Lotriderm

Patient Information Leaflet

Lotriderm, (0.64 mg + 10 mg)/g, cream
Betamethasone dipropionate + Clotrimazole
Please read all of this leaflet carefully before using this medicine, as it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Lotriderm is and what it is used for
2. Important information before using Lotriderm
3. How to use Lotriderm
4. Possible side effects
5. How to store Lotriderm
6. Contents of the pack and other information

1. What Lotriderm is and what it is used for

Lotriderm is a topical cream for application to the skin. The medicine contains the active substances
betamethasone dipropionate and clotrimazole.
Betamethasone dipropionate belongs to the group of potent corticosteroids. When applied topically, it exerts anti-inflammatory, antipruritic (anti-itch), and vasoconstrictive effects.
Clotrimazole belongs to the imidazole group of antifungal agents with local antifungal activity.
Indications
Lotriderm cream is indicated for the treatment of tinea cruris (jock itch), tinea pedis (athlete's foot), tinea of glabrous skin, and candidiasis caused by Candida albicans, when associated with inflammatory or coexisting allergic skin changes, and when caused by the fungi Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis.

2. Important information before using Lotriderm

When not to use Lotriderm:

• if the patient is allergic to betamethasone dipropionate, clotrimazole, or to other corticosteroids, imidazole derivatives, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Lotriderm, discuss this with your doctor or pharmacist.
Lotriderm must not be used under occlusive dressings (airtight coverings) or diapers.
If allergic reactions or irritation occur during treatment, discontinue use of Lotriderm and contact your doctor.
In case of bacterial infection, the doctor will initiate appropriate antibacterial treatment.
Like other corticosteroids, betamethasone dipropionate may be absorbed through the skin. Therefore, systemic adverse effects characteristic of corticosteroids may occur during treatment with Lotriderm, including suppression of adrenal cortex function, Cushing's syndrome, increased blood glucose levels, and presence of glucose in urine.
Systemic absorption of corticosteroids following topical application increases with prolonged treatment duration or application over large body surface areas.
Avoid using Lotriderm over large skin areas, on damaged skin, in high doses, or for prolonged periods.
Due to the presence of a potent corticosteroid (betamethasone dipropionate), patients receiving treatment over large body surface areas should be monitored periodically to exclude adrenal suppression. If symptoms of adrenal suppression occur, the doctor will decide whether to discontinue treatment with Lotriderm, reduce the dose, or switch to a corticosteroid with weaker activity.
Lotriderm must not be used in ophthalmology.
If the patient experiences blurred vision or other visual disturbances, contact a doctor.

Children and adolescents
Children may be more sensitive to suppression of the hypothalamic-pituitary-adrenal (HPA) axis following topical corticosteroid use, due to greater systemic absorption resulting from a higher skin surface area to body weight ratio compared to adults.
In children treated with topical corticosteroids, suppression of the HPA axis, Cushing's syndrome, growth retardation, slowed weight gain, and increased intracranial pressure have been reported.
Symptoms of adrenal insufficiency include low plasma cortisol concentration and lack of response to ACTH stimulation. Symptoms of increased intracranial pressure include bulging fontanelle, headache, and bilateral optic disc swelling.

Lotriderm and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines planned for future use.
No interactions with other medicines are known.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
This medicine may be used during pregnancy only if, in the opinion of the doctor, the benefit to the mother outweighs the risk to the mother, fetus, or newborn. The medicine should not be used in large amounts or for prolonged periods during pregnancy.
Breastfeeding
The doctor will decide whether to discontinue breastfeeding or the use of the medicine, taking into account the importance of the medicine for the mother.
If using the medicine during breastfeeding, care must be taken to prevent the medicine from coming into contact with the breast skin, as accidental ingestion by the infant and/or accidental contact with the infant's skin should be avoided.

Driving and operating machinery
There is no data available on the effect of Lotriderm on the ability to drive or operate machinery.

Lotriderm cream contains cetostearyl alcohol, propylene glycol, and benzyl alcohol.
Due to the presence of cetostearyl alcohol, the medicine may cause local skin reactions (e.g. contact dermatitis).
This medicine contains 100 mg of propylene glycol in each gram of cream. Propylene glycol may cause skin irritation. Because of propylene glycol content, the medicine should not be applied to open wounds or large areas of injured or damaged skin (e.g. burned skin) without consulting a doctor or pharmacist.
This medicine contains 10 mg of benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions or mild local irritation.

3. How to use Lotriderm

This medicine should always be used as directed by a physician. In case of doubt, consult a
physician or pharmacist.
Adults and children over 12 years of age
A thin layer of Lotriderm should be applied to the affected skin areas and the surrounding
skin usually twice daily: in the morning and evening.
Duration of treatment:

• 2 weeks for tinea cruris, tinea of the groin and glabrous skin, and candidiasis,
• 4 weeks for tinea pedis (athlete's foot).

Improvement, manifested by reduction of redness and itching, usually occurs within the first 3 to 5 days
of treatment.
If improvement does not occur within one week of treatment for tinea cruris, tinea of the groin and glabrous skin, and candidiasis, or within two weeks for tinea pedis, consult a physician, as diagnosis verification may be necessary.
If symptoms persist after two weeks of treatment for tinea cruris, tinea of the groin and glabrous skin, and candidiasis, or after four weeks for tinea pedis, contact a physician. The physician will decide whether to discontinue use of Lotriderm and initiate alternative treatment.
Use of Lotriderm for longer than 4 weeks is not recommended.
Use in children and adolescents
Lotriderm is not recommended for use in children under 12 years of age.
Use of a higher than recommended dose of Lotriderm
In case of application of a higher than recommended dose, consult a physician or pharmacist immediately.
Extensive, prolonged topical use of corticosteroids may lead to suppression of the hypothalamic-pituitary-adrenal (HPA) axis and systemic adverse effects typical of corticosteroids (see section 2).
If symptoms of adrenal suppression occur, the physician will decide whether to discontinue treatment with Lotriderm, reduce the dose, or switch to a corticosteroid with weaker activity.
Missed dose of Lotriderm
Do not apply a double dose to make up for a missed dose.
If you have any further questions regarding the use of this medicine, consult a physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
After application of the medicine, the following occur rarely (in less than 1 in 1,000 patients):
sensory disturbances, burning sensation, maculopapular rash, swelling, urticaria, and secondary infections.
After application of the medicine, due to the presence of clotrimazole, the following may occur: erythema, burning sensation,
blistering, swelling, itching, urticaria, and general skin irritation.
After application of the medicine, due to the presence of betamethasone dipropionate, the following may occur: burning sensation,
itching, irritation, dry skin, folliculitis, hypertrichosis, steroid acne, skin depigmentation, perioral dermatitis, allergic contact
dermatitis, skin maceration, secondary infections, skin atrophy, striae, miliaria, capillary fragility (petechiae), and sensitization.
Blurred vision has been observed during corticosteroid use (frequency unknown - cannot be estimated from available data).
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl .
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Lotriderm

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging.
Do not use this medicine after the expiry date stated on the carton and aluminium tube after:
"EXP". The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Lotriderm contains

• The active substances are betamethasone dipropionate and clotrimazole. Each gram of cream contains 0.64 mg of betamethasone dipropionate and 10 mg of clotrimazole.
• Other ingredients are: liquid paraffin, white soft paraffin, cetostearyl alcohol, propylene glycol, cetomacrogol 1000, benzyl alcohol, disodium dihydrogen phosphate dihydrate, concentrated phosphoric acid, sodium hydroxide (for pH adjustment), diluted phosphoric acid (for pH adjustment), purified water.

What Lotriderm looks like and contents of the pack
Lotriderm is a cream.
Pack:
An aluminium tube with a polyethylene cap containing 15 g of cream, placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Organon Polska Sp. z o.o.
ul. Marszałkowska 126/134
00-008 Warsaw
Tel.: +48 22 306 57 64
[email protected]
Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium