Patient leaflet - Rudimet 1000 mg prolonged-release tablets
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.
Polycystic ovary syndrome (PCOS) is a health condition that affects a woman's hormone levels, menstrual cycle, and ability to have children Rudimet prolonged-release tablets is used in women with PCOS to stimulate ovulation (release of an egg from the ovaries) and subsequently the chance of getting pregnant, alone or together with other treatment options.
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 ingredi-
ents 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.
175 mm
Text Area : Back
certain medicines for the treatment of high blood pressure
(ACE inhibitors and angiotensin II receptor antagonists)
Steroids such as prednisolone, mometasone, beclometha-
sone.
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, cimeti-dine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib)
Rudimet tablets with alcohol:
Avoid excessive alcohol intake while taking Rudimet tablets 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:
Rudimet 500 mg prolonged-release tablets can stimulate ovulation (release of an egg from the ovaries), in women who do not ovulate properly. Beware of an increased chance of becom-ing pregnant when using Rudimet prolonged-release tablets. Driving and using machines
Rudimet 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 Rudimet 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 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 hydro-chloride 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. 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 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 vomit-ing, 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.
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 imme-diately.
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
- decreased or low vitamin B12 levels in the blood (symp-toms may include extreme tiredness (fatigue), a sore 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: may affect up to 1 in 10,000 people
- 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: 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 informa-tion 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 INFOR-MATION 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 22.5 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.
Marketing Authorisation Holder:
Rudipharm Limited
Unit 6, Salbrook Road Industrial Estate
Salbrook Road, Redhill, Surrey, RH1 5GJ, United Kingdom
Manufacturer:
Rudipharm Limited
Oak House, Reeds Crescent,
Watford, WD24 4QP,UK
POM
To listen to or request a copy of this leaflet in Braille, large print or audio please call, 01293 827819 (UK only)
Please be ready to give the following information: Product name
Rudimet (Metformin) 750 mg Prolonged Release Tablets
Reference number
PL 49565/0071
Product name
Rudimet (Metformin) 1000 mg Prolonged Release Tablets
Reference number
PL 49565/0072
This leaflet was last revised in March 2026.
Sub-Heading: 9pt (Bold)
Normal Text: 9pt (Regular)