Proctolyn

Package leaflet: Information for the patient

Proctolyn 0.1 mg/g + 10 mg/g rectal cream

fluocinolone acetonide + ketocaine hydrochloride
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What Proctolyn is and what it is used for

Proctolyn contains two active substances: fluocinolone acetonide (a glucocorticoid) which acts against inflammation, and ketocaine hydrochloride (a local anesthetic) which reduces sensitivity in the area where it is applied.
Proctolyn belongs to a group of medicines called "anti-haemorrhoidals" (used against haemorrhoids) and is used:

• for the local treatment of internal and external haemorrhoids
• for inflammations and irritations of the skin in the anal area and around the anus (eczema and erythema)
• for anal itching and burning sensations in the anal area and around the anus
• for lesions around the anus with slow healing (anal fissures)
• in the anal area before and after surgical procedures (ano-rectal surgery).

Proctolyn acts locally, reducing inflammation, redness (congestion), itching, anal burning, and indirectly, pain.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Proctolyn

Do not use Proctolyn

• if you are allergic to fluocinolone acetonide, ketocaine hydrochloride, or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other medicines belonging to the same family (glucocorticoids such as flumetasone, triamcinolone, dexamethasone, diflucortolone, fluocinonide, diflorasone)
• if you have tuberculosis (TB)
• if you have fungal infections (mycoses)
• if you have viral diseases (Herpes simplex) or other viral skin conditions.

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

• if you have previously experienced any of the above-mentioned conditions
• if you are pregnant or breastfeeding (see section Pregnancy and breastfeeding)
• if you are a child under 12 years of age (see section Children).

Consult your doctor if you experience blurred vision or other visual disturbances.
Local application of Proctolyn in excessive doses or for prolonged periods may result in the medicine passing into the body (systemic absorption) and cause additional undesirable effects beyond those at the application site.
Moreover, the use, especially if prolonged, of topical medicines may lead to allergic reactions. In such cases, discontinue use of Proctolyn and consult your doctor, who will recommend appropriate therapy.
If there is a skin infection, appropriate antibiotic treatment should be started.
Proctolyn must not be used in the eyes and should not come into contact with the eyes.
For those engaged in sports: using this medicine without therapeutic need constitutes doping and may lead to a positive anti-doping test.
Children
In children under 12 years of age, Proctolyn should only be used after consulting a doctor and evaluating with him or her the risks and benefits of treatment.
Other medicines and Proctolyn
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Proctolyn, and your doctor may wish 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, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Indeed, during pregnancy and breastfeeding, Proctolyn should only be used after consulting your doctor and evaluating with him or her the risks and benefits of treatment.
Driving and using machines
Proctolyn does not affect the ability to drive or operate machinery.
Proctolyn contains

• methyl para-hydroxybenzoate and propyl para-hydroxybenzoate, which may cause allergic reactions (including delayed reactions);
• cetyl alcohol and stearyl alcohol, which may cause localized skin reactions (e.g. contact dermatitis);
• propylene glycol in an amount of 70 mg per gram of cream.

3. How to use Proctolyn

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is an amount of rectal cream sufficient to cover the affected area, applied 2–3 times a day.
Warning: Do not exceed the indicated dose without medical advice.
External application: Spread and gently massage.
Internal application: Use the provided cannula attached to the tube.
Rectal cream may be used in combination with Proctolyn suppositories for combined treatment.
Consult your doctor if symptoms recur or if you have noticed any recent changes in their characteristics.
Warning: Use Proctolyn only for short-term treatment.

Use in children
In children under 12 years of age, Proctolyn should be used only after consulting a doctor and evaluating with him the risks and benefits of treatment.

If you use more Proctolyn than you should
If you accidentally take an excessive dose of Proctolyn, inform your doctor immediately or go to the nearest hospital.

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

If you have any questions 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.
With intense and prolonged treatment, the following may occur:

• burning sensation
• itching
• irritation. These side effects are generally temporary. If they occur, consult your doctor or pharmacist.

Blurred vision may occur, frequency not known.
Reporting of side effects
If you experience any side effect, 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: http://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 Proctolyn

This medicinal product does not require any special storage conditions.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after "Expiry".
The expiry date refers to the last day of that month.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the packaging and the leaflet.

6. Package contents and other information

What Proctolyn contains

• The active substances are fluocinolone acetonide and ketocaine hydrochloride. One gram of rectal cream contains 0.1 mg of fluocinolone acetonide and 10 mg of ketocaine hydrochloride (equivalent to 8.9 mg of ketocaine).
• The other components are citric acid, menthol, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, stearyl alcohol, cetyl alcohol, mineral oil, sorbitan monostearate, polysorbate 60, purified water.

Description of the appearance of Proctolyn and contents of the pack
Proctolyn is a rectal cream.
It is available in tubes of 30 g of rectal cream.
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. - via Matteo Civitali, 1 - 20148 Milan, Italy.
Manufacturer
RECORDATI S.p.A. - Milano Pharmaceutical Plant - via Matteo Civitali, 1.
Temmler Italia S.r.l. - via delle Industrie, 2 - 20061 Carugate (MI).

Patient Information Leaflet

Proctolyn 0.1 mg + 10 mg suppositories

fluocinolone acetonide + chetocaine hydrochloride
Please read this leaflet carefully before using this medicine because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you notice worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Proctolyn is and what it is used for
2. What you need to know before using Proctolyn
3. How to use Proctolyn
4. Possible side effects
5. How to store Proctolyn
6. Package contents and other information

1. What Proctolyn is and what it is used for

Proctolyn contains two active substances: fluocinolone acetonide (a glucocorticoid) which acts against inflammations, and ketocaine hydrochloride (a local anesthetic) which reduces sensitivity in the area where it is applied.
Proctolyn belongs to a group of medicines called "anti-hemorrhoidals" (for treating hemorrhoids) and is used:

• for the local treatment of internal and external hemorrhoids
• for inflammations and skin irritations in the anal area and surrounding the anus (eczema and erythema)
• for itching and burning in the anal area and surrounding the anus
• for anal lesions with slow healing (anal fissures)
• in the anal area before and after surgical procedures (ano-rectal surgery).

Proctolyn works locally by reducing inflammation, redness (congestion), itching, anal burning, and indirectly pain.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Proctolyn

Do not use Proctolyn

• if you are allergic to fluocinolone acetonide, chlorketocaine hydrochloride, or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to other medicines belonging to the same family (glucocorticoids such as flumetasone, triamcinolone, dexamethasone, diflucortolone, fluocinonide, diflorasone)
• if you have tuberculosis (TB)
• if you have fungal infections (mycoses)
• if you have viral diseases (Herpes simplex) or other viral infections affecting the skin.

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

• if the above-mentioned conditions have occurred previously
• if you are pregnant or breastfeeding (see section Pregnancy and breastfeeding)
• if you are a child under 12 years of age (see section Children).

Contact your doctor if you experience blurred vision or other visual disturbances.
Local application of Proctolyn in excessive doses or for prolonged periods may lead to the medicine passing into the body (systemic absorption) and cause additional adverse effects beyond those at the application site.
Moreover, the use, especially if prolonged, of topical medicines may give rise to allergic reactions. In such a case, discontinue use of Proctolyn and consult your doctor, who will advise appropriate therapy.
If a skin infection is present, appropriate antibiotic treatment should be initiated.
Proctolyn must not be used in the eyes and should not come into contact with the eyes.
For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Children
In children under 12 years of age, Proctolyn should only be used after consulting a doctor and evaluating with him or her the risks and benefits of treatment.

Other medicines and Proctolyn
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Proctolyn, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Indeed, during pregnancy and breastfeeding, Proctolyn should only be used after consulting your doctor and evaluating with him or her the risks and benefits of treatment.

Driving and using machines
Proctolyn does not affect the ability to drive or operate machinery.

Proctolyn contains propylene glycol
This medicine contains 40 mg of propylene glycol per suppository.

3. How to use Proctolyn

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2 suppositories per day, 1 suppository in the morning and 1 in the evening.
Warning: Do not exceed the recommended dose without medical advice.
Consult your doctor if the condition recurs frequently or if you have noticed any recent changes in its characteristics.
Warning: Use Proctolyn only for short-term treatment.
The suppositories may be used in combination with Proctolyn rectal cream.
Use in children
In children under 12 years of age, Proctolyn should be used only after consulting a doctor and evaluating with him the risks and benefits of treatment.
If you use more Proctolyn than you should
In case of accidental overdose, contact your doctor immediately or go to the nearest hospital.
If you forget to use Proctolyn
Do not use a double dose to make up for the missed dose.
If you have any doubts about how to use 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.
With intensive and prolonged use, the following may occur:

• burning sensation
• itching
• irritation. These side effects are generally transient. If they occur, consult your doctor or pharmacist.

Blurred vision may occur, frequency unknown.
Reporting of side effects
If you experience any side effect, 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: http://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 Proctolyn

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Expiry”.
The expiry date refers to the last day of that month.
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.
It is important to always keep the medicine information available; therefore, retain both the carton and the leaflet.

6. Package contents and other information

What Proctolyn contains

• The active substances are fluocinolone acetonide and ketotifen hydrochloride. Each suppository contains 0.1 mg of fluocinolone acetonide and 10 mg of ketotifen hydrochloride (equivalent to 8.9 mg of ketotifen).
• The other components are citric acid, menthol, propylene glycol, polysorbate 60, sorbitan monostearate, colloidal silicon dioxide, semisynthetic glycerides.

Description of the appearance of Proctolyn and package contents
Proctolyn is available as rectal suppositories.
It is supplied in packs containing 10 suppositories.
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. - via Matteo Civitali, 1 - 20148 Milano.
Manufacturer
Zeta Farmaceutici S.p.A. - via Galvani, 10 - 36066 Sandrigo (VI).