Vomex A® Dragees - For nausea and vomiting

indication

• This preparation is an anti-nausea and vomiting drug from the group of H1 antihistamines.
• It is taken to prevent and treat nausea and vomiting of various origins, especially motion sickness. For children over 6 years and over 30 kg body weight, adolescents and adults.
• A 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 take this medicine exactly as described or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
• The dosage of dimenhydrinate should be based on the patient's body weight. In small children, a single dose may be sufficient to relieve symptoms.
• Unless otherwise prescribed by the doctor, daily doses of 5 milligrams per kilogram of body weight should not be exceeded.
• Overdoses with dimenhydrinate can be life-threatening, especially in children under three years of age, and must therefore be avoided at all costs in this age group. Therefore, never give your toddler more than 5 mg/kg body weight in 24 hours.
• The recommended dosage should under no circumstances be increased without medical advice, especially in children.
• The recommended dose is
  • Children aged 6 to 14 years and weighing more than 30 kg:
    • 1 - 3 times daily 1 tablet (corresponding to 50 - 150 mg dimenhydrinate), but not more than 3 tablets (150 mg dimenhydrinate).
  • Other lower dose forms are available for appropriate and safe dosing in children under 6 years of age or weighing less than 30 kg.
  • Adults and adolescents over 14 years of age and weighing more than 56 kg:
    • 1 - 2 dragees 1 - 4 times daily (corresponding to 50 - 400 mg dimenhydrinate), but not more than 8 dragees per day (400 mg dimenhydrinate).

• Duration of application
  • The preparation is intended for short-term use only, unless otherwise prescribed by a doctor. If symptoms persist, you should therefore consult a doctor. After 2 weeks of treatment at the latest, your doctor should check whether further treatment is necessary.

• If you take more than you should
  • Poisoning with dimenhydrinate can be life-threatening. Children are particularly at risk.
  • In case of overdose or poisoning, always seek medical advice immediately (e.g. poison control center).
  • An overdose is primarily characterized by a clouding of consciousness, which can range from severe drowsiness to unconsciousness. The following signs are also observed: dilated pupils, visual disturbances, accelerated heart rate, fever, hot, reddened skin and dry mucous membranes, constipation, states of excitement, increased reflexes and delusions. In addition, cramps and breathing disorders are possible, which can lead to respiratory paralysis and cardiac arrest after high doses.
  • The doctor assesses the severity of the poisoning and determines the necessary measures.

• If you forget to take it
  • Do not take a double dose to make up for a forgotten dose. Just carry on taking the medicine as directed here or as directed by your doctor.

• If you stop taking it
  • Please do not interrupt or stop taking the medicine without first talking to your doctor.

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

way

• To take.
• To prevent motion sickness, the first dose should be taken approximately 1/2 - 1 hour before the start of the journey. To treat nausea and vomiting, if several doses are necessary, the doses should be distributed at regular intervals throughout the day. There should be an interval of at least 6 hours between two doses.
• The tablets should be taken whole and with plenty of liquid.

Side effects

• Like all medicines, this medicine can cause side effects, although not everybody gets them.
• possible side effects
  • Depending on individual sensitivity and the dose taken, the following side effects are very common (may affect more than 1 in 10 people) - especially at the beginning of treatment: drowsiness, dizziness, vertigo and muscle weakness. These side effects may also cause impairment the following day.
• If you experience any of the following side effects, stop taking this medicine and seek medical attention immediately:
  • Allergic reactions (rare: may affect up to 1 in 1,000 people)
    • Rash, red or purple patches on the skin (purpura), itching
    • Edema (swelling of the face or neck, which may be associated with difficulty breathing)
    • Anaphylactic reactions
  • Very common: may affect more than 1 in 10 people
    • Headache
    • Sleepiness (somnolence)
    • Dizziness
  • Common: may affect up to 1 in 10 people
    • Sedation
    • Dilation of the pupil (mydriasis)
    • Heart palpitations (tachycardia)
    • Stuffy nose
    • Dry mouth
    • Muscular weakness
    • Disorders of bladder emptying
  • Uncommon: may affect up to 1 in 100 people
    • Limited memory
    • Balance disorders
    • Dizziness
    • Attention disorders
    • Coordination disorders
    • State of confusion
    • Hallucinations
    • Mood swings
    • insomnia
    • Dizziness (vertigo)
    • Muscle weakness (myasthenia)
    • Increased intraocular pressure
  • Rare: may affect up to 1 in 1,000 people
    • Hives (urticaria)
    • Accumulation of fluid in the tissue (edema)
    • Allergic reaction
    • Fear
    • Reduced visual acuity
    • Drop in blood pressure when assuming an upright position (orthostasis syndrome)
    • Unrest
    • Increased urge to move (agitation)
    • nervousness
    • Tremor
    • Constipation
    • Redness of the skin (erythema)
    • Itchy inflammatory skin disease (eczema)
    • Swelling of the face or neck (angioedema)
    • Red or purple spots on the skin (purpura)
    • Allergic skin inflammation (allergic dermatitis)
  • Very rare: may affect up to 1 in 10,000 people
    • Reduction in white blood cells (leukopenia)
    • Decrease in the number of certain blood cells (neutropenia)
    • Reduction in blood platelets (thrombocytopenia)
    • Abnormal reduction in red blood cells (hemolytic anemia)
    • Disturbances in the movement process (extrapyramidal disease)
  • Not known: Frequency cannot be estimated from the available data
    • Gastrointestinal disorders (e.g. nausea, upper abdominal pain, vomiting, diarrhea)
    • Liver dysfunction (jaundice, jaundice due to congestion of bile)
    • Light sensitivity (photosensitivity)
    • Prolongation of the QT interval in the ECG
• Additional side effects in children and adolescents
  • There is a possibility of paradoxical reactions such as restlessness, excitement, insomnia, anxiety or tremors, particularly in children.
• Elderly patients
  • Uncommon (may affect up to 1 in 100 people) side effects include balance disorders, confusion, dizziness, memory problems or problems with concentration, which are more commonly seen in older people.
• If you notice any side effects, talk to your doctor or pharmacist. This includes any side effects not listed.

Interactions

• Use with other medicines
  • Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
  • If taken at the same time as other centrally depressant drugs (drugs that affect the psyche, sleeping pills, sedatives, painkillers and anesthetics), the effects may be mutually reinforcing.
  • The "anticholinergic" effect of the drug may be increased in an unpredictable manner by the simultaneous administration of other substances with anticholinergic effects (e.g. atropine, biperiden or certain antidepressants [tricyclic antidepressants]).
  • When administered 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. In addition, there may be a drop in blood pressure and an increased impairment of the central nervous system and respiratory function. Therefore, the medicine must not be used at the same time as monoamine oxidase inhibitors.
  • Procarbazine (anti-cancer drug) may increase the effect of the preparation.
  • Concomitant use with medicines that
    • also prolong the so-called QT interval in the ECG, e.g. 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 illnesses (neuroleptics), or
    • can lead to a potassium deficiency (e.g. certain diuretics)
  • is to be avoided.
  • Taking it together with medicines for high blood pressure can lead to a greater drop in blood pressure and thus also to increased fatigue.
  • The doctor should be informed about the use before performing allergy tests, as false-negative test results are possible.
  • It should also be noted that the drug may mask any hearing damage that may occur during treatment with certain antibiotics (aminoglycosides).
  • The drug increases the effect of sympathomimetics (e.g. adrenaline, noradrenaline).
  • Please note that this information may also apply to medicines you have recently used.
• Use with alcohol
  • Alcohol should not be consumed during treatment, as alcohol can alter and intensify the effects in an unpredictable way. It will also further impair your ability to drive and operate machinery.

Contraindications

• This medicine must not be taken
  • if you are allergic to dimenhydrinate, other antihistamines or any of the other ingredients of this medicine,
  • in acute asthma attacks,
  • in the case of glaucoma (narrow-angle glaucoma),
  • if you have an adrenal gland tumor (pheochromocytoma),
  • if you suffer from a disorder of the production of blood pigment (porphyria),
  • in case of enlargement of the prostate gland (prostatic hyperplasia) with residual urine formation,
  • if you suffer from seizures (epilepsy, eclampsia),
  • if you suffer from a cardiac arrhythmia (e.g. palpitations, Wolff-Parkinson-White syndrome).
• In general, the active ingredient (dimenhydrinate) must not be used if the body weight is less than 6 kg.

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 taking this medicine.
• pregnancy
  • Dimenhydrinate can cause premature labor. The safety of taking it during pregnancy has not been proven. A risk for dimenhydrinate cannot be ruled out based on clinical data. You may only use the preparation after consulting your doctor and only if he or she considers it absolutely necessary.
• Breastfeeding
  • Dimenhydrinate passes into breast milk. The safety of use during breastfeeding has not been proven. Since undesirable effects on the breastfed child, such as increased restlessness, cannot be ruled out, you should either not take the suppositories during breastfeeding or stop breastfeeding during the period of use.

Patient information

• Warnings and Precautions
  • Please talk to your doctor or pharmacist before using the suppositories if
    • Presence of Parkinson’s disease (shaking palsy),
    • impaired liver function and/or severely impaired kidney function,
    • Potassium or magnesium deficiency,
    • slow heartbeat (bradycardia),
    • certain heart diseases (congenital long QT syndrome or other clinically significant heart damage, in particular circulatory disorders of the coronary arteries, conduction disorders),
    • concomitant use of medicines that also prolong the so-called QT interval in the ECG or that lead to hypokalaemia,
    • chronic respiratory problems and asthma,
    • Presence of symptoms that could be aggravated by anticholinergic therapy (e.g. increased intraocular pressure, narrowing in the area of ​​the pylorus or duodenum [pyloro-duodenal obstruction], benign enlargement of the prostate [prostatic hypertrophy], high blood pressure [hypertension], drop in blood pressure when assuming an upright position [orthostatic hypotension], overactive thyroid [hyperthyroidism], dizziness, sedation or serious disease affecting the coronary arteries).
    • In these cases, the tablets may only be taken after consulting a doctor.
    • With longer treatment, the development of drug dependency cannot be ruled out. For this reason, the tablets should only be used for a short time if possible.
    • After long-term daily use, sudden cessation of treatment may cause temporary sleep disturbances. In such cases, treatment should be stopped by gradually reducing the dose.
  • Children
    • Overdoses with dimenhydrinate can be life-threatening, especially in children, and must be avoided. Therefore, the tablets must not be used in children under 6 years of age or under 30 kg body weight. Other lower-dose dosage forms are available for this purpose.

• Ability to drive and use machines
  • Drowsiness, memory problems and reduced ability to concentrate can have a detrimental effect on the ability to drive or operate machinery. This is particularly true after insufficient sleep, when starting treatment or changing medications and when combined with alcohol.

Active ingredients

Excipients

Package leaflet