Leaflet: information for the user

Almagato Stadapharm 1.5 g oral suspension

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 for what it is used

2. What you need to know before starting to take 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 12 years of age and older.

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 gravidarum), 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, your doctor may recommend the lowest 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 decrease phosphorus absorption, which can lead to a decrease in blood phosphate levels (loss of appetite, muscle weakness, general discomfort, etc.) and inadequate bone mineralization (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 stools.

Children and adolescents

Do not administer antacids 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 alter the absorption of numerous medications, so, in general, taking Almagato Stadapharm 1.5 g should be spaced at least 3 hours apart from administering 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 abnormalities, e.g., digoxin, digitoxin)

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

• Lansoprazole (used to treat stomach ulcers)
• Prednisone (used to treat inflammation)
• 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 poorly soluble complexes.

• Quinidine (used to treat heart rhythm abnormalities), as Almagato Stadapharm 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 their concentrations by increasing elimination due to increased urine pH, especially with high doses of salicylate.

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

Pregnancy, lactation, and fertility

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

Pregnancy

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

Consult your doctor if you need a longer treatment, as they will indicate the appropriate dosage.

Lactation

Chronic 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 1.5 g oral suspension containssorbitol (E-420)

This medication contains 1.05 g of sorbitol (E-420) in each sachet.This sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a fructose intolerance or hereditary fructose intolerance (IHF), a rare genetic disease in which the patient cannot break down fructose, consult your doctor (or your child's doctor) before taking this medication.

Almagato Stadapharm 1.5 g oral suspension contains sulfites

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

This medication contains less than 1 mmol of sodium (23 mg) per sachet, making it essentially "sodium-free".

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, pharmacist, or nurse.

Use in adults and adolescents: The recommended dose is 1 sachet (1.5 grams of almagate), three times a day, preferably half an hour to one hour after meals. If symptoms recur, another dose can be taken before bedtime.

Do not exceed 8 grams per day (5 sachets).

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, it is not recommended to take this medication (See "Warnings and precautions" section).

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

Almagato Stadapharm should be taken orally.

The sachet should be pressed several times before opening, for complete use of its contents. The oral suspension can be taken directly from the sachet or the contents of one sachet can be poured into a half glass of water, stirred, and taken immediately.

If you take more Almagato Stadapharm than you should

Exceeding the recommended doses does not lead to 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 almagate 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 forget to take Almagato Stadapharm

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

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 everyone 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 treatment is suspended.

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 for 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 unused packaging and medications. By doing so, you will help protect the environment.

Composition of Almagato Stadapharm 1.5 g oral suspension

• The active ingredient is almagate. Each package contains 1.5 grams of almagate.

• The other components are: microcrystalline cellulose (E-460), sodium carmellose, sodium saccharin, chlorhexidine diacetate, peppermint essence (contains sulfites), sorbitol (E-420) at 70%, simethicone emulsion (silica, dimethicone, cellulose-based emulsifier and sorbic acid), and purified water.

Appearance of the product and contents of the packaging

Almagato Stadapharm is presented in the form of a white liquid with a peppermint odor.

Each box contains 12, 24, or 506 packets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

Spain

Responsible for manufacturing

GALENICUM HEALTH, S.LU.

Sant Gabriel, 50

08950 Esplugues de Llobregat (Barcelona), Spain

or

SAG MANUFACTURING, S.L.U.

Highway N-I, km 36

28750 San Agustín de Guadalix (Madrid)

Spain

Last review date of this leaflet: June 2023

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/