BETAHISTINE DIHYDROCHLORIDE 16 MG TABLETS

Active substance: BETAHISTINE DIHYDROCHLORIDE

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Serc-8 Tablets
Serc-16 Tablets

2260/2261
14.01.13[5]

(betahistine dihydrochloride)
PATIENT INFORMATION LEAFLET
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.
This medicine is available using any of the above names but will be
referred to as Serc throughout the leaflet
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.
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.
- Monoamine-oxidase inhibitors (MAOIs) - used to treat depression or
Parkinson’s disease. These may increase the exposure of Serc.
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.
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 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.
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.
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
- Keep out of the sight and reach 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.

6. FURTHER INFORMATION
What Serc contains
Each tablet contains 8 or 16 mg of betahistine dihydrochloride.
The tablets also contain microcrystalline cellulose, mannitol, citric acid
monohydrate, colloidal anhydrous silicon dioxide and talc.
What Serc looks like and contents of the pack
Serc-8 are round, flat and white tablets with ‘256’ imprinted on the one side
and plain on the reverse.
Serc-16 are round, biconvex, scored white tablets with ‘267’ imprinted on
the one either side of score and plain on the reverse.
Serc-8 is available in packs of 125 tablets and 100 Tablets
Serc-16 is available in packs of 80 tablets and 60 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Abbott Healthcare SAS, route de belleville, lieu-dit
"Maillard", Chatillon-Sur-Chalaronne, F-01400, France and Procured from
within the EU by Product Licence holder Star Pharmaceuticals Ltd,
5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PL 20636/2260- Serc-8 Tablets
PL 20636/2261- Serc-16 Tablets

Leaflet issue and revision date (Ref:) 14.01.13[5]
Serc is trademark of Abbott Healthcare Products B.V

Betahistine Dihydrochloride
8 mg Tablets
Betahistine Dihydrochloride
16 mg Tablets

2260/2261
14.01.13[5]

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. Make sure you know how
this medicine affects you before you drive or use machines.

PATIENT INFORMATION LEAFLET

3. HOW TO TAKE BETAHISTINE TABLETS
How to take Betahistine Tablets
- Swallow the tablets with water.
- Take the tablet with or after a meal.

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.

How much Betahistine Tablets to take
Always follow your doctor’s instructions because your doctor might adjust
your dose.
- Betahistine Tablets 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).

This medicine is available using any of the above names but will be
referred to as Betahistine Tablets throughout the leaflet

Keep taking your tablets. The tablets can take a while to start to work.
Betahistine Tablets is not recommended for those under 18 years old.

In this leaflet:
1. What Betahistine Tablets is and what it is used for
2. Before you take Betahistine Tablets
3. How to take Betahistine Tablets
4. Possible side effects
5. How to store Betahistine Tablets
6. Further information
1. WHAT BETAHISTINE TABLETS IS AND WHAT IT IS USED FOR
Betahistine Tablets is 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.
2. BEFORE YOU TAKE BETAHISTINE TABLETS
Do not take Betahistine Tablets 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
Betahistine Tablets.
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 Betahistine
Tablets. Also, Betahistine Tablets may lower the effect of antihistamines.
- Monoamine-oxidase inhibitors (MAOIs) - used to treat depression or
Parkinson’s disease. These may increase the exposure of Betahistine
Tablets.
Taking Betahistine Tablets with food and drink
You can drink alcohol while taking Betahistine Tablets.
You can take Betahistine Tablets with or without food.
Pregnancy and breast-feeding
Do not take Betahistine Tablets 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 Betahistine Tablets unless instructed by your
doctor. It is not known if Betahistine Tablets passes into breast milk.

How to stop taking Betahistine Tablets
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.
If you take more Betahistine Tablets than you should
If you or someone else takes too much Betahistine Tablets (an overdose),
talk to a doctor or go to a hospital straight away. Take the medicine pack
with you.
If you forget to take Betahistine Tablets
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 Betahistine Tablets can cause side effects (unwanted
effects or reactions), but not everyone gets them.
The following serious side effects may occur during treatment with
Betahistine Tablets:
- 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 Betahistine Tablets 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 BETAHISTINE TABLETS
- Keep out of the sight and reach 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.

6. FURTHER INFORMATION
What Betahistine Tablets contains
Each tablet contains 8 or 16 mg of betahistine dihydrochloride.
The tablets also contain microcrystalline cellulose, mannitol, citric acid
monohydrate, colloidal anhydrous silicon dioxide and talc.
What Betahistine Tablets looks like and contents of the pack
Betahistine Dihydrochloride 8 mg Tablets are round, flat and white tablets
with ‘256’ imprinted on the one side and plain on the reverse.
Betahistine Dihydrochloride 16 mg Tablets are round, biconvex, scored
white tablets with ‘267’ imprinted on the one either side of score and plain
on the reverse.
Betahistine Dihydrochloride 8 mg Tablets is available in packs of 125
tablets and 100 Tablets
Betahistine Dihydrochloride 16 mg Tablets is available in packs of 80
tablets and 60 tablets.
MANUFACTURER AND PRODUCT LICENCE HOLDER
Manufactured by Abbott Healthcare SAS, route de belleville, lieu-dit
"Maillard", Chatillon-Sur-Chalaronne, F-01400, France and Procured from
within the EU by Product Licence holder Star Pharmaceuticals Ltd,
5 Sandridge Close, Harrow, Middlesex HA1 1XD. Repackaged by
Servipharm Ltd.
POM

PL 20636/2260- Betahistine Dihydrochloride 8 mg Tablets
PL 20636/2261- Betahistine Dihydrochloride 16 mg Tablets

Leaflet issue and revision date (Ref:) 14.01.13[5]

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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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