Yeast-Vite

1. Name Of The Medicinal Product

Yeast-Vite

2. Qualitative And Quantitative Composition

Caffeine EP 50.0 MG

Nicotinamide 1.75 MG

Thiamine Hydrochloride (Vitamin B1) 0.167 MG

Riboflavin (Vitamin B2) 0.167 MG

3. Pharmaceutical Form

Tablet

4. Clinical Particulars

4.1 Therapeutic Indications

1. For the relief of fatigue and drowsiness.

2. The maximum daily dose will supply the recommended daily amount of Vitamins B1, B2 and Nicotinamide.

4.2 Posology And Method Of Administration

Adults and Children aged 12 years and over

2 tablets every 3 – 4 hours as required.

Do not exceed 12 tablets in any period of 24 hours.

Not to be given to children under 12 years of age, except on medical advice.

The Elderly

The normal adult dose should be taken.

4.3 Contraindications

Known sensitivity to caffeine. Hypersensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Label Warnings

Do not exceed the stated dose.

If symptoms persist, consult your doctor.

Keep out of reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Caffeine may enhance the action of Ergotamine. High doses may cause tremor and palpitations. Patients should avoid excessive intake of coffee or tea.

Other drugs which may have their action altered by caffeine are idrocilamide, mexiletine, ciprofloxacin, enoxacin, pipemidic acid, fluvoxamine, phenylpropanolamie, phenytoin, clozapine, lithium, theophylline, pentobarbital, diazepam and methoxsalen.

4.6 Pregnancy And Lactation

Consult a doctor before using if you are pregnant or breast-feeding. Caffeine may cause irritability to the breast-fed baby, therefore nursing mothers should use with caution.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

High doses of caffeine may cause tremor and palpitations.

4.9 Overdose

Any symptoms of over dosage would be related to the caffeine content. Mild over dosage leads to nausea, headache and insomnia; Major over dosage causes restlessness, excitement, muscle tremor, tinnitus, tachycardia and extrasystoles. Later there may be scintillating scotoma (blind or partially blind areas in the visual fields).

In mild to moderate over dosage, no particular treatment is indicated. In major over dosage the stomach should be emptied either by inducing emesis or by intubation and lavage. Stimulation of the nervous system may be controlled by administration, intravenously if necessary, of a tranquilliser.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Caffeine is a mild stimulant.

The maximum daily dose of product will supply the recommended daily amount of vitamins B1, B2 and nicotinamide.

5.2 Pharmacokinetic Properties

Not applicable

5.3 Preclinical Safety Data

None stated.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dried Yeast (1973)

Powdered Clove

Colloidal Anhydrous Silica

Micro Crystalline Cellulose

Lactose

Dispersed Brown 16658 (E124, E104, E132)

Maize Starch

Magnesium Stearate

6.2 Incompatibilities

Iodine, silver salts, tanning, strong caustic alkali.

6.3 Shelf Life

Three years

6.4 Special Precautions For Storage

Store at or below 25°C in a dry place.

6.5 Nature And Contents Of Container

a) Polypropylene securitainer, with polythene closure and polyether wad, containing 50 or 100 tablets.

b) Cylindrical, white (HDPE) bottle with a laminate membrane neck seal. A polypropylene screw cap and polyether wad, containing 50 or 100 tablets.

c) Cylindrical, white (HDPE) bottle, with an orange child resistant tamper evident lined closure. The bottle is fitted with a polyether wad and contains 50 or 100 tablets.

d) Blister packs comprising 25µ hard temper aluminium foil with 250µ opaque PVC film containing 12, 24 or 48 tablets.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjordur

Iceland.

8. Marketing Authorisation Number(S)

PL 30306/0081

9. Date Of First Authorisation/Renewal Of The Authorisation

19 June 2002

10. Date Of Revision Of The Text

11 DOSIMETRY

Not Applicable

12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

Not Applicable