Product Information for the User

HEMORRANE 10 mg/g Rectal Ointment

Hydrocortisone Acetate

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Follow exactly the medication administration instructions contained in this product information or those indicated by your doctor or pharmacist.
• Keep this product information, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

1. Contents of the package and additional information.

This medication contains hydrocortisone acetate, an active ingredient that belongs to a group of medications called corticosteroids used on the skin to reduce inflammation and itching.

It is indicated for local relief of pain, itching, burning, and inflammation associated with hemorrhoids in adults.

You should consult a doctor if it worsens or does not improve after 7 days.

No use HEMORRANE

• If you are allergic to the active ingredient, to other corticosteroids, or to any of the other components of this medication (listed in section 6).
• If you have bleeding hemorrhoids.
• If you have any infection caused by bacteria, viruses, or fungi 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, and mucous membranes (such as the 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, use additional treatment prescribed for the infection.
• Corticosteroids like hydrocortisone, the active ingredient in HEMORRANE, have significant effects on the body. To limit the general absorption of the medication in the blood and reduce the risk of adverse effects, avoid treatment in extensive areas, for long periods of time, and with occlusive dressings (under impermeable materials to air and water, such as bandages, dressings, or diapers, poorly breathable); otherwise, you may observe changes such as increased blood pressure, diabetes, Cushing's syndrome (disease caused by increased cortisol hormone), as well as skin striations and atrophy.

Children and adolescents

HEMORRANE is not indicated for children and adolescents.

Use of HEMORRANE with other medications

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

Until now, no interactions of HEMORRANE have been described in the approved conditions of use in this prospectus, but do not use it at the same time with other medications that should be applied to the same anorectal area, unless your doctor or pharmacist advises you to do so.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, do not use HEMORRANE unless your doctor considers it advisable.

Pregnancy

The safety of use has not been established in pregnancy; therefore, if your doctor prescribes HEMORRANE during pregnancy, do not use it in extensive areas of your body, for long periods of time, or with occlusive dressings, as it may cause systemic absorption (generalized absorption of the medication in the blood).

Breastfeeding

The passage of topical corticosteroids into breast milk is unknown, so caution is advised if they must be used during breastfeeding.

Driving and operating machines

No effects on driving and operating machines have been described.

Use in athletes

This medication contains hydrocortisone acetate, which may produce a positive result in doping control tests.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

This medication is for topical rectal use.

If symptoms do not improve in 7 days, discontinue treatment and consult your doctor.

The recommended dose is:

1 or 2 applications per day 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.

Administration Form

Clean the affected area with water and a small amount of mild soap, dry it without rubbing, with a clean towel and apply the ointment:

• For anal or perianal application: apply an amount of ointment equivalent to about 2 centimeters, with a clean gauze.
• For internal hemorrhoids, use the cannula included in the package: remove the plug and pierce the tube. Screw on the cannula. Insert the cannula into the rectum, pressing on the tube to deposit an amount of ointment equivalent to about 1 or 2 centimeters. Remove the cannula slowly as its contents are emptied. It is recommended to also apply a small amount to the exterior of the anal opening 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 cutaneous application method of this medication, no poisoning or adverse effects are expected as a result of its use.

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

If you forgot to use HEMORRANE

Do not apply a double dose to compensate for the missed doses. Apply the next dose when it is due.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

There have been rare cases of allergic reactions described.

In rare and isolated cases, local skin reactions such as itching, irritation, or pruritus may appear.

At the recommended doses, topical use rarely associates with the appearance of adverse effects resulting from cutaneous absorption and through mucous membranes.

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

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not appearing in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

This medication does not require special conditions for preservation.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of HEMORRANE:

• The active principle is acetate of hydrocortisone. 1 gram of ointment contains 11.16 mg of acetate of hydrocortisone, equivalent to 10 mg of hydrocortisone base.
• The other components are:White petrolatum.

Appearance of the product and contents of the packaging

HEMORRANE is a smooth, white ointment. It is presented in tubes containing 30 grams of ointment and a nozzle.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Faes Farma, S.A.

Autonomia Etorbidea, 10

48940 Leioa (Bizkaia)

Spain

Responsible for manufacturing

Faes Farma Portugal, S.A.

Av. Elías García nº28, 2700-327 AMADORA

PORTUGAL

Last review date of this leaflet:10/09/2013

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/