Emesan K child suppository, 5 pcs

Instructions for use for Emesan K child suppository, 5 pcs

Important notes (compulsory information):

Emesan ® K children's suppository. Active substance: Diphenhydramine hydrochloride. Applications: For the prevention and symptomatic treatment of nausea and vomiting of different cause, especially in travel sickness.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


Instructions for use: Information for users
Emesan ® K children's suppository
For use in toddlers from 8 kg body weight and children
Active substance: Diphenhydramine hydrochloride 20 mg

Read the entire leaflet carefully because it contains important information for you. This medicine is available without prescription. To achieve the best possible treatment success, Emesan ® K children's suppository, however, be used in accordance with properly.
- Lift the package leaflet. You might want to read it again.
- Ask your pharmacist if you need more information or advice.
- If your symptoms aggravate or no improvement occurs, you must definitely visit a doctor.
- If one of the side effects listed you significantly affect or notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This leaflet contains:
1. What are Emesan ® K child suppository and what are they used for?
2. What do you need before using Emesan ® K Nursery Note?
3. How are Emesan ® K child suppository to apply?
4. Which side effects are possible?
5. How are Emesan ® K Kind child suppository?
6. Further information

1. What are Emesan ® K child suppository and what are they used for?

Emesan ® K children's suppository is a remedy against nausea and vomiting from the group of H1 antihistamines. Emesan ® K children's suppository are used for the prevention and symptomatic treatment of nausea and vomiting of different cause, especially in travel sickness.

2. What do you need before using Emesan ® K Nursery Note?

Emesan ® K children's suppository must not be used:
- if you are overly (allergic) to diphenhydramine hydrochloride, soy, peanut or any other ingredients of Emesan ® K children's suppository are,
- at acute asthma,
- with green star (narrow angle glaucoma),
- For certain tumors of the adrenal leaflet (Pheochromocytom),
- when enlarged the protruding gland with residual harvesting,
- in epilepsy,
- in potassium or magnesium deficiency,
- with slow heartbeat (bradycardia),
- in certain heart diseases (innate QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary vessels, excitement piping disorders, arrhythmias),
- With simultaneous use of medicines, which also extend the so-called QT interval in ECG or lead to hypocalemia (see: when using Emesan ® K children's suppository with other medicines),
- while taking alcohol or so-called Mao inhibitors (means for the treatment of depression) as well
- During pregnancy and lactation. Toddlers with a body weight under 8 kg should not with Emesan ® K child suppository are treated.

Take special care with the application of Emesan ® K children's suppository is required,
If you suffer from one of the following diseases:
- restricted liver function
- Restricted renal function
- Chronic lung diseases or asthma
- Specific gastric functional disorders (pylorus stenosis or achalasia of the cardia)
Before starting treatment with diphenhydramine hydrochloride, specifically, specific causes of the present disease should be clarified.

Toddler:
In particular in small children, so-called paradoxic reactions (restlessness, excitation, anxiety) can occur in the treatment with diphenhydramine. Therefore, this age group iscaution required and reserved to dose. Also weakened children and children with limited liver or renal function should receive reduced doses.

Tolerance development:
After repeated application of Emesan ® K children's suppository over a longer period of time can cause a loss of effectiveness (Tolerance) come.

Dependence:
The use of the active ingredient diphenhydramine hydrochloride (included in Emesan ® K child suppository) can lead to the development of physical and mental dependence. The risk of dependency increases with the dose and duration of treatment. In patients with alcohol, drug or drug dependence in the history, this risk is increased.

When using Emesan ® K children's suppository with other medicines:
Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is not prescription-influencing medicines. Diphenhydramine hydrochloride must not be together with so-called "Mao-Inhibitors" (certain means for the treatment of depression) are given. The simultaneous administration of Emesan ® K children's suppository with other drugs, which also contain diphenhydramine, including those that are applied externally, is to be avoided. Simultaneous application with other centrally attenuating medicines such as sleep, calming, pain or anesthesis, anxiety-solvents (anxiolytic acid), medicaments for the treatment of depression or agents for the treatment of seizure disks (antiepileptica) can lead to mutual reinforcement. The so-called anticholinergic effect of diphenhydramine can be reinforced by drugs with similar effects such as atropine, beridal, tricyclic antidepressants (certain means against depression) or monoamine oxidase inhibitors. There may be an increase in intraocular pressure, urinary content or a u.. life-threatening intestinal paralysis. The use of diphenhydramine together with blood-pressure drugs can lead to increased fatigue. Simultaneous application with medicaments, which also extend the so-called QT interval in the ECG, e.g. Medium against cardiac arrhythmias (Antiarrhythmics class IA or III), certain antibiotics (e.g., Erythromycin), cisaprid, malaria agents, agents against allergies or gastrointestinal ulcers (antihistamines), means for the treatment of specific spirit-sensitive diseases (neuroleptics), or lead to a potassium deficiency (eg, certain urinary media) is too avoid. Diphenhydramine may be able to falsify the test results for allergy tests and should therefore no longer be used at least 3 days before.

When using Emesan ® K children's suppository together with food and beverages:
During treatment with Emesan ® K children's suppository must not be administered alcohol, as this changes and enhances the effect of diphenhydramine in a unpredictable manner.

Pregnancy and breast feeding period:
Ask your doctor or pharmacist for advice before applying all medicines. The active ingredient diphenhydramine hydrochloride (Include in Emesan ® K children's suppository) may not be used during pregnancy and lactation.

Driveion and use of machines:
The active ingredient diphenhydramine hydrochloride (included in Emesan kinderan ® K child suppository) can also change the response assets as far as intended use that the ability to actively participate in road traffic or to operate machines is impaired. Therefore, no vehicles may be led or dangerous machines are served. Also on the following day, residual fatigue and impaired reactivity or Decreased concentration is still disadvantageous on the ability to drive or the ability to work with machines, especially after inadequate sleeping duration or in cooperation with alcohol.

Important information about certain other ingredients of Emesan ® K children's suppository:
The medicine contains u. A. Soyl oil. Do not apply this medicine to your child if it reacts allergic to peanuts or soy. Macrogolglycerolricinoleat (Ph.eur.) Can cause mucosal irritation.

3. How are Emesan ® K child suppository to apply?

Use Emesan ® K children's suppository always accurately after the instruction in this information information. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by the doctor, the following dosing instructions apply:
> Toddlers with 8 to 10 kg:
Single dose: 1 rectal capsule (corresponding to 20 mg diphenhydramine hydrochloride)
Maximum daily dose: 1 rectal capsules (corresponding to 20 mg diphenhydramine hydrochloride)

> Toddlers with 10 to 20 kg:
Single dose: 1 rectal capsule (corresponding to 20 mg diphenhydramine hydrochloride)
Maximum daily dose: 2 rectal capsule (corresponding to 40 mg diphenhydramine hydrochloride)

> Children with 20 to 39 kg:
Single dose: 1 rectal capsule (corresponding to 20 mg diphenhydramine hydrochloride)
Maximum daily dose: 3 rectal capsule (corresponding to 60 mg diphenhydramine hydrochloride)

Special patient groups:
Shredded children and children with limited liver or renal function should be lower than lower doses than given above (see: Take special care with the application of Emesan ® K child suppository is required).
For the prevention of nausea and vomiting, a rectal capsule per day should first be applied. When an acute symptoms occur, the dose can be used to a maximum of 2 rectalapsules per day (children up to 5 years) or up to a maximum of 3 rectalapsules per day (children from 6 Years), whereby a time interval of at least 4 - 6 Hours should be adhered between the individual doses.

Type of application:
The rectal capsules must be introduced into the endtharm with the thick end (possibly after light moistening with a little water). As a result, the rectal capsules glide more easily into the intestine and an undesirable sliding out can be prevented. Between the administration of two rectal capsules should be at least a time distance of 4 - 6 hours. For the prevention of the travel sickness, the application should take place at least 30 minutes before departure.

Duration of application:
The duration of treatment with Emesan ® K child suppository should be as short as possible. In case of persistence of the complaints, please contact a doctor immediately. Please talk to your doctor or pharmacist if you have the impression that the effect of Emesan ® K children's suppository is too strong or too weak.

If you have a larger quantity Emesan ® K child suppository applied as they should:
Overdoses with diphenhydramine can be dangerous - Especially for children and toddlers. For this reason, a doctor is to be informed if there is a suspicion of overdose or poisoning (eg poisoning note call)!
Overdoses with diphenhydramine express themselves primarily dependent on the incident amount:
- By disruptions of the central nervous system (confusion, excitation states up to convulsive accidents, awareness up to the coma, breathing disturbances up to respiratory arrest) and the cardiovascular system up to the cardiac arrest. Especially in children, the exciting ZnS effects can be in the foreground. In addition, increased muscle Refl exe, fever, dry mucous membranes, visual disturbances, clogging and disorders of urinary excretion occur. Rhabdomyolysen (severe muscle damage) have also been observed. If you have further questions about the application of the medicine, ask your doctor or pharmacist.

4. Which side effects are possible?

How all medicines can Emesan ® K children's suppository
Have side effects, but not with everyone
have to.

The assessment of side effects is based on the following frequency information:
Very common: More than 1 treated from 10
Frequently: 1 to 10 treated from 100
Occasionally: 1 to 10 treated from 1,000
Rarely: 1 to 10 treated from 10,000
Very rare: less than 1 treated from 10,000
Unknown: Frequency on the basis of the available data is not estimable

Possible side effects:
The following side effects are to be expected at the beginning of the treatment:
The most commonly reported side effects are drowsiness, drowsiness and concentration disorders, AuJH during the following day, especially after inadequate sleeping duration, as well as dizziness and muscle weakness. More commonly occurring side effects are headaches, gastrointestinal complaints such as nausea, vomiting or diarrhea and so-called anticholinergic effects such as mouth dryness, constipation, heartburn, vision disorders or drainage of urination. During treatment with Emesan ® K child suppository can occur certain cardiac arrhythmias (extension of the QT interval in ECG). In addition, over-appropriation reactions, increased lighting sensation of the skin, changes of the blood image, increase in intraocular pressure, jaundice (cholestatic ectic) and so-called paradoxic reactions such as restlessness, nervousness, excitement, anxiety, trembling, or sleep disorders have been reported. In the non-intensive, long-term administration of the active ingredient diphenhydramine hydrochloride (included in Emesan ® K child suppository), the development of a drug dependence can not be ruled out. At the latest after two-week application, for this reason, the need for further treatment should be reviewed critically. Soyl oil can rarely cause allergic reactions. Please inform your doctor or pharmacist if one of the listed side effects will significantly affect it or notice side effects that are not specified in this document formation.

5. How are Emesan ® K Kind child suppository?

Store drug out of reach of children. You must not use the medicinal product after the expiration date specified on the folding box and on the blister. The expiration date refers to the last day of the month.

Storage conditions:
Do not store more than 25 ° C.
The medicine must not be disposed of in the wastewater. Ask your pharmacist how to dispose of the medicine if you no longer need it. This measure helps protect the environment.

6. Further information

What Emesan ® K child suppository included:
The active ingredient is: diphenhydramine hydrochloride
1 rectal capsule contains 20 mg diphenhydramine hydrochloride.

The other ingredients are:
Refined rapeseed oil, gelatin, partially hydrogenated soybean oil, glycerol 85%, hydrogenated soybean oil (pH. EUR.), Yellow Wax, Soylecithin 54-63% sojaphosphatide containing macrogol glycerolricinoleat (pH. EUR.), Macrogol 20000, glycerol monoolees, macrogol 1500, talc, poly (vinyl acetate), dyes titanium dioxide (E 171), iron (iii) Hydroxide oxide H2O (E 172).

Like Emesan ® K child suppository look and content of the pack:
Emesan ® K children's suppository are yellowish. Emesan ® K children's suppository are in original packs of 5 rectalapsules (N1) and 10 Rectalapsules (N2) available.

Pharmaceutical entrepreneur and manufacturer:
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Tel.: + 49 30 71094-4200
Fax: + 49 30 71094-4250

This information information was last revised in February 2011.

Source: Information of the leaflet
Status: 01/2014