Predox

Package Leaflet: Information for the Patient

Predox, 50 mg, 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, as you may Need to Read it Again.
• In Case of any Doubts, Consult a Doctor or Pharmacist.
• This Medication has been Prescribed to a Specific Person. Do not Pass it on to Others. The Medication may Harm Another Person, even if their Symptoms are the Same.
• If the Patient Experiences any Adverse Reactions, including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Predox and what is it Used for
• 2. Important Information Before Taking Predox
• 3. How to Take Predox
• 4. Possible Adverse Reactions
• 5. How to Store Predox
• 6. Package Contents and other Information

1. What is Predox and what is it Used for

Predox belongs to a Group of Medications called Prokinetic Agents. Prokinetic Agents Improve or Stimulate and Enhance the Motility (Movement) of the Gastrointestinal Tract. Administration of these Medications Results in Accelerated Gastric Emptying and Passage of Food through the Small Intestine, as well as Increased Lower Esophageal Sphincter Pressure. Additionally, Predox has Antiemetic Properties.
Predox is Indicated for the Treatment of Symptoms Resulting from Delayed Gastric Emptying, such as Abdominal Bloating, Feeling of Excessive Fullness in the Stomach, Upper Abdominal Pain, Loss of Appetite, Heartburn, Nausea, and Vomiting in Gastrointestinal Disorders that are not Caused by Peptic Ulcer Disease or Organic Disease Affecting the Passage of Food through the Gastrointestinal Tract.
Predox is also Indicated for the Symptomatic Treatment of Gastroesophageal Reflux Disease as Monotherapy or as Add-on Therapy to Proton Pump Inhibitors (Medications that Reduce Stomach Acid Secretion).
Predox is Indicated for Use in Adults.

2. Important Information Before Taking Predox

When not to Take Predox

• If the Patient is Allergic to Itopride or any other Ingredient of this Medication (Listed in Section 6).
• If Accelerated Gastric Emptying may be Harmful, e.g., in Patients with Gastrointestinal Bleeding, Mechanical Obstruction, or Perforation of the Gastrointestinal Tract.

Predox is not Indicated for Use in Children and Adolescents under 18 Years of Age, Pregnant Women, and Breastfeeding Women.

Predox and other Medications

Inform a Doctor or Pharmacist about all Medications Currently being Taken or Recently Taken, as well as any Planned Medications.
Predox and other Concurrently Used Medications may Interact with each other.

• Anticholinergic Medications (Used to Treat Asthma, Chronic Obstructive Pulmonary Disease, Diarrhea, Parkinson's Disease, or to Reduce Smooth Muscle Spasms, e.g., of the Urinary Bladder) may Decrease the Effect of Itopride.
• Due to the Effect of Itopride 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.

Predox with Food and Drink

Predox should be Taken before a Meal.

Pregnancy and Breastfeeding

If the Patient is Pregnant, Breastfeeding, or Thinks she may be Pregnant, or is Planning to have a Child, she should Consult a Doctor or Pharmacist before Taking this Medication.
The Safety of Itopride during Pregnancy has not been Established. The Use of Itopride during Pregnancy can only be Considered if the Potential Benefits of Treatment Outweigh the Risks to the Mother and the Fetus.
The Use of this Medication is not Recommended in Breastfeeding Women, due to the Lack of Experience with Itopride during Breastfeeding.

Driving and Operating Machinery

No Effects of the Medication on the Ability to Drive and Operate Machinery have been Observed; however, Impaired Concentration cannot be Ruled out. Dizziness may Occur. If such Symptoms Occur, the Patient should not Drive or Operate Machinery.

Predox contains Lactose

If the Patient has been Diagnosed with Intolerance to some Sugars, the Patient should Consult a Doctor before Taking the Medication.

3. How to Take Predox

This Medication should always be Taken as Directed by a Doctor or Pharmacist. In Case of Doubts, Consult a Doctor or Pharmacist.
For Functional Gastrointestinal Disorders not Associated with Peptic Ulcer Disease, the Recommended Daily Dose for Adults is 1 Tablet Three Times a Day before Meals for up to 8 Weeks.
For Gastroesophageal Reflux Disease, the Recommended Daily Dose for Adults is 1 Tablet Three Times a Day before Meals for up to 6 Weeks when Predox is Used as Monotherapy and up to 12 Weeks when Predox is Used as Add-on Therapy to Proton Pump Inhibitors (PPIs).
The Dose may be Reduced Depending on the Patient's Age and Disease Progression. The Exact Dosage of Predox and the Duration of Treatment will be Determined by a Doctor.

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 a Doctor. If any Adverse Reactions Occur, the Patient should Consult a Doctor. The Doctor may Recommend a Dose Reduction or Discontinuation of the Medication.

Taking more than the Recommended Dose of Predox

In Case of Taking more than the Recommended Dose of Predox or Accidental Ingestion by a Child, Consult a Doctor or Pharmacist.

Missing a Dose of Predox

In Case of Missing a Dose of Predox, Continue Taking the Medication as Scheduled. Do not Take a Double Dose to Make up for the Missed Dose.

Stopping Predox Treatment

If the Patient Stops Taking Predox too Early, Symptoms may Worsen. Before Stopping the Medication, Consult a Doctor.
In Case of any Further Doubts about the Use of this Medication, Consult a Doctor or Pharmacist.

4. Possible Adverse Reactions

Like all Medications, Predox can Cause Adverse Reactions, although not Everybody gets them.
Stop Taking Predox and Inform a Doctor Immediately:

• If Swelling of the Hands, Feet, Face, Lips, or Throat Occurs, Causing Difficulty in Swallowing or Breathing. A Rash and Itching may also Occur. These may be Symptoms of an Allergic Reaction.

During Treatment with Predox, the Following Adverse Reactions may Occur:
Uncommon(may Affect up to 1 in 100 People)

• Diarrhea
• Constipation
• Abdominal Pain
• Excessive Salivation
• Headache
• Irritability
• Sleep Disorders
• Dizziness
• Fatigue
• Chest 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)

• Skin Rash, Redness, and Itching

Unknown(Frequency cannot be Estimated from the Available Data)

• Increased Blood Test Values (ASAT, ALAT, GGTP, Alkaline Phosphatase, Bilirubin)
• Decreased Platelet Count (which may Result in Bruising and Increased Bleeding)
• Tremors
• Nausea
• Jaundice
• Male Breast Enlargement

If Galactorrhea (Milk Production and Secretion not Associated with Breastfeeding) or Gynecomastia (Male Breast Enlargement) Occurs, Treatment with this Medication should be Discontinued or Stopped.

Reporting Adverse Reactions

If any Adverse Reactions Occur, including those not Listed in this Package Leaflet, Inform a Doctor or Pharmacist. Adverse Reactions can be Reported Directly to the Department of Pharmacovigilance of 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
Adverse Reactions can also be Reported to the Marketing Authorization Holder.
Reporting Adverse Reactions will Help Gather more Information on the Safety of the Medication.

5. How to Store Predox

Keep the Medication out of Sight and Reach of Children.
Store in a Temperature below 25°C.
Do not Use this Medication after the Expiration Date Stated on the Packaging.
The Expiration Date refers to the Last Day of the Specified Month.
The Entry on the Packaging after the Abbreviation EXP Indicates the Expiration Date, and after the Abbreviation Lot/LOT Indicates the Batch Number.
Medications should not be Disposed of via Wastewater or Household Waste. Ask a Pharmacist how to Dispose of Unused Medications. This will Help Protect the Environment.

6. Package Contents and other Information

What Predox Contains

• The Active Substance of the Medication is Itopride Hydrochloride. Each Coated Tablet Contains 50 mg of Itopride Hydrochloride.
• Other Ingredients are: Lactose Monohydrate, Corn Starch, Carmellose, Magnesium Stearate, Colloidal Silica. Coating: Hypromellose 2910, Macrogol 6000, Talc, Titanium Dioxide (E 171).

What Predox Looks like and what the Packaging Contains

Predox is a White, Round, Biconvex Coated Tablet with a Diameter of 7 mm.
The Packaging Contains 40, 90, or 100 Coated Tablets, Packaged in PVC/PVDC/Aluminum Blisters.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

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

Date of the Last Update of the Package Leaflet: