PACKAGE LEAFLET: INFORMATION FOR THE USER
METFORMIN ACTAVIS 500 mg and 850 mg filmcoated tablets (tablets)
Metformin hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
In this leaflet:
1.
What Metformin Actavis is and what it is used for
2.
Before you take Metformin Actavis
3.
How to take Metformin Actavis
4.
Possible side effects
5.
How to store Metformin Actavis
6.
Further information
1.
WHAT METFORMIN ACTAVIS IS AND WHAT IT IS USED FOR
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 .
2.
BEFORE YOU TAKE METFORMIN ACTAVIS
Do not take Metformin Actavis
if you are allergic (hypersensitive) to metformin or any of the other ingredients of Metformin Actavis
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
Take special care with Metformin Actavis
If you have symptoms of disturbances in the lactoacid balance (lactic acidosis), as abdominal pain,
vomiting, muscular pain, feeling weak and having trouble breathing you should immediately contact
the hospital.
If you have diabetes developed during old age and your kidney function is reduced you should
consult your doctor before treatment with Metformin Actavis is started.
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.
1
In connection with surgery, a doctor should be consulted and the medication must be 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.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription. 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.
Taking Metformin Actavis with food and drink
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
During pregnancy, diabetes should not be treated with Metformin Actavis, but with insulin.
Ask your doctor or pharmacist for advice before starting the treatment.
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.
3.
HOW TO USE METFORMIN ACTAVIS
Always use Metformin Actavis exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
Adults
The usual dose of Metformin Actavis 500 mg is 1 tablet 2-3 times daily, but the dose may be increased to
maximum 6 tablets daily.
The usual dose of Metformin Actavis 850 mg is 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.
2
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, Metformin Actavis can cause side effects, although not everybody gets them.
Stop taking Metformin tablets and contact your doctor at once if you experience:
 Signs of serious problem with your diabetes (diabetic ketoacidosis or lactic acidosis) such as
unexpected weight loss, severe nausea or vomiting (feeling or being sick), uncontrolled rapid breathing
or abdominal pains. These symptoms can be severe, quick to appear and can be signs of serious
problems with your diabetes.
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
 Very common (occurs in more than 1 in 10 users): diarrhoea, loss of appetite, feeling or being sick,
stomach upset or pain, especially at the start of treatment.
 Common (occurs in less than 1 in 10 users): change in taste.
 Very rare (occurs in less than 1 in 10, 000 users): a mild red rash, hepatitis (inflammation of the liver
causing yellowing of the skin or eyes), changes in liver function tests.
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.
If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please inform
your doctor or pharmacist.
5.
HOW TO STORE METFORMIN ACTAVIS
No special precautions for storage.
Keep out of the reach and sight of children.
Do not use Metformin Actavis 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.
6.
FURTHER INFORMATION
What Metformin Actavis contains
-
The active substance is metformin hydrochloride 500 mg or 850 mg.
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:
3
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 available.
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: 2013-12-22
4