Patient Information Leaflet

Efektan Max, 50 mg/5 mL, oral solution in sachet
Dimenhydrinate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor or pharmacist. See section 4.
If your condition does not improve or worsens, contact your doctor.

Table of contents

What Efektan Max is and what it is used for
Important information before taking Efektan Max
How to take Efektan Max
Possible side effects
How to store Efektan Max
Contents of the pack and other information

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

Efektan Max contains the active substance dimenhydrinate, which has antiemetic, antiallergic and mild sedative properties.
Efektan Max is used to prevent motion sickness and to prevent and treat nausea and vomiting of various origins (except those caused by drugs used in cancer chemotherapy).
The onset of action occurs within 30 minutes. Therapeutic effects last for 3 to 6 hours after administration.

2. Information before using Efektan Max

When not to use 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,
pheochromocytoma (a type of tumour),
a blood disorder called porphyria,
benign prostatic hyperplasia with urinary retention,
epilepsy.
Efektan Max is not intended for children under 6 years of age.

Warnings and precautions
Before starting to use Efektan Max, discuss this with your doctor or pharmacist:

if the patient has liver function disorders,
if the patient has hyperthyroidism (overactive thyroid),
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 heart disease, circulatory system disorders, arrhythmia.

Special caution is also advised when taking concurrently certain antiarrhythmic drugs that prolong the QT interval on ECG, or drugs that lead to decreased serum potassium or magnesium levels.
Efektan Max should be used only to prevent or relieve nausea and vomiting.
Cases of drug abuse and dependence have been reported, mainly with long-term use for relaxation purposes or by patients with psychiatric disorders, at doses significantly exceeding the recommended doses.
Do not exceed the maximum daily dose.

Efektan Max and other medicines
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
Efektan Max should not be used simultaneously with antiarrhythmic drugs that depress central nervous system function.
The medicine should not be used simultaneously with atropine, tricyclic antidepressants, catecholamines, or central nervous system depressants such as sleeping pills or sedatives, as Efektan Max enhances their effects.
Efektan Max used together with bismuth salts and analgesics, psychotropic drugs, and scopolamine may cause transient visual impairment (reduced vision in darkness and impaired color vision).
Efektan Max reduces the effectiveness of corticosteroids and oral anticoagulants.
Avoid combining Efektan Max with ototoxic drugs (drugs damaging hearing), such as aminoglycoside antibiotics.
Monoamine oxidase inhibitors (MAO inhibitors, antidepressants) may enhance the antihistaminic and sedative effects of dimenhydrinate.
Particular caution is recommended when using dimenhydrinate together with drugs that prolong the QT interval on ECG (some antiarrhythmics, certain antibiotics such as erythromycin, antimalarial drugs, antihistamines, neuroleptics) and with drugs that reduce serum potassium levels (e.g. certain diuretics).
Efektan Max should be discontinued at least three days before planned allergy testing, as it may lead to false-negative results.

Taking Efektan Max with food and drink
Efektan Max may be taken regardless of meals. Alcohol consumption should be avoided during treatment with Efektan Max, as it may alter and intensify the drug's effects.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Efektan Max should not be used during the third trimester of pregnancy. During the first and second trimesters of pregnancy, and during breastfeeding, the medicine may be used only if, in the opinion of the doctor, the benefits of treatment outweigh the potential risks to the child.

Driving and operating machinery
Efektan Max impairs psychomotor performance; therefore, it should not be used 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 certain sugars, the patient should consult a doctor before taking the medicine. The medicine contains 2000 mg of sucrose per sachet. This should be taken into account in patients with diabetes.
The medicine contains 814.34 mg of propylene glycol per sachet, equivalent to 814.34 mg/5 mL.
Pregnant or breastfeeding women should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
Patients with impaired liver or kidney function should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
The medicine contains less than 1 mmol (23 mg) of sodium per sachet, meaning the medicine is considered "sodium-free".

3. How to use Efektan Max

This medicine is for oral use.
Do not exceed the maximum daily dose.
The recommended dose should be taken at least 30 minutes before planned travel or before taking a medicine that is poorly tolerated.
Due to the strength of the dose, 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, this dose may be repeated every 4 to 6 hours.
The maximum daily dose must not exceed 400 mg (no more than 8 sachets per day).

Children aged 6 to 14 years:
The recommended dose is 25 to 50 mg (maximum 1 sachet of Efektan Max 50 mg/5 mL).
For a 25 mg dose, use the lower strength medicine Efektan 25 mg/5 mL.
If necessary, the dose may be repeated every 6 to 8 hours.
The maximum daily dose in children must not exceed 5 mg/kg body weight, with a maximum of 150 mg per day (no more than 3 sachets per day).

Method of administration
The contents of one sachet should be taken directly.

Use of a higher than recommended dose of Efektan Max
If a higher than recommended dose of Efektan Max has been taken, contact a doctor immediately.
The first symptoms of overdose appear approximately 30 minutes to 2 hours after ingestion of a toxic dose (25 mg/kg body weight). Symptoms of overdose may include: dry mouth, dry and hot skin, facial flushing, itching, dilated pupils, visual disturbances, rapid and irregular heartbeat, shortness of breath, headache, dizziness, nystagmus, fever, muscle weakness, difficulty urinating, slow intestinal activity, restlessness, agitation, increased muscle reflexes, muscle spasms, disorientation, difficulty concentrating, speech disturbances, seizures, problems with coordination and balance, and drowsiness.

Symptoms of severe overdose include: seizures, seeing or hearing things that are not real (hallucinations), disturbances in thinking and reduced consciousness, breathing difficulties, loss of consciousness, and hyperthermia. In case of such symptoms, contact a doctor immediately.
Treatment of overdose should be symptomatic and supportive. Do not induce vomiting.

Missed dose of Efektan Max
If a dose is missed, take it as soon as possible.
Do not take a double dose to make up for a missed dose.

Stopping Efektan Max
Sudden discontinuation of the medicine after long-term use may cause sleep disturbances. Therefore, stopping the medicine should be done gradually by reducing the dose step by step. Contact your doctor for further medical advice.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everyone will experience them.
Very common (occurring in 1 or more out of 10 patients): drowsiness, concentration disturbances, dizziness.
Common (occurring in 1 or more out of 100 patients): restlessness, 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, muscle weakness, difficulty in urination, feeling of fatigue.
Rare (occurring in 1 or more out of 10,000 patients): haemolytic anaemia, headache, difficulty falling asleep, increased heart rate, drop in arterial blood pressure, liver function disorders, cholestatic jaundice, skin allergic reactions, skin photosensitivity.
Very rare (occurring in less than 1 out of 10,000 patients): decreased appetite, exfoliative dermatitis.

Long-term use of dimenhydrinate may lead to drug dependence.
Paradoxical reactions (e.g. anxiety, irritability, tremor) may occur in children during treatment with dimenhydrinate.

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to gather more information on the safety of the medicine.
Adverse effects can also be reported to the marketing authorization holder.

5. How to store Efektan Max

Keep this medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Efektan Max contains
The active substance is dimenhydrinate.
The other ingredients are sucrose, sodium saccharin (E 954), propylene glycol, blackcurrant flavour (propylene glycol, lactic acid, 4-(4-hydroxyphenyl)-2-butanone, butyric acid, beta-damascone, furaneol), purified water.

What Efektan Max looks like and contents of the pack
Oral solution in sachets. A colourless liquid with a blackcurrant taste and odour.
Efektan Max is packed in PET/Aluminium/PE sachets placed in a cardboard box.
The pack contains 5 or 10 single sachets, each containing 5 mL of oral solution.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Polska Sp. z o.o.
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
For further information about this medicinal product, please 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]
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