Vomex A suppositories 150 mg, 10 suppositories

Vomex A Suppositories 150 mg suppositories. 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 Suppositories 150 mg suppositories for use in adolescents and adults.
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 package leaflet contains

1. WHAT ARE VOMEX A SUPPOSITORIES AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING VOMEX A SUPPOSITORIES?
3. HOW ARE VOMEX A SUPPOSITORIES TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VOMEX A SUPPOSITORIES BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT ARE VOMEX A SUPPOSITORS AND WHAT ARE THEY USED FOR?

Vomex A suppositories are an anti-nausea and anti-vomiting medication from the H1 antihistamine group. Vomex A suppositories are used 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 USING VOMEX A SUPPOSITORS?

Vomex A suppositories must not be used:

• 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 using Vomex A suppositories if you have:

• 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 “Use of Vomex A suppositories together with other drugs”),
• chronic respiratory problems and asthma,
• Narrowing at the exit of the stomach (pyloric stenosis)
• Children under 14 years of age.

Vomex A suppositories should only be used in these cases after consulting a doctor.

Children:
Vomex A suppositories should not be used in children under 14 years of age. Lower-dose children's suppositories are available for this age group.

Using Vomex A suppositories with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. When Vomex A suppositories are used at the same time as other centrally acting depressants (medicines that affect the mind, sleeping pills, sedatives, painkillers, and anesthetics), their effects may be mutually intensified. The anticholinergic effects of Vomex A suppositories (see section 4, Possible side effects) can be unpredictably intensified by the simultaneous administration of other substances with anticholinergic effects (e.g., atropine, biperiden, or certain antidepressants [tricyclic antidepressants]). When Vomex A suppositories are administered concurrently with so-called monoamine oxidase inhibitors (medicines also used to treat depression), life-threatening paralytic ileus, urinary retention, or an increase in 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 suppositories must not be used concurrently with monoamine oxidase inhibitors.

Simultaneous 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 medications for certain mental health conditions (neuroleptics), or medications that can lead to potassium deficiency (e.g., certain diuretics), should be avoided. Using Vomex A suppositories with medications for high blood pressure may increase drowsiness. The doctor should be informed about the use of Vomex A suppositories before allergy tests are performed, as false-negative results are possible. Furthermore, it should be noted that Vomex A suppositories may mask hearing loss that may occur during treatment with certain antibiotics (aminoglycosides). Please note that this information may also apply to medications used recently.

Use of Vomex A suppositories together with alcohol:
Alcohol should not be consumed during treatment with Vomex A suppositories, as alcohol can unpredictably alter and intensify the effects of Vomex A suppositories. This will also further impair your ability to drive and operate machinery.

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

Breastfeeding:
Dimenhydrinate, the active ingredient in Vomex A suppositories, passes into breast milk. The safety of using Vomex A suppositories 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 use Vomex A suppositories while breastfeeding or discontinue breastfeeding during the period of use.

Driving and operating machinery:
Drowsiness, memory problems, and reduced concentration can impair your ability to drive or operate machinery. This applies particularly after insufficient sleep, at the start of treatment, when switching medications, and in combination with alcohol (see also Using Vomex A suppositories with other medicines/alcohol).

3. HOW TO USE VOMEX A SUPPOSITORIES?

Always use 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 adolescents, a single dose of the lowest dose in the relevant weight and age category 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. The recommended dose is: Adults and adolescents over 14 years of age receive one suppository once or twice a day. If this dosage is not effective, adults and adolescents weighing more than 70 kg may, if necessary, receive one suppository up to three times a day. The following maximum dose should also be observed: Adults and adolescents over 14 years of age should not receive more than 400 mg of dimenhydrinate per day. Vomex A suppositories should not be used in children under 14 years of age. Lower-dose children's suppositories are available for this purpose.

Method of administration:
For the prevention of travel sickness, the first dose should be administered approximately ½ to 1 hour before the start of the journey. For the treatment of nausea and vomiting, doses should be administered at regular intervals throughout the day. Suppositories should be inserted deep into the rectum.

Duration of use:
Unless otherwise prescribed by a doctor, Vomex A suppositories are 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 suppositories is necessary.

If you have used more Vomex A suppositories than you should:
Poisoning with dimenhydrinate, the active ingredient in Vomex A suppositories, can be life-threatening. Children are especially at risk. In case of an overdose or poisoning with Vomex A suppositories, a doctor (e.g., a poison control center) should be consulted immediately. An overdose of Vomex A suppositories 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 use Vomex A suppositories:
Do not use a double dose to make up for a missed dose. Continue using them as described in this leaflet or as prescribed by your doctor.

If you stop using Vomex A suppositories:
Do not interrupt or stop using Vomex A suppositories without first talking to your doctor.

If you have any further questions on the use of 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 suppositories 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 SUPPOSITORIES?

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 suppository wrapper and the outer carton after EXP. The expiry date refers to the last day of that month. Storage conditions: Do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vomex A suppositories contain:
The active ingredient is dimenhydrinate. 1 suppository contains 150 mg dimenhydrinate. The other ingredient is: hard fat.

What Vomex A suppositories look like and contents of the pack:
White to slightly yellowish suppositories. Vomex A suppositories are available in packs of 10 suppositories.

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