SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Cerumol Ear Drops

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Arachis Oil, Refined (Peanut Oil)	57.3%
Chlorobutanol Hemihydrate	5.0%

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Ear drops solution.

Oily drops for topical application

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

To loosen wax causing occlusion or partial occlusion of the external auditory meatus.

(Either a collection of soft wax or a harder wax plug.)

4.2 Posology and method of administration

At home: With the head inclined, 5 drops are put into the ear. This may cause a harmless tingling sensation. A plug of cotton wool moistened with Cerumol or smeared with petroleum jelly should then be applied to retain the liquid. One hour later, or the next morning, the plug is removed. The procedure is repeated twice a day for three days; the loosened wax may then come out on its own making syringing unnecessary. If any wax remains the doctor should be consulted so that syringing of the softened residue may be carried out.

At the surgery: If there has been no prior treatment with Cerumol, 5 drops are instilled as described above and left for at least 20 minutes. Then syringing or a probe tipped with cotton wool may be employed.

4.3 Contraindications

Otitis externa, seborrhoeic dermatitis and eczema affecting the outer ear. Perforated ear drums.

4.4 Special warnings and precautions for use

Not to be taken internally. Do not use for more than three days without consulting your doctor. Cerumol contains Arachis oil (peanut oil) and should not be taken by patients known to be allergic to peanut. As there is a possible relationship between allergy to peanut and allergy to soya, patients with soya allergy should also avoid Cerumol.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

Pregnancy

There are no or limited amount of data from the use of Arachis Oil and/or Chlorobutanol in pregnant women.

Although the risks cannot completely be excluded, systemic exposure to Arachis Oil and Chlorobutanol is thought to be negligible and the adverse effects during pregnancy are therefore not anticipated.

Lactation

There are no or limited amount of data from the use of Arachis Oil and/or Chlorobutanol in lactating women.

Although the risks cannot completely be excluded, systemic exposure of the breastfeeding woman to Arachis Oil and Chlorobutanol is thought to be negligible and the adverse effects on the breastfed newborn/infant are therefore not anticipated.

4.7 Effects on ability to drive and use machines

None known, but the actual wax plug may cause deafness.

4.8    Undesirable effects

The product may cause local irritation, redness or rash.

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

As the product is applied topically, overdosage as such is not possible. In the case of accidental ingestion, the amounts of the majority of the ingredients in the bottle are too small to give rise to toxic effects. The 550 mg of Chlorobutanol in the whole bottle might cause excessive sedation in a child.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

The drug is applied topically to aid the removal of cerumen. Thus normal pharmacological criteria cannot be applied.

The action is thought to be due to the loosening and lubricating properties of the solvent mixture, rather than its solvent properties. This is intrinsic to the solvent mixture.

Arachis Oil is an oily substance to aid lubrication of the cerumen plug (water based solvents cause swelling of cerumen). It is however too viscous to be used on its own.

Chlorobutanol This is an anti-bacterial and anti-fungal, but its main purpose in this product is to reduce the viscosity of the mixture, giving better penetrating characteristics to the oil.

p-Dichlorobenzene : is an insecticide whose presence also reduces viscosity.

5.2 Pharmacokinetic properties

The rate of loosening or dissolution of the cerumen is extremely variable. Trials have shown that Cerumol is the only one of a number of agents that was significantly better than sodium bicarbonate in aiding the removal of wax.*

*J Fraser, J Laryng. and Otology, 1970, 84, (10), 1055.

5.3 Preclinical safety data

None stated.

PHARMACEUTICAL PARTICULARS

List of excipients

Oil of Turpentine	BP	10.0%
3-methoxy butyl acetate (Butoxyl Hoechst)	House	10.0%
o-Di chl orob enzene	House	14.5%
p-Dichlorobenzene	BPC 1949	2.0%

6.2 Incompatibilities

None known.

6.3 Shelf life

5 years. Use within 6 months of opening.

10 DATE OF REVISION OF THE TEXT

11/11/2015