Diamin 500 mg Film-Coated Tablets

DIAMIN is an oral hypoglycaemic medicine used for Type 2 (non-insulin dependent) diabetes mellitus when diet has failed and especially if you are overweight. DIAMIN can be taken alone as initial therapy, or can be taken in combination with a sulphonylurea.

Do not take DIAMIN:

• if you are hypersensitive (allergic) to metformin hydrochloride or any of the other ingredients of DIAMIN (listed in section 6).
• if you suffer from any type of metabolic acidosis (too much acid is in your body) such as lactic acidosis (‘see Warnings and Precautions’) or diabetic ketoacidosis (a condition in which substances called ‘ketone bodies’ accumulate in the blood, and which can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness, or your breath developing an unusual fruity smell.
• if you suffer from diabetic pre-coma (dangerously high blood sugar or dangerously low blood sugar).
• if you have severely reduced kidney function.
• if you suffer from sudden onset conditions that can cause kidney problems. Conditions such as:
• dehydration: (if you lost too much water from your body, due to long-lasting or severe diarrhoea, or if you have vomited several times in a row)
• severe infection
• have severe problems with your blood circulation (such as shock)
• if you need to have an examination such as X-ray or scan involving the injection of contrast medicines that contain iodine into your bloodstream
• if you suffer from sudden onset or long-lasting conditions which may cause low blood oxygen (hypoxia). Conditions such as:
• heart failure or if you recently had a heart attack
• inflammation of the pancreas (pancreatitis)
• difficulty in breathing – if your lungs cannot supply enough oxygen to your organs
• shock – severe problems with your blood circulation that causes reduced oxygen delivery or increased oxygen consumption.
• if you drink a lot of alcohol or if you your liver is not functioning optimal.
• if you are pregnant or breastfeeding your baby.

Do not share medicines prescribed for you with any other person. Always take DIAMIN exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Take DIAMIN in divided doses with or after a meal. This will avoid you having side effects affecting your digestion. The usual dose for adults is one DIAMIN 500 mg tablet three times a day or one DIAMIN 850 mg twice a day. If you are elderly, your doctor will adjust the dose based on your kidney function.

Your doctor will tell you how long your treatment with DIAMIN will last. Do not stop treatment early because you feel better. If you have the impression that the effect of DIAMIN is too strong or too weak, tell your doctor or pharmacist.

If you take more DIAMIN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take DIAMIN

Do not take a double dose to make up for forgotten individual doses.

DIAMIN can have side effects. Not all side effects reported for DIAMIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DIAMIN, please consult your healthcare provider for advice.

If any of the following happens, stop taking DIAMIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,

These are all very serious side effects. If you have them, you may have had a serious reaction to DIAMIN. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Lactic acidosis. This is a less frequent but serious complication particularly if your kidneys are not working properly. Symptoms of lactic acidosis are non-specific (see Warning and precautions)

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Frequent side effects:

• low Vitamin B12 levels and folic acid in the blood.
• nausea (feeling sick)
• vomiting (being sick)
• diarrhoea
• abdominal pain (belly pain)
• loss of appetite

These side effects most often happen at the beginning of the treatment with DIAMIN. It helps if you spread the doses over the day and if you take DIAMIN with or straight after a meal.

• Constipation
• taste disturbance such as metallic taste

Less frequent side effects:

• skin reactions such as redness of the skin (erythema), itching or an itchy rash (hives).
• lack of enough red blood cells to carry adequate oxygen to your body’s tissue which can make you feel weak and tired (megaloblastic anaemia).
• low blood sugar (hypoglycaemia)
• 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).
• body produces high levels of blood acids called ketone (ketoacidosis)
• high levels of ketones (which occur when cells are broken down for energy) are present in the urine. (ketonuria)

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store at or below 25 °C. Protect from light and moisture. Keep the blisters in the original carton until required for use. Store all medicines out of reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).