Package leaflet: Information for the patient

Emorril 10 mg/g + 15 mg/g rectal cream

hydrocortisone acetate + lidocaine hydrochloride
Read 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 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.

Contents of this leaflet:

What Emorril is and what it is used for
What you need to know before using Emorril
How to use Emorril
Possible side effects
How to store Emorril
Contents of the pack and other information

1. What Emorril is and what it is used for

Emorril contains hydrocortisone acetate and lidocaine hydrochloride.

Hydrocortisone acetate belongs to a group of medicines called “corticosteroids” or “steroids”. It helps reduce inflammation and swelling of the skin and mucous membranes.
Lidocaine hydrochloride is a local anaesthetic that works by reducing pain and itching of the skin and mucous membranes. This medicine is used:
for the local treatment of haemorrhoids, which are swellings of the blood vessels around the anus that can cause discomfort, itching, and irritation to varying degrees. Haemorrhoids may be either internal (inside the anus) or external (outside the anus);
to treat irritations (eczema, erythema), lesions (fissures), itching and burning caused by haemorrhoids;
before and after surgical procedures on the anus or the terminal portion of the intestine (rectum).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before using Emorril

Do not use Emorril

if you are allergic to the active substances, to other local anaesthetics, to other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6);
in children under 12 years of age.

Warnings and precautions
If there is no noticeable improvement after a short period of treatment, consult your doctor.
Prolonged or even short-term use of topical (local) skin products may lead to sensitization (an excessive immune response to foreign substances the body has been exposed to). If this occurs, discontinue treatment and consult your doctor to begin appropriate therapy.
If you experience bleeding from the anus (rectal bleeding), stop treatment and consult your doctor.
Avoid contact with the eyes.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
This medicine must not be used in children under 12 years of age (see section 2 “Do not use Emorril”).

Other medicines and Emorril
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, consult your doctor before taking this medicine. During pregnancy, use this medicine only if your doctor considers it necessary and under their supervision.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

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

Emorril contains:

Anhydrous lanolin. May cause local skin reactions (e.g. contact dermatitis).
Methyl parahydroxybenzoate and propyl parahydroxybenzoate. May cause allergic reactions (including delayed reactions).
Propylene glycol. May cause skin irritation.

For those engaged in sports activities: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.

3. How to use Emorril

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.
External application: around the anus
The recommended dose is an amount of cream sufficient to cover the affected area, applied twice daily.
Internal application: into the rectum (the final section of the intestine)
The recommended dose is an amount of cream sufficient to cover the affected area, applied twice daily using the special cannula provided in the package. The cannula must be attached to the cream tube to facilitate internal application.
If necessary, the number of daily applications, both external and internal, may be increased.
If you use more Emorril than you should
In case of accidental ingestion or excessive use of the rectal cream, consult your doctor immediately.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the use of this medicine:

severe allergic reactions (anaphylactic reactions). If you experience difficulty breathing or swelling of the face or throat, contact the nearest hospital immediately;
allergic reactions, recognizable by skin lesions, appearance of itchy raised areas on the skin (urticaria), swelling. If you experience an allergic reaction, discontinue treatment with this medicine;
worsening of infections.
Blurred vision, frequency not known.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist.
You can also report side effects directly via the national reporting system at 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 Emorril

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 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.

6. Package contents and other information

What Emorril contains
In 1 g of rectal cream:

The active substances are hydrocortisone acetate 10 mg, lidocaine hydrochloride 15 mg.
The other components are anhydrous lanolin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, polysorbate 61, white vaseline, propylene glycol, carbomers, purified water, anhydrous citric acid.

Description of the appearance of Emorril and contents of the pack
Emorril rectal cream is supplied in a carton containing one tube with 40 g of cream and an applicator nozzle.
Marketing Authorization Holder and Manufacturer
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)