Metformin Hydrochloride Indoco 1000 mg prolonged-release tablets – patient leaflet, side effects, dosage

1. What Metformin Hydrochloride Indoco is and what it is used for

Metformin Hydrochloride Indoco prolonged-release tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of Type 2 (non-insulin dependent) diabetes mellitus.

Metformin Hydrochloride Indoco is used together with diet and exercise to lower the risk of developing Type 2 diabetes in overweight adults, when diet and exercise alone for 3 to 6 months have not been enough to control blood glucose (sugar). You are at high risk of developing Type 2 diabetes if you have additional conditions like high blood pressure, age above 40 years, an abnormal amount of lipids (fat) in the blood or a history of diabetes during pregnancy.

The medicine is particularly effective if you are aged below 45 years, are very overweight, have high blood glucose levels after a meal or developed diabetes during pregnancy.

Metformin Hydrochloride Indoco is used for the treatment of Type 2 diabetes when diet and exercise changes alone have not been enough to control blood glucose (sugar). Insulin is a hormone that enables body tissues to take glucose from the blood and to use it for energy or for storage for future use. People with Type 2 diabetes do not make enough insulin in their pancreas or their body does not respond properly to the insulin it does make. This causes a build-up of glucose in the blood which can cause a number of serious long-term problems so it is important that you continue to take your medicine, even though you may not have any obvious symptoms. Metformin Hydrochloride Indoco makes the body more sensitive to insulin and helps return to normal the way your body uses glucose.

Metformin Hydrochloride Indoco prolonged-release tablets is associated with either a stable body weight or modest weight loss.

Metformin Hydrochloride Indoco are specially made to release the drug slowly in your body and therefore are different to many other types of tablet containing metformin.

Polycystic ovary syndrome (PCOS) is a health condition that affects a woman's hormone levels, menstrual cycle, and ability to have children. Metformin Hydrochloride Indoco is used in women with PCOS to simulate ovulation (release of egg from the ovaries) and subsequently the chance of getting pregnant, alone and together with other treatment options.

2. What you need to know before you take Metformin Hydrochloride Indoco

Do not take Metformin Hydrochloride Indoco if:

• you are allergic to metformin or to any of the other ingredients of this medicine (listed in section 6). An

  allergic reaction may cause a rash, itching or shortness of breath.

• you have liver problems
• you have severely reduced kidney function

• you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose),

  nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see 'Risk of lactic acidosis' below) or ketoacidosis. Ketoacidosis is 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.

• you have lost too much water from your body (dehydration). Dehydration may lead to kidney

  problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions'). • you have a severe infection, such as an infection affecting your lung or bronchial system or your kidney.

  Severe infections may lead to kidney problems, which can put you at risk for lactic acidosis (see 'Warnings and precautions').

• you have been treated for acute heart problems or have recently had a heart attack or have severe

  circulatory problems or breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk for lactic acidosis (see 'Warnings and precautions').

• you are a heavy drinker of alcohol.
• you are under 18 years of age.

Warnings and precautions

Risk of lactic acidosis.

Metformin Hydrochloride Indoco may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease).

If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Metformin Hydrochloride Indoco for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions. Stop taking Metformin Hydrochloride Indoco and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma. Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of not being well with severe tiredness
• difficulty in breathing
• reduced body temperature and heartbeat

Lactic acidosis is a medical emergency and must be treated in a hospital.

Talk to your doctor promptly for further instructions if:

• You are known to suffer from a genetically inherited disease affecting mitochondria (the energy-

  producing components within cells) such as MELAS syndrome (Mitochondiral Encephalopathy, myopathy, Lactic acidosis and Stroke-like episodes) or Maternal inherited diabetes and deafness (MIDD).

• You have any of these symptoms after starting metformin: seizure, declined cognitive abilities,

  difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), migraine and deafness.

If you need to have major surgery you must stop taking Metformin Hydrochloride Indoco during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin Hydrochloride Indoco.

During treatment with Metformin Hydrochloride Indoco, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or if you have worsening kidney function. If you are older than 75 years, treatment with Metformin Hydrochloride Indoco should not be started to lower the risk of developing type 2 diabetes.

You may see some remains of the tablets in your stools. Do not worry- this is normal for this type of tablet.

You should continue to follow any dietary advice that your doctor has given you and you should make sure that you eat carbohydrates regularly throughout the day.

Do not stop taking this medicine without speaking to your doctor.

Other medicines and Metformin Hydrochloride Indoco

If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Metformin Hydrochloride Indoco before or at the time of injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin Hydrochloride Indoco.

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 Indoco. It is especially important to mention the following:

• Medicines which increase urine production (diuretics (water tablets) such as furosemide). • Medicines used to treat pain and inflammation (NSAID and COX-2 inhibitors, such as ibuprofen and

  celecoxib)

• Certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor

  antagonists)

• Steroids such as prednisolone, mometasone, beclometasone.

  • Sympathomimetic medicines including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also included in some dental anaesthetics.
  • Medicines that may change the amount of Metformin Hydrochloride Indoco in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Metformin Hydrochloride Indoco with alcohol

Avoid excessive alcohol intake while taking Metformin Hydrochloride Indoco since this may increase the risk of lactic acidosis (see section 'Warnings and precautions').

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, speak to your doctor in case any changes will be needed to your treatment or monitoring of your blood glucose levels.

This medicine is not recommended if you are breast-feeding or if you are planning to breast-feed your baby.

Women of childbearing potential:

Metformin Hydrochloride Indoco can stimulate ovulation (release of an egg from the overies), in women whoc do not ovulate properly. Beware of an inceased chance of becoming pregnant when using Metformin Hydrochloride Indoco.

Driving and using machines

Metformin Hydrochloride Indoco taken on its own does not cause 'hypos' (symptoms of low blood sugar or hypoglycaemia, such as faintness, confusion and increased sweating) and therefore should not affect your ability to drive or use machinery.

You should be aware, however, that Metformin Hydrochloride Indoco taken with other antidiabetic medicines can cause hypos, so in this case, you should take extra care when driving or operating machinery.

Metformin Hydrochloride Indoco contains sodium.

This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say it is essentially 'sodium-free'.

3. How to take Metformin Hydrochloride Indoco

Your doctor may prescribe Metformin Hydrochloride Indoco for you to take on its own, or in combination with other oral antidiabetic medicines or insulin.

Always take this medicine exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole with a glass of water, do not chew.

Recommended dose

Usually you will start treatment with 500 milligrams Metformin Hydrochloride Indoco daily. After you have been taking Metformin Hydrochloride Indoco for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2000 milligrams of Metformin Hydrochloride Indoco If you have reduced kidney function, your doctor may prescribe a lower dose.

Normally, you should take the tablets once a day, with your evening meal.

In some cases, your doctor may recommend that you take the tablets twice a day. Always take the tablets with food.

Polycystic ovary syndrome (PCOS)

The usual dose is 1500-2000 mg metformin hydrochloride taken once a day with the evening meal. You should check with your doctor or pharmacist when to stop taking the medicine.

If you take more Metformin Hydrochloride Indoco than you should

If you take extra tablets by mistake you need not worry, but if you have unusual symptoms, contact your doctor. If the overdose is large, lactic acidosis is more likely. Symptoms of lactic acidosis are non-specific, such as vomiting, bellyache with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heart beat. If you experience some of these symptoms, you should immediately seek medical attention, as lactic acidosis may lead to coma. Stop taking Metformin Hydrochloride Indoco immediately and contact a doctor or the nearest hospital straightaway.

If you forget to take Metformin Hydrochloride Indoco

Take it as soon as you remember with some food. Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

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

Metformin Hydrochloride Indoco 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 the Metformin Hydrochloride Indoco and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

Metformin Hydrochloride Indoco may cause abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice (may affect up to 1 user in 10,000). If you develop yellowing of the eyes and/or skin, contact your doctor immediately.

Other possible side effects are listed by frequency as follows:

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

• Diarrhoea, nausea, vomiting, stomach ache or loss of appetite. If you get these, do not stop taking the tablets as these symptoms will normally go away in about 2 weeks. It helps if you take the tablets with or immediately after a meal.

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

• Taste disturbance

• decreased or low vitamin B levels in the blood (symptoms may include extreme tiredness (fatigue), a sore

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  and red tongue (glossitis), pins and needles (paraesthesia) or pale or yellow skin). Your doctor may arrange some tests to find out the cause of your symptoms because some of these may also be caused by diabetes or due to other unrelated health problems.

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

• Skin rashes including redness, itching and hives.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metformin Hydrochloride Indoco

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date that is printed on the pack after “EXP:”. The expiry date refers to the last day of that month.

Store below 30°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help to protect the environment.

6. Contents of the pack and other information

What Metformin Hydrochloride Indoco contains

Each prolonged-release tablet contains 500 mg, 750 mg or 1000 mg of the active ingredient metformin hydrochloride. The other ingredients are carmellose sodium, magnesium stearate and hypromellose.

What Metformin Hydrochloride Indoco looks like and contents of the pack

The 500 mg tablets are white to off-white, circular, biconvex tablet plain on both sides. The 750 mg tablets are white to off-white, capsule shaped tablet plain on both sides.

The 1000 mg tablets are white to off-white, oval shaped tablet plain on both sides.

Metformin Hydrochloride Indoco are packed in:

For 500 mg – cartons containing 10, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 180, 600 tablets in blisters. For 750 mg – cartons containing 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 140, 180 or 600 tablets in blister. For 1000 mg – cartons containing 14, 20, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 140, 180 or 600 tablets in blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Indoco Remedies UK Limited

Alpha House, 296

Kenton Road,

Harrow, Middlesex

United Kingdom HA 3 8DD

Manufacturer

Elara Pharmaservices Limited

5 Garden Court, Lockington Hall,

Main Street, Lockington,

Derby, DE74 2RH,

United Kingdom

This leaflet was last revised in May 2025

Useful tips

• If you smoke, try to stop
• Take regular exercise
• Drink as little alcohol as possible
• Look after your feet. Ask about this at the surgery or hospital
• Carry a card, bracelet or disk saying you are diabetic
• Visit your diabetic clinic regularly

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