PROCTOSEDYL 20 G Cream

Зміст інструкції

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

Proctosedyl suppositories

Hydrocortisone acetate, Benzocaine, Esculin, Benzalkonium chloride

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 worsen.

Contents of this leaflet:

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

1. What is Proctosedyl and what is it used for?

Proctosedyl is a topical anti-haemorrhoidal, based on corticosteroids (a group of anti-inflammatory drugs).
Proctosedyl is used to treat the symptoms of internal or external haemorrhoids, especially in the inflammatory phases. Anal pruritus.

2. What you need to know before using Proctosedyl

Do not use Proctosedyl

• if you are allergic to hydrocortisone acetate, benzocaine, esculin, benzalkonium chloride or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other anaesthetics with a chemical structure similar to benzocaine and to substances containing the para group (sulphonamides, promethazine, etc.).
• if you have tuberculous and viral infections of the area to be treated.

Warnings and precautions
Consult your doctor or pharmacist before using Proctosedyl.
Use with appropriate caution in subjects with damaged mucous membranes which may cause excessive absorption of the active ingredients.
Corticosteroids can only be applied to infected areas if preceded or accompanied by adequate antibacterial or antifungal therapy. If therapy fails, treatment should be discontinued and the infection should be adequately treated with other measures.

Caution:Use the minimum effective dosage.
Clinical cases suggest that the administration of products containing benzocaine may cause methaemoglobinemia (increased level of methaemoglobin in the blood) referable to excessive absorption of benzocaine, particularly in children and the elderly. Symptoms such as cyanosis (pallor, greyish or bluish discoloration of the skin, lips and nails), headache, dizziness, dyspnoea (difficulty breathing), fatigue and tachycardia that occur during treatment may indicate methaemoglobinemia potentially dangerous to the patient's life (see also “If you use more Proctosedyl than you should”). If you notice any of these symptoms, immediately inform your doctor or go to the nearest hospital .
Local application of corticosteroids in excessive doses and for prolonged periods may determine generalized reactions from systemic absorption (Cushing's syndrome, inhibition of the pituitary-adrenal axis [the adrenal gland may temporarily become unable to produce adequate amounts of cortisol upon discontinuation]). Therefore, once a favourable clinical effect has been obtained, it is necessary to minimize the frequency of application and the dosage, suspending the product as soon as possible. It is in any case necessary to limit the local use of steroids to short periods of time.

Contact your doctor if you experience blurred vision or other visual disturbances.
Anti-doping tests
For those who engage in sporting activities: the use of the drug without medical necessity constitutes doping and may result in a positive anti-doping test.

Other medicines and Proctosedyl
Tell your doctor or pharmacist if you are taking, or have recently taken, other medicines, including over-the-counter medicines.
Some medicines may increase the effects of Proctosedyl 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).
It is not known whether other medicines may alter the effect of Proctosedyl.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy or breastfeeding, Proctosedyl should only be used after consulting your doctor and assessing the risk/benefit ratio in your case with him.

Proctosedyl suppositories contain benzalkonium chloride
Benzalkonium chloride may cause local irritation.

3. How to use Proctosedyl

Use this medicine following exactly the instructions in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist.
Rectal use. Remove the suppository from its packaging before use.
The recommended dose is 1-2 suppositories per day.

Warning:use only for short periods of treatment.

If you use more Proctosedyl than you should
In case of accidental intake of an excessive dose of Proctosedyl, immediately inform your doctor or go to the nearest hospital.
Symptoms due to an excess of corticosteroids are characterized by asthenia (weakness), adynamia (lack of strength), high blood pressure, edema, cardiac rhythm disturbances, hypokalemia (potassium deficiency in the blood), metabolic alkalosis (high bicarbonate levels in the blood).
Clinical cases suggest that the administration of products containing benzocaine may cause methemoglobinemia (increased level of methemoglobin in the blood). Symptoms such as cyanosis (paleness, grayish or bluish discoloration of the skin, lips and nails), headache, dizziness, dyspnea (difficulty breathing), fatigue and tachycardia that occur during treatment may indicate a potentially life-threatening methemoglobinemia and require immediate medical attention.
The recommended treatment includes, in addition to supportive therapy, intravenous infusion of methylene blue.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
These effects generally disappear after a short period, however if you should experience
any of the following symptoms you must contact your doctor or pharmacist:local allergic
reactions that present with edema, redness and itching.
It may occur with unknown frequency (the frequency cannot be defined based on the
available data): blurred vision
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
contact your doctor or pharmacist. You can also report side effects directly
through the national reporting system
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 Proctosedyl

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry date refers to the last day of that month.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
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 Proctosedyl contains
Each suppository contains :
The active ingredients are: hydrocortisone acetate 5 mg, benzocaine 50 mg, escin 10 mg, benzalkonium
chloride 0.1 mg.
The other ingredients are: medium chain triglycerides, solid semi-synthetic glycerides (Witepsol E85,
Witepsol H15).

Description of the appearance of Proctosedyl and contents of the pack
Proctosedyl suppositories are presented in a carton containing 6 suppositories.

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

Manufacturer
Doppel Farmaceutici s.r.l.
via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)

Proctosedyl rectal cream

Hydrocortisone acetate, Amileine, Benzocaine, Esculin,
Benzalkonium chloride

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

1. What is Proctosedyl and what is it used for

Proctosedyl is a topical anti-haemorrhoidal medication, based on corticosteroids (a group of anti-inflammatory drugs).
Proctosedyl is used to treat the symptoms of internal or external haemorrhoids, especially in the inflammatory phases. Anal pruritus.

2. What you need to know before you use Proctosedyl

Do not use Proctosedyl

• if you are allergic to hydrocortisone acetate, amylamine, benzocaine, esculin, benzalkonium chloride or any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to other anaesthetics with a chemical structure similar to benzocaine and to substances containing the para group (sulfonamides, promethazine, etc.).
• if you have tuberculous and viral infections of the area to be treated.

Warnings and precautions
Consult your doctor or pharmacist before using Proctosedyl.
Use with appropriate caution in subjects with damaged mucous membranes, which may cause excessive absorption of the active ingredients.
Corticosteroids can only be applied to infected areasif preceded or accompanied by adequate antibacterial or antifungal therapy. If the therapy fails, it is necessary to discontinue treatment and adequately treat the infection with other measures.

Attention:Use the minimum effective dosage.
Clinical cases suggest that the administration of products containing benzocaine may cause methemoglobinemia (increased level of methemoglobin in the blood) attributable to excessive absorption of benzocaine, particularly in children and the elderly. Symptoms such as cyanosis (pallor, greyish or bluish discoloration of the skin, lips and nails), headache, dizziness, dyspnea (difficulty breathing), fatigue and tachycardia that occur during treatment may indicate a potentially life-threatening methemoglobinemia (see also “If you use more Proctosedyl than you should”). If you notice any of these symptoms, immediately inform your doctor or go to the nearest hospital.
Local application of corticosteroids in excessive doses and for prolonged periods may determine generalized reactions from systemic absorption (Cushing's syndrome, inhibition of the pituitary-adrenal axis [the adrenal gland may temporarily become unable to produce adequate amounts of cortisol upon discontinuation]). Therefore, once a favourable clinical effect has been obtained, it is necessary to minimize the frequency of application and the dosage, suspending the product as soon as possible. It is in any case necessary to limit the local use of steroids to short periods of time.

Contact your doctor if you experience blurred vision or other visual disturbances.
Anti-doping tests
For those who engage in sporting activities: the use of the drug without medical necessity constitutes doping and may result in a positive anti-doping test.

Other medicines and Proctosedyl
Tell your doctor or pharmacist if you are taking, or have recently taken, other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Proctosedyl 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).
It is not known whether other medicines may alter the effect of Proctosedyl.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with breast milk, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy or breastfeeding, Proctosedyl should only be used after consulting your doctor and weighing the risk/benefit ratio in your case.

Proctosedyl rectal cream contains propylene glycol
This medicine contains 2.4 g of propylene glycol per 20 g. It may cause skin irritation.
Do not use this medicine in children under 4 weeks of age with open wounds or extensive areas of damaged skin (such as burns) without talking to your doctor or pharmacist.

Proctosedyl rectal cream contains benzalkonium chloride
This medicine contains 5 mg of benzalkonium chloride per 100 g. Benzalkonium chloride may cause local irritation.

3. How to use Proctosedyl

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Proctosedyl cream is used for endorectal and perianal applications.
Apply a small amount of product accompanied by a gentle massage.
If necessary, use the applicator for internal use: remove the cap, screw
the applicator onto the tube and insert it into the anus. Squeeze the tube to release a sufficient amount
of cream. After use, clean the applicator and cover it with the cap.
You should apply Proctosedyl rectal cream twice a day in acute forms. You can space out the
applications as soon as the symptoms improve.

Warning:use only for short periods of treatment.

If you use more Proctosedyl than you should
In case of accidental intake of an excessive dose of Proctosedyl, immediately inform your
doctor or go to the nearest hospital.
Symptoms due to an excess of corticosteroids are characterized by asthenia (weakness),
asthenia (lack of strength), high blood pressure, edema, cardiac rhythm disturbances,
hypokalemia (potassium deficiency in the blood), metabolic alkalosis (high levels of
bicarbonate in the blood).
Clinical cases suggest that the administration of products containing benzocaine may
cause methemoglobinemia (increased level of methemoglobin in the blood). Symptoms such as
cyanosis (pallor, grayish or bluish discoloration of the skin, lips and nails), headache,
dizziness, dyspnea (difficulty breathing), fatigue and tachycardia that occur
during treatment may indicate a methemoglobinemia potentially dangerous for the
patient's life and require immediate medical attention.
The recommended treatment includes, in addition to supportive therapy, the intravenous infusion of blue
methylene.
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.
These effects generally disappear after a short period, however if you should experience
any of the following symptoms you must consult your doctor or pharmacist:
local allergic reactions presenting with edema, redness and itching.
Blurred vision may occur with unknown frequency (frequency cannot be defined based on available
data).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly
through the national reporting system 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 Proctosedyl

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. The expiry date refers to the last day of that month.
Do not store at a temperature above 25°C. Validity after first opening: 4 weeks.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
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 Proctosedyl contains
100 g of rectal cream contains:

• The active ingredients are: hydrocortisone acetate 1 g, amylamine 1 g, benzocaine 1 g, esculin 1 g, benzalkonium chloride 5 mg.
• The other ingredients are: cholesterol, liquid paraffin, macrogol 300, macrogol 1540, macrogol 4000, polysorbate 80, propylene glycol, talc, white soft paraffin, purified water.

Description of the appearance of Proctosedyl and contents of the pack
Proctosedyl cream is presented as a cream for rectal use.
The content of the tube is 20 g.

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

Manufacturer
Doppel Farmaceutici s.r.l.
via Martiri delle Foibe, 1 - 29016 Cortemaggiore (PC)