Information

  • Aromet - 500 mg /850 mg
  • Dosage Form: Tablets
  • Pack Type: Blister
  • Pack Size: 1X10 Tablets
  • Division: Unitus

AROMET - 500/850

Metformin Tablets IP

AROMET - 500: Each Uncoated tablet contains Metformin Hydrochloride IP 500 mg

AROMET - 850: Each Uncoated tablet contains Metformin Hydrochloride IP 850 mg

Clinical Pharmacology:

AROMET tablets contain metformin hydrochloride, a medicine to treat diabetes. It belongs to a group of medicines called biguanides.

 

Metformin hydrochloride is used to treat patients with type 2 diabetes (also called 'non-insulin-dependent diabetes') when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients.

How to take Metformin Hydrochloride

  • Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
  • Metformin hydrochloride cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and get some regular exercise.

 

The recommended dose 

Children 10 years and over and adolescents usually start with 500 mg or 850 mg Metformin hydrochloride tablets once a day. The maximum daily dose is 2000 mg taken as 2 or 3 divided doses. Treatment of children between 10 and 12 years of age is only recommended on specific advice from your doctor, as experience in this age group is limited.

Adults usually start with 500 mg or 850 mg Metformin hydrochloride tablets two or three times a day. The maximum daily dose is 3000 mg taken as 3 divided doses.

If you take insulin too, your doctor will tell you how to start Metformin hydrochloride tablets.

Monitoring

Your doctor will perform regular blood glucose tests and adapt your dose of Metformin hydrochloride tablets to your blood glucose levels. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are an older person

Your doctor will also check at least once a year how well your kidneys work. You may need more frequent checks if you are an older person or if your kidneys are not working normally

How to take Metformin hydrochloride tablets

Take the tablets with or after a meal. This will avoid you having side effects affecting your digestion.

  • Do not crush or chew the tablets. Swallow each tablet with a glass of water.
  • If you take one dose a day, take it in the morning
  • If you take two divided doses a day, take them in the morning (breakfast) and evening (dinner)
  • If you take three divided doses a day, take them in the morning (breakfast), at noon (lunch) and in the evening (dinner) If, after some time, you think that the effect of Metformin hydrochloride is too strong or too weak, talk to your doctor or pharmacist.

If you take more Metformin HCl Tablets

  • If you have taken more Metformin hydrochloride tablets that you should have, you may experience lactic acidosis. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. If this happens to you, you may need immediate hospital treatment, as lactic acidosis may lead to coma. Talk to your doctor or pharmacist straight away

 

If you forget to take Metformin HCL Tablets

  • Try to take Metformin HCl as prescribed. Do not take a double dose to make up for a forgotten dose. Just resume your usual schedule. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 

Other medicines and Metformin hydrochloride

If you need to have an injection of contrast medicines that contain iodine into your bloodstream, for example for examinations such as X-ray or scan, you must stop taking Metformin hydrochloride tablets before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin

Tell your doctor if you are taking, have recently taken or might take any other medicines. You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Metformin hydrochloride. It is especially important to mention the following:

  • medicines which increase urine production
  • medicines used to treat pain and inflammation
  • certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists)
  • beta-2 agonists such as salbutamol or terbutaline
  • corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma)
  • other medicines used to treat diabetes

Metformin hydrochloride tablets with food drink and alcohol

  • Avoid excessively alcohol intake while taking Metformin hydrochloride since this may increase the risk of lactic acidosis

 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:

Metformin hydrochloride may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop taking Metformin hydrochloride and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

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

Digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhea, bellyache (abdominal pain), and loss of appetite. These side effects most often happen at the beginning of the treatment with Metformin hydrochloride. It helps if you spread the doses over the day and if you take the tablets with or straight after a meal. If symptoms continue, stop taking Metformin hydrochloride tablets and talk to your doctor.

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

changes in taste

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

lactic acidosis. This is a very rare but serious complications particularly if your kidneys are not working properly. Symptoms of lactic acidosis are vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing.

skin reactions such as redness of the skin (erythema), itching, or an itchy rash (urticaria).

low vitamin B12 levels in the blood 

abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking this medicine.

Children and adolescents

Limited data in children and adolescents showed that adverse events were similar in nature and severity to those reported in adults.

Pregnancy, breast-feeding and fertility

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
  • During pregnancy, you need insulin to treat your diabetes. Tell your doctor if you are, you think you might be or are planning to become pregnant, so that he or she may change your treatment.
  • Do not take this medicine if you are breast-feeding or if you are planning to breast-feed your baby.

Driving and using machines

 

Metformin hydrochloride on its own does not cause hypoglycemia. This means that it will not affect your ability to drive or use machines. However, take special care if you take Metformin hydrochloride tablets together with other medicines to treat diabetes that can cause hypoglycemia. Symptoms of hypoglycemia include weakness, dizziness, increased sweating, fast heartbeat, vision disorders, or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms

How to store Metformin Tablets?

  • Keep out of the reach and sight of children.        
  • Store protected from moisture.    
  • Do not use Metformin Tablets after the end of the expiry month (use-by date) shown on the product packaging. 
  • The expiry date refers to the last day of that month.

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

STORAGE:

  • Store protected from light & Moisture. Store in a cool, dry place & protect from direct sunlight.
  • Keep out of reach of children.