MOVICOL

MOVICOL aroma-free powder for oral use MP

Important notes (mandatory information)

Movicol aromafrei, powder for solution for ingestion. Indications: for the treatment of chronic constipation.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Movicol aromafrei, 13.7 g powder for solution for ingestion

Read all of this leaflet carefully because it contains important information for you. This medicine is available without prescription. However, to get the best results from Movicol aromafrei, it is important to take it exactly as directed.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must see a doctor if your symptoms worsen or do not improve.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This leaflet contains

1. WHAT IS MOVICOL AROMAFREI AND WHAT IS IT USED FOR?
2. BEFORE YOU TAKE MOVICOL AROMAFREI
3. HOW TO TAKE MOVICOL AROMAFREI
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE MOVICOL AROMAFREI
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS MOVICOL AROMAFREI AND WHAT IS IT USED FOR?

The name of this product is Movicol aromafrei, 13.7 g powder for solution for ingestion. Movicol aromafrei is a product from the group of laxatives for the treatment of acute and chronic constipation in adults, adolescents and elderly patients. It is not recommended for children under 12 years of age (other Movicol products are available for this patient group). Movicol aromafrei helps you to have comfortable bowel movements, even if you have suffered from constipation for a long time.

2. BEFORE YOU TAKE MOVICOL AROMAFREI

Do not take Movicol aromafrei if your doctor has told you that you have:

• Narrowing or blockage of the bowel.
• A hole in the bowel (perforation).
• Severe inflammatory bowel diseases such as ulcerative colitis, Crohn's disease or toxic megacolon.
• Hypersensitivity to the active substances or any of the other ingredients of Movicol aromafrei.

Take special care with Movicol aromafrei

Pregnancy and breast-feeding

Movicol aromafrei can be taken during pregnancy and breast-feeding. If you are pregnant, planning to become pregnant or breast-feeding, ask your doctor or pharmacist for advice before taking Movicol aromafrei.

Driving and using machines

Movicol aromafrei does not affect your ability to drive or operate machines.

Movicol aromafrei contains sodium

Talk to your doctor or pharmacist if you need to take 3 or more sachets daily over a prolonged period of time, especially if you have been advised to follow a low salt (sodium) diet. This medicine contains 186.87 mg sodium (main component of cooking/table salt) per sachet. This is equivalent to 9.3% of the recommended maximum daily dietary intake of sodium for an adult.

Renal impairment

No dose adjustment is required for patients with renal impairment.

Taking other medicines

The effectiveness of some medicines, such as anti-epileptic medicines, may be reduced when taken with Movicol aromafrei. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

3. HOW TO TAKE MOVICOL AROMAFREI

To maintain good health, including a healthy bowel, it is recommended to drink plenty of fluids (generally 2 to 2.5 litres per day). You can take this product at any time, with or without food and drink. Do not use if the packaging is damaged. For constipation: One dose of Movicol aromafrei is 1 sachet. Take 1 sachet of Movicol aromafrei 1 to 3 times a day, depending on the severity of your constipation.

Making up the solution

Open the sachet and pour the contents into a glass. Add approximately 125 ml or half a glass of water. Stir until the powder has dissolved completely and the Movicol aromafrei solution is clear or slightly cloudy. You can now drink the solution.

Duration of use

For constipation: Treatment with Movicol aromafrei usually lasts for about 2 weeks. If you need to take Movicol aromafrei for a longer period of time, please talk to your doctor. If your constipation is caused by an illness such as Parkinson's disease or multiple sclerosis (MS), or if you are taking medicines that cause constipation, your doctor may recommend that you take Movicol aromafrei for longer than 2 weeks. During long-term treatment, the usual dose is 1 or 2 sachets per day.

If you take more Movicol aromafrei than you should

You may get diarrhoea, which can lead to dehydration. If this happens, stop taking Movicol aromafrei and drink plenty of fluids. If you are not sure, ask your doctor or pharmacist.

If you forget to take Movicol aromafrei

Take the dose as soon as you remember.

4. POSSIBLE SIDE EFFECTS

Movicol aromafrei can have side effects, although not everybody gets them. Stop taking Movicol aromafrei and tell your doctor immediately if you get a serious allergic reaction, which causes difficulty breathing or swelling of the face, lips, tongue or throat.

Other side effects

Allergic reactions (which may cause skin rash, itching, reddening of the skin or hives), swollen hands, feet or ankles, headache and increased and decreased potassium levels in the blood. You may sometimes experience indigestion, abdominal pain or increased bowel sounds. You may also feel bloated, have wind, feel sick or vomit, have irritation around your back passage and experience mild diarrhoea when you first start taking Movicol aromafrei. These side effects usually improve once the dose of Movicol aromafrei is reduced.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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 Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE MOVICOL AROMAFREI

Keep out of the reach and sight of children. Do not use Movicol aromafrei after the expiry date which is stated on the sachet. The expiry date refers to the last day of that month. Do not store above 25°C. Once you have made up Movicol aromafrei in water and cannot drink it all straight away, keep it covered and store it in a refrigerator (2°C - 8°C). Throw away any solution that you have not used within 24 hours.

6. FURTHER INFORMATION

Each 13.7 g sachet of Movicol aromafrei contains the following ingredients

Macrogol 3350 13.125 g, sodium chloride 0.3508 g, sodium hydrogen carbonate 0.1786 g, potassium chloride 0.0502 g. Movicol aromafrei does not contain any colours, flavours or sweeteners. After dissolving each sachet in 125 ml of water, the following values are obtained: sodium 65 mmol/l, chloride 53 mmol/l, potassium 5.4 mmol/l, hydrogen carbonate 17 mmol/l.

What Movicol aromafrei looks like and contents of the pack

Movicol aromafrei is available in packs of 10 or 50 sachets. Not all pack sizes may be marketed.

Norgine B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
Netherlands

Distributed by

Norgine GmbH
Im Westpark 14
35435 Wettenberg
Germany
Telephone: 0641/98 497 0
Telefax: 0641/33 055 900
Internet: www.norgine.de
E-mail: Info@norgine.de

This leaflet was last revised in May 2019.

Source: Package leaflet information
Version: 11/2019
Indications: for the treatment of chronic constipation.