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BETAHISTINE DIHYDROCHLORIDE TABLETS 16MG

Active substance(s): BETAHISTINE DIHYDROCHLORIDE

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e-mail : artworkcd@yahoo.com
Ph : +91-09845609386

Artwork No.

041117/2

Colours Used

Customer

RI Pharma

Black

Description

Betahistine Leaflet

Keyline (Cutting Edge)

Market

UK

Language

English

Size

160 x 265 mm

Min. Font Size

Arial, 9, 14 pt

Page No.

1 of 1

Version No.

2

Date

24-11-17

Software

Coreldraw 12

Packaging Development

Quality Assurance (QA)

Quality Control (QC)

Production

160 mm

160 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

If you take more Betahistine dihydrochloride Tablets than you should
An overdose of this medicine may be dangerous. If you accidentally take too many tablets tell your
doctor or go to the nearest hospital casualty department immediately. The symptoms of a betahistine
dihydrochloride tablets overdose are nausea, vomiting, digestion problems, coordination problems and
with higher doses-fits.

Betahistine Dihydrochloride 8 mg and 16 mg Tablets
Betahistine dihydrochloride

If you forget to take Betahistine dihydrochloride Tablets
If you forget to take a dose at the right time take it as soon as you remember and if it is almost time for
your next dose, wait until that is due then go on as before. Do not take a double dose to make up for the
forgotten dose.

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 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 only. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

If you stop taking Betahistine dihydrochloride Tablets
Do not stop taking your Betahistine dihydrochloride tablet without talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects

What is in this leaflet:
1. What Betahistine Tablets is and what it is used for
2. What you need to know before you take Betahistine dihydrochloride Tablets
3. How to take Betahistine dihydrochloride Tablets
4. Possible side effects
5. How to store Betahistine dihydrochloride Tablets
6. Contents of the pack and other information

Like all medicines, these tablets can cause side effects, although not everybody gets them
The following serious side effects may occur during treatment with Betahistine:
 Allergic reactions such as: Swelling of your face, lips, tongue or neck. This may cause difficulty in
breathing.
 A red skin rash, inflamed itchy skin

1. What Betahistine dihydrochloride Tablets is and what it is used for

If any of these side effects occur you should stop treatment immediately and contact your doctor.

These tablets contain Betahistine dihydrochloride.

Common side effects (may affect up to 1 in 10 people):
Nausea, indigestion and headache

They are used to treat vertigo, tinnitus (ringing in the ears) and hearing loss associated with Meniere's
disease.

Other side effects
Itching, rash, hives, mild gastric complaints such as vomiting, stomach pain and bloating. Taking
Betahistine dihydrochloride tablets with meal can help reduce any stomach problems.

They work by reducing the pressure in your inner ear.
2. What you need to know before you take Betahistine dihydrochloride tablets

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
tell your doctor or pharmacist.

If you think any of the above points apply to you, do not take the tablets. Talk to your doctor first and
follow the advice given.
Warnings and precautions
Talk to your doctor or pharmacist before taking Betahistine tablets
 if you have a stomach ulcer
 if you suffer from asthma
 if you suffer from conditions relating to lactose such as galactose intolerance, lactase deficiency or
glucose-galactose malabsorption
Other medicines and Betahistine dihydrochloride tablets
Tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
 Antihistamines, which are used to treat allergic conditions
 Monoamine-oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. These may
inhibit metabolism of Betahistine Dihydrochloride

265 mm

265 mm

Do not take Betahistine dihydrochloride Tablets:
 if you are allergic (hypersensitive) to Betahistine dihydrochloride or any of the other ingredients of
Betahistine dihydrochloride Tablets (listed in section 6). The symptoms of an allergic reaction
include itching, nettle rash, wheezing or swelling of the hands, throat, mouth or eyelids
 if you have a phaeochromocytoma ( high blood pressure due to adrenal tumour).

Reporting of side effects:
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via Yellow Card scheme at :www.mhra.gov.uk/yellowcard
or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 BETAHISTINE TABLETS
Do not store above 30°C. Do not put them into another container as they might get mixed up.
Keep out of the sight and reach of children.
Do not use Betahistine dihydrochloride Tablets after the expiry date which is stated on the carton.
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. Contents of the pack and other information
What Betahistine Tablets contains
The active substance is betahistine dihydrochloride (8mg or 16mg). The other ingredients are lactose,
maize starch, microcrystalline cellulose, citric acid, crospovidone, povidone and Sodium stearyl
fumarate. Betahistine dihydrochloride tablets are gluten free.

Pregnancy and breast-feeding
Ask your doctor for advice before taking Betahistine tablet if you are pregnant or planning to become
pregnant or you are breast feeding .

What Betahistine dihydrochloride Tablets look like and contents of the pack
Betahistine tablets are round white tablets. The 8mg tablets have 'R3' stamped on one side with a
scoreline on the other and the 16mg tablets have 'R4' stamped on one side with a scoreline on the
other.

Driving and using machines
There is no indication that taking Betahistine dihydrochloride Tablets affects the ability to drive and use
machines. However, take care and, if affected, do not drive or operate machines.

Betahistine 8mg and 16mg tablets are available in packs of 84, 100 and 120 Tablets. Not all pack sizes
may be marketed.

Betahistine dihydrochloride Tablets contains lactose
These tablets contain lactose which is a type of sugar. Contact your doctor before taking these tablets if
you are lactose intolerant.

Marketing Authorization Holder and Manufacturer
The Marketing Authorization Holder for your tablets is:
RI Pharma Ltd, 6 St. John's Court, First Floor, Upper Forest Way, Swansea Enterprise Park, Swansea
SA6 BQQ.

3. How to take Betahistine dihydrochloride tablets
Always take Betahistine dihydrochloride tablets exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.

The manufacturer for your tablets are:
Wave Pharma Limited, 4th Floor Cavendish House, 369 Burnt Oak, Edgware, Middlesex, HA85AW, UK.

Swallow the tablets with water and always take with or after meal.

If you would like this leaflet in a different format please contact the license holder at the following
address: RI Pharma Ltd, 6 St. John's Court, First Floor, Upper Forest Way, Swansea Enterprise Park,
Swansea SA6 BQQ or e-mail at info@ri-pharma.com.

Usual dose for adults and the elderly:
The usual starting dose of Betahistine dihydrochloride 16mg three times a day.

If you would like to have any further information or want to report any side effects, please email at
info@ri- pharma.com

After you have been taking treatment for a while your doctor may change the dose to between 24 and
48mg a day.

This leaflet was last updated in November 2017

POM

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