Preparazione H

Package leaflet: Information for the patient

Preparazione H 23 mg suppositories

Saccharomyces Cerevisiae cell extract
Please read all of this leaflet carefully before you start 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.

• 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, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement, or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What Preparazione H is and what it is used for

Preparazione H is an anti-haemorrhoidal medicinal product containing the active ingredient cell extract of
Saccharomyces Cerevisiae.
Preparazione H is used for the treatment of:

• uncomplicated internal and external haemorrhoids;
• anal fissures.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment, or if the condition recurs repeatedly, or if you have noticed any recent changes in its characteristics.

2. What you need to know before using Preparazione H

DO NOT use Preparazione H

• if you are allergic to the extract of Saccharomyces cerevisiae cells or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your pharmacist before using Preparazione H.
Exercise particular caution and consult your doctor:

• if you use Preparazione H for a prolonged period, because long-term use of topical medicines may cause allergic reactions. In such case, discontinue treatment. Your doctor will provide appropriate therapy;
• if bleeding occurs;
• if the condition persists.

Other medicines and Preparazione H
Inform your pharmacist if you are currently taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Preparazione H may be used during pregnancy and while breastfeeding.
Driving and using machines
To date, no negative effects on the ability to drive vehicles or operate machinery are known.

3. How to use Preparation H

Use this medicine 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 up to 2-3 suppositories per day.

• Remove the protective wrapper;
• insert the suppository into the rectum, preferably after each bowel movement.

Do not exceed the recommended doses without first consulting your doctor.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment, or
if the condition recurs repeatedly or if you have noticed any recent change in its
characteristics.
If you use more Preparation H than you should
To date, no cases of overdose have been reported with the use of Preparation H suppositories.
If you forget to use Preparation H
Do not use a double dose to make up for the missed dose.
If you stop using Preparation H
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 may cause side effects, although not everybody gets them.
To date, no particular side effects have been reported with the use of Preparazione H.
Following the instructions contained in this leaflet reduces the risk of side effects.
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 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 Preparazione H

Do not store above 30°C.
Keep in the original packaging.
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 "Exp". 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 no longer in use. This will help protect the environment.
It is important to always have the medicine information available; therefore, keep both the carton and the leaflet.

6. Package contents and other information

What Preparazione H contains

• The active substance is Saccharomyces Cerevisiae cell extract. Each suppository contains 23 mg of Saccharomyces Cerevisiae cell extract.
• The other components are shark liver oil, Witepsol W35, cocoa butter, paraffin wax, polyethylene glycol 600 dilaurate, glycerol.

Description of the appearance of Preparazione H and pack contents
Each pack of Preparazione H contains a carton with 12 suppositories.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milano
Manufacturer
Haupt Pharma Livron – Livron (Drôme) France
Doppel Farmaceutici S.r.l. – Cortemaggiore (PC), Italy

Patient information leaflet

Preparation H 10.8 mg/g ointment

Saccharomyces cerevisiae cell extract
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 any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

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

1. What Preparazione H is and what it is used for

Preparazione H is an anti-haemorrhoidal medicinal product containing the active ingredient cell extract of
Saccharomyces Cerevisiae.
Preparazione H is used for the treatment of:

• uncomplicated internal and external haemorrhoids;
• anal fissures.

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment, or if the condition recurs repeatedly, or if you have noticed any recent change in its characteristics.

2. What you need to know before using Preparation H

DO NOT use Preparation H

• if you are allergic to the extract of Saccharomyces cerevisiae cells or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your pharmacist before using Preparation H.
Be especially careful and consult your doctor:

• if you use Preparation H for a long time, because prolonged use of topical medicines may cause allergic reactions. In this case, stop treatment. Your doctor will provide appropriate therapy;
• if bleeding occurs;
• if the condition persists.

Other medicines and Preparation H
Inform your pharmacist if you are taking, have recently taken, or might take any other medicines,
including those not requiring a prescription.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor or pharmacist before using this medicine.
Preparation H may be used during pregnancy and while breastfeeding.
Driving and using machines
To date, no negative effects on the ability to drive vehicles or use machinery are known.
Preparation H contains methyl parahydroxybenzoate and propyl parahydroxybenzoate,
which may cause allergic reactions (including delayed reactions).
Preparation H contains lanolin, which may cause local skin reactions (e.g. contact dermatitis).
Preparation H contains butylated hydroxytoluene, which may cause local skin reactions (e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Preparation H

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: 2–3 applications of ointment per day.

• Apply the ointment, if possible, after each bowel movement;
• take the applicator with protective cap provided in the package;
• remove the cap, lubricate the applicator, and screw it onto the tube;
• squeeze the Preparation H tube to fill the applicator;
• insert into the rectum and squeeze the tube again until a sufficient amount of product has been administered;
• also apply the ointment to the external area;
• after use, clean the applicator and cover it with the cap.

Do not exceed the recommended doses without first consulting your doctor.
Consult your doctor if you do not feel better or if you feel worse after a short period of treatment, if the condition recurs repeatedly, or if you have noticed any recent changes in its characteristics.
If you use more Preparation H than you should
To date, no cases of overdose have been reported with the use of Preparation H ointment.
If you forget to use Preparation H
Do not use a double dose to make up for the missed dose.
If you stop using Preparation H
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.
To date, no specific side effects have been reported with the use of Preparazione H.
Following the instructions provided in this leaflet reduces the risk of side effects.
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 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 Preparazione H

Do not store above 25°C.
Keep in the original packaging.
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 "Exp.". 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 package leaflet.

6. Package contents and other information

What Preparazione H contains

• The active substance is Saccharomyces Cerevisiae cell extract. 100 g of ointment contain 1.08 g of Saccharomyces Cerevisiae cell extract.
• The other components are shark liver oil, white vaseline, light mineral oil, Argobase L2 (liquid paraffin, wool wax, vaseline, anhydrous lanolin, ozokerite, butylated hydroxytoluene (BHT)), lanolin, glycerol, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, red thyme oil.

Description of the appearance of Preparazione H and contents of the pack
Each pack of Preparazione H contains one tube of topical ointment of 25 g or 50 g.
Marketing Authorization Holder
Haleon Italy S.r.l.
Via Monte Rosa 91
20149 Milano
Manufacturer
Haleon Italy Manufacturing S.r.l., Via Nettunense, 90, 04011, Aprilia (LT), Italy