Almax 1 g/7.5 ml oral suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Almax 1 g/7.5 ml oral suspension
almagato
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Follow exactly the instructions for administering this medicine as described in this leaflet or as directed 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 reactions, consult your doctor, pharmacist, or nurse, even if they are 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:
- What Almax is and what it is used for
- What you need to know before taking Almax
- How to take Almax
- Possible side effects
- How to store Almax
- 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 taking Almax
Do not take Almax
- If you are allergic to algeldrate (almagato) or 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, 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 phosphate absorption, which may lead—especially with prolonged treatment—to decreased blood phosphate levels (symptoms include loss of appetite, muscle weakness, general malaise, etc.) and inadequate bone mineralization (osteomalacia).
- If you are elderly, as prolonged use of aluminum-containing antacids may worsen existing bone disorders (osteoporosis and osteomalacia), due to reduced levels of phosphate 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 underlying 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 kidney disease.
Use of other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 to 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 to treat stomach or duodenal ulcers and gastric acidity, e.g., cimetidine, famotidine, ranitidine)
- Cardiac glycosides (medicines to treat heart function disorders, e.g., digoxin, digitoxin)
- Antipsychotics (medicines to treat behavioral disorders and psychiatric symptoms, e.g., chlorpromazine)
- Lansoprazole (a medicine to treat stomach ulcers)
- Corticosteroids (prednisone)
- Gabapentin (a medicine to treat epilepsy)
- Ketoconazole (a medicine to treat 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 to treat heart rhythm disorders), as 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), as Almax may reduce their concentrations due to increased elimination caused by elevated urinary pH, especially at high salicylate doses.
Consult your doctor if you are scheduled for a gastric fluid analysis, as Almax may interfere with 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 necessary, consult your doctor, who will advise you on the appropriate regimen.
If you are pregnant or think you might be pregnant, consult your doctor or pharmacist before taking any medication. Taking medication during pregnancy can be harmful to the embryo or fetus and should be monitored by your doctor. |
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 nursing infant.
Driving and use of machinery
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 informed you (or your child) that you have an intolerance to certain sugars, or if you (or your child) 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 medicine. Sorbitol may cause gastrointestinal discomfort 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., essentially "sodium-free".
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 children over 12 years of age: The recommended dose is 7.5 ml (1 gram of algeldrate), three times daily, preferably half an hour to one hour after meals. If symptoms recur, an additional dose may be taken before bedtime.
Do not exceed 8 grams per day (8 doses of 7.5 ml).
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 insufficiency (See section “Warnings and precautions”).
If you have mild or moderate kidney disease, your doctor may recommend lower doses (See section “Warnings and precautions”).
Almax is for oral use.
Shake the suspension bottle vigorously before measuring the dose, and use the dosing cup provided. The oral suspension may be taken directly with the dosing cup, or poured into half a glass of water, stirred, and taken immediately.
If you take more Almax than you should
Poisoning is not expected at the recommended doses. 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, stating 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; otherwise, wait until the next scheduled dose, unless symptoms occur, in which case the dose may be taken earlier. Take 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 will experience them.
Due to its low intestinal absorption, adverse effects of almagate are infrequent. In some cases (frequency not known), 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 these are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines at 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 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 medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.
6. Package contents and other information
Composition of Almax 1 g/7.5 ml oral suspension:
- The active substance is almagate. Each 7.5 ml of oral suspension contains 1 gram of almagate.
- The other components are microcrystalline cellulose (E-460), sodium carmellose, calcium saccharin (E-954), chlorhexidine diacetate, peppermint flavour, 70% non-crystallizable sorbitol solution (E-420), simethicone emulsion (purified water, simethicone, polyoxyethylene sorbitan tristearate (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 medicinal product and contents of the pack
Almax is a white-yellowish liquid with a peppermint odour and flavour. It is supplied in glass bottles containing 225 ml of suspension.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 revision of this package leaflet: April 2022
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/