HEMORRANE 10 mg/g RECTAL OINTMENT

2. What you need to know before you start using HEMORRANE

Do not use HEMORRANE

• If you are allergic to the active ingredient, other corticosteroids, or any of the other components of this medicine (listed in section 6).
• If you have bleeding hemorrhoids.
• If you have any bacterial, viral, or fungal infection in the area to be treated.
• If you have tuberculosis.

Warnings and precautions

Consult your doctor or pharmacist before starting to use HEMORRANE.

• The continued use of HEMORRANE should not exceed 7 days.
• Avoid any contact with the eyes, mouth, open wounds, as well as mucous membranes (e.g., genital area). In case of accidental application in these areas, rinse with plenty of water.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If irritation occurs in the application area, discontinue treatment and consult your doctor or pharmacist.
• If your doctor diagnoses a bacterial, viral, or fungal infection, you should also use the additional treatment prescribed for the infection.
• Corticosteroids like hydrocortisone, the active ingredient of HEMORRANE, have significant effects on the body. To limit the generalized absorption of the medicine into the blood and reduce the risk of side effects, treatment in extensive areas, for long periods, and with occlusive dressings (under materials impermeable to air and water, such as bandages, dressings, or diapers, with little transpiration) should be avoided; otherwise, alterations such as increased blood pressure, diabetes, Cushing's syndrome (a disease caused by increased cortisol hormone), as well as stretch marks and skin atrophy may be observed.

Children and adolescents

HEMORRANE is not indicated in children and adolescents.

Using HEMORRANE with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

To date, no interactions with HEMORRANE have been described under the approved conditions of use in this package leaflet, but it should not be used at the same time with other medicines that must be applied to the same anorectal area, unless indicated by your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, you should not use HEMORRANE unless your doctor considers it necessary.

Pregnancy

Its safety for use during pregnancy has not been established; therefore, if your doctor prescribes HEMORRANE during pregnancy, you should not use it on extensive areas of your body, nor for long periods, nor with occlusive dressings, due to the possibility of systemic absorption (generalized absorption of the medicine into the blood).

Breastfeeding

It is unknown whether topical corticosteroids pass into breast milk; therefore, caution is advised if they need to be used during breastfeeding.

Driving and using machines

No effects on driving or using machines have been described.

Use in athletes

This medicine contains hydrocortisone acetate, which can produce a positive result in doping tests.

3. How to use HEMORRANE

Follow the instructions for administration of the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

This medicine is for topical rectal use.

If symptoms do not improve within 7 days, you should discontinue treatment and consult your doctor.

The recommended dose is:

1 or 2 daily applications in the anal and/or rectal area, with an amount of ointment equivalent to about 2 centimeters. It is recommended to do this in the morning and at night.

Method of administration

Wash the affected area with water and a little mild soap, dry it without rubbing with a clean towel, and apply the ointment:

• In case of anal or perianal application: apply an amount of ointment equivalent to about 2 centimeters, with a clean gauze.
• In case of internal hemorrhoids, the cannula included in the package should be used: remove the cap and puncture the tube. Screw on the cannula. Insert the cannula into the rectum, pressing on the tube to deposit an amount of ointment equivalent to approximately 1 or 2 centimeters. Slowly remove the cannula as its contents are emptied. It is also recommended to apply a small amount to the outside of the anal orifice and the folds of the anal margins.

It is recommended to perform the applications after intestinal evacuation and personal hygiene.

If you use more HEMORRANE than you should

Due to the topical application of this medicine, phenomena of intoxication or side effects as a consequence of its use are not expected.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use HEMORRANE

Do not apply a double dose to make up for forgotten doses. Apply the next dose when it is due.

If you have any other 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.

The use of anti-inflammatory drugs (corticosteroids) on the skin may cause side effects, especially after prolonged application, in extensive areas, with occlusive dressings or materials.

Allergic reactions have been described in rare cases.

In rare and isolated cases, local cutaneous adverse reactions such as burning, irritation, or itching may appear.

At the recommended doses, topical use is rarely associated with the appearance of side effects as a consequence of cutaneous and mucous absorption.

If increased sensitivity or irritation occurs in the treated area, discontinue treatment and consult your doctor.

With an unknown frequency (cannot be estimated from the available data): blurred vision.

If you consider that any of the side effects you are suffering from is serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of HEMORRANE

Keep this medicine out of the sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition of HEMORRANE:

• The active ingredient is hydrocortisone acetate. 1 gram of ointment contains 11.16 mg of hydrocortisone acetate, equivalent to 10 mg of hydrocortisone base.
• The other components are: Liquid Paraffin.

Appearance of the product and contents of the pack

HEMORRANE is a greasy ointment and white in color. It is presented in tubes containing 30 grams of ointment and a cannula.

Marketing authorization holder and manufacturer

Marketing authorization holder

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Manufacturer

Faes Farma Portugal, S.A.

Av. Elías García nº28, 2700-327 AMADORA

PORTUGAL

Date of the last revision of this package leaflet:10/09/2013

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/