Almagato Stadapharm 1,5 g oral suspension

Package leaflet: Information for the user

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 exactly the instructions for administration of the medicine contained in this leaflet or as directed 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 adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 14 days.

Contents of this leaflet

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. How to store Almagato Stadapharm
6. Contents of the pack and other information

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

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

It is indicated for the relief and symptomatic treatment of acid reflux and heartburn in adults and adolescents aged 12 years and older.

You should consult a doctor if 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 almagate or to any of the other ingredients of this medicine (listed in section 6).
• If you have Alzheimer's disease.
• If you have undiagnosed gastrointestinal bleeding, hemorrhoids, fluid retention (edema), liver complications during pregnancy (gestational toxemia), or diarrhea.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine:

• If you have mild or moderate kidney disease, as aluminum and magnesium ions may accumulate in the body over time. In such cases, you may be advised to take the lowest dose. This medicine is not recommended in severe renal insufficiency.

• If you are on a low-phosphorus diet, have diarrhea, malabsorption, or are severely weakened, since aluminum salts reduce phosphate absorption, which may lead, especially with prolonged treatment, to low blood phosphate levels (symptoms such as loss of appetite, muscle weakness, general malaise, etc.) and inadequate bone mineralization (osteomalacia).

• If you are elderly, since long-term use of aluminum-containing antacids may worsen existing bone disorders (osteoporosis and osteomalacia), due to reduced phosphate and calcium levels.

Inform your doctor if you experience any symptoms indicating gastrointestinal bleeding, such as vomiting blood or black-colored stools.

Children and adolescents

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

Other medicines and Almagato Stadapharm

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Antacids alter the absorption of many medicines; therefore, in general, Almagato Stadapharm 1.5 g should be taken at least 3 hours apart from any other medication.

It is especially important that you 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)
• Antiulcer agents (medicines to treat stomach or duodenal ulcers and stomach acidity, e.g. cimetidine, famotidine, ranitidine)
• Digitalis glycosides (medicines to treat heart function disorders, e.g. digoxin, digitoxin)
• Antipsychotics (medicines to treat behavioral disorders and psychiatric symptoms, e.g. chlorpromazine)
• Lansoprazole (a medicine to treat stomach ulcers)
• Corticosteroids (prednisone)
• Gabapentin (a medicine to treat epilepsy)
• Ketoconazole (a medicine to treat fungal infections)
• Medicines for treating infections, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chlortetracycline, demeclocycline, doxycycline)
• Iron salts (iron sulfate)

since this medicine may reduce the absorption of the above-listed medicines due to changes in gastric conditions or formation of poorly soluble complexes.

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

• Salicylates (medicines to relieve pain and reduce fever and inflammation, e.g. acetylsalicylic acid), as this medicine may reduce their concentrations due to increased elimination caused by elevated urinary pH, especially at high salicylate doses.

Consult your doctor if you are scheduled for an analysis of gastric composition, as Almagato Stadapharm may alter the test results.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you might be pregnant, or are planning 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/neonatal abnormalities.

If a longer treatment is needed, consult your doctor, who will advise you on the appropriate regimen.

Lactation

Chronic or excessive use of medications containing algeldrate should be avoided.

Although small amounts of aluminium and magnesium may be excreted in breast milk from mothers treated with algeldrate, their concentration is not high enough to cause adverse effects in the nursing infant.

Driving and use of machines

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

Algeldrate Stadapharm 1.5 g oral suspension contains sorbitol (E-420)

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

Algeldrate Stadapharm 1.5 g oral suspension contains sulphites

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

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

3. How to take Almagato Stadapharm

Follow exactly the instructions for use provided in this leaflet or those given by your doctor, pharmacist, or nurse. In case of doubt, consult your doctor, pharmacist, or nurse.

Use in adults and adolescents: The recommended dose is 1 sachet (1.5 grams of almagate) three times daily, preferably from half an hour to one hour after meals. If discomfort recurs, an additional dose may be taken before going to bed.

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

Use in elderly patients: Dose adjustment is not required (see section “Warnings and precautions”).

Use in patients with kidney disease: This medicine is not recommended if you have severe renal insufficiency (see section “Warnings and precautions”).

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

Almagato Stadapharm is for oral use.

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 one sachet can be poured into half a glass of water, stirred, and taken immediately.

If you take more Almagato Stadapharm than you should

At the recommended doses, poisoning with this medicine is not expected. In patients on a low-phosphorus diet and/or undergoing prolonged treatment with high doses, a decrease in blood phosphate levels and inadequate bone mineralization may occur.

If you have taken more almagate than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 missed doses. Take the missed dose as soon as possible if the elapsed time is short; otherwise, wait until the next scheduled dose, unless discomfort occurs, in which case the dose may be taken earlier. Take subsequent doses at the recommended intervals.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

Due to its low intestinal absorption, adverse effects with almagate are uncommon. Occasionally (frequency not known), diarrhoea has been reported, which generally resolves after discontinuation of treatment.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines at Website: www.notificaram.es. By reporting adverse 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 EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Almagato Stadapharm 1.5 g oral suspension

• The active substance is almagate. Each sachet contains 1.5 grams of almagate.

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

Appearance of the medicine and contents of the pack

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

Each box contains 12, 24 or 506 sachets.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio 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 most recent revision of this leaflet: June 2023

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