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Indicated in adults and adolescents from 12 years old to relieve and treat heartburn
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1. What it is Almax and what it is used
Almax belongs to a group of medicines called antacids, which are compounds that work by neutralizing excess stomach acid.
It is indicated for the symptomatic relief and treatment of heartburn and heartburn in adults and children over 12 years.
You should consult a doctor if worsens or does not improve after 14 days old.
2. What you need to know before you start taking Almax
Do not take Almax if:
- If you are allergic to almagato or any of the other ingredients of this medicine (listed in section 6).
- If you have Alzheimer''s disease.
- If you have undiagnosed bleeding of the digestive tract, hemorrhoids, fluid retention (edema), liver complication during pregnancy (toxemia of pregnancy) or diarrhea.
Warnings and Precautions
Consult your doctor, pharmacist or nurse before you start taking Almax:
- If you have mild kidney disease or moderate since the aluminum and magnesium ions can accumulate in the body long term. In this case it is possible to recommend lower doses. Almax is not recommended in severe renal impairment.
- If you follow a diet low in phosphorus, have diarrhea, malabsorption or is very weak, since aluminum salts decrease the absorption of phosphorus, which can cause, especially with prolonged treatment, decreased phosphate content in blood ( loss of appetite, muscle weakness, malaise, etc.) and insufficient bone mineralization (osteomalacia).
- If you are an elderly patient as the continued use of aluminum-containing antacids may aggravate existing disease of bone (osteoporosis and osteomalacia) due to the reduction of phosphorus and calcium.
Tell your doctor if you have any symptoms indicating gastrointestinal bleeding, such as vomiting blood or black discoloration of the stool.
Children and adolescents
Antacids should not be administered to children under 12, because they can hide other existing diseases (eg appendicitis). In the smallest there is a risk of increased blood magnesium or aluminum toxicity, especially if they are dehydrated or have kidney disease
Using other medicines
Tell your doctor or pharmacist that you are taking, have recently taken or might take any other medicines.
Antacids modify the absorption of many medicines which, generally speaking, swallowing Almax must distance (2-3 hours) of administration of any medicine.
It is especially important to tell your doctor if you take any of the following medications:
· Anti-inflammatory medicines (medicines used to treat pain and inflammation, eg. Flufenamic or mefenamic acid, indomethacin)
· Anti-Ulcer (medicines to treat stomach ulcer or duodenal ulcer and heartburn among others, eg. Cimetidine, famotidine, ranitidine)
· Digitalis (medicines to treat abnormal heart function, eg. Digoxin, digitoxin)
· Antipsychotics (medicines to treat behavioral disorders and psychiatric symptoms, eg. Chlorpromazine)
· Lansoprazole (medicine to treat stomach ulcers)
· Corticosteroids (prednisone)
· Gabapentin (medicine to treat epilepsy)
· Ketoconazole (medicine to treat fungal infections)
· Medicines to treat infections, such as penicillamine, quinolone antibiotics (ciprofloxacin), tetracyclines (chlortetracycline, demeclocycline, doxycycline)
· Iron salts (ferrous sulphate) as Almax may decrease the absorption of medicines listed above by changing conditions of the stomach or by the formation of poorly soluble complexes.
· Quinidine (medicine to treat heart rhythm disorders), as Almax may enhance their toxicity by decreasing their removal due to increased urine pH.
· Salicylates (medicines to relieve pain and reduce fever and inflammation, eg. Acetylsalicylic acid) because Almax can decrease their concentrations by increased elimination due to increased urine pH, especially with high doses of salicylate.
Consult your doctor if you go for an analysis of the composition of the stomach, as Almax can alter the outcome of the analysis.
Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before using this medicine.
Avoid chronic or overuse of Almax during pregnancy because of the risk of abnormalities in the fetus / newborn.
Should you require longer treatment, consult your doctor who will tell you the proper guidance.
If you are pregnant or think you might be, ask your doctor or pharmacist before taking any medicine. Drug use during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.
Avoid chronic or overuse of Almax.
Although you can remove small amounts of aluminum and magnesium in breast milk in mothers treated with Almax, its concentration is not high enough to cause adverse effects on the infant.
Driving and using machines
Almax does not affect your ability to drive or operate machinery.
3. How to take Almax
Follow exactly the instructions of medicine administration in this leaflet or as 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 tablespoon of 7.5 ml (1 gram of almagato), three times a day, preferably half an hour after meals. If you have back discomfort can take another dose before bedtime. should not exceed 8 grams per day (8 tablespoons 7.5 ml).
Use in elderly patients: There is no need to modify the dose (See section "Warnings and precautions").
Use in patients with kidney disease: If you have severe renal impairment is not recommended to take Almax (See section "Warnings and precautions").
If you have a disease of mild to moderate kidney, may your doctor may recommend lower doses (see section "Warnings and precautions").
Almax should be taken orally.
Should vigorously shake the bottle of the suspension before removing the dose and use the accompanying spoon. The oral suspension can be taken directly with the spoon or can pour the contents in half a glass of water, stir and take then.
If you take more than you should Almax
At recommended doses are not expected with this medication poisoning. In patients with a diet low in phosphorus and / or prolonged treatment with high doses, it may appear a decrease in blood phosphate content and insufficient bone mineralization.
If Almax has taken more than you should, immediately consult your doctor or pharmacist, or call a poison control center, phone (+034) 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 missed doses. Take the missed when you can if the time interval is small, or wait until the next dose if there are no discomfort, in which case it can be taken before dose. Take the following doses indicated separation between shots.
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 poor intestinal absorption, almagato adverse effects are rare. Sometimes (not data available to estimate the frequency), described diarrhea, which usually disappear after discontinuation of treatment.
Communication adverse effects
If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it comes to possible side effects not listed in this leaflet. You can also communicate directly through the Spanish Pharmacovigilance System for Medicinal Products for Human Use, Website: www.notificaram.es. By communicating adverse effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children. It does not require any special storage conditions.
Do not use this medicine after the expiry date on the carton after EXP. The expiry date is the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required in Point SIGRE pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.
6. Contents of the pack and other information
Almax composition 1 g / 7.5 ml oral suspension:
- The active substance is almagato. Each 7.5 ml of oral suspension containing 1 g of almagate
- The other ingredients are microcrystalline cellulose (E-460), carmellose sodium, saccharin calcium (E-954), chlorhexidine diacetate, peppermint oil, sorbitol solution (E-420) 70% non-crystallizable, emulsion simethicone and purified water.
Looks like and contents of the pack
Almax is a liquid of yellowish-white, color and smell minty. It comes in glass bottles containing 225 ml of suspension.
Authorization holder responsible for marketing and manufacturing
Holder of the marketing authorization
General Mitre, # 151
08022 - Barcelona (Spain).
Responsible for manufacturing
Pharmaceutical Industries Almirall, S.A.
Ctra. Nacional II, Km. 593
08740 Sant Andreu de la Barca - Barcelona (Spain)
This leaflet was approved in July 2013
The 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/
Source: Spanish Agency for Medicines and Health Products