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VOMACUR 70 dimenhydrinate suppositories

Hexal AG

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VOMACUR 70 dimenhydrinate suppositories

Active ingredient: dimenhydrinate.

Areas of application:
Prevention and treatment of motion sickness, dizziness, nausea, vomiting.
Dimenhydrinate is for the sole treatment of v. Cytostatics-induced Nausea and vomiting not suitable.

For motion sickness, dizziness, nausea and vomiting.

VOMACUR 70 dimenhydrinate suppositories Active ingredients

  • 70 mg dimenhydrinate

Dimenhydrinate suppositories Auxiliary materials

  • Hard fat

Indication / application

  • The preparation is a remedy for nausea and vomiting from the group of H 1 antihistamines.
  • It is a medicine used to prevent and treat motion sickness, dizziness, nausea and vomiting.
  • Note
    • Dimenhydrinate is not suitable for the sole treatment of nausea and vomiting following drug treatment for cancer (cytostatic therapy).
    • If you don't feel better or even worse after 14 days, contact your doctor.

Dimenhydrinate suppositories dosage

  • Always use this medicine exactly as described or exactly 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 small and light children, a single dose of the lowest dose in the relevant weight or age group 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 dose is:
    • Children with a body weight of 15 to 25 kg
      • 1 suppository once a day
    • Children with a body weight of 25 to 40 kg
      • 1 suppository 2 times a day
    • Children from 40 kg body weight and adolescents from 14 years
      • 1 suppository 2 to 3 times a day
  • Overdosing with dimenhydrinate, the active ingredient of the preparation, can be life-threatening, especially in children under 3 years of age and must therefore be avoided under all circumstances, especially in this age group. Therefore, never give your toddler more than 5 mg / kg body weight in 24 hours.
    • Child weight
      • 15 kg
    • Maximum daily dose (per 24 hours)
      • 70 mg
  • In addition, the following upper limits should be adhered to:
    • Children from 6 to 14 years of age receive a maximum of 150 mg dimenhydrinate per day.
    • Adolescents aged 14 and over receive a maximum of 400 mg dimenhydrinate per day.

 

  • Duration of application
    • Unless otherwise prescribed by the doctor, the drug is intended for short-term use only.
    • A doctor should therefore be consulted if the symptoms persist. After 2 weeks of treatment at the latest, your doctor should check whether treatment is still required.
  • 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 of the preparation, can be life-threatening. Children are particularly at risk.
    • In the event of an overdose or poisoning, a doctor (e.g. poisoning emergency number) should be asked for advice immediately.
    • An overdose is primarily characterized by the various stages of clouding of consciousness, which can range from severe sleepiness to unconsciousness.
    • In addition, the following signs are observed:
      • Dilation of the pupil
      • Visual disturbances
      • accelerated heart activity
      • fever
      • hot, reddened skin and dry mucous membranes
      • constipation
      • Anxiety and agitation
      • increased reflexes and delusions
    • In addition, convulsions and breathing disorders are possible, which after high doses can lead to respiratory paralysis and cardiovascular arrest.
    • The doctor assesses the severity of the poisoning and determines the necessary measures.

 

  • If you forget to use it
    • Do not use double the amount to make up for a forgotten application.

 

  • If you cancel the application
    • Please do not interrupt or stop using it without talking to your doctor first.

 

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

Dimenhydrinate suppositories way

  • As a prophylaxis against motion sickness, the first dose is given about 1/2 - 1 hour before the start of the journey. To treat nausea and vomiting, the doses are distributed at regular intervals throughout the day.
  • The suppositories should be inserted deep into the rectum.

Dimenhydrinate suppositories Side effects

  • Like all medicines, this medicine can have side effects, although not everybody gets them.
  • Significant side effects or signs to look out for and what to do if they're affected:
    • If you are affected by any of the side effects listed below, stop using the product and contact your doctor as soon as possible.
      • Depending on the individual's sensitivity and the dose used, the following side effects are very common (may affect more than 1 in 10 people) - especially at the start of treatment: drowsiness, drowsiness, dizziness and muscle weakness. These side effects can still lead to impairments on the following day.
      • Frequently (may affect up to 1 in 10 people) the so-called "anticholinergic" side effects may include dry mouth, increased heart rate (tachycardia), a nasal congestion, visual disturbances, increased intraocular pressure and urination disorders. For example, nausea, stomach pain, vomiting, constipation or diarrhea) and mood swings were observed. Furthermore, especially in children, there is the possibility of so-called "paradoxical reactions" such as restlessness, agitation, insomnia, anxiety or tremors occurring.
      • Also is over
        • allergic skin reactions,
        • Skin sensitivity to light (avoid direct sunlight!) And
        • Liver dysfunction (cholestatic jaundice) has been reported.
      • Blood cell damage can occur in exceptional cases.
    • Other possible side effects:
      • In the event of prolonged treatment with dimenhydrinate, the development of drug dependency cannot be ruled out. For this reason, the medicinal product should only be used for a short time if possible.
      • After long-term daily use, sudden stopping of the treatment may cause temporary 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.

Dimenhydrinate suppositories Interactions

  • Use with other medicines
    • Tell your doctor or pharmacist if you are taking / using, have recently taken / used, or may take / use any other medicines.
    • Simultaneous use of dimenhydrinate with other central depressant drugs (drugs that affect the psyche, sleeping pills, tranquilizers, painkillers and anesthetics) can lead to a mutual intensification of the effects.
    • The "anticholinergic" effect of dimenhydrinate can be increased in an unforeseeable way by the simultaneous administration of other substances with "anticholinergic" effects (e.g. atropine, biperiden or certain agents against depression [tricyclic antidepressants]).
    • Simultaneous administration of dimenhydrinate with so-called monoamine oxidase inhibitors (drugs that are also used to treat depression) may lead to life-threatening intestinal paralysis, urinary retention or an increase in intraocular pressure. In addition, it can lead to a drop in blood pressure and increased functional impairment of the central nervous system and breathing. Therefore, the preparation must not be used at the same time as inhibitors of monoamine oxidase.
    • Simultaneous use with drugs that
      • also extend the so-called QT interval in the EKG, e.g. B.
        • Agents against cardiac arrhythmias (antiarrhythmics class IA or III)
        • certain antibiotics (e.g. erythromycin)
        • Cisapride
        • Malaria remedies
        • Agents against allergies or stomach / intestinal ulcers (antihistamines)
        • Means for the treatment of special mental and emotional diseases (neuroleptics)
      • or
        • lead to a potassium deficiency (e.g. certain diuretics) should be avoided.
    • Using dimenhydrinate with medicines for high blood pressure can make you feel more tired.
    • The doctor should be informed about the use of dimenhydrinate before performing allergy tests
      , as false-negative test results are possible.
    • It should also be noted that dimenhydrinate may mask any hearing damage that may occur during treatment with certain antibiotics (aminoglycosides).
  • Use with alcohol
    • During treatment with this preparation, alcohol should not be drunk, as alcohol can change and intensify the effects of dimenhydrinate in unpredictable ways. The ability to drive and use machines will also be further impaired.

Dimenhydrinate suppositories Contraindications

  • The drug must not be used
    • if you are allergic to dimenhydrinate, other antihistamines or the other ingredients of this medicine
    • if you have an acute asthma attack
    • glaucoma (narrow-angle glaucoma)
    • if you have a tumor of the adrenal gland (pheochromocytoma)
    • if you suffer from a disorder in the production of pigments in the blood (porphyria)
    • with enlargement of the prostate gland (prostatic hyperplasia) with residual urine formation
    • if you have seizures (epilepsy, eclampsia)
    • in children weighing less than 14 kg. Other forms of administration with a lower content of active ingredients are available for this purpose.

pregnancy and breast feeding period

  • Ask your doctor or pharmacist for advice before using this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant, or are planning to become pregnant.
  • pregnancy
    • Dimenhydrinate, the active ingredient of the preparation, can cause premature labor. The safety of use in pregnancy has not been proven. Based on clinical data, a risk for dimenhydrinate cannot be excluded.
    • You may only use the medicine after consulting your doctor and only if he considers it to be absolutely necessary.
  • Breastfeeding
    • Dimenhydrinate, the active ingredient of the preparation, passes into breast milk. The safety of use during breastfeeding has not been proven.
    • Since undesirable effects such as increased restlessness on the breast-fed child cannot be ruled out, you should either not use dimenhydrinate while breastfeeding or stop breastfeeding while it is being used.

Dimenhydrinate suppositories Patient information

  • Warnings and Precautions
    • Please talk to your doctor or pharmacist before using the preparation
      • impaired liver function
      • Irregular heartbeat (e.g. rapid heartbeat)
      • Deficiency in potassium or magnesium
      • slow heartbeat (bradycardia)
      • certain heart diseases (congenital QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary arteries, conduction disorders, arrhythmias)
      • Simultaneous use of drugs that also prolong the so-called QT interval in the ECG or lead to hypokalaemia
      • chronic breathing difficulties and asthma
      • Narrowing at the exit of the stomach (pyloric stenosis)
      • Children under 6 years.
    • In these cases, the drug may only be used after consulting a doctor.
    • Particularly in infants and toddlers up to 3 years of age, the preparation can cause serious side effects such as seizures. The indication for treatment should therefore be made strict in this patient group. Young children with simple gastrointestinal flu or febrile infections should not be treated with this medicine. In these cases, however, care should be taken to ensure a sufficient supply of fluids and electrolytes.
    • children
      • The medicine should not be used in children under 6 years of age. For this purpose, preparations with a lower potency are available.

 

  • Driving and using machines
    • Drowsiness, memory problems and poor concentration can have a detrimental effect on your ability to drive or work with machines. This is particularly true after insufficient sleep time, when starting treatment and changing preparations, and when interacting with alcohol.