Aviomarin

Package Leaflet: Information for the User

AVIOMARIN

Dimenhydrinate
50 mg, tablets

Read the entire leaflet carefully, as it contains important information for the patient.

This medicine is available without a prescription, so that some conditions can be treated without the help of a doctor.
However, to achieve good treatment results, the Aviomarin medicine should be used with caution.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, a doctor, pharmacist, or nurse should be consulted.
• This medicine has been prescribed for a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Aviomarin and what is it used for
• 2. Important information before using Aviomarin
• 3. How to use Aviomarin
• 4. Possible side effects
• 5. How to store Aviomarin
• 6. Contents of the pack and other information

1. WHAT IS AVIOMARIN AND WHAT IS IT USED FOR

Aviomarin contains the active substance dimenhydrinate (dimenhydramine), which has antiemetic, antihistamine, and mild sedative effects.
The medicine is used to prevent motion sickness and to prevent and treat nausea and vomiting of other origins (except those caused by anti-cancer chemotherapy).
The onset of action occurs within 20-30 minutes. The therapeutic effects are observed for 3 to 6 hours after administration of the medicine.

2. IMPORTANT INFORMATION BEFORE USING AVIOMARIN

When not to use Aviomarin

• if the patient is allergic to the active substance, antihistamines, or any of the other ingredients of the medicine (listed in section 6).
• if the patient has:
• acute asthma attack
• glaucoma with narrow angle of filtration,
• chromaffin tumor,
• porphyria,
• prostate hypertrophy and urine retention in the bladder,
• epilepsy. Due to the dose size (strength), Aviomarin, 50 mg, tablets are not intended for children under 6 years of age.

Warnings and precautions

Caution should be exercised when using Aviomarin in patients:

• with liver function disorders,
• with hyperthyroidism,
• with bradycardia (slow heart rate), hypertension,
• with hypokalemia, magnesium deficiency in the blood,
• with chronic respiratory difficulties, asthma,
• with pyloric stenosis,
• with congenital long QT syndrome or other heart function disorders, e.g., coronary artery disease, cardiovascular diseases, arrhythmia.

Special caution is also recommended when taking certain anti-arrhythmic drugs that prolong the QT interval in the ECG or lead to a decrease in potassium or magnesium levels in the serum.

Aviomarin and other medicines:

The doctor should be informed about all medicines currently or recently used by the patient, as well as any medicines planned to be used.
Aviomarin should not be used simultaneously with anti-arrhythmic drugs, central nervous system depressants, or alcohol.
The medicine should not be used simultaneously with atropine, tricyclic antidepressants, catecholamines, central nervous system depressants, such as sleeping pills or sedatives, as Aviomarin enhances their effects. Aviomarin used with bismuth salts and painkillers, psychotropic drugs, and scopolamine may cause transient visual impairment (impairment of vision in the dark and color vision).
Aviomarin weakens the effects of corticosteroids and oral anticoagulants.
It is recommended to avoid combining Aviomarin with ototoxic medicines (damaging hearing), such as aminoglycoside antibiotics.
Monoamine oxidase inhibitors (MAO, antidepressants) may enhance the antihistamine and sedative effects of dimenhydrinate.
Special caution is recommended when using dimenhydrinate with medicines that prolong the QT interval in the ECG (some anti-arrhythmic drugs, some antibiotics, e.g., erythromycin, antimalarial drugs, antihistamines, neuroleptics) and with medicines that decrease potassium levels in the serum (e.g., some diuretics).
Aviomarin should be discontinued at least three days before planned allergy tests due to the possibility of obtaining false-negative results.

Using Aviomarin with food and drink:

Aviomarin can be taken regardless of meals. The tablet should be swallowed with a sufficient amount of water.

Pregnancy and breastfeeding

Before using any medicine, a doctor should be consulted.
Aviomarin should not be used in the third trimester of pregnancy. In the first and second trimesters of pregnancy, as well as during breastfeeding, the medicine can be used only if, in the doctor's opinion, the benefits of treatment outweigh the potential risk to the child.

Driving and operating machinery

Aviomarin impairs psychophysical fitness, so it should not be used by people driving vehicles and operating machinery in motion.

3. HOW TO USE AVIOMARIN

Aviomarin should be taken orally.
The recommended dose should be taken at least 30 minutes before the planned trip or administration of a poorly tolerated medicine.
Adults and adolescents over 14 years:
The recommended dose is 50 mg to 100 mg. If necessary, it can be repeated every 4 to 6 hours.
The maximum daily dose should not exceed 400 mg.
Children from 6 to 14 years:
The recommended dose is 50 mg. If necessary, it can be repeated every 6 to 8 hours.
The maximum daily dose in children should not exceed 5 mg/kg body weight, but not more than 150 mg per day.
Aviomarin is intended for children who are able to swallow the tablet independently.
Due to the dose size (strength), Aviomarin, 50 mg, tablets are not intended for children under 6 years of age.

Using a higher dose of Aviomarin than recommended

The first symptoms of overdose occur after about 30 minutes to 2 hours after taking a toxic dose (25 mg/kg body weight) and are mainly: headaches and dizziness, increasing fatigue and drowsiness. After some time, additional symptoms may occur: skin itching, vasodilation, pupil dilation with slowed reaction to light and accommodation paresis, nystagmus, muscle weakness, decreased reflexes, and urinary retention.
Heart rate is significantly accelerated, blood pressure is elevated or decreased. In the further course, symptoms of central nervous system depression (speech disorders, disorientation in time and space, clumsiness, coma) or central nervous system stimulation (seizures, hallucinations) gradually increase.
In case of dimenhydrinate overdose, intensive symptomatic treatment should be applied.

Missing a dose of Aviomarin

A missed dose should be taken as soon as possible.
A double dose should not be taken to make up for a missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Aviomarin can cause side effects, although they may not occur in every patient.
Very common (occurring in 1 or more out of 10 patients) side effects are: drowsiness, concentration disorders, dizziness.
Common (occurring in 1 or more out of 100 patients) side effects are: stimulation, sleep disorders, anxiety, tremors, vision disorders, increased intraocular pressure, nausea, vomiting, diarrhea (in case of allergy to dimenhydrinate), constipation, abdominal pain, dryness of the oral mucosa, feeling of weakness and fatigue, difficulty urinating, muscle weakness.
Rare (occurring in 1 or more out of 10,000 patients) side effects are: accelerated heart rate, decreased blood pressure, hemolytic anemia, headaches, insomnia, allergic skin reactions, increased sensitivity of the skin to sunlight, liver function disorders, cholestatic jaundice.
Very rare (occurring in less than 1 out of 10,000 patients) side effects are: exfoliative dermatitis and decreased appetite.
Long-term use of dimenhydrinate may lead to drug dependence.
During the use of dimenhydrinate in children, paradoxical reactions may occur (e.g., anxiety, irritability, tremors).
Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. HOW TO STORE AVIOMARIN

Store at a temperature below 25°C. Protect from light.
The medicine should be stored in a place inaccessible and invisible to children.
The medicine should not be used after the expiration date stated on the packaging.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aviomarin contains

The active substance of the medicine is dimenhydrinate.
Excipients: microcrystalline cellulose, talc, anhydrous colloidal silica, magnesium stearate

What Aviomarin looks like and contents of the pack

White, round tablets with the inscription "A" on one side.
The pack contains 3, 5, or 10 tablets.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Kraków
Date of leaflet approval:April 2022