an oral solution in sachet
Macrogol 3350, Sodium chloride, Sodium bicarbonate, Potassium chloride
What Movicol is and what it is used for
The name of this medicine is Movicol. It is a laxative for the temporary treatment of constipation in adults, adolescents, and the elderly. It is not recommended for children under 12 years.
Movicol helps you to have a pleasant bowel function even if you have been constipated for a long time. Movicol can also be used for long-term treatment and very severe constipation, so-called fecaloma, after a doctor’s prescription.
Macrogol 3350, sodium chloride, sodium bicarbonate, and potassium chloride contained in Movicol may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
You must talk to a doctor if you do not feel better or worse within 14 days.
What you need to know before taking Movicol
Do not take Movicol unless your doctor tells you that you are suffering from the following:
- constrictions in the intestine (intestinal obstructions, ileus )
- ulcers in the intestinal wall
- severe inflammatory bowel diseases such as ulcerative colitis, Crohn’s disease or toxic megacolon
- if you are allergic to active substances or any of the other ingredients of this medicine (listed in section 6).
Warnings and Precautions:
When you take Movicol, you should continue to drink a lot. The liquid content of Movicol should not replace your normal fluid intake.
Heart problems:
Follow the special instructions in section 3 if you have been prescribed Movicol by a doctor for very severe constipation, so-called fecaloma.
Other medicines and Movicol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medications, e.g. against epilepsy, may be less effective when using Movicol.
If you need to thicken liquids to be able to swallow them safely, Movicol can counteract the effect of the thickener.
Pregnancy and breastfeeding
Movicol can be used during pregnancy and breastfeeding. If you are pregnant, trying to conceive, or breastfeeding, ask your pharmacist or doctor for advice before taking Movicol.
Driving and using machines
Movicol does not affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Movicol contains sodium
Talk to your doctor or pharmacist if you need 3 or more doses daily for an extended time, especially if you have been advised to follow a low-salt ( sodium ) diet.
Movicol contains 186.87 mg sodium (the main ingredient in table salt/table salt) per sachet. This corresponds to 9.3% of the recommended maximum sodium intake for an adult.
How to take Movicol
This medicine can be taken at any time, with or without food.
Drink Movicol directly from the sachet. The solution does not need to be further diluted.
It is recommended to drink enough fluids daily (generally 2.0 to 2.5 liters) to maintain good health.
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. If you are not sure, talk to your doctor, pharmacist, or nurse.
Constipation:
One dose of Movicol is 1 sachet of 25 ml.
Take 1-3 sachets daily in divided doses depending on how severe your constipation is.
Fecal:
Before taking Movicol for treatment of feces, it should be established that you have this diagnosis. 8 sachets of Movicol per day are necessary for the treatment of the fecal matter. The 8 sachets should be taken within 6 hours for up to 3 days if necessary. If you have heart problems, do not take more than 2 sachets per hour.
It is recommended that patients taking Movicol for feces drink 1 liter of extra fluid every day.
Duration of treatment:
Constipation:
The treatment time with Movicol in case of temporary constipation is normally about 2 weeks. If symptoms worsen or do not improve within 14 days, consult a doctor. If your constipation is caused by a disease such as Parkinson’s disease or multiple sclerosis (MS), or if you are taking medicines that cause constipation, your doctor may recommend that you use Movicol for more than 2 weeks. If you need to take Movicol for more than 2 weeks talk to a doctor.
In long-term treatment, the dose can usually be reduced to 1 or 2 sachets daily.
Fecal:
Treatment with Movicol in a fecal matter may be up to 3 days.
If you take more Movicol than you should:
You can get diarrhea which can lead to dehydration. Discontinue treatment with Movicol until diarrhea subsides and drink plenty of fluids. Ask your doctor or pharmacist if you are unsure.
If you forget to take Movicol:
Take a dose as soon as you remember to take it.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately and stop using Movicol if you:
- Gets a severe allergic reaction that causes difficulty breathing or swelling of the face, lips, tongue or throat.
Other side effects are:
Allergic reactions that may cause skin rash, itching, reddening of the skin or hives, swollen hands, feet or ankles, headache, and high or low levels of potassium in the blood.
Sometimes you may have stomach upset, stomach pain, or stomach noise. You may also feel bloated, suffer from gas, feel nauseous or vomit. You may also experience tenderness around the rectal opening and may experience mild diarrhea when you start using Movicol. These side effects are generally better if you reduce the amount of Movicol you use.
How to store Movicol
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 sachet and carton after EXP. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
Store in a cold place. Do not freeze.
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.
Contents of the pack and other information
Content declaration
| Macrogol 3350Sodium chlorideSodium bicarbonatePotassium chloride | 13.125 g0.3508 g0.1786 g0.0502 g |
Movicol also contains sucralose, purified water as well as strawberry and banana flavors that contain natural flavors (strawberry and banana extracts) flavoring agents (including celery), and propylene glycol.
| SodiumChloridePotassiumHydrocarbonate | 8.125 mmol6.675 mmol0.675 mmol2.125 mmol |
What the medicine looks like and contents of the pack
Movicol oral solution in a sachet is a clear, colorless to light yellow liquid.
Movicol oral solution in sachets is available in packs containing 10, 20, 30, and 50 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Norgine BV
Antonio Vivaldi Street 150
1083 HP Amsterdam
Netherlands
Manufacturer
Norgine Pharma
29 rue Ethé Virton
28100 Dreux Cedex
France
This medicinal product is authorized under the European Economic Area under the names:
| Belgium | MOVICOL Unidose |
| Germany | MOVICOL ready to drink |
| Finland | MOVICOL Ready To Take |
| Ireland | MOVICOL Ready To Take |
| Italy | MOVICOL |
| Portugal | MOVICOL Unidose |
| Spain | MOVICOL oral solution on sober |
| Sweden | Movicol oral solution in sachet |
| UK | MOVICOL Ready to Take |