Dermodrin - Ointment

Cooling antihistamine ointment for application to the skin.

Application

1. What is Dermodrin ointment and what is it used for?

Cooling antihistamine ointment for use on the skin.

Mode of action
Diphenhydramine hydrochloride, the active ingredient in Dermodrin, is an antihistamine and anti-allergic, an anti-itch and 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 applying the ointment and lasts for 2-6 hours.

Application areas:
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).

MONTAVIT GesmbH

How is it applied?

What is Dermodrin ointment and what is it used for?

Cooling antihistamine ointment for use on the skin.

Mode of action
Diphenhydramine hydrochloride, the active ingredient in Dermodrin, is an antihistamine and anti-allergic, an anti-itch and pain relief agent for allergies and skin conditions.
Dermodrin ointment has a cooling effect as an oil-in-water emulsion.
Dermodrin ointment is 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 is felt shortly after applying the ointment and lasts for 2-6 hours.

Application areas:
Dermodrin ointment is used for the treatment of 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).

MONTAVIT GesmbH

What should you pay attention to before taking it?

What should you be aware of before using Demodrin Ointment?

Dermodrin Ointment must not be used
- if you are allergic to diphenhydramine hydrochloride, to other antihistamines, to peanut or soya or to any of the other ingredients of this medicine listed in section 6. other ingredients mentioned in section 6 of this medicine,
- in newborn babies and children under 2 years of age
- on open wounds or on mucous membranes, on large areas of skin, such as inflamed and injured skin, especially in patients suffering from chickenpox, shingles or measles, or if the skin is blistered.

Warnings and precautions
Please talk to your doctor or pharmacist before using Dermodrin Ointment.
- If you expose treated skin areas to sunlight for a long time, this may cause possible photosensitivity reactions.
- If there is no improvement or your symptoms worsen, you must consult a doctor in any case.
- Wash your hands after application so that Dermodrin ointment does not come into contact with the eyes.
- Diphenhydramine should be used with special caution in sleep apnoea (cessation of breathing during sleep) [or if there is a known family history of sudden infant death syndrome].

In elderly, debilitated or acutely ill patients, Dermodrin ointment is used with special caution.

Use Dermodrin Ointment with other medicines
Inform your doctor or pharmacist if you are using, have recently used or might use any other medicines.
No interactions with other medicines have been observed after the use of Dermodrin ointment.

Dermodrin ointment should not be used at the same time as other medicines containing diphenhydramine.

If applied topically over a large area, interactions cannot be ruled out with certainty. This applies in particular to the simultaneous use of medicines containing diphenhydramine or so-called monoaminooxidase inhibitors (certain antidepressants or medicines against Parkinson's disease).
Atropine and tricyclic antidepressants may potentiate certain properties of diphenhydramine hydrochloride, the concomitant use of centrally depressant medicines such as psychotropic drugs, sleeping pills, opioid painkillers, antihypertensive drugs and alcohol may lead to an unpredictable, mutual potentiation of effects.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

MONTAVIT GesmbH
Dermodrin Ointment must not be used during the first 3 months of pregnancy. In the rest of pregnancy, Dermodrin should only be used after a careful risk/benefit assessment by the doctor and after determining the individual dose. Extensive use should be avoided, especially on inflamed and injured skin.
The routine use of diphenhydramine of 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 substance (diphenhydramine) passes into breast milk.

Driving and operating machinery
Dermodrin Ointment has no or negligible effect on the ability to drive and operate machinery.

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

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How should the medicine be taken?

How to use Demodrin Ointment?

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

The recommended dose is
Adults and adolescents aged 12-18 years apply a 5-15 cm strand of ointment (corresponding to 18-54 mg diphenhydramine) to the affected skin area 3 - 4 times a day, depending on the size of the area to be treated.
The daily dose of 300 mg diphenhydramine hydrochloride, corresponding to 15 g Dermodrin ointment, must not be exceeded. 300 mg is equivalent to 3/4 of a 20g tube, 1/3 of a 50g tube and 1/6 of a 100g tube.

For children 6 - 11 years, apply a strand of ointment about 8-10 cm long 3 - 4 times daily. The maximum daily dose of 150 mg diphenhydramine (equivalent to 41 cm ointment strand/day) must not be exceeded.

In children aged 2 - 5 years, an ointment strand approximately 3 cm long is applied 2 - 3 times daily. The maximum daily dose of 37 mg diphenhydramine (equivalent to 10 cm of ointment/day) must not be exceeded.

The duration of treatment should be as short as possible.

Dose recommendations for patients at risk
In elderly, debilitated and acutely ill patients as well as in severely impaired liver function or severe renal dysfunction, the dosage should be adjusted to the clinical picture.

If the symptoms do not improve after two weeks of uninterrupted use, you must consult a doctor in any case.

If you have used a larger quantity of Dermodrin ointment than you should

MONTAVIT GesmbH
No case of overdose with Dermodrin ointment has been reported so far.
If you take Dermodrin ointment by mistake, contact a doctor immediately.
If you forget to use Dermodrin ointment
Do not use twice the amount if you have forgotten to use it before.

If you stop using Dermodrin Ointment
If you have any further questions on the use of this medicine, ask your doctor or pharmacist

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What are the possible side effects?

How to store Demodrin Ointment?

Keep this medicine out of the reach of children.

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

You must not use the medicine after the expiry date which is stated on the tube after <<usable until:>>. The expiry date refers to the last day of the month indicated.

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

Special instructions for storage

5 How to store Demodrin ointment?

Keep this medicine out of the reach of children.

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

You must 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 waste water or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it.

You are helping to protect the environment.

Special notes on the content

Contents of the pack and other information
What Dermodrin ointment contains
- The active substance is: Diphenhydramine hydrochloride
- 1 g ointment contains 20 mg diphenhydramine hydrochloride.
- The other ingredients are: Methyl 4-hydroxybenzoate (0.15 % g/g), Peanut oil, bleached wax, cetyl alcohol, paraffinum solidum, vaselinum album, glycerol, hostacerin T-3, polysorbate 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 contents in a folding carton.

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