Package Leaflet: Information for the User

Almax 500 mg Chewable Tablets

Almagato

Read this leaflet carefully before you start taking this medicine because 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 you get worse 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 medication (listed in section 6).
• If you have Alzheimer's disease.
• If you have undiagnosed gastrointestinal bleeding, hemorrhoids, fluid retention (edema), liver complications during pregnancy (toxemia gravidarum), or diarrhea.

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, you may be recommended lower doses. Almax is not recommended for severe kidney failure.
• If you are on a low-phosphorus diet, have diarrhea, malabsorption, or are severely weakened, as aluminium salts can decrease phosphorus absorption, which may lead to a decrease in blood phosphate levels (loss of appetite, muscle weakness, general discomfort, 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.

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

Children and adolescents

Anti-acids should not be administered 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 in the blood or aluminium toxicity, especially if they are dehydrated or have kidney disease.

Use of other medications

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

Antacids modify the absorption of numerous medications, so, in general, Almax intake should be spaced (2-3 hours) from the administration of any other medication.

It is especially important to inform your doctor if you are taking any of the following medications:

• Non-steroidal anti-inflammatory drugs (medications used to treat pain and inflammation, e.g. flufenamic acid or mefenamic acid, indomethacin)
• Anti-ulcer medications (medications used to treat stomach ulcers or duodenal ulcers and stomach acid, e.g. cimetidine, famotidine, ranitidine)
• Digitals (medications used to treat heart function abnormalities, e.g. digoxin, digitoxin)
• Antipsychotics (medications used to treat behavioral disorders and psychiatric symptoms, e.g. chlorpromazine)
• Lansoprazole (medication used to treat stomach ulcers)
• Corticosteroids (prednisone)
• Gabapentin (medication used to treat epilepsy)
• Ketoconazole (medication used to treat fungi)
• Antibiotics, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chlor tetracycline, demeclocycline, doxycycline)
• Iron salts (sulfate of iron)

as Almax may decrease the absorption of the listed medications by changing stomach conditions or forming poorly soluble complexes.

• Quinidine (medication used to treat heart rhythm abnormalities), as Almax may potentiate its toxicity by decreasing its elimination due to increased urine pH.

• Salicylates (medications used to relieve pain and reduce fever and inflammation, e.g. acetylsalicylic acid), as Almax may decrease 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 if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Prolonged or excessive use of Almax during pregnancy should be avoided due to the risk of fetal/recumbent alterations.

Consult your doctor if you need prolonged treatment, and they 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.

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 12 years of age and older:The recommended dose is 2 tablets (1 gram of almagate) three times a day, preferably half an hour to one hour after meals. If symptoms recur, another dose may be taken before bedtime.

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

Use in elderly patients:No dose adjustment is necessary (See "Warnings and precautions").

Use in patients with kidney disease:If you have severe kidney failure, 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.

The tablets may be chewed or dissolved in the mouth.

If you take more Almax than you should

Overdose is not expected at the recommended doses. 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

Do not take a double dose to make up for the missed dose. Take the missed dose as soon as you remember if the time elapsed is small, or wait to take the next dose as scheduled, unless you experience discomfort, in which case you may take it before. Take the next doses with the recommended 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 may produce adverse effects, although not everyone 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 discontinued..

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 the Spanish System of 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 of Almax 500 mg chewable tablets

• The active ingredient is almagate. Each tablet contains 500 mg of almagate.
• The other components are: mannitol (E-421), povidone (E-1201), potato starch, calcium saccharin, ammonium glycyrrhizate, magnesium stearate, and peppermint essence.

Appearance of the product and contents of the packaging

Almax is presented in the form of round, flat tablets identified on one of its faces with “almax”, of a white-yellowish color, with a minty smell and taste. Each box contains 18, 24, 48, or 54 tablets, arranged in blisters of 2 or 8 units.

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).

This leaflet was approved in October 2019

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/