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Vitamin B Compound Strong Tablets

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Document: leaflet MAH GENERIC_PL 33414-0011 change

PACKAGE LEAFLET: INFORMATION FOR THE USER

VITAMIN B COMPOUND STRONG TABLETS

Read all of this leaflet carefully because it

contains important information for you.

This medicine is available without prescription.

However, you still need to take it carefully to

get the best results from it.

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

-    Ask your pharmacist if you need more information or advice.

-    You must contact your pharmacist or doctor if your symptoms worsen or do not improve.

-    If you notice any side effects, please tell your doctor or pharmacist.


• the effects on the skin which occur in pellagra (a condition caused by nicotinamide deficiency).


2. BEFORE YOU TAKE VITAMIN B COMPOUND STRONG


THIS LEAFLET CONTAINS


1.    What Vitamin B Compound Strong is for

2.    Before you take Vitamin B Compound Strong

3.    How to take Vitamin B Compound Strong

4.    Possible side effects

5.    How to store Vitamin B Compound Strong

6.    Further information


1. WHAT VITAMIN B COMPOUND STRONG IS FOR


The name of this medicine is Vitamin B Compound Strong. It contains the active ingredients Nicotinamide, Pyridoxine, Riboflavine and Thiamine, which belong to the vitamin B complex group of medicines.

It may be used for the treatment of conditions which are a result of a deficiency in some of the B vitamins, such as:

•    swelling of the tongue, mouth or lips, swelling of nerves which can cause pain, tenderness or loss of function and the growth of new blood vessels in the eye which can affect vision.

•    the effects on the heart which occur in beri beri (a condition caused by vitamin B1 (thiamine) deficiency).


Do not take Vitamin B Compound Strong if you are:

• allergic (hypersensitive) to Nicotinamide, Pyridoxine, Riboflavine, Thiamine or any of the other ingredients in Vitamin B Compound Strong tablets (listed in section 6 of this leaflet).

Do not take this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking it.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken, any other medicines, including medicines bought without a prescription.

This is because Vitamin B Compound Strong can affect the way some medicines work. Also, some medicines can affect the way Vitamin B Compound Strong works.

In particular, tell your doctor or pharmacist if you are taking the medicine Levodopa to treat Parkinson's disease.

Pregnancy and breast-feeding

If you are pregnant, planning to become pregnant, or are breast-feeding ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients in Vitamin B Compound Strong tablets

This medicine contains glucose (a type of sugar). If you have been told you have an intolerance to some sugars contact your doctor before taking this medicine.


3. HOW TO TAKE VITAMIN B COMPOUND STRONG


Follow the instructions provided in this leaflet.


If you are not sure how you need to take Vitamin B Compound Strong, talk to your doctor or pharmacist.

Taking Vitamin B Compound Strong tablets

Swallow the tablets whole with a glass of water.

Dosages:

Adults including the elderly and children over 3 years :

1 - 2 tablets three times a day Children under 3 years:

Not recommended

If you take more Vitamin B Compound Strong than you should

If you take too many tablets, contact your doctor or nearest hospital casualty department immediately.

If you forget to take Vitamin B Compound Strong

If you forget to take a dose take it as soon as you remember and then take the next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or 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


4. POSSIBLE SIDE EFFECTS


Vitamin B Compound Strong tablets are unlikely to cause any side effects, as any excess vitamin B is naturally excreted from the body.

Reporting of side effects If you get any of side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.


5. HOW TO STORE VITAMIN B COMPOUND STRONG


Keep out of the reach and sight of children.

Store Vitamin B Compound Strong tablets below 25°C, in a dry place.

Store in the original package.

Do not use these tablets after the expiry date, which is stated on the container. The expiry date refers to the last day of that month.


What Vitamin B Compound Strong tablets contain

Each Vitamin B Compound Strong tablet contains the vitamins;

•    Thiamine hydrochloride 5 mg

•    Riboflavine 2 mg

•    Pyridoxine hydrochloride 2 mg

•    Nicotinamide 20 mg

The other ingredients are: talc, magnesium stearate, stearic acid, dextrose monohydrate (glucose), colloidal anhydrous silica, hypromellose, ethylcellulose, diethyl phthalate and Opaspray K-1 -9231 Brown (hydroxypropyl cellulose , titanium dioxide, iron oxide yellow, iron oxide red, iron oxide black)

What Vitamin B Compound Strong tablets look like and contents of the pack

Vitamin B Compound Strong are dark chocolate coloured film-coated, engraved tablets.

Vitamin B Compound Strong tablets come in containers of 100 and 500 tablets and in blister pack of 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Chelonia Healthcare Limited,

Boumpoulinas 11, 3rd Floor,

Nicosia, P.C. 1060,

Cyprus

Manufacturer

DDSA Pharmaceuticals Limited,

310 Old Brompton Road,

London,

SW5 9JQ

For more information about this product, please contact the Marketing Authorisation Holder.

This leaflet was last revised in 10/2014

CL0011/G/PIL/CL2


Product' Vitamin B Compound Strong Tablets

MA Holder: Chelonia

Printing Colours: | Black

Non-Printing Colours:

Final Preparation Date For Submission: 29/10/2014

PL No.' PL 33414/0011

Packing Site Technical Approval:

00/00/0000

Authority Approval Date: 00/00/0000 Latest Implementation Deadline: 00/00/0000

Pack Size: All Pack

Dimensions: 148 X 210 mm (A5)

Livery: Chelonia

Created By: A Patel

Manufacturer: -Market: UK Component: Leaflet

Artwork Code: CL0011/G/PIL/CL2

Print Proof Approval:

00/00/0000

Bar Code: -

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