Ranmet xr

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Package leaflet: 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
Metformini hydrochloridum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist immediately. See section 4.

Table of contents

1. What Ranmet XR is and what it is used for
2. What you need to know 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 Ranmet XR is and what it is used for

Ranmet XR contains the active substance metformini hydrochloridum, which belongs to a group of medicines known as biguanides and is used in the treatment of diabetes.
Ranmet XR is used in the treatment of type 2 diabetes (also known as non-insulin-dependent diabetes) in adult patients in whom diet and physical exercise alone do not provide adequate control of blood glucose (sugar) levels. Insulin is a hormone that enables the body to take up glucose from the blood and use it to produce energy 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 excessively high blood glucose levels, which may result in various serious and long-term complications; therefore, it is important to continue taking the medicine even if you do not have any noticeable symptoms. Ranmet XR increases the body's sensitivity to insulin and helps the body return to proper glucose utilization.
Treatment with Ranmet XR is associated with maintenance of stable body weight or even moderate weight reduction.
Ranmet XR has been specially formulated to release the active ingredient slowly into the body, which differentiates it from many other types of metformin-containing tablets.
Adult patients may take Ranmet XR either as monotherapy or in combination with other antidiabetic medicines (oral agents or insulin).

2. Important information before using Ranmet XR

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When not to use 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 hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, sudden 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 may lead to diabetic pre-coma. Symptoms include: abdominal pain, rapid and deep breathing, drowsiness or unusual fruity odour of breath
• if the patient has excessive loss of body water (dehydration), e.g. due to prolonged or severe diarrhoea or repeated vomiting. Dehydration may lead to kidney dysfunction, which may result in lactic acidosis (see section "Warnings and precautions" below)
• if the patient has a severe infection, e.g. pneumonia or kidney infection. Severe infections may lead to kidney dysfunction, which may result in lactic acidosis (see section "Warnings and precautions" below)
• if the patient has been treated for heart failure or recently suffered a myocardial infarction, or has severe circulatory disorders or breathing difficulties. These conditions may lead to tissue hypoxia, increasing the risk of lactic acidosis (see section "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, consult a doctor before using this medicine.
Consult a doctor if:

• the patient requires an X-ray examination or other imaging procedure involving intravenous administration of an iodine-containing contrast agent (see section "Ranmet XR and other medicines" below)
• the patient requires a major surgical procedure. The use of Ranmet XR must be discontinued for a certain period before and after the examination or surgery. The doctor will decide whether alternative treatment is necessary during this time. It is important to strictly follow the doctor's instructions.

Warnings and precautions
Before starting treatment with Ranmet XR, discuss this with your doctor.
After starting treatment:
If the patient has diabetes, blood and urine should be regularly tested for glucose.
While being treated with Ranmet XR, the doctor will monitor the patient's kidney function at least once a year, or more frequently if the patient is elderly and/or has worsening kidney function.
Risk of lactic acidosis
Ranmet XR may cause a very rare but serious adverse effect called lactic acidosis, especially if the patient has kidney dysfunction. The risk of lactic acidosis increases in cases of uncontrolled diabetes, severe infection, prolonged fasting or alcohol consumption, dehydration (see more detailed information below), liver dysfunction, and any medical conditions in which a part of the body is inadequately supplied with oxygen (e.g. acute severe heart disease).
If any of the above conditions apply to the patient, consult a doctor for further instructions.
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Ranmet XR should be temporarily discontinued if the patient develops a medical condition that may lead to dehydration (significant loss of body water), such as severe vomiting, diarrhoea, fever, or exposure to high temperatures, or if the patient drinks less fluid than usual. Consult a doctor for further instructions.
Ranmet XR should be discontinued and the patient should immediately contact a doctor or the nearest hospital if any symptoms of lactic acidosis occur, as this condition may lead to coma.
Symptoms of lactic acidosis include:

• vomiting,
• abdominal pain,
• muscle cramps,
• general malaise associated with severe fatigue,
• difficulty breathing, decreased body temperature and slowed heart rate.

Lactic acidosis is an acute, life-threatening condition requiring immediate hospital treatment.
Contact a doctor immediately for further instructions if:

• The patient has a genetically inherited mitochondrial disorder (energy-producing structures in cells), such as MELAS syndrome (mitochondrial encephalopathy, myopathy, lactic acidosis and stroke-like episodes) or maternally inherited diabetes and deafness (MIDD).
• After starting metformin treatment, the patient experiences any of the following symptoms: seizures, worsening cognitive function, difficulty moving, symptoms indicating nerve damage (e.g. pain or numbness), migraine or deafness.

If the patient is undergoing major surgery, Ranmet XR must not be used during the procedure and for some time afterwards. The doctor will decide when the patient should stop and restart treatment with Ranmet XR.
Ranmet XR does not cause hypoglycaemia (low blood glucose levels). However, if Ranmet XR is used in combination with other antidiabetic medicines that may cause hypoglycaemia (such as sulphonylurea derivatives, insulin, meglitinides), there is a risk of hypoglycaemia. If symptoms of hypoglycaemia occur, such as weakness, dizziness, increased sweating, rapid heartbeat, blurred vision or difficulty concentrating, eating food or drinking a sugary beverage usually helps.
The patient may notice tablet remnants in the stool. This is normal for this type of tablet and should not be a cause for concern.
Continue to follow all dietary advice given by the doctor and ensure regular intake of carbohydrates throughout the day.
Do not discontinue treatment with this medicine without consulting a 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
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If the patient is to receive an intravenous iodine-containing contrast agent, for example during an X-ray examination or computed tomography, the patient must stop taking Ranmet XR before or at the latest at the time of injection. The doctor will decide when the patient should stop and restart treatment with Ranmet XR.
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The patient may require more frequent monitoring of blood glucose levels and kidney function assessments, or dose adjustments of Ranmet XR by the doctor. It is particularly important to inform about the following medicines:

• 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 in the treatment of asthma),
• corticosteroids such as prednisolone, mometasone, beclomethasone (used in the treatment of various conditions, e.g. severe skin inflammation or asthma),
• other medicines used to treat diabetes,
• sympathomimetic medicines including epinephrine and dopamine, used in the treatment of myocardial infarction and low blood pressure. Epinephrine is also an ingredient in some local anaesthetics used in dentistry,
• medicines that may alter metformin blood levels, especially if the patient has reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib, olaparib).

Ranmet XR, food, drink and alcohol
Ranmet XR should be taken with a meal or immediately after a meal, for example during dinner.
Avoid consuming excessive amounts of alcohol while taking Ranmet XR, as this may increase the risk of lactic acidosis (see section "Warnings and precautions").
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine, as treatment may need to be changed. Ranmet XR should not be used if the patient is pregnant.
Use of this medicine is not recommended if the patient is breastfeeding or planning to breastfeed.
Driving and operating machinery
Ranmet XR itself does not cause hypoglycaemia (symptoms of low blood glucose levels, such as fainting, disorientation and excessive sweating) and therefore does not affect the patient's ability to drive or operate machinery.
However, particular caution should be exercised when driving or operating machinery if Ranmet XR is used together with other antidiabetic medicines that may cause low blood glucose levels.

3. How to use Ranmet XR

Your doctor may prescribe Ranmet XR alone or in combination with other oral antidiabetic medicines or insulin.
This medicine should always be taken exactly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
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Ranmet XR does not replace the benefits of a healthy lifestyle. You should follow your doctor's advice regarding diet and maintain regular physical activity.
Dosage
Treatment usually starts with a dose of 500 mg of Ranmet XR once daily.
After approximately two weeks of treatment, your doctor may adjust the dose based on blood glucose measurements. The maximum dose of Ranmet XR is 2000 mg per day. If you have impaired kidney function, your doctor may prescribe a lower dose.
If you are also using insulin, your doctor will inform you how to start taking Ranmet XR.
How to take the tablets
The tablets are usually taken once daily with the evening meal.
In some cases, your doctor may recommend taking the tablets twice daily. The tablets should always be taken with food.
Swallow the tablets whole with a glass of water. Do not chew, divide or crush the tablets.
If at any time you feel that the effect of Ranmet XR is too strong or too weak, 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 following an assessment of kidney function.
Taking more Ranmet XR than prescribed
If you accidentally take extra tablets, do not be alarmed, but if unusual symptoms occur, contact your doctor. Symptoms may include:
weakness, disorientation, rapid breathing, nausea, vomiting or abdominal pain.
If the overdose is significant, there is a greater risk of lactic acidosis. This is a life-threatening condition requiring hospital treatment (see also section 4 "Possible side effects").
If you forget to take Ranmet XR
As soon as you remember, take the missed dose with a meal.
Do not take a double dose to make up for a forgotten dose.
Stopping Ranmet XR
Do not stop taking this medicine without first consulting your doctor. If you stop taking Ranmet XR, your blood glucose levels may rise again.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient notices any of the adverse reactions listed below, they should
discontinue use of Ranmet XR and contact a doctor immediately.
Very rarely (may affect up to 1 in 10,000 patients):
Ranmet XR may very rarely cause a very serious adverse reaction known as lactic acidosis (see section "Warnings and precautions"). If lactic acidosis occurs in a patient, treatment with Ranmet XR must be stopped and immediate contact must be made with a doctor or the nearest hospital, as lactic acidosis may lead to coma.
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• Abnormal liver function test results and hepatitis, which may cause jaundice. If yellowing of the eyes and/or skin occurs, contact a doctor immediately.

Other possible adverse reactions are listed below according to frequency of occurrence:
Very common (may affect more than 1 in 10 patients):

• diarrhoea, nausea, vomiting, abdominal pain or loss of appetite. If these adverse reactions occur, do not stop taking the tablets, as these symptoms usually resolve within about 2 weeks. It may help to take the tablets with food or immediately after a meal.

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

• taste disturbances.

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

• decreased vitamin B levels, which may lead to anaemia,
• skin rashes including: skin redness, skin itching and urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store RANMET XR

Keep this medicine out of 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 the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ranmet XR contains

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

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

Marketing Authorisation Holder:
Ranbaxy (Poland) Sp. z o.o.
ul. Idzikowskiego 16
00-710 Warszawa
Poland

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 medicinal product is authorised in the European Economic Area and 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
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Slovakia: Metformin Fairmed XR 500 mg, 750 mg, 1000 mg