Instructions Procto-Glyvenol rectal cream tube 30 g with nozzle
Composition
active ingredients: tribenoside, lidocaine hydrochloride;
100 g of cream contains tribenoside 5 g, lidocaine hydrochloride 2 g;
excipients: polyethylene glycol cetostearyl ether, cetyl alcohol, isopropyl palmitate, mineral oil, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sorbitol solution (E 420), stearic acid, sorbitan stearate, purified water.
Dosage form
Rectal cream.
Main physicochemical properties: homogeneous white cream with a faint characteristic odor.
Pharmacotherapeutic group
Preparations for the treatment of hemorrhoids and anal fissures for topical use, combinations. ATX code C05A X03.
Pharmacological properties
Pharmacodynamics
Tribenoside is a local treatment for hemorrhoids. Tribenoside reduces capillary permeability and increases vascular tone, has anti-inflammatory properties. The antagonistic effect of the drug is directed at some endogenous substances that play the role of mediators in the development of inflammation and pain.
Lidocaine is a local anesthetic that soothes the itching, burning, and pain caused by hemorrhoids.
Pharmacokinetics
Absorption. The systemic bioavailability of tribenoside after rectal administration is only 30% of that achieved after oral or intravenous administration. Approximately 2–20% of the tribenoside contained in the rectal cream is absorbed through the skin. The maximum plasma concentration of tribenoside and metabolites is reached 2 hours after rectal administration of 400 mg tribenoside and is 1 μg/mL.
Lidocaine is readily absorbed from mucous membranes but poorly absorbed from intact skin. The bioavailability of lidocaine after rectal administration is approximately 50%. The maximum plasma concentration of lidocaine is reached 112 minutes after rectal administration of 300 mg of lidocaine and is 0.70 μg/ml.
Distribution: Lidocaine is clearly bound to alpha1-acid glycoprotein.
Metabolism: Tribenoside is extensively metabolized in the body. Lidocaine is rapidly metabolized in the liver.
Excretion: 20% to 27% of a rectally administered tribenoside dose is excreted in the urine as metabolites.
Lidocaine metabolites and less than 10% of unchanged lidocaine are excreted in the urine.
Indication
Local treatment of external and internal hemorrhoids.
Contraindication
Hypersensitivity to any component of the drug, including amide local anesthetics.
Interaction with other medicinal products and other types of interactions
Patients taking class 1 antiarrhythmic drugs (e.g. tocainide, mexiletine) or other local anesthetics should use the drug with caution, as there is a risk of cumulative systemic effects due to the presence of lidocaine. Monoamine oxidase inhibitors enhance the local analgesic effect of lidocaine.
Application features
The drug should be used with caution in patients with severe heart failure, renal failure, and hepatic failure.
Patients are advised to consult a doctor if the condition does not improve after one week of use or if any other symptoms appear that were not observed previously, in order to exclude other possible causes of these disorders.
In addition, when treating hemorrhoids with the drug Procto-Glivenol, it is necessary to follow recommendations for anal hygiene, an active lifestyle, and a healthy diet to ensure soft stools.
Procto-Glyvenol, rectal cream, contains cetyl alcohol, which may cause local skin reactions (e.g. contact dermatitis), and methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
The medicine package contains a latex nozzle for rectal administration of the cream. Latex can cause serious allergic reactions.
It is necessary to avoid contact of the medicinal product with the eyes.
The cream should not be swallowed.
Use during pregnancy or breastfeeding
Pregnancy and breastfeeding.
There have been no controlled studies on the potential effects of tribenoside and lidocaine in pregnant or breastfeeding women. As a precaution, Procto-Glyvenol rectal cream should not be used during the first trimester of pregnancy.
The drug can be used from the 4th month of pregnancy and in breastfeeding women, following the recommended dosage, taking into account the possible risk to both the mother and the child.
Fertility.
Studies show that lidocaine does not affect fertility.
There are no data on the potential effects of tribenoside on fertility.
The ability to influence the reaction speed when driving or working with other mechanisms
The use of Procto-Glyvenol has no or negligible effect on the ability to drive or operate other mechanisms.
Method of administration and doses
The rectal cream is administered morning and evening until the acute symptoms disappear. After that, the cream can be applied once a day. The duration of treatment is determined by the doctor depending on the severity of the disease.
For internal hemorrhoids, the cream should be applied using a nozzle that is included separately in the package and screwed onto the tube. The nozzle is covered with a protective cap that must be removed before each use of the cream.
30 g of cream (1 tube) is enough for approximately 20–30 injections.
Children
Do not use in children, as there is no data on the use of the drug in this age group.
Overdose
There is no data on overdose of the drug Procto-Glyvenol. Overdose is not expected if the drug is used according to the dosage regimen.
In animal studies, effects on the central nervous and cardiovascular systems were observed with lidocaine overdose.
In case of accidental ingestion, the stomach should be rinsed immediately and a doctor should be consulted. There is no specific antidote for lidocaine.
Side effects
Rare adverse reactions reported during treatment are local reactions such as burning, pain, rash and itching, which may extend beyond the application site. In addition to these undesirable effects, the administration of Procto-Glyvenol rectal cream may in very rare cases cause an anaphylactic reaction, including symptoms such as angioedema and facial swelling.
List of adverse reactions.
Adverse reactions are listed below by MedDRA system organ class. Frequency: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000); very rare (<1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
| On the part of the immune system |
| Very rare | Anaphylactic reactions |
| From the heart |
| Very rare | Cardiovascular disorders |
| Respiratory, thoracic and mediastinal disorders |
| Very rare | Bronchospasm |
| Skin and subcutaneous tissue disorders |
| Rarely | Hives, contact dermatitis |
| Very rare | Quincke's edema |
| General complications and application site reactions |
| Rarely | Discomfort, mild burning, itching, rash, pain at the application site |
| Very rare | Facial swelling, fever, hemorrhoidal hemorrhages |
Given that lidocaine is rapidly absorbed from the mucous membrane, systemic effects are possible.
Expiration date
3 years.
Storage conditions
Keep out of reach of children.
Store at a temperature not exceeding 25 °C.
Packaging
30 g of cream in a tube; 1 tube complete with a nozzle in a cardboard box.
Vacation category
Without a prescription.
Producer
VAMPHARMA S.R.L., Italy.
Address
VIA KENNEDY, 5, COMAZZO (LO), 26833, Italy.
