20 mg/ml Oral solution, single-dose sodium cromoglycate
What is Lomudal GI and what is it used for?
Lomudal GI contains the active substance sodium cromoglycate and is used in case of food allergy and/or difficulty in tolerating certain foods. Lomudal GI can be used for both treatment of children (from 2 years and up) and adults.
The mode of action is not clear. The treatment should take place in combination with the most important foods that cause symptoms to be removed from the diet.
What you need to know before using Lomudal GI
Do not use Lomudal GI:
- if you are allergic to sodium cromoglycate or any of the other ingredients of this medicine (listed in section 6).
Other medicines and Lomudal GI:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
No adverse effects on the fetus have been demonstrated.
Breast-feeding
Lomudal GI passes into breast milk, but there is no information to suggest that breastfeeding women’s use of Lomudal GI would have adverse effects on the baby.
Driving and using machines:
Lomudal GI has no or negligible effect on the ability to drive and 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.
How to use Lomudal GI
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who will tailor it individually for you.
The recommended starting dose is:
For adults: 10 ml (200 mg) 4 times daily.
For children 2-14 years: 5 ml (100 mg) 4 times daily.
After starting treatment, it can take up to a couple of weeks before you feel better. It is therefore important to follow the doctor’s prescription and not to interrupt treatment or change the dose.
Instructions for use
Turn off the top of the single-dose container.
Lomudal GI can be taken directly into the mouth or mixed with water or juice. The medicine should be taken about 15 minutes before a meal and should be rinsed around the mouth before swallowing, to avoid possible absorption of allergens via the oral mucosa.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare ( may affect up to 1 in 1,000 people ) :
- nausea
- vomiting
- diarrhea
- upset stomach, stomach upset
- skin rash and joint pain
How to store Lomudal GI
Keep this medicine out of the sight and reach of children.
Sensitive to light. Store in the outer carton.
Do not store above 25 ° C. Store in a cold place.
Do not use this medicine after the expiry date which is stated on the carton after EXP. day. The expiration date is the last day of the specified month.
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.
Contents of the pack and other information
Content declaration
Content declaration
- The active substance is sodium cromoglycate 20 mg / ml
- The other ingredients (excipients) are purified water.
What the medicine looks like and contents of the pack
Lomudal GI is a clear, colorless solution. It is available in packs of 100×10 ml and 96×10 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sanofi AB, Box 30052, 104 25 Stockholm
Manufacturer
Laboratory Unither
Espace Industriel Nord
151 rue A.Durouchez
CS 28028
80084 Amiens Cedex 2 France