COHORTAN 5 mg/g + 5 mg/g RECTAL OINTMENT

Introduction

Package Leaflet: Information for the User

Cohortan 5 mg/g + 5 mg/g Rectal Ointment

Hydrocortisone, Cincocaine Hydrochloride

Read all of this leaflet carefully before you start using this medicine.It contains important information for you.

• Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.
• Keep this leaflet, you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist even if it is a side effect not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the Package Leaflet:

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

1. What is Cohortan and what is it used for

This medicine belongs to the group of medicines called "topical anti-hemorrhoidal preparations containing corticosteroids".

This medicine owes its activity to its two active principles, hydrocortisone (anti-inflammatory) and cincocaine hydrochloride (local anesthetic).

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

2. What you need to know before using Cohortan

• Do not usethis medicine if you are allergic to hydrocortisone and/or cincocaine or to any of the other components of this medicine (listed in section 6).
• If you have hemorrhoidal bleeding. If you have uncontrolled bacterial, viral, or fungal infections.
• If you have tuberculosis.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use this medicine.

• Contact your doctor if you experience blurred vision or other visual disturbances.

It should be used with the following precautions:

• Continuous use of this medicine should not exceed 7 days.
• Any contact with the eyes, mouth, open wounds, as well as with mucous membranes (e.g., genital area) should be avoided. In case of accidental application to these areas, rinse with plenty of water.

• In case of irritation in the application area, the use of this medicine should be suspended and, if necessary, appropriate treatment should be initiated.
• If an associated infection occurs, it is advisable to incorporate specific complementary treatment.
• Although the medicine is applied locally, absorption of the product may occur, and in the case of prolonged treatments, possible systemic side effects of the active principle should be monitored.
• Corticosteroids, such as hydrocortisone, 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 (disease caused by increased cortisol hormone), as well as stretch marks and skin atrophy may be observed.

Children and Adolescents

This medicine is not indicated in children and adolescents.

Other Medicines and Cohortan

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

To date, no interactions of this medicine have been described under the approved conditions of use in this 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 and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Its safety for use during pregnancy has not been established; therefore, if your doctor prescribes this medicine during pregnancy, it should not be used 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 the ability to drive and use machines have been described.

Cohortan contains Castor Oil

This medicine may cause skin reactions because it contains castor oil.

Use in Athletes

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

3. How to use Cohortan

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

Recommended dose

It is recommended to apply a small amount of ointment equivalent to two centimeters in the anal and/or rectal area two or three times a day.

Method of administration

• It is advisable to perform the applications in the morning and at night, preferably after intestinal evacuation and personal hygiene.
• Prior to application, the area should be cleaned with warm water and soap, and the ointment should be applied with a clean gauze or, in the case of internal hemorrhoids, using the attached cannula. 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 advisable to apply a small amount to the outside of the anal orifice and the folds of the anal margins.
• Wash your hands immediately before and after each application.

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

If you use more Cohortan than you should:

If you have used more medicine than you should, or in case of accidental ingestion of the product, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount used.

If you forget to use Cohortan

Apply this medicine as soon as possible.

Do not use a double dose to make up for forgotten doses.

If you stop treatment with Cohortan

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.

Blurred vision may appear with an unknown frequency. In isolated cases, local adverse reactions may occur, mainly due to hypersensitivity to the preparation, and even more so in prolonged treatments. At the recommended doses, systemic side effects (not local) are rarely produced. If sensitivity or irritation occurs in the treated area, treatment should be suspended.

Corticosteroids, if used excessively or for a prolonged period, can cause adverse reactions such as sodium and water retention with edema, mobilization of calcium and phosphates, elevation of blood glucose levels, delayed wound healing, and increased propensity to infections. Adrenal suppression may occur, which can be prolonged over time if treatment has been prolonged. In this case, the interruption of treatment should be gradual.

However, given the recommended duration of treatment with this medicine (7 days), such side effects are not expected.

If you observe any other reaction not described in this leaflet, consult 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 leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Cohortan

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

Keep the tube perfectly closed. Do not store at a temperature above 30°C.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in 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 Cohortan

• The active principles are hydrocortisone and cincocaine hydrochloride. Each gram of ointment contains 5 mg of hydrocortisone and 5 mg of cincocaine hydrochloride.
  • The other components are: castor oil, α-tocopherol, liquid vaseline, and solid vaseline.

Appearance of the product and contents of the pack

Rectal ointment, white, soft, and homogeneous in appearance, similar to vaseline, and barely perceptible odor.

This medicine is packaged in a 30g aluminum tube, internally coated, closed with a cap, and accompanied by a plastic cannula.

Marketing Authorization Holder

LABORATORIO REIG JOFRE, S.A.

Gran Capitán 10,

08970 Sant Joan Despí

Barcelona, Spain

Manufacturer

Bioglan AB

Box 50310. 202 13 Malmö

Date of the last revision of this leaflet: August 2021

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