Local treatment of external and internal haemorrhoids.

Should be applied morning and evening until acute symptoms have diminished, after which the dosage can be reduced to once a day.

Rectacure should be used with precaution in patients suffering from severe hepatic damage.

There is no clinical experience with tribenoside and lidocaine hydrochloride in children.

Rectacure contains benzyl alcohol, cetostearyl alcohol and propylene glycol
Rectacure contains benzyl alcohol. Each 1 g of Rectacure 5%/2% Cream contains 10 mg benzyl alcohol, which may cause mild local irritation.

Rectacure contains cetostearyl alcohol. Each 1 g of Rectacure 5%/2% Cream contains 72 mg cetostearyl alcohol, which may cause local skin reaction (e.g. contact dermatitis).

Rectacure contains propylene glycol. Each 1 g of Rectacure 5%/2% Cream contains 100 mg propylene glycol.

None Reported

Pregnancy
There is no adequate data for use in pregnant women.

Animal experiments on tribenoside or the combination with tribenoside and lidocaine are not available. It is also not known whether tribenoside passes the placenta. Lidocaine has some embryotoxicity. Under these circumstances, Rectacure cream should not be administered during pregnancy, especially in the first three months, unless clearly necessary.

Lactation
Lidocaine can enter the mother's milk. The benefit for the mother is to be balanced against the risk to the child. Care should be taken to either treat or breast-feed. Ask a doctor or pharmacist before use.

There is no known effect on the ability to drive or operate machines caused by the use of Rectacure.

Immune system disorders
Very rare (<1/10,000): Anaphylactic reactions, including angioneurotic oedema, face oedema, bronchospasm and cardiovascular disorders.

Skin and subcutaneous tissue disorders
Rare (>1/10,000, <1/1,000): Skin reactions at the application site have occurred and may include application site burning, rash, pruritus and urticaria. These signs and symptoms may spread beyond the application site.

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:

• Saudi Arabia

The National Pharmacovigilance Centre (NPC)

SFDA Call Center: 19999

E-mail: npc.drug@sfda.gov.sa

Website: https://ade.sfda.gov.sa

• Other GCC States

Please contact the relevant competent authority.

There is no experience of overdosage with tribenoside and lidocaine hydrochloride.

In case of accidental oral ingestion gastric lavage is recommended together with symptomatic treatment and general supportive measures.

Pharmaceutical group: Antihemorrhoidals for topical use.

ATC code: C05AD01, C05AX05, C05CX01 Products containing local anaesthetics.

Tribenoside reduces capillary permeability and improves vascular tone. It also has anti-inflammatory properties and exerts an antagonistic action on a number of endogenous substances, which play a role as mediators in the development of inflammation and pain.

Lidocaine is a local anaesthetic, which relieves itching, smarting and pain caused by haemorrhoids.

Absorption
the systemic bioavailability of tribenoside in suppositories is only 30% of that which would be achieved by oral or intravenous adminstration.
About 2-20% of the tribenoside contained in the cream is absorbed through the skin. Peak plasma levels of 1 μg/ml (tribenoside and metabolites) were noted 2 hours after administration of 1 suppository (400 mg tribenoside) per rectum.

 Lidocaine is easily absorbed by mucous membranes and less so by intact skin. The bioavailability of lidocaine is about 50% after rectal administration. The highest plasma levels (0.70 μg/ml) after administration of a suppository (containing lidocaine hydrochloride 300 mg) were reached after 112 min.

 Distribution
Lidocaine is strongly bound to acid alpha-glycoprotein.

 Biotransformation
Tribenoside is intensively metabolized in the body. Metabolism of lidocaine in the liver is rapid.

 Elimination
Tribenoside: 20-27% of the dose administered in the suppository is excreted in the urine in the form of metabolites.
Lidocaine: Metabolites are excreted in urine with less than 10% unchanged lidocaine.

Toxicity:

• Tribenoside: Acute and repeated dose toxicity studies with tribenoside showed the product to be practically non-toxic by oral administration. Pharmacokinetic data demonstrated rapid and complete metabolic clearance after absorption. Rectal application produces effective local concentrations with minimal systemic exposure and is, therefore, not expected to produce a toxicological profile different from oral tribenoside.
• Lidocaine: Acute toxicity studies with lidocaine showed lower toxicity after oral application, compared to intravenous, because of a first-pass effect. Rectal application resulted in plasma levels intermediate between oral and intravenous. There are no nonclinical repeated dose toxicity data for lidocaine.

Reproductive toxicity:

• Tribenoside: No reproduction toxicity studies are available. Limited genotoxicity data do not indicate a mutagenic potential for tribenoside.
• Lidocaine: The limited evidence suggests that lidocaine does not adversely affect reproduction and is not teratogenic or genotoxic.

• Benzyl alcohol
• Liquid paraffin
• White soft paraffin
• Cetostearyl alcohol
• Cetomacrogol
• Propylene glycol
• Purified water

Not applicable

Store below 30°C.

Store in the original package.

Collapsible aluminum tubes.

Pack size: 1 Tube (30 g).

Avoid contact with the eyes.

Medicines should be kept out of the reach of children.