Serc 16mg Tablets
S850 Leaflet Serc 20150604
PACKAGE LEAFLET: INFORMATION FOR USER SERC 16mg TABLETS
(betahistine dihydrochloride)
Your medicine is known as Serc 16mg Tablets but will be referred to as Serc throughout the following leaflet.
Information for another strength of Serc (Serc 8mg Tablets) also may be present in this leaflet.
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 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 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.
• 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.
6. FURTHER INFORMATION
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 SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Store in the original package to protect from light.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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.
What Serc contains
• Each tablet contains 16mg of the active ingredient, betahistine dihydrochloride,
• Serc Tablets also contain the following inactive ingredients: microcrystalline cellulose, mannitol, citric acid, colloidal anhydrous silica and talc.
What Serc looks like and contents of the pack
• Serc Tablets are round, biconvex, white tablets marked ‘267' on either side of a scoreline on one side and plain on the reverse.
• Serc Tablets are available as blister packs of 60 tablets. Product Licence holder
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA01DX.
Manufacturer
This product is manufactured by Abbott Healthcare SAS, Route de Belleville - Lieu-dit Maillard, 01400 Chatillon sur Chalaronne, France.
|POM | PL 19488/0850 Leaflet revision date: 04 June 2015
Serc is a registered trade mark of Solvay Pharmaceuticals B.V.,
The Netherlands.
S850 Leaflet Serc 20150604
S850 Leaflet Betahistine 20150604
PACKAGE LEAFLET: INFORMATION FOR USER BETAHISTINE DIHYDROCHLORIDE 16 mg TABLETS
Your medicine is known as Betahistine Dihydrochloride 16mg Tablets but will be referred to as Betahistine Dihydrochloride throughout the following leaflet.
Information for another strength of Betahistine Dihydrochloride (Betahistine Dihydrochloride 8mg Tablets) also may be present in this leaflet.
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 Betahistine Dihydrochloride is and what it is used for
2. Before you take Betahistine Dihydrochloride
3. How to take Betahistine Dihydrochloride
4. Possible side effects
5. How to store Betahistine Dihydrochloride
6. Further information
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 Betahistine Dihydrochloride. Also, Betahistine Dihydrochloride 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 Betahistine Dihydrochloride.
Taking Betahistine Dihydrochloride with food and drink
You can take Betahistine Dihydrochloride with or without food.
Pregnancy and breast-feeding
Do not take Betahistine Dihydrochloride 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 Betahistine Dihydrochloride unless instructed by your doctor. It is not known if Betahistine Dihydrochloride passes into breast milk.
Driving and using machines
Betahistine Dihydrochloride 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 Betahistine Dihydrochloride (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 BETAHISTINE DIHYDROCHLORIDE
1. WHAT BETAHISTINE DIHYDROCHLORIDE IS AND WHAT IT IS USED FOR
Betahistine Dihydrochloride 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 BETAHISTINE DIHYDROCHLORIDE
Do not take Betahistine Dihydrochloride 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 Betahistine Dihydrochloride.
How to take Betahistine Dihydrochloride
• Swallow the tablets with water.
• Preferably take the tablet with a meal.
How much Betahistine Dihydrochloride to take
Always follow your doctor's instructions because your doctor might adjust your dose
• Betahistine Dihydrochloride 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.
Betahistine Dihydrochloride is not recommended for those under 18 years old.
How to stop taking Betahistine Dihydrochloride
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 Betahistine Dihydrochloride than you should
If you or someone else takes too much Betahistine Dihydrochloride (an overdose), talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Betahistine Dihydrochloride
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
6. FURTHER INFORMATION
Like all medicines, Betahistine Dihydrochloride can cause side effects (unwanted effects or reactions), but not everyone gets them. The following serious side effects may occur during treatment with Betahistine Dihydrochloride:
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 Betahistine Dihydrochloride 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 BETAHISTINE DIHYDROCHLORIDE
• KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
• Do not store above 25°C.
• Store in the original package to protect from light.
• Do not use after the expiry date printed on the carton label or blister strip.
• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.
• If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.
• 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.
What Betahistine Dihydrochloride contains
• Each tablet contains 16mg of the active ingredient, betahistine dihydrochloride,
• Betahistine Dihydrochloride Tablets also contain the following inactive ingredients: microcrystalline cellulose, mannitol, citric acid, colloidal anhydrous silica and talc.
What Betahistine Dihydrochloride looks like and contents of
the pack
• Betahistine Dihydrochloride Tablets are round, biconvex, white tablets marked ‘267' on either side of a scoreline on one side and plain on the reverse.
• Betahistine Dihydrochloride Tablets are available as blister packs of 60 tablets.
Product Licence holder
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA01DX.
Manufacturer
This product is manufactured by Abbott Healthcare SAS, Route de Belleville - Lieu-dit Maillard, 01400 Chatillon sur Chalaronne,
France.
|POM | PL 19488/0850 Leaflet revision date: 04 June 2015
S850 Leaflet Betahistine 20150604