Cohortan 5 mg/g + 5 mg/g rectal ointment
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Cohortan 5 mg/g + 5 mg/g rectal ointment
Hydrocortisone, Cinchocaine hydrochloride
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Follow exactly the instructions for administration of the medicine provided in this leaflet or as directed 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.
Leaflet contents:
- What Cohortan is and what it is used for
- What you need to know before using Cohortan
- How to use Cohortan
- Possible adverse effects
- How to store Cohortan
- Contents of the pack and other information
1. What Cohortan is and what it is used for
This medicine belongs to a group of medicines known as "topical anorectal corticosteroid preparations".
The activity of this medicine is due to its two active ingredients: hydrocortisone (anti-inflammatory) and cinchocaine hydrochloride (local anaesthetic).
It is indicated for the local relief of pain, itching, burning, and inflammation associated with haemorrhoids in adults.
2. What you need to know before using Cohortan
- Do not use this medicine if you are allergic to hydrocortisone and/or cinchocaine or to any of the other ingredients of this medicine (listed in section 6).
- If you have haemorrhoidal bleeding.
- If you have uncontrolled bacterial, viral, or fungal infections.
- If you have tuberculosis.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use this medicine.
- Contact your doctor if you experience blurred vision or other visual disturbances.
The following precautions must be observed:
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Continued use of this medicine should not exceed 7 days.
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Avoid contact with the eyes, mouth, open wounds, and mucous membranes (e.g., the genital area). In case of accidental application to these areas, rinse thoroughly with plenty of water.
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If irritation occurs at the application site, treatment with this medicine should be discontinued and, if necessary, appropriate treatment initiated.
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If an associated infection is present, specific additional treatment should be added.
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Although this medicine is applied locally, absorption of the product may occur. With prolonged treatment, possible systemic adverse effects of the active ingredient should be monitored.
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Corticosteroids such as hydrocortisone have significant effects on the body. To limit systemic absorption into the bloodstream and reduce the risk of adverse effects, treatment over large areas, for long periods, or under occlusive dressings (using air- and water-impermeable materials such as bandages, dressings, or non-breathable diapers) should be avoided. Otherwise, adverse effects such as increased blood pressure, diabetes, Cushing's syndrome (a disease caused by elevated cortisol hormone levels), as well as skin striae and atrophy, may occur.
Children and adolescents
This medicine is not indicated for use in children and adolescents.
Other medicines and Cohortan
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No interactions have been reported so far under the approved conditions of use described in this leaflet. However, this medicine should not be used simultaneously with other medicines intended for application on the same anorectal area, unless directed by your doctor or pharmacist.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
The safety of this medicine during pregnancy has not been established. Therefore, if your doctor prescribes this medicine during pregnancy, you should not use it over large areas of the body, for prolonged periods, 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 they must be used during breastfeeding.
Driving and using machines:
No effects on the ability to drive or operate machinery have been reported.
Cohortan contains castor oil
This medicine may cause skin reactions because it contains castor oil.
Use in athletes
This medicine contains hydrocortisone, which may result in a positive doping test.
3. How to use Cohortan
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose
It is recommended to apply a small amount of ointment equivalent to two centimeters to the anal and/or rectal area two or three times a day.
Method of administration
- It is advisable to apply the ointment in the morning and at night, preferably after bowel movement and personal hygiene.
- Before application, clean the area with lukewarm water and soap, and apply the ointment using a clean gauze, or, in case of internal haemorrhoids, using the provided cannula. Remove the cap and pierce the tube. Screw on the cannula. Insert the cannula into the rectum, pressing the tube to deposit an amount of ointment equivalent to approximately 1 or 2 centimeters. Slowly withdraw the cannula as its contents are being emptied. It is also recommended to apply a small amount externally around the anal opening and the folds at the margins of the anus.
- Wash your hands thoroughly before and immediately after each application.
Consult a doctor if symptoms worsen or do not improve after 7 days, or if bleeding occurs.
If you use more Cohortan than you should:
If you have used more medicine than recommended, or if the product has been accidentally ingested, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount used.
If you forget to use Cohortan
Apply the medicine as soon as possible.
Do not use a double dose to make up for missed doses.
If you stop using Cohortan
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 cause adverse effects, although not everyone experiences them.
Blurred vision may occur, but the frequency is unknown. In isolated cases, local adverse reactions may appear, mainly due to hypersensitivity to the preparation, particularly with prolonged treatment. Systemic (non-local) adverse effects are rare at the recommended doses. If sensitivity or irritation develops at the treated site, treatment should be discontinued.
Corticosteroids, if used excessively or for a prolonged period, may cause adverse reactions such as sodium and water retention with edema, mobilization of calcium and phosphates, increased blood glucose levels, delayed wound healing, and increased susceptibility to infections. Adrenal suppression may occur, which may persist over time if treatment has been prolonged. In such cases, treatment discontinuation should be gradual.
However, given the recommended duration of treatment with this medicine (7 days), such adverse effects are not expected.
If you notice any other reactions not described in this leaflet, consult 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 Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 tightly closed. Do not store above 30°C.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Cohortan
- The active substances are hydrocortisone and cinchocaine hydrochloride. Each gram of ointment contains 5 mg of hydrocortisone and 5 mg of cinchocaine hydrochloride.
- The other components are: castor oil, ?-tocoferol, liquid paraffin and solid paraffin.
Nature and contents of the container
White, soft, homogeneous rectal ointment with a vaseline-like appearance and a faint odour.
This medicine is packaged in a 30 g aluminium tube, internally lacquered, closed with a cap and supplied with a plastic cannula.
Marketing Authorisation 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 most recent 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/