ULTRAPROCT Suppository

Зміст інструкції

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

Ultraproct rectal ointment

fluocortolone pivalate + fluocortolone caproate + cinchocaine hydrochloride

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you to.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen.

Contents of this leaflet:

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

1. What is Ultraproct and what is it used for

Ultraproct contains two active ingredients: fluocortolone (as pivalate and as caproate) and cinchocaine hydrochloride.
Fluocortolone (pivalate and caproate) belongs to the category of medicines called corticosteroids, anti-inflammatory drugs.
Cinchocaine hydrochloride belongs to the category of medicines called local anesthetics.
Ultraproct is indicated for the treatment of internal and external hemorrhoids (swollen and inflamed veins inside the anal canal and around the anus), anal fissures (small wounds of the anal margin) and proctitis (inflammation of the rectum).
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Ultraproct

Do not use Ultraproct

• if you are allergic to fluocortolone pivalate, fluocortolone caproate or cinchocaine hydrochloride, or to any of the other ingredients of this medicine (listed in section 6);
• if there are tuberculous, syphilitic (due to syphilis) or viral (smallpox, chickenpox, vaccination pustules) lesions present in the area to be treated.

Warnings and precautions
Consult your doctor or pharmacist before using Ultraproct.
Avoid contact with the eyes.
Wash your hands thoroughly after using the medicine.
If a fungal infection (fungal infection) is present in the area to be treated, your doctor will prescribe an antimycotic locally in association.
The use, especially if prolonged, of products for local use, can give rise to sensitization phenomena (allergy). In this case, discontinue treatment and consult your doctor to establish suitable therapy.
In the event of local applications on extensive surfaces, on damaged skin or in the presence of an occlusive bandage, corticosteroids may be absorbed in quantities sufficient to cause distant adverse effects.
The duration of treatment should not exceed, where possible, 4 weeks.
If latex products, such as condoms, are used simultaneously in the same area of treatment with Ultraproct, its excipients may damage these same latex products.
Consequently, the latter may no longer be effective as contraceptives or as protection against sexually transmitted diseases such as HIV infection. Consult your doctor or pharmacist if you need more information.
Contact your doctor if you experience blurred vision or other visual disturbances.

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

Children
In early infancy, the medicine should be administered only in cases of actual need, under the direct supervision of the doctor.

Other medicines and Ultraproct
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines.
Some medicines may increase the effects of Ultraproct 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 or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Do not use Ultraproct during the first trimester of pregnancy, unless the benefits outweigh the potential risks to the baby.
If you are pregnant, use the medicine only when necessary and under the direct supervision of your doctor.

Driving and operating machinery
Ultraproct does not impair the ability to drive vehicles or operate machinery.

Ultraproct contains castor oil
This medicine contains castor oil, hydrogenated castor oil macrogol 400 monoricinoleate which may cause localized skin reactions.

Ultraproct containsCitrus Rose fragrance oil
This medicine contains a fragrance (Citrus Rose fragrance oil) which in turn contains allergens (amyl cinnamal, benzyl alcohol, benzyl benzoate, cinnamal, cinnamyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, hydroxycitronellal, linalool) which may cause allergic reactions.

3. How to use Ultraproct

Use this medicine following exactly the instructions in this leaflet or as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply a thin layer of rectal ointment.
On the first day, 3-4 applications of the preparation are recommended to achieve a faster
disappearance of symptoms; subsequently, 2 applications per day will be sufficient.
To prevent relapses, treatment should be continued with one application per day for a few more days
after the complete disappearance of the symptoms.
The intrarectal introduction of the ointment can be performed using the special cannula attached
to the package, taking care to apply it after evacuation of the bowels. A small
amount of cream can be applied to the rectum by gently squeezing the tube (for use and cleaning
of the applicator see section 5. How to store Ultraproct).

If you use more Ultraproct than you should
In the event of accidental oral intake, symptoms such as convulsions, inhibition
or cessation of respiratory functions and cardiovascular disorders (depression or cessation of
cardiac functions) may occur.
In case of accidental intake of an excessive dose of Ultraproct, immediately inform
your doctor or go to the nearest hospital.
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 everybody gets them.
Rare cases of local irritation with burning and cases of allergy in predisposed individuals have been reported,
towards one or more of the medicine's components, especially cinchocaine hydrochloride.
Allergic reactions at the skin level may occur in rare cases.
For prolonged treatment periods (more than 4 weeks), symptoms may manifest locally such as skin atrophy (thinning of the skin).
The low doses of active ingredients contained in the medicine make the onset of distant secondary effects, due to absorption into the body, unlikely. If these were to occur,
they would have the general characteristics of the classic secondary effects of corticosteroids, albeit to a very limited extent.
Blurred vision may occur with unknown frequency (the frequency cannot be defined based on available data).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ultraproct

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 “Scad.” The
expiry date refers to the last day of that month. The expiry date indicated refers to the
product in intact packaging, correctly stored.
Use of the applicator:
do not use the applicator if damaged. Screw the applicator completely onto the tube. After each
use, clean the outside of the applicator with a paper swab, then remove the product
remaining in the applicator with a cotton ball and clean thoroughly again with a paper swab.
Rinse the applicator under warm water for about 1 minute and dry the outside
of the applicator with a paper swab.
Validity after first opening: 3 months.
Store at a temperature below 25°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 protect the environment.

6. Contents of the pack and other information

What Ultraproct contains

• The active ingredients are: fluocortolone pivalate, fluocortolone caproate, cinchocaine hydrochloride. 1 g of rectal ointment contains: 0.918 mg of fluocortolone pivalate, 0.945 mg of fluocortolone caproate, 5 mg of cinchocaine hydrochloride.
• The other ingredients are: 2-octyldodecanol, refined castor oil, hydrogenated castor oil, macrogol 400 monoricinoleate, Citrus Rose fragrance oil. *Citrus Rose fragrance oil contains the following allergens: amyl cinnamal, , benzyl alcohol, benzyl benzoate, cinnamal, cinnamyl alcohol, citral, citronellol, coumarin, d-limonene, eugenol, farnesol, geraniol, , hydroxycitronellal, linalool (see section 2).

Description of the appearance of Ultraproct and contents of the pack
Rectal ointment, tube of 30 g + 1 cannula.

Marketing Authorisation Holder
Karo Pharma AB, Box 16184, SE-103 24 Stockholm, Sweden.

Manufacturer
LEO Pharma Manufacturing Italy S.r.l Via E. Schering,21 – 20090 Segrate (Milan), Italy.

Ultraproct suppositories

fluocortolone pivalate + fluocortolone caproate + cinchocaine hydrochloride

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms get worse.

Contents of this leaflet:

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

1. What is Ultraproct and what is it used for

Ultraproct contains two active ingredients: fluocortolone (as pivalate and as caproate) and cinchocaine hydrochloride.
Fluocortolone (pivalate and caproate) belongs to the category of medicines called corticosteroids, anti-inflammatory drugs.
Cinchocaine hydrochloride belongs to the category of medicines called local anesthetics.
Ultraproct is indicated for the treatment of internal hemorrhoids (swollen and inflamed veins inside the anal canal), anal fissures (small wounds of the anal verge) and proctitis (inflammation of the rectum).
See your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Ultraproct

Do not use Ultraproct

• if you are allergic to fluocortolone pivalate, fluocortolone caproate or cinchocaine hydrochloride, or to any of the other ingredients of this medicine (listed in section 6);
• if there are tuberculous, syphilitic (due to syphilis) or viral (smallpox, chickenpox, vaccination pustules) lesions present in the area to be treated.

Warnings and precautions
Consult your doctor or pharmacist before using Ultraproct.
Avoid contact with the eyes.
Wash your hands thoroughly after using the medicine.
If a fungal infection (fungal infection) is present in the area to be treated, your doctor will prescribe an antimycotic for local use in association.
The use, especially if prolonged, of products for local use, can give rise to sensitization (allergy) phenomena.
In this case, discontinue treatment and consult your doctor to establish appropriate therapy.
In the event of local applications on extensive surfaces, on damaged skin or in the presence of an occlusive bandage,
corticosteroids may be absorbed in quantities sufficient to cause distant undesirable effects.
The duration of treatment should not exceed, if possible, 4 weeks.
If latex products, such as condoms, are used simultaneously in the same area of treatment with Ultraproct, its excipient may
damage these same latex products.
Consequently, the latter may no longer be effective as contraceptives or as protection
against sexually transmitted diseases such as HIV infection. Consult your doctor or pharmacist if you need more information.
Contact your doctor if you experience blurred vision or other visual disturbances.

For athletes:the use of the medicine without therapeutic necessity constitutes doping and
may still result in positive doping tests.

Children
In early infancy, the medicine should be administered only in cases of actual need, under the direct
control of the doctor.

Other medicines and Ultraproct
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Some medicines may increase the effects of Ultraproct 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 with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Do not use Ultraproct during the first trimester of pregnancy, unless the benefits outweigh the
potential risks to the baby.

Driving and operating machinery
Ultraproct does not impair the ability to drive vehicles or operate machinery.

3. How to use Ultraproct

Use this medicine following exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one suppository per day.
After the complete disappearance of symptoms, it is recommended to continue treatment for another
week using 1 suppository every 2 days.
It is advisable to insert the suppository after bowel movement.
If the suppositories have become soft due to heat, they should be immersed in cold water,
before opening the packaging, until they have regained a sufficiently hard consistency.

If you use more Ultraproct than you should
In the event of accidental oral intake, symptoms such as convulsions, inhibition
or cessation of respiratory functions and cardiovascular disorders (depression or cessation of
cardiac functions) may occur.
In case of accidental intake of an excessive dose of Ultraproct, immediately inform your
doctor or go to the nearest hospital.
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 everybody gets them.
Rare cases of local irritation with burning and cases of allergy in predisposed individuals have been reported,
to one or more of the medicine's components, especially cinchocaine hydrochloride.
Allergic reactions at the skin level may occur in rare cases.
For prolonged treatment periods (more than 4 weeks), symptoms at the local level such as skin atrophy (thinning of the skin) may occur.
The low doses of active ingredients contained in the medicine make the onset of distant secondary effects, due to absorption into the body, unlikely.
If these were to occur, they would have the general character of the classic secondary effects of corticosteroids, albeit to a very limited extent.
Blurred vision may occur with unknown frequency (the frequency cannot be defined based on available data).

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ultraproct

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 “Scad”. The
expiry date refers to the last day of that month. The expiry date indicated refers to the
product in intact packaging, correctly stored.
Store in a refrigerator (2°C – 8°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 protect the environment.

6. Contents of the pack and other information

What Ultraproct contains

• The active ingredients are: fluocortolone pivalate, fluocortolone caproate, cinchocaine hydrochloride. 1 suppository contains 0.612 mg of fluocortolone pivalate, 0.630 mg of fluocortolone caproate, 1 mg of cinchocaine hydrochloride.
• The other ingredients are: saturated fatty acid triglycerides.

Description of the appearance of Ultraproct and contents of the pack
Box containing 2 strips of 6 suppositories (12 suppositories).

Marketing Authorisation Holder
Karo Pharma AB, Box 16184, SE-103 24 Stockholm, Sweden.

ManufacturerIstituto de Angeli S.r.l
Località Prulli, 103/C
50066 Reggello (Florence)
Italy