Oily Phenol Injection 5% w/v

Injection.

4.1 Therapeutic indications Analgesic sclerosing agent in the treatment of internal haemorrhoids4.2 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 injection4.3 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 stated4.6 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.

5.1 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

6.1 List of excipients Almond oil6.2 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 applicable6.5 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 and other handling None