Package leaflet: Information for the user

Itokin, 50 mg, coated tablets
Itopride hydrochloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are the same.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

What Itokin is and what it is used for
What you need to know before taking Itokin
How to take Itokin
Possible side effects
How to store Itokin
Contents of the pack and other information

1. What Itokin is and what it is used for

Itokin belongs to a group of medicines called prokinetic agents. Prokinetic agents improve or stimulate and enhance gastrointestinal motility (movement). These medicines accelerate gastric emptying and the passage of food through the small intestine, and increase the tone of the lower oesophageal sphincter. Additionally, Itokin has antiemetic properties.
Itokin is indicated for the treatment of symptoms associated with delayed gastric emptying, such as a feeling of fullness in the stomach or upper abdominal pain, loss of appetite, heartburn, nausea and vomiting in gastrointestinal disorders not caused by peptic ulcer disease or organic disease affecting the rate of passage of food through the gastrointestinal tract.
Itokin is indicated for use in adults.

2. Important information before taking Itokin

When not to take Itokin:

if the patient is allergic to itopride or any of the other ingredients of this medicine (listed in section 6).
if the patient has a condition in which accelerated gastric emptying may be harmful, e.g. in patients with gastrointestinal bleeding, obstruction, or perforation.

Itokin is not indicated for use in children, pregnant or breastfeeding women.
Itokin and other medicines
You should tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken,
as well as any medicines the patient plans to take.
Itokin and other concomitantly used medicines may affect each other's action.

Anticholinergic medicines (used in the treatment of asthma, chronic obstructive pulmonary disease, diarrhoea, Parkinson's disease, or to reduce smooth muscle spasms, e.g. of the urinary bladder) may reduce the effect of itopride.
Due to the action of itopride on the gastrointestinal tract, it may affect the absorption of other

medicines, particularly drugs with a narrow therapeutic index, drugs with prolonged release, or
drugs released in the small intestine.
Itokin with food and drink
Itokin should be taken before meals.
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.
The safety of itopride use during pregnancy has not been established. Therefore, Itokin may be
used during pregnancy or in women who may be pregnant only when the benefits of treatment
outweigh the potential risks.
Itokin is not recommended for use in breastfeeding women due to lack of experience with itopride
during breastfeeding.
Driving and operating machinery
Although no effect of the product on the ability to drive or operate machinery has been observed,
a decrease in attention cannot be excluded. Dizziness may rarely occur. If such symptoms occur,
the patient should not drive or operate machinery.
Itokin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact
a doctor before taking this medicine.

3. How to take Itokin

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The dose may be reduced depending on the course of the disease. The exact dosage and duration of treatment will be determined by the doctor.
Adults
The recommended dose for adults is 1 tablet three times daily, taken before meals.
Use in children and adolescents
Due to lack of safety data, use of this medicine is not recommended in children and adolescents.
Patients with hepatic or renal impairment and elderly patients
Patients with impaired liver or kidney function, as well as elderly patients, will be closely monitored by the doctor. In case of any adverse symptoms, contact a doctor. The doctor may recommend reducing the dose or discontinuing treatment.
Taking more Itokin than recommended
If more Itokin is taken than recommended, or if the medicine is accidentally ingested by a child, contact a doctor or pharmacist immediately.
Missing a dose of Itokin
If a dose of Itokin is missed, continue taking the medicine according to the regular dosing schedule. Do not take a double dose to make up for the missed dose.
Stopping Itokin treatment
If the patient stops taking Itokin too early, symptoms may worsen.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
You should stop taking Itokin and contact your doctor immediately or go to hospital if you experience:

swelling of the hands, feet, face, lips or throat, causing difficulty in swallowing or breathing. A rash and itching may also occur. These may be symptoms of an allergic reaction. The following adverse reactions may occur during treatment with Itokin:

Uncommon (may occur in up to 1 in 100 people)

diarrhoea
abdominal pain
constipation
excessive salivation
irritability
headache
sleep disturbances
dizziness
fatigue
chest pain or back pain
increased prolactin hormone levels
changes in blood laboratory test results (decreased white blood cell count, increased urea and creatinine levels)

Rare (may occur in up to 1 in 1000 people)

skin rash, redness and itching

Frequency unknown (frequency cannot be estimated from the available data)

increased blood test values (AspAT, AlAT, GGTP, alkaline phosphatase, bilirubin)
decreased platelet count (which may manifest as bruising and increased bleeding)
tremor
nausea
jaundice
gynaecomastia (enlargement of breasts in males)

If galactorrhoea (production and secretion of milk unrelated to breastfeeding) or gynaecomastia (enlargement of breasts in males) occurs, treatment with this medicine should be discontinued or stopped.

Reporting of adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store the medicine Itokin

Keep this medicine out of sight and reach of children.
Store below 25°C.
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. These measures will help protect the environment.

6. Contents of the packaging and other information

What Itokin contains
The active substance is itopride hydrochloride; each coated tablet contains 50 mg of itopride hydrochloride.

Other components are: Tablet core: monohydrate lactose, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate, anhydrous colloidal silicon dioxide. Tablet coating: hypromellose 2910, macrogol 6000, talc, titanium dioxide (E 171).

What Itokin looks like and contents of the pack
Itokin is a white, round, biconvex coated tablet with a diameter of 7 mm.
PVC/PVDC/Aluminium blisters, placed in a cardboard box.
Pack contents: 10, 20, 30, 40, 90 or 100 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Tel. + 48 61 66 51 500
[email protected]

Manufacturer
Medochemie Ltd– Central Factory
1-10 Constantinoupoleos Street
3011, Limassol
Cyprus