Hemorrane 10 mg/g rectal ointment

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HEMORRANE 10 mg/g rectal ointment

Hydrocortisone acetate

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.
• Keep this leaflet, as you may need to read 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 effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Contents of this leaflet:

1. What HEMORRANE is and what it is used for.

2. What you need to know before using HEMORRANE.

3. How to use HEMORRANE.

4. Possible side effects.

5. How to store HEMORRANE.

6. Contents of the pack and other information.

1. What HEMORRANE is and what it is used for

This medicine contains hydrocortisone acetate, an active ingredient belonging to a group of medicines called corticosteroids, which is used on the skin to reduce inflammation and itching.

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

You should consult a doctor if symptoms worsen or do not improve after 7 days.

2. What you need to know before using HEMORRANE

Do not use HEMORRANE

• If you are allergic to the active substance, to other corticosteroids, or to any of the other ingredients of this medicine (listed in section 6).
• If your hemorrhoids are bleeding.
• If you have a 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.

• Prolonged use of HEMORRANE should not exceed 7 days.
• Avoid contact with the eyes, mouth, open wounds, and mucous membranes (e.g., genital area). In case of accidental application to these areas, rinse thoroughly with plenty of water.
• Contact your doctor if you experience blurred vision or other visual disturbances.
• If irritation develops at the application site, discontinue treatment and consult your doctor or pharmacist.
• If your doctor diagnoses a bacterial, viral, or fungal infection, you should also use any additional treatment prescribed for the infection.
• Corticosteroids such as hydrocortisone, the active ingredient in HEMORRANE, have significant effects on the body. To limit systemic absorption into the bloodstream and reduce the risk of adverse effects, treatment over large areas, prolonged periods, or under occlusive dressings (air- and water-impermeable materials such as bandages, dressings, or non-breathable diapers) should be avoided. Otherwise, adverse effects such as high blood pressure, diabetes, Cushing's syndrome (a condition caused by elevated levels of the hormone cortisol), as well as skin striae and atrophy may occur.

Children and adolescents

HEMORRANE is not indicated for use in children and adolescents.

Use of HEMORRANE with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

No interactions have been reported for HEMORRANE under the approved conditions of use described in this leaflet. However, it should not be used simultaneously with other topical medications intended for the same anorectal area unless directed by your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The safety of HEMORRANE during pregnancy has not been established. Therefore, if your doctor prescribes HEMORRANE during pregnancy, avoid use over large body areas, prolonged durations, or under occlusive dressings, as systemic absorption (widespread absorption of the medicine into the bloodstream) may occur.

Breastfeeding

It is unknown whether topical corticosteroids pass into breast milk. Therefore, caution is advised if use during breastfeeding is necessary.

Driving and use of machinery

No effects on driving or operating machinery have been reported.

Use in athletes

This medicine contains hydrocortisone acetate, which may result in a positive test in doping controls.

3. How to use HEMORRANE

Follow exactly the instructions for administering this medicine provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

This medicine is for topical rectal use.

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

Recommended dose:

1 or 2 applications per day to the anal and/or rectal area, using an amount of ointment equivalent to about 2 centimeters. It is recommended to apply in the morning and at night.

Method of administration

Wash the affected area with water and a mild soap, then dry gently without rubbing using a clean towel, and apply the ointment:

• In case of anal or perianal application: apply an amount of ointment equivalent to about 2 centimeters using a clean gauze pad.
• In case of internal hemorrhoids, use the applicator nozzle supplied in the package: remove the cap and pierce the tube. Screw on the nozzle. Insert the nozzle into the rectum and press the tube to deposit an amount of ointment equivalent to approximately 1 or 2 centimeters. Slowly withdraw the nozzle as it empties. It is also advisable to apply a small amount externally around the anal opening and skin folds surrounding the anus.

It is recommended to perform the application after bowel movement and personal hygiene.

If you use more HEMORRANE than you should

Due to the topical cutaneous route of administration of this medicine, intoxication or adverse effects are not expected as a consequence of its use.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses. Apply the next dose at the scheduled time.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone experiences them.

The use of anti-inflammatory drugs (corticosteroids) on the skin may cause adverse effects, especially after prolonged application, over extensive areas, or when used under dressings or occlusive materials.

Allergic reactions have been reported on rare occasions.

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

At the recommended doses, topical use rarely leads to adverse effects resulting from cutaneous absorption or absorption through mucous membranes.

If increased sensitivity or irritation develops at the treated site, discontinue treatment and consult your doctor.

Frequency not known (cannot be estimated from the available data): blurred vision.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish System of Pharmacovigilance of Human Medicines: https://www.notificaram.es/. By reporting adverse 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 any special storage conditions.

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

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

6. Contents of the package and other information

Composition of HEMORRANE:

• The active substance is hydrocortisone acetate. One gram of ointment contains 11.16 mg of hydrocortisone acetate, equivalent to 10 mg of hydrocortisone base.
• The other component is: Hydrous wool fat (Vaselina filante).

Appearance of the medicine and contents of the pack

HEMORRANE is a greasy ointment, white in colour. It is supplied in tubes containing 30 grams of ointment and an applicator nozzle.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: 10/09/2013

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/