Gastal (o smaku miemtovim)

PATIENT INFORMATION LEAFLET: USER INFORMATION

GASTAL (mint flavor) 450 mg + 300 mg lozenges

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

important for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Gastal and what is it used for
• 2. Important information before taking Gastal
• 3. How to take Gastal
• 4. Possible side effects
• 5. How to store Gastal
• 6. Package contents and other information

1. WHAT IS GASTAL AND WHAT IS IT USED FOR

Gastal lozenges are an antacid that neutralizes excess stomach acid, acting protectively on the mucous membrane of the esophagus, stomach, and duodenum. The medicine eliminates symptoms associated with hyperacidity (heartburn, reflux). Gastal is characterized by a rapid onset of action, and its therapeutic activity lasts for up to 2 hours. The indications for use are:

• symptomatic treatment of disorders associated with hyperacidity (heartburn, dyspepsia) without organic gastrointestinal disease;
• symptomatic treatment of disorders associated with hyperacidity in the course of the following diseases:
• gastritis (inflammation of the stomach mucosa);
• gastric and/or duodenal ulcer disease;
• gastroesophageal reflux disease (GERD);
• hiatal hernia.

2. IMPORTANT INFORMATION BEFORE TAKING GASTAL

When not to take Gastal

Do not take Gastal:

• if the patient has a known hypersensitivity (allergy) to aluminum or magnesium salts or any other component of the medicine;
• if the patient has severe kidney function disorders.

Warnings and precautionsIf the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine (contains lactose and sorbitol). It is recommended to consult a doctor during long-term use of the medicine (more than 2 weeks). The medicine should be used with caution in patients with kidney function disorders or those undergoing hemodialysis. Children: The medicine is not recommended for children under 6 years of age. In young children, the use of magnesium hydroxide may cause hypermagnesemia (elevated magnesium levels in the blood), especially if they have kidney function disorders or dehydration.

Gastal and other medicines

Gastal enhances the effect of levodopa and nalidixic acid. It reduces the effect of tetracycline antibiotics, ciprofloxacin, ofloxacin, salicylates, isoniazid, naproxen, iron preparations, and cardiac glycosides. These medicines should be taken at least 2 hours after or 1 hour before taking Gastal. Magnesium hydroxide may affect the action of certain medicines. Patients should inform their doctor or pharmacist if they are taking salicylates.

Gastal with food and drink

The medicine is recommended to be taken about 1 hour after a meal. If necessary, after sucking the lozenge, patients can drink milk or water. In case of heartburn, the medicine can be taken regardless of meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Gastal can be used during pregnancy and breastfeeding only after consulting a doctor.

Driving and operating machinery:

The medicine does not affect the ability to drive and operate machinery.

3. HOW TO TAKE GASTAL

Unless otherwise prescribed by a doctor, the medicine should be taken as follows: Adults:

• functional disorders of the gastrointestinal tract: heartburn, dyspepsia - 1 to 2 lozenges as needed;
• gastritis, gastric and/or duodenal ulcer disease, gastroesophageal reflux disease, hiatal hernia - 1 to 2 lozenges, 3 to 4 times a day, about 1 hour after meals and before bedtime. Do not take more than 8 lozenges per day. It is not recommended to use the medicine for more than 2 weeks without consulting a doctor.

Use in children from 6 to 12 years:
Half of the adult dose should be used.
The lozenges should be sucked. This allows for rapid onset of action and increases efficacy.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor.

Taking a higher dose of Gastal than recommended

There are no reports of overdose cases. In case of suspected overdose, the doctor will provide symptomatic treatment.
In case of taking a higher dose than recommended, patients should immediately consult their doctor or pharmacist.

Missing a dose of Gastal

The medicine should be taken as soon as possible. Do not take a double dose to make up for a missed dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Gastal can cause side effects, although not everybody gets them.
The frequency of side effects is defined as follows: rare (≥ 1/10,000 to <1>Gastrointestinal disorders
Rare: nausea, diarrhea, constipation
Unknown frequency: abdominal pain
Immune system disorders
Very rare (single cases): allergic reactions.
Metabolic and nutritional disorders
Very rare: hypermagnesemia (elevated magnesium levels in the blood). Observed after prolonged administration of magnesium hydroxide in patients with kidney function disorders.
If any side effects occur, including any not listed in this leaflet, patients should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the 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

• e-mail: ndl@urpl.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 GASTAL

• The medicine should be stored out of the reach and sight of children.
• Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging after: Expiry date.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Gastal contains

The active substances are: aluminum hydroxide with magnesium carbonate, dried gel (450 mg) and magnesium hydroxide (300 mg). The other ingredients are: mannitol, sodium cyclamate, sodium saccharin, lactose monohydrate, sorbitol, corn starch, talc, magnesium stearate, peppermint flavor.

What Gastal looks like and what the package contains

Gastal lozenges are white to creamy, round, with a smooth surface, and beveled edges.
The package contains 24, 48, or 60 lozenges.

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
tel. (22) 234 93 00

Manufacturer

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

Date of last update of the leaflet: