Ranmet Xr

Leaflet accompanying the packaging: information for the user

Ranmet XR, 500 mg, prolonged-release tablets

Ranmet XR, 750 mg, prolonged-release tablets

Ranmet XR, 1000 mg, prolonged-release tablets

Metformin hydrochloride

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Ranmet XR and what is it used for
• 2. Important information before taking Ranmet XR
• 3. How to take Ranmet XR
• 4. Possible side effects
• 5. How to store Ranmet XR
• 6. Contents of the pack and other information

1. What is Ranmet XR and what is it used for

Ranmet XR contains the active substance metformin hydrochloride, which belongs to a group of medicines called biguanides and is used to treat diabetes.
Ranmet XR is used to treat type 2 diabetes (also known as non-insulin-dependent) in adults, where diet and exercise alone are not enough to control blood sugar levels. Insulin is a hormone that allows the body to take up glucose from the blood and use it for energy or store it for future use. In type 2 diabetes, the pancreas does not produce enough insulin or the body does not respond properly to the insulin produced. This leads to high blood sugar levels, which can cause a number of serious and long-term problems, so it is important to continue taking the medicine even if you do not have any obvious symptoms. Ranmet XR makes the body more sensitive to insulin and helps the body to use glucose properly.
Taking Ranmet XR is associated with either maintaining body weight or only a small increase in body weight.

2. Important information before taking Ranmet XR

When not to take Ranmet XR

• if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6)
• if you have severe liver disease
• if you have severe kidney disease
• if you have uncontrolled diabetes, for example with severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, 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 can lead to diabetic pre-coma. Symptoms include abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odor from the mouth
• if you have severe dehydration (loss of water from the body), for example due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney problems, which can cause lactic acidosis (see "Warnings and precautions" below)
• if you have a severe infection, for example pneumonia or kidney infection. Severe infections can lead to kidney problems, which can cause lactic acidosis (see "Warnings and precautions" below)
• if you have been treated for heart failure or have recently had a heart attack, or have severe circulatory problems or breathing difficulties. This can lead to tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below)
• if you abuse alcohol
• if you are under 18 years old.

If any of the above situations apply to you, you should consult your doctor before taking this medicine.
You should consult your doctor if:

• you are going to have an X-ray or other imaging procedure with an iodine-containing contrast agent (see "Ranmet XR with other medicines" below)
• you are going to have a major surgical procedure. You should not take Ranmet XR during the procedure and for a certain period after it. Your doctor will decide when you should stop and restart taking Ranmet XR.

Warnings and precautions

Before starting to take Ranmet XR, you should discuss it with your doctor.
After starting to take the medicine:
If you have diabetes, you should regularly check your blood and urine for glucose.
During treatment with Ranmet XR, your doctor will check your kidney function at least once a year or more often if you are elderly and/or have impaired kidney function.

Risk of lactic acidosis

Ranmet XR may cause a very rare but very serious side effect called lactic acidosis, especially if you have kidney problems. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver disease, and any conditions in which a part of the body is not getting enough oxygen (e.g. acute severe heart disease).
If any of the above situations apply to you, you should consult your doctor for more detailed instructions.

You should stop taking Ranmet XR for a short time if you have a condition that may lead to dehydration (severe loss of water from the body),

such as severe vomiting, diarrhea, fever, exposure to high temperatures or if you drink less fluid than usual. You should consult your doctor for more detailed instructions.

You should stop taking Ranmet XR and contact your doctor or the nearest hospital immediately if you experience any symptoms of lactic acidosis,

as this condition can lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general feeling of being unwell with severe fatigue,
• breathing difficulties, decreased body temperature, and slow heart rate.

Lactic acidosis is a life-threatening condition that requires immediate treatment in a hospital.
You should contact your doctor immediately for further instructions if:

• You have a genetically inherited disease affecting the mitochondria (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis, and stroke-like episodes) or maternally inherited diabetes and deafness.
• You experience any of the following symptoms after starting to take metformin: seizures, impaired cognitive function, difficulty moving, signs of nerve damage (e.g. pain or numbness), migraine, and hearing loss.

If you are going to have a major surgical procedure, you should not take Ranmet XR during the procedure and for a certain period after it. Your doctor will decide when you should stop and restart taking Ranmet XR.
Ranmet XR does not cause hypoglycemia (low blood sugar). However, if Ranmet XR is taken with other diabetes medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If you experience symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, vision problems, or difficulty concentrating, eating food or drinking a sugary drink usually helps.
You may find remains of the tablets in your stool. Do not worry, as this is normal with this type of tablet.
You should continue to follow your doctor's advice about diet and make sure you eat carbohydrates regularly throughout the day.
You should not stop taking this medicine without consulting your doctor.

Children and adolescents

This medicine should not be used in children and adolescents. It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.

Ranmet XR with other medicines

If you are going to have an iodine-containing contrast agent injected into your bloodstream, for example for an X-ray or CT scan, you should stop taking Ranmet XR before or at the latest at the time of the injection. Your doctor will decide when you should stop and restart taking Ranmet XR.
You should tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. You may need more frequent blood sugar checks and kidney function tests, or your doctor may need to adjust your dose of Ranmet XR. It is especially important to tell your doctor about the following medicines, such as:

• diuretics (medicines that increase urine production),
• medicines used to treat pain and inflammation (NSAIDs and COX-2 inhibitors, such as ibuprofen and celecoxib),
• certain medicines used to treat high blood pressure (ACE inhibitors and angiotensin II receptor antagonists),
• beta-2 adrenergic receptor agonists, such as salbutamol or terbutaline (used to treat asthma),
• corticosteroids, such as prednisolone, mometasone, beclometasone (used to treat various diseases, such as severe skin inflammation or asthma),
• other diabetes medicines,
• sympathomimetic medicines, including epinephrine and dopamine, used to treat heart attack and low blood pressure. Epinephrine is also a component of some anesthetic medicines used in dentistry,
• medicines that may change the level of metformin in your blood, especially if you have impaired kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Ranmet XR with food, drink, and alcohol

Ranmet XR should be taken with a meal or immediately after a meal, for example with dinner.
You should avoid drinking excessive amounts of alcohol while taking Ranmet XR,
as this may increase the risk of lactic acidosis (see "Warnings and precautions").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medicine. You should not take Ranmet XR if you are pregnant.
Ranmet XR is not recommended if you are breastfeeding or planning to breastfeed.

Driving and using machines

Ranmet XR itself does not cause hypoglycemia (symptoms of low blood sugar, such as fainting, disorientation, and increased sweating) and therefore does not affect your ability to drive or use machines.
However, you should be careful when driving or using machines if you are taking Ranmet XR with other diabetes medicines that can cause low blood sugar.

3. How to take Ranmet XR

Your doctor may recommend taking Ranmet XR alone or in combination with other oral diabetes medicines or insulin.
This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Ranmet XR does not replace the benefits of a healthy lifestyle. You should follow your doctor's advice about diet and exercise.

Dosage

Treatment usually starts with a dose of 500 mg of Ranmet XR once a day.
After about two weeks of taking the medicine, your doctor may adjust the dose based on your blood sugar measurements. The maximum dose of Ranmet XR is 2000 mg per day. If you have kidney problems, your doctor may prescribe a lower dose.
If you are also taking insulin, your doctor will tell you how to start taking Ranmet XR.

How to take the tablets

Usually, you should take the tablets once a day with your evening meal.
In some cases, your doctor may recommend taking the tablets twice a day. You should always take the tablets with a meal.
Swallow the tablets whole with a glass of water, do not chew, break, or crush the tablets.
If after some time you feel that the effect of Ranmet XR is too strong or too weak, you should consult your doctor or pharmacist.

Use in children and adolescents

Children and adolescents under 18 years of age should not take this medicine.

Use in elderly patients

The dose should be determined after assessing kidney function.

Taking a higher dose of Ranmet XR than recommended

If you accidentally take extra tablets, you should not worry, but if you experience unusual symptoms, you should contact your doctor. Symptoms may include weakness, disorientation, rapid breathing, and nausea, vomiting, or abdominal pain.
If the overdose is significant, the risk of lactic acidosis is higher. This is a life-threatening condition that requires immediate treatment in a hospital (see also section 4 "Possible side effects").

Missing a dose of Ranmet XR

As soon as you remember, you should take the missed dose with any meal.
You should not take a double dose to make up for a missed dose.

Stopping treatment with Ranmet XR

You should not stop taking this medicine without consulting your doctor. If you stop taking Ranmet XR, your blood sugar levels may increase again.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following side effects, you should stop taking Ranmet XR and contact your doctor immediately.

Very rare(may affect up to 1 in 10,000 people):
Ranmet XR may very rarely cause a very serious side effect called lactic acidosis (see "Warnings and precautions"). If this happens to you, you should stop taking Ranmet XR and contact your doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

• Abnormal liver function test results and liver inflammation, which can cause jaundice. If you experience yellowing of the eyes and/or skin, you should contact your doctor immediately.

Other possible side effects are listed according to their frequency:

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

• diarrhea, nausea, vomiting, abdominal pain, or loss of appetite. If you experience these side effects, you should not stop taking the tablets, as these symptoms usually disappear within about 2 weeks. Taking the tablets with a meal or immediately after a meal may help.

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

• taste disturbances.

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

• reduced vitamin B12 levels, which can cause anemia,
• skin rashes, including redness of the skin, itching, and hives.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ranmet XR

The medicine should be stored out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
The medicine does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ranmet XR contains

• The active substance of Ranmet XR is metformin (in the form of hydrochloride). Each prolonged-release tablet contains 500 mg, 750 mg, or 1000 mg of metformin hydrochloride, which corresponds to 390 mg, 585 mg, or 780 mg of metformin.
• The other ingredients are magnesium stearate, colloidal silica, anhydrous, povidone K30, and hypromellose K100M.

What Ranmet XR looks like and contents of the pack

Ranmet XR, 500 mg, prolonged-release tablets are white or almost white capsules-shaped tablets, 16.5 mm long and 8.2 mm wide, with "XR500" embossed on one side and smooth on the other.
Ranmet XR, 750 mg, prolonged-release tablets are white or almost white capsules-shaped tablets, 19.6 mm long and 9.3 mm wide, with "XR750" embossed on one side and smooth on the other.
Ranmet XR, 1000 mg, prolonged-release tablets are white or almost white capsules-shaped tablets, 21.1 mm long and 10.1 mm wide, with "XR1000" embossed on one side and smooth on the other.
Ranmet XR is available in packs containing blisters of 14, 30, 60, 90, 120, 180, or 600 prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warsaw

Manufacturer/Importer:

Strides Pharma UK Ltd
Unit 4 Metro Centre Tolpits Lane
Watford Hertfordshire WD18 9SS
United Kingdom
Fairmed Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck
Germany
McDermott Laboratories Limited T/A Gerard Laboratories T/A Mylan Dublin
35/36 Baldoyle Industrial Estate,
Grange Road,
Dublin 13,
Ireland
Mylan Hungary Kft
H-2900 Komarom
Mylan utca 1,
Hungary
Terapia SA,
124 Fabricii Street, 400632 Cluj-Napoca,
Cluj County,
Romania

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Denmark: Lyomet
Hungary: Metformin Fairmed 500 mg, 750 mg, 1000 mg retard tabletta
Poland: Ranmet XR
Czech Republic: Glucomet
Slovakia: Metformin Mylan XR 500 mg, 750 mg, 1000 mg
Date of last revision of the leaflet: 24.03.2025