What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 20046/0255.


Metformin 100mg/ml Oral Solution

PACKAGE LEAFLET: INFORMATION FOR THE USER

Metformin 100mg/ml Oral Solution

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 further questions, ask your doctor, pharmacist or nurse.
  • 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Metformin 100mg/ml Oral Solution (called Metformin Oral Solution throughout the rest of this leaflet).

What is in this leaflet

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

1. What Metformin Oral Solution is and what it is used for

What Metformin Oral Solution is:

Metformin Oral Solution contains metformin, a medicine to treat diabetes. It belongs to a group of medicines called biguanides.

Insulin is a hormone produced by the pancreas that makes your body take in glucose (sugar) from the blood. Your body uses glucose to produce energy or stores it for future use.

If you have diabetes, your pancreas does not make enough insulin or your body is not properly able to use the insulin that it produces. This leads to a high level of glucose in your blood. Metformin Oral Solution helps to lower your blood glucose to as normal a level as possible.

If you are an overweight adult, taking Metformin Oral Solution over a long period of time also helps to lower the risk of complications associated with diabetes. Metformin is associated with either a stable body weight or modest weight loss.

What Metformin Oral Solution is used for:

Metformin Oral Solution is used to treat patients with type 2 diabetes (also called 'non-insulin dependent diabetes') when diet and exercise alone have not been enough to control your blood glucose levels. It is used particularly in overweight patients.

Adults can take Metformin Oral Solution on its own or together with other medicines to treat diabetes (medicines taken by mouth or insulin).

Children 10 years and over and adolescents can take Metformin Oral Solution on its own or together with insulin.

2. What you need to know before you take Metformin Oral Solution

Do not take Metformin Oral Solution:

  • if you are allergic to metformin or any of the other ingredients of this medicine (listed in section 6)
  • if you have kidney or liver problems or if you have severely reduced kidney function
  • if you have uncontrolled diabetes, for example severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactate 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 can lead to diabetic pre-coma. Symptoms include stomach pain, fast and deep breathing, sleepiness or your breath developing an unusual fruity smell. In rare instances this could lead to unconsciousness.
  • if you have lost too much water from your body (dehydration), due to long-lasting or severe diarrhoea, or if you have vomited several times in a row. Dehydration may lead to kidney problems, which can put you at risk of lactic acidosis (see ‘Warnings and Precautions’ below)
  • if you have a severe infection, such as an infection affecting your lungs, bronchial system or your kidneys. Severe infections may lead to kidney problems, which can put you at risk of lactic acidosis (see ‘Warnings and Precautions’’ below)
  • if you are being treated for heart failure or have recently had a heart attack, have severe problems with your circulation (such as shock) or have breathing difficulties. This may lead to a lack in oxygen supply to tissue which can put you at risk of lactic acidosis (see ‘Warnings and Precautions’’ below)
  • if you drink a lot of alcohol.

If any of the above applies to you, talk to your doctor before you start taking this medicine.

Make sure you ask your doctor for advice if:

  • you need to have an examination such as an X-ray or scan, involving the injection of contrast medicines into your bloodstream that contain iodine
  • you need to have major surgery.

You must stop taking Metformin Oral Solution for a certain period of time before and after the examination or the surgery. Your doctor will decide whether or not you need any other treatment during this period. It is important that you follow your doctor’s instructions precisely.

Warning and precautions

Talk to your doctor, pharmacist or nurse before taking Metformin Oral Solution.

Take special care with Metformin Oral Solution

Risk of lactic acidosis:

Metformin Oral Solution may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly. The risk of developing lactic acidosis is also increased with uncontrolled diabetes, serious infections, prolonged fasting or alcohol intake, dehydration (see further information below), liver problems and any medical conditions in which a part of the body has a reduced supply of oxygen (such as acute severe heart disease). If any of the above apply to you, talk to your doctor for further instructions.

Stop taking Metformin Oral Solution for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. Talk to your doctor for further instructions.

Stop taking Metformin oral solution and contact a doctor or the nearest hospital immediately possible if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.

Symptoms of lactic acidosis include:

  • vomiting
  • stomach ache (abdominal pain)
  • muscle cramps
  • a general feeling of not being well with severe tiredness
  • difficulty in breathing
  • reduced body temperature and heartbeat.

If this happens to you, you may need immediate treatment in hospital. Stop taking Metformin Oral Solution immediately and contact your doctor or go to the nearest hospital straight away.

Lactic acidosis is a medical emergency and must be treated in a hospital.

If you need to have major surgery you must stop taking Metformin Oral Solution during and for some time after the procedure. Your doctor will decide when you must stop and when you can restart your treatment with Metformin Oral Solution.

During treatment with Metformin Oral Solution your doctor will check your kidney function at least once a year and more frequently if you are elderly or if you have worsening kidney function.

Metformin Oral Solution on its own does not cause hypoglycaemia (a blood glucose level which is too low). However, if you take Metformin Oral Solution together with other medicines to treat 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, fast heartbeat, vision disorders or difficulty in concentration, it usually helps to eat or drink something containing sugar.

Other medicines and Metformin Oral Solution

If you need to have an injection of contrast medium that contains iodine into your blood stream, for example for in the context of an X-ray or scan, you must stop taking Metformin Oral Solution before or at the time of the injection. Your doctor will decide when you must stop and when to restart your treatment with Metformin Oral Solution.

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

You may need more frequent blood glucose and kidney function tests or your doctor may need to adjust the dosage of Metformin Oral Solution. It is especially important to mention the following:

  • medicines which increase urine production (diuretics)
  • sympathomimetics such as salbutamol or terbutaline (used to treat asthma)
  • corticosteroids (used to treat a variety of conditions, such as severe inflammation of the skin or in asthma)
  • other medicines to treat diabetes
  • medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
  • certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists, verapamil).
  • medicines used to treat infections (rifampicin, trimethoprim, isavuconazole)
  • medicines used to treat heartburn (cimetidine)
  • medicines used to treat HIV/AIDS (dolutegravir)
  • medicines used to treat heart conditions such as angina (ranolazine)
  • medicines used to treat different types of cancers (vandetanib, crizotinib, olaparib).

Metformin Oral Solution with food, drink and alcohol

Avoid excessive alcohol intake while taking Metformin Oral Solution since this may increase the risk of lactic acidosis (see section “Warnings and precautions”). This also applies to medicines that contain alcohol.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. So that he or she may change your treatment.

During pregnancy, you need insulin to treat your diabetes.

Breast-feeding

It is not recommended to take Metformin Oral Solution during breast-feeding. Your doctor will decide whether you should stop breast-feeding whilst you are treated with Metformin Oral Solution.

Driving and using machines

Metformin Oral Solution on its own does not cause hypoglycaemia (a blood glucose level which is too low). This means that it will not affect your ability to drive or use machines.

However, take special care if you take Metformin Oral Solution together with other medicines to treat diabetes that can cause hypoglycaemia (such as sulphonylureas, insulin, meglitinides). Symptoms of hypoglycaemia include weakness, dizziness, increased sweating, fast heartbeat, vision disorders or difficulty in concentration. Do not drive or use machines if you start to feel these symptoms.

Metformin Oral Solution contains

  • liquid maltitol (75%) and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Sucrose may also be harmful to teeth
  • sodium methyl and propyl parahydroxybenzoates. These may cause allergic reactions (possibly delayed)
  • sodium (7mg per 5ml dose). To be taken into consideration by patients on a controlled sodium diet
  • potassium (14.5mg per 5ml dose). To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet
  • sodium sulfite. This may rarely cause severe hypersensitivity (allergic) reactions and bronchospasm
  • ethanol. This medicinal product contains small amounts of ethanol (alcohol), less than 100mg per 10ml.

3. How to take Metformin Oral Solution

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

Metformin Oral Solution cannot replace the benefits of a healthy lifestyle. Continue to follow any advice about diet that your doctor has given you and get some regular exercise.

If you have reduced kidney function, your doctor may prescribe a lower dose.

How to take this medicine

  • this solution contains 100mg of metformin in 1ml
  • taking this medicine with or just after food will avoid you having side effects affecting your digestion
  • if you take one dose a day, take it in the morning (breakfast)
  • if you take two divided doses a day, take them in the morning (breakfast) and evening (dinner)
  • if you take three divided doses a day, take them in the morning (breakfast), at noon (lunch) and in the evening (dinner).

If, after some time, you think that the effect of Metformin Oral Solution is too strong or too weak, talk to your doctor or pharmacist.

The recommended dose is

Adults

  • The usual starting dose is 500mg (5ml) or 850mg (8.5ml) two or three times a day
  • The maximum daily dose is 3000mg (30ml) taken as 3 divided doses.

If you take insulin too, your doctor will tell you how to start taking Metformin Oral Solution.

Elderly: Your doctor may prescribe a different dose.

Use in children and adolescents

  • The usual dose of metformin is 500mg (5ml) or 850mg (8.5ml) once a day
  • The maximum daily dose is 2000mg (20ml) taken as 2 or 3 divided doses.

Treatment of children between 10 and 12 years of age is only recommended on specific advice from your doctor, as experience in this age group is limited.

Patients with kidney problems

  • Your doctor will decide the best dose for you depending on your kidney function
  • Kidney function should be closely monitored (every 3-6 months).

Monitoring

  • Your doctor will adapt your dose of Metformin Oral Solution to your blood glucose levels. Make sure that you talk to your doctor regularly. This is particularly important for children and adolescents or if you are elderly
  • Your doctor will also check, at least once a year, how well your kidneys work. You may need more frequent checks if you are elderly or if your kidneys are not working normally.

Directions for opening the bottle and using the syringe

Open the bottle by pressing the cap and turn it anticlockwise (Figure 1).

Insert the syringe into the bottle.

Whilst holding the bottom ring, pull the piston upwards to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by the doctor (Figure 2).

Remove the oral syringe from the bottle and wipe the body of the syringe with a tissue to remove excess solution.

Empty the contents of the syringe onto a spoon or directly into the mouth by pressing the plunger down.

Close the bottle with the plastic screw cap.

Wash the syringe with water after every use and leave it to air dry.

If you take more Metformin Oral Solution than you should

If you have taken more Metformin Oral Solution than you should have, you may experience lactic acidosis.

Symptoms of lactic acidosis are vomiting, stomach ache (abdominal pain) with muscle cramps, a general feeling of being unwell, with severe tiredness and difficulty in breathing. Contact your doctor or go to the nearest hospital straight away.

If you forget to take Metformin Oral Solution

Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Metformin Oral Solution

Keep taking this medicine until your doctor tells you to stop.

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

4. Possible side effects

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

1) Metformin Oral Solution may cause a very rare (may affect up to 1 user in 10,000), but very serious side effect called lactic acidosis (see section “Warnings and precautions”). If this happens you must stop taking Metformin Oral Solution and contact a doctor or the nearest hospital immediately and contact your doctor or go to the nearest hospital straight away, as lactic acidosis may lead to coma. The following side effects may occur: vomiting, stomach ache (abdominal pain) with muscle cramps, a general feeling of being unwell, with severe tiredness and difficulty in breathing.

2) Abnormalities in liver function tests or hepatitis (inflammation of the liver; this may cause tiredness, loss of appetite, weight loss, with or without yellowing of the skin or whites of the eyes). If this happens to you, stop taking this medicine and inform your doctor immediately.

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

  • digestive problems, such as feeling sick (nausea), being sick (vomiting), diarrhoea, stomach ache (abdominal pain) and loss of appetite. These side effects most often happen at the beginning of treatment with Metformin Oral Solution. It helps if you spread the doses over the day and if you take the doses with or straight after a meal. If symptoms continue, stop taking Metformin Oral Solution and talk to your doctor.

Common (may affect up to 1 in 10 people)

  • changes in taste.

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

  • skin reactions such as redness of the skin (erythema), itching or an itchy rash (urticaria)
  • low vitamin B12 levels in the blood.

Additional side effects in children and adolescents

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

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Metformin Oral Solution

Keep this medicine out of the sight and reach of children. If a child is treated with Metformin Oral Solution, parents and carers are advised to oversee how this medicine is used.

Do not use this medicine after the expiry date which is stated on the bottle label and carton after Exp. The expiry date refers to the last day of that month.

Do not store above 25°C.

Once the medicine is opened, use within 28 days.

Do not use this medicine if you notice that the appearance or smell of your medicine has changed. Talk to your pharmacist.

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 Oral Solution contains

  • the active substance is metformin hydrochloride. Each 1ml of solution contains 100mg of metformin hydrochloride
  • the other ingredients are Sodium methyl parahydroxybenzoate (E219), Sodium propyl parahydroxybenzoate (E217), Sodium dihydrogen phosphate dihydrate, Di-sodium hydrogen phosphate anhydrous (E339), Liquid Maltitol (75%) (E965), Acesulfame potassium (E950), Caramel colour (E150b) (containing sucrose and sodium sulfite (E221)), Peppermint flavour, Peach flavour (containing ethanol), Hydrochloric acid (for pH adjustment) and Purified water.

What Metformin Oral Solution looks like and contents of the pack

Metformin Oral Solution is a clear brown solution with characteristic odour.

It comes in an amber glass bottle, containing 150ml of solution, with a child resistant screw-cap, along with a 10ml oral syringe.

Marketing Authorisation Holder

Focus Pharmaceuticals Ltd.
Capital House
85 King William Street
London
EC4N 7BL
United Kingdom

Manufacturer

Farmasierra Manufacturing, S.L.
Ctra. De Irún
Km 26,200
28709 San Sebastián de los Reyes (Madrid)
Spain

This leaflet was last revised in May 2018.

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