Package leaflet:

Patient Information
Alugastrin
1.02 g/15 ml, oral suspension
Dihydroxyaluminii natrii carbonas
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used 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 adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 14 days in adults or after 7 days in children, or if symptoms worsen, consult a doctor.

Leaflet Contents

What Alugastrin is and what it is used for
Important information before taking Alugastrin
How to take Alugastrin
Possible side effects
How to store Alugastrin
Contents of the pack and other information

1. What Alugastrin is and what it is used for

Alugastrin is a medicine that neutralizes excess hydrochloric acid in gastric juice. It does not cause
excessive alkalization of gastric juice or secondary stimulation of hydrochloric acid secretion. It acts
protectively on the mucous membranes of the oesophagus, stomach, and duodenum. It relieves pain symptoms associated
with gastric hyperacidity.
For symptomatic use:

in gastric hyperacidity;
in episodic gastro-oesophageal reflux disease (e.g. heartburn, acid regurgitation, sour taste in the mouth);
in gastric and duodenal mucosal damage caused by ulcerogenic factors (e.g. non-steroidal anti-inflammatory drugs – painkillers and anti-inflammatory medicines, often used for colds);
in peptic ulcer disease of the stomach and duodenum. If there is no improvement after 14 days in adults or after 7 days in children, or if symptoms worsen, consult a doctor.

2. Important information before using Alugastrin

When not to use Alugastrin

if the patient is allergic to sodium dihydroxyglycinate carbonate or any of the other ingredients of this medicine (listed in section 6);
if the patient has severe renal impairment.

Warnings and precautions
Use with caution in patients prone to constipation.
In children under 6 years of age, the medicine should be used only after a physician has diagnosed the cause of symptoms.
Long-term use of high doses of the medicine may lead to hypophosphatemia (aluminium contained in the medicine binds phosphates in the small intestine, forming insoluble compounds).
The medicine contains 163 mg of sodium per dose (15 ml); this should be taken into account in patients with impaired renal function and in patients controlling sodium intake in their diet.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
The medicine may cause allergic reactions (delayed-type reactions possible).

Alugastrin and other medicines
Inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Alugastrin reduces gastrointestinal absorption of certain orally administered medicines, e.g.:

H-receptor antagonists (medicines reducing gastric hydrochloric acid secretion, used in the treatment of gastric and duodenal ulcer disease, e.g. ranitidine);
phenytoin (an anticonvulsant and antiarrhythmic medicine used in epilepsy treatment);
fluoroquinolones (medicines used in the treatment of bacterial infections of the respiratory, urinary and genital systems, gastrointestinal tract, skin, soft tissues, bones and joints, e.g. ciprofloxacin);
cardiac glycosides (medicines used in heart failure, e.g. digoxin);
ketoconazole (a medicine used in fungal infections of the skin and nails);
tetracyclines (a group of antibiotics used in bacterial infections of the respiratory and urinary systems, Lyme disease, skin infections, e.g. doxycycline);
salicylates (medicines with antipyretic, analgesic and anti-inflammatory effects, commonly used for colds);
iron preparations (medicines used in iron deficiency anemia);
reduces the effectiveness of sucralfate (a medicine used in the treatment of gastric and duodenal ulcer disease).
Intervals between administration of Alugastrin and other oral medicines should be observed as recommended by the physician.

Alugastrin with food and drink
It is recommended to take the medicine after meals or between meals.

Pregnancy, breastfeeding and fertility
Consult a doctor or pharmacist before using any medicine.
During pregnancy (especially in the first trimester) and breastfeeding, the medicine may be used only if clearly necessary. Do not use long-term or in high doses.

Driving and operating machinery
Alugastrin has no effect on the ability to drive or operate machinery.

Alugastrin contains 163 mg of sodium per dose (15 ml). This should be taken into account in patients with impaired renal function and in patients controlling sodium intake in their diet. If the medicine is taken daily for longer than 1 month or in repeated doses more frequently than 2 days per week, patients—especially those controlling sodium intake in their diet—should consult a doctor or pharmacist.

Alugastrin contains 1.2 g of sorbitol per dose (15 ml). Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot break down fructose—the patient should consult a doctor before taking the medicine or giving it to a child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Alugastrin contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate.
The medicine may cause allergic reactions (delayed-type reactions possible).

3. How to use Alugastrin

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Recommended dose
Adults and children over 6 years: unless otherwise advised by a doctor, take 15 ml (one tablespoon) one hour after meals and at bedtime, or when symptoms occur.
Shake the bottle vigorously for about 30 seconds before use.
Use of a higher than recommended dose of Alugastrin
If Alugastrin is taken in excess of the recommended dose, diarrhoea and swelling of the feet and lower legs may occur.
Missed dose of Alugastrin
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Side effects occurring commonly (in less than 1 in 10 people):
chalky taste, mild constipation, stomach cramps.

Side effects occurring uncommonly (in less than 1 in 100 people):
nausea or vomiting, whitish discoloration of stool.

Side effects occurring rarely (in less than 1 in 1,000 people):
in case of long-term use or use of high doses:
persistent constipation, loss of appetite, unusual weight loss, muscle weakness, phosphate loss (bone pain, swelling of wrists or ankles).

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder. Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Alugastrin

Store 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 container. The expiry date refers to the last day of the stated month.
Shelf-life after opening: 30 days.
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 Alugastrin contains

The active substance is sodium dihydroxyaluminium carbonate. Each dose (15 ml) contains 1.02 g of sodium dihydroxyaluminium carbonate.
Other ingredients (excipients) are: sorbitol liquid, non-crystallizing, xanthan gum, methyl 4-hydroxybenzoate (E 218), simethicone (emulsion), propyl 4-hydroxybenzoate, sodium saccharin, chlorhexidine digluconate solution, peppermint oil with reduced menthol content, purified water.

What Alugastrin looks like and contents of the pack
The medicine is a white suspension with a minty odour and taste.
The high-density polyethylene (HDPE) bottle with a tamper-evident cap made of high-density polyethylene (HDPE) and a sealing insert made of low-density polyethylene (LDPE) contains 250 ml or 375 ml of suspension. A patient leaflet is included in the pack.
Marketing Authorisation Holder
URGO Sp. z o.o.
Al. Jerozolimskie 142 B
02-305 Warsaw
Tel./Fax: 22 616 33 48 / 22 617 69 21
Manufacturer
SENSILAB Polska Spółka z ograniczoną odpowiedzialnością – Spółka komandytowo-akcyjna
ul. gen. Mariana Langiewicza 58
95-050 Konstantynów Łódzki
Polfarmex SA
ul. Józefów 9
99-300 Kutno
Detailed information about this medicine is available from the marketing authorisation holder, including for blind and partially sighted people (audio version, CD) by calling: 22 616 33 48