Phenol

Oily Phenol Injection 5% w/v.

Each ml of solution contains 50 mg Phenol BP.

Injection.

Analgesic sclerosing agent in the treatment of internal haemorrhoids

By submucosal injection

Adults and the elderly

2 - 3 ml injected at the base of the haemorrhoid. Several sites may be injected but the maximum total at any one time is 10 ml.

Children

The use of oily phenol injection BP is contraindicated in children and neonates.

Oily Phenol Injection, BP 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, BP 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 (eg prostatic abscess). Care in choosing the correct site of injection is mandatory.

Not applicable

General disorders and administration site conditions:

Pyrexia

Pain

Discomfort

Irritation

Ulcer

Tissue necrosis

Immune system disorders:

Hypersensitivity

Nervous system disorders:

Dizziness

Hepatobiliary disorders:

Hepatitis

Infections and infestations:

Abscess

Prostatic abscess

Necrotizing fasciitis

Retroperitoneal sepsis

Renal and urinary disorders:

Dysuria

Urinary incontinence

Reproductive system and breast disorders:

Impotence

Symptoms:

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.

Treatment: 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.

The injection produces submucosal fibrosis, fixing the mucosa to the underlying muscle.

Not applicable

Not applicable

Almond oil BP

None stated

3 years (36 month) when packaged in glass ampoules

18 month when packaged in glass vials with rubber caps and aluminium crimps.

Not applicable

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 aluminium caps.

None

Macarthys Laboratories Limited

T/A Martindale Pharmaceuticals

Martindale Pharmaceuticals

Bampton Road, Romford, RM3 8UG.

PL 01883/6153R

First authorised: 22^nd June, 1989

Last renewal:18^th October, 1994

17/06/2010