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PACKAGE LEAFLET: INFORMATION FOR THE USER

NALCROM® 100mg CAPSULES

(sodium cromoglicate)

Read all of this leaflet carefully before you start using this

medicine

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is NALCROM 100mg CAPSULES

but will be referred to as Nalcrom Capsules throughout this

leaflet.

In this leaflet:

1.    What Nalcrom Capsules are and what they are used for

2.    Before you take Nalcrom Capsules

3.    How to take Nalcrom Capsules

4.    Possible side effects

5.    How to store Nalcrom Capsules

6.    Further information

Nalcrom Capsules 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. Before you take Nalcrom Capsules

► J Do not take this medicine and tell your doctor if:

x You are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of Nalcrom Capsules (listed in Section 6: 'Further information') 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 take more Nalcrom Capsules 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 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: www.mhra.gov.uk/yellowcard By reporting side effects, you can help provide more information on the safety of this medicine.

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 blister / carton label after 'Exp'. The expiry date refers to the last day of that month.

Store in a dry place. Protect from light.

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. Further information

SODIUM CROMOGLICATE 100mg CAPSULES

Read all of this leaflet carefully before you start using this

medicine

•    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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is SODIUM CROMOGLICATE

100mg CAPSULES but will be referred to as Sodium

cromoglicate Capsules throughout this leaflet.

In this leaflet:

1.    What Sodium cromoglicate Capsules are and what they are used for

2.    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.    Further information

1. What Sodium cromoglicate Capsules are and what they are used for_

Sodium cromoglicate Capsules 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

^ Do not take this medicine and tell your doctor if:

x You are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of Sodium cromoglicate Capsules (listed in Section 6: 'Further information')

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 take more Sodium cromoglicate Capsules 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 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: www.mhra.gov.uk/yellowcard By reporting side effects, you can help provide more information on the safety of this medicine.

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 blister / carton label after 'Exp'. The expiry date refers to the last day of that month.

Store in a dry place. Protect from light.

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. Further information

What Sodium cromoglicate Capsules contain

The active substance is sodium cromoglicate. Each capsule contains 100mg sodium cromoglicate.

The other ingredients are: gelatine and black printing ink.

What Sodium cromoglicate Capsules look like and contents of the pack

•    Sodium cromoglicate Capsules are hard gelatin capsules with a clear cap and body, marked 'SODIUM' and 'CROMOGLICATE 100 mg' in black respectively and containing a white powder.

•    Sodium cromoglicate Capsules are available in blister packs containing 20 capsules.

Manufactured by: ITC Farma Srl, Via Pontina 5, Km 29, 00040 Pomezia, Rome.

Procured from within the EU and repackaged by the Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK.

SODIUM CROMOGLICATE 100mg CAPSULES,

PL No: 18799/2204    _

Leaflet date: 30.03.2015    I ^POM I