Alugastrin

Package Leaflet: Information for the Patient

Alugastrin, 340 mg, Chewable Tablets

(Dihydroxyaluminum Sodium Carbonate)

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 the 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 additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their 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, they should consult a doctor .

Table of Contents of the Leaflet

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

1. What is Alugastrin and what is it used for

Alugastrin is a medicine that neutralizes excess stomach acid. It does not cause excessive alkalization of stomach acid and secondary stimulation of acid secretion. It acts protectively on the mucous membrane of the esophagus, stomach, and duodenum. It alleviates painful symptoms associated with excess stomach acid.

Take as needed:

• for excess stomach acid;
• for episodic reflux esophagitis (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 - pain and anti-inflammatory medications, 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, they should consult a doctor .

2. Important information before taking Alugastrin

When not to take Alugastrin

• if the patient is allergic to dihydroxyaluminum sodium carbonate or any other component of this medicine (listed in section 6);
• if the patient has 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).

Alugastrin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Alugastrin reduces the absorption of some orally administered medicines, such as:

• histamine H2-receptor antagonists (medicines that reduce stomach acid secretion, used to treat gastric and duodenal ulcer disease, e.g., ranitidine);
• phenytoin (a medicine with antiepileptic and antiarrhythmic effects, used to treat epilepsy);
• fluoroquinolones (medicines used to treat bacterial infections of the respiratory, urinary, gastrointestinal, skin, and soft tissue, bone, and joint systems, e.g., ciprofloxacin);
• cardiac glycosides (medicines used to treat heart failure, e.g., digoxin);
• ketokonazole (a medicine used to treat fungal infections of the skin and nails);
• tetracycline (a group of antibiotics used to treat bacterial infections of the respiratory, urinary, and gastrointestinal systems, e.g., doxycycline);
• salicylates (medicines with antipyretic, analgesic, and anti-inflammatory effects, often used for colds);
• iron preparations (medicines used to treat iron deficiency anemia);
• reduces the effectiveness of sucralfate (a medicine used to treat gastric and duodenal ulcer disease). Follow the doctor's recommendation for intervals between taking Alugastrin and other oral medicines.

Alugastrin with food and drink

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

Pregnancy, breastfeeding, and fertility

Before taking any medicine, 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 for a long time or in high doses.

Driving and using machines

Alugastrin does not affect the ability to drive or operate machinery.

Alugastrin contains sodium

The medicine contains 57 - 114 mg of sodium per dose, which should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.

3. How to take Alugastrin

This medicine should always be taken exactly as described in the package 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 of age: chew or suck 1 or 2 tablets 1 hour after meals and before bedtime or when symptoms occur. The maximum daily dose is 6 tablets.

Overdose of Alugastrin

In case of taking a higher dose of Alugastrin than recommended, diarrhea, swelling of the feet and ankles 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 about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Alugastrin can cause side effects, although not everybody gets them.

Frequent side effects (occurring in 1 to 10 out of 100 patients):

chalky taste, mild constipation, stomach cramps.

Uncommon side effects (occurring in 1 to 10 out of 1,000 patients):

nausea or vomiting, pale stools.

Rare side effects (occurring in 1 to 10 out of 10,000 patients):

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 any possible side effects not listed in the leaflet, inform your doctor or pharmacist.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products

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 will help gather more information on the safety of the medicine.

5. How to store Alugastrin

Store in a temperature below 25°C. Store in the original packaging to protect from moisture.

Keep the medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the blister pack and carton after EXP.

The expiration date refers to the last day of the specified month.

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. Package contents and other information

What Alugastrin contains

• The active substance of the medicine is dihydroxyaluminum sodium carbonate. Each tablet contains 340 mg of dihydroxyaluminum sodium carbonate.
• The other ingredients (excipients) are: mannitol, potato starch, sodium carmellose, magnesium stearate, flavor and fragrance enhancer mint, sodium saccharin.

What Alugastrin looks like and contents of the pack

The medicine is in the form of white, round tablets with a mint flavor and aroma, packaged in blisters.

The outer packaging contains 10, 20, 40, or 60 tablets in blisters and a patient information leaflet.

Not all pack sizes may be marketed.

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

Coripharma ehf.

Reykjavíkurvegur 78,

Hafnarfjörður, IS-220,

Iceland

Detailed information about this medicine is available from the marketing authorization holder, including for the blind and partially sighted (audio version, CD) at phone number:

22 616 33 48

Date of last revision of the leaflet: