Active ingredients: Hydrocortisone
Proctosoll rectal cream
Why is Proctosoll used? What is it for?
Proctosoll is a cream indicated in the symptomatic treatment of uncomplicated external hemorrhoids.
It is applied locally to hemorrhoids and contains 3 active ingredients:
- Benzocaine which has the function of relieving local pain (local anesthetic).
- Hydrocortisone acetate which serves to reduce inflammation and itching.
- Sodium heparin which reduces blood clotting (anticoagulant). The action of these active ingredients produces a reduction in the symptoms of hemorrhoids, especially in the acute phase.
Contraindications When Proctosoll should not be used
DO NOT use Proctosoll
- if you are allergic to benzocaine, hydrocortisone acetate and sodium heparin or any of the other ingredients of this medicine (listed in section 6)
- if you have skin lesions due to forms of tuberculosis
- in case of simultaneous virus infections.
Precautions for use What you need to know before taking Proctosoll
- This medicine should not be used for prolonged treatments, after a short period of treatment without appreciable results consult your doctor.
- Use the minimum amount of cream to obtain the desired effect, applying Proctosoll with caution especially in case of severe lesions or inflammation of the rectal mucosa, as excessive use can cause a high absorption of the active ingredients.
- Excessive application or for prolonged periods of cortisone-based drugs can alter absorption by the body.
- High absorption of benzocaine can cause severe reactions especially in children and elderly patients.
- Stop the treatment and consult your doctor if you experience allergic reactions after using the medicine for a long time.
Interactions Which drugs or foods can modify the effect of Proctosoll
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Take special care in case of simultaneous treatment with other medicines that reduce blood clotting (anticoagulants).
Warnings It is important to know that:
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding use Proctosoll only in case of real need and only after consulting your doctor and having evaluated with him the relationship between the expected benefit and the possible risk for the fetus or infant.
Driving and using machines
Proctosoll does not affect the ability to drive or use machines.
For those who carry out sports activities
The use of the drug without the need for treatment constitutes doping and can give positive results for doping tests.
Proctosoll contains propylene glycol
Proctosoll contains propylene glycol which can cause skin irritation.
Proctosoll contains butylated hydroxyanisole
Proctosoll contains butylhydroxyanisole which may cause local skin reactions (eg contact dermatitis) or irritation of the eyes and mucous membranes.
Dose, Method and Time of Administration How to use Proctosoll: Posology
Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose in acute forms is 2-3 applications per day, especially after defecation (evacuation). Use the special cannula screwed onto the tube to distribute the cream.
Use the medicine only for short periods of treatment and do not exceed the indicated doses without your doctor's advice.
Overdose What to do if you have taken too much Proctosoll
Tell your doctor immediately or go to the nearest hospital if you have used too much of the medicine.
Side Effects What are the side effects of Proctosoll
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur locally:
- sense of burning
- irritation
- dryness of the skin
- inflammation of the hair (folliculitis)
- acne-like skin rashes, such as pimples (acne eruptions)
- excessive hair development (hypertrichosis)
- dark spots on the skin (skin hyperpigmentation)
- thinning of the skin (skin atrophy).
The side effects listed above are usually transient. It is advisable to stop the treatment and consult your doctor in case of any occurrence of the local reactions listed above and typical of cortisone-based therapies.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package. The expiry date refers to the last day of that month.
Do not store above 30 ° C.
Do not use this medicine if the pack has been opened or damaged.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
It is important to always have the information about the medicine available, so keep both the box and the package leaflet.
Deadline "> Other information
What Proctosoll contains
- The active ingredients are: Benzocaine, hydrocortisone acetate, sodium heparin. 100 g of cream contain: 5 g of benzocaine, 0.5 g of hydrocortisone acetate, 5,000 I.U. of sodium heparin.
- The other ingredients are: cetylstearyl alcohol, isopropyl myristate, propylene glycol, cetylstearyl alcohol 20 OE, dimethicotone, isothiazolinone, menthol, disodium EDTA, butyldroxyanisole, purified water.
What Proctosoll looks like and contents of the pack
Proctosoll comes in the form of a cream for rectal use. Each pack contains a tube with 20 grams of cream and a cannula to distribute the cream.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
PROCTOSOLL "RECTAL CREAM"
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
g 100 of cream contain:
• BENZOCAINE ................................................ ..... g 5
• HYDROCORTISONE ACETATE .............................. g 0.5
• SODIUM HEPARIN ........................................... U.I. 5,000
For excipients, see 6.1
03.0 PHARMACEUTICAL FORM -
Cream (rectal use).
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Symptomatic treatment of uncomplicated external hemorrhoids.
04.2 Posology and method of administration -
In acute forms, especially after evacuation, apply the cream 2-3 times a day.
Do not exceed the recommended dose.
04.3 Contraindications -
Hypersensitivity to components or other closely related substances from a chemical point of view.
Skin lesions of a tuberculous nature.
Viral infections.
04.4 Special warnings and appropriate precautions for use -
After a short period of treatment, without noticeable results, consult your doctor.
The excessive application and / or for prolonged periods of cortisone can give rise to generalized reactions from systemic absorption.
The use, especially if prolonged, of products for topical use can give rise to sensitization phenomena. In this case it is necessary to interrupt the treatment and institute a suitable therapy.
The efficacy and safety of benzocaine depend on a correct dosage; therefore it is necessary to use the minimum quantity of the preparation sufficient to obtain the desired effect by applying it with caution in subjects with severely damaged mucous membranes or site of inflammatory processes that could cause excessive absorption of the active principle.
High absorption of benzocaine can cause severe reactions, particularly in children and elderly patients.
Keep this medicine out of the reach of children.
04.5 Interactions with other medicinal products and other forms of interaction -
Particular attention in the use must be observed in concomitance with other anticoagulant treatments.
04.6 Pregnancy and breastfeeding -
In pregnant women, use should only be carried out in case of real need and under direct medical supervision.
04.7 Effects on ability to drive and use machines -
The product does not affect the ability to drive and use machines.
04.8 Undesirable effects -
Sometimes there may be a sensation of burning, irritation, dry skin, folliculitis, acne eruptions, hypertrichosis, hyperpigmentation and skin atrophy.
Any appearance of any local reaction typical of corticotherapy can be remedied by stopping the treatment.
04.9 Overdose -
There are no known symptoms of overdose.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group:
Antihemorrhoids for topical use - corticosteroid-based products (ATC Code C05AA01).
The pathogenesis of hemorrhoids is still controversial today. Hemorrhoidal syndrome is characterized by inflammation of the anorectal area, pain, bleeding and itching.
PROCTOSOLL thanks to the anti-inflammatory and anti-itching action of hydrocortisone acetate, the anticoagulant action of sodium heparin and the local anesthetic action of benzocaine, produces a regression of haemorrhoidal symptoms, especially in the acute phase.
The active components of PROCTOSOLL are widely known and of consolidated use both individually and in combination.
Their use in low dosages and for topical use, minimizes systemic effects.
05.2 "Pharmacokinetic properties -
05.3 Preclinical safety data -
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Cetylstearyl alcohol, Isopropyl myristate, Propylene glycol, Cetylstearyl alcohol 20 OE, Dimethicone, Isothiazolinone, Menthol, disodium EDTA, Butylhydroxyanisole, Purified water.
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
3 years.
06.4 Special precautions for storage -
Store at a temperature not exceeding 30 ° C.
06.5 Nature of the immediate packaging and contents of the package -
Aluminum tube with blind hole protected with paint consisting of a mixture of epoxy and melanin resins, equipped with a polythene screw cap and dispensing cannula.
20 g tube of cream.
06.6 Instructions for use and handling -
No special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Alfa Wassermann S.p.A.
Registered office - Via E. Fermi, n.1 - Alanno (PE)
Administrative office - Via Ragazzi del "99 n. 5 - Bologna
08.0 MARKETING AUTHORIZATION NUMBER -
AIC n. 027377011
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
06.06.1991 / 01.06.2010
10.0 DATE OF REVISION OF THE TEXT -
25.06.2016
