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SERC-16

Active substance: BETAHISTINE DIHYDROCHLORIDE

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Betahistine
SOLID 1000557432

pharmacode > > >
v1.0

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Sere contains betahistine. This medicine is called
a histamine analogue. It is used to treat:
o dizziness (vertigo)
o ringing in the ears (tinnitus)
o hearing loss suffered by people with Meniere's
disease

In particular, tell your doctor or pharmacist if you
are taking any of the following medicines:
o Anti-histamines - these may (in theory) lower
the effect of Sere. Also, Sere may lower the
effect of anti-histamines.
o Monoamine-oxidase inhibitors (MAOis) - used
to treat depression or Parkinson's disease.
These may increase the exposure of Sere.

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

Taking Sere with food and drink
You can take Sere with or without food.

1. What Sere is and what it is used for

Betahistine dihydrochloride

2. Before you take Sere
Read all of this leaflet carefully before
you start taking this medicine.
o Keep this leaflet. You may need to read it
again.
o If you have any further questions, ask your
doctor or pharmacist.
o 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.
o 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 Sere is and what it is used for
2. Before you take Sere
3. How to take Sere
4. Possible side effects
5. How to store Sere
6. Further information

Do not take Sere if:
o You are allergic to any of the ingredients in the
tablets (see section 6 for further details).
o 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:
o you have a stomach ulcer
o you have asthma
o you are pregnant or planning to become
pregnant
o 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 Sere.
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 Sere 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 Sere unless
instructed by your doctor. It is not known if Sere
passes into breast milk.
Driving and using machines
Sere 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 Sere (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 Sere
How to take Sere
o Swallow the tablets with water.
o Preferably take the tablet with a meal.
How much Sere to take
Always follow your doctor's instructions because
your doctor might adjust your dose
o Sere is available in two strengths, an 8 mg
tablet and a 16 mg tablet.
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Betahistine
SOLID 1000557432

• 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.
Sere is not recommended for those under 18 years
old.
How to stop taking Sere
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 t~~lets for
some time to make sure that the med1c1ne has
worked completely.
If you take more Sere than you should
If you or someone else takes too much Sere (an
overdose), talk to a doctor or go to a hospital
straight away. Take the medicine pack with you.
If you forget to take Sere
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 pharmac1st.
4. Possible side effects

Like all medicines, Sere can cause side effects
(unwanted effects or reactions), but not everyone
gets them.
The following serious side effects may occur
during treatment with Sere:

Allergic reactions such as:
.
• swelling of your face, lips, tongue or neck. Th1s
may cause difficulty breathing.

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• 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 s~ch
as vomiting, stomach pain and bloating. Tak1ng
Sere with food can help reduce any stomach
problems.
Reporting of side effects
If you get any side effe~t~, talk to your doc~or,
pharmacist or nurse. Th1s 1ncludes any poss1ble
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.uklyellowcard.
By reporting side effects you can ~elp p~o.vide
more information on the safety of th1s med1c1ne.
5. How to store Sere
• Keep out of the reach and sight of children.
• This medicine should preferably be locked in a
cupboard or medicine cabinet.
• Do not use the tablets after the expiry date
which is printed on the carton and blister pack.
• Do not store your tablets above 25°C and keep
them in the original package.
• If your doctor stops your treatment, return any
unused tablets to a pharmacist.

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.

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6. Further information
What Sere contains
Each tablet contains 8 or 16 mg of betahistine
dihydrochloride.
The tablets also contain microcrystalline cellulose,
mannitol E421, citric acid monohydrate, colloidal
anhydrous silica and talc.
What Sere looks like and contents of the pack
Serc-8 are round, flat, white to almost white and
with '256' imprinted on one face of the tablet.
Serc-16 are round, bioconvex, scored, white to
almost white and with '267' imprinted on one
face of the tablet.
Serc-8 is available in packs of 120 tablets and
containers with 500 or 1000 tablets.
Serc-16 is available in packs of 84 tablets and
containers with 500 or 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
The Marketing Authorisation Holder is:
Abbott Healthcare Products Limited,
Abbott House, Vanwall Business Park,
Vanwall Road, Maidenhead, SL6 4XE, UK.
The Manufacturer is:
Abbott Healthcare SAS,
01400 Chatillon-sur-Chalaronne, France.

For information in large print, tape, CD or Braille,
phone 02380 467000.
This leaflet was revised in May 2014.

® Registered trademark

a

Abbott

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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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