Childrens Nappy Rash Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Children’s Nappy Rash Cream or Infant Nappy Rash Cream Boots Antiseptic Nappy Rash Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients %w/w
Cetrimide Ph Eur 0.5
Dimethicone 20 Ph Eur 10.0
3 PHARMACEUTICAL FORM
Cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment and prevention of nappy rash.
For topical application to the skin.
Use during each nappy change.
Clean and thoroughly towel dry the nappy area.
Spread the cream lightly and evenly over the whole nappy area and then rub gently into the skin.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Do not use if the skin is weeping or badly inflamed. Avoid contact with the eyes.
For external use only.
Keep all medicines out of the reach of children
4.5 Interaction with other medicinal products and other forms of interaction
There are no clinically significant interactions
The safety of Children’s Nappy Rash Cream during pregnancy and lactation has not been established but is not considered to constitute a hazard during these periods.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
The following frequencies are taken as a basis when evaluating undesirable effects:
|
Very common: |
> 1/10 |
|
Common: |
> 1/100 to < 1/10 |
|
Uncommon: |
> 1/1,000 to < 1/100 |
|
Rare: |
> 1/10,000 to < 1/1,000 |
|
Very rare: |
> 1/10,000 |
Not known: cannot be estimated from the available data
Infections and infestations:
Very rare: Exacerbation of infection-related inflammations (e.g. development of necrotising fasciitis) coinciding with the use of non-steroidal antiinflammatory drugs has been described. This is possibly associated with the mechanism of action of the non-steroidal anti-inflammatory drugs. If signs of an infection occur or get worse during use of Ibuprofen the patient is therefore recommended to go to a doctor without delay. It is to be investigated whether there is an indication for anti-infective/antibiotic therapy.
Haematological:
Very rare: haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Immune System:
Not known: In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed (see section 4.4 Special warnings and precautions for use).
Hypersensitivity reactions:
Uncommon: Hypersensitivity reactions with urticaria and pruritus.
Very rare: severe hypersensitivity reactions. Symptoms could be: facial, tongue and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).
Not known: Respiratory tract reactivity, e.g. asthma, aggravated asthma, bronchospasm, dyspnoea. Exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Nervous System:
Uncommon: Headache.
Very rare: Aseptic meningitis - single cases have been reported very rarely. Cardiovascular and Cerebrovascular:
Not known: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke), (see section 4.4 Special warnings and precautions for use).
Gastrointestinal:
The most commonly-observed adverse events are gastrointestinal in nature. Uncommon: abdominal pain, nausea, dyspepsia.
Rare: diarrhoea, flatulence, constipation and vomiting Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis. Exacerbation of ulcerative colitis and Crohn’s disease (see section 4.4 Special warnings and precautions for use).
Hepatic:
Very rare: liver disorders.
Skin and subcutaneous tissue disorders:
Uncommon: Various skin rashes.
Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis can occur.
Not known: In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection (see also "Infections and infestations").
Renal:
Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and oedema.
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
It is unlikely that systemic toxicity will result from the ingestion of Children’s Nappy Rash Cream although it may give rise to gastrointestinal irritation and possibly laxation
Treatment should be symptomatic.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Dimethicone 20 is water repellent and will protect the skin against water soluble irritants. Cetrimide is a quaternary ammonium disinfectant having bactericidal activity against both gram-positive and gram-negative organisms.
Pharmacokinetic properties
5.2
None stated.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Chlorocresol Liquid paraffin Cetostearyl alcohol Zinc oxide
Perfume compound DROM 442996 Purified water.
6.2 Incompatibilities
None stated.
6.3 Shelf life
24 months
6.4 Special precautions for storage
Store below 250C.
6.5 Nature and contents of container
A polypropylene tub fitted with a polypropylene cap or a green or white polyethylene cap.
Pack size: 125gm or 300gm
6.6 Special precautions for disposal
None stated
7 MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8 MARKETING AUTHORISATION NUMBER(S)
PL 00014/5260R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
25 July 1989 / 24 January 1995
10 DATE OF REVISION OF THE TEXT
07/10/2015