RUDIMET 1000 MG PROLONGED-RELEASE TABLETS - patient leaflet, side effects, dosage

4. possible side effects

Like all medicines, Rudimet tablets can cause side effects, although not everybody gets them. The following side effects may occur: Rudimet 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 Rudimet tablets and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.

Rudimet 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: 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: may affect up to 1 in 10 people:

• Taste disturbance

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

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

Reporting of suspected adverse reactions

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: . 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store rudimet tablets

Keep Rudimet tablets out of the sight and reach of children. Do not use this medicine after the expiry date

which is stated on the carton after ‘EXP:’. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions.

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

6. contents of the pack and other information what rudimet tablets contain:

The active substance is Rudimet 750 mg equivalent to 585 mg metformin and Rudimet 1000mg equivalent to 780mg metformin. The other ingredients are: microcrystalline cellulose, hypromellose, povidone and magnesium stearate.

What Rudimet tablets looks like and contents of the pack

Rudimet 750mg prolonged release Tablets are 18 mm x 8.5 mm, white to off-white, capsule shaped biconvex tablets, debossed with ‘750’ on one side and plain on other side.

Rudimet 1000mg prolonged release Tablets are 22 mm x 10 mm, white to off-white, oval shaped biconvex tablets, debossed with ‘1000’ on one side and plain on other side.

Rudimet Tablets are supplied in blister packs of 14, 28 and 56 tablets and containers of 120 and 170 tablets.

Not all pack sizes may be marketed.

Rudimet 750 mg prolonged release tablets: PL 49565/0071

Rudimet 1000 mg prolonged release tablets: PL 49565/0072

This leaflet was last revised in August 2021

Manufacturer:

Medreich PLC POM |

Warwick House, Plane Tree Crescent

Feltham, TW13 7HF

Marketing Authorisation Holder:

Rudipharm Limited

Unit 6, Salbrook Road Industrial Estate

Salbrook Road, Redhill, Surrey, RH1 5GJ, United Kingdom

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Rudimet 750 mg and 1000mg Prolonged Release Tablets 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 or nurse
• 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4
• The name of this medicine is Rudimet 750mg prolonged release

tablets and Rudimet 1000mg prolonged release tablets but it will be referred to as Rudimet Tablets throughout this leaflet.

What is in this leaflet

• 1. What Rudimet tablets are and what they are used for

• 2. What you need to know before you take Rudimet tablets

• 3. How to take Rudimet tablets

• 4. Possible Side effects

• 5. How to store Rudimet tablets

• 6. Contents of the pack and other information

• 1. WHAT RUDIMET TABLETS ARE AND WHAT THEY ARE USED FOR

Rudimet tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of diabetes. Rudimet tablets is used for the treatment of Type 2 (non-insulin dependent) diabetes mellitus.

Rudimet tablets are 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.

Rudimet tablets are 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. Rudimet tablets make the body more sensitive to insulin and helps return to normal the way your body uses glucose.

Rudimet tablets are associated with either a stable body weight or modest weight loss.

Rudimet 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 rudimet tablets:

Do not take Rudimet 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 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 ‘Warning and precautions’).
• You have a severe infection, such as an infection affecting your lung or bronchial system or your kidney. Sever infections may lead to kidney problems, which can put you at risk for lactic acidosis (see ‘Warning 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 ‘Warning and precautions’).
• You are a heavy drinker of alcohol.
• You are under 18 years of age.

Warning and precautions

Risk of lactic acidosis

Rudimet 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 Rudimet 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 Rudimet 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 Rudimet tablets during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Rudimet tablets.

During treatment with Rudimet 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 Rudimet tablets 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 Rudimet tablets:

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 Rudimet tablets before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Rudimet 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 Rudimet 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, beclomethasone.
• 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 Rudimet tablets in your blood, especially if you have reduced kidney function (such as Verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)

3. how to take rudimet tablets

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

Always take Rudimet 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 one metformin hydrochloride 500mg prolonged release tablet daily. After you have been taking Rudimet 500 mg prolonged release tablets for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2000 milligrams of Rudimet tablets. Please note that Rudimet Tablets cannot be split to administer a 500mg dose. Your doctor will prescribe an alternative product. 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 Rudimet 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 heartbeat. If you experience some of these symptoms.

You should immediately seek medical attention, as lactic acidosis may lead to coma. Stop taking Rudimet tablets immediately and contact a doctor or the nearest hospital straight away.

If you forget to take Rudimet tablets

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

Rudimet 750/1000 mg Tablets – PIL

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Rudimet 750/1000 mg Tablets

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