Vomex A, 100 ml Sirup

active ingredients

• 16.5 mg dimenhydrinate

ingredients

• cherry flavor
• water, purified
• 2500 mg sucrose
• 142 mg propylene glycol
• glycerol

Indication :

• The preparation is a remedy for nausea and vomiting from the group of H ₁ antihistamines.

• It is taken to prevent and treat nausea and vomiting of various origins, especially in motion sickness.

• For toddlers and children from 6 kg body weight.

• 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. Check with your doctor or pharmacist if you are not sure.

• The dosage of dimenhydrinate should be based on the patient's body weight. For small and light children, a single dose of the lowest dose in the relevant weight or age class can be sufficient to alleviate the symptoms.

• Overdoses of dimenhydrinate, the active ingredient in 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. Therefore, never give your toddler more than 5mg/kg body weight in 24 hours.

• The recommended dosage should not be increased on one's own initiative, especially in children.

• The recommended dose is

  • Small children from 6 kg body weight

    • 1.25 mg of dimenhydrinate per kilogram of body weight, 3 times a day.

  • 1 ml of syrup corresponds to 3.3 mg of dimenhydrinate.

• The following table serves as a guide:

  • Child's body weight: 6 - 10 kg

    • Single dose (upper limit): 2.5 ml (equivalent to 8.25 mg dimenhydrinate)

    • Total daily dose (upper limit): 3 times 2.5 ml (equivalent to 24.75 mg dimenhydrinate)

  • Child's body weight: > 10 - 15 kg

    • Single dose (upper limit): 5.0 ml (equivalent to 16.5 mg dimenhydrinate)

    • Total daily dose (upper limit): 3 times 5.0 ml (equivalent to 49.5 mg dimenhydrinate)

  • Child's body weight: > 15 - 25 kg

    • Single dose (upper limit): 7.5 ml (equivalent to 24.75 mg dimenhydrinate)

    • Total daily dose (upper limit): 3 - 4 times 7.5 ml (equivalent to 74.25 - 99 mg dimenhydrinate)

  • Child's body weight: > 25 - 30 kg

    • Single dose (upper limit): 12.5 ml (equivalent to 41.25 mg of dimenhydrinate)

    • Total daily dose (upper limit): 3 times 12.5 ml (equivalent to 124 mg dimenhydrinate)

• Children over 30 kg body weight can, if necessary, be given 15 ml of syrup (equivalent to 50 mg dimenhydrinate per single dose) 3 times a day, corresponding to a daily total of 150 mg dimenhydrinate.

• The specified upper dosage limits must not be exceeded.

• Higher dosage forms are available for adults.

• duration of use

  • Unless otherwise prescribed by the doctor, the drug is intended for short-term use only. 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 of the medicine is too strong or too weak.

• If you take more than you should

  • Poisoning with dimenhydrinate, the active ingredient in this preparation, 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 forget to take a dose

  • Do not double the amount to make up for a forgotten dose, but continue as directed here or as directed by your doctor.

• If you stop taking it

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

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

way :

• To take.

• To prevent travel sickness, the first dose is given about 1/2 - 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, if several are necessary. There should be a gap of at least 6 hours between two doses.

Side effects :

• Like all medicines, this medicine can cause side effects, although not everybody gets them.

• possible side effects

  • Depending on the 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: sleepiness, drowsiness, dizziness and muscle weakness. These side effects can also lead to impairments the following day.

  • If you experience any of the following side effects, stop taking this medication and seek medical help immediately:

    • Allergic reactions (rare: may affect up to 1 in 1,000 people)

      • Rash, red or purple spots on the skin (purpura), itching

      • edema (swelling of the face or neck which may cause difficulty breathing)

      • Anaphylactic reactions

    • Very common: may affect more than 1 in 10 people

      • Headache

      • sleepiness (somnolence)

      • drowsiness

    • Common: may affect up to 1 in 10 people

      • sedation

      • Dilation of the pupil (mydriasis)

      • racing heart (tachycardia)

      • Stuffy nose

      • dry mouth

      • muscular weakness

      • Disturbances in the emptying of the urinary bladder

    • Uncommon: may affect up to 1 in 100 people

      • Impaired 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)

      • Storage of fluid in the tissue (edema)

      • Allergic reaction

      • Fear

      • Decreased visual acuity

      • Drop in blood pressure when standing upright (orthostasis syndrome)

      • restlessness

      • Increased urge to move (agitation)

      • nervousness

      • shaking (tremor)

      • constipation

      • skin redness (erythema)

      • Itchy inflammatory skin disease (eczema)

      • swelling of the face or throat (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 the number of red blood cells (haemolytic anaemia)

      • Movement disorders (extrapyramidal disease)

    • Not known: frequency cannot be estimated from the available data

      • Gastrointestinal disorders (eg, nausea, upper abdominal pain, vomiting, diarrhea)

      • Liver dysfunction (jaundice, jaundice caused by bile buildup)

      • Sensitivity to light (photosensitivity)

      • Prolongation of the QT interval in the ECG

  • Additional side effects in children and adolescents

    • There is a possibility, especially in children, of paradoxical reactions such as restlessness, excitement, insomnia, anxiety or tremors.

  • Elderly patients

    • Uncommon (may affect up to 1 in 100 people) problems with balance, confusion, dizziness, problems with memory or concentration, which are more common in older people.

• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not specified.

Interactions :

• Taking 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 can be mutually intensified.

  • The "anticholinergic" effect of the preparation 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 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 can develop under certain circumstances. It can also lead to a drop in blood pressure and an increased functional impairment of the central nervous system and breathing. Therefore, the drug must not be taken at the same time as monoamine oxidase inhibitors.

  • Procarbazine (anti-cancer drug) may increase the effects of dimenhydrinate.

  • Concomitant use with drugs that

    • also lengthen the so-called QT interval in the ECG, e.g. B. Drugs for cardiac arrhythmias (antiarrhythmics class IA or III), 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.

  • Taking it together with medicines for high blood pressure can lead to an increased drop in blood pressure and thus 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 medicinal product may under certain circumstances cover up hearing damage that may occur during treatment with certain antibiotics (aminoglycosides).

  • Dimenhydrinate increases the effect of sympathomimetics (e.g. adrenaline, noradrenaline).

  • Please note that this information may also apply to recently used medicines.

• Consumed 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 taken

  • 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),

  • if you suffer from a cardiac arrhythmia (e.g. tachycardia, Wolff-Parkinson-White syndrome).

• In general, the active ingredient of the drug (dimenhydrinate) should not be used if the body weight is less than 6 kg.

Pregnancy and lactation :

• 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 substance in the preparation, can induce premature labour. 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 take the medicine after consulting your doctor and only if he/she considers it absolutely necessary.

• lactation

  • Dimenhydrinate, the active substance 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 breastfed child cannot be ruled out, you should either not take the drug while breastfeeding or stop breastfeeding while you are taking it.

Patient Notes :

• Warnings and Precautions

  • Please talk to your doctor or pharmacist before taking this medicine

    • Presence of Parkinson's disease (shaking paralysis),

    • impaired liver function and/or severely impaired kidney function,

    • cardiac arrhythmia (e.g. tachycardia),

    • 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 vessels, conduction disorders),

    • Simultaneous use of drugs that also prolong the so-called QT interval in the ECG or that lead to hypokalemia,

    • chronic breathing difficulties and asthma, the 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 gland [prostatic hypertrophy], high blood pressure [hypertension], drop in blood pressure when sitting in an upright position [orthostatic hypotension], overactive thyroid gland [hyperthyroidism], dizziness, sedation or serious coronary artery disease).

  • In these cases, the medicinal product may only be taken after consultation with the doctor.

  • With prolonged treatment, the development of drug dependence cannot be ruled out. For this reason, the syrup should only be used briefly 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.

  • Children

    • Dimenhydrinate can cause severe side effects such as seizures, especially in infants and small children up to the age of 3 years. The indication for treatment should therefore be strictly defined in this patient group. Young children with simple gastric 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 liquid and electrolytes.

    • The product should not be used in children weighing less than 6 kg.

• 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 beginning of treatment and change of preparation as well as in combination with alcohol.

The total dose should not be exceeded without consulting a doctor or pharmacist.

Type of application?
Take the medicine undiluted. Shake well before use.

Duration of use?
The duration of use depends on the type of symptoms and/or the course of the disease. You should not use the medicine for more than 2 weeks without medical advice.

overdose?
An overdose can cause drowsiness, impaired consciousness, hallucinations and cardiovascular disorders. If you suspect an overdose, contact a doctor immediately.

In general, pay attention to a conscientious dosage, especially for babies, small children and the elderly. If in doubt, ask your doctor or pharmacist about any effects or precautions.

A dosage prescribed by the doctor may deviate from the information on the package leaflet. Therefore, since the doctor adjusts them individually, you should use the medicine according to his instructions.

dosage

What speaks against an application?

Always:
- Hypersensitivity to the ingredients
- Epilepsy
- Seizures during pregnancy (eclampsia)
- Angle-closure glaucoma
- Pheochromocytoma (adrenaline-producing tumor)
- Porphyria (metabolic disease)
- Enlarged prostate with residual urine

Under certain circumstances - talk to your doctor or pharmacist about this:
- Narrowing in the digestive tract, especially in the stomach
- cardiac arrhythmia
- bronchial asthma
- chronic obstructive airway disease (chronic airway disease with a narrowing of the airways)
- limited liver function

Which age group should be considered?
- Adults: As a rule, the drug should not be used in this group. There are preparations that are more suitable in terms of the strength of the active ingredient and/or dosage form.

What about pregnancy and lactation?
- Pregnancy: consult your doctor. Various considerations play a role in whether and how the drug can be used during pregnancy.
- Breast-feeding: According to current knowledge, it is not recommended to use it. You may be to consider a weaning.

If you have been prescribed the drug despite a contraindication, talk to your doctor or pharmacist. The therapeutic benefit can be higher than the risk that the use entails in the event of a contraindication.

What adverse effects may occur?

- Gastrointestinal symptoms such as:
  - Nausea
  - Vomiting
  - Stomach pain -
  Diarrhea -
  Constipation - Dry mouth -
Dizziness
- Drowsiness
- Drowsiness
-
Muscle weakness
- Mood swings
- Visual disturbances
- Rapid heart rate
- Increased intraocular pressure
- Difficulty urinating
- Stuffy nose feeling

Especially in children:
- restlessness
- excitement
- insomnia
- anxiety
- tremors

If you notice any discomfort or changes during treatment, contact your doctor or pharmacist.

For the information at this point, side effects are primarily taken into account that occur in at least one in 1,000 patients treated.

Storage

Storage before opening
The medicinal product must be stored away from heat.
Storage after opening or preparation
The medicinal product may be used for a maximum of 3 months after opening/preparation!
The medicinal product must be stored at room temperature after opening/preparation!

What should you consider?
- The ability to react can also be impaired when used as intended, especially in higher doses or in combination with alcohol. Be particularly careful when driving or using machines (including household ones) that could injure you.
- Avoid excessive UV radiation, eg in solariums or when sunbathing extensively, because the skin reacts more sensitively while using the medicine.
- Sudden stopping may cause problems or discomfort. Therefore, the treatment should be ended slowly, i.e. with a gradual taper of the dose. It is best to seek advice from your doctor or pharmacist.
- Warning: If you use the medicine for a long time, the body can get used to it and you may need an increasing dose to feel an effect.
- Beware of intolerance to sucrose. If you have to follow a diabetic diet, you should consider the sugar content.
- There may be medicines with which interactions occur. You should therefore generally tell your doctor or pharmacist about any other medicine you are already using before starting treatment with a new medicine. This also applies to medicines that you buy yourself, use only occasionally or have been using for some time.

How does the ingredient of the medicine work?

The active ingredient blocks receptors for a specific messenger substance called histamine. With this blockade, he suppresses a vasodilatation and increased blood flow to the smallest hair vessels (capillaries) triggered by histamine. It also fights nausea via the same mechanism and has a calming effect.

What is included in medicines?

Manufacturer: Klinge Pharma GmbH