Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Sodium cromoglicate 100mg/5ml oral solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Sodium cromoglicate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Sodium cromoglicate oral solution contains the active substance sodium cromoglicate, which belongs to a group of medicines called anti-inflammatory drug, antiallergic agents, excluding corticosteroids. Eating certain foods may cause allergic reactions. Substances which can cause an inflammatory reaction in your stomach or intestine are released during this allergic reaction from mast cells. The release of these substances can lead to symptoms such as nausea, abdominal pain, diarrhoea, tightness, nose allergy, skin rashes, gall bumps or eczema. Sodium cromoglicate is an agent that inhibits the release of these substances. Sodium cromoglicate is prescribed by your doctor to prevent allergic symptoms caused by food ingredients that cannot always be avoided.
2.
What you need to know before you take it
e sodium cromoglicate oral solution
Do not use sodium cromoglicate oral solution If you are allergic to sodium cromoglicate or any of the other ingredients of this medicine. (listed in section 6) Warnings and Precautions Talk to your doctor or pharmacist before using sodium cromoglicate oral solution.
Do not use sodium cromoglicate if you have a medical history of a sudden severe allergic reaction (anaphylactic shock) or other life-threatening reactions to food. Children and adolescents Do not use sodium cromoglicate oral solution in children under 2 years. It is not known whether sodium cromoglicate is harmful in children under 2 years. Other medicines and sodium cromoglicate oral solution Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This also applies to medicines that you can get without a prescription. Sodium cromoglicate oral solution with food, drink and alcohol Take sodium cromoglicate oral solution 15 minutes before meals (see section 3 'How to use sodium cromoglicate'). Pregnancy, breast feeding and fertility 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. Use only during pregnancy after consultation with your doctor. Driving and using machines No studies on the effects on the ability to drive and use machines have been performed. An effect is unlikely.
3.
How to take it
sodium cromoglicate oral solution
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Take sodium cromoglicate oral solution 15 minutes before the meal. If you need to use sodium cromoglicate oral solution 4 x a day, then this means that you should take 3 x sodium cromoglicate oral solution before meals (3 meals a day) and 1 x before bedtime. The recommended dose is Adults: Drink 4 times a day the content of 2 ampoules of 5 ml before the meal. Use in Children: Drink 4 times a day the content of 1 ampoule of 5 ml before the meal. If the treatment does not produce enough results within 2-3 weeks, then your doctor may increase the dose. If the treatment results in adequate results, then your doctor will try to reduce the dose. The optimal dosage will be determined individually for each individual. Nutrients, for which you are allergic, may occasionally cause an allergic reaction in the mouth. If this is the case, then you should rinse your mouth with the solution before swallowing it.
If you take more sodium cromoglicate oral solution than you should In general, there are no adverse effects to be expected when too much sodium cromoglicate oral solution is taken. If you forget to take sodium cromoglicate oral solution Do not take a double dose to make up for a forgotten dose.
If you stop taking sodium cromoglicate oral solution If you stop taking sodium cromoglicate oral solution, then the symptoms may return for which you received sodium cromoglicate oral solution. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In some cases, nausea, vomiting, abdominal pain, rash and joint pain have been reported. Very rarely, an allergic reaction has been reported. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard 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 it
sodium cromoglicate oral solution
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 label and carton after 'EXP'. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions. 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 oral solution contains –
The active substance is sodium cromoglicate. Each ml of oral solution contains 20 mg sodium cromoglicate.
–
The other ingredient is water for injections.
What sodium cromoglicate oral solution looks like and the contents of the pack Sodium cromoglicate oral solution is clear colorless solution. Free from any visible particles. Sodium cromoglicate oral solution is available in 5 ml ampoule of LDPE Blow fill seal (BFS) container with twist off cap. Pack sizes: 8 ampoules, 96 ampoules Not all pack sizes may be marketed Marketing Authorisation Holder and Manufacturer Brown & Burk UK Ltd 5 Marryat Close
Hounslow West Middlesex TW4 5DQ United Kingdom This medicinal product is authorised in the Member States of the EEA under the following names: Netherlands: Natriumcromoglicaat BB 100mg, drank United Kingdom: Sodium cromoglicate 100 mg/5 ml oral solution This leaflet was last revised in 05/2018
Frequently asked questions about Sodium cromoglicate 100mg/5ml oral solution
How do I take Sodium cromoglicate 100mg/5ml oral solution?
Sodium cromoglicate 100mg/5ml oral solution comes as oral solution containing 100mg / 5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Sodium cromoglicate 100mg/5ml oral solution?
The active substance in Sodium cromoglicate 100mg/5ml oral solution is sodium cromoglicate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Sodium cromoglicate 100mg/5ml oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Sodium cromoglicate 100mg/5ml oral solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: sodium cromoglicate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Prophylactic treatment of allergic symptoms caused by components of the feed, if these components cannot be avoided.
4.2. Posology and method of administration
Posology
The optimal dosage should be determined individually for each patient. The prescribed dose should be taken 15 minutes before the meal. 3 times before the meal and 1 time before bedtime in case of 4x daily dose.
Adults:
Drink the content of 2 ampoules of 5 ml (200 mg) 4 x day.
Paediatric population:
Drink the content of an ampoule of 5 ml (100 mg) 4 x day.
There is insufficient data to assess potential harmfulness about the use of sodium cromoglicate in children below 2 years of age.
If an unsatisfactory result is achieved within 2-3 weeks, the dosage may be increased up to a maximum of 40 mg/kg/day. Try to decrease the dosage, if a satisfactory result has been achieved.
If feed allergy already occurs in the mouth, it is recommended to rinse the mouth with the oral solution prior to swallowing.
Method of administration
Oral use
4.3. Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1
4.4. Special warnings and precautions for use
Do not use in patients with a medical history of anaphylactic shock or other life-threatening reactions to food.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6. Fertility, pregnancy and lactation
Pregnancy:
There are no or limited amount of data from the use of sodium cromoglicate in pregnant women.
Animal studies are insufficient with respect to reproductive toxicity and fertility. (see section 5.3)
Sodium cromoglicate is not recommended during first trimester of pregnancy and in women of childbearing potential not using contraception.
Breast-feeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to sodium cromoglicate is presumed negligible. Sodium cromoglicate can be used during breast-feeding.
Fertility
There are no data indicating a harmful effect of sodium cromoglicate on fertility.
4.7. Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed. An effect is unlikely.
4.8. Undesirable effects
Side effects can occur in the following frequencies: very often (≥ 1/10), often (≥ 1/100, < 1/10), sometimes (≥ 1/1.000, < 1/100), rarely (≥ 1/10.000, < 1/1.000), very rarely (< 1/10.000), not known (cannot be determined by the available data).
Nutrition and metabolic disorders
rarely:
• nausea
• vomit
• diarrhea
• stomach complaints.
Skin and subcutaneous tissue disorders
rarely:
• skin rash.
Skeletal muscle and connective tissue disorders
rarely:
• joint pain.
General diseases and site disorders
very rarely:
• hypersensitivity reactions.
Reporting of suspected adverse effects
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No cases of overdose have been reported
💬 Ask about this leaflet
Ask anything about Sodium cromoglicate 100mg/5ml oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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- Eycrom 2% w/v eye drops, solution
- Librachrom 2% w/v eye drops, solution
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- Opticrom Allergy 2% w/v Eye Drops, Solution (Aspire MAH)
- Opticrom Allergy Single Dose 2% w/v Eye Drops, Solution
- Opticrom Aqueous 2% w/v Eye Drops, Solution (Aspire MAH)
- Opticrom Hayfever 2% w/v Eye Drops, solution (Aspire MAH)
- Optrex Allergy 2% w/v Eye Drops, Solution (eye drops)
- Optrex Hayfever Relief 2% w/v Eye Drops
- Sodium cromoglicate 2 %w/v Eye drops, Solution_PL 25298/0305