VOMEX A children's suppositories 40 mg 10 pc dimenhydrinate, motion sickness

Klinge Pharma GmbH

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VOMEX A children's suppositories 40 mg motion sickness, dimenhydrinate

Active ingredient
dimenhydrinate

VOMEX A children's suppositories, dimenhydrinate, motion sickness Areas of application
For the prevention and treatment of nausea and vomiting of various origins, especially in the case of motion sickness.
For use on toddlers and children.

For nausea and vomiting, from a body weight of 8 kg.

active ingredients

  • 40 mg dimenhydrinate

excipients

  • hard fat

indication

  • Means against nausea and vomiting from the group of H 1 antihistamines.
  • It is used to prevent and treat nausea and vomiting of various origins, especially in motion sickness.
  • Notice:
    • Dimenhydrinate is not suitable for the sole treatment of nausea and vomiting following drug-based cancer treatment (cytostatic therapy).
    • If you do not feel better or if you feel worse after 14 days, contact your doctor.

dosage

  • Always use this medicine exactly as described or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
  • The dosage of dimenhydrinate should be based on the patient's body weight. In the case of small and light adolescents, a single dose of the lowest dosage in the relevant weight and age class can be sufficient to alleviate the symptoms.
  • Unless otherwise prescribed by the doctor, daily doses of 5 milligrams per kilogram of body weight should not be exceeded.
  • The recommended dosage should not be increased on one's own initiative, especially in children.
  • The recommended dose is:
    • Infants from 8 to 15 kg
      • One suppository once a day (equivalent to 40 mg dimenhydrinate).
    • Overdosing with dimenhydrinate, the active substance of the drug, can be life-threatening, especially in children under the age of three, and must therefore be avoided at all costs in this age group.
    • Children from 15 to 25 kg
      • One suppository twice a day (equivalent to 80 mg dimenhydrinate).
    • Children over 25kg
      • If necessary, you can receive a suppository (equivalent to 80 - 120 mg dimenhydrinate) 2 - 3 times a day.
    • In addition, the following upper limit should be observed:
      • Children from 6 to 14 years receive a maximum of 150 mg of dimenhydrinate per day.
    • Higher dosage forms are available for adults.

 

  • Duration of use:
    • Unless otherwise prescribed by the doctor, the suppositories are only intended for short-term use. If symptoms persist, a doctor should therefore be consulted. After 2 weeks of treatment at the latest, your doctor should check whether further treatment is necessary.
    • Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

 

  • If you use more than you should:
    • Poisoning with dimenhydrinate, the active ingredient in the suppositories, can be life-threatening. Children are particularly at risk.
    • In the event of an overdose or poisoning, a doctor (e.g. poison emergency call center) must be consulted immediately.
    • Overdose is primarily characterized by a clouding of consciousness, which can range from severe drowsiness to unconsciousness. In addition, the following signs are observed: dilation of the pupils, visual disturbances, accelerated cardiac activity, fever, hot, reddened skin and dry mucous membranes, constipation, states of excitement, increased reflexes and delusions. In addition, cramps and respiratory disorders are possible, which can lead to respiratory paralysis and cardiovascular arrest after high doses.
    • The doctor assesses the severity of the poisoning and determines the necessary measures.

 

  • If you forgot the application
    • Do not apply a double dose to make up for a forgotten application, but continue to use as directed or as directed by your doctor.

 

  • If you cancel the application
    • Please do not interrupt or stop use without first discussing this with your doctor.

 

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

way

  • The suppositories should be inserted deep into the rectum (rectal use).
  • To prevent travel sickness, the first dose is given about ½ - 1 hour before the start of the journey.
  • For the treatment of nausea and vomiting, the doses are distributed at regular intervals throughout the day.

side effects

  • Like all medicines, this medicine can cause side effects, although not everybody gets them.
  • When assessing side effects, the following frequency information is usually used as a basis:
    • Very common: may affect more than 1 in 10 people
    • Common: may affect up to 1 in 10 people
    • Uncommon: may affect up to 1 in 100 people
    • Rare: may affect up to 1 in 1,000 people
    • Very rare: may affect up to 1 in 10,000 people
    • Not known: frequency cannot be estimated from the available data
  • possible side effects
    • Depending on the individual sensitivity and the dose used, the following side effects occur very often - especially at the beginning of treatment: drowsiness, drowsiness, dizziness and muscle weakness. These side effects can also lead to impairments the following day.
    • So-called "anticholinergic" side effects such as dry mouth, increased heart rate (tachycardia), a blocked nose, blurred vision, increased intraocular pressure and urinary disorders can often occur.
    • Gastrointestinal symptoms (e.g. nausea, stomach pain, vomiting, constipation or diarrhea) and mood swings have also been observed. There is also the possibility, especially in children, of the occurrence of so-called "paradoxical reactions" such as restlessness, excitement, insomnia, anxiety or tremors.
    • In addition, allergic skin reactions and photosensitivity of the skin (avoid direct sunlight!) and liver dysfunction (cholestatic jaundice) have been reported.
    • Blood cell damage can occur in exceptional cases.
  • Other possible side effects:
    • With prolonged treatment with dimenhydrinate, the development of drug dependence cannot be ruled out. For this reason, the drug should only be used for a short time if possible.
    • After long-term daily use, sudden cessation of treatment may temporarily cause sleep disturbances. Therefore, in these cases, treatment should be stopped by gradually reducing the dose.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

interactions

  • Use together with other medicines
    • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
    • Simultaneous use with other centrally depressant drugs (drugs that affect the psyche, sleeping pills, sedatives, painkillers and anesthetics) can lead to a mutual intensification of the effects.
    • The "anticholinergic" effect of the drug can be increased in an unforeseeable manner by the simultaneous administration of other substances with anticholinergic effects (e.g. atropine, biperiden or certain antidepressants [tricyclic antidepressants]).
    • If taken at the same time as so-called monoamine oxidase inhibitors (medicines that are also used to treat depression), life-threatening intestinal paralysis, urinary retention or an increase in intraocular pressure may develop. It can also lead to a drop in blood pressure and an increased functional impairment of the central nervous system and breathing. Therefore, the medicinal product must not be used simultaneously with monoamine oxidase inhibitors.
    • Simultaneous use with drugs that
      • also lengthen the so-called QT interval in the ECG, e.g. B. Drugs for cardiac arrhythmias (class IA or III antiarrhythmics), certain antibiotics (e.g. erythromycin), cisapride, antimalarials, drugs for allergies or stomach / intestinal ulcers (antihistamines) or drugs for the treatment of specific mental disorders (neuroleptics), or
      • can lead to potassium deficiency (e.g. certain diuretics)
    • is to be avoided.
    • Use with medicines to treat high blood pressure can lead to increased tiredness.
    • The doctor should be informed about the application before performing allergy tests, as false negative test results are possible.
    • It should also be noted that the drug may cover up hearing damage that may occur during treatment with certain antibiotics (aminoglycosides).
    • Please note that this information may also apply to recently used medicines.
  • Use together with alcohol
    • No alcohol should be drunk during treatment, as alcohol can alter and intensify the effect in an unpredictable manner. It also further impairs the ability to drive and use machines.

Contraindications

  • The drug must not be used
    • if you are allergic to dimenhydrinate, other antihistamines or any of the other ingredients of this medicine,
    • in acute asthma attack,
    • with glaucoma (narrow-angle glaucoma),
    • if you have an adrenal gland tumor (pheochromocytoma)
    • if you suffer from a blood pigment production disorder (porphyria),
    • in case of enlargement of the prostate gland (prostatic hyperplasia) with residual urine,
    • if you suffer from seizures (epilepsy, eclampsia).

pregnancy and breast feeding period

  • If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
  • pregnancy
    • Dimenhydrinate, the active ingredient in suppositories, can induce preterm labor. The safety of use during pregnancy has not been proven. A risk for dimenhydrinate cannot be ruled out on the basis of clinical data. You may only use the preparation after consulting your doctor and only if he/she considers it absolutely necessary.
  • lactation
    • Dimenhydrinate, the active ingredient in the suppositories, passes into breast milk. The safety of use during breastfeeding has not been proven. Since undesirable effects such as increased restlessness on the breastfed child cannot be ruled out, you should either not use the suppositories while breastfeeding or stop breastfeeding during the time of use.

patient notes

  • Warnings and Precautions
    • Please talk to your doctor or pharmacist before using the suppositories
      • impaired liver function,
      • cardiac arrhythmia (e.g. tachycardia),
      • potassium or magnesium deficiency,
      • slow heartbeat (bradycardia),
      • Certain heart diseases (congenital QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary vessels, conduction disorders, arrhythmias),
      • Simultaneous use of drugs that also prolong the so-called QT interval in the ECG or lead to hypokalemia,
      • chronic breathing problems and asthma,
      • Narrowing of the outlet of the stomach (pyloric stenosis).
    • In these cases, the suppositories may only be used after consulting a doctor.

 

  • Ability to drive and use machines
    • Drowsiness, memory problems and reduced concentration can have an adverse effect on the ability to drive or use machines. This applies in particular after insufficient sleep, at the start of treatment and change of preparation as well as in combination with alcohol.

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