Mobillek

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: patient information

Mobillek, 50 mg, chewable tablets

Dimenhydrinate

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

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

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Mobillek and what is it used for
• 2. Important information before taking Mobillek
• 3. How to take Mobillek
• 4. Possible side effects
• 5. How to store Mobillek
• 6. Package contents and other information

1. What is Mobillek and what is it used for

Mobillek contains the active substance dimenhydrinate, 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 chemotherapy and gastritis). The onset of action occurs within 15-30 minutes.

2. Important information before taking Mobillek

When not to take Mobillek:

• 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, prostatic hyperplasia, and urinary retention or epilepsy. Due to the dose size (strength), Mobillek is not intended for children under 6 years of age.

Warnings and precautions

Caution should be exercised when using Mobillek in patients:

• with liver or kidney 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, such as coronary artery disease, cardiovascular diseases, arrhythmia;
• taking medications that prolong the QT interval in the ECG or medications that lead to hypokalemia;
• in elderly patients with increased susceptibility to orthostatic hypotension, dizziness, and sedation.

Mobillek and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Mobillek should not be used concurrently with anti-arrhythmic medications, central nervous system depressants, or alcohol.
The medicine should not be used concurrently with atropine, tricyclic antidepressants, catecholamine amines, or central nervous system depressants, such as sleeping pills or sedatives, as Mobillek enhances their effects.
Dimenhydrinate enhances the effects of other anticholinergic medications, such as atropine or tricyclic antidepressants. Monoamine oxidase inhibitors (MAOIs, antidepressants) may enhance the antihistamine and sedative effects of dimenhydrinate.
Mobillek used with bismuth salts and painkillers, psychotropic medications, and scopolamine may cause transient visual impairment (impairment of dark vision and color vision).
Mobillek reduces the effects of corticosteroids and oral anticoagulants.
Dimenhydrinate in combination with blood pressure-lowering medications may enhance their hypotensive effects.
Particular caution is advised when using dimenhydrinate with medications that prolong the QT interval in the ECG (some anti-arrhythmic medications, some antibiotics, e.g., erythromycin, antimalarial medications, antihistamines, neuroleptics) and medications that reduce potassium levels in the serum (e.g., some diuretics).
It is recommended to avoid combining Mobillek with ototoxic medications (harmful to hearing), such as aminoglycoside antibiotics.
Administration of Mobillek should be discontinued at least three days before scheduled allergy tests, due to the possibility of obtaining false-negative results.

Mobillek with food and drink

The medicine can be taken regardless of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Mobillek 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 only be used if, in the doctor's opinion, the benefits of treatment outweigh the potential risk to the child.

Driving and operating machinery

Mobillek impairs psychophysical abilities, including drowsiness and reduced alertness. The medicine should not be used in individuals who drive vehicles or operate machinery.

Mobillek contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, which means it is considered "sodium-free".

The medicine contains maltodextrin, a source of glucose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Mobillek

This medicine should always be taken exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
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 of age: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 between 6 and 14 years of age: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 no more than 150 mg per day. Mobillek is intended for children who are able to chew and swallow the tablet.
Due to the dose size (strength), Mobillek, 50 mg, chewable tablets are not intended for children under 6 years of age.

Overdose of Mobillek

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 characterized by 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, ataxia, and coma) or central nervous system stimulation (seizures, hallucinations) gradually increase.
In case of dimenhydrinate overdose, intensive symptomatic treatment should be applied.

Missed dose of Mobillek

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, Mobillek can cause side effects, although not everybody gets them.
Very common(occurring in 1 or more out of 10 patients) side effects include:
drowsiness, concentration disorders, dizziness.
Common(occurring in 1 or more out of 100 patients) side effects include:
excitement, sleep disorders, anxiety, tremors, vision disorders, increased intraocular pressure, nausea, vomiting, diarrhea (in case of dimenhydrinate allergy), 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 include:
accelerated heart rate, decreased blood pressure, hemolytic anemia, headaches, insomnia, skin allergic reactions, increased sensitivity to sunlight, liver function disorders, cholestatic jaundice.
Very rare(occurring in less than 1 out of 10,000 patients) side effects include:
exfoliative dermatitis and decreased appetite.
Prolonged use of dimenhydrinate may lead to drug dependence.
During the use of dimenhydrinate in children, paradoxical reactions (e.g., anxiety, irritability, tremors) may occur.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Mobillek

Store in a temperature below 25°C. Store in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiration date stated on the box and blister after: EXP.
The expiration date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. Consult a pharmacist on how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Mobillek contains

• The active substance of the medicine is dimenhydrinate.
• Other ingredients (excipients) are: microcrystalline cellulose, type 101, heavy magnesium oxide, red iron oxide (E 172), purified water, colloidal silica, anhydrous, butyl methacrylate copolymer, basic, microcrystalline cellulose, type 102, crospovidone, type A, strawberry flavor [maltodextrin, propylene glycol, strawberry flavor, ascorbic acid], bitter taste masking flavor [sucralose, maltodextrin, propylene glycol, arabic gum, maltol (E 636), 4-hydroxy-2,5-dimethyl-3(2H)-furanone, 4-(4-hydroxyphenyl)-2-butanone], sodium stearyl fumarate.

What Mobillek looks like and what the package contains

Pink, speckled, round, biconvex chewable tablets.
The package contains 5 or 10 chewable tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Date of last revision of the leaflet: