Topster
Italy
Table of Contents
Package leaflet: Information for the user
Topster 42 mg rectal foam
Beclometasone dipropionate
Please read this leaflet carefully before using 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Topster is and what it is used for
- What you need to know before using Topster
- How to use Topster
- Possible side effects
- How to store Topster
- Contents of the pack and other information
1. What Topster is and what it is used for
Topster rectal foam contains the active substance beclometasone dipropionate and belongs to a class of medicines known as topical corticosteroids.
Corticosteroids are hormones naturally produced by the adrenal glands (so called because they are located above the kidneys) and have many important functions, including the control of inflammatory responses.
Topster rectal foam is used for the local treatment of chronic conditions causing inflammation and lesions, known as ulcers, in the colon (ulcerative colitis) and in the mucosa of the rectum and sigmoid (ulcerative proctosigmoiditis), either at the first occurrence of inflammation or during subsequent relapses.
2. What you need to know before using Topster
Do not use Topster if:
- you are allergic to the active substance 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 intestinal perforations, obstructions, or the presence of pus (abscess) in the intestine;
- you are in the first three months of pregnancy (see section "Pregnancy and breastfeeding").
Topster must 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 stomach or duodenal ulcers (ulcers in the first part of the intestine);
- you suffer from high blood pressure (hypertension);
- you have osteoporosis, a disease characterized by loss and fragility of bone tissue;
- you have reduced hormone secretion from the adrenal glands (adrenal insufficiency);
- you are beyond the third month of pregnancy or are breastfeeding (see section "Pregnancy and breastfeeding").
Contact your doctor if:
- you are switching from systemic corticosteroid therapy (e.g. tablets or injectable solutions) to locally-acting medicines such as Topster;
- you have an intestinal infection or develop one during treatment with Topster. In such cases, your doctor will prescribe antibiotic therapy immediately;
- you experience blurred vision or other visual disturbances.
Your doctor may carry out monitoring tests at the beginning of treatment with Topster or if treatment is prolonged.
Children and adolescents
Topster must not be used in children under 12 years of age.
Other medicines and Topster
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Be cautious when using Topster together with other medicines containing cortisone or corticosteroids, as Topster may enhance the effect of these medicines.
Some medicines may increase the effects of Topster, and your doctor may wish to monitor you closely if you are taking such medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Topster during the first three months of pregnancy.
If you are beyond the third month of pregnancy, your doctor will assess whether the potential benefits of treatment for you outweigh the potential risks to the unborn child.
Breastfeeding
During breastfeeding, Topster should only be used when strictly necessary and under direct medical supervision.
Driving and using machines
No effects of Topster on the ability to drive vehicles or use machinery are known.
Topster rectal foam contains propyl parahydroxybenzoate and methyl parahydroxybenzoate which may cause allergic reactions (including delayed reactions).
This medicine contains 982 mg of propylene glycol per dose, equivalent to 393 mg/g.
For individuals engaged in sports
Using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.
3. How to use Topster
Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 3 mg (one dose) of Topster rectal foam daily, preferably administered in the evening before going to bed, for at least 4 weeks.
To dispense the correct dose of foam, press the dosing head of the bottle only once.
Instructions for using Topster rectal foam
Use the multidose container with the dosing head pointing downwards, upside down.
To dispense one dose of foam:
- shake the multidose container well before use (for about 15 seconds);
- when using the container for the first time, remove and discard the tamper-evident seal located beneath the dosing head;
- attach the rectal cannula to the dispensing site of the metering valve;
- rotate the dosing head so that the dispensing site aligns with the groove at the base of the dosing head;
- hold the bottle upside down and insert the rectal cannula into the anal orifice; lubricate the cannula with vaseline before use. To facilitate insertion, place one foot on a chair or lie on your side;
- firmly press the dosing head and keep it pressed for about 5 seconds;
- release the dosing head: the foam is dispensed only during this step;
- wait approximately 5 seconds;
- remove the rectal cannula from the anal orifice;
- detach the rectal cannula from the dispensing site and discard it; it is normal for the rectal cannula to still be filled with foam.
- rotate the dosing head so that the groove at the base of the dosing head is no longer aligned with the dispensing site. This prevents accidental release of foam if the dosing head is pressed inadvertently.
Use in children and adolescents
Topster must not be used in children under 12 years of age.
If you use more Topster than you should
There are no known cases of overdose. In case of accidental ingestion/absorption of an excessive dose of Topster, inform your doctor immediately or go to the nearest hospital.
If you forget to use Topster
Do not use a double dose to make up for the missed dose.
If you stop using Topster
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
No side effects due to systemic absorption (throughout the body) of the medicine have been reported.
Common side effects (may affect up to 1 in 10 people):
- sensation of warmth and/or burning around the anus;
- painful contraction of the anus (tenesmus);
- poor adaptability to the medicine's applicator.
Side effects with unknown frequency (frequency cannot be estimated
based on the available data):
- Blurred vision
It is possible that difficulty in retaining the foam at the site of administration may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following website:
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 stated on the packaging after the word "Exp.". The expiry date refers to the last day of that month.
Store below 25°C.
The container is under pressure; keep it away from fire, even when empty.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Topster contains
The active substance is beclometasone dipropionate.
The multidose container contains 42 mg of beclometasone dipropionate. Each
delivered dose contains 3 mg of beclometasone dipropionate.
The other ingredients are: methyl p-hydroxybenzoate, propyl p-hydroxybenzoate,
disodium edetate, cetostearyl polyoxyethylene sorbitan 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 a rectal foam contained in a pressurized multidose aluminum container, sufficient for the delivery of 14 doses.
Each package contains inside 14 single-use rectal applicators to be attached to the multidose 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)
Patient Information Leaflet: Information for the user
Topster 3 mg rectal suspension
Beclometasone dipropionate
Please read this leaflet carefully before using this medicine,
as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Topster is and what it is used for
- What you need to know before using Topster
- How to use Topster
- Possible side effects
- How to store Topster
- Contents of the pack and other information
1. What Topster is and what it is used for
Topster rectal suspension contains the active substance beclometasone dipropionate and
belongs to a class of medicines known as locally-acting corticosteroids.
Corticosteroids are hormones naturally produced by the adrenal glands (so-called because they are located above the kidneys) and have many important functions, including the control of inflammatory responses.
Topster rectal suspension is used for the local treatment of chronic diseases causing inflammation and lesions, known as ulcers, of the colon (ulcerative colitis) and of the rectum and sigmoid mucosa (ulcerative proctosigmoiditis), in cases of initial onset or subsequent reactivation of inflammation.
2. What you need to know before using Topster
Do not use Topster if:
- you are allergic to the active substance 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 intestinal perforations, obstructions, or presence of pus (abscess) in the intestine;
- you are in the first three months of pregnancy (see section “Pregnancy and breastfeeding”).
Topster must 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 stomach or duodenal ulcers (lesions in the stomach or first part of the intestine);
- you suffer from high blood pressure (hypertension);
- you have osteoporosis, a disease characterized by loss and fragility of bone tissue;
- you have reduced hormone secretion from the adrenal glands (adrenal insufficiency);
- you are beyond the third month of pregnancy or are breastfeeding (see section “Pregnancy and breastfeeding”).
Talk to your doctor if:
- you are switching from systemic corticosteroid medicines (e.g. tablets or injectables) to locally-acting medicines such as Topster;
- you have an intestinal infection or if such an infection develops during treatment with Topster. In this case, your doctor will prescribe immediate antibiotic therapy;
- you experience blurred vision or other visual disturbances.
Your doctor may carry out monitoring tests at the beginning of treatment with
Topster, or if treatment is prolonged.
Children and adolescents
Topster must not be used in children under 12 years of age.
Other medicines and Topster
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Be cautious when using Topster together with other medicines containing cortisone or corticosteroids, as Topster may enhance the effect of these medicines.
Some medicines may increase the effects of Topster, and your doctor may wish to monitor you closely if you are taking such medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Topster during the first three months of pregnancy.
If you are beyond the third month of pregnancy, your doctor will assess whether the potential benefits of treatment for you outweigh the potential risks to the unborn child.
Breastfeeding
During breastfeeding, Topster should be used only if clearly needed and under the direct supervision of a doctor.
Driving and using machines
No effects of Topster on the ability to drive or use machinery are known.
Topster rectal suspension contains ethyl parahydroxybenzoate and methyl parahydroxybenzoate which may cause allergic reactions (including delayed reactions).
For those engaged in sports activities
Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
3. How to use Topster
Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 3 mg (one dose) of Topster rectal suspension daily, preferably administered in the evening before going to bed, for at least 4 weeks.
Instructions for using Topster rectal suspension
For correct use of the rectal suspension:
- shake the single-dose bottle well before use;
- remove the cannula cap;
- to facilitate insertion of the cannula, lie on your left side and keep your left leg straight; bend your right leg;
- insert the rectal cannula attached to the bottle into the anal orifice. Lubricate the cannula with vaseline before use;
- squeeze the bottle with gradual and constant pressure until it is completely emptied;
- after administration of Topster, remain lying on your left side for approximately 30 minutes.
Maximum effectiveness of Topster rectal suspension is achieved when the medicine is left to act at the site of administration throughout the night.
Use in children and adolescents
Topster must not be used in children under 12 years of age.
If you use more Topster than you should
Cases of overdose are unknown. If you accidentally ingest or take an excessive dose of Topster, inform your doctor immediately or go to the nearest hospital.
If you forget to use Topster
Do not use a double dose to make up for a forgotten dose.
If you stop treatment with Topster
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
No side effects due to systemic absorption (throughout the body) of the medicine have been reported.
Common side effects (may affect up to 1 in 10 people):
- sensation of warmth and/or burning at the anus;
- painful contraction of the anus (tenesmus);
- poor adaptability to the medicine applicator;
Side effects with unknown frequency (frequency cannot be estimated
from the available data):
- Blurred vision
It is possible that difficulty in retaining the suspension at the site of administration may occur.
Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at the following address:
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 stated on the packaging after the word “Exp.”. The expiry date refers to the last day of that month.
Store below 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Topster contains
- The active substance is beclometasone dipropionate. Each single-dose vial contains 3 mg of beclometasone dipropionate.
- The other components are: methyl p-hydroxybenzoate, ethyl p-hydroxybenzoate, disodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium carboxymethylcellulose, purified water.
Description of the appearance of Topster and contents of the pack
Topster is a rectal suspension contained in single-dose vials made of polyethylene,
60 ml in size, with a tamper-evident seal.
Each pack contains 10 single-dose vials and 10 single-use rectal cannulas.
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)
Package leaflet: Information for the user
Topster 3 mg suppositories
Beclometasone dipropionate
Please read this leaflet carefully before using this medicine, as 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Topster is and what it is used for
- What you need to know before using Topster
- How to use Topster
- Possible side effects
- How to store Topster
- Package contents and other information
1. What Topster is and what it is used for
Topster suppositories contain the active substance beclometasone dipropionate and belong to a class of medicines known as locally-acting corticosteroids. Corticosteroids are hormones naturally produced by the adrenal glands (so called because they are located above the kidneys) and have many important functions, including controlling inflammatory responses.
Topster suppositories are used for the local treatment of chronic diseases causing inflammation and lesions, known as ulcers, of the rectal and sigmoid mucosa (ulcerative proctosigmoiditis), in cases of initial 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 substance 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 intestinal perforations, obstructions, or presence of pus (abscess) in the intestine;
- you are in the first three months of pregnancy (see section “Pregnancy and breastfeeding”).
Topster must 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 in the first part of the intestine, called duodenum;
- you suffer from high blood pressure (hypertension);
- you have osteoporosis, a disease characterized by loss and fragility of bone tissue;
- you have reduced hormone secretion from the adrenal glands (adrenal insufficiency);
- you are beyond the third month of pregnancy or are breastfeeding (see section “Pregnancy and breastfeeding”).
Talk to your doctor if:
- you are switching from systemic corticosteroid medicines (e.g. tablets or injectable solutions) to locally-acting medicines such as Topster;
- you have an intestinal infection or if one develops during treatment with Topster. In this case, your doctor will prescribe antibiotic therapy immediately;
- you experience blurred vision or other visual disturbances.
Your doctor may carry out monitoring tests at the beginning of treatment with Topster or if treatment is prolonged.
Children and adolescents
Topster must not be used in children under 12 years of age.
Other medicines and Topster
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
Be cautious when using Topster together with other medicines containing cortisone or corticosteroids, as Topster may enhance the effect of these medicines.
Some medicines may increase the effects of Topster, and your doctor may decide to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Topster during the first three months of pregnancy.
If you are beyond the third month of pregnancy, your doctor will assess whether the potential benefits of treatment for you outweigh the potential risks for the unborn child.
Breastfeeding
During breastfeeding, Topster should only be used if clearly necessary and under direct medical supervision.
Driving and operating machinery
No effects of Topster on the ability to drive or operate machinery are known.
For those engaged in sports
Using this medicine without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.
3. How to use Topster
Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 Topster suppository, twice daily—one in the morning (preferably after bowel movement) and one in the evening before bedtime—for at least 4 weeks.
Use in children and adolescents
Topster must 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 the event of accidental ingestion/absorption of an excessive dose of Topster, inform your doctor immediately or go to the nearest hospital.
If you forget to use Topster
Do not use a double dose to make up for the forgotten dose.
If you stop treatment with Topster
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everyone experiences them.
No side effects due to systemic absorption (throughout the body) of the medicine have been reported.
Common side effects (may affect up to 1 in 10 people):
- sensation of warmth and/or burning around the anus;
- painful contraction of the anus (tenesmus);
Side effects with unknown frequency (frequency cannot be estimated from the available data):
- Blurred vision
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 stated on the packaging after the word "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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Topster contains
- The active substance is beclometasone dipropionate. Each suppository contains 3 mg of beclometasone dipropionate.
- The other components are: solid semisynthetic glycerides.
Description of Topster and contents of the pack
Topster is available in the form of suppositories.
Each pack contains 10 suppositories in PVC/PE thermoformed blisters.
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)