2 x PROCTO-GLYVENOL CREAM 30G - MADE IN IRLANDIA- FREE SHIPPING
PROCTO-GLYVENOL CREAM 30G
Procto-Glyvenol in the form of rectal cream is a preparation intended for the treatment of external and internal haemorrhoids.
Dosage
Procto-Glyvenol rectal cream should be used in the morning and evening until acute symptoms disappear. The dose can then be reduced by applying the cream once a dayComposition
The active substances are: tribenoside and lidocaine hydrochloride.1 g of cream contains 50 mg of tribenoside + 20 mg of lidocaine hydrochloride
The other ingredients are: sorbltate stearate (Arlacel 60); macrogol cetostearyl ether (Cetomacrogol 1000); cetyl alcohol; isopropyl palmltynate; liquid paraffin; methyl parahydroxybenzoate; propyl parahydroxybenzoate; liquid sorbitol, non-crystallising; stearic acid; Purified Water.
Action
Tribenoside has anti-inflammatory, anti-edema, analgesic and antipruritic properties, and also prevents damage to the vascular endothelium.Lidocaine is a local anesthetic and relieves discomfort caused by haemorrhoids such as itching, burning and pain.
indications
The preparation is indicated in the treatment of haemorrhoids.Contraindications
Do not use Procto-Glyvenol if you are allergic (hypersensitive) to tribenoside, lidocaine or any of the other ingredients.Side effects
Like all medicines, Procto-Glyvenol can cause side effects, although not everybody gets them. Side effects that may occur with Procto-Glyvenol include:Rare (affects less than 1 in 1,000 patients): skin reactions such as injection site burning, rash, itching and hives. These symptoms may also occur outside the injection site.
Very rare (affects less than 1 in 10,000 patients): anaphylactic reactions including angioedema, facial edema, bronchospasm and cardiovascular disorders.
Other possible side effects related to the presence of certain excipients in Procto-Glyvenol cream: cetyl alcohol may cause local skin reactions (e.g. contact dermatitis), methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (delayed type).
Warnings and Precautions
Procto-Glyvenol should be kept out of the reach and sight of children. Do not store above 30 ° C.Pregnancy and breastfeeding
Consult a doctor before use during pregnancy and breastfeeding.Use of the preparation in children and adolescents
Procto-Glyvenol should not be used in children.
Instructions For the use of medicine PROCTO - GLYVENOL
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
Tags: PROCTO-GLYVENOL
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