SERC 16MG TABLETS
Active substance: BETAHISTINE DIHYDROCHLORIDE
View full screen / Print PDF » Download PDF ⇩
Transcript
SERC 16mg TABLETS (betahistine dihydrochloride) Patient Information Leaflet
This product is known as the above name but will referred to as Serc throughout this leaflet. Another strength (8mg) is also available. 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 Mnire'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. Monamine-oxidase inhibitors (MAOIs) used to treat depression or Parkinsons disease. These may increase the exposure of Serc.
DATE:
27mm
CUSTOMER APPROVED:
DATE:
Taking Serc with food and drink You can drink alcohol while taking Serc. 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 You can drive and use machines while you are taking this treatment, so long as this medicine does not make you sleepy.
UK PIL DATED SEPTEMBER 2011
Make sure you know how this medicine affects you before you drive or use machines. 3. How to take Serc How to take Serc Swallow the tablets with water. Take the tablet with or after a meal. How much Serc to take Always follow your doctors 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 use by those under 18 years old.
Black
WARNING!
Colour Swatch
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Q.A. APPROVED:
CUSTOMER: Waymade PRODUCT: Serc 8mg tabs
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
17/10/12
05-0440
DT
CODE:
6464/1926A
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
PROOF HISTORY: v.1 - waymade - 17/10/12
Leaflet Flat Size = 148 x 317
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Notes:
WARNING!
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.
27mm
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. Other side effects Headache, itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking Serc with food can help reduce any stomach problems. If any of the side effects become serious, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Serc Serc 16mg tablets should not be stored above 25C. Store in the original package. Do not use after the expiry date printed on the carton label or blister strip. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. If the tablets become discoloured or show any other signs of deterioration, you should ask your doctor or pharmacist before taking them. 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.
CUSTOMER APPROVED:
DATE:
6. Further information Your medicine is called Serc 16mg Tablets. Each tablet contains 16mg of the active ingredient, betahistine dihydrochloride. Each tablet is white, round, plain on one side and 267 either side of a breakline on the other side. Serc 16mg tablets also contain the following: mannitol, microcrystalline cellulose, citric acid, colloidal anhydrous silica, and talc. These are the inactive ingredients.
DATE:
Serc 16mg tablets are available as blister packs of 30, 90 and 120 tablets. POM PL No: 6464/1926
DATE OF PROOF:
PRE-PRESS NO.:
This product is manufactured by Abbott Healthcare S.A.S., Route de Belleville Lieu-dit Maillard 01400 Chtillon-sur-Chalaronne France, and is procured from within the EU and repackaged by the Product Licence holder: Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR Leaflet revision and issue date (Ref.) 8.10.2012 Serc is a registered trademark of Solvay Pharmaceuticals B.V.
770-7631A
Black
WARNING!
Colour Swatch
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Q.A. APPROVED:
ARTWORKER:
17/10/12
05-0440
DT
UK PIL DATED SEPTEMBER 2011
CUSTOMER: Waymade PRODUCT: Serc 8mg tabs
CODE:
6464/1926A
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
PROOF HISTORY: v.1 - waymade - 17/10/12
Leaflet Flat Size = 148 x 317
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Notes:
This product is known as the above name but will referred to as Serc throughout this leaflet. Another strength (8mg) is also available. 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 Mnire'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. Monamine-oxidase inhibitors (MAOIs) used to treat depression or Parkinsons disease. These may increase the exposure of Serc.
DATE:
27mm
CUSTOMER APPROVED:
DATE:
Taking Serc with food and drink You can drink alcohol while taking Serc. 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 You can drive and use machines while you are taking this treatment, so long as this medicine does not make you sleepy.
UK PIL DATED SEPTEMBER 2011
Make sure you know how this medicine affects you before you drive or use machines. 3. How to take Serc How to take Serc Swallow the tablets with water. Take the tablet with or after a meal. How much Serc to take Always follow your doctors 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 use by those under 18 years old.
Black
WARNING!
Colour Swatch
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Q.A. APPROVED:
CUSTOMER: Waymade PRODUCT: Serc 8mg tabs
DATE OF PROOF:
PRE-PRESS NO.:
ARTWORKER:
17/10/12
05-0440
DT
CODE:
6464/1926A
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
PROOF HISTORY: v.1 - waymade - 17/10/12
Leaflet Flat Size = 148 x 317
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Notes:
WARNING!
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.
27mm
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. Other side effects Headache, itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking Serc with food can help reduce any stomach problems. If any of the side effects become serious, or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist. 5. How to store Serc Serc 16mg tablets should not be stored above 25C. Store in the original package. Do not use after the expiry date printed on the carton label or blister strip. KEEP OUT OF THE SIGHT AND REACH OF CHILDREN. If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to. If the tablets become discoloured or show any other signs of deterioration, you should ask your doctor or pharmacist before taking them. 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.
CUSTOMER APPROVED:
DATE:
6. Further information Your medicine is called Serc 16mg Tablets. Each tablet contains 16mg of the active ingredient, betahistine dihydrochloride. Each tablet is white, round, plain on one side and 267 either side of a breakline on the other side. Serc 16mg tablets also contain the following: mannitol, microcrystalline cellulose, citric acid, colloidal anhydrous silica, and talc. These are the inactive ingredients.
DATE:
Serc 16mg tablets are available as blister packs of 30, 90 and 120 tablets. POM PL No: 6464/1926
DATE OF PROOF:
PRE-PRESS NO.:
This product is manufactured by Abbott Healthcare S.A.S., Route de Belleville Lieu-dit Maillard 01400 Chtillon-sur-Chalaronne France, and is procured from within the EU and repackaged by the Product Licence holder: Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR Leaflet revision and issue date (Ref.) 8.10.2012 Serc is a registered trademark of Solvay Pharmaceuticals B.V.
770-7631A
Black
WARNING!
Colour Swatch
WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.
Q.A. APPROVED:
ARTWORKER:
17/10/12
05-0440
DT
UK PIL DATED SEPTEMBER 2011
CUSTOMER: Waymade PRODUCT: Serc 8mg tabs
CODE:
6464/1926A
WARNING!
THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.
PROOF HISTORY: v.1 - waymade - 17/10/12
Leaflet Flat Size = 148 x 317
ARIAL REGULAR FONT SIZE 8 ARIAL BOLD FONT SIZE 8 BRIDGED TO CRESTOR 6464/2069 2070
Notes:
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
