Gasprid

Package Leaflet: Information for the User

GASPRID, 5 mg, tablets

GASPRID, 10 mg, tablets

(Cisapride)

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

• 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 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 any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What is Gasprid and what is it used for

Gasprid is a medicine in the form of tablets for oral administration, containing 5 mg or 10 mg of cisapride. The preparation is used exclusively in adults for the treatment of acute and severe symptomatic exacerbation of chronic idiopathic or occurring in the course of diabetes, delayed gastric emptying, when other treatment methods are ineffective.
Gasprid stimulates the motility of the gastrointestinal tract, increases the tension of the lower esophageal sphincter, accelerates gastric and duodenal emptying, and the passage of food through the intestines.

2. Important information before taking Gasprid

When not to take Gasprid

• if the patient is allergic to cisapride or any of the other ingredients of this medicine (listed in section 6)
• if the patient is taking any of the following medicines at the same time: antifungal agents (e.g., ketoconazole, fluconazole), macrolide antibiotics (e.g., azithromycin, erythromycin, clarithromycin), HIV protease inhibitors (e.g., ritonavir and indinavir), nefazodone - an antidepressant, antiarrhythmic agents (e.g., quinidine, hydroquinidine, disopyramide, procainamide) or (e.g., amiodarone, sotalol), bepridil - an antihypertensive agent, halofantrine - an antimalarial agent, certain quinolone antibiotics (especially: sparfloxacin, grepafloxacin, gatifloxacin, moxifloxacin), tricyclic and tetracyclic antidepressants (e.g., amitriptyline, maprotiline); vincamine - a vasodilator, neuroleptics (such as: phenothiazines, primozide, sertindole, haloperidol, droperidol, sultopride), ziprasidone - an antipsychotic agent, difemanil

or certain antihistamines (such as: astemizole and terfenadine).

• in case of potassium or magnesium deficiency
• in case of significant bradycardia (slow heart rate)
• in case of significant arrhythmias
• in case of uncontrolled heart failure
• in patients with congenital QT interval prolongation or a family history of congenital QT interval prolongation
• in case of fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency. Gasprid should not be used in cases where stimulation of gastrointestinal motility may be dangerous (organic obstructions).

Warnings and precautions

Before starting to take Gasprid, you should discuss it with your doctor or pharmacist:

• if the patient currently has or has had heart disease (ventricular arrhythmias, second- or third-degree atrioventricular block, sinoatrial node dysfunction, coronary heart disease, heart failure). The doctor will weigh the potential benefits against the risks of taking Gasprid,
• if there has been a sudden death in the patient's immediate family,
• if the patient has kidney failure,
• if the patient has liver failure,
• if the patient has severe lung disease,
• if the patient has respiratory failure,
• if the patient has factors predisposing to electrolyte imbalance disorders [especially patients taking diuretics that cause hypokalemia (decreased potassium levels in the blood) and patients treated with insulin for acute reasons],
• if the patient has severe vomiting and (or) chronic diarrhea,
• if the patient is being treated with oral anticoagulants.

If any of the above situations apply to the patient (and in case of doubts), before taking Gasprid, you should consult a doctor, pharmacist, or nurse.

Gasprid and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Taking oral anticoagulants (e.g., acenocoumarol) at the same time may lead to an increased effect of the anticoagulant and a risk of bleeding. Remember to adjust the dose of the oral anticoagulant during treatment and up to 8 days after the end of cisapride treatment.
A temporary increase in the sedative effect of diazepam may occur, caused by increased absorption rate.
Do not take Gasprid with grapefruit juice or alcohol.

Gasprid with food and drink

The medicine should be taken at least 15 minutes before a meal and before bedtime.
During cisapride treatment, it is not recommended to consume grapefruit juice repeatedly.
The tablet should be swallowed whole, do not divide or chew it.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The medicine may be used during pregnancy only if, in the doctor's opinion, the benefit to the mother outweighs the potential risk to the fetus.
In studies of a large group of people, cisapride did not increase the incidence of fetal malformations. Nevertheless, when using Gasprid during pregnancy, especially in the first trimester, the expected benefits of using the medicine should be weighed against the potential risk.
Breastfeeding
Although the passage of cisapride into breast milk is minimal, breastfeeding is not recommended during Gasprid treatment.

Elderly patients

In elderly patients, there is no need to change the dosage of the medicine.

Patients with renal or hepatic impairment

In patients with liver or kidney failure, it is recommended to reduce the daily dose by half.

Driving and using machines

The medicine does not affect the ability to drive or use machines. It does not cause sedation or drowsiness. However, Gasprid may accelerate the absorption of substances that act depressively on the central nervous system, such as barbiturates or alcohol. Therefore, if Gasprid is taken at the same time as these substances, caution should be exercised.

Gasprid contains lactose.

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking the medicine.
Gasprid contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Gasprid

This medicine should always be taken exactly as advised by your doctor. If you are unsure, consult your doctor or pharmacist.
Gasprid is intended only for adults.
Treatment with Gasprid should be started in a hospital setting and closely monitored by a specialist doctor experienced in the treatment of acute and severe symptomatic exacerbation of chronic idiopathic or occurring in the course of diabetes, delayed gastric emptying (gastroparesis).
Method of administration
Gasprid should be taken 15 minutes before a meal and preferably before bedtime, (when a fourth dose of the medicine is necessary), with a liquid.
Recommended dose
The recommended dose of Gasprid is 10 mg three to four times a day. Do not take more than 40 mg per day.
Do not take Gasprid with grapefruit juice.
Gasprid should only be used for short-term treatment.
Do not divide or chew the tablets.

Taking a higher dose of Gasprid than recommended

Symptoms
Symptoms that may occur as a result of an overdose are: abdominal cramps and frequent bowel movements.
Arrhythmias may also occur.
Treatment
In case of an overdose, hospitalization is necessary. Activated charcoal administration, clinical observation of the patient, and EKG monitoring are recommended. Particular attention should be paid to the EKG record of heart function, with particular emphasis on QT interval prolongation or bradycardia, as well as electrolyte balance disorders (especially hypokalemia and hypomagnesemia).

Missing a dose of Gasprid

Take it as soon as you remember, unless it is time for the next dose.
Do not take a double dose to make up for a missed dose.
If you have any doubts about taking the medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Gasprid can cause side effects, although not everybody gets them.
There have been reports of serious arrhythmias, even life-threatening, in some cases. In most cases, these effects occurred in patients who were taking other medicines at the same time and (or) had a history of heart disease or factors that increase the risk of arrhythmias.
Frequency of side effects:

• very common- more than 1 in 10 patients
• common- more than 1 in 100 patients, but less than 1 in 10 patients
• uncommon- more than 1 in 1000 patients, but less than 1 in 100 patients
• rare- more than 1 in 10,000 patients, but less than 1 in 1,000 patients
• very rare- less than 1 in 10,000 patients

The following side effects have been observed:

Common

Gastrointestinal disorders:
Transient abdominal cramps, rumbling in the abdomen, and diarrhea.

Uncommon

General disorders:
Cases of hypersensitivity, including rash, urticaria, and itching, mild and transient headaches or dizziness. There have also been reports of dose-dependent frequent urination.

Very rare

Nervous system disorders:
Single cases of seizures and other symptoms such as: muscle stiffness, facial rigidity, slowed movement, restlessness, involuntary muscle contractions.
Reproductive system and breast disorders:
Transient cases of gynecomastia (breast tissue growth) and galactorrhea, sometimes with elevated prolactin levels.
Liver and biliary disorders:
Reports of transient liver function disorders, with or without jaundice.
Respiratory, thoracic, and mediastinal disorders:
Bronchospasm.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell 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 181C, 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 Gasprid

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: Expiry date (EXP). The expiry date refers to the last day of the 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 Gasprid contains

• The active substance of the medicine is cisapride. Each Gasprid tablet contains 5 mg or 10 mg of cisapride in the form of cisapride monohydrate.
• The other ingredients are: lactose monohydrate (see section 2, "Gasprid contains lactose"), microcrystalline cellulose, potato starch, povidone, croscarmellose sodium, magnesium stearate, polysorbate 80.

What Gasprid 5 mg tablets look like and contents of the pack

Tablets.
1 blister of 30 tablets (30 tablets) in a cardboard box.

What Gasprid 10 mg tablets look like and contents of the pack

Tablets.
2 blisters of 15 tablets (30 tablets) in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel.: (22) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow

Date of last revision of the leaflet: