ALMAX FORTE 1.5 g ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Almax Forte 1.5 g Oral Suspension

Almagate

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 14 days.

Contents of the Package Leaflet:

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

1. What is Almax Forte 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 your symptoms worsen or do not improve after 14 days.

2. What you need to know before taking Almax Forte

Do not take Almax Forte

• 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, your doctor may recommend a lower dose. Almax is not recommended in severe renal 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 exacerbate existing bone disease (osteoporosis and osteomalacia) due to reduced phosphorus and calcium levels.

Inform your doctor if you experience any symptoms that may indicate gastrointestinal bleeding, such as vomiting blood or blackening of stools.

Children and Adolescents

Antacids 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 levels in the blood or aluminum toxicity, especially if they are dehydrated or have kidney disease.

Use of Other Medications

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 numerous medications, so, in general, the intake of Almax Forte 1.5 g should be spaced out (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 for treating stomach or duodenal ulcers and heartburn, e.g., cimetidine, famotidine, ranitidine)
• Digitalis (medications for treating heart function disorders, e.g., digoxin, digitoxin)
• Antipsychotics (medications for treating behavioral disorders and psychiatric symptoms, e.g., chlorpromazine)
• Lansoprazole (medication for treating stomach ulcers)
• Corticosteroids (prednisone)
• Gabapentin (medication for treating epilepsy)
• Ketoconazole (medication for treating fungal infections)
• Medications for treating infections, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chlortetracycline, demeclocycline, doxycycline)
• Iron salts (iron sulfate)

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

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

Consult your doctor if you are going to have a stomach composition analysis, as Almax may 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.

If 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.

Almax Forte 1.5 g Oral Suspensioncontains sorbitol (E-420), benzoic acid (E-210), and sodium

This medication contains 1.05 g of sorbitol (E-420) per sachet. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor before taking this medication. Sorbitol can cause gastrointestinal discomfort and a mild laxative effect.

This medication contains 0.0028 mg of benzoic acid (E-210) (contained in the simethicone emulsion) per sachet.

This medication contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".

3. How to Take Almax Forte

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

Use in Adults and Children Over 12 Years Old:The recommended dose is 1 sachet (1.5 grams of almagate), three times a day, preferably 30 minutes to 1 hour after meals. If symptoms recur, an additional 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" section).

Use in Patients with Kidney Disease:If you have severe renal failure, Almax is not recommended (see "Warnings and Precautions" section).

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

Almax should be taken orally.

The sachet should be pressed several times before opening to ensure complete use of its contents. The oral suspension can be taken directly from the sachet or the contents of a sachet can be poured into a half glass of water, stirred, and taken immediately.

If You Take More Almax Forte 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 Forte

Do not take a double dose to make up for forgotten doses. Take the forgotten dose as soon as possible if the time interval is short, or wait for the next dose if there are no symptoms, in which case it can be taken 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 will experience 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 reported, 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 not listed in this package 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 Forte

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 stated 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 any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofAlmax Forte1.5 g Oral Suspension

• The active ingredient is almagate. Each sachet contains 1.5 grams of almagate.
• The other components are microcrystalline cellulose (E-460), sodium carmellose, calcium saccharin (E-954), chlorhexidine diacetate, peppermint flavor, 70% non-crystallizable sorbitol solution (E-420), simethicone emulsion (purified water, simethicone, polyoxyethylene sorbitan trioleate (E-436), methylcellulose (E-461), polyethylene glycol stearate, glycerol monostearate (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 Package Contents

Almax Forte is a white liquid with a mint flavor and odor. Each box contains 12, 24, or 506 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Almirall, S.A.

General Mitre, 151

08022 – Barcelona (Spain).

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra de Martorell, 41-61

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

Revision Date of this Package Leaflet:April 2022

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/