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Package leaflet: Information for the patient

Metformin Actavis 500 mg and 850 mg filmcoated tablets

metformin hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, 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 signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Metformin Actavis is and what it is used for

2. What you need to know before you take Metformin Actavis

3. How to take Metformin Actavis

4. Possible side effects

6. Contents of the pack and other information

Metformin Actavis is used in diabetes mellitus in adults, especially in overweight patients, when diet and exercise have not reduced sugar levels.

Metformin Actavis lowers the blood sugar in diabetes without causing the levels to drop too low. Metformin Actavis can be used as single treatment or in combination with other oral medications (sulfonylureas) or together with insulin, to reduce the blood sugar .

Do not take Metformin Actavis

- if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6).

- if you have liver problems or drink a lot of alcohol

- if you have kidney problems

- if you have severe heart or pulmonary disease

- if you have a tendency for developing diabetic ketoacidosis and diabetic pre-coma

- if you have a severe infection

- if you are seriously dehydrated (lost a lot of water from your body, which can happen if you have severe sickness or diarrhoea)

- in the condition of shock

Warnings and precautions

Please note the following particular risk of lactic acidosis. Metformin Actavis may cause a very rare, but very serious complication called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, prolonged fasting or alcohol intake, body fluid deficit (dehydration) due to severe diarrhoea or vomiting, liver problems and any medical conditions in which a region of the body is deprived with a lack of oxygen supply (such as acute severe heart diseases). It is important to you to comply with your medication intake, dietary instructions and regular exercise program because this can reduce the risk of lactic acidosis. The onset of lactic acidosis can be subtle and the symptoms can be non-specific such as vomiting, bellyache (abdominal pain) with muscle cramps, a general feeling of not being well with severe tiredness, and difficulty in breathing. Further symptoms are reduced body temperature and heart beat. If you experience some of these symptoms, you should seek immediately medical attention, as lactic acidosis may lead to coma. Stop taking Metformin Actavis immediately and contact a doctor or the nearest hospital straight away.

Talk to your doctor or pharmacist before taking Metformin Actavis

If you are going to undergo an x-ray procedure where a contrast agent is used containing iodine, the treatment with Metformin Actavis must be stopped before or at the start of the procedure. Medication may not be restarted again until 48 hours after the procedure and only after the kidney function has been tested again and found to be normal.

In connection with surgery, a doctor should be consulted and the medication mustbe stopped.

When Metformin Actavis is taken together with other antidiabetic medications such as insulin or other antidiabetics such as sulphonureas or meglitinides, the possibility of low blood sugar (hypoglycaemia) can occur. Symptoms of low blood sugar such as sweating, shakiness, anxiety, palpitation of the heart and hunger might appear. In such cases it is often helpful to drink milk or take sugar or something similar.

Patients should continue their diet with a regular distribution of carbohydrates during the day. Patients who are overweight should continue on their low energy diet.

Usual laboratory tests for monitoring diabetes should be done on a regular basis.

Other medicines and Metformin Actavis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Especially:

• Glucocorticoids ( a group of anti-inflammatory medicines used to treat for example asthma and inflammation of the skin)

• Sympathomimetics (medicines affecting a certain part of the nervous system for example adrenaline and medicines used to treat asthma)

• Diuretics (medicines to increase urine output)

• Contrast agents containing iodine (used inconnection with x-ray procedure) see Take special care with Metformin Actavis.

Metformin Actavis with alcohol

High alcohol intake might increase the risk of acidity in the blood, especially in the case of liver problems or malnutriation. Therefore it is recommended to avoid alcohol during treatment with Metformin Actavis.

Pregnancy and breast-feeding

Pregnancy

During pregnancy, diabetes should not be treated with Metformin Actavis, but with insulin.

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Breast-feeding

Metformin Actavis passes on to human breast milk. Breast-feeding during metformin treatment is not recommended.

Driving and using machines

Metformin Actavis as a single drug treatment does not cause hypoglycemia and has therefore no effects on the ability of driving or using machines. Though, there is a risk for hypoglycemia when metformin is given in combination with other antidiabetic medicines or insulin, make sure you are not affected before driving or using machinery.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults

The usual dose of Metformin Actavis 500 mgis 1 tablet 2-3 times daily, but the dose may be increased to maximum 6 tablets daily.

The usual dose of Metformin Actavis 850 mgis 1 tablet 2-3 times daily, but the dose may be increased to maximum 3 tablets daily.

Elderly

The dosage should be adjusted based on kidney function.

The tablets should be taken together with food in order to reduce the risk for gastro-intestinal side effects.

If you take more Metformin Actavis than you should

If you suspect overdose or intoxication always contact your doctor, the hospital or toxicological information centre. Symptoms of overdose are feeling sick, vomiting, diarrhoea, metal taste, low blood sugar, lactic acidosis, circulatory disturbance and shock.

If you forget to take Metformin Actavis

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

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

Stop taking Metformin tablets and contact your doctor at once if you experience:

Other side effects:

Some patients, who have been taking Metformin tablets for a long time, have experienced reduced levels of vitamin B₁₂ in their blood (a type of anaemia causing breathlessness on exertion, pale skin and poor resistance to infections). This would be detected by a blood test.

Reporting of side effects
If you get any side effects, talk toyour doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metformin Actavis

No special precautions for storage.

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 carton or label after EXP. The expiry date refers to the last day of that month.

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.

6. Contents of the pack and other information

What Metformin Actavis contains

• The active substance is metformin hydrochloride. Each tablet contains 500 mg or 850 mg metformin hydrochloride respectively.

• The other ingredients are:

Tablet core - povidone, stearic acid, silica, colloidal anhydrous.

Film-coat - hypromellose, titanium dioxide (E171), macrogol 400.

What Metformin Actavis looks like and the contents of the pack

500mg tablets: white, circular, biconvex, film-coated, impressed “MF” on one face.

850mg tablets: white, circular, biconvex, film-coated, impressed “MH” on one face.

Metformin Actavis 500mg tablets are supplied in:

Blister packs containing 30, 50, 100 tablets

Plastic bottles containing 30, 50, 100, 300, 400 tablets

Metformin Actavis 850mg tablets are supplied in:

Blister packs containing 20, 30, 60, 100 tablets

Plastic bottles containing 20, 30, 60, 100 tablets

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Marketing Authorisation holder:

Actavis Group PTC ehf.

Reykjavikurvegi 76-78

IS-220 Hafnarfjordur

Isaland

Manufacturer

Actavis UK Limited

Whiddon Valley,

BARNSTAPLE,

N Devon EX32 8NS

Balkanpharma-Dupnitsa AD

3 Samokovsko Shosse Str.

Dupnitsa 2600,

Bulgaria

Actavis Nordic A/S

Ornegardsvej 16,

DK-2820, Gentofte,

Denmark

850mg only

PharmaPack International B.V.

Bleiswijkseweg 51

2712 PB Zoetermeer

The Netherlands

MPF B.V. (Manufacturing Packaging Farmaca)

Appelhof 13, 8465 RX Oudehaske, The Netherlands

MPF B.V. (Manufacturing Packaging Farmaca)

Neptunus 12, 8448 CN Heerenveen, The Netherlands

This product is authorised in the Member States of the EEA under the following names:

Sweden, Denmark, Finland, Norway: Metformin Actavis

Portugal: Metformina Aurovitas

This leaflet was revised in 2016-05-04