AMLO-DENK 10 Tablet

Use to treat high blood pressure (hypertension) or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s or variant angina.

In patients with high blood pressure this medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina Amlo-Denk 10 works by improving blood supply to the heart muscle which then receives more oxygen and as a result chest pain is prevented. This medicine does not provide immediate relief of chest pain from angina.

Dosage

The usual initial dose is 5mg once daily. Max.10mg once daily.

This medicine can be used before or after food and drinks. Take this medicine at the same time each day with a drink of water. Do not take this medicine with grapefruit juice.

See the package insert about the details: Use in children and adolescents.

- If you are allergic to amlodipine or any of the other ingredients of this medicine, or to any other calcium antagonists. This may be itching, reddening of the skin or difficulty in breathing.

- If you have severe low blood pressure (hypotension).

- If you have narrowing of the aortic heart value (aortic stenosis) or 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.

Visit doctor immediately if the patient experience any of the following 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 whole body, severe itching, blistering, peeling and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson Syndrome) or other allergic reactions

- Heart attack, abnormal heart beat

- Inflamed pancreas which may cause severe abdominal and back pain accompanied with feeling very unwell

If any of these cause or if they last for more than 1 week, contact doctor.

Very common:

- Ankle swelling (oedema)

Common:

- Headache, dizziness, sleepiness (especially at the beginning of treatment)

- Palpitations (awareness of heart beat), flushing

- Abdominal pain, feeling sick (nausea)

- Altered bowel habits, diarrhoea, constipation, indigestion

- Tiredness, weakness

- Visual disturbances, double vision

- Muscle cramps

If any of these get serious, tell doctor or pharmacist.

Uncommon:

- Mood changes, anxiety, depression, sleeplessness

- Trembling, taste abnormalities, fainting

- Numbness or tingling sensation in your limbs; loss of pain sensation

- Ringing in the ears

- Low blood pressure

-Sneezing/running nose caused by inflammation of the lining of the nose (rhinitis)

- Cough

- Dry mouth, vomiting (being sick)

- Hair loss, increased sweating, itchy skin, red patches on skin, skin discolouration

- Disorder in passing urine, increased need to urinate at night, increased number of times of passing urine

- Inability of obtain an erection; discomfort or enlargement of the breasts in men

- Pain, feeling unwell

- Joint or muscle pain, back pain

- Weight increase or decrease

Rare:

- Confusion

Very rare:

- Decreased numbers 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)

- A disorder of the nerves which can cause weakness, tingling or numbness

- 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

- ketoconazole, itraconazole

- ritonavir, indinavir, nelfinavir

- rifampicine, erythromycin, clarithromycin

- hypericum perforatum (St. John’s Wort)

- verapamil, diltiazem

- dantrolene

- tacrolimus

- simvastatin

- cyclosporine

Pregnancy

The safety of amlodipine in human pregnancy has not been established. If the patient thinks she might be pregnant, or is planning to get pregnant, she must tell doctor before taking this medicine.

Breast-feeding

It is not known whether amlodipine is passed into breast milk. If she is breast-feeding or about to start breast-feeding she must tell doctor before taking this medicine.

Patients should inform doctor if they have or have had any of the following conditions:

- Recent heart attack

- Heart failure

- Severe increase in blood pressure (Hypertensive crisis)

- Liver disease

- Elderly and his/her dose needs to be increased

Children and adolescents

Amlodipine has not been studied in children under the age of 6 years. Amlodipine should only be used for hypertension in children and adolescents from 6 years to 17 years of age.

Pharmacotherapeutic group: Calcium channel blockers, selective calcium channel blockers with mainly vascular effects

Amlodipine is a calcium ion influx inhibitor of the dihydropyridine group (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle.