Zgaginstop antacidum

Package leaflet: information for the user

Zgaginstop Antacidum, 680 mg + 80 mg, chewable tablets
Calcii carbonas + Magnesii subcarbonas ponderosus
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

Contents of the leaflet

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

Zgaginstop Antacidum is mint-flavoured tablets that neutralise hydrochloric acid in
the stomach.
Zgaginstop Antacidum is used to treat heartburn and associated symptoms, such as gastric discomfort and gastroesophageal reflux (acid regurgitation).
If there is no improvement after 7 days, or if your condition worsens, consult your doctor.

2. Important information before taking Zgaginstop Antacidum

When not to take Zgaginstop Antacidum:

• if the patient is allergic to calcium carbonate, magnesium carbonate, or any of the other ingredients of this medicine (listed in section 6),
• if the patient has elevated calcium levels or decreased phosphate levels in the blood,
• if the patient has increased calcium levels in urine or kidney stones,
• if the patient has severe renal insufficiency. In case of doubt, consult a doctor or pharmacist.

Warnings and precautions:
Before starting treatment with Zgaginstop Antacidum, discuss with a doctor or
pharmacist:

• if the patient has mild or moderate kidney function impairment, as regular blood tests should be performed in such cases.

Do not exceed the recommended dose and do not use the medicine for longer than 7 days without consulting a
doctor. Like any medicine that neutralizes gastric hydrochloric acid, these tablets may mask symptoms
of other, more serious diseases; therefore, prolonged use of this medicine should be avoided.
Children and adolescents
Use in children under 12 years of age is not recommended.
Interaction of Zgaginstop Antacidum with other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines you plan to take.
If the patient is taking any of the following medicines, consult a doctor or
pharmacist before using Zgaginstop Antacidum, as it may affect the efficacy of the
medicine:

• tetracyclines and quinolones (antibiotics),
• levothyroxine (thyroid hormone),
• eltrombopag (used to increase platelet count),
• digoxin (used in certain heart conditions),
• thiazide diuretics (diuretic medicines used to treat fluid retention and high blood pressure),
• fluorides (used to prevent dental caries),
• phosphates (used for bowel cleansing before surgical procedures),
• iron preparations.

To achieve optimal benefits from all medicines, Zgaginstop Antacidum should be
taken at least 4 hours before or after eltrombopag (used to increase platelet production in the body, which play a key role in blood clotting), and 1 to 2 hours after 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 may be taken during pregnancy and breastfeeding, provided the medicine is used according to the indications.

3. How to take Zgaginstop Antacidum

This medicine should always be taken exactly as described in this patient leaflet, or as advised by your
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Recommended dose:
Adults and adolescents (aged over 12 years): 1–2 tablets should be sucked, chewed, or dissolved
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 there is no improvement after 7 days, or if symptoms worsen, consult your doctor. Prolonged use of
the medicine should be avoided.
Use in children and adolescents
Zgaginstop Antacidum is not recommended for children under 12 years of age.
Accidental overdose of Zgaginstop Antacidum
Drink plenty of water and consult your doctor or pharmacist. Symptoms of overdose may include:
nausea, vomiting, constipation, and muscle weakness.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
The occurrence of adverse reactions is unlikely when the recommended dose is used. If any of the following adverse reactions occur, the medicine should be discontinued and medical advice should be sought immediately.
Allergic reactions to the ingredients of the medicine, such as rash, itching, breathing difficulties, and swelling of the face, mouth or throat, have been reported rarely, as well as anaphylactic shock (anaphylactic shock is a severe, sudden allergic reaction characterized by low blood pressure, shock, palpitations, breathing difficulties, bronchospasm, skin reactions, abdominal pain or cramps, vomiting and diarrhoea).
Prolonged use of high doses, especially in patients with impaired kidney function, may lead to elevated levels of calcium and magnesium in the blood. Symptoms may include nausea, vomiting, stomach upset, diarrhoea, fatigue, muscle weakness, headache, kidney problems and taste disturbances. In rare cases, prolonged use of high doses may lead to milk-alkali syndrome, which in turn may cause increased calcium levels in the blood.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, 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 allows the collection of additional information on the safety of the medicine.

5. How to store Zgaginstop Antacidum

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following:
Expiry date (EXP). The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture. There are no special requirements
regarding storage temperature.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the pack and other information

What Zgaginstop Antacidum contains

• The active substances are: calcium carbonate and heavy magnesium carbonate. Each chewable tablet contains 680 mg of calcium carbonate and 80 mg of heavy magnesium carbonate.
• Other ingredients are: colloidal anhydrous silica; pregelatinized maize starch; copovidone; xylitol (E 967); low-substituted hydroxypropyl cellulose LH-11; peppermint flavour: flavouring and aroma substances, natural flavouring and aroma substances (pulegone, menthofuran), maltodextrin and arabic gum (E 414); menthol flavour spray dried: flavouring and aroma substances, arabic gum (E 414); talc and magnesium stearate.

What Zgaginstop Antacidum looks like and contents of the pack
Zgaginstop Antacidum chewable tablets are square-shaped, white or almost white, biconvex tablets with rounded edges. Tablet dimensions: length 15 mm, width 15 mm and thickness 3.9 – 4.3 mm.
The tablets are packed in PVC/PVDC/Aluminium blisters with push-through foil, containing 8 tablets each.
The cardboard box contains 16, 24, 48 or 96 chewable tablets and a leaflet.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warszawa
Tel: 22 32 16 240
Importer:
Alkaloid-INT d.o.o.
Šlandrova ulica 4
1231 Ljubljana – Črnuče
Slovenia
This medicinal product is authorised in the following names in the Member States of the European Economic Area:
Bulgaria GATTART 680 mg/80 mg chewable tablets
Croatia GATTART 680 mg/80 mg tablete za žvakanje
Czech Republic Gattart
Poland Zgaginstop Antacidum
Romania Gattart 680 mg/80 mg comprimate masticabile
Slovakia GATTART 680 mg/80 mg
Slovenia GATTART 680 mg/80 mg žvečljive tablete
Iceland Ríflúxín 680 mg/80 mg tuggutöflur