Patient Information Leaflet: Information for the User

Efektan, 25 mg/5 mL, oral solution in sachet
Dimenhydrinatum
Please read all of this leaflet carefully before taking this medicine, as it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as advised by your
doctor or pharmacist.

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

Table of Contents

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

1. What Efektan is and what it is used for

Efektan contains the active substance dimenhydrinate (dimenhydrynat), which has antiemetic, antiallergic, and mild sedative properties.
Efektan is used to prevent motion sickness and to prevent and treat nausea and vomiting of various causes (except those induced 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

When not to use Efektan

if the patient is allergic to dimethydrinate, antihistamines, or any of the other ingredients of the medicine (listed in section 6),
if the patient has:
acute asthma attack,
narrow-angle glaucoma,
phaeochromocytoma (a type of tumour),
a blood disorder called porphyria,
benign prostatic hyperplasia and urinary retention,
epilepsy.
Efektan is not intended for children under 6 years of age.

Warnings and precautions
Before starting to use Efektan, consult a doctor or pharmacist:

if the patient has impaired liver function,
if the patient has hyperthyroidism (overactive thyroid),
if the patient has bradycardia (slow heart rate) or hypertension,
if the patient has low blood potassium or low blood magnesium levels,
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 disorders, e.g.: coronary heart disease, cardiovascular disease, arrhythmia.

Particular caution is also advised when taking concurrently certain antiarrhythmic drugs that prolong the QT interval on ECG, or drugs that reduce serum potassium or magnesium levels.
Efektan 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 in patients with psychiatric disorders, at doses significantly exceeding the recommended doses.
Do not exceed the maximum daily dose.

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

Taking Efektan with food and drink
Efektan may be taken regardless of meals. Alcohol consumption should be avoided during treatment with Efektan, 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 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 impairs psychomotor performance; therefore, it should not be used by persons driving vehicles or operating machinery.

Efektan 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

This medicine is for oral use.
Do not exceed the maximum daily dose.
The recommended dose should be taken at least 30 minutes before a planned journey or before taking a poorly tolerated medicine.
Due to the dose 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 mg to 100 mg (2–4 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 16 sachets per day).

Children aged 6 to 14 years:
The recommended dose is 25 to 50 mg (1–2 sachets).
If necessary, this 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 6 sachets per day).

Administration method
The contents of one sachet should be taken directly.

Use of a higher than recommended dose of Efektan
If a higher than recommended dose of Efektan has been taken, contact a doctor immediately.
The first symptoms of overdose occur 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 function, 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 and loss of consciousness, hyperthermia. If any of these symptoms occur, contact a doctor immediately.
Treatment of overdose should be symptomatic and supportive. Do not induce vomiting.

Missed dose of Efektan
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
Stopping the medicine abruptly after long-term treatment may cause sleep disturbances. Therefore, discontinuation should be done gradually by reducing the dose. Consult a 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 all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Very common (occurring in 1 or more out of 10 patients) adverse effects include: drowsiness,
concentration disturbances, dizziness.
Common (occurring in 1 or more out of 100 patients) adverse effects include: excitation,
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) adverse effects include:
haemolytic anaemia, headache, difficulty in 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) adverse effects include:
decreased appetite, exfoliative dermatitis.
Prolonged use of dimenhydrinate may lead to drug dependence.
When dimenhydrinate is used in children, paradoxical reactions (e.g. anxiety, irritability, tremor) may occur.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring of 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 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.
Adverse effects can also be reported to the marketing authorization holder.

5. How to store Efektan

Keep this medicine out of sight and reach of children.
Do not store above 25°C. Do not store in a 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 required. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Efektan 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 looks like and contents of the pack
Oral solution in sachets. A colourless liquid with a blackcurrant taste and odour.
Efektan 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 medicine, 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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