Prokit

Package Leaflet: Information for the User

Prokit, 50 mg, Coated Tablets

Itopride Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to you by a doctor. 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, inform your doctor or pharmacist. See section 4.

Package Leaflet Contents:

• 1. What is Prokit and what is it used for
• 2. Important information before taking Prokit
• 3. How to take Prokit
• 4. Possible side effects
• 5. How to store Prokit
• 6. Contents of the pack and other information

1. What is Prokit and what is it used for

Prokit contains itopride, which belongs to a group of medicines called prokinetic agents. Prokinetic agents improve or stimulate and enhance the motility (movement) of the gastrointestinal tract by acting as antagonists on dopamine D receptors and inhibiting the action of acetylcholinesterase. Administration of these agents results in accelerated gastric emptying and passage of food through the small intestine, as well as increased lower esophageal sphincter pressure. Additionally, Prokit has antiemetic properties.
Prokit 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 peptic ulcer disease or organic disease affecting the passage of food through the gastrointestinal tract.
Prokit is also indicated for the symptomatic treatment of gastroesophageal reflux disease as monotherapy or as adjunctive therapy to proton pump inhibitors (drugs that reduce stomach acid secretion).
Prokit is indicated for use in adults.

2. Important information before taking Prokit

When not to take Prokit:

• if you are allergic to itopride or any of the other ingredients of this medicine (listed in section 6).
• if accelerated gastric emptying may be harmful, e.g., in patients with gastrointestinal bleeding, obstruction, or perforation.

Warnings and precautions

Before taking Prokit, discuss it with your doctor or pharmacist.
Prokit enhances the effects of acetylcholine and should be used with caution.
Although clinical studies indicate that the frequency of adverse reactions in patients aged 65 and over is not greater than in younger patients, in elderly patients, adverse reactions may occur due to the overall deterioration of liver and kidney function.

Children and adolescents

Do not use Prokit in children and adolescents under 16 years of age.

Prokit and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Prokit and other medicines taken at the same time may affect each other's action.

• No interactions between Prokit and warfarin, diazepam, diclofenac, ticlopidine, nifedipine, and nicardipine are known.
• Anticholinergic agents (used to treat asthma, chronic obstructive pulmonary disease, diarrhea, Parkinson's disease, or to reduce muscle spasms, e.g., of the urinary bladder) may reduce the effect of itopride.
• Due to the effect of itopride on the gastrointestinal tract, it may affect the absorption of other oral medicines, especially those with a narrow therapeutic index, prolonged-release medicines, or those released in the small intestine.
• Anti-ulcer agents (drugs used to prevent and treat gastrointestinal ulcers), such as cimetidine, ranitidine, teprenone, and cetrexate, do not affect the prokinetic action of Prokit on the gastrointestinal tract.

Prokit with food and drink

Take Prokit before meals.

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 medicine.
Prokit may be used during pregnancy or in women who may become pregnant only if prescribed by a doctor, if the benefits of treatment outweigh the potential risk.
If you are breastfeeding, your doctor will decide whether to stop taking Prokit or stop breastfeeding, considering the risk of adverse reactions in the breastfed child.

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 attention may be impaired. Dizziness may occur very rarely. If such symptoms occur, do not drive or operate machines until they resolve.

Prokit contains lactose

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine.

Prokit contains sodium

Prokit contains less than 1 mmol (23 mg) of sodium per coated tablet, which means it is essentially 'sodium-free'.

3. How to take Prokit

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
In the case of functional gastrointestinal disorders, non-ulcer dyspepsia, the recommended daily dose for adults is 1 tablet three times a day before meals for a maximum of 8 weeks.
In the case of gastroesophageal reflux disease, the recommended daily dose for adults is 1 tablet three times a day before meals for a maximum of 6 weeks when Prokit is used as monotherapy and for a maximum of 12 weeks when Prokit is used as adjunctive therapy to proton pump inhibitors (PPIs).
Your doctor may reduce these doses depending on your age and symptoms. Your doctor will determine the exact dose of Prokit and the duration of treatment.

Patients with liver or kidney impairment

If you have liver or kidney impairment, your doctor will closely monitor your health. If you experience adverse reactions, your doctor will decide on the necessary actions, such as reducing the dose or stopping treatment.

Use in children and adolescents

Do not use Prokit in children and adolescents under 16 years of age.

Overdose of Prokit

In case of overdose or accidental ingestion by a child, contact a doctor or pharmacist. No cases of itopride overdose are known.

Missed dose of Prokit

If you miss a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a missed dose.

Stopping Prokit treatment

If you stop taking Prokit too early, your symptoms may worsen. Before stopping treatment, talk to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Prokit can cause side effects, although not everybody gets them.
Stop taking Prokit and inform your doctor:

• If you experience swelling of the hands, feet, face, lips, or throat, causing difficulty in swallowing or breathing. You may also experience rash and itching. These may be symptoms of an allergic reaction.

The following side effects may occur during treatment with Prokit:
Uncommon(may affect up to 1 in 100 people):

• diarrhea
• constipation
• abdominal pain
• excessive salivation
• headache
• irritability
• sleep disturbances
• dizziness
• chest pain or back pain
• fatigue
• increased prolactin levels
• changes in laboratory 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):

• severe allergic reactions that may cause breathing difficulties
• increased blood test results (ASAT, ALAT, GGTP, alkaline phosphatase, bilirubin)
• decreased platelet count (which may manifest as bruising and increased bleeding)
• tremors
• nausea
• jaundice
• gynecomastia (breast enlargement in men)

If you experience galactorrhea (milk production and secretion not associated with breastfeeding) or gynecomastia, stop or discontinue treatment with this medicine.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prokit

Keep this medicine out of the sight and reach of children.
There are no special storage precautions.
Do not use this medicine after the expiry date which is stated on the carton and blister after 'EXP'. The expiry date refers to the last day of that month.
Medicines should 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 pack and other information

What Prokit contains

The active substance is itopride hydrochloride. Each coated tablet contains 50 mg of itopride hydrochloride.
The other ingredients are: lactose monohydrate, corn starch, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, Opadry II White 85F18422 (hypromellose, titanium dioxide (E 171), macrogol 3350, talc).

What Prokit looks like and contents of the pack

Prokit is a white or almost white, round, biconvex tablet with a score line, 7 mm in diameter. The score line on the tablet is only to facilitate breaking the tablet to make it easier to swallow and not to divide it into equal doses.
Prokit is available in blister packs (transparent PVC/PVDC/Aluminum) in packs containing 20, 30, 40, 90, or 100 coated tablets.

Marketing authorization holder and manufacturer

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Praha 4, Czech Republic
For more detailed information on this medicine, contact the local representative of the marketing authorization holder:
biuro@promedcs.com

This medicine is authorized in the Member States of the European Economic Area under the following names:

Poland:
Prokit

Date of last revision of the package leaflet: 03.07.2023