Procto-Glyvenol in the form of rectal cream is a preparation intended for the treatment of external and internal haemorrhoids.
Use of the preparation in children and adolescents
Procto-Glyvenol should not be used in children.
Ingredients:
Active ingredients: tribenoside, lidocaine hydrochloride.
100 g of cream contains tribenoside 5 g, lidocaine hydrochloride 2 g.
Inactive ingredients: polyethylene glycol ester, cetyl alcohol, isopropalmityl, mineral oil, metilparahydrobensoat (E218), propilparahydrobensoat (E216), sorbitol (E420), stearic acid, sorbitansteanat, purified water.
Medication form: rectal cream. Main physical and chemical properties: white homogeneous cream with slight scent.
Pharmaceutical group: supplements for local application to treat hemorrhoids and rectal wounds. Other supplements and combinations. Code ATX, C05A, X03.
Pharmaceutical properties:
Pharma dynamics: Procto – Glyvenol is a combination drug for local application on external and internal hemorrhoids. Tribenoside alleviates soreness and promoting wound healing. Tribenoside helps to relieve inflammation and pain, while also preventing blood clots by promoting fibrinolysis. It works for hemorrhoids by acting on the epidermal cells and regulating types of glycoproteins, which helps contribute to the reconstruction of basement membranes, thereby contributing to the healing process of the hemorrhoids.
Lidocaine hydrochloride is a local anesthetic, and it can significantly reduce pain by producing a numbing effect. This is achieved by acting on the neuronal cell membranes so as to prevent the occurrence of pain signals.
Pharma kinetics: Procto – Glyvenol acts locally and does not provide systemic action. After rectal insertion, tribenoside reaches therapeutic concentration at the area of application and only small amount of this substance penetrates system blood circulation. When applied rectally tribenoside bioavailability is 30%. Peak plasma concentrations of 1mkg/ml of tribenoside are reached 2 hours after rectal administration. Tribenoside is intensively metabolized in the bodyand 20-27 % of the dose is excreted in the urine in the form of metabolites. Lidocaine is quickly absorbed by mucous membrane and less is absorbed by undamaged health skin. Lidocaine bioavailability is approximately 50% after rectal application. The drug is quickly metabolized by liver. 10% of unchanged lidocaine excreted in the urine.
Clinical characteristics:
Usage:topical treatment of external and internal hemorrhoids
Do not use if: You have ever had an allergic reaction to this product or any of its ingredients,
.you have intolerance to active ingredients.
Drug Interactions:
Patients using anti arrhythmic drugs of class I or any other local anesthetics should use this product carefully due to possible negative effects of lidocaine.
Specific application:
Patients with heart conditions, kidney and liver disorders should be careful to use Procto-Glyvenol
Due to the content of cetyl alcohol,
Procto-Glyvenol may cause local skin irritation. Some adverse allergic reaction
may appear with a delay due to the content of metilparahydrobensoat and
propilparahydrobensoat. Procto-Glyvenol package includes latex tip which may
also cause allergic reaction. It is recommended to contact your healthcare
provider is symptoms do not improve after 1 week of application or if new
symptoms appear to exclude any possible side effects and complications. In
addition to treating your hemorrhoids with Procto – Glyvenol, it is advised to
keep the anal are in a good state of hygiene, to getsufficient exercise, and to
take whatever measures you can to ensure that
your stools remain soft. Avoid contact with eye. Do not take orally.
Usage during pregnancy or breastfeeding:
Procto-Glyvenol should not be used during 1 trimester of pregnancy. Procto-Glyvenol is safe to use after 4th month of pregnancy and while breastfeeding following physician directions and dose considering possible risks for the mother and child.
Usage while operating machinery or driving:
Procto-Glyvenol does not affect or may have minor effect on driving and operating machinery.
Administration and Dosage:
Rectal application for adults only.
Procto-Glyvenol hemorrhoid cream is indicated for local use, and should be applied directly to the affected area (the anus) twice per day (in the morning and at night). Subsequently the dose can be reduced to once per day. In all cases, the duration of treatment will be decided upon by the physician based on how the patient responds to treatment. For internal hemorrhoids use the tip included in package. Remove protective cap before each use.
30 g of cream is usually enough for 20-30 applications.
Children. This drug should not be used for children
Overdose:There are no known cases of overdose. If you exceed recommended dose consult your healthcare provider. In case of overdose, symptomatic treatment is recommended.
Side effects:
Skin: rarely (>1/10,000), <1/1000) slight discomfort in the area of application, pain, light burning, rash, itching.
Immune system: rarely (>1/10,000) hypersensitivity is possible such as anaphylactic reaction, angioedema, face swelling
Heart and cardiovascular: rarely (>1/10,000)cardiovascular disorder
Other: fever
Shelf life:3 years.
Storage:Store medicines at room temperature, away from heat and direct light.
Packaging:30 mg tube, 1 tube with a tip per box
No prescription needed.
Manufacturer: RECORDATI S.p.A., Italy
Manufacture’s address:VIA M. CIVITALI, 1 - 20148 MILAN, ITALY
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