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in the blood at regular intervals.
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.
See also information under Contraindications.
If any of these apply to the patient, he/she should tell the doctor before taking Wamlox.
Wamlox contains sodium: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Driving and using machines: This medicine may make the patient feel dizzy. This can affect how well the patient can concentrate. So, if the patient is unsure how this medicine will affect him/her, he/she should not drive, use machinery, or do other activities that he/she needs to concentrate on.
Use in Children: The use of Wamlox in children and adolescents is not recommended (aged below 18 years old).

Pregnancy: The patient must tell the doctor if she thinks she is (or might become) pregnant. The doctor will normally advise the patient to stop taking Wamlox before she becomes pregnant or as soon as she knows she is pregnant and will advise the patient to take another medicine instead of Wamlox. Wamlox 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: Amlodipine has been shown to pass into breast milk in small amounts. The patient should tell the doctor if she is breast-feeding or about to start breast-feeding. Wamlox is not recommended for mothers who are breast-feeding, and the doctor may choose another treatment for the patient if she 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: A 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 Wamlox: 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 heartbeat 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, lightheadedness; excessive sweating; skin rash all over the body; itching; muscle spasm.
If any of these affect the patient severely, he/she should tell the doctor.
Side effects reported with amlodipine or valsartan alone and either not observed with Wamlox or observed with a higher frequency than with Wamlox: Amlodipine: Consult a doctor immediately if any of the following very rare, severe side effects are experienced 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 heartbeat; 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, the patient should contact the doctor.
Common (may affect up to 1 in 10 people): Dizziness, sleepiness; palpitations (awareness of the heartbeat); 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 any of these are experienced, tell the doctor straight away.
Reporting of side effects: If any side effects occur, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.

Other medicines and Wamlox: Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines. The doctor may need to change the dose or 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: other medicines used to lower blood pressure, called ACE inhibitors 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]; 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) [kidney function may also be checked by the doctor]; 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); antibiotics (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, tacrolimus).
Wamlox with food and drink: Grapefruit and grapefruit juice should not be consumed by people who are taking Wamlox. 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 Wamlox.

Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Store below 30°C.

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.

P₁S₁S₃