PACKAGE LEAFLET: INFORMATION FOR THE USER

BETAISTINA DOC 24 mg tablets

Equivalent medicine
Read this leaflet carefully before taking this medicine, as it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.
Contents of this leaflet:

What BETAISTINA DOC is and what it is used for
What you need to know before taking BETAISTINA DOC
How to take BETAISTINA DOC
Possible side effects
How to store BETAISTINA DOC
Contents of the pack and other information

1. What BETAISTINA DOC is and what it is used for

BETAISTINA DOC contains betahistine. This medicine is known as an histamine analogue.
It is used to treat:

dizziness (vertigo)
ringing in the ears (tinnitus)
hearing loss affecting people with Ménière's syndrome.

The medicine works by improving blood flow in the inner ear. This reduces the increase in pressure.

2. What you need to know before taking BETAISTINA DOC

Do not take BETAISTINA DOC

If you are allergic to betahistine or to any of the other ingredients of this medicine (listed in section 6)
If you have high blood pressure due to an adrenal gland tumour (pheochromocytoma)

If any of these situations apply to you, do not take this medicine and consult your doctor.
Warnings and precautions
Talk to your doctor before taking BETAISTINA DOC

If you have a stomach ulcer
If you have asthma
If you are pregnant or planning to become pregnant
If you are breastfeeding

If any of these situations apply to you, discuss them with 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 are taking BETAISTINA DOC.
Children and adolescents
The use of BETAISTINA DOC is not recommended in children and adolescents under 18 years of
age.
Other medicines and BETAISTINA DOC
No interaction between BETAISTINA DOC and other medicines is known. If you experience
any adverse effects, inform your doctor or pharmacist.
Inform your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those not requiring a prescription.
BETAISTINA DOC with food, drinks and alcohol
You may drink alcohol during treatment with BETAISTINA DOC.
You may take BETAISTINA DOC with or without food.
Pregnancy and breastfeeding
Do not take BETAISTINA DOC if you are pregnant unless your doctor decides it is absolutely
necessary.
Ask your doctor for advice.
Do not breastfeed during treatment with BETAISTINA DOC unless your doctor advises you to do so.
It is not known whether BETAISTINA DOC passes into breast milk.
Driving and using machines
You may drive and use machines during treatment, provided that this medicine does not cause you
drowsiness.
Make sure you know how this medicine affects you before driving or using machines.
BETAISTINA DOC contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before
taking this medicine.

3. How to take BETAISTINA DOC

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
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Swallow the tablet with a little water.
Take the tablet during or after meals.

The recommended dose is half to one tablet twice daily.
The tablet can be divided into equal parts.
Continue taking the tablets as directed. It may take some time before the tablets become effective.
Always follow your doctor's instructions, as your doctor may adjust the dose.

Use in children
BETAISTINA DOC is not recommended for use in children.

If you take more BETAISTINA DOC than you should
If you or someone else takes too much BETAISTINA DOC (overdose), contact a doctor or go to hospital immediately. Take the medicine packaging with you.

If you forget to take BETAISTINA DOC
If you forget to take a tablet, wait until your next scheduled dose. Do not try to make up for the missed dose.

If you stop taking BETAISTINA DOC
Continue taking the tablets until your doctor tells you to stop.
Even if you feel better, your doctor may decide that you should continue taking the tablets for some time to ensure the medicine has worked completely.

If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following serious side effects may occur during treatment with BETAISTINA DOC:
Allergic reactions such as:

swelling of the face, lips, tongue or neck. This may cause difficulty in breathing.
Skin redness, itchy skin inflammation.

If any of these side effects occur, you must stop treatment immediately and contact your doctor.
Common side effects (may affect from 1 to 10 out of 100 patients):
Nausea, indigestion, and headache.
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Other side effects
Drowsiness, itching, urticaria, mild gastrointestinal disturbances such as vomiting, stomach pain, and bloating. Taking BETAISTINA DOC with food may help reduce stomach problems.
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.

5. How to store BETAISTINA DOC

Keep this medicine out of the sight and reach of children.
This medicine should preferably be stored locked in a cupboard or medicine cabinet.
Do not use the tablets after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store in a dry place in the original packaging.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What BETAISTINA DOC contains
The active substance is betahistine dihydrochloride.
One tablet contains 24 mg of betahistine dihydrochloride.
The other components are povidone, microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silica, crospovidone and stearic acid.

Description of the appearance of BETAISTINA DOC and contents of the pack
Circular, biconvex tablet, almost white to white in colour, with a break line on one side. The tablet can be divided into two equal doses.
The tablets are available in cardboard boxes containing 20, 30, 40, 50, 60 or 100 tablets in blisters.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
DOC Generici Srl, Via Turati 40, 20121 Milano

Responsible manufacturer for batch release
Catalent Germany Schorndorf GmbH
Steinbeisstrasse 2,
D-73614 Schorndorf,
Germany
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This medicinal product has been authorised in the Member States of the European Economic Area (EEA) under the following names:
Netherlands: BETAHISTINA 2HCl 24 mg, tabletten
Italy: BETAISTINA DOC 24 mg tablets

This leaflet was approved in:
April 2013
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