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Hydrocortisone 2.5 Mg Muco-Adhesive Buccal Tablets

Document: leaflet MAH BRAND_PL 17507-0190 change

Patient Information Leaflet

Corlan® 2.5mg Muco-Adhesive Buccal Tablets

Read all of this leaflet carefully because it contains important information for you.

•    This medicine is available without prescription. However, you still need to use Corlan® 2.5mg Buccal Tablets carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    You must contact a doctor if your symptoms worsen or do not improve after five days.

•    In this leaflet Corlan® 2.5mg Muco-Adhesive Buccal Tablets will be called Corlan® 2.5mg Buccal Tablets.

In this leaflet:

1.    What Corlan® 2.5mg Buccal Tablets are for

2.    Before you use Corlan® 2.5mg Buccal Tablets

3.    How to use Corlan® 2.5mg Buccal Tablets

4.    Possible side effects

5.    How to store Corlan® 2.5mg Buccal Tablets

6.    Further information

1.    What Corlan® 2.5mg Buccal Tablets are for

Corlan® 2.5mg Buccal Tablets belong to a group of medicines called corticosteroids.

Corlan® 2.5mg Buccal Tablets works by reducing any swelling and inflammation in your mouth.

Corlan® 2.5mg Buccal Tablets is used to treat mouth ulcers. Only use this medicine if:

•    Your doctor or dentist has told you to

•    You know you have a condition called recurrent aphthous ulceration.

You must not use Corlan® 2.5mg Buccal Tablets to treat ulcers caused by either wearing dentures or an injury or infection.

You must see your doctor or dentist about getting treatment for these.

Corlan® 2.5mg Buccal Tablets contains a different type of steroid to those misused by sports people.

2.    Before you use Corlan® 2.5mg Buccal Tablets

Do not use Corlan® 2.5mg Buccal Tablets if:

•    You are allergic to hydrocortisone

•    You are allergic to any of the other ingredients of Corlan® 2.5mg Buccal Tablets (see section 6)

•    You have an infection of your mouth.

If any of the above applies to you talk to your doctor or pharmacist.

Check with your doctor before using Corlan® 2.5mg Buccal Tablets if:

•    You keep getting ulcers or they become severe

•    You are taking any other medicines, including those without a prescription.

Pregnancy and breast-feeding

There may be a small chance that this medicine may harm an unborn baby.

If you are pregnant, trying to become pregnant or are breast-feeding ask your doctor or pharmacist for advice before using Corlan® 2.5mg Buccal Tablets.

Warnings about the ingredients in Corlan® 2.5mg Buccal Tablets

Corlan® 2.5mg Buccal Tablets contain 68mg of lactose per tablet. It is not suitable for people who are unable to tolerate a sugar called lactose. This rare condition may have been passed down from someone in your family. Tell your doctor or pharmacist before taking Corlan® 2.5mg Buccal Tablets if this applies to you.

3.    How to use Corlan® 2.5mg Buccal Tablets

Children using this medicine should follow the instructions given by their doctor.

Adults using this medicine should follow the instructions given below.

If you do not understand the instructions or you are not sure, ask your doctor or pharmacist. Adults and Elderly

•    Do not suck Corlan® 2.5mg Buccal Tablets

•    Put one tablet as near to the ulcer as you can and let it dissolve.

•    If you have more than one ulcer, swap the tablet from one ulcer to another. Do not use more than one tablet at a time.

•    Use one tablet four times each day for up to five days. This is a treatment course

•    If the ulcers heal you can stop using the medicine.

Remember: if after 5 days treatment the ulcers have not healed or more come back soon after finishing the course, you must see your doctor.

Children under 12 years

•    Children under 12 years must see a doctor before starting each course of Corlan® 2.5mg Buccal Tablets.

•    Your doctor will tell you the correct way for a child to use this medicine.

If you use more Corlan® 2.5mg Buccal Tablets than you should

If you accidentally use too much Corlan® 2.5mg Buccal Tablets, contact the nearest hospital casualty department or your doctor as soon as possible.

If you forget to use Corlan® 2.5mg Buccal Tablets

Do not use a double dose to make up for a missed dose. Simply use the next dose as planned. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4.    Possible side effects

Like all medicines Corlan® 2.5mg Buccal Tablets can cause side effects, although not everybody gets them.

Only use this medicine for a short a time as possible.

Only use it directly on the ulcers. This will make the chance of getting any side effects less.

The following side effects can occur with corticosteroid medicines like Corlan® 2.5mg Buccal Tablets:

•    Allergic reactions

•    If you have diabetes it may get worse

•    If you have an infection of your mouth it may get worse.

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.

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 the Yellow Card Scheme (Website: 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 Corlan® 2.5mg Buccal Tablets

Keep out of the reach and sight of children.

Do not use Corlan® 2.5mg Buccal Tablets after the expiry date on the pack. The expiry date refers to the last day of that month. Store below 25°C. Replace the cap firmly after use. Medicines should not be disposed of via wastewater or household waste. Return any medicine you no longer need to your pharmacist.

6.    Further information

What Corlan® 2.5mg Buccal Tablets contains

The active substance is 2.5 mg hydrocortisone.

The other ingredients are lactose, acacia and magnesium stearate.

What Corlan® 2.5mg Buccal Tablets looks like

Corlan® 2.5mg Buccal Tablets is a small white tablet with 'Corlan Evans' written on one side. Corlan® 2.5mg Buccal Tablets come in plastic containers with 20 tablets.

Marketing Authorisation Holder

Auden Mckenzie (Pharma Division) Ltd, Whiddon Valley, Barnstaple, North Devon,

EX32 8NS, UK.

Manufacturer

Tiofarma BV, Benjamin Franklinstraat 9, 3261 LW Oud-Beijereland, The Netherlands.

This leaflet was last updated September 2015.

If this leaflet is difficult to see or read or you would like it in a different format, please contact Auden Mckenzie (Pharma Division) Ltd, Whiddon Valley, Barnstaple, North Devon,

EX32 8NS, UK.