For local treatment of external and internal haemorrhoids.

Adults:
During the acute phase of the symptoms: apply the cream or 1 suppository in the morning and
evening; reduce to 1 application or 1 suppository per day thereafter.
30 g of cream (1 tube) is enough for approximately 20–30 applications.
Avoid any contact with the eyes.
For adults only. Not suitable for children.
Using the cream:
• clean the area concerned with a suitable cloth,
• dry thoroughly (with a soft cloth or a towel) before applying the cream.
For external use (without applicator):
Apply the cream around the anus with a clean finger.
For use in the anal canal (with applicator):
• after removing the seal from the tube, screw the supplied applicator on to the tube,
• remove the protective cap from the applicator,

• carefully insert the applicator into the anus, not too deeply, and gently press on
the tube,
• after each use, clean the outside of the applicator with a moistened cloth or
moistened cotton and replace the protective cap.
Wash hands thoroughly with soap and water after use.
Using the suppositories:
• wash hands thoroughly before and after use,
• detach 1 suppository from the strip and remove the wrapping,
• before inserting the suppository, clean the area concerned with a soft cloth or a
towel and gently dry,
• carefully insert the suppository into the anus so that it does not protrude,
• do not use aids, such as petroleum jelly or oils, to facilitate insertion.

When there is anal bleeding, suspected blood in stool, or when other unusual symptoms occur,
a medical examination is indicated.
When the symptoms occur for the first time, self-medication must not last for more than
2 weeks. Repeated treatments will only take place after a confirmed diagnosis has been made
by a doctor.
Procto-Glyvenol should be used with caution in patients with severe liver function disorders.
There is no clinical experience available with regard to use in children.
Avoid any contact with the eyes and do not swallow the preparation.
Procto-Glyvenol Cream contains cetyl alcohol which may cause local skin reactions
(e.g. contact dermatitis).
The cream contains methyl parahydroxybenzoate and propyl parahydroxybenzoate;
these substances may trigger allergic reactions, as well as delayed reactions.

No interaction studies have been performed.
Lidocaine should be used with caution in patients taking beta blockers or other antiarrhythmic
drugs, as the potential toxic effects (e.g. myocardial depression) are additive.

Pregnancy/Lactation
Insufficient data available on use in pregnant patients.
There are no animal studies on tribenoside or the combination of tribenoside and lidocaine.
Similarly, it is not known if tribenoside crosses the placenta. Lidocaine shows some

embryotoxicity. Under these conditions, Procto-Glyvenol should not be used during
pregnancy, particularly in the first three months, except where absolutely necessary.
Lidocaine may pass into breast milk. The benefits for the mother should be weighed up against
the risks to the child. As a precaution, treatment of breastfeeding should be stopped.

No corresponding studies have been performed.

The following adverse reactions are arranged based on system organ class and frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon
(≥1/1000, <1/100), rare (≥1/10,000, <1/1000), very rare (<1/10,000), not known (cannot be
estimated from the available data).
Immune system disorders
Very rare: anaphylactic reactions (angioedema).
Cardiac disorders
Very rare: cardiovascular disorders.
Respiratory, thoracic and mediastinal disorders
Very rare: bronchospasm.
Skin and subcutaneous tissue disorders
Rare: urticaria.
General disorders and administration site conditions

Rare: pruritus, eruption, pain.

No cases of overdose have been reported.
The systemic toxicity of lidocaine can affect the central nervous system and the cardiovascular
system. In case of accidental ingestion, symptomatic treatment and general support measures
are recommended.
The action to be taken depends on the clinical requirements and the recommendations of the
Swiss Toxicological Information Centre.

To report any side effect(s):
Kingdom of Saudi Arabia
- National Pharmacovigilance centre (NPC)
• Fax: +966112057662
• Reporting Hotline: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa
- GlaxoSmithKline - Head Office, Jeddah
• Tel: +966126536666
• Mobile: +966569049882
• Email: saudi.safety@gsk.com
• Website: https://gskpro.com/en-sa/
• P.O. Box 55850, Jeddah 21544, Saudi Arabia
For any information about this medicinal product, please contact:
- GlaxoSmithKline - Head Office, Jeddah
• Tel: +966126536666
• Mobile: +966569049882
• Email: gcc.medinfo@gsk.com
• Website: https://gskpro.com/en-sa/
• P.O. Box 55850, Jeddah 21544, Saudi Arabia

ATC code: C05AD01
The effect of tribenoside is based on reducing capillary permeability and increasing vascular
tonicity, and on its local anti-inflammatory and antagonistic properties with regard to a range
of endogenous substances that play an important role as mediators in the onset of
inflammation and in the origin of pain.
Lidocaine is a local anaesthetic that relieves the pain, burning sensation and itching caused
by haemorrhoids.

Absorption
The systemic bioavailability of tribenoside in suppository form is only 30% in comparison with
oral administration (capsules). When Procto-Glyvenol cream is applied, approximately 2–20%
of tribenoside is absorbed percutaneously. Two hours after insertion of a suppository (400 mg
of tribenoside) into the rectum, maximum plasma concentrations of tribenoside of 1 μg/mL and
of metabolites are observed.
Lidocaine is readily absorbed by the mucous membranes, but only moderately by intact skin.
Following rectal administration, the bioavailability of lidocaine is approximately 50%. The
maximum plasma concentration of 0.70 μg/mL is reached 122 minutes after insertion of
a suppository containing 300 mg of lidocaine.
Distribution
Lidocaine binds variably to plasma proteins in a concentration-dependent manner, primarily
to alpha-1-acid glycoproteins (approximately 60–80% for concentrations of 1–4 μg/mL).
Metabolism
Tribenoside is extensively metabolised in the body. Lidocaine is rapidly metabolised in the liver.
Elimination
Tribenoside: After insertion of a suppository, 20–27% of the dose is excreted in the urine in
the form of metabolites.
Lidocaine: Less than 10% is eliminated unchanged; metabolites are excreted in the urine.

There are no relevant preclinical data on tribenoside or the combination of tribenoside and
lidocaine.
Mutagenicity studies with lidocaine have yielded negative results. However, there is evidence
to suggest that the lidocaine metabolite, 2,6-xylidine, has mutagenic effects in rats and
probably also in humans. These indications come from in vitro tests using this metabolite at
very high, almost toxic, concentrations. There are no data to suggest that the parent
substance, lidocaine, is equally mutagenic. Moreover, 2,6-xylidine showed tumourigenic
potential in a carcinogenicity study in rats with transplacental exposure and post-natal
treatment of animals for 2 years. In this highly sensitive test system, malignant and benign
tumours were observed at very high doses, particularly in the nasal cavity (ethmoturbinals).
As the significance of these findings for humans cannot be ruled out with sufficient certainty,
high doses of lidocaine should not be administered for a prolonged period.
Reproductive toxicity studies conducted with lidocaine have not shown any evidence to
suggest teratogenicity, but embryotoxicity has been observed (reduced foetal weight).
Behavioural changes have been reported in the descendants of rats that received a dose of
lidocaine during pregnancy corresponding to almost the maximum recommended dose in
humans.

Excipients:
Suppositories: solid semi-synthetic glycerides.
Cream: cetyl alcohol, isopropyl palmitate, macrogol cetostearyl ether, liquid paraffin, sorbitan
stearate, liquid sorbitol (non-crystallisable), stearic acid, purified water; methyl
parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

NA

Keep Procto-Glyvenol out of the reach of children.
Store at room temperature (15-25°C).
Procto-Glyvenol Cream:
In case of use with the applicator: use within 14 days of first opening.

NA

NA