Leaflet: information for the user

Almagato Stadapharm 500 mg chewable tablets

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

- Keep this leaflet, as you may need to read it again.

- If you need advice or more information, consult your pharmacist.

- If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

- You should consult a doctor if you get worse or do not improve after 14 days.

1. What Almagato Stadapharm is and what it is 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. Contents of the pack and additional information

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

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

Consult a doctor if symptoms worsen or do not improve after 14 days.

Do not take Almagato Stadapharm

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication:

• If you have mild or moderate kidney disease, as aluminum and magnesium ions may accumulate in the body over time. In this case, you may be recommended a lower dose. This medication is not recommended for severe kidney failure.
• If you follow a low-phosphorus diet, have diarrhea, malabsorption, or are severely weakened, as aluminum salts can decrease phosphorus absorption, which may lead to a decrease in blood phosphate levels (loss of appetite, muscle weakness, general discomfort, etc.) and insufficient mineralization of bones (osteomalacia) over time.

• If you are an elderly patient, as long-term use of aluminum-containing antacids may exacerbate existing bone diseases (osteoporosis and osteomalacia) due to reduced phosphorus and calcium levels.

Inform your doctor if you experience any symptoms indicating gastrointestinal bleeding, such as vomiting blood or black stool color.

Children and adolescents

Anti-acids should not be administered to children under 12 years old, as they may mask 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 medications and Almagato Stadapharm

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Antacids modify the absorption of numerous medications, so, in general, Almagato Stadapharm 500 mg should be taken 2-3 hours apart from any other medication.

It is especially important to inform your doctor if you take any of the following medications:

• Anti-inflammatory non-steroidal medications (used to treat pain and inflammation, e.g., flufenamic acid or mefenamic acid, indomethacin)

Antiulcer medications (used to treat stomach ulcers or duodenal ulcers and stomach acid, e.g., cimetidine, famotidine, ranitidine)

• Digitals (used to treat heart function alterations, e.g., digoxin, digitoxin)

Antipsychotics (used to treat behavioral disorders and psychiatric symptoms, e.g., chlorpromazine)

• Lansoprazole (used to treat stomach ulcers)
• Prednisone (corticosteroids)
• Gabapentin (used to treat epilepsy)
• Ketoconazole (used to treat fungal infections)
• Medications for treating infections, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chlor tetracycline, demeclocycline, doxycycline)

Salt of iron (sulfate of iron)

as this medication may decrease the absorption of the listed medications by changing stomach conditions or forming insoluble complexes.

• Quinidine (used to treat heart rhythm alterations), as this medication may potentiate its toxicity by decreasing its elimination due to increased urine pH.

• Salicylates (used to relieve pain and reduce fever and inflammation, e.g., acetylsalicylic acid), as this medication may decrease its concentrations due to increased elimination caused by increased urine pH, especially with high salicylate doses.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Prolonged or excessive use of Almagato Stadapharm during pregnancy should be avoided due to the risk of fetal or newborn alterations.

If you need a longer treatment, consult your doctor, who will indicate the appropriate dosage.

Breastfeeding

Prolonged or excessive use of medications containing almagato should be avoided.

Although small amounts of aluminum and magnesium may 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 operating machinery

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

Almagato Stadapharm 500 mg chewable tablets contain sulfites

This medication may cause severe allergic reactions and bronchospasm (sudden feeling of choking) due to the presence of sulfites.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor, pharmacist, or nurse. In case of doubt, ask your doctor or pharmacist or nurse.

Use in adults and adolescents: The recommended dose is 2 tablets (1 gram of almagate) three times a day, preferably half to one hour after meals. If symptoms recur, another dose may 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").

Use in patients with kidney disease: If you have severe renal insufficiency, this medication is not recommended (See "Warnings and precautions").

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

This medication should be taken orally.

Tablets can be chewed or dissolved in the mouth.

If you take more Almagato Stadapharm than you should

Exceeding the recommended doses is not expected to cause intoxication with this medication. 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 Toxicological Information Service, phone 915 620 420, indicating the medication and the amount taken.

If you forgot to take Almagato Stadapharm

Do not take a double dose to make up for the missed doses. Take the missed dose as soon as you remember if the time elapsed is small, or wait to take the next dose as scheduled, unless you experience discomfort, in which case you may take it before bedtime. Take the next doses with the recommended interval between doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Due to the low intestinal absorption, the adverse effects of almagate are infrequent. Occasionally (no data is available to estimate the frequency), diarrhea has been described, which generally disappears after suspension of treatment.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicinal Products for Human Use, Website:www.notificaram.es.By reporting adverse effects, you can contribute toproviding more information about the safety of this medication.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the Sigre Point of your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Almagato Stadapharm 500 mg chewable tablets

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

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

Appearance of the product and contents of the packaging

Almagato Stadapharm is presented in the form of white, chewable tablets with a peppermint odor.

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

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA Laboratory S.L.

Frederic Mompou, 5

08960 Sant Just Desvern, Barcelona

Spain

Responsible manufacturer

GALENICUM HEALTH, S.LU.

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

Last review date of this leaflet:June2024

The detailed information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/