Summary of Product Characteristics (SmPC) - Nelsons Sulfur 30C pillules
1 NAME OF THE MEDICINAL PRODUCT
Nelsons Sulfur 30c Pillules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulfur 30c
Also contains
Lactose 15% w/w
Sucrose 85% w/w
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pillules
White to off-white spherical
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A HOMEOPATHIC MEDICINAL PRODUCT used within the homeopathic tradition for the symptomatic relief of pimples and spots of mild acne that are not infected or inflamed, and skin prone to eczema, irritation and itching.
4.2 Posology and method of administration
Adults, the elderly and children (over 2 years): Take 2 pillules every 2 hours for the first 6 doses, then 4 times daily until symptoms improve for up to a maximum of 7 days.
Pillules should either be chewed or placed under the tongue until dissolved and are to be taken between meals.
Press base twice to release 2 pillules into cap. Unscrew the cap. Place pillules directly into mouth without touching them.
If symptoms persist or worsen after using the product for 7 days, a doctor or a qualified healthcare practitioner should be consulted.
Not for use in children under 2 years of age.
4.3 Contraindications
Hypersensitivity to Sulfur preparations or any of the excipients.
Do not use for infected spots or inflamed spots associated with infection.
4.4 Special warnings and precautions for use
Do not use if seal is broken.
Handle carefully, homeopathic medicine in an inner glass vial.
Do not use to treat acute erythroderma, acute inflammatory, oozing or infected skin lesions. If not treated adequately, acne may cause scarring. A doctor or qualified healthcare practitioner should be consulted if the skin is broken or infected.
If symptoms persist or worsen after using the product for 7 days, a doctor or a qualified healthcare practitioner should be consulted.
Contains lactose and sucrose - Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency of glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
None known
4.6 Fertility, pregnancy and lactation
Pregnancy: There is no evidence of the safety of the product in human pregnancy, nor is there any evidence from animal studies. Although no adverse events have been observed, the use of this product during pregnancy should be avoided unless under the guidance of a doctor.
Lactation: There is no evidence to suggest that the product should not be used during lactation.
4.7 Effects on ability to drive and use machines
Sulfur 30c pillules has no influence on the ability to drive and use machines.
4.8 Undesirable effects
There are no known adverse effects.
If any adverse effects are experienced, a doctor or pharmacist should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
None known.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group – other therapeutic products
ATC code V03
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose
Sucrose
6.2 Incompatibilities
None known.
6.3 Shelf life
60 months.
6.4 Special precautions for storage
Do not store above 250C
6.5 Nature and contents of container
Container: Type I neutral glass with polypropylene outer.
Closure: Polypropylene dispenser mechanism with tamper – evident seal.
Pack size: 84 pillules.
6.6 Special precautions for disposal
Return any unused medicine to your pharmacist for safe disposal.
7 MARKETING AUTHORISATION HOLDER
A Nelson & Co Limited
5-9 Endeavour Way
Wimbledon
London
SW19 8UH
8 MARKETING AUTHORISATION NUMBER(S)
NR 01175/0186
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19/02/2013
10 DATE OF REVISION OF THE TEXT
17/03/2016