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You may be able to get this leaflet in large print, Braille or as an audio CD, call the RNIB Medicine Leaflet line on 0800 198 5000 for more information.

The product codes for this leaflet are: PL 00512/0076, PL 00512/0088

 

Serc

Company Details

Abbott Healthcare Products Limited


Abbott HouseVanwall Business ParkVanwall RoadMaidenhead SL6 4XE
Telephone:
Fax:
Medical Information e-mail:medinfo.shl@abbott.com

PATIENT INFORMATION LEAFLET

Serc®-8

Serc®-16

Betahistine dihydrochloride

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

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 Ménière'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 (MAOls) - 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 Ménière'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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the United Kingdom national reporting system 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 reach and sight 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 E421, citric acid monohydrate, colloidal anhydrous silica and talc.

What Serc looks like and contents of the pack

Serc-8 are round, flat, white to almost white and with '256' imprinted on one face of the tablet.

Serc-16 are round, bioconvex, scored, white to almost white and with '267', imprinted on one face of the tablet.

Serc-8 is available in packs of 120 tablets and containers with 500 or 1000 tablets.

Serc-16 is available in packs of 84 tablets and containers with 500 or 1000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Abbott Healthcare Products Limited
Abbott House
Vanwall Business Park
Vanwall Road
Maidenhead
SL6 4XE
UK

The Manufacturer is:

Abbott Healthcare SAS
01400 Châtillon-sur-Chalaronne
France

For information in large print, tape, CD or Braille, phone 02380 467000.

This leaflet was revised in May 2014.

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