UNIROID-HC Ointment (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Uniroid-HC Ointment.

2. Qualitative and quantitative composition

Each gram of ointment contains hydrocortisone 5 mg and cinchocaine hydrochloride 5 mg. Excipient(s) with known effect: Each gram of ointment contains 5 mg cetostearyl alcohol. For the full list ...

3. Pharmaceutical form

Ointment. An off-white, odourless, smooth, translucent ointment.

4.1. Therapeutic indications

Uniroid-HC Ointment is indicated primarily for the treatment of external haemorrhoids for the short-term relief of pain, irritation and associated pruritus ani. Uniroid-HC Ointment can also be used for ...

4.2. Posology and method of administration

Posology Adults Treatment with Uniroid-HC Ointment should be limited to seven days. Patients should be advised to return to their doctor if the condition persists beyond this time. Directions for use and ...

4.3. Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. This product is contra-indicated in tuberculosis, anal thrush and most viral lesions of the skin including herpes ...

4.4. Special warnings and precautions for use

Since the use of occlusive dressings may increase the risk of sensitivity, such dressings should be avoided. Paediatric population Uniroid-HC Ointment is not recommended for use in children unless recommended ...

4.5. Interaction with other medicinal products and other forms of interaction

No interactions have been reported.

4.6. Pregnancy and lactation

Pregnancy There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and ...

4.7. Effects on ability to drive and use machines

Not relevant.

4.8. Undesirable effects

Recurrent or prolonged application may increase the risk of contact sensitisation particularly to cinchocaine. The possibility of systemic absorption should be borne in mind when prescribing preparations ...

4.9. Overdose

Not applicable to a product with this route of administration.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Agents for treatment of haemorrhoids and anafissures for topical use corticosteroids ATC code: C05AA01 Hydrocortisone The principle pharmacological actions of ...

5.2. Pharmacokinetic properties

Hydrocortisone Hydrocortisone is passed through the skin, particularly in denuded areas. About 90% of plasma hydrocortisone is bound to plasma proteins, mainly to globulin, less so to albumin. In the liver ...

5.3. Preclinical safety data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6.1. List of excipients

Cetostearyl alcohol White soft paraffin

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Do not store above 25°C. Store in the original package.

6.5. Nature and contents of container

Externally white enamelled and printed; internally lacquered aluminium tube with medium density polyethylene nozzle applicator and white plug seal cap. The product is available in tubes of 30g and 15g. ...

6.6. Special precautions for disposal and other handling

Not applicable.

7. Marketing authorization holder

Chemidex Pharma Limited, Chemidex House, Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB, United Kingdom

8. Marketing authorization number(s)

PL 17736/0001

9. Date of first authorization / renewal of the authorization

3 November 2000 / 25 April 2003

10. Date of revision of the text

09/09/2020

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