TOPSTER 42 mg Rectal Foam

Зміст інструкції

1. Topster 42 mg rectal foam
   1. What is Topster and what is it used for
   2. How to use Topster
   3. Possible side effects
   4. How to store Topster
   5. Contents of the pack and other information
2. Topster 3 mg rectal suspension
   1. What is Topster and what is it used for
   2. How to use Topster
   3. Possible side effects
   4. How to store Topster
   5. Contents of the pack and other information
3. Topster 3 mg suppositories
   1. What is Topster and what is it used for
   2. How to use Topster
   3. Possible side effects
   4. How to store Topster
   5. Contents of the pack and other information

Topster 42 mg rectal foam

Beclometasone dipropionate

Read this leaflet carefully before you start to use this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Topster is and what it is used for
• 2. What you need to know before you use Topster
• 3. How to use Topster
• 4. Possible side effects
• 5. How to store Topster
• 6. Contents of the pack and other information

1. What is Topster and what is it used for

Topster rectal foam contains the active ingredient beclometasone dipropionate and
belongs to a class of medicines called local corticosteroids. Corticosteroids are hormones that are naturally produced by the adrenal glands (so called because they are located above the kidney) and have many and
important functions, including controlling inflammatory responses.
Topster rectal foam is used for the local treatment of chronic diseases
that cause inflammation and lesions, called ulcers, of the colon (ulcerative colitis) and
the mucosa of the rectum and sigmoid colon (ulcerative proctosigmoiditis), in case of first onset
of inflammation or subsequent reactivation.

2. What you need to know before using Topster
Do not use Topster if:

• you are allergic to the active ingredient beclometasone dipropionate or to any of the other ingredients of this medicine (listed in section 6);
• you have tuberculosis;
• you have an intestinal infection caused by fungi or viruses;
• you have perforations, obstructions or the presence of pus (abscess) at the intestinal level;
• you are in the first three months of pregnancy (see section “Pregnancy and breastfeeding”).

Topster should not be used in children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Topster if:

• you have severe liver problems (hepatic insufficiency);
• you have severe kidney problems (renal insufficiency);
• you have high levels of sugar (glucose) in the blood (diabetes mellitus);
• you have lesions (ulcers) in the stomach or the first part of the intestine, called the duodenum;
• you suffer from high blood pressure (hypertension);
• you have osteoporosis, a disease characterized by loss and fragility of bone tissue;
• you have a decrease in the secretion of hormones by the adrenal glands (adrenal insufficiency);
• you have entered the third trimester of pregnancy or are breastfeeding (see section “Pregnancy and breastfeeding”).

Talk to your doctor if:

• you are switching from taking systemic corticosteroids (e.g. tablets or injections) to local-acting medicines such as Topster;
• you have an intestinal infection or if it occurs during treatment with Topster. In this case, the doctor will immediately prescribe antibiotic therapy;
• you experience blurred vision or other visual disturbances.

The doctor may subject you to control tests in the initial phase of treatment with
Topster, or in case of prolonged treatment.

Children and adolescents
Topster should not be used in children under 12 years of age.

Other medicines and Topster
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines, including over-the-counter medicines.
Be careful when using Topster with other medicines that contain
cortisone or corticosteroids, as Topster may enhance the effect of these medicines.
Some medicines may increase the effects of Topster and your doctor may want to
monitor you closely if you are taking these medicines (including some
medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.

Pregnancy
Do not use Topster in the first three months of pregnancy.
If you have entered the third trimester of pregnancy, your doctor will assess whether the possible benefits of
treatment for you outweigh the potential risks to the baby.

Breastfeeding
During breastfeeding, Topster should only be used if absolutely necessary
and under the direct control of your doctor.

Driving and using machines
There are no known effects of Topster on the ability to drive vehicles or operate
machinery.

Topster rectal foam contains propyl para-hydroxybenzoate and methyl para-
hydroxybenzoatewhich may cause allergic reactions (even delayed).
This medicine contains 982 mg of propylene glycol per dose equivalent to 393
mg/g.

For athletes
The use of the medicine without therapeutic necessity constitutes doping and may in any case result in a positive doping test.

3. How to use Topster

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 3 mg (one dose) of Topster rectal foam per day, to be administered preferably in the evening, before bedtime, for at least 4 weeks.
To deliver the correct dose of foam, press the dosing head of the bottle once.

Instructions for use of Topster rectal foam
Use the multidose container holding the dosing head facing downwards, by inverting it.
To deliver a dose of foam:

• 1. shake the multidose container well before use (for about 15 seconds);

• 2. when using the container for the first time, remove and discard the warranty tab located under the dosing head;
• 3. apply the rectal cannula to the delivery site of the dosing valve;
• 4. rotate the dosing head so as to align the delivery site with the recess located at the base of the dosing head itself;
• 5. hold the bottle upside down and insert the rectal cannula into the anal orifice; lubricate the cannula with petroleum jelly before use. To facilitate insertion of the cannula, place one foot on a chair or lie on your side;
• 6. press the dosing head firmly and hold it down for about 5 seconds;
• 7. release the dosing head: only during this operation is the foam dispensed;
• 8. wait about 5 seconds;
• 9. remove the rectal cannula from the anal orifice;
• 10. detach the rectal cannula from the delivery site and discard it; it is normal for the rectal cannula to still be full of foam.
• 11. rotate the dosing head so that the recess located at the base of the dosing head is no longer aligned with the delivery site. This will prevent foam from escaping if you accidentally press the dosing head.

Use in children and adolescents
Topster should not be used in children under 12 years of age.

If you use more Topster than you should
Cases of overdose are not known. In case of ingestion/accidental intake of an excessive dose of Topster, immediately inform your doctor or go to the nearest hospital.

If you forget to use Topster
Do not use a double dose to make up for a missed dose.

If you stop using Topster
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Not all people will experience these side effects.
No side effects have been reported due to systemic absorption (throughout the
body) of the medicine.
Common side effects (may affect up to 1 in 10 people):

• sensation of heat and/or burning at the anus;
• painful contraction of the anus (tenesmus);
• poor adaptability to the medicine’s applicator.

Side effects with unknown frequency (frequency cannot be estimated on the basis of
the available data)

• Blurred vision

It is possible to experience difficulty retaining the foam at the site of
administration.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly through
the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Topster

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging
after the words “Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 25°C.
The container is under pressure, keep it away from fire even when empty.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Topster contains
The active ingredient is beclometasone dipropionate.
The multi-dose container contains 42 mg of beclometasone dipropionate. Each
delivered dose contains 3 mg of beclometasone dipropionate.
The other ingredients are: methyl parahydroxybenzoate, propyl parahydroxybenzoate,
disodium salt of ethylenediaminetetraacetic acid, sorbitan cetostearyl polyoxyethylene esters,
polysorbate 20, propylene glycol, polyoxyethylene fatty acid glycerides,
isobutane, propane, butane, purified water.

Description of the appearance of Topster and contents of the pack
Topster is presented as a rectal foam in a pressurized multi-dose aluminum
container, sufficient for the delivery of 14 doses.
Each pack contains 14 single-use rectal cannulae to be applied to the
multi-dose container.

Marketing authorization holder and manufacturer

Marketing Authorization Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
SOFAR S.p.A.
Via Firenze 40,
Trezzano Rosa (MI)

Topster 3 mg rectal suspension

Beclometasone dipropionate

Read this leaflet carefully before taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Topster is and what it is used for
• 2. What you need to know before you use Topster
• 3. How to use Topster
• 4. Possible side effects
• 5. How to store Topster
• 6. Contents of the pack and other information

1. What is Topster and what is it used for

Topster rectal suspension contains the active ingredient beclometasone dipropionate and
belongs to a class of medicines called topical corticosteroids. Corticosteroids are hormones that are naturally produced by the adrenal glands (so called because they are located above the kidney) and have many and
important functions, including controlling inflammatory responses.
Topster rectal suspension is used for the local treatment of chronic diseases that cause inflammation and lesions, called ulcers, of the colon (ulcerative colitis) and the mucosa of the rectum and sigmoid colon (ulcerative proctosigmoiditis), in case of first
occurrence of inflammation or subsequent reactivation.

2. What you need to know before using Topster
Do not use Topster if:

• you are allergic to the active ingredient beclometasone dipropionate or to any of the other ingredients of this medicine (listed in section 6);
• you have tuberculosis;
• you have an intestinal infection caused by fungi or viruses;
• you have perforations, obstructions or the presence of pus (abscess) at the intestinal level;
• you are in the first three months of pregnancy (see section “Pregnancy and breastfeeding”).

Topster should not be used in children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Topster if:

• you have severe liver problems (hepatic insufficiency);
• you have severe kidney problems (renal insufficiency);
• you have high blood sugar levels (diabetes mellitus);
• you have lesions (ulcers) in the stomach or the first part of the intestine, called the duodenum;
• you suffer from high blood pressure (hypertension);
• you have osteoporosis, a disease characterized by loss and fragility of bone tissue;
• you have a decrease in the secretion of hormones by the adrenal glands (adrenal insufficiency);
• you have entered the third trimester of pregnancy or are breastfeeding (see section “Pregnancy and breastfeeding”).

Talk to your doctor if:

• you are switching from taking systemic corticosteroids (e.g. tablets or injections) to locally acting medicines such as Topster;
• you have an intestinal infection or if it occurs during therapy with Topster. In this case, the doctor will immediately prescribe antibiotic therapy;
• you experience blurred vision or other visual disturbances.

The doctor may subject you to control tests in the initial phase of treatment with
Topster, or in case of prolongation of the treatment.

Children and adolescents
Topster should not be used in children under 12 years of age.

Other medicines and Topster
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines, including over-the-counter medicines.
Be careful when using Topster together with other medicines that contain
cortisone or corticosteroids, as Topster may enhance the effect of these medicines.
Some medicines may increase the effects of Topster and your doctor may want to
monitor you closely if you are taking these medicines (including some
medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.

Pregnancy
Do not use Topster in the first three months of pregnancy.
If you have entered the third trimester of pregnancy, the doctor will assess whether the possible benefits of
treatment for you outweigh the potential risks to the baby.

Breastfeeding
During breastfeeding, Topster should only be used if absolutely necessary
and under the direct control of the doctor.

Driving and using machines
There are no known effects of Topster on the ability to drive vehicles or operate
machinery.

Topster rectal suspension contains ethyl para-hydroxybenzoate and methyl para-
hydroxybenzoatewhich may cause allergic reactions (including delayed reactions).

For athletes
The use of the medicine without therapeutic necessity constitutes doping and may still result in a positive doping test.

3. How to use Topster

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 3 mg (one dose) of Topster rectal suspension per day, to be administered preferably in the evening, before going to bed, for at least 4 weeks.

Instructions for use of Topster rectal suspension
For correct use of the rectal suspension:

• 1. shake the single-dose bottle well before use;
• 2. remove the cannula cap;
• 3. to facilitate insertion of the cannula, lie on your left side and keep your left leg straight. Keep your right leg bent;
• 4. insert the rectal cannula attached to the bottle into the anal opening. Lubricate the cannula with petroleum jelly before use;
• 5. compress the bottle applying gradual and constant pressure until it is completely emptied;

• 6. after administering Topster, remain lying on your left side for about 30 minutes.

The maximum efficacy of Topster rectal suspension is achieved when the medicine
is allowed to act at the site of administration throughout the night.

Use in children and adolescents
Topster should not be used in children under 12 years of age.

If you use more Topster than you should
No cases of overdose are known. In case of accidental ingestion/administration of
an excessive dose of Topster, immediately inform your doctor or go to the nearest
hospital.

If you forget to use Topster
Do not use a double dose to make up for a missed dose.

If you stop using Topster
If you have any doubts about the use of this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
No side effects have been reported due to systemic absorption (throughout the body) of the medicine.
Common side effects (may affect up to 1 in 10 people):

• sensation of heat and/or burning at the anus;
• painful contraction of the anus (tenesmus);
• poor adaptability to the medicine’s applicator;

Side effects with unknown frequency (frequency cannot be defined based on available data):

• Blurred vision

It is possible to experience difficulty retaining the suspension at the site of administration.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Topster

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging
after the words “Exp.”. The expiry date refers to the last day of that month.
Store at a temperature below 30°C.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Topster contains

• The active ingredient is beclometasone dipropionate. Each single-dose bottle contains 3 mg of beclometasone dipropionate.
• The other ingredients are: methyl parahydroxybenzoate, ethyl parahydroxybenzoate, disodium salt of ethylenediaminetetraacetic acid, monobasic sodium phosphate dihydrate, dibasic sodium phosphate dodecahydrate, sodium carboxymethylcellulose, purified water.

Description of the appearance of Topster and contents of the pack
Topster is presented in the form of a rectal suspension contained in single-dose bottles of
polyethylene of 60 ml, with a tamper-evident seal.
Each pack contains 10 single-dose bottles and an equal number of single-use rectal
cannulae.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturer
SOFAR S.p.A.
Via Firenze 40,
Trezzano Rosa (MI)

Topster 3 mg suppositories

Beclometasone dipropionate

Read this leaflet carefully before taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Topster is and what it is used for
• 2. What you need to know before you use Topster
• 3. How to use Topster
• 4. Possible side effects
• 5. How to store Topster
• 6. Contents of the pack and other information

1. What is Topster and what is it used for

Topster suppositories contain the active ingredient beclometasone dipropionate and
belong to a class of medicines called topical corticosteroids. Corticosteroids are hormones that are naturally produced by the adrenal glands (so called because they are located above the kidney) and have many and
important functions, including controlling inflammatory responses.
Topster suppositories are used for the local treatment of chronic diseases that
cause inflammation and lesions, called ulcers, of the rectal and sigmoid mucosa
(ulcerative proctosigmoiditis), in case of first onset of inflammation or
subsequent reactivation.

2. What you need to know before using Topster
Do not use Topster if:

• you are allergic to the active ingredient beclometasone dipropionate or to any of the other ingredients of this medicine (listed in section 6);
• you have tuberculosis;
• you have an intestinal infection caused by fungi or viruses;
• you have perforations, obstructions or presence of pus (abscess) at the intestinal level;
• you are in the first three months of pregnancy (see section “Pregnancy and breastfeeding”).

Topster should not be used in children under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using Topster if:

• you have severe liver problems (hepatic insufficiency);
• you have severe kidney problems (renal insufficiency);
• you have high levels of sugars (glucose) in the blood (diabetes mellitus);
• you have lesions (ulcers) in the stomach or in the first part of the intestine, called the duodenum;
• you suffer from high blood pressure (hypertension);
• you have osteoporosis, a disease characterized by loss and fragility of bone tissue;
• you have a decrease in the secretion of hormones by the adrenal glands (adrenal insufficiency);
• you have entered the third month of pregnancy or are breastfeeding (see section “Pregnancy and breastfeeding”).

Talk to your doctor if:

• you are switching from taking systemic corticosteroids (e.g. tablets or injections) to locally acting medicines such as Topster;
• you have an infection in the intestine or if it occurs during therapy with Topster. In this case, the doctor will immediately prescribe antibiotic therapy;
• you experience blurred vision or other visual disturbances.

The doctor may subject you to control tests in the initial phase of treatment with
Topster, or in case of prolongation of the treatment.

Children and adolescents
Topster should not be used in children under 12 years of age.

Other medicines and Topster
Tell your doctor or pharmacist if you are taking, have recently taken or
may take any other medicines, including over-the-counter medicines.
Be careful when using Topster with other medicines that contain
cortisone or corticosteroids, as Topster may enhance the effect of these medicines.
Some medicines may increase the effects of Topster and your doctor may want to
keep you under close observation if you are taking these medicines (including some
medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before using
this medicine.

Pregnancy
Do not use Topster in the first three months of pregnancy.
If you have entered the third month of pregnancy, the doctor will assess whether the possible benefits of
treatment for you outweigh the potential risks to the baby.

Breastfeeding
During breastfeeding, Topster should only be used if absolutely necessary
and under the direct control of the doctor.

Driving and using machines
No effects of Topster on the ability to drive vehicles or use machines are known.

For athletes
The use of the medicine without therapeutic need constitutes doping and may in any case result in positive doping tests.

3. How to use Topster

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 Topster suppository, twice a day, one in the morning
(preferably after bowel movement) and one in the evening, before going to bed, for
at least 4 weeks.

Use in children and adolescents
Topster should not be used in children under 12 years of age.

If you use more Topster than you should
Cases of overdose are not known. If you accidentally ingest/take an excessive dose of
Topster, immediately inform your doctor or go to the nearest hospital.

If you forget to use Topster
Do not use a double dose to make up for a missed dose.

If you stop using Topster
If you have any doubts about the use of this medicine, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
No side effects have been reported due to systemic absorption (throughout the body) of the medicine.
Common side effects (may affect up to 1 in 10 people):

• sensation of heat and/or burning at the anus;
• painful contraction of the anus (tenesmus);

Side effects with unknown frequency (frequency cannot be estimated based on available data):

• Blurred vision

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system at:
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Topster

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 packaging
after the words “Exp.”. The expiry date refers to the last day of that month.
Store in the original packaging, away from sources of heat.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help to
protect the environment.

6. Contents of the pack and other information

What Topster contains

• The active ingredient is beclometasone dipropionate. Each suppository contains 3 mg of beclometasone dipropionate.
• The other ingredients are: solid semi-synthetic glycerides.

Description of the appearance of Topster and contents of the pack
Topster is presented in the form of suppositories.
Each pack contains 10 suppositories contained in PVC/PE blisters
heat-sealed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Alfasigma S.p.A. - Via Ragazzi del ’99, n. 5 - 40133 Bologna (BO)

Manufacturers
DOPPEL Farmaceutici S.r.l.
Via Martiri delle foibe 1
29016 Cortemaggiore (PC)
SPECIAL PRODUCT’S LINE S.p.A
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR)