Serc-8 Tablets Serc-16 Tablets

(betahistine dihydrochloride) PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking 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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This medicine is available using the above name but will be referred to as Serc throughout the leaflet.

In this leaflet:

1.    What Serc is and what it is used for

2.    Before you take Serc

3.    How to take Serc

4.    Possible side effects

5.    How to store Serc

6.    Further information

1.    WHAT SERC IS AND WHAT IT IS USED FOR

Serc contains betahistine. This medicine is called a histamine analogue. It is used to treat:

-    dizziness (vertigo)

-    ringing in the ears (tinnitus)

-    hearing loss suffered by people with Meniere's disease

This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure.

2.    BEFORE YOU TAKE SERC Do not take Serc if:

-    You are allergic to any of the ingredients in the tablets (see section 6 for further details).

-    You have high blood pressure due to an adrenal tumour (phaeochromocytoma).

If any of the above applies to you, do not take this medicine and talk to your doctor.

Take special care and tell your doctor if:

-    you have a stomach ulcer

-    you have asthma

-    you are pregnant or planning to become pregnant

-    you are breast-feeding

If any of the above applies to you, talk to your doctor before taking this medicine.

Your doctor will tell you whether it is safe for you to start taking this medicine.

Your doctor may also want to monitor your asthma while you take Serc. Taking other medicines

Please tell your doctor or pharmacist if you are taking or have taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

-    Anti-histamines - these may (in theory) lower the effect of Serc. Also, Serc may lower the effect of anti-histamines.

-    Monoamine-oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. These may increase the exposure of Serc.

Taking Serc with food and drink

You can take Serc with or without food.

Pregnancy and breast-feeding

Do not take Serc if you are pregnant unless your doctor has decided that it is absolutely necessary. Ask your doctor for advice.

Do not breast-feed while using Serc unless instructed by your doctor. It is not known if Serc passes into breast milk.

Driving and using machines

Serc is not likely to affect your ability to drive or use tools or machinery. However, remember that diseases for which you are being treated with Serc (vertigo, tinnitus and hearing loss associated with Meniere's syndrome) can make you feel dizzy or be sick, and can affect your ability to drive or use machines.

3.    HOW TO TAKE SERC How to take Serc

-    Swallow the tablets with water.

-    Preferably take the tablet with a meal.

How much Serc to take

Always follow your doctor's instructions because your doctor might adjust your dose.

-    Serc is available in two strengths, an 8 mg tablet and a 16 mg tablet.

-    The usual starting dose is 16 mg three times a day (48 mg).

-    Your doctor may lower your dose to 8 mg three times a day (24 mg).

Keep taking your tablets. The tablets can take a while to start to work.

Serc is not recommended for those under 18 years old.

How to stop taking Serc

Keep taking your tablets until your doctor tells you to stop.

Even when you start feeling better, your doctor may want you to carry on taking the tablets for some time to make sure that the medicine has worked completely.

If you take more Serc than you should

If you or someone else takes too much Serc (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Serc

If you miss a tablet, wait until the next dose is due. Do not try to make up for the dose you have missed.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Serc can cause side effects (unwanted effects or reactions), but not everyone gets them.

The following serious side effects may occur during treatment with Serc:

Allergic reactions such as:

-    swelling of your face, lips, tongue or neck. This may cause difficulty breathing.

-    a red skin rash, inflamed itchy skin

If any of these side effects occur you should stop treatment immediately and contact your doctor.

Common side effects (at least 1 in 100 and less than 1 in 10 patients): Nausea, indigestion, headaches.

Other side effects

Itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking Serc with food can help reduce any stomach problems.

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 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 SERC

-    Keep out of the sight and reach of children.

-    This medicine should preferably be locked in a cupboard or medicine cabinet.

-    Do not use the tablets after the expiry date, which is printed on the carton and blister pack.

-    Do not store your tablets above 25°C and keep them in the original package.

-    If your doctor stops your treatment, return any unused tablets to a pharmacist.

-    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 Serc contains

Each tablet contains 8 or 16 mg of betahistine dihydrochloride.

The tablets also contain microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silicon dioxide and talc.

What Serc looks like and contents of the pack

Serc-8 are round, flat and white tablets with ‘256' imprinted on the one side and plain on the reverse.

Serc-16 are round, biconvex, scored white tablets with ‘267' imprinted on the one either side of score and plain on the reverse.

Serc-8 is available in packs of 125 tablets and 100 tablets.

Serc-16 is available in packs of 80 tablets and 60 tablets.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Manufactured by Abbott Healthcare SAS, route de belleville, lieu-dit "Maillard", Chatillon-Sur-Chalaronne, F-01400, France and Procured from within the EU by Product Licence holder Star Pharmaceuticals Ltd,

5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet issue and revision date (Ref:) 15.09.15[8] Serc is trademark of Abbott Healthcare Products B.V

Betahistine Dihydrochloride 8 mg Tablets

Betahistine Dihydrochloride 16 mg Tablets

PATIENT INFORMATION LEAFLET

Read all of this leaflet carefully before you start taking 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 becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This medicine is available using any of the above names but will be referred to as Betahistine Tablets throughout the leaflet

In this leaflet:

1.    What Betahistine Tablets is and what it is used for

2.    Before you take Betahistine Tablets

3.    How to take Betahistine Tablets

4.    Possible side effects

5.    How to store Betahistine Tablets

6.    Further information

1. WHAT BETAHISTINE TABLETS IS AND WHAT IT IS USED FOR

Betahistine Tablets is a histamine analogue. It is used to treat:

-    dizziness (vertigo)

-    ringing in the ears (tinnitus)

-    hearing loss suffered by people with Meniere's disease

This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure.

2. BEFORE YOU TAKE BETAHISTINE TABLETS Do not take Betahistine Tablets if:

-    You are allergic to any of the ingredients in the tablets (see section 6 for further details).

-    You have high blood pressure due to an adrenal tumour (phaeochromocytoma).

If any of the above applies to you, do not take this medicine and talk to your doctor.

Take special care and tell your doctor if:

-    you have a stomach ulcer

-    you have asthma

-    you are pregnant or planning to become pregnant

-    you are breast-feeding

If any of the above applies to you, talk to your doctor before taking this medicine.

Your doctor will tell you whether it is safe for you to start taking this medicine.

Your doctor may also want to monitor your asthma while you take Betahistine Tablets.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

-    Anti-histamines - these may (in theory) lower the effect of Betahistine Tablets. Also, Betahistine Tablets may lower the effect of antihistamines.

-    Monoamine-oxidase inhibitors (MAOIs) - used to treat depression or Parkinson's disease. These may increase the exposure of Betahistine Tablets.

Taking Betahistine Tablets with food and drink

You can take Betahistine Tablets with or without food.

Pregnancy and breast-feeding

Do not take Betahistine Tablets if you are pregnant unless your doctor has decided that it is absolutely necessary. Ask your doctor for advice. Do not breast-feed while using Betahistine Tablets unless instructed by your doctor. It is not known if Betahistine Tablets passes into breast milk.

Driving and using machines

Betahistine Tablets is not likely to affect your ability to drive or use tools or machinery. However, remember that diseases for which you are being treated with Betahistine Tablets (vertigo, tinnitus and hearing loss associated with Meniere's syndrome) can make you feel dizzy or be sick, and can affect your ability to drive or use machines.

3. HOW TO TAKE BETAHISTINE TABLETS How to take Betahistine Tablets

-    Swallow the tablets with water.

-    Preferably take the tablet with a meal.

How much Betahistine Tablets to take

Always follow your doctor's instructions because your doctor might adjust your dose.

-    Betahistine Tablets is available in two strengths, an 8 mg tablet and a 16 mg tablet.

-    The usual starting dose is 16 mg three times a day (48 mg).

-    Your doctor may lower your dose to 8 mg three times a day (24 mg).

Keep taking your tablets. The tablets can take a while to start to work. Betahistine Tablets is not recommended for those under 18 years old.

How to stop taking Betahistine Tablets

Keep taking your tablets until your doctor tells you to stop.

Even when you start feeling better, your doctor may want you to carry on taking the tablets for some time to make sure that the medicine has worked completely.

If you take more Betahistine Tablets than you should

If you or someone else takes too much Betahistine Tablets (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.

If you forget to take Betahistine Tablets

If you miss a tablet, wait until the next dose is due. Do not try to make up for the dose you have missed.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines Betahistine Tablets can cause side effects (unwanted effects or reactions), but not everyone gets them.

The following serious side effects may occur during treatment with Betahistine Tablets:

Allergic reactions such as:

-    swelling of your face, lips, tongue or neck. This may cause difficulty breathing.

-    a red skin rash, inflamed itchy skin

If any of these side effects occur you should stop treatment immediately and contact your doctor.

Common side effects (at least 1 in 100 and less than 1 in 10 patients): Nausea, indigestion, headaches.

Other side effects

Itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking Betahistine Tablets with food can help reduce any stomach problems.

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 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 BETAHISTINE TABLETS

-    Keep out of the sight and reach of children.

-    This medicine should preferably be locked in a cupboard or medicine cabinet.

-    Do not use the tablets after the expiry date, which is printed on the carton and blister pack.

-    Do not store your tablets above 25°C and keep them in the original package.

-    If your doctor stops your treatment, return any unused tablets to a pharmacist.

-    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 Betahistine Tablets contains

Each tablet contains 8 or 16 mg of betahistine dihydrochloride.

The tablets also contain microcrystalline cellulose, mannitol, citric acid monohydrate, colloidal anhydrous silicon dioxide and talc.

What Betahistine Tablets looks like and contents of the pack

Betahistine Dihydrochloride 8 mg Tablets are round, flat and white tablets with ‘256' imprinted on the one side and plain on the reverse.

Betahistine Dihydrochloride 16 mg Tablets are round, biconvex, scored white tablets with ‘267' imprinted on the one either side of score and plain on the reverse.

Betahistine Dihydrochloride 8 mg Tablets is available in packs of 125 tablets and 100 Tablets

Betahistine Dihydrochloride 16 mg Tablets is available in packs of 80 tablets and 60 tablets.

MANUFACTURER AND PRODUCT LICENCE HOLDER

Manufactured by Abbott Healthcare SAS, route de belleville, lieu-dit "Maillard", Chatillon-Sur-Chalaronne, F-01400, France and Procured from within the EU by Product Licence holder Star Pharmaceuticals Ltd,

5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet issue and revision date (Ref:) 15.09.15[8]