Aviorexan

Package Leaflet: Information for the User

Aviorexan, 50 mg + 50 mg, Coated Tablets

Dimenhydrinate + Caffeine

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If you do not feel better or if you feel worse, you should contact a doctor.

Table of Contents of the Leaflet:

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

1. What is Aviorexan and what is it used for

Aviorexan is a combination medicine containing two active substances: dimenhydrinate and caffeine.
Dimenhydrinate belongs to a group of antihistamine medicines. Caffeine has a stimulating effect on the nervous system. Both substances help reduce the symptoms of motion sickness. Caffeine counteracts the sedative effect of dimenhydrinate.
The medicine is indicated for the prevention and treatment of symptoms associated with motion sickness (nausea, vomiting, dizziness).
The onset of action occurs within 15-30 minutes. The therapeutic effects are observed for 3 to 6 hours after administration of the medicine.

2. Important information before taking Aviorexan

When not to take Aviorexan:

• if you are allergic to dimenhydrinate, caffeine, or any of the other ingredients of this medicine (listed in section 6).
• if you have:
• porphyria,
• acute asthma attack,
• severe cardiovascular disorders,
• uncontrolled hypertension,
• insomnia and anxiety disorders,
• epilepsy,
• gastric and (or) duodenal ulcers,
• severe liver disorders,
• glaucoma with a narrow angle of filtration,
• adrenal gland tumor (pheochromocytoma).

Aviorexan is not recommended for use in children and adolescents under 12 years of age.

Warnings and precautions

Before starting treatment with Aviorexan, you should discuss it with your doctor or pharmacist.
Caution should be exercised when using in patients with hypersensitivity to other antihistamine medicines, as cross-reactions may occur.
Caution should be exercised in patients:

• with hypersensitivity to allergy-relieving medicines (antihistamines) or xanthine derivatives (e.g., theophylline and aminophylline used in the treatment of asthma and chronic obstructive pulmonary disease),
• with prostate enlargement,
• with difficulty urinating,
• with narrowing of the gastrointestinal tract or pyloric stenosis,
• with hyperthyroidism,
• with glaucoma with a closed angle of filtration,
• with bronchial and (or) pulmonary diseases: chronic bronchitis, asthma, chronic obstructive pulmonary disease, pulmonary emphysema,
• with heart rhythm disorders,
• with coronary heart disease,
• with diabetes.

Elderly patients may be more susceptible to side effects caused by dimenhydrinate.

Aviorexan and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Aviorexan should not be used with the following medicines:

• barbiturates (often used as sedatives), sedatives and tranquilizers (used to treat nervous tension, depression, and anxiety), atropine (a muscle relaxant often used during eye exams) - concurrent use may cause drowsiness or sleepiness;
• tricyclic antidepressants (used to treat depression and anxiety) - Aviorexan may enhance their effect;
• phototoxic medicines (medicines that increase skin sensitivity to sunlight and cause allergic reactions due to sun exposure) - Aviorexan may enhance their effect;
• aminoglycosides (a type of antibiotic) - they may damage the inner ear, and during Aviorexan use, such damage may be masked;
• disulfiram (used to treat alcoholism) - caffeine may exacerbate alcohol withdrawal syndrome;
• MAO inhibitors (used to treat depression) - concurrent use may cause increased blood pressure and heart rate (tachycardia);
• lithium (used to treat bipolar disorder) - caffeine may increase lithium excretion by the kidneys;
• theophylline (used to treat asthma and chronic obstructive pulmonary disease) - caffeine may decrease its excretion.

Contraceptives slow down caffeine metabolism in the liver.
Additionally, Aviorexan may alter skin reactions to allergens during skin tests. You should not use Aviorexan for at least three days before planned allergy tests.

Aviorexan with food and drink

Taking Aviorexan with a meal may reduce the risk of gastrointestinal irritation.
During Aviorexan use, you should avoid consuming alcohol, as it may alter and enhance the effect of the medicine's components.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use Aviorexan 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.
The medicine passes into breast milk; it should be used with caution, only after careful consideration of the benefit-to-risk ratio for the mother and the risk to the breastfed child.

Driving and using machines

Dimenhydrinate impairs psychophysical performance; therefore, it should not be used by people driving vehicles and operating machines.

3. How to take Aviorexan

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If you have any doubts, consult a doctor or pharmacist.

Adults and adolescents over 12 years of age

The recommended dose is 1-2 tablets.
If necessary, the dose can be repeated after 4-6 hours.
Do not exceed the dose of 8 tablets per day.
In the prevention of motion sickness symptoms, the first dose should be taken no later than 30 minutes before the planned trip.

Use in children under 12 years of age

It is not recommended to use the medicine in children under 12 years of age.

Patients with liver or kidney function disorders and elderly patients

Caution should be exercised in patients with liver and (or) kidney function disorders, as well as in elderly patients.
The medicine is contraindicated in patients with severe liver disorders.

Method of administration

Oral administration.
The tablet should be swallowed whole, washed down with water or milk.

Overdose of Aviorexan

In case of overdose or accidental ingestion by a child, contact a doctor or pharmacist.

Missed dose of Aviorexan

In case of a missed dose, continue taking the medicine according to the regular dosing schedule. Do not take a double dose to make up for the missed dose.

Stopping Aviorexan treatment

If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Aviorexan can cause side effects, although not everybody gets them.
The following side effects may occur during treatment with Aviorexan:

Side effects related to dimenhydrinate:

Rare(may affect up to 1 in 1000 people)

• anemia,
• leukopenia (reduced white blood cell count),
• thrombocytopenia (reduced platelet count),
• pancytopenia (reduced count of all blood cell types, i.e., white, red, and platelets),
• agranulocytosis (significant reduction or absence of granulocytes in the blood).

Very rare(may affect up to 1 in 10,000 people)

• paradoxical stimulation (especially in children, paradoxical reactions such as insomnia, nervousness, confusion, convulsions, irritability, euphoria, delirium, palpitations, and convulsions may occur),
• tachycardia (rapid heart rate)*,
• heart rhythm disorders* (including extrasystoles - extra heartbeats, heart block),
• increased blood pressure,
• decreased blood pressure,
• increased bronchial secretion that may lead to breathing difficulties.

* reactions usually associated with dimenhydrinate overdose
Frequency not known(frequency cannot be estimated from the available data)

• anaphylactic reactions,
• allergic reactions,
• decreased appetite,
• stimulation,
• sleep disorders,
• anxiety,
• tremors,
• drowsiness,
• sedation,
• dizziness,
• headache,
• vision disorders,
• increased eye pressure,
• nausea,
• vomiting,
• diarrhea,
• constipation,
• abdominal pain,
• dry mouth,
• skin allergic reactions,
• increased skin sensitivity to sunlight,
• dermatitis,
• itching,
• rash,
• flushing,
• difficulty urinating,
• sexual function disorders,
• exacerbation of porphyria,
• fatigue.

Side effects related to caffeine:

Common(may affect up to 1 in 10 people)

• insomnia,
• stimulation,
• increased blood pressure,
• decreased blood pressure,

Uncommon(may affect up to 1 in 100 people)

• decreased blood glucose levels,
• increased blood glucose levels,
• anxiety (high doses may cause nervousness and anxiety),
• irritability,
• headache,
• tinnitus,
• hot flashes,
• tachycardia (rapid heart rate),
• heart rhythm disorders,
• palpitations (unpleasant sensation of irregular and (or) forceful heartbeats),
• rapid breathing,
• nausea,
• vomiting,
• diarrhea,
• abdominal pain,
• urinary frequency (need to urinate more often than usual).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181 C, 02-222 Warsaw
Phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Aviorexan

Store the medicine out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiration date stated on the carton after: Expiration Date (EXP).
The expiration date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aviorexan contains

The active substances of the medicine are dimenhydrinate and caffeine.
Each coated tablet contains 50 mg of dimenhydrinate (Dimenhydrinatum) and 50 mg of caffeine (Coffeinum).

• Other ingredients are: Tablet core: microcrystalline cellulose, crospovidone Type A, povidone K 29/32, colloidal silica anhydrous, magnesium stearate. Tablet coating: hypromellose, titanium dioxide (E 171), macrogol 6000, talc.

What Aviorexan looks like and contents of the pack

Aviorexan is a white, round, biconvex coated tablet with "NC" embossed on one side.
PA/Aluminum/PVC/Aluminum blisters in a cardboard box.
The pack contains: 10 coated tablets.

Marketing authorization holder

Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
Phone: +48 61 66 51 500
e-mail: [email protected]

Manufacturer

Laboratorios Normon, S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos - Madrid
Spain

Date of last revision of the leaflet: