ALMAGATO STADAPHARM 500 MG CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Almagato Stadapharm 500 mg chewable tablets

Read this package leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

Contents of the Package Leaflet

1. What is Almagato Stadapharm and what is it used for
2. What you need to know before taking Almagato Stadapharm
3. How to take Almagato Stadapharm
4. Possible side effects
5. Storage of Almagato Stadapharm
6. Package Contents and Additional Information

1. What is Almagato Stadapharm and what is it used for

Almagato Stadapharm belongs to a group of medicines called antacids, which are compounds that act by neutralizing excess stomach acid.

It is indicated for the relief and symptomatic treatment of heartburn and stomach acid in adults and adolescents.

You should consult a doctor if your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Almagato Stadapharm

Do not take Almagato Stadapharm

• If you are allergic to almagato or any of the other components of this medicine (listed in section 6).
• If you have Alzheimer's disease.
• If you have undiagnosed digestive tract bleeding, hemorrhoids, fluid retention (edema), liver complications during pregnancy (toxemia of pregnancy), or diarrhea.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before taking this medicine:

• If you have mild or moderate kidney disease, as aluminum and magnesium ions can accumulate in the body over time. In this case, your doctor may recommend the lowest dose. This medicine is not recommended in severe kidney failure.
• If you are on a low-phosphorus diet, have diarrhea, malabsorption, or are severely debilitated, as aluminum salts reduce phosphorus absorption, which can cause, especially with prolonged treatment, a decrease in blood phosphate levels (loss of appetite, muscle weakness, general discomfort, etc.) and insufficient bone mineralization (osteomalacia).

• If you are an elderly patient, as the continued use of antacids containing aluminum can worsen existing bone disease (osteoporosis and osteomalacia) due to reduced phosphorus and calcium levels.

Tell your doctor if you experience any symptoms that may indicate digestive tract bleeding, such as vomiting blood or black stools.

Children and Adolescents

Antacids should not be given to children under 12 years old, as they may mask other existing diseases (e.g., appendicitis). In younger children, there is a risk of increased magnesium levels in the blood or aluminum toxicity, especially if they are dehydrated or have kidney disease.

Other Medicines and Almagato Stadapharm

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medicine.

Antacids alter the absorption of many medicines, so, in general, the intake of Almagato Stadapharm 500 mg should be spaced out (2-3 hours) from the administration of any other medicine.

It is especially important to inform your doctor if you are taking any of the following medicines:

• Non-steroidal anti-inflammatory drugs (medicines used to treat pain and inflammation, e.g., flufenamic acid or mefenamic acid, indomethacin)

Anti-ulcer medicines (medicines for treating stomach ulcers or duodenal ulcers and heartburn, among others, e.g., cimetidine, famotidine, ranitidine)

• Digitalis (medicines for treating heart function disorders, e.g., digoxin, digitoxin)

Antipsychotics (medicines for treating behavioral disorders and psychiatric symptoms, e.g., chlorpromazine)

• Lansoprazole (medicine for treating stomach ulcers)
• Corticosteroids (prednisone)
• Gabapentin (medicine for treating epilepsy)
• Ketoconazole (medicine for treating fungi)
• Medicines for treating infections, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chlotetracycline, demeclocycline, doxycycline)

as this medicine may reduce the absorption of the aforementioned medicines due to changes in stomach conditions or the formation of poorly soluble complexes.

• Quinidine (medicine for treating heart rhythm disorders), as this medicine may increase its toxicity by reducing its elimination due to increased urine pH.

• Salicylates (medicines for relieving pain and reducing fever and inflammation, e.g., acetylsalicylic acid), as this medicine may decrease their concentrations due to increased elimination caused by increased urine pH, especially with high doses of salicylate.

Consult your doctor if you are going to have a stomach composition analysis, as Almagato Stadapharm may alter the test results.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Chronic or excessive use of Almagato Stadapharm should be avoided during pregnancy due to the risk of fetal/newborn disorders.

If you need prolonged treatment, consult your doctor, who will indicate the appropriate treatment.

Breastfeeding

Chronic or excessive use of medicines containing almagato should be avoided.

Although small amounts of aluminum and magnesium can be eliminated through breast milk in mothers treated with almagato, their concentration is not high enough to cause adverse effects in the infant.

Driving and Using Machines

Almagato Stadapharm does not affect your ability to drive or operate machinery.

Almagato Stadapharm 500 mg Chewable Tablets Contain Sulfites

This medicine may cause severe allergic reactions and bronchospasm (sudden feeling of suffocation) because it contains sulfites.

3. How to Take Almagato Stadapharm

Follow the administration instructions of the medicine contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor or pharmacist or nurse.

Use in Adults and Adolescents:the recommended dose is 2 tablets (1 gram of almagato) three times a day, preferably 30 minutes to 1 hour after meals. If symptoms recur, another dose can be taken before bedtime.

Do not exceed 8 grams per day (16 tablets).

Use in Elderly Patients:no dose adjustment is necessary (see "Warnings and Precautions" section).

Use in Patients with Kidney Disease:if you have severe kidney failure, this medicine is not recommended (see "Warnings and Precautions" section).

If you have mild or moderate kidney disease, your doctor may recommend lower doses (see "Warnings and Precautions" section).

This medicine should be taken orally.

The tablets can be chewed or dissolved in the mouth.

If You Take More Almagato Stadapharm Than You Should

At the recommended doses, no intoxication with this medicine is expected. In patients with a low-phosphorus diet and/or prolonged treatment with high doses, a decrease in blood phosphate levels and insufficient bone mineralization may occur.

If you have taken more Almagato Stadapharm than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service, phone 915 620 420, indicating the medicine and the amount taken.

If You Forget to Take Almagato Stadapharm

Do not take a double dose to make up for forgotten doses. Take the forgotten dose when you can if the time interval is small, or wait for the next dose, provided there are no symptoms, in which case you can take it before. Take the next doses with the indicated time interval between them.

If you have any other doubts about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Due to the low intestinal absorption, the side effects of almagato are rare. Occasionally (no data are available to estimate the frequency), diarrhea has been reported, which usually disappears after treatment is discontinued.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use, Website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Almagato Stadapharm

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

No special storage conditions are required.

Do not use this medicine after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Almagato Stadapharm 500 mg Chewable Tablets

•The active ingredient is almagato. Each tablet contains 500 mg of almagato.

•The other ingredients are: mannitol (E-421), povidone (E-1201), potato starch, sodium saccharin, ammonium glycyrrhizate, magnesium stearate, and peppermint flavor (contains sulfites).

Appearance of the Product and Package Contents

Almagato Stadapharm is presented in the form of white, mint-flavored chewable tablets.

Each box contains 18, 24, 48, or 54 tablets.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA S.L.

Frederic Mompou, 5

08960 Sant Just Desvern, Barcelona

Spain

Manufacturer

GALENICUM HEALTH, S.L.U.

Sant Gabriel, 50

08950 Esplugues de Llobregat (Barcelona), Spain

or

SAG MANUFACTURING, S.L.U.

Ctra. N-I, km 36

28750 San Agustín de Guadalix, Madrid

Spain

Date of the Last Revision of this Package Leaflet:June 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/