Alugastrin

Leaflet attached to the packaging:

Information for the patient

Alugastrin

1.02 g/15 ml, oral suspension
Dihydroxyaluminum sodium carbonate

You should carefully read the contents of the leaflet 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 your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 14 days in adults or after 7 days in children, there is no improvement or the patient feels worse, you should contact a doctor .

Table of contents of the leaflet

• 1. What is Alugastrin and what is it used for
• 2. Important information before using Alugastrin
• 3. How to use Alugastrin
• 4. Possible side effects
• 5. How to store Alugastrin
• 6. Contents of the packaging and other information

1. What is Alugastrin and what is it used for

Alugastrin is a medicine that neutralizes excess hydrochloric acid in gastric juice. It does not cause excessive alkalization of gastric juice and secondary stimulation of hydrochloric acid secretion. It has a protective effect on the mucous membrane of the esophagus, stomach, and duodenum. It alleviates painful symptoms associated with excess hydrochloric acid in gastric juice.
It should be used symptomatically:

• for excess hydrochloric acid in gastric juice;
• for episodic esophageal reflux disease (e.g., heartburn, acid reflux, regurgitation of acidic stomach contents);
• for mucosal damage to the stomach and duodenum caused by ulcerogenic factors (e.g., non-steroidal anti-inflammatory drugs - painkillers and anti-inflammatory drugs, often used for colds);
• for gastric and duodenal ulcer disease. If after 14 days in adults or after 7 days in children, there is no improvement or the patient feels worse, you should consult a doctor .

2. Important information before using Alugastrin

When not to use Alugastrin

• if you are allergic to dihydroxyaluminum sodium carbonate or any of the other ingredients of this medicine (listed in section 6);
• if you have severe kidney failure.

Warnings and precautions

Use with caution in patients with a tendency to constipation.
In children under 6 years of age, it can only be used after a doctor has diagnosed the cause of the symptoms.
Long-term use of high doses of the medicine may lead to hypophosphatemia (aluminum in the medicine binds to phosphates in the small intestine, forming insoluble compounds).
The medicine contains 163 mg of sodium per dose (15 ml), which should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.
If you have previously been diagnosed with intolerance to certain sugars, you should consult a doctor before taking the medicine.
The medicine may cause allergic reactions (possible late-type reactions).

Alugastrin with food and drink

It is recommended to take the medicine after meals or between meals.

Pregnancy, breastfeeding, and fertility

Before using any medicine, you should consult a doctor or pharmacist.
During pregnancy (especially in the first trimester) and breastfeeding, the medicine should only be used if necessary. Do not use it for a long time or in high doses.

Driving and using machines

Alugastrin does not affect the ability to drive or operate machines.
Alugastrin contains 163 mg of sodium per dose(15 ml), which should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake. If you are taking the medicine daily for more than 1 month or in repeated doses more than 2 days a week, you should consult a doctor or pharmacist.
Alugastrin contains 1.2 g of sorbitol per dose (15 ml). Sorbitol is a source of fructose. If you have previously been diagnosed with intolerance to certain sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, you should consult a doctor before taking the medicine or giving it to your 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 (possible late-type reactions).

3. How to use Alugastrin

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult a doctor or pharmacist.
Recommended dose
Adults and children over 6 years: if your doctor does not recommend otherwise, take 15 ml (1 tablespoon) 1 hour after meals and before bedtime or when symptoms occur.
Shake the bottle before use.

Using a higher dose of Alugastrin than recommended

If you use a higher dose of Alugastrin than recommended, you may experience diarrhea, swelling of the feet and ankles.

Missing a dose of Alugastrin

Do not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (in less than 1 in 10 people):
chalky taste, mild constipation, stomach cramps.
Uncommon side effects (in less than 1 in 100 people):
nausea or vomiting, pale stools.
Rare side effects (in less than 1 in 1000 people):
in case of long-term use or high doses:
persistent constipation, loss of appetite, unusual weight loss, muscle weakness, phosphate loss (bone pain, swelling of the wrists or ankles).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to 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 gather more information on the safety of the medicine.

5. How to store Alugastrin

Store in a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Shelf life after opening: 30 days.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Alugastrin contains

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

What Alugastrin looks like and what the packaging contains

The medicine is a white suspension with a minty smell and taste.
A polyethylene (HDPE) bottle with a screw cap and a polyethylene (LDPE) seal contains 250 ml or 375 ml of suspension. The packaging includes a patient information leaflet.

Marketing authorization 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 authorization holder, including for the blind and partially sighted (audio version, CD) at:
22 616 33 48

Date of last update of the leaflet: