Almagato Stadapharm 500 mg chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Almagato Stadapharm 500 mg chewable tablets

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

Follow exactly the instructions for taking this 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 not listed in this leaflet. See section 4.
• You should consult a doctor if you get worse or do not improve after 14 days.

Contents of the 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 adverse 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 acidity and heartburn in adults and adolescents.

You should consult a doctor if your condition 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 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, haemorrhoids, fluid retention (oedema), liver complications during pregnancy (gestational toxemia), or diarrhoea.

Warnings and precautions

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

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

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

• If you are elderly, since prolonged use of aluminium-containing antacids may worsen pre-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-coloured stools.

Children and adolescents

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

Other medicines and Almagato Stadapharm

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Antacids alter the absorption of many medicines; therefore, administration of Almagato Stadapharm 500 mg should be separated by 2–3 hours from the intake of any other medicine.

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)
• Anti-ulcer medicines (medicines for treating stomach or duodenal ulcers and gastric acidity, e.g. cimetidine, famotidine, ranitidine)
• Digitalis glycosides (medicines for treating heart rhythm disorders, e.g. digoxin, digitoxin)
• Antipsychotics (medicines for treating behavioural disorders and psychiatric symptoms, e.g. chlorpromazine)
• Lansoprazole (a medicine for treating stomach ulcers)
• Corticosteroids (prednisone)
• Gabapentin (a medicine for treating epilepsy)
• Ketoconazole (a medicine for treating fungal infections)
• Medicines for treating infections, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chlortetracycline, demeclocycline, doxycycline)
• Iron salts (ferrous sulphate)

as 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 for treating heart rhythm disorders), as this medicine 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 with high salicylate doses.

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

Pregnancy, breastfeeding and fertility

If you are pregnant, 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/neonatal abnormalities.

If prolonged treatment is required, consult your doctor, who will advise you on the appropriate regimen.

Lactation

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

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

Driving and operating machinery

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

Hydrotalcite Stadapharm 500 mg chewable tablets contain sulfites

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

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. If in doubt, consult your doctor, pharmacist, or nurse.

Use in adults and adolescents: The recommended dose is 2 tablets (1 gram of almagate) three times a day, preferably from half an hour to one hour after meals. If discomfort recurs, an additional dose may be taken before bedtime.

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

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

Use in patients with kidney disease: if you have severe renal impairment, this medicine is not recommended (See section “Warnings and precautions”).

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

This medicine is for oral use.

The tablets may be chewed or dissolved in the mouth.

If you take more Almagato Stadapharm than you should

Poisoning is not expected at the recommended doses. 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 Almagato Stadapharm than you should, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 915 620 420, stating the medicine taken and the amount ingested.

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 only a short time has passed, or 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 of hydrotalcite are uncommon. Occasionally (frequency unknown), diarrhoea has been reported, which usually 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 Medicinal Products, 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. Return any unused medicines and their containers to the Sigre Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Almagato Stadapharm 500 mg chewable tablets

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

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

Appearance of the medicinal product and contents of the pack

Almagato Stadapharm is presented as white chewable tablets with a peppermint odour.

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

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this leaflet: June 2024

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