Vomex A Syrup, 100 ml

Vomex A Syrup. Active ingredient: Dimenhydrinate. Indications: For the prevention and treatment of nausea and vomiting of various origins, especially motion sickness.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vomex A Syrup 330 mg/100 ml for use in infants and children.
Active ingredient: Dimenhydrinate.

Read the entire package leaflet carefully before you start using this medicine because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or even feel worse after 14 days, consult your doctor.

What this leaflet contains:

1. WHAT IS VOMEX A SYRUP AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VOMEX A SYRUP?
3. HOW SHOULD VOMEX A SYRUP BE TAKED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VOMEX A SYRUP BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS VOMEX A SYRUP AND WHAT IS IT USED FOR?

Vomex A Syrup is an anti-nausea and anti-vomiting medication from the H1 antihistamine group. Vomex A Syrup is taken for the prevention and treatment of nausea and vomiting of various origins, especially motion sickness. Note: Dimenhydrinate is not suitable for the sole treatment of nausea and vomiting resulting from cancer treatment with chemotherapy (cytostatic therapy). If you do not feel better or even feel worse after 14 days, consult your doctor.

2. WHAT SHOULD YOU KNOW BEFORE TAKING VOMEX A SYRUP?

Vomex A Syrup must not be taken:

• if you are allergic to dimenhydrinate, other antihistamines or any of the other ingredients of this medicine listed in section 6,
• in case of an acute asthma attack,
• in glaucoma (narrow-angle glaucoma),
• if you have an adrenal gland tumor (pheochromocytoma),
• if you suffer from a disorder in the production of blood pigment (porphyria),
• in cases of enlarged prostate gland (benign prostatic hyperplasia) with residual urine formation,
• if you suffer from seizures (epilepsy, eclampsia).

Warnings and precautions:
Please talk to your doctor or pharmacist before taking Vomex A syrup if:

• impaired liver function,
• Cardiac arrhythmias (e.g., rapid heartbeat),
• Potassium or magnesium deficiency,
• slowed heartbeat (bradycardia),
• certain heart conditions (congenital QT syndrome or other clinically significant heart damage, especially coronary artery disease, conduction disorders, arrhythmias),
• simultaneous use of drugs that also prolong the so-called QT interval in the ECG or lead to hypokalemia (see under “Taking Vomex A Syrup with other medicines”),
• chronic respiratory problems and asthma,
• Narrowing at the exit of the stomach (pyloric stenosis).

Vomex A syrup should only be taken in these cases after consulting a doctor.

Important information about certain other ingredients of Vomex A syrup:
This medicine contains sucrose. Therefore, please only take Vomex A syrup after consulting your doctor if you know that you have an intolerance to certain sugars. Note for diabetics: 100 ml of syrup contains 50 g of sucrose (sugar), corresponding to approximately 4.17 bread units (BU). Patients with diabetes mellitus should take this into account.

Children:
Vomex A syrup should not be used in children weighing less than 6 kg.

Taking Vomex A syrup with other medicines:
Inform your doctor or pharmacist if you are taking/using, have recently taken/used, or intend to take/use any other medicines. When Vomex A Syrup is taken at the same time as other centrally acting depressants (medicines that affect the mind, such as sleeping pills, sedatives, painkillers, and anesthetics), the effects of both medicines may be intensified. The anticholinergic effect of Vomex A Syrup (see section 4, "Possible side effects") may be unpredictably increased by the simultaneous administration of other substances with anticholinergic effects (e.g., atropine, biperiden, or certain antidepressants [tricyclic antidepressants]). When Vomex A syrup is taken concurrently with monoamine oxidase inhibitors (MAOIs), medications also used to treat depression, life-threatening paralytic ileus, urinary retention, or increased intraocular pressure may develop. Furthermore, a drop in blood pressure and increased impairment of central nervous system and respiratory function may occur. Therefore, Vomex A syrup must not be taken at the same time as MAOIs. Concurrent use with medications that also prolong the QT interval on an electrocardiogram (ECG), such as antiarrhythmics (class IA or III), certain antibiotics (e.g., erythromycin), cisapride, antimalarials, antihistamines (allergy medications or medications for stomach/intestinal ulcers), or neuroleptics (medications for specific mental health conditions), or medications that can lead to potassium deficiency (e.g., certain diuretics), should be avoided. Taking Vomex A syrup with medication for high blood pressure can lead to increased drowsiness. The doctor should be informed about the use of Vomex A syrup before allergy tests are performed, as false-negative test results are possible. Furthermore, it should be noted that Vomex A syrup may mask hearing damage that may occur during treatment with certain antibiotics (aminoglycosides). Please note that this information may also apply to medications taken recently.

Taking Vomex A syrup with alcohol:
No alcohol should be consumed during treatment with Vomex A syrup, as alcohol can unpredictably alter and intensify the effects of Vomex A syrup. Driving ability and the ability to operate machinery will also be further impaired.

Pregnancy and breastfeeding:
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy:
Dimenhydrinate, the active ingredient in Vomex A Syrup, can induce premature labor. The safety of using Vomex A Syrup during pregnancy has not been established. A risk associated with dimenhydrinate cannot be ruled out based on clinical data. You should only take Vomex A Syrup after consulting your doctor and only if they consider it absolutely necessary.

Breastfeeding:
Dimenhydrinate, the active ingredient in Vomex A Syrup, passes into breast milk. The safety of using Vomex A Syrup while breastfeeding has not been established. Since adverse effects, such as increased restlessness, cannot be ruled out in the breastfed infant, you should either not take Vomex A Syrup while breastfeeding or you should stop breastfeeding while taking Vomex A Syrup.

Driving and operating machinery:
Drowsiness, memory problems, and reduced concentration can impair your ability to drive or operate machinery. This is especially true after insufficient sleep, at the start of treatment, when switching medications, and when combined with alcohol (see also Taking Vomex A Syrup with other medicines).

3. HOW TO TAKE VOMEX A SYRUP:

Always take this medicine exactly as described in this leaflet 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 small and light children, a single dose of the lowest dose in the relevant weight or age category may be sufficient to relieve symptoms. Unless otherwise prescribed by your doctor, daily doses of 5 milligrams per kilogram of body weight should not be exceeded. The recommended dosage should never be increased without consulting your doctor, especially in children.

The recommended dose is:

• Children aged 6 to 14 years: 3 - 4 times daily 7.5 - 15 ml syrup (corresponding to 25 - 50 mg dimenhydrinate per dose), but not more than 150 mg dimenhydrinate per day.
• Infants weighing 6 kg or more: 1.25 mg dimenhydrinate per kilogram of body weight 3-4 times daily.

Overdoses of dimenhydrinate, the active ingredient in Vomex A, can be life-threatening, especially in children under three years of age, and must therefore be avoided under all circumstances in this age group. 1 ml of syrup corresponds to 3.3 mg of dimenhydrinate.

The following table serves as a guide:

Higher-dose formulations are available for adults.

Method of administration:
For oral use. To prevent motion sickness, the first dose should be taken approximately 30 minutes to 1 hour before the start of the journey. To treat nausea and vomiting, doses should be taken at regular intervals throughout the day.

Duration of use:
Unless otherwise prescribed by a doctor, Vomex A Syrup is intended for short-term use only. If symptoms persist, a doctor should be consulted. After a maximum of 2 weeks of treatment, your doctor should assess whether continued treatment with Vomex A Syrup is necessary. Please talk to your doctor or pharmacist if you feel that the effect of Vomex A Syrup is too strong or too weak.

If you have taken more Vomex A Syrup than you should:
Poisoning with dimenhydrinate, the active ingredient in Vomex A Syrup, can be life-threatening. Children are particularly at risk. In case of an overdose or poisoning with Vomex A syrup, a doctor (e.g., a poison control center) should be consulted immediately. An overdose of Vomex A syrup is primarily characterized by impaired consciousness, ranging from severe drowsiness to unconsciousness. Other symptoms include: dilated pupils, visual disturbances, rapid heartbeat, fever, hot, flushed skin and dry mucous membranes, constipation, agitation, increased reflexes, and hallucinations. Furthermore, seizures and respiratory distress are possible, which, after high doses, can lead to respiratory paralysis and cardiac arrest. The doctor will assess the severity of the poisoning and determine the necessary treatment.

If you forget to take Vomex A Syrup:
Do not take a double dose to make up for a missed dose. Instead, continue taking Vomex A Syrup as described in this leaflet or as prescribed by your doctor.

If you stop taking Vomex A Syrup:
Do not interrupt or stop taking Vomex A Syrup without first consulting your doctor.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. POSSIBLE 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 used, the following side effects occur very frequently – especially at the beginning of treatment: drowsiness, dizziness, vertigo, and muscle weakness. These side effects can also cause impairment the following day. Commonly occurring anticholinergic side effects include dry mouth, increased heart rate (tachycardia), nasal congestion, visual disturbances, increased intraocular pressure, and difficulty urinating. Gastrointestinal problems (e.g., nausea, stomach pain, vomiting, constipation, or diarrhea) and mood swings have also been observed. Furthermore, especially in children, so-called paradoxical reactions such as restlessness, agitation, insomnia, anxiety, or tremors may occur. Allergic skin reactions, photosensitivity (avoid direct sunlight!), and liver dysfunction (cholestatic jaundice) have also been reported. Blood cell damage can occur in exceptional cases.

Other possible side effects:
With prolonged treatment using dimenhydrinate, the development of drug dependence cannot be ruled out. For this reason, Vomex A Syrup should only be used for short periods if possible. After prolonged daily use, temporary sleep disturbances may occur if treatment is stopped abruptly. Therefore, in these cases, treatment should be discontinued by gradually reducing the dose.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VOMEX A SYRUP?

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date refers to the last day of that month. Once opened, use within 3 months. Storage conditions: Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vomex A Syrup contains:
The active ingredient is dimenhydrinate. 1 ml of syrup contains 3.3 mg of dimenhydrinate. The other ingredients are: cherry flavoring, propylene glycol, glycerol 99%, sucrose, and purified water. Note for diabetics: 100 ml of Vomex A syrup contains 50 g of sucrose (equivalent to 4.17 bread units).

(Apo) Usually ship out within 3-5 business days