SODIUM CROMOGLICATE 100MG HARD CAPSULES
Active substance(s): SODIUM CROMOGLICATE
PACKAGE LEAFLET: INFORMATION FOR THE USER
100 MG CAPSULES
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may
harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
Fonts: Vectora Light & Vectora Black
Colours: n Black
Size: 400 x 150mm
Read all of this leaflet carefully before you start taking this medicine because
it contains important information for you.
What is in this leaflet
1. What Sodium Cromoglicate is and what it is used for
2. What you need to know before you take Sodium Cromoglicate
3. How to take Sodium Cromoglicate
4. Possible side effects
5. How to store Sodium Cromoglicate
6. Contents of the pack and other information
1. WHAT SODIUM CROMOGLICATE IS AND WHAT IT IS USED FOR
Sodium Cromoglicate 100mg Capsules (called Sodium Cromoglicate throughout this
leaflet) belongs to a group of medicines called anti-allergics.
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Product: Sodium Cromoglicate Capsules PIL
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It works by stopping the release of the natural substances in your body that can cause
an allergic reaction. It also lowers your response when you are exposed to substances
to which you are allergic.
What Sodium Cromoglicate is used for
• Sodium Cromoglicate is used to treat allergic reactions to certain foods.
• It is only used if you have had a test proving that you are allergic to these foods.
• As part of your treatment your doctor should advise you to avoid eating certain foods
which may cause an allergic reaction.
How much to take
Adults (including the elderly)
• Two capsules, four times a day, before meals.
• When your symptoms improve, your doctor may lower your dose.
Children (aged between 2 and 14 years)
• One capsule, four times a day, before meals.
• When your child’s symptoms improve, your doctor may lower the dose.
If you take more Sodium Cromoglicate than you should
Talk to your doctor or go to a hospital straight away.
Remember to take any medicine that is left with you so the doctor knows what you
If you forget to take Sodium Cromoglicate
If you forget a dose, take it as soon as you remember it. However, if it is nearly time
for your next dose, skip the missed dose. Do NOT take a double dose to make up for
a forgotten dose.
If you stop taking Sodium Cromoglicate
Keep taking this medicine until your doctor tells you to stop. Do NOT stop taking
Sodium Cromoglicate just because you feel better. If you stop, your food allergies may
come back or get worse.
If you have any further questions on the use of this medicine, ask your doctor or
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sodium Cromoglicate can cause side effects, although not
everybody gets them.
STOP taking Sodium Cromoglicate and go and see a doctor or go to hospital
IMMEDIATELY if you have an allergic reaction to this medicine:
• The signs may include a rash, swallowing or breathing problems, swelling of your
lips, face, throat or tongue.
Talk to your doctor or pharmacist if any of the side effects get serious or
last longer than a few days, or if you notice any side effects not listed in
• Skin rashes.
• Pain in your joints.
• Feeling sick (nausea).
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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting
side effects you can help provide more information on the safety of this medicine.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SODIUM CROMOGLICATE
Do not take Sodium Cromoglicate and tell your doctor:
• If you are allergic to sodium cromoglicate or any of the other ingredients of this
medicine (listed in section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing problems,
swelling of your lips, face, throat or tongue. If you have an allergic reaction to this
medicine, stop taking Sodium Cromoglicate and go and see a doctor or go
to hospital straight away (see section 4).
Do NOT use this medicine if any of the above applies to you. If you are not sure, talk to
your doctor or pharmacist before taking Sodium Cromoglicate.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.
3. HOW TO TAKE SODIUM CROMOGLICATE
Always take this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
Method of administration
• Take this medicine by mouth.
• Take this medicine before a meal.
• If signs of allergy do not improve within 2-3 weeks, your doctor may double how
much you take. Your dose should not exceed 40 mg per kilogram of your body
weight per day.
• If you feel the effect of your medicine is too weak or too strong, do NOT change the
dose yourself, but ask your doctor.
5. HOW TO STORE SODIUM CROMOGLICATE
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle
label. The expiry date refers to the last day of that month.
After first opening the container, the capsules should be used within 1 month.
Keep the bottle tightly closed in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Sodium Cromoglicate contains
The active substance is: sodium cromoglicate. Each capsule contains 100 mg of
The other ingredients are: purified water, gelatin and edible ink. The ink contains
shellac (E904), propylene glycol, black iron oxide (E172) and potassium hydroxide.
What Sodium Cromoglicate looks like and contents of the pack
Sodium Cromoglicate 100 mg Capsules are transparent gelatine capsules with a
circular double band on the body and cap.
The capsules are available in a white opaque HDPE bottle containing 100 capsules.
Marketing Authorisation Holder and Manufacturer
NRIM Limited, Unit 15 Moorcroft, Harlington Road, Hillingdon, UB8 3HD, United
This leaflet was last revised in 10/2015.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.