ALMAX 1g/7.5ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Almax 1 g/7.5 ml Oral Suspension

Almagate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet, 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 leaflet. See section 4.
• You should consult a doctor if it worsens or does not improve after 14 days.

Contents of the Package 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. Contents of the pack and further information

1. What is Almax and what is it used for

Almax belongs to a group of medicines 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 medicine (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 lower doses. 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 treatments, 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 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 medicines

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

Antacids alter the absorption of numerous medicines, so, in general, the intake of Almax should be spaced out (2-3 hours) from the administration of any other medicine.

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 drugs (medicines to treat stomach or duodenal ulcers and heartburn, among others, e.g., cimetidine, famotidine, ranitidine)
• Digitalis (medicines to treat heart function disorders, e.g., digoxin, digitoxin)
• Antipsychotics (medicines to treat behavioral disorders and psychiatric symptoms, e.g., chlorpromazine)
• Lansoprazole (medicine to treat stomach ulcers)
• Corticosteroids (prednisone)
• Gabapentin (medicine to treat epilepsy)
• Ketoconazole (medicine to treat fungi)
• Medicines for the treatment of infections, such as penicillamine, quinolones (ciprofloxacin), tetracyclines (chlortetracycline, demeclocycline, doxycycline)
• Iron salts (iron sulfate)

as Almax may decrease the absorption of the above-mentioned medicines due to changes in stomach conditions or the formation of poorly soluble complexes.

• Quinidine (medicine to treat heart rhythm disorders), as Almax may potentiate its toxicity by reducing its elimination due to increased urine pH.

• Salicilates (medicines to relieve pain and reduce fever and inflammation, e.g., acetylsalicylic acid), as Almax may decrease 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 may alter the analysis result.

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 medicine.

Pregnancy

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

In case you need more 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 1 g/7.5 ml Oral Suspension contains sorbitol (E-420), benzoic acid (E-210), and sodium

This medicine contains 525 mg of sorbitol (E-420) in each 7.5 ml dose. 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 disease in which the patient cannot break down fructose, consult your doctor before taking this medicine. Sorbitol can cause gastrointestinal upset and a mild laxative effect.

This medicine contains 0.001875 mg of benzoic acid (E-210) (contained in the simethicone emulsion) in each 7.5 ml dose.

This medicine contains less than 1 mmol of sodium (23 mg) per 7.5 ml dose; i.e., it is essentially "sodium-free".

3. How to take Almax

Follow exactly the administration instructions of the medicine contained in this 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 one 7.5 ml dose (1 gram of almagate), three times a day, preferably half an hour to an hour after meals. If discomfort recurs, another dose can be taken before bedtime.

Do not exceed 8 grams per day (8 doses of 7.5 ml).

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.

It is recommended to shake the suspension bottle vigorously before extracting the dose and use the measuring cup provided. The oral suspension can be taken directly with the measuring cup or poured into a half glass of water, stirred, and taken immediately.

If you take more Almax than you should

At the recommended doses, no intoxication with this medicine 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 medicine 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 interval is small, or wait for the next dose, provided that there are no discomforts, in which case it can be taken beforehand. Take the following doses with the indicated time interval between doses.

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

4. Possible side effects

Like all medicines, Almax can cause side effects, although not everybody gets 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 of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System, Website: www.notificaram.es. By reporting side 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 expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If in doubt, consult your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Almax 1 g/7.5 ml Oral Suspension:

• The active ingredient is almagate. Each 7.5 ml of oral suspension contains 1 gram of almagate.
• The other ingredients 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 pack contents

Almax is a white-yellowish liquid with a mint flavor and odor. It is presented in glass bottles containing 225 ml of suspension.

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).

Date of the last revision of this leaflet:April 2022

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