Patient leaflet - NALCROM 100 MG CAPSULES / SODIUM CROMOGLICATE 100 MG CAPSULES
Nalcrom® 100mg Capsules
(sodium cromoglicate)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
-
■ 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.
What is in this leaflet:
-
1. What Nalcrom Capsules are and what they are used for
-
2. What you need to know before you take Nalcrom Capsules
-
3. How to take Nalcrom Capsules
-
4. Possible side effects
-
5. How to store Nalcrom Capsules
-
6. Contents of the pack and other information
1. What Nalcrom Capsules are and what they are used for
Nalcrom 100mg Capsules (called Nalcrom Capsules in this leaflet) contain a medicine called sodium cromoglicate. This belongs 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 Nalcrom Capsules are used for:
-
■ Nalcrom Capsules are used to treat allergic reactions to certain foods.
-
■ It is only used if you have had a test to prove 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 nalcrom capsules
Do not take Nalcrom if:
-
■ You are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of Nalcrom Capsules (listed in Section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Nalcrom Capsules.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or think you may be pregnant.
If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine.
3. how to take nalcrom capsules
Always take Nalcrom Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
-
■ 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 be larger than 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 forget to take Nalcrom Capsules
If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.
If you stop taking Nalcrom Capsules
Keep taking Nalcrom Capsules until your doctor tells you to stop. Do not stop taking Nalcrom Capsules 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 product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Nalcrom Capsules can cause side effects, although not everybody gets them.
Stop taking Nalcrom Capsules and see a doctor or go to a hospital straight away if:
-
■ You have an allergic reaction to Nalcrom Capsules.
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 gets serious or lasts 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: 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.
If you take more Nalcrom 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.
5. how to store nalcrom capsules
-
■ Keep out of the sight and reach of children.
-
■ Do not use Nalcrom Capsules after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
-
■ Store in the original package to protect from light.
-
■ If the capsules become discoloured or show signs of deterioration, you should seek the advice of your pharmacist.
-
■ If your doctor decides to stop your treatment, take any capsules you have left back to the pharmacy.
-
■ Medicines 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 pack and other information
What Nalcrom Capsules contain
■ The active substance is sodium cromoglicate.
Each capsule contains lOOmg of sodium cromoglicate.
What Nalcrom Capsules look like and contents of the pack
Nalcrom Capsules are hard gelatine capsules with a clear, colourless cap and body, printed with ‚SODIUM CROMOGLICATE 100 mg‘ in black and containing a white powder.
Nalcrom Capsules are available in packs of 20 and 100 capsules.
Manufacturer
Manufactured by: ITC FARMA Srl – Via Pontina 5, Km 29 00040 Pomezia, Rome.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.
PL No.: 21828/0715 POM
Nalcrom® is a registered trademark of Fisons Ltd.
Blind or partially sighted?
Is this leaflet hard to see or read?
Call +44 (0) 1302 365000 (Regulatory)
Please be ready to give the following information:
Product name:
Nalcrom lOOmg Capsules
Reference No: 21828/0715
PACKAGE LEAFLET: INFORMATION FOR THE USER
Sodium Cromoglicate 100mg Capsules
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
-
■ 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.
What is in this leaflet:
-
1. What Sodium Cromoglicate Capsules are and what they are used for
-
2. What you need to know before you take Sodium Cromoglicate Capsules
-
3. How to take Sodium Cromoglicate Capsules
-
4. Possible side effects
-
5. How to store Sodium Cromoglicate Capsules
-
6. Contents of the pack and other information
-
1. What Sodium Cromoglicate Capsules are and what they are used for
Sodium Cromoglicate 100mg Capsules (called Sodium Cromoglicate Capsules in this leaflet) contain a medicine called sodium cromoglicate. This belongs 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 Capsules are used for:
-
■ Sodium Cromoglicate Capsules are used to treat allergic reactions to certain foods.
-
■ It is only used if you have had a test to prove 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 capsules
Do not take Sodium Cromoglicate if:
-
■ You are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of Sodium Cromoglicate Capsules (listed in Section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Sodium Cromoglicate Capsules.
Pregnancy and breast-feeding
Talk to your doctor before taking this medicine if you are pregnant, might become pregnant or think you may be pregnant.
If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking this medicine.
3. how to take sodium cromoglicate capsules
Always take Sodium Cromoglicate Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Taking this medicine
-
■ 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 be larger than 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 forget to take Sodium Cromoglicate Capsules If you forget a dose, take it as soon as you remember it.
However, if it is nearly time for the 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 Capsules Keep taking Sodium Cromoglicate Capsules until your doctor tells you to stop. Do not stop taking Sodium Cromoglicate Capsules 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 product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, Sodium Cromoglicate Capsules can cause side effects, although not everybody gets them.
Stop taking Sodium Cromoglicate Capsules and see a doctor or go to a hospital straight away if:
-
■ You have an allergic reaction to Sodium Cromoglicate Capsules.
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 gets serious or lasts 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: 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.
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.
5. how to store sodium cromoglicate capsules
-
■ Keep out of the sight and reach of children.
-
■ Do not use Sodium Cromoglicate Capsules after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
-
■ Store in the original package to protect from light.
-
■ If the capsules become discoloured or show signs of deterioration, you should seek the advice of your pharmacist.
-
■ If your doctor decides to stop your treatment, take any capsules you have left back to the pharmacy.
-
■ Medicines 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 pack and other information
What Sodium Cromoglicate Capsules contain
-
■ The active substance is sodium cromoglicate.
Each capsule contains lOOmg of sodium cromoglicate.
What Sodium Cromoglicate Capsules look like and contents of the pack
Sodium Cromoglicate Capsules are hard gelatine capsules with a clear, colourless cap and body, printed with ‚SODIUM CROMOGLICATE 100 mg‘ in black and containing a white powder.
Sodium Cromoglicate Capsules are available in packs of 20 and 100 capsules.
Manufacturer
Manufactured by: ITC FARMA Srl – Via Pontina 5, Km 29 00040 Pomezia, Rome.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.
Product Licence holder: Landmark Pharma Ltd.,
-
7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.