Document: leaflet MAH BRAND_PL 46302-0048 change

• leaflet MAH BRAND_PL 43900-0051
• leaflet MAH BRAND_PL 46302-0048
• leaflet MAH BRAND_PLPI 20636-2261

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1. What Sere is and what it is used for

Sere 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 Sere

Do not take Sere 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 Sere.

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 Sere. Also, Sere 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 Sere.

Taking Sere with food and drink

You can take Sere with or without food. Pregnancy and breast-feeding

Do not take Sere 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 Sere unless instructed by your doctor. It is not known if Sere passes into breast milk.

Driving and using machines

Sere 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 Sere (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 Sere

How to take Sere

•    Swallow the tablets with water.

•    Preferably take the tablet with a meal.

How much Sere to take

Always follow your doctor’s instructions because your doctor might adjust your dose

•    Sere is available in two strengths, an 8 mg tablet and a 16 mg tablet.

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•    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.

Sere is not recommended for those under 18 years old.

How to stop taking Sere

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 Sere than you should

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

If you forget to take Sere

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, Sere can cause side effects (unwanted effects or reactions), but not everyone gets them.

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

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 Sere 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 Sere

•    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 Sere 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 Sere 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:

Mylan Products Ltd.,

20 Station Close, Potters Bar,

Herts, EN6 1TL, UK The Manufacturer is:

Mylan Laboratories SAS,

01400 Chatillon-sur-Chalaronne, France.

This leaflet was revised in June 2016.

® Registered trademark

(HE Mylan

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