COMPOUND MACROGOL 13.8G POWDER FOR ORAL SOLUTION - patient leaflet, side effects, dosage

Package Leaflet: Information for the patient

macrogol 3350 / sodium chloride / sodium hydrogen carbonate / potassium chloride

Read all of this leaflet carefully to get the best results from it before you start taking this medicine because it contains important information for you.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

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

• – Ask your pharmacist if you need more information or advice.

• – 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.

• – You must talk to a doctor if you do not feel better or if you feel worse after 14 days for chronic constipation.

What is in this leaflet

• 1. What Macrogol is and what it is used for

• 2. What you need to know before you take Macrogol

• 3. How to take Macrogol

• 4. Possible side effects

• 5. How to store Macrogol

• 6. Contents of the pack and other information

1. what macrogol is and what it is used for

Compound Macrogol 13.8g Powder for Oral Solution is a laxative used for the treatment of constipation, (especially if constipation lasts a long time) in adults, adolescents and the elderly. It is not recommended for children below 12 years of age. Macrogol 3350 makes your faeces softer and easier to pass, giving you relief from constipation. The electrolytes (salts) help to maintain your body’s normal levels of sodium, potassium and water while you are being treated for constipation.

2. what you need to know before you take macrogol

Do not take Macrogol

• – if you are allergic to macrogol 3350, sodium chloride, sodium hydrogen carbonate, potassium chloride, or any of the other ingredients in this medicine (listed in section 6)

• – if you have a perforated gut (bowel) wall

• – if you have a blockage in your intestine (gut obstruction, ileus)

• – if you have severe inflammatory bowel disease such as ulcerative colitis, Crohn’s disease or toxic megacolon

Talk to your doctor or pharmacist before taking this medicine.

Warnings and precautions

If you develop side effects such as swelling, shortness of breath, feeling tired, dehydration (symptoms include increasing thirst, dry mouth and weakness) or heart problems you should stop taking Macrogol and contact your doctor immediately.

If you experience sudden abdominal pain or rectal bleeding when taking Macrogol for bowel preparation, contact your doctor or seek medical advice immediately.

Children

Do not give this medicine to children below 12 years of age.

Other medicines and Macrogol

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

Some medicines, e.g. anti-epileptics, may not work as effectively during use with Macrogol.

Therefore, other medicines should not be taken orally for one hour before and for one hour after taking this medicine.

If you need to thicken fluids in order to swallow them safely, Macrogol may counteract the effect of the thickener.

Pregnancy and breast-feeding

Macrogol can be taken during pregnancy and whilst breast-feeding. If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

Macrogol contains sodium, sorbitol and potassium

This medicine contains 188 mg sodium (main component of cooking/table salt) in each sachet. This is equivalent to 9.4% of the recommended maximum daily dietary intake of sodium for an adult.

The maximum recommended daily dose of this medicine when used for constipation contains 564 mg sodium (found in table salt). This is equivalent to 28.2 % of the recommended maximum daily dietary intake for sodium.

Talk to your doctor or pharmacist if you need three or more sachets daily for a prolonged period, especially if you have been advised to follow a low salt (sodium) diet.

This medicine contains 0.6 mmol (or 24.4 mg) potassium per sachet. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.

The lemon lime flavour in this medicine contains 0.8 mg sorbitol (E420) in each sachet.

3. how to take macrogol

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

Constipation

A dose of Macrogol is 1 sachet dissolved in 125 ml (1/4 pint) of water. Take this 1–3 times a day according to the severity of your constipation.

Treatment with this medicine usually lasts for about 2 weeks. If you need to take this medicine for longer, please see your doctor. If your constipation is caused by an illness such as Parkinson’s disease or multiple sclerosis (MS), or if you take medicines that cause constipation your doctor may recommend that you take this medicine for longer than 2 weeks. If you need to take this medicine for longer, please see your doctor. Usually for long term treatment the dose can be lowered to either 1 or 2 sachets a day.

How to mix

Open the sachet and pour the contents into a glass. Add about 125 ml or a quarter pint of water to the glass. Stir well until all the powder has dissolved and the solution is clear or slightly hazy, then drink it.

This medicine should be taken orally.

Children

Do not give this medicine to children below 12 years of age.

If you take more Macrogol than you should

This can cause severe pain and bloated stomach, vomiting (sickness) or diarrhoea. Excessive diarrhoea can lead to dehydration. If this occurs, stop taking this medicine and drink plenty of fluids. If you are worried contact your doctor or pharmacist.

If you forget to take Macrogol

Take the dose as soon as you remember to take it.

4. possible side effects

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

If you experience any of the following side effects, stop taking Macrogol and see your doctor immediately:

• – If you get signs of an allergy, such as a rash, itching, reddening of the skin, shortness of breath, difficulty in breathing, or swelling of the face, lips, tongue or throat.

• – If you get signs of a change in your body’s fluid or electrolyte levels (salts levels), such as swelling (mainly in the ankles), feeling weak, dehydration, increasingly tired or increased thirst with headache. These symptoms may be a sign that the potassium levels in your blood are higher or lower than normal.

Other side effects include:

• – swollen hands, feet or ankles

• – headaches

• – indigestion, stomach ache or rumbles

• – feel bloated, suffer from wind, feel sick or vomit

• – soreness of the anus (bottom)

• – diarrhoea (when starting to take this medicine)

• – change in your body’s fluid or electrolyte levels (low levels of sodium)

5. how to store macrogol

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 and sachet after “EXP”. The expiry date refers to the last day of that month.

Do not store above 25 °C.

Reconstituted Macrogol solution can be covered and stored in the refrigerator (2°C to 8°C), and should be used within twenty-four hours. After twenty-four hours, any unused solution should be discarded.

Do not use this medicine if you notice that any of the sachets are damaged.

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 Macrogol contains

The active substances are:

Each sachet contains:

macrogol 3350 sodium chloride

sodium hydrogen carbonate potassium chloride

The other ingredients are colloidal anhydrous silica, saccharin sodium, orange flavour (orange flavour contains: flavouring substances and flavouring preparations, maltodextrin, acacia gum (E414), alpha-tocopherol (E307)) and lemon lime flavour (lemon lime flavour contains: natural lemon oil, natural powder lemon flavour, powder lime flavour, maltodextrin, mannitol (E421), gluconolactone (E575), sorbitol (E420), acacia gum (E414), colloidal anhydrous silica (E551)).

What Macrogol looks like and contents of the pack

Macrogol is a white crystalline powder.

The sachet is composed of PAP/ALU/PE.

Each sachet contains 13.8 g of powder and is packed in cartons containing 2, 6, 8, 10, 20, 30, 50, 60 (2×30) and 100 (2×50) sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sandoz Limited

Park View, Riverside Way

Watchmoor Park

Camberley, Surrey

GU15 3YL

United Kingdom

Manufacturer

Klocke Pharma-Service GmbH

Strassburger Strasse 77

77767 Appenweier

Germany or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1, 39179

Barleben

Germany or

Hermes Pharma Ges.m.b.H. Schwimmschulweg 1a 9400 Wolfsberg

Austria

This leaflet was last revised in 11/2021.

PIL.1319.011.0d

Align SPC and PIL in accordance with CMDh conclusions

AD