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BETAHISTINE DIHYDROCHLORIDE TABLETS 8MG

Active substance: BETAHISTINE DIHYDROCHLORIDE

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0278 Leaflet Serc 20150608

PACKAGE LEAFLET: INFORMATION FOR USER

SERC TABLETS 8mg
BETAHISTINE DIHYDROCHLORIDE TABLETS 8mg
(betahistine dihydrochloride)

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:


Your medicine is known by either of the above names but will be
referred to as Serc in the following leaflet.

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.

Information for other strength of Serc (Serc Tablets 16mg) also may
be present in this leaflet.
Read all of this leaflet carefully before you start taking this
medicine.

Taking Serc with food and drink



Keep this leaflet. You may need to read it again.

You can take Serc with or without food.



If you have any further questions, ask your doctor or
pharmacist.

Pregnancy and breast-feeding



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:

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.



Preferably take the tablet with a meal.

How much Serc to take



dizziness (vertigo)



Always follow your doctor’s instructions because your doctor might
adjust your dose

ringing in the ears (tinnitus)



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).

 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.
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.

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.

Take special care and tell your doctor if:


you have a stomach ulcer

If you take more Serc than you should



you have asthma



you are pregnant or planning to become pregnant

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.



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.

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

6. FURTHER INFORMAT ION

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:

What Serc contains


Each tablet contains 8mg of the active ingredient betahistine
dihydrochloride



Serc also contain microcrystalline cellulose, mannitol, citric
acid, anhydrous colloidal silica and talc.

Allergic reactions such as:


swelling of your face, lips, tongue or neck. This may cause
difficulty breathing.



What Serc looks like and contents of the pack

a red skin rash, inflamed itchy skin



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.

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 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.



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.

Product Licence holder
Procured from within the EU and repackaged by the PL holder:
S&M Medical Ltd, Chemilines House, Alperton Lane, Wembley,
HA0 1DX.
Manufacturer
Serc is a manufactured by Abbott Healthcare SAS, Route de
Belville, Lieu-dit “Maillard”, 01400 Chatillon-sur-Chalaronne,
France.
POM

PL 08747/0278

Leaflet revision date: 08 June 2015
Serc is a registered trade mark of Solvay Pharmaceuticals BV, The
Netherlands.
0278 Leaflet Serc 20150608

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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.

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