Summary of Product Characteristics (SmPC) - Oily Phenol injection 5% w/v
1 NAME OF THE MEDICINAL PRODUCT
Oily Phenol 5% w/v Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 50 mg Phenol.
3 PHARMACEUTICAL FORM
Injection.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Analgesic sclerosing agent in the treatment of internal haemorrhoids
4.2 Posology and method of administration
Posology
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.
Paediatric population
The use of oily phenol injection is contraindicated in children and neonates (see section 4.3).
Elderly
No alternative dosage schedules have been suggested.
Method of administration
By submucosal injection
4.3 Contraindications
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.
4.4 Special warnings and precautions for use
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.
4.5 Interaction with other medicinal products and other forms of interaction
None stated
4.6 Fertility, pregnancy and lactation
Pregnancy
Safety in pregnancy has not been established. The effects on the foetus are unknown, therefore Oily Phenol is not recommended for use during pregnancy.
Breast-feeding
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.
4.7 Effects on ability to drive and use machines
Effects of phenol oily injection are not likely to affect the patient’s ability to
drive and use machinery.
4.8 Undesirable effects
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
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.
4.9 Overdose
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.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antivaricose therapy
ATC Code: C05BB05
The injection produces submucosal fibrosis, fixing the mucosa to the underlying muscle.
5.2 Pharmacokinetic properties
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.
5.3 Preclinical safety data
No data available
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Almond oil
6.2 Incompatibilities
Incompatible with alkaline salts, acetanilide, phenazone, piperazine, quinine salts, phenacetin and iron salts. Phenol coagulates albumin and gelatinises
collodion.
6.3 Shelf life
3 years (36 month) when packaged in glass ampoules 18 months when packaged in glass vials with rubber caps and aluminum crimps.
6.4 Special precautions for storage
Not applicable
6.5 Nature and contents of container
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.
6.6 Special precautions for disposal
None
7. MARKETING AUTHORISATION HOLDER
Macarthys Laboratories Limited
T/A Martindale Pharmaceuticals
Martindale Pharmaceuticals
Bampton Road, Romford, RM3 8UG.
8. MARKETING AUTHORISATION NUMBER
PL 01883/6153R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
First authorised: 22nd June, 1989
Last renewal:18th October, 1994
10 DATE OF REVISION OF THE TEXT
03/08/2018