Betahistine Dihydrochloride Tablets 8mg
0278 Leaflet Serc 20150608
PACKAGE LEAFLET: INFORMATION FOR USER SERC TABLETS 8mg
Your medicine is known by either of the above names but will be referred to as Serc in the following leaflet.
Information for other strength of Serc (Serc Tablets 16mg) also may be present in this leaflet.
• 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
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.
• 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 Meniere'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.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
6. FURTHER INFORMATION
Like all medicines, Serc can cause side effects (unwanted effects or reactions), but not everyone gets them.
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 8mg of the active ingredient betahistine dihydrochloride
• Serc also contain microcrystalline cellulose, mannitol, citric acid, anhydrous colloidal silica and talc.
• Serc tablets are white, round tablets imprinted 256 on one side and plain on the other.
• Serc tablets are available as blister packs of 60 tablets.
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
Serc is a manufactured by Abbott Healthcare SAS, Route de Belville, Lieu-dit “Maillard”, 01400 Chatillon-sur-Chalaronne,
Serc is a registered trade mark of Solvay Pharmaceuticals BV, The Netherlands.
0278 Leaflet Serc 20150608
• Store the tablets at room temperature, in the original packaging.
• Do not take the tablets after the expiry date shown on the pack.
• If the tablets show any signs of deterioration check with your pharmacist who will tell you what to do.
• If your doctor tells you to stop taking the tablets, take any which you have left back to your pharmacist for safe disposal. Only keep the tablets if the doctor tells you to.
• 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.