Efektan

Leaflet attached to the packaging: information for the user

Efektan, 25 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 and what is it used for
• 2. Important information before taking Efektan
• 3. How to take Efektan
• 4. Possible side effects
• 5. How to store Efektan
• 6. Contents of the packaging and other information

1. What is Efektan and what is it used for

Efektan contains the active substance dimenhydrinate (dimenhydramine), which has antiemetic, antihistamine, and mild sedative effects.
Efektan is used to prevent motion sickness and to prevent and treat nausea and vomiting of other origins (except those caused by anti-cancer chemotherapy drugs).
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

When not to take Efektan

• 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,
• glaucoma with a narrow angle of filtration,
• chromaffin tumor (a type of cancer),
• porphyria (a blood disease),
• prostate enlargement and urine retention in the bladder,
• epilepsy.
• Efektan is not intended for children under 6 years of age.

Warnings and precautions

Before starting to take Efektan, 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, such as coronary artery disease, circulatory system disease, arrhythmia.

Special caution is also recommended when taking certain anti-arrhythmic drugs that can prolong the QT interval in the ECG, or those that can decrease potassium or magnesium levels in the serum.
Efektan 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 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 should not be taken with anti-arrhythmic drugs that depress the activity of the central nervous system.
The medicine should not be taken with atropine, tricyclic antidepressants, catecholamines, or drugs that depress the central nervous system, such as sleeping pills or sedatives, as Efektan enhances their effects.
Efektan taken with bismuth salts and painkillers, psychotropic drugs, and scopolamine may cause transient vision disturbances (impairment of vision in the dark and color vision).
Efektan weakens the effects of corticosteroids and oral anticoagulants.
The patient should avoid combining Efektan with ototoxic drugs (damaging hearing), such as aminoglycoside antibiotics.
Monoamine oxidase inhibitors (MAOIs, antidepressants) may enhance the antihistamine and sedative effects of dimenhydrinate.
Special caution is recommended when taking dimenhydrinate with drugs that can prolong the QT interval in the ECG (certain anti-arrhythmic drugs, certain antibiotics, such as erythromycin, antimalarial drugs, antihistamines, neuroleptics) and with drugs that can decrease potassium levels in the serum (such as certain diuretics).

Taking Efektan with food and drink

Efektan can be taken regardless of meals.
The patient should avoid consuming alcohol while taking Efektan, 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 should not be taken in 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 impairs psychophysical abilities, so it should not be taken by people driving vehicles or operating machinery.

Efektan contains sucrose, propylene glycol, and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.
The medicine contains 2000 mg of sucrose in each sachet.
This should be taken into account in patients with diabetes.
The medicine contains 814.34 mg of propylene glycol in each sachet, 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 that the medicine is considered "sodium-free".

3. How to take Efektan

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 is not intended for children under 6 years of age.
Adults and adolescents over 14 years of age:
The recommended dose is 50-100 mg (2-4 sachets).
If necessary, it can be repeated every 4 to 6 hours.
The maximum daily dose should not exceed 400 mg (no more than 16 sachets per day).
Children from 6 to 14 years of age:
The recommended dose is 25-50 mg (1-2 sachets).
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 6 sachets per day).

Method of administration

The contents of one sachet should be taken directly.

Taking a higher dose of Efektan than recommended

In case of taking a higher dose of Efektan than recommended, 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, constipation, anxiety, agitation, tremors, vision disturbances, and drowsiness.
Symptoms of severe overdose include: seizures, seeing or hearing things that do not exist (hallucinations), disturbances in thinking and decreased consciousness, breathing difficulties, and loss of consciousness, hyperthermia.
In case of such symptoms, the patient should immediately contact their doctor.
Treatment of overdose should be symptomatic and supportive.
Vomiting should not be induced.

Missing a dose of Efektan

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

Sudden cessation of treatment with Efektan after long-term use may cause sleep disturbances.
Therefore, the medicine should be discontinued by gradually reducing the dose.
The patient should contact 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 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: 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, fatigue.
Rare (occurring in 1 or more out of 10,000 patients)side effects include: 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 include: decreased appetite, exfoliative dermatitis.
Long-term use of dimenhydrinate may lead to drug dependence.
During the use of 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 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.: +48 22 49 21 301
fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, it is possible to gather more information on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Efektan

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 stated is the last day of the given month.
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.
Such measures will help protect the environment.

6. Contents of the packaging and other information

What Efektan contains

The active substance of Efektan 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 looks like and contents of the packaging

Oral solution in sachets.
Colorless liquid with a blackcurrant flavor and aroma.
Efektan 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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