Metformin Almus

Patient Information Leaflet: Information for the User

Metformina Almus 850 mg film-coated tablets, 1000 mg film-coated tablets

Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Metformina Almus is and what it is used for
2. What you need to know before taking Metformina Almus
3. How to take Metformina Almus
4. Possible side effects
5. How to store Metformina Almus
6. Contents of the pack and other information

1. What Metformina Almus is and what it is used for

Metformina Almus contains metformin, a medicine used to treat diabetes. It belongs to a
group of active substances called biguanides.
Insulin is a hormone produced by the pancreas that enables the body to absorb glucose
(sugar) from the blood. The body uses glucose to produce energy or stores it for future use.
If you have diabetes, your pancreas does not produce enough insulin, or your body is unable
to use properly the insulin it produces. This leads to high levels of glucose in the blood. Metformina Almus helps lower blood glucose to a level as close to normal as possible.
If you are overweight, taking Metformina Almus over a long period of time also helps reduce
the risk of diabetes-related complications. Metformina Almus has been associated with both stabilization and modest reduction in body weight.
Metformina Almus is used to treat patients with type 2 diabetes (also known as “non-insulin-dependent diabetes”) when diet and exercise alone have not been sufficient to control blood glucose levels. It is particularly used in overweight patients.
Adults may take Metformina Almus alone or in combination with other antidiabetic medicines (oral medications or insulin).
Children aged 10 years and older and adolescents may take Metformina Almus alone or in combination with insulin.

2. What you need to know before taking Metformina Almus

Do not take Metformina Almus

• If you are allergic (hypersensitive) to metformin or to any of the other ingredients of this medicine (see “What Metformina Almus contains” in section 6).
• If you have liver problems.
• If you have severely reduced kidney function.
• If you have uncontrolled diabetes associated, for example, with severe hyperglycaemia (high blood glucose levels), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see below “Risk of lactic acidosis”) or ketoacidosis. Ketoacidosis is a condition in which substances called “ketone bodies” accumulate in the blood and may lead to diabetic pre-coma. Symptoms include stomach pain, rapid and deep breathing, drowsiness, and breath with an unusual fruity odour.
• If your body has lost too much water (dehydration), for example due to prolonged or severe diarrhoea or if you have vomited repeatedly. Dehydration can cause kidney problems which may put you at risk of lactic acidosis (see section “Warnings and precautions”).
• If you have a severe infection, such as an infection affecting the lungs, bronchial system or kidneys. Severe infections can cause kidney problems which may put you at risk of lactic acidosis (see section “Warnings and precautions”).
• If you are being treated for acute heart failure or have recently had a heart attack, or if you have serious circulatory problems (such as shock) or breathing difficulties. These conditions may cause inadequate oxygen supply to tissues, which may put you at risk of lactic acidosis (see section “Warnings and precautions”).
• If you drink large amounts of alcohol.

If you are in any of the above conditions, consult your doctor before starting this medicine.
Make sure you ask your doctor for advice if:

• you need to undergo tests such as X-rays or diagnostic scans requiring injection into the bloodstream of iodine-containing contrast agents
• you need to undergo surgery

You must stop taking Metformina Almus for a certain period of time before and after the test or surgical procedure. Your doctor will decide whether you need alternative treatment during this time. It is important that you follow your doctor’s instructions precisely.

Warnings and precautions
Risk of lactic acidosis
Metformina Almus may cause a very rare but very serious side effect called lactic acidosis, particularly if the kidneys are not functioning properly. The risk of developing lactic acidosis is higher in the presence of uncontrolled diabetes, severe infections, prolonged fasting or alcohol consumption, dehydration (see below for further information), liver problems, or any other medical condition characterised by reduced oxygen supply to part of the body (such as in severe heart disease).
If you have any of the medical conditions described above, consult your doctor for further instructions.

Contact your doctor immediately for further instructions if:

• You know you have a hereditary genetic disease affecting mitochondria (the components that produce energy within cells), such as MELAS syndrome (Mitochondrial Encephalopathy, myopathy, Lactic Acidosis and Stroke-like episodes) or maternally inherited diabetes and deafness (MIDD, Maternal Inherited Diabetes and Deafness).
• You experience any of the following symptoms after starting metformin: seizures, reduced cognitive abilities, difficulty with body movements, symptoms indicating nerve damage (e.g. pain or numbness), headache, or deafness.

Stop taking Metformina Almus temporarily if you have a medical condition that may be associated with dehydration (significant loss of body fluids), such as severe vomiting, diarrhoea, fever, heat exposure, or if you are drinking less fluid than normal. Consult your doctor for further instructions.

If you experience any of the symptoms of lactic acidosis, stop taking Metformina Almus and contact your doctor or the nearest hospital immediately, because lactic acidosis can lead to coma.
Symptoms of lactic acidosis include:

• vomiting
• stomach ache (abdominal pain)
• muscle cramps
• a general feeling of being unwell accompanied by severe fatigue
• difficulty breathing
• reduced body temperature and slower heart rate

Lactic acidosis is a medical emergency and must be treated in hospital.
If you are undergoing major surgery, you must stop taking Metformina Almus during the procedure and for a certain period afterwards. Your doctor will decide when you should stop and when you should restart treatment with Metformina Almus.

Metformina Almus alone does not cause hypoglycaemia (low blood glucose levels).
However, if you take Metformina Almus together with other medicines for diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides), there is a risk of hypoglycaemia. If you experience symptoms of hypoglycaemia such as weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating, it is usually helpful to eat or drink something containing sugar.

During treatment with Metformina Almus, your doctor will check your kidney function at least once a year, or more frequently if you are elderly and/or if kidney function worsens.

Other medicines and Metformina Almus
If you are due to receive an injection of an iodinated contrast agent into the bloodstream, for example for an X-ray, you must stop taking Metformina Almus before or during the injection. Your doctor will decide when you should stop and when you should restart treatment with Metformina Almus.

Tell your doctor if you are taking, have recently taken or might take any other medicine. You may need to have your blood glucose and kidney function tested more frequently, or your doctor may decide to adjust your dose of Metformina Almus.

It is particularly important to mention the following:

• medicines that increase urine production (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 agonists such as salbutamol or terbutaline (used to treat asthma)
• corticosteroids (used to treat various conditions, such as severe skin inflammation or asthma)
• medicines that may alter the amount of metformin in the blood, especially if you have reduced kidney function (such as verapamil, rifampicin, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole, crizotinib and olaparib)
• other medicines used to treat diabetes

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription.

Metformina Almus with food and drink
Avoid excessive alcohol consumption during treatment with Metformina Almus, as this may increase the risk of lactic acidosis (see section “Warnings and precautions”).

Pregnancy and breastfeeding
During pregnancy, insulin is required to treat diabetes. Inform your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant, so that your treatment can be adjusted.
This medicine is not recommended if you are breastfeeding or intend to breastfeed your baby.

Driving and using machines
Metformina Almus alone does not cause hypoglycaemia (low blood glucose levels). This means it does not impair your ability to drive or operate machinery.
However, take particular care if you take Metformina Almus together with other medicines for diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, rapid heartbeat, visual disturbances or difficulty concentrating. Do not drive or operate machinery if you begin to experience these symptoms.

3. How to take Metformina Almus

Always take Metformina Almus exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Metformina Almus cannot replace the benefits of a healthy lifestyle. Continue to follow all dietary advice given by your doctor and exercise regularly.

Recommended dose
Children aged 10 years and older and adolescents usually start with 500 mg or 850 mg of metformin once daily (for the 500 mg dose, other medicines must be used). The maximum daily dose is 2000 mg, taken in 2 or 3 separate doses. Treatment of children aged between 10 and 12 years is recommended only on specific medical advice, as experience in this age group is limited.

Adults usually start with 500 mg or 850 mg of metformin two or three times daily (for the 500 mg dose, other medicines must be used). The maximum daily dose is 3000 mg, taken in 3 separate doses.

If you have reduced kidney function, your doctor may prescribe you a lower dose.
If you are also taking insulin, your doctor will advise you on how to start taking Metformina Almus.

Monitoring

• Your doctor will regularly monitor your blood glucose levels and adjust the dose of Metformina Almus according to your blood sugar levels. You should consult your doctor regularly. This is particularly important for children and adolescents or if you are elderly.
• Your doctor will also check your kidney function at least once a year. You may need more frequent checks if you are elderly or if your kidneys do not function normally.

How to take Metformina Almus
Take Metformina Almus during or after a meal. This will help you avoid gastrointestinal side effects.
Do not crush or chew the tablets. Swallow each tablet with a glass of water.

• If you take one dose per day, take it in the morning (with breakfast).
• If you take two doses per day, take them in the morning (with breakfast) and in the evening (with dinner).
• If you take three doses per day, take them in the morning (with breakfast), at midday (with lunch), and in the evening (with dinner).

If, after some time, you think that the effect of Metformina Almus is too strong or too weak, consult your doctor or pharmacist.

If you take more Metformina Almus than you should
If you have taken more Metformina Almus than you should have, you may develop lactic acidosis. Symptoms of lactic acidosis are non-specific and include vomiting, stomach pain (abdominal pain) with muscle cramps, a general feeling of being unwell with extreme tiredness and difficulty breathing. Further symptoms include lowered body temperature and heart rate.
If you experience any of these symptoms, seek immediate medical attention, as lactic acidosis can lead to coma. Stop taking Metformina Almus and contact a doctor or go to the nearest hospital immediately.

If you forget to take Metformina Almus
Do not take a double dose to make up for a forgotten dose. Take the next dose at the scheduled time.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Metformina Almus may cause a very rare (may occur in up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this occurs, you must stop taking Metformina Almus and seek immediate medical attention at your doctor’s office or nearest hospital, because lactic acidosis can lead to coma.

Very common side effects (occur in more than 1 in 10 people)

• Gastrointestinal problems such as feeling sick (nausea), sickness (vomiting), diarrhoea, stomach ache (abdominal pain), and loss of appetite. These side effects most often occur at the beginning of treatment with Metformina Almus. It may be helpful to divide the daily dose throughout the day and to take Metformina Almus during or immediately after meals. If symptoms persist, stop taking Metformina Almus and consult your doctor.

Common side effects (occur in less than 1 in 10 people)

• Altered taste.

Very rare side effects (occur in less than 1 in 10,000 people)

• Lactic acidosis. This is a very rare but serious complication, particularly if the kidneys are not functioning properly. Symptoms of lactic acidosis are non-specific (see section “Warnings and precautions”).
• Abnormal liver function tests or hepatitis (liver inflammation; may cause fatigue, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If you experience such symptoms, stop taking Metformina Almus and contact your doctor;
• Skin reactions such as redness of the skin (erythema), itching, or itchy rash (urticaria);
• Low levels of vitamin B12 in the blood.

Children and adolescents
Limited data in children and adolescents have shown that adverse events were similar in nature and severity to those reported in adults.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metformina Almus

Keep this medicine out of the sight and reach of children.
This medicine requires no special storage conditions.
Do not use this medicine after the expiry date stated on the carton or blister after "Exp.:". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Metformina Almus contains

• The active substance is metformin hydrochloride.
  Metformina Almus 850 mg film-coated tablets: Each tablet contains 850 mg of metformin hydrochloride, equivalent to 662.9 mg of metformin.
  Metformina Almus 1000 mg film-coated tablets: Each tablet contains 1000 mg of metformin hydrochloride, equivalent to 780 mg of metformin.
• The other components are povidone, anhydrous colloidal silica, magnesium stearate, hypromellose, polyethylene glycol 6000, and talc.

Description of the appearance of Metformina Almus and contents of the pack
Metformina Almus 850 mg tablets are white to off-white film-coated tablets, elongated in shape (19.0 mm x 9.8 mm), engraved with “Rx” on one side and “850” on the other.
Metformina Almus 1000 mg tablets are white to off-white film-coated tablets, elongated in shape (19.0 mm x 9.8 mm), engraved with “Rx” on one side and “1000” on the other.
The tablets are available in the following blister pack sizes:
Metformina Almus 850 mg film-coated tablets: 28, 30, 40, 50, 56, 84 and 90 tablets.
Metformina Almus 1000 mg film-coated tablets: 28, 30, 50, 56, 60, 84 and 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Almus S.r.l.
Via Cesarea 11/10
16121 Genoa
Italy

Manufacturer
Rx Farma (Malta) Limited
Kw20a, Zona Industrijali Ta'Kordin
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
France: Metformine ALMUS 500 mg, 850 mg & 1000 mg, comprimé pelliculé
Italy: Metformina Almus
Spain: Metformina Almus Pharma 850 mg & 1000 mg comprimidos recubiertos con película EFG