concentrate for oral solution
What Movicol Orange is and what it is used for
The name of this medicine is Movicol Orange.
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 Orange helps you to have a pleasant bowel function even if you have been constipated for a long time.
You must not use Movicol Orange if you have very serious constipation called fecal impaction.
Macrogol 3350, sodium chloride, sodium bicarbonate, and potassium chloride contained in Movicol Orange 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 if you feel worse after 14 days.
Before you take Movicol Orange
Do not take Movicol Orange if your doctor has told you that you have:
- narrowing of the intestine (intestinal obstruction, ileus )
- ulcers in the intestinal wall
- a severe inflammatory bowel disease such as ulcerative colitis , Crohn’s disease or toxic megacolon
- allergy to the active substances or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
When you take Movicol Orange, you should continue to drink a lot. The liquid in Movicol Orange should not replace your normal fluid intake.
Other drugs and Movicol Orange:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medications, e.g. Anti-epileptic medicines (medicines for epilepsy ) may not work as well when you use Movicol Orange.
If you need to thicken liquids to be able to swallow them safely, Movicol Orange can counteract the effect of the thickener.
Pregnancy and breastfeeding
Movicol Orange 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 Orange.
Driving and using machines
Movicol Orange 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 Orange contains ethyl and methyl parahydroxybenzoate, ethanol, benzyl alcohol and sodium
This medicine contains ethyl and methyl parahydroxybenzoate which may cause allergic reactions, possibly with delay.
It also contains
- small amounts of ethanol (alcohol), less than 100 mg per 25 ml dose.
- 45.6 mg of benzyl alcohol in each diluted dose of 125 ml.
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 Orange contains 186.87 mg sodium (the main ingredient in table salt/table salt) per 25 ml dose. This corresponds to 9.3% of the recommended maximum daily sodium intake for an adult.
Do not exceed the indicated dose one.
How to take Movicol Orange
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.
This medicine can be taken at any time with or without food.
This product must be diluted before use.
One dose of Movicol Orange consists of 25 ml of solution diluted in 100 ml of water.
Take such a dose 1-3 times a day depending on how severe your constipation is.
How to mix:
Open the bottle and pour out 25 ml or five teaspoons of 5 ml each. Pour the liquid into a glass and then add 100 ml (about half a glass) of water. Stir well until all the liquid has been mixed evenly and the diluted Movicol Orange is transparent and then drink the solution.
Rinse the dosing cap after use and replace the bottle.
Duration of treatment:
Treatment with Movicol Orange usually lasts about 2 weeks. If you need to take Movicol Orange for a long time, talk to your 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 take Movicol Orange for longer than 2 weeks.
In long-term treatment, the dose can usually be reduced to 1 or 2 doses a day.
If you take more Movicol Orange than you should
You can get severe diarrhea which can lead to dehydration. If this happens, stop taking Movicol Orange and drink plenty of fluids. If you have any further questions, ask your doctor or pharmacist.
If you forget to take Movicol Orange
Take a dose as soon as you remember.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you have a severe allergic reaction that causes difficulty breathing or swelling of the face, lips, tongue, or throat, tell your doctor immediately and stop taking Movicol Orange, concentrate for oral solution.
Other allergic reactions may occur which may cause skin rash, itching, redness or hives, swollen hands, feet or ankles, and headache.
Other side effects may include indigestion, stomach pain, wheezing as well as high or low potassium levels in the blood. You may feel bloated, suffer from gas, feel sick or vomit, you may also feel soreness in the anus and may have mild diarrhea when you start taking Movicol Orange which normally improves if you reduce the amount of Movicol Orange that you take.
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.
How to store Movicol Orange
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 bottle and carton after EXP. The expiration date is the last day of the specified month.
Store in a cold place. Do not freeze.
Discard the remaining product 30 days after first opening the bottle.
Once you have diluted Movicol Orange in water, keep the solution covered if you cannot drink it immediately. Discard any solution that has not been used within 24 hours.
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
25 ml Movicol Orange contains the following:
| Macrogol 3350 | 13.125 g |
| Sodium chloride | 0.3507 g |
| Sodium bicarbonate | 0.1785 g |
| Potassium chloride | 0.0466 g |
Movicol Orange contains 186.87 mg (8.125 mmol) of sodium (the main ingredient in table salt/table salt) per 25 ml dose. This corresponds to 9.3% of the recommended maximum daily intake of sodium for an adult. See section 2 “Movicol Orange contains ethyl and methyl parahydroxybenzoate, ethanol, benzyl alcohol, and sodium”.
Movicol Orange also contains purified water, orange flavor, and acesulfame potassium (E950) as well as sucralose (E955) as sweeteners.
It also contains a preservative containing benzyl alcohol, methyl parahydroxybenzoate (E218), and ethyl parahydroxybenzoate (E214).
The orange flavor contains the following ingredients: flavors, flavors, and ethanol (alcohol).
When 25 ml is diluted in 100 milliliters of water, it gives the corresponding:
| Sodium | 65 millimoles/liter |
| Chloride | 53 millimoles/liter |
| Potassium | 5.4 millimoles / liter |
| Hydrocarbonate | 17 millimoles / liter |
What the medicine looks like and contents of the pack
Movicol Orange is a clear colorless liquid.
Each package consists of a carton with a plastic bottle of Movicol Orange containing 500 ml of solution and a plastic dosing cup.
Marketing Authorization Holder and Manufacturer
Norgine BV,
Antonio Vivaldi Street 150
1083 HP Amsterdam
Netherlands
The manufacturer is Norgine Pharma Dreux, 29, Rue Ethé Virton, 28109 Dreux Cedex, France
Or
Norgine Limited, New Road, Hengoed, Mid Glamorgan, CF82 8SJ, UK.
This medicinal product is authorized in the EEA Member States under the following names:
| Austria | MOVICOL Liquid Orange |
| Belgium | MOVICOL Liquid Orange Flavor /MOVICOL Liquid Taste orange /MOVICOL Liquid orange flavor |
| Finland | MOVICOL Appelsiini |
| Germany | Macrogol Norgine Orange Flavor Concentrate for solving ingestion |
| Ireland | MOVICOL Liquid Orange flavor |
| Italy | MOVICOL 13.9 g / 25 ml concentrate for oral solution, gusto Arancio |
| Luxembourg | MOVICOL Liquid Taste orange |
| Netherlands | Movicolon Liquid Orange |
| Portugal | MOVICOL Laranja |
| Spain | Movicol Sabor Orange concentrated for oral solution |
| Sweden | Movicol Orange |
| UK | MOVICOL Liquid Orange flavor |