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

•    Decreased vitamin B₁₂ levels

•    Skin rashes including redness, itching and hives.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov. uk/yellowcard.

By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Meijumet Tablets

Keep this medicine out of the sight and reach of children.

Do not use them after the expiry date which is stated on the label, carton or bottle after EXP. The expiry date refers to the last day of that month. Discard bottle contents 6 months after opening.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    Contents of the pack and other information What Meijumet Tablet contains:

The active substance is metformin hydrochloride 1000 mg equivalent to 780 mg metformin. The other ingredients are: microcrystalline cellulose, hypromellose, povidone and magnesium stearate.

What Meijumet Tablets looks like and contents of the pack

Meijumet Tablets are 22.5 mm x 10 mm, white to off-white, oval shaped biconvex tablets, debossed with ‘1000’ on one side and plain on other side.

Meijumet Tablets are supplied in blister packs of 14, 28 and 56 tablets and containers of 120 tablets.

Not all pack sizes may be marketed.

This leaflet was last revised in 09/2016

PL 21880/0179

I POM I 0179/0/PIL/001/I

Marketing Authorisation Holder and Manufacturer: MEDREICH PLC

Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail: info@medreich.co.uk

121XXXX-V1

Package leaflet: Information for the patient

Meijumet 1000 mg prolonged release 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 of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

•    The name of this medicine is Meijumet 1000 mg prolonged release Tablets but it will be referred to as Meijumet Tablets throughout this leaflet.

What is in this leaflet:

1.    What Meijumet Tablets are and what they are used for

2.    What you need to know before you take Meijumet Tablets

3.    How to take Meijumet Tablets

4.    Possible Side effects

5.    How to store Meijumet Tablets

6.    Contents of the pack and other information

1.    What Meijumet Tablets are and what they are used for

Meijumet Tablets contain the active ingredient metformin hydrochloride and belong to a group of medicines called biguanides, used in the treatment of diabetes.

Meijumet Tablets are used for the treatment of Type 2 (non-insulin dependent) diabetes mellitus when diet and exercise changes alone have not been enough to control blood glucose (sugar). Insulin is a hormone that enables body tissues to take glucose from the blood and to use it for energy or for storage for future use.

People with Type 2 diabetes do not make enough insulin in their pancreas or their body does not respond properly to the insulin it does make. This causes a build-up of glucose in the blood which can cause a number of serious long-term problems so it is important that you continue to take your medicine, even though you may not have any obvious symptoms.

Meijumet Tablets makes the body more sensitive to insulin and helps return to normal the way your body uses glucose.

Meijumet Tablets is associated with either a stable body weight or modest weight loss.

Meijumet Tablets are specially made to release the drug slowly in your body and therefore are different to many other types of tablet containing metformin.

This medicine is intended for adult patients only.

2.    What you need to know before you take Meijumet Tablets Do not take Meijumet Tablets:

•    if you are allergic to metformin or to any of the other ingredients (listed in section 6). An allergic reaction may cause a rash, itching or shortness of breath.

•    if you have ketosis (this is a symptom of uncontrolled diabetes in which substances called ‘ketone bodies’ accumulate in the blood-you may notice that your breath has an unusual, fruity odour).

•    if you have long-term kidney or liver problems.

•    if you have had serious complications with your diabetes or other serious conditions which resulted in rapid weight loss, nausea, vomiting or dehydration.

•    if you have a severe infection or have recently suffered a severe injury.

This section is continued overleaf —>

•    if you have been treated for heart problems or have recently had a heart attack or have severe circulatory problems or breathing difficulties.

•    if you are a heavy drinker of alcohol.

•    if you are under 18 years of age.

Warnings and precautions

Talk to your doctor or pharmacist before using Meijumet Tablets

After you have started taking your medicine:

If you have diabetes you should have your blood or urine tested for sugar regularly. You should return to your doctor at least once a year to check the function of your kidneys (more often if you are elderly or if you have kidney problems).

If you start to lose weight unexpectedly or suffer severe nausea or vomiting, uncontrolled rapid breathing or abdominal pains, stop taking the medicine and tell your doctor straight away. This can be a sign of a rare, hut serious, complication with your diabetes called ‘lactic acidosis’ which means there is too much acid in the blood (see ‘Possible side effects’).

You may see some remains of the tablets in your stools. Do not worry; this is normal for this type of tablet.

If you need to have an X-ray examination involving the injection of a dye, tell the doctor that you take Meijumet Tablets as you may need to stop taking it for a few days afterwards.

Tell your doctor if you are going to have an operation under general anaesthetic, as you may need to stop taking Meijumet Tablets for a couple of days before and after the procedure.

You should continue to follow any dietary advice that your doctor has given you and you should make sure that you eat carbohydrates regularly throughout the day.

Children and adolescents

This medicine is intended for adult patients only and not to be used in children.

Other medicines and Meijumet Tablets:

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

If you are taking any of the following medicines, your blood sugar levels may need to be checked more often and your dose adjusted:

•    Steroids such as prednisolone, mometasone, beclometasone.

•    Diuretics (water tablets) such as furosemide.

•    Sympathomimetic medicines including epinephrine and dopamine used to treat heart attacks and low blood pressure. Epinephrine is also included in some dental anaesthetics.

Meijumet Tablets with food and drink and alcohol:

You should avoid drinking alcohol and using alcohol-containing medicines as this will increase the risk of lactic acidosis.

Pregnancy and breast-feeding

Do not take Meijumet Tablets if you are pregnant or breast feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Meijumet Tablets taken on its own does not cause ‘hypos’ (symptoms of low blood sugar or hypoglycaemia, such as faintness, confusion and increased sweating) and therefore should not affect your ability to drive or use machinery.

You should be aware; however, that Meijumet Tablets taken with other antidiabetic medicines can cause hypos, so in this case you should take extra care when driving or operating machinery.

3.    How to take Meijumet Tablets

Your doctor may prescribe Meijumet Tablets for you to take on its own, or in combination with other oral antidiabetic medicines or insulin.

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets whole with a glass of water, do not chew or crush the tablets.

Usually you will start treatment with one metformin hydrochloride 500 mg prolonged release tablet daily. After you have been taking metformin hydrochloride prolonged release tablets for about 2 weeks, your doctor may measure your blood sugar and adjust the dose. The maximum daily dose is 2000 milligrams of Meijumet Tablets. Normally, you should take the tablets once a day, with your evening meal. Please note that Meijumet 1000 mg Tablets cannot be split to administer a 500mg dose. Your doctor will prescribe an alternative product.

In some cases, your doctor may recommend that you take the tablets twice a day. Always take the tablets with food.

If you take more Meijumet Tablets than you should

If you take extra tablets by mistake you need not worry, but if you have unusual symptoms, contact your doctor. These symptoms may include weakness, confusion, fast breathing and new onset of nausea, vomiting or stomach pain. If the overdose is large, a rare side effect “lactic acidosis” (too much acid in the blood) is more likely and this is a medical emergency requiring treatment in hospital (see ‘Possible side effects’).

If you forget to take Meijumet Tablets

Take it as soon as you remember with some food. Do not take a double dose to make up for a forgotten dose.

If you stop taking Meijumet Tablets

Do not stop taking this medicine without speaking to your doctor. As the treatment for diabetes is usually life long, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.    Possible side effects

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

If you notice any of the following, stop taking Meijumet Tablets and see your doctor immediately:

•    unexpected weight loss

•    weakness

•    confusion

•    very severe nausea or vomiting

•    very fast breathing which you cannot stop

•    stomach pains or feeling cold

These can be signs of serious problems with your diabetes and may mean you have a very rare side effect called “lactic acidosis” (too much acid in the blood). If this happens, see a doctor as you will need treatment straight away.

•    Abnormal liver function tests and hepatitis (inflammation of the liver) which may result in jaundice. If you develop yellowing of the eyes and/or skin contact your doctor immediately:

Other possible side effects are listed by frequency as follows:

Very common (may affect more than 1 in 10people):

•    Diarrhoea, nausea, vomiting, stomach ache or loss of appetite. If you get these, do not stop taking the tablets as these symptoms will normally go away in about 2 weeks. It helps if you take the tablets with or immediately after a meal.

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

•    Taste disturbance

COLOURS | Red 032 C | Black

MEDREICH LIMITED				Title: Art Work Approval Form
Product	Meijumet PR Tablets -1000 mg - S/L - English - PIL			Specification:	Printed on 56 - 60 GSM Maplitho Paper
Customer	MEDREICH PLC, UK
Reason for Issue	PIF No:. New Product			Colours:	2 - Red 032 C & Black
				Dimensions:	190 x 285 mm (Open Size) 190 x 36 mm (Folded Size)
Related FG Codes	130XXXX Pharmacode No		XXXX
				No. of Folds (only for PIL)	3	Artwork made to		80%
Item Code	121XXXX-V1 (WOA) Layout No.: NA
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WIN\\192.168.1.33\pdc\Artworks\Medreich\UK Products\Apcer Pharma\Meijumet\Metformin PR Tablets\1000 mg\PIL \Meijumet PR Tablets - 1000 mg - SL - English - PlL.ai

07.09.16(RR)

MED/MEI/PIL/01

Format No.: CO-QA005-F03-02

Internal Approval issued on

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