Topster - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf life and Storage Composition and pharmaceutical form

Active ingredients: Beclometasone (Beclometasone dipropionate)

TOPSTER 3mg rectal suspension - 10 vials with cannula
TOPSTER 42mg rectal foam - pressurized container + 14 cannulas
TOPSTER 3mg suppositories

Indications Why is Topster used? What is it for?

PHARMACOTHERAPEUTIC CATEGORY

Intestinal anti-inflammatories: Corticosteroid for local use.

THERAPEUTIC INDICATIONS

Suspension and rectal foam

Topical treatment of colitis and ulcerative proctosigmoiditis in the first attack or exacerbation phase.

Suppositories

Ulcerative proctosigmoiditis in the first attack or flare-up phase.

Contraindications When Topster should not be used

Hypersensitivity to the active substance or to any of the excipients.

Local tuberculous, fungal and viral infections. Local perforations, obstructions, abscesses.

Generally contraindicated in pregnancy and lactation (see Special warnings) and in pediatric age.

Precautions for use What you need to know before taking Topster

The transition from continuous therapy with general cortisone drugs (tablets - ampoules) to local therapy with Topster must be carried out with caution and always under medical supervision.

Patients must be instructed on the correct administration methods for optimal therapeutic results.

A treatment duration of at least 4 weeks is recommended.

In any case, it is advisable both in the initial period of treatment and for a possible prolongation of the same, to subject patients to periodic clinical checks.

Although no systemic effects have been reported, control of adrenal function is recommended in case of prolonged treatments.

The abuse and the need to prolong the administration can induce variations in the therapeutic response: the patient's condition in these cases must in any case be re-evaluated.

Interactions Which drugs or foods can modify the effect of Topster

The effects of other medicinal products containing cortisone may be enhanced.

Warnings It is important to know that:

There is no information on the safety of use for prolonged use in severe hepatic and renal insufficiency, diabetes mellitus, gastroduodenal ulcer, severe arterial hypertension, osteoporosis, hypoadrenalism.

In the event of pre-existing intestinal infection or occurring during treatment, an adequate antibiotic therapy should be instituted immediately.

The suspension and rectal foam contain para-hydroxybenzoates: these excipients can cause delayed allergic reactions such as contact dermatitis; more rarely they can cause immediate reactions with urticaria and bronchospasm.

Use in pregnancy and lactation: the product should not be used in the first trimester of pregnancy and should be used under strict medical supervision, in subsequent periods, after careful evaluation of the risk / benefit ratio.

Even during the breastfeeding period, the drug should be used only in case of real need and always under medical supervision.

For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.

Dosage and method of use How to use Topster: Dosage

There are currently no studies authorizing the use of Topster in children.

Rectal suspension

We recommend a single-dose bottle a day, to be administered possibly in the evening, before going to bed, for at least 4 weeks.

Instructions for Use

  1. Shake the bottle well before use.
  2. Remove the cannula cover.
  3. To apply, lie down on the left side keeping the left leg straight and bending the right leg.
  4. Insert the rectal cannula applied to the bottle into the anal orifice, previously lubricated with petroleum jelly.
  5. Compress the bottle with gradual and constant pressure until the bottle is completely empty.
  6. After introducing the preparation, remain lying down in the above position for about 30 minutes.
  7. A better efficacy of the product is obtained by leaving it in place all night.

Rectal foam

We recommend one dose of TOPSTER rectal foam per day, to be administered possibly in the evening, before going to bed, for at least 4 weeks.

For each administration, press the dosing head of the bottle once, otherwise the recommended dose is exceeded.

Instructions for Use

The foam bottle should be used with the dosing head pointing downwards, i.e. the bottle should be turned upside down.

  1. Shake the bottle very well before use (for about 15 seconds)
  2. Tear off (and discard), when used for the first time, the guarantee tab located under the dosing head.
  3. Apply the rectal cannula to the dispensing nozzle of the metering valve.
  4. Rotate the dosing head in such a way as to align the dispensing nozzle with the recess located at the base of the dosing head itself.
  5. Keeping the bottle upside down, introduce the rectal cannula, previously lubricated with vaseline, into the anal orifice, keeping one foot resting on a chair or lying on one side.
  6. Press the dosing head firmly and keep it pressed for about 5 seconds.
  7. Release the dosing head: the foam is dispensed only during this operation.
  8. Wait about 5 seconds.
  9. Remove the rectal cannula from the anal orifice.
  10. Detach the rectal cannula from the delivery nozzle and then discard it; it is normal for the rectal cannula to still be filled with foam.
  11. Rotate the dosing head in such a way that the notch located at the base of the dosing head is no longer aligned with the dispensing nozzle to prevent the foam from escaping by inadvertently pressing the dosing head.

Suppositories

We recommend a Topster suppository twice a day, preferably once in the morning after evacuation, and once in the evening, before going to bed, for at least 4 weeks.

Overdose What to do if you have taken too much Topster

There are no known cases of overdose.

In case of accidental ingestion / intake of an excessive dose of Topster, notify your doctor immediately or go to the nearest hospital.

Side Effects What are the side effects of Topster

No undesirable effects attributable to the systemic absorption of the preparation have been reported.

Locally it can occur: sensation of heat and / or anal burning, tenesmus, poor adaptability to the dispenser and to retain the preparation in the case of foam and suspension.

Compliance with the instructions given in this leaflet reduces the risk of undesirable effects.

The patient is invited to communicate to his doctor or pharmacist any undesirable effect other than those indicated above.

Expiry and Retention

See the expiration date indicated on the package. This date refers to the product in intact and correctly stored packaging.

ATTENTION: do not use the product beyond the expiration date indicated on the package.

STORAGE

Rectal suspension

Store at a temperature not exceeding 30 ° C.

Rectal foam

Store at a temperature not exceeding 30 ° C. The bottle should not be thrown into the fire even when it is empty.

Suppositories

Store in the original package, away from heat sources.

Composition and pharmaceutical form

COMPOSITION

TOPSTER 3mg rectal suspension

One single-dose bottle contains

Active ingredient: Beclomethasone dipropionate 3mg

Excipients: methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, disodium salt of ethylenediaminetetraacetic acid, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, sodium carboxymethylcellulose, purified water.

TOPSTER 42mg rectal foam

One bottle contains

Active ingredient: Beclomethasone dipropionate 42mg (each dose corresponds to 3mg)

Excipients: Methyl p-hydroxybenzoate, Sodium propyl p-hydroxybenzoate, Disodium salt of ethylenediaminetetraacetic acid, Cetostearylpolyoxyethylenesters of sorbitan, Polysorbate 20, Propylene glycol, Polyoxyethylene fatty acid glycerides, Isobutane, Propane, Butane water.

TOPSTER 3mg suppositories

One suppository contains

Active ingredient: Beclomethasone dipropionate 3mg

Excipients: Solid semisynthetic glycerides

PHARMACEUTICAL FORM AND CONTENT

Rectal suspension: Box of 10 single-dose vials of 3mg with relative disposable rectal cannulas

Rectal Foam: Pressurized container of 14 doses of 3mg + 14 disposable rectal cannulas.

Suppositories: Box of 10 suppositories of 3mg.

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.

Further information on Topster can be found in the "Summary of Features" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction 04.6 Pregnancy and lactation 04.7 Effects on ability to drive and use machines 04.8 Undesirable effects 04.9 Overdose 05.0 PHARMACOLOGICAL PROPERTIES 05.1 Pharmacodynamic properties 05.2 Pharmacokinetic properties 05.3 Preclinical safety data 06.0 PHARMACEUTICAL PARTICULARS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the primary packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER 08.0 MARKETING AUTHORIZATION NUMBER CIO 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIO DRUGS, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON PREPARATION AND QUALITY CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

TOPSTER

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

TOPSTER 3mg rectal suspension:

One single-dose bottle contains:

Active ingredient: Beclomethasone dipropionate 3mg

TOPSTER 42mg rectal foam:

One bottle contains:

Active ingredient: Beclomethasone dipropionate42mg

(each dose corresponds to 3mg)

TOPSTER 3mg suppositories:

One suppository contains:

Active ingredient: Beclomethasone dipropionate 3mg

For excipients see point 6.1.

03.0 PHARMACEUTICAL FORM

Rectal suspension; rectal foam; suppositories.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

Suspension and rectal foam:

Topical treatment of colitis and ulcerative proctosigmoiditis in the first attack or exacerbation phase.

Suppositories:

Ulcerative proctosigmoiditis in the first attack or flare-up phase.

04.2 Posology and method of administration

There are currently no studies authorizing the use of TOPSTER in children.

Rectal suspension:

We recommend a single-dose bottle a day, to be administered possibly in the evening, before going to bed, for at least 4 weeks.

Instructions for Use:

Shake the bottle well before use.

Remove the cannula cover.

To apply, lie down on the left side keeping the left leg straight and bending the right leg.

Insert the rectal cannula applied to the bottle into the anal orifice, previously lubricated with petroleum jelly.

Compress the bottle with gradual and constant pressure until the bottle is completely empty.

After introducing the preparation, remain lying down in the position indicated above for about 30 minutes.

A better efficacy of the product is obtained by leaving it in place overnight.

Rectal foam:

A dose of TOPSTER rectal foam a day, to be administered possibly in the evening, before going to bed, for at least 4 weeks.

For each administration, press the dosing head of the bottle once, otherwise the recommended dose is exceeded.

Instructions for Use:

The foam bottle should be used with the dosing head pointing downwards, i.e. the bottle should be turned upside down.

Shake the bottle very well before use (for about 15 seconds)

Tear off (and discard), when used for the first time, the guarantee tab located under the dosing head.

Apply the rectal cannula to the dispensing nozzle of the metering valve.

Rotate the dosing head in such a way as to align the dispensing nozzle with the notch located at the base of the dosing head itself.

Keeping the bottle upside down, introduce the rectal cannula, previously lubricated with petroleum jelly, into the anal orifice, keeping one foot resting on a chair or lying on one side.

Press the dosing head firmly and keep it pressed for about 5 seconds.

Release the dosing head: foam is dispensed only during this operation.

Wait about 5 seconds.

Remove the rectal cannula from the anal orifice.

Detach the rectal cannula from the delivery nozzle and then discard it; it is normal for the rectal cannula to still be full of foam.

Rotate the dosing head so that the notch located at the base of the dosing head is no longer aligned with the dispensing nozzle to prevent the foam from escaping by inadvertently pressing the dosing head.

Suppositories:

We recommend a Topster suppository twice a day, preferably once in the morning after evacuation, and once in the evening, before going to bed, for at least 4 weeks.

04.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

Local tuberculous, fungal and viral infections. Local perforations, obstructions, abscesses. Generally contraindicated in pregnancy and lactation (see 4.6) and in pediatric age.

04.4 Special warnings and appropriate precautions for use

The transition from continuous therapy with general cortisone drugs (tablets - ampoules) to local therapy with TOPSTER it must be done with caution and always under medical supervision.

Patients must be instructed on the correct administration methods for optimal therapeutic results.

A treatment duration of at least 4 weeks is recommended.

It is however advisable, both in the initial period of treatment, and for a possible prolongation of the same, to subject patients to periodic clinical checks.

Although no systemic effects have been reported, control of adrenal function is recommended in case of prolonged treatments.

The abuse and the need to prolong the administration can induce variations in the therapeutic response: the patient's condition in these cases must in any case be re-evaluated.

There is no information on the safety of use for prolonged use in severe hepatic and renal insufficiency, diabetes mellitus, gastroduodenal ulcer, severe arterial hypertension, osteoporosis, hypoadrenalism.

In the event of pre-existing intestinal infection or occurring during treatment, adequate antibiotic therapy should be immediately instituted.

The suspension and rectal foam contain para-hydroxybenzoates: these excipients can cause delayed allergic reactions such as contact dermatitis; more rarely they can cause immediate reactions with urticaria and bronchospasm.

04.5 Interactions with other medicinal products and other forms of interaction

The effects of other medicinal products containing cortisone may be enhanced.

04.6 Pregnancy and breastfeeding

The product should not be administered in the first trimester of pregnancy and should be used under strict medical supervision, in subsequent periods, after careful evaluation of the risk / benefit ratio.

Even during the breastfeeding period, the drug should be used only in case of real need and always under medical supervision.

04.7 Effects on ability to drive and use machines

You don't notice.

04.8 Undesirable effects

No undesirable effects attributable to the systemic absorption of the preparation have been reported.

Locally it can occur: sensation of heat and / or anal burning, tenesmus, poor adaptability to the dispenser and to retain the preparation in the case of foam and suspension.

04.9 Overdose

There are no known cases of overdose.

05.0 PHARMACOLOGICAL PROPERTIES

05.1 Pharmacodynamic properties

Pharmacotherapeutic Group: A07EA07 - Intestinal anti-inflammatories: corticosteroids for local use.

Beclometasone dipropionate, active ingredient of Topster, exhibits the pharmacodynamic characteristics of a potent anti-inflammatory steroid.

In various experimental tests it has in fact shown to exert for topical application an "intense, prolonged, dose-dependent and localized anti-inflammatory activity in the application areas, without interference on the pituitary-adrenal axis."

05.2 Pharmacokinetic properties

The kinetic and metabolism studies conducted in vitro and in vivo both in humans and in experimental animals by different routes of administration have shown that the little or no systemic activity of Beclometasone dipropionate after topical or oral administration is due not only to limited absorption but also to the rapid inactivation that the drug undergoes during the hepatic "first pass".

The primary route of elimination of the drug and its metabolites after oral administration is via faecal and only less than 10% of the drug and its metabolites are excreted in the urine.

After topical rectal treatment, plasma concentrations of Beclometasone dipropionate, monopropionate and alcohol lower than 1 ng / ml were recorded in the healthy volunteer, indicating that systemic absorption of the product is extremely low for this route of administration.

Even in subjects suffering from distal intestinal inflammatory pathology, treated with Beclometasone dipropionate topically at a dose of 2 - 3 mg per day for 4 weeks, no traces of Beclometasone dipropionate and its metabolites were found in plasma or urine.

05.3 Preclinical safety data

Beclometasone dipropionate did not cause any death or toxic symptoms either by acute oral administration in rats and mice at doses of 2 and 3 g / kg, respectively, and by intramuscular administration at doses of 500 and 1000 mg / kg.

For subcutaneous administration in rats at doses between 0.1 mg / kg per day and 100 mg / kg per day for 180 days and 300 mg / kg per day for 90 days and for epicutaneous administration in rabbits at a dose of 0.1 g per day of 0.125% ointment and cream for 42 days, manifestations of toxicity were found only with the highest doses.

06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

Rectal suspension: methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, disodium salt of ethylenediaminetetraacetic acid, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, sodium carboxymethylcellulose, purified water.

Rectal foam: methyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate, disodium salt of ethylenediaminetetraacetic acid, cetostearyl polyoxyethylene esters of sorbitan, polysorbate 20, propylene glycol, glycerides of polyoxyethylene fatty acids, isobutane, propane, butane, purified water.

Suppositories: solid semisynthetic glycerides.

06.2 Incompatibility

Not relevant.

06.3 Period of validity

3 years.

06.4 Special precautions for storage

Rectal suspension:

Store at a temperature not exceeding 30 ° C.

Rectal foam:

Store at a temperature not exceeding 30 ° C.

The bottle should not be thrown into the fire even when it is empty.

Suppositories:

Store in the original package, away from heat sources.

06.5 Nature of the immediate packaging and contents of the package

Rectal suspension:

60 ml polyethylene bottles, with guarantee seal. The package consists of 10 single-dose bottles with relative disposable rectal cannulas.

Rectal foam:

Multi-dose aluminum containers. The closure system consists of a dosing valve on which a rectal cannula can be inserted and removed. The package consists of a pressurized container of 14 doses + 14 disposable rectal cannulas.

Suppositories:

Heat-sealed PVC cells grouped in pieces of five suppositories. The package consists of 10 suppositories.

06.6 Instructions for use and handling

No special instructions.

07.0 MARKETING AUTHORIZATION HOLDER

SOFAR SpA - via Isonzo 8 - 20135 Milan

08.0 MARKETING AUTHORIZATION NUMBER

TOPSTER 3mg rectal suspension - 10 vials with cannula: A.I.C. n. 031115049

TOPSTER 42mg rectal foam - pressurized container + 14 cannulas: A.I.C. n. 031115013

TOPSTER 3mg suppositories - 10 suppositories: A.I.C. n. 031115025

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

April 1999

10.0 DATE OF REVISION OF THE TEXT

01/11/2006

11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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