ALMAX 500 MG CHEWABLE TABLETS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Almax 500 mg chewable tablets

almagato

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

Follow exactly the instructions for use provided in this leaflet or those given 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 you worsen or 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 adverse effects
5. Storage of 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 symptoms worsen or do 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 to any of the other components 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 taking Almax:

• If you have mild or moderate kidney disease, as aluminum and magnesium ions may accumulate in the body over time. In such cases, lower doses may be recommended. Almax is not recommended in severe renal insufficiency.

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

• If you are an elderly patient, since long-term 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-colored stools.

Children and adolescents

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

Use of other medicines

Inform your doctor or pharmacist about any other medicines you are currently taking, have recently taken, or might need to take.

Antacids alter the absorption of many medicines; therefore, Almax should generally be taken at least 2–3 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)
• Antiulcer agents (medicines for treating stomach or duodenal ulcers and gastric acidity, e.g., cimetidine, famotidine, ranitidine)
• Cardiac glycosides (medicines for treating heart function disorders, e.g., digoxin, digitoxin)
• Antipsychotics (medicines for treating behavioral disorders and psychiatric symptoms, e.g., chlorpromazine)
• Lansoprazole (a medicine for treating stomach ulcers)
• Corticosteroids (prednisone)
• Gabapentin (a medicine for treating epilepsy)
• Ketoconazole (a medicine for treating fungal infections)
• Medicines for treating infections, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chlortetracycline, demeclocycline, doxycycline)
• Iron salts (ferrous 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 for treating heart rhythm disorders), since Almax may enhance its toxicity by reducing its elimination due to increased urinary pH.

• Salicylates (medicines to relieve pain and reduce fever and inflammation, e.g., acetylsalicylic acid), since Almax may decrease their concentrations due to increased elimination caused by elevated urinary pH, especially with high doses of salicylate.

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 may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

If prolonged treatment is required, 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 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 gram of algeldrate) three times daily, preferably 30 minutes to one hour after meals. If symptoms recur, an additional dose may be taken before going to bed.

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

Use in elderly patients: Dose adjustment is not required (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

Poisoning is unlikely at the recommended doses. However, 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, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 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 only a short time has passed, or wait until the next scheduled dose if no symptoms are present. However, if symptoms occur, the dose may be taken earlier. Continue taking subsequent doses at the recommended intervals.

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

4. Possible adverse effects

Like all medicines, Almax may produce adverse effects, although not everyone experiences them.

Due to its low intestinal absorption, adverse effects of almagate are uncommon. Occasionally (frequency cannot be estimated from available data), diarrhoea has been reported, which generally resolves after discontinuation of treatment.

Reporting of 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaram.es. By reporting adverse effects, 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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Package contents and other information

Composition of Almax 500 mg chewable tablets

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

Appearance of the medicinal product and contents of the pack

Almax is presented as flat, round tablets, marked on one side with "almax", white-yellowish in color, with a characteristic peppermint odor and taste. Each box contains 18, 24, 48 or 54 tablets, arranged in blisters of 2 or 8 units.

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).

This leaflet was approved in October 2019

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