Zgaginstop Antacidum

Package Leaflet: Information for the Patient

Zgaginstop Antacidum, 680 mg + 80 mg, Chewable Tablets

Calcium Carbonate + Magnesium Carbonate, Heavy

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

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact a doctor.

Table of Contents of the Leaflet

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

1. What is Zgaginstop Antacidum and what is it used for

Zgaginstop Antacidum is a mint-flavored chewable tablet that neutralizes stomach acid in the body.
Zgaginstop Antacidum is used to treat heartburn and associated symptoms, such as stomach discomfort and acid reflux.
If after 7 days there is no improvement or you feel worse, you should contact a doctor.

2. Important information before taking Zgaginstop Antacidum

When not to take Zgaginstop Antacidum:

• if you are allergic to calcium carbonate, magnesium carbonate, or any of the other ingredients of this medicine (listed in section 6),
• if you have high levels of calcium or low levels of phosphate in the blood,
• if you have high levels of calcium in the urine or kidney stones,
• if you have severe kidney impairment. In case of doubt, consult a doctor or pharmacist.

Warnings and precautions:

Before taking Zgaginstop Antacidum, discuss it with your doctor or pharmacist:

• if you have mild or moderate kidney function impairment, as regular blood tests may be necessary.

Do not exceed the recommended dose and do not take the medicine for more than 7 days without consulting a doctor. Like any antacid, these tablets may mask the symptoms of other, more serious diseases, so prolonged use of this medicine should be avoided.

Children and adolescents

The use of this medicine is not recommended in children under 12 years of age.

Zgaginstop Antacidum with 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.
If you are taking any of the following medicines, talk to your doctor or pharmacist before taking Zgaginstop Antacidum, as it may affect the action of the medicine:

• tetracyclines and quinolones (antibiotics),
• levothyroxine (thyroid hormone),
• eltrombopag (used to increase platelet count),
• digoxin (used for certain heart conditions),
• thiazide diuretics (diuretics used to treat fluid retention and high blood pressure),
• fluorides (used to prevent tooth decay),
• phosphates (used to cleanse the bowel before surgery),
• iron preparations.

To get the most benefit from all medicines, Zgaginstop Antacidum should be taken at least 4 hours before or after taking eltrombopag (used to increase platelet production in the body) and 1 to 2 hours after taking other medicines.

Zgaginstop Antacidum with food and drink

Avoid taking this medicine with large amounts of milk and dairy products.

Pregnancy, breastfeeding, and fertility

The tablets can be taken during pregnancy and breastfeeding, provided the medicine is used as directed.

3. How to take Zgaginstop Antacidum

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.
The recommended dose is:
Adults and adolescents(over 12 years): 1-2 tablets should be sucked or chewed in case of heartburn and associated symptoms (listed in section 1). It is recommended to take the medicine 1 hour after meals and before bedtime.
Do not take more than 11 tablets per day.
If after 7 days there is no improvement or you feel worse, you should contact a doctor. Prolonged use of the medicine should be avoided.

Use in children and adolescents

The use of this medicine is not recommended in children under 12 years of age.

Overdose of Zgaginstop Antacidum

Drink plenty of water and consult a doctor or pharmacist. Symptoms of overdose include: nausea, vomiting, constipation, and muscle weakness.
In case of any further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The occurrence of side effects is unlikely when the recommended dose is taken. If you experience any of the following side effects, stop taking the medicine and seek medical attention immediately.
Rarely, allergic reactions to the ingredients of the medicine have been reported, such as rash, itching, difficulty breathing, and swelling of the face, mouth, or throat, as well as anaphylactic shock (anaphylactic shock is a severe, sudden allergic reaction that can cause low blood pressure, shock, palpitations, difficulty breathing, bronchospasm, skin reactions, pain, or cramps in the abdomen, vomiting, and diarrhea).
Prolonged use of high doses, especially in patients with kidney function impairment, may cause elevated levels of calcium and magnesium in the blood. Symptoms may include nausea, vomiting, stomach upset, diarrhea, fatigue, muscle weakness, headache, kidney problems, and taste disturbances. In rare cases, prolonged use of high doses may lead to milk-alkali syndrome, which can cause elevated levels of calcium in the blood.

Reporting side effects

If you experience any side effects, including those not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to:
Department for Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Zgaginstop Antacidum

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after:
Expiry date (EXP). The expiry date refers to the last day of the month.
Store in the original package to protect from moisture. There are no special storage temperature recommendations for the medicine.
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 Zgaginstop Antacidum contains

• The active substances are: calcium carbonate and magnesium carbonate, heavy. Each chewable tablet contains 680 mg of calcium carbonate and 80 mg of magnesium carbonate, heavy.
• The other ingredients are: colloidal anhydrous silica; maize starch; copovidone; xylitol (E 967); hypromellose, low substituted; peppermint flavor: flavoring agents and flavor enhancers, natural flavoring agents (pulegone, menthofuran), maltodextrin, and arabic gum (E 414); menthol dry spray: flavoring agents, arabic gum (E 414); talc and magnesium stearate.

What Zgaginstop Antacidum looks like and contents of the pack

Zgaginstop Antacidum chewable tablets are white or almost white, square, biconvex tablets with rounded edges. The dimensions of the tablet are: length 15 mm, width 15 mm, and thickness 3.9-4.3 mm.
The tablets are packaged in PVC/PVDC/Aluminum blisters, each containing 8 tablets.
The cardboard box contains 16, 24, 48, or 96 chewable tablets and a leaflet.
Not all pack sizes may be marketed.

Marketing authorization holder:

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Phone: 22 32 16 240

Importer:

Alkaloid-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana – Črnuče
Slovenia

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

Bulgaria
GATTART 680 mg/80 mg chewable tablets
Croatia
GATTART 680 mg/80 mg tablets for chewing
Czech Republic
Gattart
Poland
Zgaginstop Antacidum
Romania
Gattart 680 mg/80 mg masticable tablets
Slovakia
GATTART 680 mg/80 mg
Slovenia
Island
GATTART 680 mg/80 mg chewable tablets
Ríflúxín 680 mg/80 mg chewable tablets

Date of last revision of the leaflet: