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Sodium Cromoglicate 100 mg hard capsules – patient leaflet, side effects, dosage

Updated:
Key facts
Status:
Prescription only (POM)
Medicine strength:
100 mg
Contains active substance:

Patient leaflet - Sodium Cromoglicate 100 mg hard capsules

1. What Sodium Cromoglicate is and what it is used for

Sodium Cromoglicate 100mg Capsules (called Sodium Cromoglicate throughout this leaflet) belong to a group of medicines called anti-allergics.

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.

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, and 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 a 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 breastfeeding, 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.

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 have taken.

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.

Unicorn Creation

Leaflet Size : 150 x 400 mm

Folding Size : 75 x 40 mm

Date : 14/01/2026

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 about the use of this medicine, ask your doctor or pharmacist.

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 this leaflet:

§ 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: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

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 30 days.

Keep the bottle tightly closed in order to protect from moisture. Store in the original package in order to protect from light.

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 sodium cromoglicate.

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:

Pharma Regulatory Solutions Limited, 20 Campbell Road, Woodley, Reading, RG5 3NA, United Kingdom.

Manufacturer:

Medley Pharma Limited, Unit 2A Olympic Way, Sefton Business Park, Bootle, L30 1RD, United Kingdom.

This leaflet was last revised in 01/2026.

To request a copy of this leaflet in braille, large print or audio format, contact the licence holder at the above address.

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk) · Marketing authorisation: PL 41734/0008

Last revision stated in the text: January 2026 · MHRA data as of 13 October 2026

What the sections and the side effect frequencies mean: How to read a patient leaflet

Found a mistake? Tell us on the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Sodium Cromoglicate 100 mg hard capsules

What these facts mean

Prescription needed?? Yes, prescription-only medicine (POM)
Active substance? Sodium cromoglicate
Strength? 100 mg
Pharmaceutical form? Oral capsule
Transparent capsule with circular double band on body and cap, containing white to off-white powder.
How is it taken? Oral
Excipients? Gelatin, Shellac, Propylene Glycol, Black iron Oxide (E172), Potassium Hydroxide
Pack sizes 100 capsule
Is it available?? Listed as available (NHS Dictionary of Medicines and Devices – not a record of current supplies)
Shelf life? 36 months
After first opening: 1 month
Storage Keep the bottle tightly closed in order to protect from moisture.
Drug group (ATC)? Antiallergic agents, excluding corticosteroids
  1. A Alimentary tract and metabolism drugs
    1. A07 Antidiarrheals, intestinal antiinflammatory/antiinfective agents
      1. A07E Intestinal antiinflammatory agents
        1. A07EB Antiallergic intestinal antiinflammatory drugs, excl. corticosteroids
          1. A07EB01 cromoglicic acid
Marketing authorisation? PL 15764/0161 (first authorised 1 March 2016), PL 41734/0008
Marketing authorisation holder? Strandhaven Limited t/a Somex Pharma
Codes? GTIN 5060090470287 · BNF 01050400

Sources: the MHRA product information (products.mhra.gov.uk) and the NHS Dictionary of Medicines and Devices (dm+d), release 11.1.0 of 9 November 2026, NHS Business Services Authority. Contains public sector information licensed under the Open Government Licence v3.0.