Almax Forte 750 mg chewable tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Almax Forte 750 mg chewable tablets

almagato

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

Always follow exactly the instructions for administration of the medicine 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 any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 14 days.

Contents of the leaflet

1. What Almax is and what it is used for
2. What you need to know before taking Almax
3. How to take Almax
4. Possible side effects
5. How to store Almax
6. Contents of the pack and other information

1. What Almax is and what it is used for

Almax 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 acid reflux and heartburn in adults and children over 12 years of age.

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

2. What you need to know before starting to take Almax

Do not take Almax

• 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, hemorrhoids, fluid retention (edema), liver complications during pregnancy (gestational toxemia), or diarrhea.

Warnings and precautions

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

• If you have mild or moderate kidney disease, since aluminum and magnesium ions may accumulate in the body over time. In this case, you may be advised to take the lowest dose. Almax is not recommended in severe renal impairment.

• If you are on a low-phosphorus diet, have diarrhea, malabsorption, or are severely debilitated, since aluminum salts reduce phosphate absorption, which may lead, especially with prolonged treatment, to decreased phosphate levels in the blood (loss of appetite, muscle weakness, general malaise, etc.) and inadequate bone mineralization (osteomalacia).

• If you are an elderly patient, since prolonged use of aluminum-containing antacids may worsen existing bone disorders (osteoporosis and osteomalacia), due to reduced levels of phosphorus and calcium.

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

Children and adolescents

Antacids should not be administered to children under 12 years of age, as other existing conditions (e.g., appendicitis) may be masked. In younger children, there is a risk of increased magnesium levels in the blood or aluminum toxicity, especially if they are dehydrated or have any kidney disease.

Other medicines and Almax

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

Antacids can alter the absorption of many medicines; therefore, in general, Almax should be taken at least 3 hours apart from any other medication.

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 agents (medicines used to treat stomach or duodenal ulcers and acid reflux, among others, e.g. cimetidine, famotidine, ranitidine)
• Digitalis glycosides (medicines used to treat heart function disorders, e.g. digoxin, digitoxin)
• Antipsychotics (medicines used to treat behavioral disorders and psychiatric symptoms, e.g. chlorpromazine)
• Lansoprazole (a medicine used to treat stomach ulcers)
• Corticosteroids (prednisone)
• Gabapentin (a medicine used to treat epilepsy)
• Ketoconazole (a medicine used to treat fungal infections)
• Medicines used to treat infections, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chlortetracycline, demeclocycline, doxycycline)
• Iron salts (iron sulfate)

as Almax may reduce the absorption of the above-listed medicines due to changes in gastric conditions or formation of poorly soluble complexes.

• Quinidine (a medicine used to treat heart rhythm disorders), since Almax may enhance its toxicity by reducing its elimination due to increased urinary pH.
• Salicylates (medicines used to relieve pain and reduce fever and inflammation, e.g. acetylsalicylic acid), since Almax may reduce their concentrations due to increased elimination caused by elevated urinary pH, especially with high-dose salicylate therapy.

Consult your doctor if you are scheduled for an analysis of gastric composition, as Almax may alter the test results.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become 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/neonatal disturbances.

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

Lactation

Chronic or excessive use of Almax should be avoided.

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

Driving and operating machinery

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

3. How to take Almax

Follow exactly the instructions for use of the medicine provided in this leaflet or those indicated by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Use in adults and adolescents over 12 years of age: The recommended dose is 2 tablets (1.5 grams of algeldrate) three times daily, preferably taken from half an hour to one hour after meals. If symptoms recur, an additional dose may be taken before going to bed.

The maximum daily dose should not exceed 8 grams (10 tablets).

Use in elderly patients: Dose adjustment is not necessary (See section "Warnings and precautions").

Use in patients with kidney disease: Almax is not recommended if you have severe renal impairment (See section "Warnings and precautions").

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

Almax should be taken orally.

The tablets may be chewed or allowed to dissolve in the mouth.

If you take more Almax than you should

At the recommended doses, poisoning with this medication is not expected. 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 Almax than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at 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 missed doses. Take the missed dose as soon as possible if the elapsed time is short, or wait until the next scheduled dose, unless discomfort occurs, in which case it may be taken earlier. Take subsequent doses at the recommended intervals.

If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Almax can cause adverse effects, although not everyone will experience them.

Due to its low intestinal absorption, adverse effects of almagate are uncommon. Occasionally (frequency not known), diarrhoea has been reported, which generally resolves after discontinuation of treatment.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if these adverse reactions are not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaram.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Almax

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 must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Almax Forte 750 mg chewable tablets

• The active substance is almagate. Each tablet contains 750 mg of almagate.
• The other components are: mannitol, povidone, potato starch, calcium saccharin, ammonium glycyrrhizinate, magnesium stearate and peppermint flavor.

Appearance of the product and contents of the package

Almax is presented as white, round, flat tablets, with a mint odor and flavor, and marked "Almax" on one side. Each box contains 24 or 48 tablets, arranged in blisters 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 most recent review of this leaflet: September 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/