Information

  • AMLOTUS 2.5/ 5/ 10 mg
  • Dosage Form: Tablets
  • Pack Type: ALU-ALU
  • Pack Size: 1X15 Tablets
  • Division: Unitus

AMLOTUS - 2.5/ 5/ 10

Amlodipine

AMLOTUS- 2.5: Each film-coated tablet contains Amlodipine Besylate IP equivalent to Amlodipine 2.5 mg.

AMLOTUS- 5: Each film-coated tablet contains Amlodipine Besylate IP equivalent to Amlodipine 5 mg.

AMLOTUS- 10: Each film-coated tablet contains Amlodipine Besylate IP equivalent to Amlodipine 10 mg.

Clinical Pharmacology:

AMLOTUS is a type of medicine known as a calcium channel blocker (CCB). It is used to treat high blood pressure (hypertension) and a type of chest pain called angina. It can be used by itself or with other medicines to treat these conditions.

Amlodipine may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of the following conditions:

  • high blood pressure (hypertension)
  • chest pain due to narrowing of the blood vessels of the heart muscle (angina pectoris) or the more rare form of chest pain caused by cramping of the blood vessels of the heart muscle called Prinzmetal or variant angina.

If you suffer from high blood pressure, Amlodipine works by relaxing blood vessels, so that blood passes through them more easily.

If you suffer from angina, Amlodipine works by improving blood supply to the heart muscle which then receives more oxygen, and as a result chest pain is prevented. Amlodipine does not provide immediate relief of chest pain from angina.

Always take Amlodipine tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Methods and routes of administration

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

Adults

The usual starting dose is 5 mg once daily. If necessary, your doctor may increase the dose to 10 mg once daily.

Use in children and adolescents (6 -17 years old)

The recommended usual starting dose is 2.5 mg a day. The maximum recommended dose is 5 mg a day

Elderly patients

There is no special dosage for the elderly; however, care must be taken when the dose is increased.

  • If you have kidney problems

The normal dosage is recommended. Amlodipine cannot be removed from the blood by dialysis (artificial kidney). Amlodipine tablets should be administered with particular caution to patients undergoing dialysis.

  • If you have liver problems

Your doctor will decide if this medicine is suitable for you and the correct dose for you to take.

  • If you take more Amlodipine tablets than you should

contact your nearest hospital casualty department. Please carry with you the product leaflet or remaining tablets for better identification of the doctor. The person concerned should be made to lie down with their arms and legs up (resting on a couple of cushions, for example). Symptoms of an overdose are: extreme dizziness and/or feeling very light-headed, faint or weak, problems with breathing, having to urinate very often. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness.

  • If you forget to take Amlodipine tablets

Do not worry. If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

  • If you stop taking Amlodipine tablets

Your doctor will advise you how long to take this medicine. Your condition may return if you stop using this medicine before you are advised.

If you have any further questions on the use of this product, ask your doctor or pharmacist

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Some medicines (including medicines obtained without a prescription, herbal medications or natural products) may interact with Amlodipine. This means that the action of both medicines can be changed.

In particular, tell your doctor if you are taking any of the following medicines:

  • Medicines that can lower blood pressure
  • Ketoconazole, itraconazole, Clarithromycin, erythromycin, telithromycin, rifampicin, rifabutin, Nefazodone, Dexamethasone, dantrolene, tacrolimus, simvastatin, cyclosporine, Phenobarbital, phenytoin, carbamazepine, Ritonavir, Indinavir, Nelfinavir, Nevirapine.
  • Amlodipine tablets may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

 

Taking Amlodipine tablets with food and drink

  • Amlodipine tablets should be taken with a glass of liquid (e.g. a glass of water) with or without food.
  • Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine tablets 

 

  • Very common (may affect more than 1 in 10 people)

Edema (fluid retention)

  • Common (may affect up to 1 in 10 people)

Headache, dizziness, sleepiness (especially at the beginning of treatment)Palpitations (awareness of your heartbeat),flushingAbdominal pain, feeling sick(nausea), Altered bowel habits, diarrhea, constipation, indigestion, Tiredness, weakness, Visual disturbances, double vision, Muscle cramps, Swollen ankles

  • Uncommon (may affect up to 1 in 100 people)

Enlarged breasts or discomfort in men,  sleep disorders, irritability, depression pain, feeling unwell, dry mouth, uncontrolled shaking, pins and needles, increased sweating, problems with your eye-sight (visual disturbances)Mood changes, anxiety, depression, sleeplessnessTrembling, taste abnormalitiesNumbness or tingling sensation in your limbs, loss of pain sensationSneezing/running nose caused by inflammation of the lining of the nose (rhinitis), Disorder in passing urine increased need to urinate at night, increased number of times of passing urine, ringing or buzzing in the ears

  • Rare (may affect up to 1 in 1,000 people)

Confusion

  • Very rare (may affect up to 1 in 10,000 people)

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 the blood (hyperglycemia)A disorder of the nerves which can cause weakness, tingling or numbnessSwelling of the gumsAbdominal bloating (gastritis)

Pregnancy and breast-feeding  

The safety of amlodipine in human pregnancy has not been established. If you think you might be pregnant or are planning to get pregnant, you must tell your doctor before you take Amlodipine tablets.  

Amlodipine has been shown to pass into breast milk in small amounts. If you are breastfeeding or about to start breast-feeding you must tell your doctor before taking Amlodipine tablets. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines  

Amlodipine tablets may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy or tired or give you a headache, do not drive or use machines and contact your doctor immediately.

Such side effects are more likely to occur at the start of treatment or following an increase in dose. If you suffer from these effects, you should not drive or perform other activities that require you to be alert.