PACKAGE LEAFLET: INFORMATION FOR THE USER

DALIVIT DROPS

(Vitamin A Palmitate, Vitamin D2, Vitamin B1,

Vitamin B2, Vitamin B6, Vitamin C, Nicotinamide)

Read all of this leaflet carefully because it contains important information for you.

This medicine is available both with or without prescription. However, you still need to use Dalivit Drops carefully to get the best results from it.

•    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 gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

1. WHAT DALIVIT DROPS ARE AND WHAT THEY ARE USED FOR

The name of this medicine is Dalivit Drops.

Dalivit Drops are a multivitamin preparation and contain seven essential vitamins. The necessary vitamins are usually provided by a balanced diet, but if any of the essential vitamins are absent from food for long periods of time, poor growth or certain deficiency diseases can occur.

This medicine helps prevent vitamin deficiencies and to maintain normal growth and health during the early years of infancy and childhood.

Specific functions of active ingredients -

•    Vitamin A and Vitamin D2 are for the development of bones, teeth and skin and the prevention of rickets.

•    Vitamins B1, B2, B6 and Nicotinamide are for the development and functioning of the nervous system.

•    Vitamin C helps develop healthy blood, gums and cartilage and also aids iron absorption.

2. BEFORE YOU TAKE DALIVIT DROPS

Do not take Dalivit Drops if you or your child:

•    are allergic to any of the active ingredients or any other ingredients in this medicine (see section 6)

•    suffer from too much calcium in the blood (hypercalcaemia)

Do not take vitamins A and D in excess from other sources, whilst using this medicine. High levels of Vitamins A and D can be found in cod liver oil or other fish liver oils.

Taking other medicines

You should tell your doctor or pharmacist if you are taking or have taken any of the following medicines:

•    Neomycin, used to treat liver problems and high cholesterol

•    Retinoids, used to treat eye problems

•    Barbiturates, phenytoin and primidone, used to treat epilepsy

•    Diuretic thiazides like bendrofluazide, used to treat kidney problems

Pregnancy and Breast-Feeding

Do not take Dalivit Drops if you are pregnant or trying to become pregnant.

If you are a nursing mother, your baby may receive an extra-amount of calcium while you are taking Dalivit Drops. Check before taking this medicine with your doctor.

Important information about some of the ingredients of Dalivit Drops

DALIVIT DROPS DO NOT CONTAIN PEANUT OIL.

This product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Also contains sodium methyl hydroxybenzoate (E219), which may cause allergic reactions (possibly delayed).

3. HOW TO GIVE/USE DALIVIT DROPS

Dalivit Drops have a built-in dropper to help you measure out an exact dose. To use, unscrew the cap and tilt the bottle forward. Allow the drops to form and count them as they come out.

Dalivit Drops can be given by allowing them to fall directly on the back of the tongue. However, you will probably find it easier to add them to fruit juices or other drinks. The drops mix in easily. Do not leave the drink standing after you have mixed it, or the vitamins could lose some of their effects.

Dosage

Infants from 6 weeks to one year of age: 7 drops daily in a single dose or as directed by the doctor.

Children older than 1 year: 14 drops daily or as directed by the doctor.

If you take/give more Dalivit Drops than you should

If too many drops are taken, contact your nearest casualty department or tell your doctor immediately.

Excessive doses of Vitamin A and D can lead to hypervitaminosis. Please contact your doctor or pharmacist if you experience any of the following symptoms:

•    Loss of appetite

•    Feeling sick

•    Vomiting

•    Rough dry skin

•    Frequent urination

•    Thirst

•    Loss of hair

•    Painful bones and joints

•    Raised calcium and phosphate plasma levels which can be observed in blood tests

•    Raised calcium and phosphate concentrations in urine which can be observed in urine tests

If you forget to take Dalivit Drops

Take another dose as soon as you remember, then go on as normal. Do not take a double up dose to make up for a forgotten dose.

If you are not sure of anything, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

The active ingredients in Dalivit Drops are all vitamins, which are an essential part of a normal diet. Side effects are not to be expected when the drops are used at the recommended dose.

Please see section 3 for information on the possible effects of overdosage of vitamins A and D.

Reporting of side effects

If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: 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 DALIVIT DROPS

Keep out of the reach and sight of children.

Do not use Dalivit Drops after the “exp date” which is stated on the bottle.

Do not store above 25^oC. Keep the bottle in the outer carton in order to protect from light.

Dalivit Drops should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of Dalivit Drops when they are no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

Each 0.6 ml of Dalivit Drops contains the following active ingredients:

•    Vitamin A palmitate 5,000 units

•    Ergocalciferol (vitamin D2) 400 units

•    Thiamine hydrochloride (vitamin B1) 1 mg

•    Riboflavin (vitamin B2) 400 micrograms

•    Pyridoxine hydrochloride (vitamin B6) 500 micrograms

•    Ascorbic acid (vitamin C) 50 mg

•    Nicotinamide 5 mg

The other ingredients are sodium hydroxide, polysorbate 80, sucrose and sodium methyl hydroxybenzoate (E219).

What Dalivit Drops looks like and contents of the pack

This is a yellowish, orange-coloured liquid, slightly viscous.

Dalivit Drops are supplied in a 25 ml bottle or 50 ml bottle with an integral dropper.

Marketing Authorisation Holder:

Boston Healthcare Ltd., 6 Navigation Court, Calder Park, Wakefield WF2 7BJ Manufactured by:

Sidefarma, Rua da Guine, 26 - 2689-514 Prior Velho - Portugal This leaflet was last revised in June 2015.

Dalivit is a registered trade mark.