Efektan Max

Leaflet attached to the packaging: information for the user

Efektan Max, 50 mg/5 mL, oral solution in a sachet

Dimenhydrinate

You should carefully read the contents of the leaflet before using 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 advised by a doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell 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 Efektan Max and what is it used for
• 2. Important information before taking Efektan Max
• 3. How to take Efektan Max
• 4. Possible side effects
• 5. How to store Efektan Max
• 6. Contents of the packaging and other information

1. What is Efektan Max and what is it used for

Efektan Max contains the active substance dimenhydrinate (dimenhydramine), which has antiemetic, antihistaminic, and mildly sedative effects.
Efektan Max is used to prevent motion sickness and to prevent and treat nausea and vomiting of other origins (except those caused by anticancer chemotherapy).
The onset of action occurs after 30 minutes. The therapeutic effects are observed for 3 to 6 hours after administration of the medicine.

2. Important information before taking Efektan Max

When not to take Efektan Max

• if the patient is allergic to dimenhydrinate, antihistamines, or any of the other ingredients of the medicine (listed in section 6),
• if the patient has:
• acute asthma attack,
• narrow-angle glaucoma,
• chromaffin tumor (a type of tumor),
• porphyria (a blood disorder),
• prostate enlargement and urine retention in the bladder,
• epilepsy.
• Efektan Max is not intended for children under 6 years of age.

Warnings and precautions

Before starting to take Efektan Max, the patient should discuss it with their doctor or pharmacist:

• if the patient has liver function disorders,
• if the patient has hyperthyroidism (excessive thyroid activity),
• if the patient has bradycardia (slow heart rate), hypertension,
• if the patient has potassium or magnesium deficiency in the blood,
• if the patient has chronic breathing difficulties,
• if the patient has asthma,
• if the patient has pyloric stenosis,
• if the patient has congenital long QT syndrome or other heart function disorders, e.g., coronary artery disease, cardiovascular disease, arrhythmia.

Special caution is also recommended when taking dimenhydrinate with certain antiarrhythmic drugs that prolong the QT interval in the ECG, or those that lead to a decrease in potassium or magnesium levels in the serum.
Efektan Max should only be used to prevent or alleviate nausea and vomiting.
There have been reports of abuse and dependence on the medicine, mainly with long-term use for relaxation purposes or by patients with mental disorders, in doses that significantly exceeded the recommended doses.
The maximum daily dose should not be exceeded.

Efektan Max and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Efektan Max should not be taken at the same time as antiarrhythmic medicines that depress the activity of the central nervous system.
The medicine should not be taken at the same time as atropine, tricyclic antidepressants, catecholamines, or drugs that depress the central nervous system, such as sleeping pills or sedatives, as Efektan Max enhances their effects.
Efektan Max taken with bismuth salts and painkillers, psychotropic drugs, and scopolamine may cause transient visual disturbances (impairment of vision in the dark and color vision).
Efektan Max weakens the effects of corticosteroids and oral anticoagulants.
The patient should avoid combining Efektan Max with ototoxic drugs (damaging to hearing), such as aminoglycoside antibiotics.
Monoamine oxidase inhibitors (MAOIs, antidepressants) may enhance the antihistaminic and sedative effects of dimenhydrinate.
Special caution is recommended when taking dimenhydrinate with drugs that prolong the QT interval in the ECG (certain antiarrhythmic drugs, certain antibiotics, e.g., erythromycin, antimalarial drugs, antihistamines, neuroleptics) and with drugs that decrease potassium levels in the serum (e.g., certain diuretics).
The patient should stop taking Efektan Max at least three days before planned allergy tests, as this may result in false-negative test results.

Taking Efektan Max with food and drink

Efektan Max can be taken regardless of meals.
The patient should avoid consuming alcohol while taking Efektan Max, as it may alter and enhance its effects.

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.
Efektan Max should not be taken during the third trimester of pregnancy. In the first and second trimesters of pregnancy, as well as during breastfeeding, the medicine can only be taken if, in the doctor's opinion, the benefits of treatment outweigh the potential risk to the child.

Driving and operating machinery

Efektan Max impairs psychophysical abilities, so it should not be taken by people driving vehicles or operating machinery.

Efektan Max contains sucrose, propylene glycol, and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. Each sachet contains 2000 mg of sucrose. This should be taken into account in patients with diabetes.
Each sachet contains 814.34 mg of propylene glycol, which corresponds to 814.34 mg/5 mL.
Pregnant or breastfeeding women should not take this medicine without their doctor's recommendation.
The doctor may decide to perform additional tests on such patients.
Patients with liver or kidney function disorders should not take this medicine without their doctor's recommendation. The doctor may decide to perform additional tests on such patients.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, which means it is considered "sodium-free".

3. How to take Efektan Max

This medicine should be taken orally.
Do not exceed the maximum daily dose.
The recommended dose should be taken at least 30 minutes before the planned trip or administration of a poorly tolerated medicine.
Due to the dose size (strength), Efektan Max is not intended for use in children under 6 years of age.
Adults and adolescents over 14 years of age:
The recommended dose is 50 mg to 100 mg (1-2 sachets).
If necessary, it can be repeated every 4 to 6 hours.
The maximum daily dose should not exceed 400 mg (no more than 8 sachets per day).
Children from 6 to 14 years of age:
The recommended dose is 25 to 50 mg (a maximum of 1 sachet of Efektan Max 50 mg/5 mL).
If a dose of 25 mg is required, a lower-strength medicine, Efektan 25 mg/5 mL, should be administered.
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 (no more than 3 sachets per day).

Method of administration

The contents of one sachet should be taken directly.

Taking a higher dose of Efektan Max than recommended

If a higher dose of Efektan Max than recommended is taken, the patient should immediately contact their doctor.
The first symptoms of overdose occur after about 30 minutes to 2 hours after taking a toxic dose (25 mg/kg body weight). Symptoms of overdose may include: dry mouth, dry and hot skin, facial flushing, itching, pupil dilation, vision disturbances, rapid and irregular heartbeat, shortness of breath, headache, dizziness, nystagmus, fever, muscle weakness, urinary retention, slow bowel movement, anxiety, agitation, increased muscle reflexes, muscle spasms, disorientation, concentration problems, speech disorders, seizures, coordination and balance problems, and drowsiness.
Symptoms of severe overdose are: seizures, seeing or hearing things that do not exist (hallucinations), disturbances in thinking and decreased consciousness, breathing difficulties, and loss of consciousness, hyperthermia. If such symptoms occur, the patient should immediately contact their doctor.
Treatment of overdose should be symptomatic and supportive. The patient should not be given an emetic.

Missing a dose of Efektan Max

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

Stopping treatment with Efektan Max

Sudden cessation of treatment with the medicine after long-term use may cause sleep disturbances.
Therefore, the medicine should be discontinued by gradually reducing the dose. The patient should consult their doctor for further medical advice.
If the patient has any further questions about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Efektan Max can cause side effects, although not everybody gets them.
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: agitation, sleep disorders, anxiety, tremors, vision disturbances, increased intraocular pressure, nausea, vomiting, diarrhea (in case of allergy to dimenhydrinate), constipation, abdominal pain, dry mouth, muscle weakness, urinary retention, feeling of tiredness.
Rare (occurring in 1 or more out of 10,000 patients)side effects are: hemolytic anemia, headaches, difficulty falling asleep, rapid heartbeat, decreased blood pressure, liver function disorders, cholestatic jaundice, skin allergic reactions, increased sensitivity of the skin to sunlight.
Very rare (occurring in less than 1 out of 10,000 patients)side effects are: decreased appetite, exfoliative dermatitis.
Long-term use of dimenhydrinate may lead to drug dependence.
When taking dimenhydrinate in children, paradoxical reactions may occur (e.g., anxiety, irritability, tremors).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of 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
By reporting side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Efektan Max

The medicine should be stored out of sight and reach of children.
Do not store above 25°C. Do not store in the refrigerator or freeze.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Efektan Max contains

The active substance of the medicine is dimenhydrinate.
The other ingredients are sucrose, sodium saccharin (E 954), propylene glycol, blackcurrant flavor (propylene glycol, lactic acid, 4-(4-hydroxyphenyl)-2-butanone, butyric acid, damaskone beta, furaneol), purified water.

What Efektan Max looks like and contents of the packaging

Oral solution in sachets. Colorless liquid with a blackcurrant flavor and aroma.
Efektan Max is packaged in PET/Aluminum/PE sachets placed in a cardboard box.
The packaging contains 5 or 10 single sachets, each containing 5 mL of oral solution .

Marketing authorization holder and manufacturer

Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
To obtain more detailed information about the medicine, the patient should contact:
Gedeon Richter Polska Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]

Date of last revision of the leaflet:

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