Aviomarin
Poland
Table of Contents
Package leaflet: Information for the user
AVIOMARIN
Dimenhydrinate
50 mg, tablets
Please read the entire leaflet carefully, as it contains important information for the patient.
This medicine is available without a prescription so that certain conditions can be treated without medical assistance.
However, in order to achieve a good treatment outcome, Aviomarin should be used carefully.
- Keep this leaflet, as you may need to read it again.
- If you have any doubts, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for a specific individual. Do not give it to others. This medicine may harm another person, even if their symptoms are the same.
- If any adverse effects occur in the patient, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Contents of the leaflet
- What Aviomarin is and what it is used for
- Important information before taking Aviomarin
- How to take Aviomarin
- Possible side effects
- How to store Aviomarin
- Contents of the package and other information
1. WHAT AVIOMARIN IS AND WHAT IT IS USED FOR
Aviomarin contains dimenhydrinate as the active substance, which has antiemetic, antiallergic, and mild sedative properties.
The medicine is used to prevent motion sickness and to prevent and treat nausea and vomiting of other causes (except those induced by drugs used in cancer chemotherapy).
The onset of action occurs within 20–30 minutes. Therapeutic effects last for 3 to 6 hours after administration.
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 this medicine (listed in section 6),
- if the patient has:
- acute asthma attack,
- narrow-angle glaucoma,
- pheochromocytoma,
- porphyria,
- benign prostatic hyperplasia with urinary retention,
- epilepsy.
Due to its strength (potency), Aviomarin 50 mg tablets are not intended for children under 6 years of age.
Warnings and precautions
Exercise caution when administering Aviomarin to patients:
- with impaired liver function,
- with hyperthyroidism,
- with bradycardia (slowed heart rate), hypertension,
- with hypokalemia, magnesium deficiency in blood,
- with chronic breathing difficulties, asthma,
- with pyloric stenosis,
- with congenital long QT syndrome or other cardiac disorders, e.g., coronary heart disease, cardiovascular diseases, arrhythmia.
Particular caution is also advised when Aviomarin is taken concomitantly with certain antiarrhythmic drugs that prolong the QT interval in ECG, or those leading to decreased serum potassium or magnesium levels.
Aviomarin and other medicines
Inform your doctor about all medicines currently used or recently used, as well as any medicines planned for future use.
Aviomarin must not be used simultaneously with antiarrhythmic drugs that depress central nervous system function, or with alcohol.
Do not use Aviomarin together with atropine, tricyclic antidepressants, catecholamines, or central nervous system depressants such as sedatives or hypnotics, as Aviomarin may enhance their effects.
Aviomarin, when used with bismuth salts, analgesics, psychotropic drugs, and scopolamine, may cause transient visual disturbances (impaired vision in darkness and color vision).
Aviomarin reduces the effectiveness of corticosteroids and oral anticoagulants.
Avoid combining Aviomarin with ototoxic drugs (drugs that damage hearing), such as aminoglycoside antibiotics.
Monoamine oxidase inhibitors (MAO inhibitors, antidepressant drugs) may enhance the antihistaminic and sedative effects of dimenhydrinate.
Extreme caution is recommended when using dimenhydrinate together with drugs that prolong the QT interval in ECG (e.g., certain antiarrhythmics, certain antibiotics such as erythromycin, antimalarial drugs, antihistamines, neuroleptics) and with drugs that reduce serum potassium levels (e.g., certain diuretics).
Aviomarin should be discontinued at least three days before planned allergy testing, as it may lead to false-negative results.
Taking Aviomarin with food and drink
Aviomarin may be taken regardless of meals. The tablet should be taken with sufficient amount of water.
Pregnancy and breastfeeding
Before taking any medicine, consult a doctor.
Do not use Aviomarin during the third trimester of pregnancy. During the first and second trimesters of pregnancy, as well as during breastfeeding, Aviomarin should only be used if, in the opinion of the physician, the benefits of treatment outweigh the potential risks to the child.
Driving and operating machinery
Aviomarin impairs psycho-motor performance. Therefore, it should not be used by individuals who drive motor vehicles or operate mechanical equipment.
3. HOW TO USE AVIOMARIN MEDICINAL PRODUCT
Aviomarin should be taken orally.
The recommended dose should be taken at least 30 minutes before the planned journey or ingestion of a poorly tolerated drug.
Adults and adolescents over 14 years of age:
The recommended dose is 50 mg to 100 mg. If necessary, it may be repeated every 4 to 6 hours.
The maximum daily dose should not exceed 400 mg.
Children aged 6 to 14 years:
The recommended dose is 50 mg. If necessary, it may be repeated every 6 to 8 hours.
The maximum daily dose in children should not exceed 5 mg/kg body weight, with a maximum of 150 mg per day.
Aviomarin is intended for children who are able to swallow the tablet independently.
Due to the dosage strength, Aviomarin 50 mg tablets are not intended for children under 6 years of age.
Use of a higher than recommended Aviomarin dose
The first symptoms of overdose occur approximately 30 minutes to 2 hours after ingestion of a toxic dose (25 mg/kg b.w.) and consist mainly of: headache and dizziness, increasing fatigue and drowsiness. After some time, additional symptoms may appear: skin itching, skin blood vessel dilation, pupil dilation with slowed reaction to light and accommodation paralysis, nystagmus, decreased muscle strength, diminished tendon reflexes, and urinary retention.
Heart function is distinctly accelerated, and blood pressure may be elevated or lowered. In the further course, symptoms of central nervous system depression gradually increase (speech disturbances, disorientation in time and space, motor incoordination, coma) or central nervous system stimulation (seizures, hallucinations).
In case of dimenhydrinate overdose, intensive symptomatic treatment should be administered.
Missed dose of Aviomarin
A missed dose should be taken as soon as possible.
Do not take a double dose to make up for a missed dose.
4. POSSIBLE ADVERSE REACTIONS
Like all medicines, Aviomarin may cause adverse reactions, although not everyone experiences them.
Very common (occurring in 1 or more out of 10 patients) adverse reactions include: drowsiness,
concentration disturbances, dizziness.
Common (occurring in 1 or more out of 100 patients) adverse reactions include: excitement,
sleep disturbances, anxiety, tremor, visual disturbances, increased intraocular pressure,
nausea, vomiting, diarrhoea (in case of hypersensitivity to dimenhydrinate), constipation, abdominal pain,
dryness of the oral mucosa, feeling of weakness and fatigue, difficulty in urination, muscle weakness.
Rare (occurring in 1 or more out of 10,000 patients) adverse reactions include:
accelerated heart rate, decrease in blood pressure, haemolytic anaemia, headache, insomnia,
skin allergic reactions, photosensitivity, liver function disorders, cholestatic jaundice.
Very rare (occurring in less than 1 out of 10,000 patients) adverse reactions include:
exfoliative dermatitis and decreased appetite.
Long-term use of dimenhydrinate may lead to drug dependence.
Paradoxical reactions (e.g. anxiety, irritability, tremor) may occur in children during dimenhydrinate use.
Reporting of adverse reactions
If any adverse symptoms occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 2-222 Warsaw
Tel: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of using this medicine.
5. HOW TO STORE AVIOMARIN
Store below 25°C. Protect from light.
Keep the medicine in a place inaccessible and out of sight of children.
Do not use the medicine after the expiry date stated on the packaging.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Aviomarin contains
The active substance is dimenhydrinate.
Excipients: microcrystalline cellulose, talc, colloidal anhydrous silica, magnesium stearate.
What Aviomarin looks like and contents of the pack
White, round tablets with the imprint “A” on one side.
The pack contains 3, 5 or 10 tablets.
Marketing Authorisation 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