METFORMIN 100 MG / ML ORAL SOLUTION - patient leaflet, side effects, dosage

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 diabetes1) when diet and exerci

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

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 1 OOmg of metformin in 1 ml
• 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). w<j_.

Insert the syringe into the bottle.

Whilst holding the bottom ring, pull the " [£/ piston upwards to the graduation mark —J corresponding to the quantity in millilitres

(ml) prescribed by the doctor (Figure 2). ( j

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

4. Possible side effects                           * 1

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 Bl 2 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.

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 lOOmg of metformin hydrochloride

• – the other ingredients are Sodium methyl

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 Irun, Km 26,200,

28709 San Sebastian de los Reyes (Madrid), Spain

This leaflet was last revised in September 2020.

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