SERC 16MG TABLETS

Active substance: BETAHISTINE DIHYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
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.

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 Ménière's disease
This medicine works by improving blood flow in the inner ear. This lowers the build up of pressure.

WARNING!

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.

DATE:

CUSTOMER
APPROVED:

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.

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.

18/04/13
6464/1926A

TVT CHECKED

Taking Serc with food and drink
You can drink alcohol while taking Serc.
You can take Serc with or without food.

CODE:

DATE OF PROOF:

DATE:

DECEMBER 2012

DT
ARTWORKER:
Serc 8mg tabs
PRODUCT:

CUSTOMER: Waymade

REF:

Q.A.
APPROVED:

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.

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 Ménière’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.
• Take the tablet with or after 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.

Colour
Swatch

Black

WARNING!

27mm

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.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

PROOF HISTORY:
v.1 - waymade - 18/04/13

Leaflet Flat Size = 148 x 317

SERC® 16mg TABLETS
(betahistine dihydrochloride)
Patient Information Leaflet

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.

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.

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 Serc with
food can help reduce any stomach problems.



WARNING!

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.

DECEMBER 2012

DT

18/04/13

REF:

ARTWORKER:

DATE OF PROOF:

Serc 8mg tabs

6464/1926A

PRODUCT:

CODE:

DATE:

Serc 16mg tablets also contain the following:
mannitol, microcrystalline cellulose, citric acid, colloidal anhydrous silica, and talc. These are the inactive
ingredients.

CUSTOMER: Waymade

Q.A.
APPROVED:



5. How to store Serc
Serc 16mg tablets should not be stored above 25°C. 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.

Serc 16mg tablets are available as blister packs of 30, 90 and 120 tablets.

TVT CHECKED

POM

PL No: 6464/1926

This product is manufactured by Abbott Healthcare S.A.S., Route de Belleville Lieu-dit “Maillard”
01400 Châtillon-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.) 18.04.2013
Serc is a registered trademark of Solvay Pharmaceuticals B.V.

Colour
Swatch

Black

WARNING!






DATE:

CUSTOMER
APPROVED:

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.

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.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

27mm

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.

PROOF HISTORY:
v.1 - waymade - 18/04/13

Leaflet Flat Size = 148 x 317

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.

Expand view ⇕

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web3)