Patient Information Leaflet    EP00104

Ketovite Liquid

Oral Liquid

Multivitamin preparation

Read all of this leaflet carefully before you start taking this medicine. 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 is available without prescription. However, you still need to take Ketovite Liquid carefully to get the best results from it. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

•    You must contact a doctor if your symptoms worsen or do not improve.

•    There are usually no undesirable effects after taking Ketovite Liquid. If you do notice any unexpected effects, stop taking it and tell your doctor or pharmacist.

In this leaflet:

1.    What Ketovite Liquid is and what it is used for

2.    Before you take Ketovite Liquid

3.    How to take Ketovite Liquid

4.    Possible side effects

5.    How to store Ketovite Liquid

6.    Further information

1.    WHAT KETOVITE LIQUID IS, AND WHAT IT IS USED FOR

Ketovite Liquid is a sugar-free therapeutic supplement for the prevention of vitamin deficiency. It is used in conditions such as:

•    galactosaemia (a disorder of milk sugar digestion)

•    disaccharide intolerance (a reaction to sugars such as sucrose, lactose and maltose)

•    phenylketonuria (an inability to digest one of the essential amino acids)

•    in other disorders of starch, sugar or amino acid metabolism

•    in patients who are on restricted, specialised or synthetic diets

Ketovite Liquid is a multivitamin preparation, intended for use at the same time as Ketovite Tablets.

2.    BEFORE YOU TAKE KETOVITE LIQUID

Do not take Ketovite Liquid if you

•    are allergic (hypersensitive) to any of the ingredients of the liquid (see list in section 6 ‘Further information’)

•    have hypercalcaemia (high blood calcium level)

•    are taking other vitamin preparations, especially those containing Vitamins A and D, such as cod-liver oil. Take special care with Ketovite Liquid (and speak with your doctor)

•    If you have trouble digesting fatty foods as the absorption of some of the vitamins may be reduced.

Taking other medicines

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

Tell you doctor if you are taking an oral contraceptive pill as The Pill’ may reduce Vitamin B12 blood levels. Absorption of some of the vitamins in Ketovite Liquid may be reduced if you are also taking:

•    neomycin

•    colestyramine

•    liquid paraffin

•    aminoglycosides

•    aminosalicylic acid

•    anticonvulsants

•    biguanides

•    chloramphenicol

•    cimetidine

•    colchicine

•    potassium salts

•    methyldopa

Ask your doctor or pharmacist for advice.

Pregnancy and breast-feeding

Do not take this medicine if you are pregnant or likely to become pregnant as large doses of Vitamin A may damage the baby if taken during the first three months of pregnancy.

If you are breast-feeding, large amounts of Vitamin D may cause poor bone formation in your baby.

Ask your doctor or pharmacist for advice before taking any medicine.

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Important information about some of the ingredients of Ketovite Liquid

This medicine contains methyl parahydroxybenzoate (E218), which may cause allergic reactions (possibly delayed).

3.    HOW TO TAKE KETOVITE LIQUID

Dosage

Always take Ketovite Liquid exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure. The usual dose is 5 ml daily.

If you take more Ketovite Liquid than you should

Do not take more than you have been prescribed or than is recommended, as this may lead to too high a dose level, particularly of Vitamin A and Vitamin D.

If you forget to take Ketovite Liquid

You may take the dose later on during the same day. Do not take a double dose to make up for a forgotten dose.

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

4.    POSSIBLE SIDE EFFECTS

There are usually no undesirable effects after taking Ketovite Liquid.

Reporting of side effects

If you 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

www.mhra.gov.uk/yellowcard

Ireland

HPRA Pharmacovigilance Earlsfort Terrace IRL- Dublin 2 Tel: +353 1 6764971 Fax: +353 1 6762517 www.hpra.ie

email: medsafety@hpra.ie

5.    HOW TO STORE KETOVITE LIQUID

Keep out of the reach and sight of children.

Do not use Ketovite Liquid after the expiry date which is stated on the bottle after Exp. Date. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

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 Ketovite Liquid contains

The active ingredients are vitamin A (as palmitate) 2500 IU, vitamin D² (ergocalciferol) 400 IU, cyanocobalamin 12.5 microgram and choline chloride 150 mg, in each 5 ml.

The other ingredients are methylcellulose, saccharin, methyl parahydroxybenzoate (E218), polysorbate 80, ascorbic acid, alpha tocopherol, terpeneless orange oil, ammonia solution and purified water.

What Ketovite Liquid looks like and contents of the pack

Ketovite Liquid is a pale pink to yellow oral liquid which you take by mouth (oral use).

Ketovite Liquid is available in bottles of 150 ml.

Marketing authorisation holder and manufacturer

The Marketing Authorisation for Ketovite Liquid is held by Essential Pharmaceuticals Ltd, 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB, UK.

The liquid is manufactured by Dales Pharmaceuticals Ltd., Skipton, North Yorkshire, BD23 2RW UK.

This leaflet was last revised in November 2014.

EP00104

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