Neo - Emedyl - dragées

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Neo Emedyl Dragees are used to prevent and treat travel sickness in adults and adolescents aged 12 years and over.

Application

What are Neo Emedyl Dragess and what are they used for?

Areas of application
Neo Emedyl Dragees are used to prevent and treat travel sickness in adults and adolescents aged 12 years and over .

Mode of action
Neo Emedyl Dragees contain the active ingredient dimenhydrinate, a proven remedy against dizziness, nausea and vomiting. It acts directly on the balance centre and vomiting centre in the brain and is therefore suitable for preventing and treating the symptoms of travel sickness (dizziness, nausea and vomiting as a result of sea, air, rail, bus and car travel).

Caffeine counteracts the sedative effect of dimenhydrinate. It has a stimulating effect on the cerebral cortex, the respiratory and circulatory centre and promotes cardiac output. 1 dragee contains about as much caffeine as ½ cup of filter coffee or 1 cup of black tea. Caffeine reduces tiredness.

How is it used?

What are Neo Emedyl Dragees and what are they used for?

Areas of application

Neo Emedyl Dragees are used to prevent and treat travel sickness in adults and adolescents aged 12 years and over.

Mode of action

Neo Emedyl Dragees contain the active ingredient dimenhydrinate, a proven remedy against dizziness, nausea and vomiting. It acts directly on the balance centre and vomiting centre in the brain and is therefore suitable for preventing and treating the symptoms of travel sickness (dizziness, nausea and vomiting as a result of sea, air, rail, bus and car travel).

Caffeine counteracts the sedative effect of dimenhydrinate. It has a stimulating effect on the cerebral cortex, the respiratory and circulatory centre and promotes cardiac output. 1 dragee contains about as much caffeine as ½ cup of filter coffee or 1 cup of black tea. Caffeine reduces tiredness.

What should you consider before taking it?

What should you consider before taking Neo Emedyl Dragees?

Neo Emedyl Dragees must not be taken,

- if you are allergic to dimenhydrinate and caffeine or any of the other ingredients listed in section 6 of this medicine.
- by children under 12 years of age.
- in the last 3 months of pregnancy.
- during breastfeeding.
- if you have an acute asthma attack.
- if you suffer from increased intraocular pressure (glaucoma).
- if you suffer from convulsive seizures, such as epilepsy.
- if you suffer from porphyria (a disorder in the formation of blood pigment).
- if you have been diagnosed with a phaeochromocytoma (tumour of the adrenal medulla).
- if you have a narrowing of the gastrointestinal tract or bladder neck.
- if you have intestinal paralysis or obstruction.
- if you are currently taking or have taken MAO inhibitors (medicines for treating depression) within the last week.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Neo Emedyl Dragees.

Special care should be taken when taking Neo Emedyl Dragees if you

- suffer from chronic respiratory problems, asthma or emphysema (overinflation of the lungs).
- have an enlarged prostate with residual urine.
- have increased intracranial pressure or circulatory disorders of the brain.
- have a potassium or magnesium deficiency.
- have heart muscle weakness.
- suffer from heart rhythm disorders or bradycardia (slow heart rate).
- have stomach or intestinal ulcers and bleeding.
- suffer from hyperthyroidism.
- have severe liver and kidney dysfunction.


It is strongly advised to avoid drinking alcohol at the same time.

Both dimenhydrinate and caffeine can trigger habituation effects. Neo Emedyl Dragees should therefore be used for as short a time as possible.

If the symptoms persist or if the expected success is not achieved by using the product, medical advice should be sought as soon as possible.

A pregnancy must be reported to the doctor before treatment with Neo Emedyl Dragees is started.

Taking Neo Emedyl Dragees 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.

The effects of the following may be mutually reinforced:

- Sedatives, hypnotics, painkillers containing morphine or morphine-like substances, and alcohol can reduce responsiveness.
- the effect of blood pressure lowering medicines may be increased.
- certain medicines for Parkinson's disease and depression (so-called tricyclic antidepressants and MAO inhibitors) can enhance and prolong the properties of Neo Emedyl Dragees. This can lead to intestinal paralysis, urinary retention or acute increase in intraocular pressure.
- the simultaneous use of disulfiram, bupropion and agents that cause muscle twitching can lead to cramps.
- Neo Emedyl Dragees must not be taken together with alcohol.

Neo Emedyl Dragees should not be taken at the same time as other medicines containing dimenhydrinate, diphenhydramine, 8-chlorotheophylline or caffeine.
You should avoid the simultaneous use of Neo Emedyl Dragees with other medicinal products that additionally prolong the contraction of the heart chamber muscles (QT interval), such as antiarrhythmics of classes Ia and III (medicines for treating heart rhythm disorders), antibiotics, antimalarials, neuroleptics (medicines for treating mental disorders) and antihistamines, as this can lead to heart rhythm disorders, dizziness and fainting or potassium deficiency.

The damaging effect of certain antibiotics (aminoglycoside antibiotics) and certain anticancer drugs (cisplatin) on the inner ear is masked.

Stop taking Neo Emedyl Dragees at least 3 days before an allergy test, as they can falsify the result.

Taking Neo Emedyl Dragees with food and drink

Neo Emedyl Dragees must not be taken together with alcohol.

Caution is advised when taking in conjunction with caffeinated foods or beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Medical advice is recommended before using Neo Emedyl Dragees in the first 6 months of pregnancy, taking into account the caffeine content of the preparation.

Neo Emedyl Dragees must not be taken in the last 3 months of pregnancy, as they can trigger labour at this stage.

Neo Emedyl Dragees must not be used during breastfeeding.

Driving and operating machinery

You must not drive a car or operate tools and machinery because this medicine can impair your responsiveness. This applies to an even greater extent in conjunction with alcohol or other agents that depress brain function.

Neo Emedyl Dragees contain sucrose (sugar)

This medicine contains sucrose. Please only take Neo Emedyl Dragees after consulting your doctor if you are aware that you suffer from sugar intolerance.

How should the medicine be taken?

How should Neo Emedyl Dragees be taken?

Always take 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 aged 12 years and over take 1 dragee 30 minutes before the start of the journey, then 1 further dragee every 4 to 6 hours.

The maximum daily dose of 6 dragees must not be exceeded.
Neo Emedyl Dragees should be taken with sufficient non-alcoholic fluid (e.g. 1 glass of water).

The duration of treatment should be as short as possible.

In case of prolonged use, the treatment must be checked by a doctor.

In elderly or weakened patients and patients with severe liver damage, the dose should be reduced and therefore carefully adjusted to the clinical picture by the doctor before taking it.

In kidney damage, the interval between taking the dragees should be extended to 6 to 12 hours (moderate damage) or 12 to 18 hours (severe kidney damage) depending on the degree of damage.

Use in children

Neo Emedyl Dragees are not suitable for children under 12 years of age.

If you have taken more Neo Emedyl Dragees than you should

please contact a doctor immediately.

Signs of overdose (poisoning) can include altered states of consciousness (such as drowsiness, hallucinations), anxiety, agitation, convulsions, tremors, dizziness, hypotension, dry mouth, skin redness, fever, dilated pupils, hearing and visual disturbances, heart rhythm disorders, rapid or slow pulse.

Note for the doctor:

Therapeutic measures:

Measures to reduce absorption: gastric emptying (flushing), gastric lavage can also be beneficial hours after overdose, treatment with activated charcoal, acceleration of intestinal passage (sodium sulphate). The therapy of dimenhydrinate intoxication is symptomatic with supportive measures such as artificial respiration, intravenous fluid administration and external cooling in case of overheating.

Convulsions can be controlled with intravenous diazepam. Do not give stimulants!

Physostigmine (0.02 to 0.06 mg/kg body weight intravenously) can be given several times as an antidote for central anticholinergic effects. Atropine is recommended in case of physostigmine overdose.

Vasopressors such as noradrenaline or phenylephrine can be used in case of hypotension, but adrenaline must not be given as it can paradoxically further lower blood pressure.

If you forget to take Neo Emedyl Dragees

Do not take double the amount to make up for a forgotten dose.

If you stop taking Neo Emedyl Dragees

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

What side effects are possible?

How should Neo Emedyl Dragees be stored?

Do not store above 30 °C.

Store in the original packaging to protect the contents from light and moisture.

Keep this medicine out of the reach of children.
Do not use this medicine after the expiry date which is stated on the container after <<use by:>>. 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. In doing so, you help to protect the environment.

Special storage instructions

How should Neo Emedyl Dragees be stored?

Do not store above 30°C.
Store in the original packaging to protect the contents from light and moisture.

Keep this medicine out of the reach of children.

Do not use the medicine after the expiry date which is stated on the container after <<use by:>>. 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. In doing so, you help to protect the environment.

Special information on the content

Contents of the pack and further information

What Neo Emedyl Dragees contain

- The active ingredients are: dimenhydrinate and caffeine.
1 coated tablet contains 50 mg dimenhydrinate and 50 mg caffeine.
- The other ingredients are: magnesium stearate, crospovidone, maltodextrin, hydroxypropylcellulose, gum arabic, sucrose, methylcellulose, talc, calcium carbonate, povidone, titanium dioxide, glycerol 85 %, silicon dioxide, yellow iron oxide (E 110), cochineal red A (E 124), montan glycol wax.

What Neo Emedyl Dragees look like and contents of the pack

Blister with 12 orange-red coated tablets

12 tablets in a folding box (1 blister in a folding box) or

36 tablets in a folding box (3 blisters in a folding box)

Not all pack sizes may be marketed.