HRI Night Tablets - SPC
1. Name of the medicinal product
HRI Night Tablets
2. Qualitative and quantitative composition
One tablet contains: 45 mg Valerian Powdered Extract 4:1 (equivalent to 180mg Valerian); 16.82 mg Passiflora Powdered Extract 5.35:1 (equivalent to 90mg Passiflora); 22.5 mg Wild Lettuce Powdered Extract 4:1 (equivalent to 90mg Wild Lettuce); 30 mg Powdered Hops; 60 mg Vervain Powder.
For full list of excipients, see section 6.1.
3. Pharmaceutical form
Dark grey round biconvex sugar coated tablet.
4. Clinical particulars
4.1. Therapeutic indications
Promotes refreshing natural sleep.
4.2. Posology and method of administration
For oral administration.
Adults, the elderly and children over 12 years: Three or four tablets to be taken one hour before bedtime.
Children under 12 years of age: Not recommended.
4.3. Contraindications
There are no known contra-indications to this product.
4.4. Special warnings and precautions for use
Do not exceed the stated dose or take on an empty stomach. If you accidentally take too many HRI Night Tablets, consult your doctor.
Not to be taken by children under 12 years of age.
Store out of reach of children.
4.5. Interaction with other medicinal products and other forms of interaction
There are no known interactions with this product.
4.6. Pregnancy and lactation
Not to be taken during pregnancy or lactation without consulting your doctor.
4.7. Effects on ability to drive and use machines
These tablets may cause drowsiness. If affected, do not drive or operate machinery.
4.8. Undesirable effects
There are no known undesirable effects.
4.9. Overdose
No special procedures or antidotes are likely to be needed in healthy adults.
5. Pharmacological properties
5.1. Pharmacodynamic properties
Valerian, Passiflora, Wild Lettuce, Hops and Vervain are traditionally used for the sedative action, particularly in cases of sleep disorders.
5.2. Pharmacokinetic properties
None stated.
5.3. Preclinical safety data
No remarks.
6 Pharmaceutical particulars
6.1. List of excipients
• Sucrose Ph. Eur
• Calcium Hydrogen Phosphate
• Calcium Carbonate
• Purified Talc
• Powdered Acacia BP
• Magnesium Stearate
• Croscarmellose Sodium Ph. Eur
• Stearic Acid BP
• Titanium Dioxide Ph. Eur
• Iron Oxide Black
• Shellac
• Carnauba Wax
• Beeswax
6.2. Incompatibilities
None known.
6.3. Shelf life
Three years from date of manufacture.
6.4. Special precautions for storage
Store below 25°C in a dry place. Protect from light.
6.5. Nature and contents of container
The product container is a 60ml amber glass jar with a foil tamper-evident seal and white polypropylene screw cap, contained in a carton. Leaflet enclosed.
Each jar contains 50 tablets.
Carton: white backed folded box board and colour printed.
6.6. Instructions for Use/Handling
Do not use if tamper-evident seal is broken.
7. Marketing Authorisation Holder
Jessup Health Limited
(Trading as Jessup Marketing)
27 Old Gloucester Street
London WC1N 3XX
8. Marketing Authorisation number
PL 14404/0002
9. Date of revision of the text
July 2007

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