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 doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 adult patients, in whom diet and exercise alone do not provide adequate control of blood glucose levels. Insulin is a hormone that allows the body to take up glucose from the blood and use it for energy production or store it for later use. In patients with type 2 diabetes, the pancreas does not produce enough insulin or the body does not respond properly to the insulin produced. This leads to an excessive increase in blood glucose levels, which can cause a number of serious and long-term problems, which is why it is important to continue taking the medicine even if there are no 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 maintaining a stable body weight or moderate weight loss.
Ranmet XR has been specially developed to release the medicine slowly from the tablet into the body, which distinguishes it from many other types of metformin tablets.
Adult patients can take Ranmet XR as the only medicine or in combination with other anti-diabetic medicines (oral or insulin).

2. Important information before taking Ranmet XR

When not to take Ranmet XR

• if the patient is allergic to metformin or any of the other ingredients of this medicine (listed in section 6)
• if the patient has chronic liver function disorders
• if the patient has significantly reduced kidney function
• if the patient has uncontrolled diabetes, for example with severe hyperglycemia (high blood sugar), nausea, vomiting, diarrhea, sudden weight loss, lactic acidosis (see "Risk of lactic acidosis" below) or diabetic ketoacidosis. Diabetic 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 breath odor
• if the patient has excessive water loss from the body (dehydration), for example due to prolonged or severe diarrhea or repeated vomiting. Dehydration can lead to kidney function disorders, which can cause lactic acidosis (see "Warnings and precautions" below)
• if the patient has a severe infection, for example pneumonia or kidney infection. Severe infections can lead to kidney function disorders, which can cause lactic acidosis (see "Warnings and precautions" below)
• if the patient has been treated for heart failure or has recently had a heart attack, or has severe circulatory disorders or breathing difficulties. This can lead to tissue hypoxia, which can increase the risk of lactic acidosis (see "Warnings and precautions" below)
• if the patient abuses alcohol
• if the patient is under 18 years of age.

If any of the above situations apply to the patient, they should consult a doctor before taking this medicine.
The patient should consult a doctor if:

• the patient is to undergo an X-ray examination or other imaging examination with intravascular administration of a contrast agent containing iodine (see "Ranmet XR and other medicines" below)
• the patient needs to undergo a major surgical procedure. The patient should stop taking Ranmet XR for a certain period before and after the examination or surgical procedure. The doctor will decide whether another treatment should be used during this time. It is essential to follow the doctor's instructions.

Warnings and precautions

Before starting treatment with Ranmet XR, the patient should discuss it with their doctor.
After starting treatment with Ranmet XR:

If the patient has diabetes, they should regularly check their blood and urine for glucose.
The doctor will monitor the patient's kidney function at least once a year or more often if the patient is elderly and/or has deteriorating kidney function.

Risk of lactic acidosis

Ranmet XR may rarely cause a very serious side effect called lactic acidosis, especially if the patient has kidney function disorders. The risk of lactic acidosis increases in the case of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more information below), liver function disorders, and any conditions in which a part of the body is not sufficiently supplied with oxygen (e.g., acute severe heart disease).
If any of the above situations apply to the patient, they should consult their doctor for more detailed instructions.

The patient should stop taking Ranmet XR for a short time if they have a condition that may be associated with dehydration (significant water loss from the body),

such as severe vomiting, diarrhea, fever, exposure to high temperatures, or if the patient drinks less fluid than usual. The patient should consult their doctor for more detailed instructions.

The patient should stop taking Ranmet XR and immediately contact their doctor or the nearest hospital if they 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 slowed heart rate.

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

• The patient has 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.
• The patient has experienced any of the following symptoms after starting metformin: seizures, cognitive impairment, difficulty moving, signs of nerve damage (e.g., pain or numbness), migraine, and hearing loss.

If the patient is to undergo a major surgical procedure, they should not take Ranmet XR during the procedure and for a certain period after it. The doctor will decide when the patient should stop and resume treatment with Ranmet XR.
Ranmet XR does not cause hypoglycemia (low blood sugar). However, if Ranmet XR is taken in combination with other anti-diabetic medicines that can cause hypoglycemia (such as sulfonylureas, insulin, meglitinides), there is a risk of hypoglycemia. If the patient experiences symptoms of hypoglycemia, such as weakness, dizziness, increased sweating, rapid heartbeat, vision disturbances, or difficulty concentrating, eating food or drinking a sugary drink usually helps.
The patient may notice tablet residues in their stool. They should not be concerned, as this is normal with this type of tablet.
The patient should continue to follow their doctor's dietary recommendations and ensure they eat carbohydrates regularly throughout the day.
The patient should not stop taking this medicine without consulting their doctor.

Children and adolescents

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

Ranmet XR and other medicines

If the patient is to be injected with a contrast agent containing iodine into their bloodstream, for example for an X-ray examination or computed tomography, they should stop taking Ranmet XR before or at the latest at the time of the injection. The doctor will decide when the patient should stop and resume treatment with Ranmet XR.
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. The patient may need more frequent blood glucose monitoring and kidney function tests, or their doctor may need to adjust the dose of Ranmet XR. It is especially important to inform their doctor about the following medicines, such as:

• diuretics,
• 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 medicines used to treat diabetes,
• 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 the blood, especially if the patient has reduced 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 during dinner.
The patient should avoid consuming 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine, as they may need to change their treatment. Ranmet XR should not be used during pregnancy.
Ranmet XR is not recommended during breastfeeding or if the patient plans 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 the patient's ability to drive or operate machinery.
However, the patient should be careful when driving or operating machinery if they are taking Ranmet XR in combination with other anti-diabetic medicines that can cause low blood sugar.

3. How to take Ranmet XR

The doctor may recommend taking Ranmet XR alone or in combination with other oral anti-diabetic medicines or insulin.
This medicine should always be taken according to the doctor's instructions. If the patient has any doubts, they should consult their doctor or pharmacist.
Ranmet XR does not replace the benefits of a healthy lifestyle. The patient should follow their doctor's dietary recommendations and engage in regular physical activity.

Dosage

Treatment usually starts with a dose of 500 mg of Ranmet XR once a day.
After about two weeks of taking the medicine, the doctor may adjust the dose based on the patient's blood glucose measurement. The maximum dose of Ranmet XR is 2000 mg per day. If the patient has kidney function disorders, the doctor may prescribe a lower dose.
If the patient is also taking insulin, the doctor will inform them how to start taking Ranmet XR.

How to take the tablets

Usually, the patient should take one tablet once a day with their evening meal.
In some cases, the doctor may recommend taking two tablets a day. The tablets should always be taken with a meal.
The patient should swallow the tablets whole, with a glass of water, without chewing, dividing, or crushing them.
If the patient feels that the effect of Ranmet XR is too strong or too weak after some time, they should consult their 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 of the medicine should be determined after assessing the patient's kidney function.

Taking a higher dose of Ranmet XR than recommended

If the patient accidentally takes extra tablets, they should not be concerned, but if they experience unusual symptoms, they should contact their 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 hospital treatment (see also section 4 "Possible side effects").

Missing a dose of Ranmet XR

As soon as the patient remembers, they should take the missed dose with a meal.
The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Ranmet XR

The patient should not stop taking this medicine without consulting their doctor first. If the patient stops taking Ranmet XR, their blood glucose levels may increase again.

4. Possible side effects

Like all medicines, Ranmet XR can cause side effects, although not everybody gets them.

If the patient notices any of the following side effects, they should stop taking Ranmet XR and contact their 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 the patient, they should stop taking Ranmet XR and contact their doctor or the nearest hospital immediately, as lactic acidosis can lead to coma.

• Abnormal liver function test results and hepatitis, which can cause jaundice. If the patient's eyes and/or skin turn yellow, they should contact their 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 such side effects occur, the patient 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 disorders.

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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Ranmet XR

The medicine should be stored out of sight and reach of children.
The patient should not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
The medicine does not require special storage conditions.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. 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, respectively.
• 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 the inscription "XR500" 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 the inscription "XR750" 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 the inscription "XR1000" 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