METFORMIN HYDROCHLORIDE TILLOMED 1000 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

Metformin Hydrochloride Tillomed 500 mg, 750 mg, 1000 mg

Metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The full name of this medicine is Metformin Hydrochloride Tillomed 500, 750, 1000 mg Prolonged-release Tablets but within the leaflet it will be referred to as Metformin Tablets

What is in this leaflet:

• 1. What Metformin Tablets is and what it is used for

• 2] What you need to know before you take Metformin Tablets

• 3. How to take Metformin Tablets

• 4. Possible side effects

• 5. How to store Metformin Tablets

• 6. Contents of the pack and other information

1 what metformin tablets is and what it is used for

Metformin Tablets contains the active ingredient metformin hydrochloride and belongs to a group of medicines called biguanides, used in the treatment of Type 2 (non-insulin dependent) diabetes mellitus.

Metformin Tablets 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 Tablets 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 buildup 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 Tablets makes the body more sensitive to insulin and helps return to normal the way your body uses glucose.

Metformin Tablets is associated with either a stable body weight or modest weight loss.

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

2] what you need to know before you take metformin tablets do not take metformin tablets 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 tablets 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 tablets 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 tablets 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.

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

During treatment with Metformin tablets, 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 tablets should not be started to lower the risk of developing type 2 diabetes.

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 tablets

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

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 tablets. 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 in your blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Metformin tablets with alcohol:

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

Fertility, pregnancy and breast-feeding

Do not take Metformin tablets if you are pregnant or breast feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Metformin tablets 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 tablets taken with other antidiabetic medicines can cause hypos, so in this case you should take extra care when driving or operating machinery.

3] how to take metformin tablets

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

Always take Metformin tablets 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 tablets daily. After you have been taking Metformin tablets for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2000 milligrams of Metformin tablets.

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.

If you take more Metformin tablets 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 tablets immediately and contact a doctor or the nearest hospital straightaway.

If you forget to take Metformin tablets

Take it as soon as you remember with some food.

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

If you have any further questions of the use of this medicine ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Metformin tablets can cause side effects, although not everybody gets them.

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

Metformin tablets 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 (affects more than 1 person in 10):

• 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 (affects less than 1 person in 10, but more than 1 person in 100): Taste disturbance.

Very rare (affects less than 1 person in 10,000):

• Decreased vitamin B12 levels
• Skin rashes including redness, itching and hives.

How to store Metformin Tablets

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

Do not use this medicine after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions in the marketed packs.

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

6]

Contents of the pack and other information

What Metformin tablets contains

The active ingredient is Metformin hydrochloride.

Each Prolonged-release Tablet contains 500, 750 or 1000 milligrams of the active ingredient metformin hydrochloride corresponding to 390 mg, 585 mg or 780 mg metformin base respectively.

Metformin Hydrochloride Tillomed 500 mg and 750 mg Prolonged-release Tablets

The other ingredients are:

hypromellose K-100M, hypromellose K-15M, povidone K30, colloidal anhydrous silica, magnesium stearate, film coating Opadry OY-7300 containing: hypromellose 2910, titanium dioxide, macrogol 400.

Metformin Hydrochloride Tillomed 1000 mg Prolonged-release Tablets

The other ingredients are:

hypromellose K-100M, povidone K30, colloidal anhydrous silica, magnesium stearate, film coating Opadry OY-7300 containing: hypromellose 2910, titanium dioxide, macrogol 400.

What Metformin tablets looks like and content of the pack

The 500 mg tablets are white, oval shaped, 18.10 mm x 10.00 mm, film coated tablets, debossed “MT” on one side and “500” on other side.

The 750 mg tablets are white, oval shaped, 19.10 mm x 10.60 mm film coated tablets, debossed “MT” on one side and “750” on other side.

The 1000 mg tablets are white, oval shaped, 20.20 mm x 11.40 mm, film coated tablets, debossed “MT” on one side and “1000” on other side.

Blister pack comprises of clear PVC/PVDC as a forming material and plain Aluminium foil as the lidding material.

Pack size: 28 and 56 tablets.

Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Tillomed Laboratories Ltd

220 Butterfield

Great Marlings

Luton, LU2 8DL

United Kingdom

This leaflet was last revised in 04/2019