Dermodrin ointment

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Cooling antihistamine ointment for application to the skin.

Application

What is Dermodrin Ointment and what is it used for?

Cooling antihistamine ointment for application to the skin.

Mode of action

Diphenhydramine hydrochloride, the active ingredient in Dermodrin Ointment, is an antihistamine and anti-allergic agent, an anti-itching agent and a pain reliever for allergies and skin conditions.

Dermodrin Ointment has a cooling effect as an oil-in-water emulsion.

Dermodrin Ointment is intended for external use only.

The creamy, white, completely non-irritating and odourless preparation is easy to rub in and spread on the skin.

The effect occurs shortly after application of the ointment and lasts for 2 to 6 hours.

Areas of application

Dermodrin Ointment is used to treat itching, local pain and hypersensitivity reactions of the skin in

- Allergies
- Insect bites
- Eczema, hives, itchy wound edges and skin abrasions
- Minor burns, sunburn
- Itchy skin rashes after sun exposure (sun allergy).

What should you consider before taking it?

What should you consider before using Dermodrin Ointment?

Dermodrin Ointment must not be used,

- if you are allergic to diphenhydramine hydrochloride, to other antihistamines, peanuts or soya or to any of the other ingredients of this medicine listed in section 6.
- in newborns and children under 2 years of age.
- on open wounds or on mucous membranes, on large areas of skin, such as on inflamed and injured skin, especially in patients who have chickenpox, shingles or measles or who have blisters on their skin.

Warnings and precautions

Talk to your doctor or pharmacist before using Dermodrin Ointment.

- If you expose treated skin areas to sunlight for a long period of time, this can trigger possible light hypersensitivity reactions.
- If there is no improvement or if your symptoms worsen, you must consult a doctor in any case.
- Wash your hands after use so that Dermodrin Ointment does not come into contact with your eyes.
- Diphenhydramine should be used with special caution in sleep apnoea (respiratory arrest during sleep) [or if there is a history of sudden
infant death in the family].

Dermodrin Ointment is used with special caution in elderly, weakened or acutely ill patients.

Use of Dermodrin Ointment together with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines.

No interactions with other medications have been observed to date after application of Dermodrin Ointment.

Dermodrin Ointment should not be used at the same time as other medications that contain diphenhydramine.

Interactions cannot be ruled out with certainty in the case of large-scale external use. This applies in particular to the simultaneous use of medications that contain diphenhydramine or so-called monoamine oxidase inhibitors (certain antidepressants or anti-Parkinson drugs).

Atropine and tricyclic antidepressants can enhance certain properties of diphenhydramine hydrochloride, the simultaneous use of centrally depressant drugs such as psychotropic drugs, sleeping pills, opioid painkillers, blood pressure lowering drugs and alcohol can lead to an unpredictable, mutual enhancement of the effects.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Dermodrin Ointment must not be used in the first 3 months of pregnancy. During the rest of the pregnancy, Dermodrin Ointment should only be used after careful consideration of the benefits and risks by the doctor and after determining the individual dose. Large-scale use should be avoided, especially on inflamed and injured skin.

Routine use of diphenhydramine during pregnancy is not recommended due to the lack of controlled clinical studies [this applies especially to the last 2 weeks of pregnancy].

Dermodrin Ointment must not be used during breast-feeding, as the active ingredient (diphenhydramine) passes into breast milk.

Driving and using machines

Dermodrin Ointment has no or negligible influence on the ability to drive and use machines.

Dermodrin Ointment contains

- 14.53 % peanut oil. Dermodrin Ointment must not be used if you are hypersensitive (allergic) to peanuts or soya.
- Methyl-4-hydroxybenzoate, which can cause mild irritation to the skin, eyes and mucous membranes.
- Cetyl alcohol, which can cause localised skin irritation (e.g. contact dermatitis).

How should the medicine be taken?

How to use Dermodrin Ointment?

Always use this medicine exactly as described in this leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.


The recommended dose is

Adults and adolescents from 12 to 18 years of age apply a 5 to 15 cm long strip of ointment (corresponding to 18 to 54 mg diphenhydramine) to the affected area of skin 3 to 4 times a day, depending on the size of the area to be treated. The maximum daily dose of 300 mg diphenhydramine hydrochloride, corresponding to 15 g Dermodrin Ointment, must not be exceeded. 300 mg correspond to ¾ of a
20 g tube, 1/3 of a 50 g tube and 1/6 of the 100 g tube.

In children from 6 to 11 years of age, a strip of ointment approx. 8 to 10 cm long is applied 3 to 4 times a day. The maximum daily dose of 150 mg diphenhydramine (corresponding to 41 cm of ointment strip per day) must not be exceeded.

In children from 2 to 5 years of age, a strip of ointment approx. 3 cm long is applied 2 to 3 times a day, the maximum daily dose of 37 mg diphenhydramine (corresponding to 10 cm of ointment strip per day) must not be exceeded.

The duration of treatment should be as short as possible.

Dosage recommendation for risk patients
In elderly, weakened and acutely ill patients as well as in patients with severely impaired liver function or severe impairment of kidney function, the dosage should be adjusted to the clinical picture.
If the symptoms do not improve after two weeks of continuous use, you must consult a doctor in any case.
If you have used more Dermodrin Ointment than you should

No case of overdose with Dermodrin Ointment has been reported to date.

If Dermodrin Ointment is accidentally ingested, please contact a doctor immediately.
If you forget to use Dermodrin Ointment

Do not use twice the amount if you have forgotten the previous application.

If you stop using Dermodrin Ointment

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

What side effects are possible?

How to store Dermodrin Ointment?

Keep this medicine out of the reach of children.

Store in the original package to protect the contents from light.

The shelf life after opening the container is 12 months.

Do not use this medicine after the expiry date which is stated on the tube after <>. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. You help to protect the environment.

Special storage conditions

5. How to store Demodrin Ointment?

Keep this medicine out of the reach of children.

Store in the original package to protect the contents from light.
The shelf life after opening the container is 12 months.

Do not use the medicine after the expiry date which is stated on the tube after <>. The expiry date refers to the last day of the month indicated.

Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it.You help to protect theUmwelt..

Special information on the content

Contents of the pack and further information

What Dermodrin Ointment contains

- The active ingredient is: Diphenhydramine hydrochloride
1 g of ointment contains 20 mg of diphenhydramine hydrochloride.

- The other ingredients are: Methyl-4-hydroxybenzoate (0.15 %), peanut oil, bleached wax, cetyl alcohol, Paraffinum solidum, Vaselinum album, Glycerol, Hostacerin T-3, Polysorbat 80, Isobornyl acetate, Sodium hydroxide for pH adjustment, purified water.


What Dermodrin Ointment looks like and contents of the pack

White, odourless ointment for application to the skin.

Pack sizes: Tubes of 20 g, 50 g and 100 g content in a folding box.