This information is intended for use by health professionals
Oily Phenol 5% w/v Injection.
Each ml of solution contains 50 mg Phenol.
Analgesic sclerosing agent in the treatment of internal haemorrhoids
Adults and the elderly
2- 3 ml of oily phenol injection into the sub-mucosal layer at the base of the haemorrhoid. Several sites may be injected but the maximum total at any one time is 10 ml.
The use of oily phenol injection is contraindicated in children and neonates (see section 4.3).
No alternative dosage schedules have been suggested.
Method of administration
By submucosal injection
Oily Phenol Injection, is contraindicated in patients who are hypersensitive to phenol, nuts and in particular almond oil or any component of the product.
It should not be used over large areas, since sufficient amounts may be absorbed to give rise to toxic symptoms.
Oily Phenol Injection, is also contraindicated in neonates and children.
For submucosal injection only. Not for intrathecal use. Care should also be taken to avoid accidental intravenous injection. The injection may cause severe pain if it is too close to the anal verge. Complications of therapy can include local ulceration and sterile abscess formation. These complications may be serious following a misplaced injection (e.g. prostatic abscess). Care in choosing the correct site of injection is mandatory.
Safety in pregnancy has not been established. The effects on the foetus are unknown, therefore Oily Phenol is not recommended for use during pregnancy.
It is not known whether Oily Phenol is excreted in breast milk. Since safety in infants has not been established, Oily Phenol injection is not recommended for use whilst breast-feeding.
Effects of phenol oily injection are not likely to affect the patient's ability to drive and use machinery.
General disorders and administration site conditions:
Immune system disorders:
Nervous system disorders:
Infections and infestations:
Renal and urinary disorders:
Reproductive system and breast disorders:
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
The symptoms of overdosage after submucosal injection of Oily Phenol are not known, but are likely to be similar to symptoms observed after excessive exposure to phenol in other preparations. Absorption of phenol after application of dilute phenol solutions to extensive wounds has resulted in abdominal pains, dizziness, methaemoglobinaemia, haemoglobinurea, cyanosis, cardiac arrhythmias, ECG abnormalities, and may result in respiratory failure, circulatory failure, coma and death.
There is no specific antidote for actute phenol overdose. Treatment of overdose is symptomatic and supportive. If the product has been swallowed, empty the stomach by aspiration and lavage, taking care to avoid perforation, before carrying out the above procedure.
Pharmacotherapeutic group: Antivaricose therapy
ATC Code: C05BB05
The injection produces submucosal fibrosis, fixing the mucosa to the underlying muscle.
Phenol is absorbed from the gastro-intestinal tract and through skin and mucous membranes. It is metabolised to phenylglucoronide and phenylsulphate and small amounts are oxidised to catechol and quinol which are mainly conjugated. The metabolites are excreted in the urine; on oxidation to quinones they may tint the urine green.
No data available
Incompatible with alkaline salts, acetanilide, phenazone, piperazine, quinine salts, phenacetin and iron salts. Phenol coagulates albumin and gelatinises collodion.
3 years (36 month) when packaged in glass ampoules
18 months when packaged in glass vials with rubber caps and aluminum crimps.
Clear glass ampoules containing 2 ml or 5 ml of product. 10 ampoules are packed into cartons. Glass vials containing 25 ml of product closed with rubber bungs sealed with aluminum caps. Not all pack sizes may be marketed.
Macarthys Laboratories Limited
T/A Martindale Pharmaceuticals
Bampton Road, Romford, RM3 8UG.
First authorised: 22nd June, 1989
Last renewal:18th October, 1994