ALMAX FORTE 750 MG CHEWABLE TABLETS MINT FLAVOR

Introduction

Leaflet: information for the user

Almax Forte 750 mg chewable tablets mint flavor

Almagate

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as 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 side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 14 days.

Contents of the leaflet

1. What is Almax and what is it used for
2. What you need to know before taking Almax
3. How to take Almax
4. Possible side effects
5. Storage of Almax
6. Package contents and additional information

1. What is Almax and what is it used for

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 heartburn and stomach acid in adults and children over 12 years old.

You should consult a doctor if it worsens or does not improve after 14 days.

2. What you need to know before taking Almax

Do not take Almax

• If you are allergic to almagate or any of the other components of this medication (listed in section 6).
• If you have Alzheimer's disease.
• If you have undiagnosed digestive tract bleeding, hemorrhoids, fluid retention (edema), liver complications during pregnancy (toxemia of pregnancy), 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 aluminum and magnesium ions can accumulate in the body over time. In this case, they may recommend the lowest dose. Almax is not recommended in severe kidney failure.
• If you are on a low-phosphorus diet, have diarrhea, malabsorption, or are severely debilitated, as aluminum salts reduce phosphorus absorption, which can cause, especially with prolonged treatment, a decrease in blood phosphate levels (loss of appetite, muscle weakness, general discomfort, etc.) and insufficient bone mineralization (osteomalacia).

• If you are an elderly patient, as the continued use of antacids containing aluminum can worsen existing bone disease (osteoporosis and osteomalacia) due to reduced phosphorus and calcium levels.

Inform your doctor if you experience any symptoms that indicate digestive tract bleeding, such as vomiting blood or black stools.

Children and adolescents

Antacids should not be given to children under 12 years old, as they can mask other existing diseases (e.g., appendicitis). In younger children, there is a risk of increased magnesium levels in the blood or aluminum toxicity, especially if they are dehydrated or have kidney disease.

Other medications and Almax

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

Antacids alter the absorption of many medications, so, in general, the intake of Almax should be spaced (at least 3 hours) from the administration of any other medication.

It is especially important that you 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 to treat stomach or duodenal ulcers and heartburn, e.g., cimetidine, famotidine, ranitidine)
• Digitalis (medications to treat heart function disorders, e.g., digoxin, digitoxin)
• Antipsychotics (medications to treat behavioral disorders and psychiatric symptoms, e.g., chlorpromazine)
• Lansoprazole (medication to treat stomach ulcers)
• Corticosteroids (prednisone)
• Gabapentin (medication to treat epilepsy)
• Ketoconazole (medication to treat fungi)
• Medications for the treatment of infections, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chloretracycline, demeclocycline, doxycycline)
• Iron salts (iron sulfate)

as Almax can reduce the absorption of the above medications due to changes in stomach conditions or the formation of poorly soluble complexes.

• Quinidine (medication to treat heart rhythm disorders), as Almax can potentiate its toxicity by reducing its elimination due to increased urine pH.
• Salicylates (medications to relieve pain and reduce fever and inflammation, e.g., acetylsalicylic acid), as Almax can reduce their concentrations due to increased elimination caused by increased urine pH, especially with high doses of salicylate.

Consult your doctor in case you are going to have a stomach composition analysis, as Almax can alter the test results.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Chronic or excessive use of Almax should be avoided during pregnancy due to the risk of fetal/newborn disorders.

In case you need prolonged treatment, consult your doctor, who will indicate the appropriate regimen.

Breastfeeding

Chronic or excessive use of Almax should be avoided.

Although small amounts of aluminum 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 using machines

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

3. How to take Almax

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor, pharmacist, or nurse. If in doubt, ask your doctor, pharmacist, or nurse.

Use in adults and children over 12 years old:The recommended dose is 2 tablets (1.5 grams of almagate) three times a day, preferably 30 minutes to 1 hour after meals. If discomfort recurs, another dose can be taken before bedtime.

Do not exceed 8 grams per day (10 tablets).

Use in elderly patients:No dose modification is necessary (see "Warnings and precautions" section).

Use in patients with kidney disease:If you have severe kidney failure, Almax is not recommended (see "Warnings and precautions" section).

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

Almax should be taken orally.

The tablets can be chewed or dissolved in the mouth.

If you take more Almax than you should

At the recommended doses, no intoxication with this medication is expected. 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 forgotten doses. Take the forgotten dose when you can if the time elapsed is short, or wait to take the next dose if there are no discomforts, in which case you can take it before. Take the following doses with the indicated time interval between doses.

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

4. Possible side effects

Like all medications, Almax can cause side effects, although not everyone experiences them.

Due to the low intestinal absorption, the side effects of almagate are rare. Occasionally (no data are available to estimate the frequency), diarrhea has been described, which usually disappears after treatment is discontinued.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, Website: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Almax

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 shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and unused medications at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Almax Forte 750 mg chewable tablets mint flavor

• The active ingredient is almagate. Each tablet contains 750 mg of almagate.
• The other ingredients are: mannitol, povidone, potato starch, calcium saccharinate, ammonium glycyrrhizate, magnesium stearate, and mint flavor.

Appearance of the product and package contents

Almax is presented in the form of round, flat tablets identified on one of their faces with "Almax", white in color, with a mint odor and flavor. Each box contains 24 or 48 tablets, arranged in plates of 8.

Marketing authorization holder and manufacturer

Marketing authorization holder

Almirall, S.A.

General Mitre, nº 151

08022 – Barcelona (Spain).

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell, 41-61

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

Date of the last revision of this leaflet: September 2023

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