ALMAGATO STADAPHARM 1.5 G ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Almagato Stadapharm 1.5 g oral suspension

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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

• Keep this leaflet, 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 leaflet. See section 4.
• You should consult a doctor if it worsens or does 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. Contents of the pack and further 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 from 12 years of age.

You should consult a doctor if it worsens or does 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 a lower dose. This medicine is not recommended in severe renal 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 indicate digestive tract bleeding, such as vomiting blood or black stools.

Children and Adolescents

Antacids should not be given to children under 12 years of age, 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 might take any other medicine.

Antacids alter the absorption of many medicines, so, in general, the intake of Almagato Stadapharm 1.5 g should be spaced out (at least 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 drugs (medicines to treat stomach ulcers or duodenal ulcers and heartburn, among others, e.g., cimetidine, famotidine, ranitidine)

• Digitalis (medicines to treat heart function disorders, e.g., digoxin, digitoxin)

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

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

as this medicine may decrease the absorption of the above-mentioned medicines due to changes in stomach conditions or the formation of poorly soluble complexes.

• Quinidine (medicine to treat heart rhythm disorders), as Almagato Stadapharm may increase its toxicity by reducing its elimination due to increased urine pH.

• Salicylates (medicines to relieve pain and reduce 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 using 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 1.5 g Oral Suspension ContainsSorbitol (E-420)

This medicine contains 1.05 g of sorbitol (E-420) per sachet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Almagato Stadapharm 1.5 g Oral Suspension Contains Sulfites

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it is considered essentially "sodium-free".

3. How to Take Almagato Stadapharm

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. If you have any doubts, ask your doctor, pharmacist, or nurse.

Use in Adults and Adolescents:the recommended dose is 1 sachet (1.5 grams of almagato), three times a day, preferably half an hour to one hour after meals. If discomfort recurs, 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 renal 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).

Almagato Stadapharm should be taken orally.

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

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 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 that there are no discomforts, in which case it can be taken earlier. Take the next doses with the indicated time interval between them.

If you have any further questions 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 everybody 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 described, which usually disappears after treatment is discontinued.

Reporting of Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, 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 expiry date stated on the packaging after CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Almagato Stadapharm 1.5 g Oral Suspension

• The active ingredient is almagato. Each sachet contains 1.5 grams of almagato.

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

Appearance of the Product and Contents of the Pack

Almagato Stadapharm is presented as a white liquid with a mint flavor.

Each box contains 12, 24, or 50 sachets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratory STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

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 Leaflet: June 2023

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/