Calamine Lotion BP

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Calamine; Zinc oxide

Available from:

Pinewood Laboratories Ltd,

ATC code:

D02AB

INN (International Name):

Calamine; Zinc oxide

Dosage:

5%w/v +15 percent weight/volume

Pharmaceutical form:

Cutaneous suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Zinc products

Authorization status:

Marketed

Authorization date:

1999-04-16

Patient Information leaflet

B/N:
EXP:
200 ml
FOR USE ON THE SKIN ONLY
CALAMINE LOTION BP is a cutaneous suspension and is used for the
relief of sunburned
skin and mild skin irritations such as pruritus, dermatitis and
rashes. It can also be used
as an astringent, antiperspirant, antiseptic and to control bleeding.
BEFORE YOU USE CALAMINE LOTION BP: Apply to the affected areas of the
skin as required.
No special dosage. Avoid application prior to any x-rays. If you have
any further
questions on the use of this product, ask your doctor or pharmacist.
IF YOU ACCIDENTALLY SWALLOW CALAMINE LOTION BP: contact your doctor or
pharmacist.
PREGNANCY OR BREASTFEEDING:
This medicine can be used during pregnancy and breastfeeding;
however, safety during pregnancy and breast-feeding has not been
established. If you are
unsure talk to your doctor. SIDE EFFECTS are unlikely with the use of
this product but can
include allergic reactions including irritation, rash or itching.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. You can also report
side effects directly via
HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1
6764971; Fax:
[phone]; Website: www.hpra.ie; e-mail: [e-mail], By
reporting side
effects you can help provide more information on the safety of this
medicine.
STORING CALAMINE LOTION BP: Keep out of the sight and reach of
children. Do not store
above 25˚C. Do not use after the expiry date shown on the label. Your
pharmacist will
dispose of any unused lotion.
CALAMINE LOTION BP CONTAINS: Calamine 15% w/v and Zinc Oxide 5% w/v.
Also includes
sodium citrate, liquified phenol, glycerol (E422), bentonite and
purified water.
PRODUCT AUTHORISATION HOLDER AND MANUFACTURER:
Pinewood Laboratories Ltd.,
Ballymacarbry, Clonmel, Co. Tipperary. PA 281/51/1
REVISION DATE:
August 2014
Calamine Lotion BP
B
A
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Calamine 15% w/v and
Zinc Oxide 5% w/v
CALAMINE LOTION
CALAMINE LOTION
CALAMINE LOTION
23LL

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calamine Lotion BP
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calamine Lotion BP contains Calamine 15% w/v and Zinc Oxide 5% w/v.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous suspension
Pale pink cutaneous suspension, with phenolic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calamine has a mild astringent action on the skin. It is used as an
astringent, antiperspirant, styptic, corrosive and mild
antiseptic.
Calamine Lotion also allays the pain and swelling of pruritus,
sunburn, dermatitis, skin irritations and rashes.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Calamine Lotion is for external use only.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
Poison: Not to be taken orally.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Keep all medicines away from children.
Avoid application prior to x-ray (zinc oxide may affect the outcome of
the x-ray).
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Zinc oxide may mask x-ray pictures under certain circumstances.
4.6 FERTILITY, PREGNANCY AND LACTATION
Safety during pregnancy and lactation has not been established.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
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4.8 UNDESIRABLE EFF