Package Insert: Information for the User

Almax Forte 1.5 g Oral Suspension

Almagate

Read this entire package insert carefully before taking this medicine, as it contains important information for you.

Follow exactly the administration instructions contained in this package insert or those given by your doctor, pharmacist, or nurse.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does 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 acidity 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 Forte

• If you are allergic to aluminium phosphate 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 the lowest dose. Almax is not recommended for severe kidney failure.
• If you are on a low-phosphate diet, have diarrhoea, malabsorption, or are severely weakened, as aluminium salts can reduce phosphate 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) over time.
• 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 phosphate 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 Forte 1.5 g should be taken at least 3 hours apart from 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 fungal infections)
• 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 listed medicines by altering stomach conditions or forming insoluble 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Chronic 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

Chronic or excessive use of Almax should be avoided.

Although small amounts of aluminium and magnesium may be eliminated in 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 Forte 1.5 g Oral Suspensioncontains sorbitol (E-420), benzoic acid (E-210), and sodium

This medicine contains 1.05 g of sorbitol (E-420) in each sachet.Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have a fructose intolerance or hereditary fructose intolerance (HF), 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 0.0028 mg of benzoic acid (E-210) (contained in the simeticone emulsion) in each sachet.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; 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: 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").

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 must 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 half a glass of water, stirred, and taken immediately.

If you take more Almax Forte 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 Toxicology Information Service, phone 915 620 420, indicating the medication and the amount taken.

If you forget to take Almax Forte

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 bedtime. Take the next doses at the recommended interval.

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

Like all medications, Almax may produce adverse effects, although not all people will experience them.Some individuals may not suffer from these effects.

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 medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need.This will help protect the environment..

Composition ofAlmax Forte1.5 g oral suspension

• The active ingredient is almagate. Each packet contains 1.5 grams of 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 Forte is a white liquid with a peppermint odor and taste. Each box contains 12, 24, or 506 packets.

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).

Review date of this prospectus: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/