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Serc 16mg Tablets

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SERC® 16mg TABLETS (betahistine dihydrochloride)

Patient Information Leaflet


27mm


'This product is known as the above name but will referred to as Serc throughout this leaflet. Another strength (8mg) is also available.


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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.

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


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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 drink alcohol while taking Serc.

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.

•    Take the tablet with or after 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.



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WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY    WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT

ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY    USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

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27mm


'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.


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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.


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


5. How to store Serc

•    Serc 16mg tablets should not be stored above 25°C. Store in the original package.

•    Do not use after the expiry date printed on the carton label or blister strip.

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.

•    If the tablets become discoloured or show any other signs of deterioration, you should ask your doctor or pharmacist before taking them.

•    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.


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6. Further information

Your medicine is called Serc 16mg Tablets. Each tablet contains 16mg of the active ingredient, betahistine dihydrochloride. Each tablet is white, round, plain on one side and '267' either side of a breakline on the other side.

Serc 16mg tablets also contain the following:

mannitol, microcrystalline cellulose, citric acid, colloidal anhydrous silica, and talc. These are the inactive ingredients.

Serc 16mg tablets are available as blister packs of 30, 90 and 120 tablets.


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POM    PL No: 6464/1926


This product is manufactured by Abbott Healthcare S.A.S., Route de Belleville Lieu-dit “Maillard”

01400 Chatillon-sur-Chalaronne, France, and is procured from within the EU and repackaged by the Product Licence holder:

Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR Leaflet revision and issue date (Ref.) 18.04.2013 Serc is a registered trademark of Solvay Pharmaceuticals B.V.


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WARNING! WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY    WARNING! THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT

ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY    USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.