VOMACUR

VOMACUR 40 suppositories

Important notes (mandatory information)

Vomacur 40 mg suppositories. Active ingredient: Dimenhydrinate. Areas of application: for the prevention and treatment of motion sickness, dizziness, nausea and vomiting.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vomacur 40 mg suppositories 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 directed by your doctor or pharmacist.

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

What this package leaflet contains

1. WHAT IS VOMACUR 40 MG AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING VOMACUR 40 MG?
3. HOW SHOULD VOMACUR 40 MG BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD VOMACUR 40 MG BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS VOMACUR 40 MG AND WHAT IS IT USED FOR?

Vomacur 40 mg is an anti-nausea and vomiting agent from the group of H1 antihistamines. Vomacur 40 mg is a medicine for the prevention and treatment of motion sickness, dizziness, nausea and vomiting. Note: Dimenhydrinate is not suitable for the sole treatment of nausea and vomiting in the wake of drug-based cancer treatment (cytostatic therapy). If you do not feel better or if you feel worse after 14 days, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE USING VOMACUR 40 MG?

Vomacur 40 mg 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 an acute asthma attack.
• in glaucoma (narrow-angle glaucoma).
• if you have an adrenal gland tumour (phaeochromocytoma).
• if you suffer from a disorder of blood pigment production (porphyria).
• in enlargement of the prostate gland (prostate hyperplasia) with residual urine.
• if you suffer from seizures (epilepsy, eclampsia).

Warnings and precautions

Please talk to your doctor or pharmacist before using Vomacur 40 mg, if:

• impaired liver function.
• heart rhythm disorders (e.g. heart palpitations).
• potassium or magnesium deficiency.
• slowed heart rate (bradycardia).
• certain heart conditions (congenital QT syndrome or other clinically significant heart damage, especially coronary artery disease, conduction disorders, arrhythmias).
• concurrent use of medicines that also prolong the so-called QT interval on the ECG or lead to hypokalaemia (see section "Using Vomacur 40 mg with other medicines").
• chronic respiratory problems and asthma.
• narrowing at the outlet of the stomach (pyloric stenosis).

Vomacur 40 mg may only be used in these cases after consulting a doctor.

In infants and toddlers up to 3 years of age in particular, Vomacur 40 mg can cause serious side effects such as seizures. The indication for treatment should therefore be strictly defined in this patient group. Toddlers with simple gastrointestinal flu or febrile infections should not be treated with Vomacur 40 mg. In these cases, however, care should be taken to ensure an adequate supply of fluids and electrolytes.

Using Vomacur 40 mg with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines. When Vomacur 40 mg is used together with other centrally depressant medicines (medicines that affect the psyche, sleeping pills, sedatives, painkillers and anaesthetics), the effects can be mutually reinforced. The "anticholinergic" effect of Vomacur 40 mg (see section 4 "What side effects are possible?") can be unpredictably increased by the simultaneous administration of other substances with "anticholinergic" effects (e.g. atropine, biperiden or certain antidepressants [tricyclic antidepressants]). If Vomacur 40 mg is given together with so-called monoamine oxidase inhibitors (medicines also used to treat depression), life-threatening intestinal paralysis, urinary retention or an increase in intraocular pressure may develop. In addition, blood pressure may drop and central nervous system and respiratory function may become more impaired. Therefore, Vomacur 40 mg must not be used at the same time as monoamine oxidase inhibitors.

Concomitant use with medicines that:

• also prolong the so-called QT interval on the ECG, e.g.
  • antiarrhythmics (class IA or III)
  • certain antibiotics (e.g. erythromycin)
  • cisapride
  • antimalarials
  • antihistamines or gastrointestinal ulcer medicines (antihistamines)
  • neuroleptics (medicines for treating specific mental illnesses)

or

• can lead to potassium deficiency (e.g. certain diuretics)

should be avoided.

The use of Vomacur 40 mg together with medicines for high blood pressure can lead to increased fatigue. The doctor should be informed about the use of Vomacur 40 mg before carrying out allergy tests, as false-negative test results are possible. It should also be noted that Vomacur 40 mg may mask any hearing loss that may occur during treatment with certain antibiotics (aminoglycosides).

Using Vomacur 40 mg with alcohol

Alcohol should not be consumed during treatment with Vomacur 40 mg, as alcohol can alter and enhance the effect of Vomacur 40 mg in an unpredictable way. Driving ability and the ability to operate machinery are also further impaired as a result.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect 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 ingredient in Vomacur 40 mg, can trigger premature labour. The safety of using Vomacur 40 mg during pregnancy has not been proven. A risk cannot be ruled out for dimenhydrinate based on clinical data. You should only use Vomacur 40 mg after consulting your doctor and only if they consider it absolutely necessary.

Breastfeeding

Dimenhydrinate, the active ingredient in Vomacur 40 mg, passes into breast milk. The safety of using Vomacur 40 mg during breastfeeding has not been proven. Since adverse effects, such as increased restlessness, on the breastfed child cannot be ruled out, you should either not use Vomacur 40 mg during breastfeeding or stop breastfeeding while using Vomacur 40 mg.

Driving and operating machinery

Drowsiness, memory impairment and reduced concentration can have a negative effect on driving ability or the ability to work with machinery. This applies in particular after insufficient sleep, at the start of treatment and when changing preparations, as well as in combination with alcohol (see also section "Using Vomacur 40 mg with alcohol").

3. HOW SHOULD VOMACUR 40 MG BE USED?

Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. 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 dosage in the respective weight or age class may be sufficient to relieve 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:

• Toddlers weighing 8 to under 16 kg: 1 suppository of Vomacur 40 mg once a day.
• Children weighing 16 to 25 kg: 1 suppository of Vomacur 40 mg twice a day.
• Children weighing over 25 kg: 1 suppository of Vomacur 40 mg 2 to 3 times a day.

Overdosage with dimenhydrinate, the active ingredient in Vomacur 40 mg, 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's weight	Maximum daily dose (per 24 hours)
8 kg	40 mg
16 kg	80 mg

In addition, the following upper limit should be observed: Children aged 6 to 14 years receive a maximum of 150 mg dimenhydrinate per day. Higher-dose dosage forms are available for adults.

Method of administration

For the prophylaxis of motion sickness, the first dose is taken approx. 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. The suppositories should be inserted deep into the rectum.

Duration of use

Vomacur 40 mg is intended for short-term use only, unless otherwise prescribed by your doctor. If symptoms persist, a doctor should be consulted. At the latest after 2 weeks of treatment, your doctor should check whether treatment with Vomacur 40 mg is still necessary.

Please talk to your doctor or pharmacist if you have the impression that the effect of Vomacur 40 mg is too strong or too weak.

If you have used more Vomacur 40 mg than you should

Poisoning with dimenhydrinate, the active ingredient in Vomacur 40 mg, can be life-threatening. Children are particularly at risk. In the event of an overdose or poisoning with Vomacur 40 mg, a doctor (e.g. poison control centre) should be consulted immediately for advice. An overdose of Vomacur 40 mg is primarily characterised by a clouding of consciousness, which can range from severe drowsiness to unconsciousness. In addition, the following signs are observed: dilated pupils, visual disturbances, rapid heart rate, fever, hot, flushed skin and dry mucous membranes, constipation, anxiety and agitation, increased reflexes and delusions. In addition, convulsions and respiratory problems are possible, which can lead to respiratory paralysis and cardiovascular arrest at high doses. The severity of the poisoning and the necessary measures are assessed by the doctor.

If you forget to use Vomacur 40 mg

Do not use double the amount to make up for a forgotten dose.

If you stop using Vomacur 40 mg

Please do not interrupt or stop using Vomacur 40 mg without first talking to your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Important side effects or signs to watch out for and what to do if you are affected

If you are affected by any of the following side effects, stop using Vomacur 40 mg and see your doctor as soon as possible. Depending on individual sensitivity and the dose used, the following side effects occur very frequently (may affect more than 1 in 10 people) - especially at the start of treatment: drowsiness, dizziness, dizziness and muscle weakness. These side effects can also lead to impairments on the following day. Dry mouth, increased heart rate (tachycardia), feeling of a blocked nose, visual disturbances, increased intraocular pressure and difficulty urinating can often occur (may affect up to 1 in 10 people) as so-called "anticholinergic" side effects. Gastrointestinal complaints (e.g. nausea, pain in the stomach area, vomiting, constipation or diarrhoea) and mood swings have also been observed. Furthermore, there is the possibility of so-called "paradoxical reactions" such as restlessness, agitation, insomnia, anxiety or trembling, especially in children. Allergic skin reactions, photosensitivity of the skin (avoid direct sunlight!) and liver function disorders (cholestatic jaundice) have also been reported. Blood cell damage can occur in exceptional cases.

Other possible side effects

With prolonged treatment with dimenhydrinate, the development of drug dependence cannot be ruled out. For this reason, Vomacur 40 mg should only be used for a short period of time if possible. After prolonged daily use, sleep disturbances may occur temporarily if treatment is stopped suddenly. In these cases, treatment should therefore be discontinued by gradually reducing the dose.

Reporting of side effects

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

5. HOW SHOULD VOMACUR 40 MG BE STORED?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and foil strip after "use by". The expiry date refers to the last day of the month indicated. Storage conditions: Do not store above 25°C. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vomacur 40 mg contains

The active ingredient is dimenhydrinate. 1 suppository contains 40 mg dimenhydrinate. The other ingredient is hard fat.

What Vomacur 40 mg looks like and contents of the pack

White torpedo-shaped suppository. Vomacur 40 mg is available in packs of PVC/PE foil strips with 5 and 10 suppositories. Not all pack sizes may be marketed.

Pharmaceutical entrepreneur

Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Telefax: (08024) 908-1290
E-mail: service@hexal.com

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben

This leaflet was last revised in August 2017.

Source: Package information
Status: 02/2018
Active ingredient: Dimenhydrinate. Areas of application: for the prevention and treatment of motion sickness, dizziness, nausea and vomiting.