Serc

• 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.

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

• 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.

• 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.

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.

You can take Serc with or without food.

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.

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.

• Swallow the tablets with water.
• Preferably take the tablet with a meal.

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.

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

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.

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

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.

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.

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.

The Marketing Authorisation Holder is:

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