Leaflet: information for the user

Almax 1 g/7.5 ml Oral Suspension

Almagato

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 your symptoms worsen or do not improve after 14 days.

Almax belongs to a group of medications called 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 individuals 12 years of age and older.

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

Do not take Almax

• If you are allergic to aluminium or any of the other components 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 (toxaemia), or diarrhoea.

Warnings and precautions

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

• If you have mild or moderate kidney disease, as aluminium and magnesium ions may accumulate in the body over time. In this case, your doctor may recommend lower doses. Almax is not recommended for severe kidney failure.
• If you are on a low-phosphorus diet, have diarrhoea, malabsorption, or are severely weakened, as aluminium salts can reduce phosphorus absorption, which may lead to a decrease in blood phosphate levels (loss of appetite, muscle weakness, general malaise, etc.) and inadequate mineralization of bones (osteomalacia) with prolonged treatment.
• If you are an elderly patient, as long-term use of aluminium-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 aluminium toxicity, especially if they are dehydrated or have kidney disease.

Use of other medicines

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

Antacids can alter the absorption of numerous medicines, so, in general, Almax intake should be separated (2-3 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)
• Antiulcer medicines (medicines to treat stomach ulcers or duodenal ulcers and stomach acid, e.g. cimetidine, famotidine, ranitidine)
• Digitals (medicines to treat heart rhythm disorders, e.g. digoxin, digitoxin)
• Antipsychotics (medicines to treat behaviour 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 to treat infections, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chlor tetracycline, demeclocycline, doxycycline)
• Iron salts (sodium iron)

as Almax may reduce the absorption of the above-listed medicines by changing stomach conditions or forming poorly soluble complexes.

• Quinidine (medicine to treat heart rhythm disorders), as Almax 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 Almax may reduce their concentrations by increasing their 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 Almax may alter the test results.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Prolonged or excessive use of Almax during pregnancy should be avoided due to the risk of fetal or newborn complications.

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

Breastfeeding

Prolonged or excessive use of Almax should be avoided.

Although small amounts of aluminium and magnesium can be eliminated through breast milk in mothers treated with Almax, their concentration is not high enough to cause adverse effects in the infant.

Driving and operating machinery

Almax does not affect your ability to drive or operate machinery.

Almax 1 g/7.5 ml Oral Suspension contains sorbitol (E-420), benzoic acid (E-210), and sodium

This medicine contains 525 mg of sorbitol (E-420) in each 7.5 ml dose....Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a condition that affects your ability to digest certain sugars, or if you 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. Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

This medicine contains 0.001875 mg of benzoic acid (E-210) (contained in the simethicone emulsion) in each 7.5 ml dose.

This medicine contains less than 1 mmol of sodium (23 mg) per 7.5 ml dose; it is 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 or pharmacist or nurse.

Use in adults and those over 12 years old:The recommended dose is 7.5 ml (1 gramof 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 exceed8 gramsper day (8 doses of 7.5 ml).

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, Almax 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").

Almax should be taken orally.

It is advisable to shake the suspension bottle vigorously before extracting the dose and use the dosing cup provided.The oral suspension can be taken directly with the dosing cup or the contents can be poured into half a glass of water, stirred, and taken subsequently.

If you take more Almax than you should

At the recommended doses, overdose is not expected 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 Almax than you should, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone915 620 420, indicating the medication and the amount taken.

If you forget to take Almax

Do not take a double dose to compensate for the missed dose. 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. Take the next doses with the indicated interval between doses.

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

Like all medications, Almax can 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 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 not listed in this prospectus.You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use, Website:www.notificaram.es.By reporting adverse effects, you can contribute to providing 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 unused medications at the SIGRE collection point at the 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 ofAlmax 1 g/7.5 ml oral suspension:

• The active ingredient is almagate. Each 7.5 ml of oral suspension contains1 gramof almagate
• The other components are microcrystalline cellulose(E-460), sodium carmellose, calcium saccharin(E-954), chlorhexidine diacetate, peppermint essence, sorbitol solution(E-420)at 70% non-crystallizable, simethicone emulsion (purified water, simethicone, polyoxethylene sorbitan triestearate (E-436), methylcellulose (E-461), polyethylene glycol stearate, glycerol monoestearate (E-471), xanthan gum (E-415), benzoic acid (E-210), sulfuric acid (E-513), sorbic acid (E-200)) and purified water.

Appearance of the product and contents of the packaging

Almax is a white-yellowish liquid with a peppermint odor and taste. It is presented in glass bottles containing 225 ml of suspension.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Almirall, S.A.

General Mitre, nº 151

08022 – Barcelona (Spain).

Responsible for manufacturing

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

08740 Sant Andreu de la Barca‑Barcelona (Spain).

Date of the last review of this leaflet:April 2022

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