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Napiers Ascovita

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Napiers Ascovita

Box's Herbals Seagreens Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

360 mg of Kelp thallus (Ascophyllum nodosum L. (Le Jolis) or Ascophyllum canaliculatum L. (Kuntze))

Each tablet contains 50 mg of lactose and 100 mg of sucrose (see section 4.4 ‘Special warnings and precautions for use.’)

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Coated tablet, round.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the relief of rheumatic or muscular pain, and general aches and pains in the muscles and joints, based on traditionally use only.

4.2 Posology and method of administration

For oral use only.

Adults and the elderly: Take one tablet three times a day.

If symptoms worsen or do not improve after 4 weeks a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active ingredients or iodine or to malt or to any of the excipients.

Patients with thyroid disorder.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

The use in children under 18 years of age is not recommended because data are insufficient and medical advice should be sought.

Do not take with any medicines or dietary supplements containing iodine.

If symptoms worsen or do not improve after 4 weeks a doctor or a qualified healthcare practitioner should be consulted.

If articular pain accompanied by swelling of the joint, redness or fever are present, a doctor should be consulted.

This product contains lactose and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

Do not take with any medicines or dietary supplements containing iodine.

Do not take with medicines for thyroid disorders.

4.6 Fertility, pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established. In the absence of sufficient data the use of this product during pregnancy and lactation is not recommended.

Studies on the effect on fertility have not been performed.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive or operate machines have been performed.

4.8 Undesirable effects

None known.

If adverse reactions occur, a doctor or qualified health care practitioner should be consulted.

4.9 Overdose

No cases known.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2


Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Malt Extract

Sucrose

Maltodextrin

Lactose

Talc

Magnesium Stearate Pre-gelatinised Starch Aniseed Oil.

6.2 Incompatibilities

Not known.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C. Store in the original container.

6.5 Nature and contents of container

Glass bottle with a Bakelite type screw-cap closure, packed in a cardboard carton: 50, 100, 150 and 200 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

There are no special precautions for disposal.

7    MARKETING AUTHORISATION HOLDER

Highland Herbs Limited 10 Payne Street Glasgow G4 0LF

8    MARKETING AUTHORISATION NUMBER(S)

THR 43751/0014

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

26/03/2013

10 DATE OF REVISION OF THE TEXT

20/01/2015