Cilaxoral 7.5 mg/ml Oral Drops, Sodium Picosulphate Solution
1. What Cilaxoral Is And What It Is Used For
The active substance in Cilaxoral, sodium picosulphate, is converted in the large intestine to an active substance that initiates the movements of the large intestine so that the intestinal contents are transported more quickly. At the same time, water remains in the colon. This means that the stool has a softer consistency and the bowel movement is facilitated.
Cilaxoral English is used for temporary constipation and to facilitate bowel emptying in hemorrhoids and ulcers around the rectal opening.
2. What You Need To Know Before You Use
Do Not Use Cilaxoral English
- In severe abdominal pain
- When stopping in the intestines
- In case of severe dehydration (dehydration)
- If you are allergic to sodium picosulphate or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions
Prolonged use can lead to disturbed fluid and electrolyte balance and lack of potassium in the blood. If you need laxatives daily for a long time, the cause of constipation should be investigated by a doctor.
Children
Cilaxoral should not be given to children under 12 years of age.
Cilaxoral With Food, Drink And Alcohol
Cilaxoral English can be mixed with food or drink.
Pregnancy And Breastfeeding
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as your experience with pregnant women is limited.
Breast-feeding
Sodium picosulphate does not pass into breast milk. This medicine can therefore be used during breast-feeding.
Driving And Using Machines
Cilaxoral has no known effect on the ability to drive and use machines.
Cilaxoral Contains Sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How To Use Cilaxoral
- Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Dose one should be adjusted individually so that the stool is soft enough. Adults preferably start with 10 drops in the evening. Dose one can then be reduced or increased so that the stool becomes reasonably soft.
- Do not take more than 20 drops per day.
- Cilaxoral is used daily for a maximum of one week. You may then be able to switch to every other day’s medication. After another week, every third day of medication can be tried and after another week, the treatment is stopped.
- 10 drops of medicine is equivalent to 5 mg of sodium picosulphate.
- Cilaxoral can be mixed with food or drink.
Use For Children
Cilaxoral should not be given to children under 12 years of age.
4. Possible Cilaxoral Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people ):
- Stomach cramps
Rare Cilaxoral side effects (may affect up to 1 in 1,000 people):
- Skin rash
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How To Store Cilaxoral
- 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. The expiration date is the last day of the specified month.
- Shelf life in the opened package: 6 months.
The medicine 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
6. Contents Of The Packaging And Other Information
Content Declaration
- The active substance is sodium picosulphate. 1 ml oral drops solution contains 7.5 mg sodium picosulphate
- The other ingredients are
- Sodium benzoate (E211)
- Sorbitol 70% (E420, sweetener)
- Sodium citrate
- Citric acid monohydrate
- Purified water
- Neutral taste
What The Medicine Looks Like And The Contents Of The Pack
- Colorless to a pale yellow-brown solution.
- Packaging: Drip bottle of 30 ml
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Ferring Läkemedel AB
Box 4041
203 11 Malmö
Manufacturer
Merckle GmbH
PO Box 1161
89135 Blaubeuren
Germany