Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Metformin 750mg 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 750mg Prolonged-Release 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.
Metformin 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 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 makes the body more sensitive to insulin and helps return to the normal way your body uses glucose.
Metformin is associated with either a stable body weight or modest weight loss.
Metformin 750mg 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.
Do not take Metformin 750mg Prolonged-Release Tablets if
you:
* are allergic to metformin or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may cause a rash, itching or shortness of breath.
* have liver problems.
* have severely reduced kidney function.
* 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.
* 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 section "Warnings and precautions').
* 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 section "Warnings and precautions").
M@RNINGSIDE HEALTHCARE
¢ 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 section "Warnings and precautions").
* are a heavy drinker of alcohol.
* are under the age of 18 years.
Warning and precautions Talk to your doctor or pharmacist before taking Metformin 750mg Prolonged-Release Tablets.
Risk of lactic acidosis
Metformin 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 750mg Prolonged-Release 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 750mg Prolonged-Release 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 during and for some time after the procedure. Your doctor will decide when you must stop and when to restart your treatment with Metformin.
During treatment with Metformin, 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 750mg Prolonged-Release 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 Metformin 750mg Prolonged-Release Tablets
If you need to have an injection of contrast medium that contains iodine into your bloodstream, for example in context of an X-ray or scan, you must stop taking Metformin before or at the time of injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin.
Tell your doctor or pharmacist 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. It is especially
important to mention the following:
¢ 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 which increase urine production (diuretics (water tablets) such as furosemide).
* Certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
« Medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).
¢ 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).
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SAP Code: 30100020300 PP000622 Lit-Metformin HCL 750mg tablets IH_V1
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Issued For Approval =| 06.04.2023 15:08
TEMPLE Packaging Pvt. Ltd. Tel:- 28476601, Email:- [email protected] Customer =| VERGO PHARMA SAP Code =| 30100020300
Location =| Goa File No. | 77446
Product Name :-| Lit- Metformin HCL 750mg tablets IH Artwork Sr.No. —:-| 90/04/23
Product Code =| PP000622 Customer A/W No. :-| 0277LAMUKNA-P1-003 Version No. =| 01 Old File No. =| 65263
Date *106.04.2023 15:08 Old Product Code :-| PPQ00489
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Metformin 750mg Prolonged-Release Tablets with food, drink and alcohol
The tablets should be swallowed whole with a glass of water during or immediately after meals.
Avoid excessive alcohol intake while taking Metformin 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.
Driving and using machines
Metformin 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 taken with other antidiabetic medicines can cause hypos, so in this case you should take extra care when driving or operating machinery.
Important information about Metformin 750mg Prolonged-Release Tablets
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor may prescribe Metformin 750mg Prolonged-Release Tablets for you to take on its own, or in combination with other oral antidiabetic medicines or insulin.
Swallow the tablets whole with a glass of water, do not chew.
The recommended dose is:
Usually you will start treatment with 500 mg Metformin prolonged-release tablets daily. After you have been taking Metformin prolonged-release tablets for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2000 mg of Metformin prolonged-release 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 750mg Prolonged-Release 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 Metformin immediately and contact a doctor or the nearest hospital straightaway.
If you forget to take Metformin 750mg Prolonged-Release Tablets
Take the missed dose as soon as you remember with some food, unless it's nearly time for the next one. Do not take a double dose to make up a forgotten dose.
If you stop taking Metformin 750mg Prolonged-Release Tablets
If you stop taking Metformin, tell your doctor as soon as possible, as your diabetes will not be controlled.
If you have any further questions on the use of this medicine ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may occur:
Metformin may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section "Warnings and precautions"). If this happens you must stop taking Metformin 750mg Prolonged-Release Tablets and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Metformin 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.
* Decreased or low vitamin B12 levels in the blood (symptoms 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 side effects
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 information on the safety of this medicine.
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 blister and carton after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
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 protect the environment.
What Metformin 750mg Prolonged-Release Tablets contain The active substance is metformin hydrochloride. Each prolonged-release tablet contains 750 mg of metformin hydrochloride.
The other ingredients are carmellose sodium, magnesium stearate, hypromellose, cellulose microcrystalline and silica colloidal anhydrous.
What Metformin 750mg Prolonged-Release Tablets look like and contents of the pack
Metformin 750mg Prolonged-Release Tablets are white to off-white, capsule shaped tablets, plain on both the sides. Metformin 750mg Prolonged-Release Tablets are available in blister packs of 7, 10, 14, 20, 28, 30, 56, 60, 84, 90, 100 and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Morningside Healthcare Ltd.
Unit C, Harcourt Way
Leicester, LE19 1WP
United Kingdom
Manufacturer
Morningside Pharmaceuticals Ltd.
5 Pavilion Way, Loughborough, LE11 5GW
United Kingdom
This leaflet was last revised in August 2022.
PP000622 M0277LAMUKNA-P 1-003
ww OSE
210 mm Back
SAP Code: 30100020300 PP000622 Lit-Metformin HCL 750mg tablets IH_V1
Issued For Final Production :-
Issued For Re-Approval
Issued For Approval =| 06.04.2023 15:08
TEMPLE Packaging Pvt. Ltd. Tel:- 28476601, Email:- [email protected] Customer =| VERGO PHARMA SAP Code =| 30100020300
Location | Goa File No. | 77446
Product Name :-| Lit- Metformin HCL 750mg tablets IH Artwork Sr.No. —:-| 90/04/23
Product Code =| PP000622 Customer A/W No. :-| 0277LAMUKNA-P1-003 Version No. =| 01 Old File No. =| 65263
Date *106.04.2023 15:08 Old Product Code :-| PP000489
Artwork Status | Final Barcode -| NA
Open Size -|210X350 MM Pharmacode | 000622
Folding Size | Folded-210x30mm Perforation -| NA
Substrate 140 GSM BIBLE PAPER Gluing =| NA
Cover Page (PAD) :-| NA Font Name >| NA
Cover Pg Substrate :- Font Size +) NA
No.of Pages / PAD :-
[Remark | NA
[Printing Colours
sac an
Note - This approval will be considered for final printing. Please recheck for corrections indicated earlier, in this proof also.
Development
Prepared by : Checked by : Q.A. Checked : Approved by : surendran 06/04/2023 CUSTOMER APPROVAL Checked By Approved By Packaging Production Regulatory Affairs | Quality Assurance
]_ Digitally signed by Rashmi Rashmi de Date: 2023.04.13
Surade iissts0s30
Metformin 750mg prolonged release tablets comes as tablet containing 750mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Metformin 750mg prolonged release tablets is metformin hydrochloride.
Medicines with the same active substance include: Glucophage 500 mg film coated tablets, Glucophage 850 mg film coated tablets, Glucophage SR 1000 mg prolonged release tablets, Glucophage SR 500 mg prolonged release tablets, Glucophage SR 750 mg prolonged release tablets, Glucophage SR 850 mg prolonged release tablets. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Metformin 750mg prolonged release tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Ask anything about Metformin 750mg prolonged release tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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