Pill Identifier App

SERC-8

Active substance: BETAHISTINE DIHYDROCHLORIDE

View full screen / Print PDF » Download PDF ⇩

Transcript
Assessed against UK PIL dated August 2004

Final draft / Mock-up

By PisanoB at 2:48 pm, 10/3/05

Serc -8
®

(betahistine dihydrochloride)
Patient Information Leaflet
WHAT YOU NEED TO KNOW ABOUT YOUR MEDICINE
Please read this Patient Information Leaflet carefully before you start to take your medicine. This leaflet
provides a summary of information about your medicine. Please ask your doctor or pharmacist if you have any
questions or are not sure about anything to do with this medicine. Keep this leaflet in a safe place, you may
wish to refer to it later.
YOUR MEDICINE
Your medicine is called SERC-8 and will be referred to as such throughout this Patient Information Leaflet. They
are white, circular, flat tablets, marked '256' on one side and 'DUPHAR' on the other side.
Each blister pack contains 120 tablets (4 blisters of 30)
WHAT IS IN YOUR MEDICINE?
Each tablet contains 8mg betahistine dihydrochloride as the active ingredient.
Your medicine also contains the following inactive ingredients:
microcrystalline cellulose, mannitol, citric acid, anhydrous colloidal silica and talc.
WHO MANUFACTURED YOUR MEDICINE?
The tablets are manufactured by Solvay Pharma, S.A., Av. Diagonal, Spain and are procured from within the EU
and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, B98 0RE.
POM PL Number:

15184/0222

WHAT IS YOUR MEDICINE USED FOR?
SERC-8 is a type of medicine called a histamine analogue. It works by improving blood flow in the inner ear,
which reduces the build up of pressure. It is this pressure in the ear, which is thought to cause the vertigo
(dizziness), tinnitus (ringing in the ears) and hearing loss suffered by people with Meniere's syndrome.
BEFORE TAKING YOUR MEDICINE
Make sure it is safe for you to take this medicine. Check to see if any of the following apply to you. If your
answer is YES to any of the following, discuss it with your doctor or pharmacist. This information will help your
doctor decide how to treat your condition.
* Are you allergic to any of the ingredients in SERC-8 tablets?
* Are you pregnant, planning to become pregnant, or breast-feeding?
* Has your doctor told you that you have phaeochromocytoma (high blood pressure due to adrenal tumour)?
* Have you ever had a stomach ulcer?
* Do you suffer from asthma?
If you think the answer is yes for any of these questions, please tell your doctor or pharmacist.
This information will help your doctor decide how to treat your condition.
This product contains mannitol which may have a laxative effect.
QUESTIONS YOU MAY HAVE ABOUT SERC-8 TABLETS:
Can I continue to drink alcohol while taking these tablets? Yes.
Will SERC-8 tablets make me feel drowsy? No - your responses will not be affected- you may still drive and
operate machinery.
Can I take other medicines while I am taking SERC-8 tablets? Yes.
TAKING YOUR MEDICINE
Follow your doctor's instructions. The normal starting dose is two SERC-8 tablets three times a day.
The maintenance dose is usually in the range of 24 - 48mg daily. There is no recommended dose for children.
SERC-8 tablets may take some time to have its full effect, so do not worry if you do not start feeling better right
away. Your doctor may review the dose you take according to your own needs and symptoms, once the
medicine has had time to work. You should take your tablets preferably with or after meals. Swallow the tablets
with water.

Serc -8
®

(betahistine dihydrochloride)
Patient Information Leaflet (continued)
WHAT TO DO IF AN OVERDOSE IS TAKEN?
If someone takes too many SERC-8 tablets, you should contact a doctor immediately or go to the nearest
hospital casualty department. Take SERC-8 pack with you.
WHAT TO DO IF YOU MISS A DOSE?
If you miss a dose, take it as soon as you remember. if the next dose is nearly due, ignore the missed dose
and carry on as normal with the next dose.
AFTER TAKING YOUR MEDICINE
Side effects with SERC-8 tablets are very uncommon. A few people have complained of stomach upsets
(including indigestion), headaches, itching or rashes. You should see your doctor if you are concerned by any
of these, or if you think you have any other side effects caused by SERC-8 tablets.
EXPIRY DATE.
Do not use this medicine after the expiry date shown on the carton label or blister strip.
If your doctor tells you to stop taking this medicine, return any unused tablets to your pharmacist for safe
disposal. Only keep this medicine, if your doctor tells you to.
If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will
tell you what to do.
STORING YOUR MEDICINE
* KEEP THIS MEDICINE OUT OF THE REACH AND SIGHT OF CHILDREN.
NOT STORE ABOVE 25°C.
* DO not take your tablets out of the blister strip until it is time to take your dose.
Do
*
IMPORTANT
Remember this medicine is for you. Only a doctor can prescribe it. Never give your medicine to other people.
It may harm them, even if their symptoms are the same as yours.
This leaflet does not tell you everything about your medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist. He/she will have additional information about this medicine and will
be able to advise you.
Serc is a registered trademark of Solvay Pharmaceuticals B.V.
Leaflet reference and revision date:

15184/0222/ANP

11/07/05

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
(web4)