Itokin

Package Leaflet: Information for the User

Itokin, 50 mg, Film-Coated Tablets

Itopride Hydrochloride

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have Any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication Has Been Prescribed for You Only. Do Not Pass it on to Others. It May Harm Them, Even if Their Symptoms are the Same as Yours.
• If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents:

• 1. What is Itokin and What is it Used For
• 2. Important Information Before Taking Itokin
• 3. How to Take Itokin
• 4. Possible Side Effects
• 5. How to Store Itokin
• 6. Package Contents and Other Information

1. What is Itokin and What is it Used For

Itokin Belongs to a Group of Medications Called Prokinetic Agents. Prokinetic Agents Improve or Stimulate the Motility (Movement) of the Gastrointestinal Tract. Administration of These Medications Results in Faster Gastric Emptying and Passage of Food Through the Small Intestine, as Well as Increased Lower Esophageal Sphincter Pressure. Additionally, Itokin Has Antiemetic Properties. Itokin is Indicated for the Treatment of Symptoms Resulting from Delayed Gastric Emptying, Such as a Feeling of Fullness in the Stomach or Pain in the Upper Abdomen, Loss of Appetite, Heartburn, Nausea, and Vomiting in Gastrointestinal Disorders That are Not Caused by Ulcer Disease or Organic Disease Affecting the 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 You are Allergic to Itopride or Any of the Other Ingredients of this Medication (Listed in Section 6).
• If You Have a Condition Where Faster Gastric Emptying May be Harmful, Such as Patients with Gastrointestinal Bleeding, Obstruction, or Perforation.

Itokin is Not Indicated for Use in Children, Pregnant Women, and Breastfeeding Women.

Itokin and Other Medications

Tell Your Doctor or Pharmacist About All Medications You are Currently Taking or Have Recently Taken, as Well as Any Medications You Plan to Take. Itokin and Other Medications May Affect Each Other's Action.

• Anticholinergic Medications (Used to Treat Asthma, Chronic Obstructive Pulmonary Disease, Diarrhea, Parkinson's Disease, or to Reduce Muscle Spasms, Such as Urinary Bladder Spasms) May Decrease the Effect of Itopride.
• Due to Itopride's Effect on the Gastrointestinal Tract, it May Affect the Absorption of Other Medications, Especially Those with a Narrow Therapeutic Index, Medications with Prolonged Release, or Those Released in the Small Intestine.

Itokin Should be Taken Before a Meal.

Itokin with Food and Drink

Itokin Should be Taken Before a Meal.

Pregnancy and Breastfeeding

If You are Pregnant or Breastfeeding, Think You May be Pregnant, or are Planning to Have a Baby, Ask Your Doctor or Pharmacist for Advice Before Taking this Medication. The Safety of Itopride in Pregnant Women Has Not Been Established. Therefore, Itokin Should Only be Used During Pregnancy or in Women Who May Become Pregnant if the Benefits of Treatment Outweigh the Potential Risks. It is Not Recommended to Use Itokin in Breastfeeding Women, Due to the Lack of Experience with Itopride During Breastfeeding.

Driving and Using Machines

Although No Effect of the Product on the Ability to Drive and Use Machines Has Been Observed, it Cannot be Ruled out that Concentration May be Impaired. Dizziness May Occur Rarely. If These Symptoms Occur, Do Not Drive or Operate Machines.

Itokin Contains Lactose

If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking this Medication.

3. How to Take Itokin

Always Take this Medication Exactly as Your Doctor or Pharmacist Has Told You. If You are Not Sure, Ask Your Doctor or Pharmacist. The Dose May be Reduced Depending on the Course of the Disease. Your Doctor Will Determine the Exact Dosage and Duration of Treatment.

Adults

The Recommended Dose for Adults is 1 Tablet Three Times a Day, Before Meals.

Use in Children and Adolescents

Due to the Lack of Data on Safety, it is Not Recommended to Use Itokin in Children and Adolescents.

Patients with Liver or Kidney Impairment and Elderly Patients

Patients with Liver or Kidney Impairment, as Well as Elderly Patients, Will be Closely Monitored by Their Doctor. If Any Side Effects Occur, Contact Your Doctor. Your Doctor May Recommend Reducing the Dose or Stopping Treatment.

Overdose of Itokin

If You Take More Itokin Than You Should, or if a Child Accidentally Takes Itokin, Contact Your Doctor or Pharmacist.

Missing a Dose of Itokin

If You Miss a Dose of Itokin, Continue Taking it According to Your Regular Dosing Schedule. Do Not Take a Double Dose to Make Up for a Missed Dose.

Stopping Itokin Treatment

If You Stop Taking Itokin Too Early, Your Symptoms May Worsen. If You Have Any Further Questions on the Use of this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medications, Itokin Can Cause Side Effects, Although Not Everybody Gets Them. Stop Taking Itokin and Contact Your Doctor or Go to the Hospital Immediately if You Experience:

• Swelling of the Hands, Feet, Face, Lips, or Throat, Causing Difficulty in Swallowing or Breathing. You May Also Experience a Rash and Itching. These May be Signs of an Allergic Reaction. During Treatment with Itokin, the Following Side Effects May Occur:

Uncommon(May Affect Up to 1 in 100 People)

• Diarrhea
• Abdominal Pain
• Constipation
• Excessive Salivation
• Irritability
• Headache
• Sleep Disorders
• Dizziness
• Fatigue
• Chest Pain or Back Pain
• Increased Prolactin Levels
• Changes in Blood Test Results (Decreased White Blood Cell Count, Increased Urea and Creatinine Levels) Rare(May Affect Up to 1 in 1,000 People)
• Rash, Redness, and Itching of the Skin Frequency Not Known(Frequency Cannot be Estimated from the Available Data)
• Increased Blood Test Results (ASAT, ALAT, GGTP, Alkaline Phosphatase, Bilirubin)
• Decreased Platelet Count (Which May Cause Bruising and Increased Bleeding)
• Tremors
• Nausea
• Jaundice
• Enlargement of the Breasts in Men

If You Experience Galactorrhea (Milk Production and Secretion Not Associated with Breastfeeding) or Gynecomastia (Enlargement of the Breasts in Men), Stop or Discontinue Treatment with this Medication.

Reporting Side Effects

If You Experience Any Side Effects, Including Those Not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. You Can Report Side Effects Directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, 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. You Can Also Report Side Effects to the Marketing Authorization Holder. By Reporting Side Effects, You Can Help Provide More Information on the Safety of this Medication.

5. How to Store Itokin

Keep this Medication Out of the Sight and Reach of Children. Store in a Temperature Below 25°C. Do Not Use this Medication After the Expiration Date Stated on the Carton After the EXP Date. The Expiration Date Refers to the Last Day of the Month. Medications Should Not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist How to Dispose of Medications No Longer Required. This Will Help Protect the Environment.

6. Package Contents and Other Information

What Itokin Contains

The Active Substance is Itopride Hydrochloride; Each Film-Coated Tablet Contains 50 mg of Itopride Hydrochloride.

• Other Ingredients Are: Core: Lactose Monohydrate, Corn Starch, Carmellose, Magnesium Stearate, Colloidal Silica. Coating: Hypromellose 2910, Macrogol 6000, Talc, Titanium Dioxide (E 171).

What Itokin Looks Like and Contents of the Package

Itokin is a White, Round, Biconvex Film-Coated Tablet with a Diameter of 7 mm. PVC/PVDC/Aluminum Blister Packs, Packaged in a Cardboard Box. The Package Contains: 10, 20, 30, 40, 90, or 100 Film-Coated Tablets. Not All Pack Sizes May be Marketed.

Marketing Authorization Holder

Biofarm Sp. z o.o., ul. Wałbrzyska 13, 60-198 Poznań, Tel. +48 61 66 51 500, biofarm@biofarm.pl

Manufacturer

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

Date of Last Revision of the Package Leaflet: 14.04.2025