Active ingredients: Magnesium hydroxide, Aluminum oxide
MAALOX 400 mg + 400 mg chewable tablets
Maalox package inserts are available for packs:- MAALOX 400 mg + 400 mg chewable tablets
- MAALOX 460 mg + 400 mg oral suspension
- MAALOX 400 mg + 400 mg chewable tablets without sugar
Indications Why is Maalox used? What is it for?
This medicine contains two active substances: magnesium hydroxide and aluminum oxide, hydrate. These belong to a group of medicines called 'antacids'. MAALOX works by decreasing the amount of acid in your stomach.
This medicine is used to treat the following symptoms:
- occasional heartburn;
- occasional excessive stomach acid.
Talk to your doctor if you don't feel better or if you feel worse.
Contraindications When Maalox should not be used
Do not use MAALOX:
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction are skin rashes, swelling of the lips, tongue, face and throat, trouble breathing;
- if you suffer from porphyria (a rare inherited disorder of blood metabolism);
- if you have severe kidney problems;
- if your body is severely wasted (cachexia);
- in children and adolescents under 18 years of age.
Precautions for use What you need to know before taking Maalox
Talk to your doctor or pharmacist before taking MAALOX:
- if you have bowel problems or constipation, if you have minor kidney problems or if you are elderly because this medicine may make your bowel problems worse;
- if you are on a low-phosphorus diet, if you have low levels of phosphates in the blood (hypophosphataemia) or in case of long-term treatment. This medicine reduces phosphate levels in the blood and can cause bone problems.
Children
This medicine should not be used in children and adolescents under 18 years of age.
Interactions Which drugs or foods can modify the effect of Maalox
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This medicine can interact with other medications. If you are taking other medicines, you must wait at least 2 hours before taking MAALOX and at least 4 hours if you are taking certain antibiotics (fluoroquinolones).
This medicine may interfere with the action of:
- drugs against stomach acid (H2 antagonists);
- heart and blood pressure medications (atenolol, digoxin, metoprolol and propranolol);
- anti-infective drugs (cefdinir, cefpodoxime, tetracyclines, ethambutol, fluoroquinolones, isoniazid, lincosamides, penicillamines, ketoconazole);
- drugs against malaria (chloroquine);
- anti-inflammatory drugs (diflunisal, glucocorticoids, indomethacin);
- drugs for bone diseases (bisphosphonates);
- thyroid medications (levothyroxine);
- drugs against schizophrenia (phenothiazine neuroleptics);
- drugs to lower cholesterol (rosuvastatin);
- drugs containing iron or sodium fluoride.
Also you need to see your doctor if you are taking:
- drugs containing polystyrene sulfonate (Kayexalate), due to the risk of metabolic and intestinal problems;
- drugs containing aluminum hydroxide and citrates, due to the risk of increased aluminum in the blood;
- quinidine (heart medicine) due to the risk of increased quinidine levels.
Warnings It is important to know that:
Pregnancy and breastfeeding
This medicine can only be taken if your doctor has deemed it necessary and under your supervision. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine does not affect the ability to drive or use machines.
MAALOX contains sorbitol and sucrose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Dose, Method and Time of Administration How to use Maalox: Posology
Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist. Do not exceed the indicated doses.
The recommended dose in adults and adolescents over 18 years of age is: 1-2 tablets 4 times a day, to be taken 20-60 minutes after meals and at bedtime. How to use: chew or suck the tablets. You may swallow water or milk after taking this medicine.
Overdose What to do if you have taken too much Maalox
If you take more MAALOX than you should
In case of accidental ingestion / intake of an excessive dose of this medicine, consult your doctor immediately or go to the nearest hospital.
If you take high doses of this medicine you may experience:
- diarrhea (see section 2 "Warnings and precautions"), abdominal pain and vomiting;
- worsening of bowel problems if you suffer from constipation, have minor kidney problems or are elderly.
If you forget to take MAALOX
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Side Effects What are the side effects of Maalox
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking MAALOX and contact your doctor or the nearest hospital immediately if you experience: difficulty breathing or swallowing, swelling of the face, hands and feet, eyes, lips and / or tongue, rash, itching , hives and dizziness, as these can be symptoms of severe allergic reactions (angioedema and anaphylactic reaction).
The following side effects may occur with the use of this medicine:
Uncommon (may affect up to 1 in 100 people):
- constipation (constipation) or diarrhea (see section 2 "Warnings and precautions").
Frequency not known (frequency cannot be estimated from the available data):
- excessive reaction of the body to foreign substances (hypersensitivity reaction, even severe), appearance on the skin of swellings that cause itching (urticaria) and itching;
- changes in levels of magnesium, aluminum and phosphate in the blood which can cause bone problems (see section 2 "Warnings and precautions").
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine. .
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use.
This will help protect the environment.
Composition and pharmaceutical form
What MAALOX contains
- The active ingredients are: magnesium hydroxide and aluminum oxide, hydrate. Each tablet contains 400 mg of magnesium hydroxide and 400 mg of aluminum oxide, hydrated.
- The other ingredients are: sucrose powder with starch, sorbitol, mannitol, magnesium stearate, mint flavoring powder, sodium saccharin, sucrose.
Description of what MAALOX looks like and contents of the pack
MAALOX 400 mg + 400 mg chewable tablets comes in a box containing 40 chewable tablets.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
MAALOX
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
100 ml of suspension contain:
- Active principles:
magnesium hydroxide 3.65 g;
aluminum hydroxide 3.25 g.
Excipient (s) with known effect:
methyl parahydroxybenzoate, propyl parahydroxybenzoate, sorbitol.
For the full list of excipients, see section 6.1.
One tablet contains:
- Active principles:
magnesium hydroxide 400 mg;
aluminum oxide hydrate 400 mg.
Excipient (s) with known effect:
sucrose powder with starch, sucrose, sorbitol.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM
Oral suspension.
Chewable tablets.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Symptomatic treatment of occasional heartburn and hyperacidity of the stomach.
04.2 Posology and method of administration
MAALOX 3.65% + 3.25% oral suspension
Dosage
Swallow 2 to 4 teaspoons or 1 - 2 sachets of oral suspension 4 times a day, 20 - 60 minutes after meals and at bedtime.
Method of administration
Shake well before use. It can also be taken in water or milk.
MAALOX 400 mg + 400 mg chewable tablets
Dosage
1-2 tablets 4 times a day well chewed or sucked, 20 - 60 minutes after meals and before bedtime.
Method of administration
The tablets should be well chewed or sucked. Their intake can be followed by the ingestion of water or milk.
Pediatric population
Pediatric administration of the drug is not recommended.
Do not exceed the maximum indicated dose.
04.3 Contraindications
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
- Patients with porphyria.
- Severe forms of renal failure (see section 4.4).
- Generally contraindicated in pediatric age.
- State of cachexia.
04.4 Special warnings and appropriate precautions for use
Aluminum hydroxide can cause constipation and an overdose of magnesium salts can cause bowel hypomotility; high doses of this medicine can cause or aggravate intestinal obstruction and ileus in patients at higher risk, such as those with renal impairment, with underlying constipation, with impaired bowel motility, in children (0 to 24 months) , or elderly.
Aluminum hydroxide is not well absorbed from the gastrointestinal tract, and systemic effects are therefore rare in patients with normal renal function. However, excessive doses or long-term use, or even normal doses in patients with low phosphorus diets or in children (0 to 24 months), can lead to phosphate elimination (due to an aluminum-phosphate bond) accompanied by an increase in bone resorption and hypercalciuria with risk of osteomalacia. It is advisable to consult a doctor in case of use long-term or in patients at risk of hypophosphataemia.
In patients with renal impairment, plasma levels of aluminum and magnesium tend to increase causing hyperalluminaemia and hypermagnesaemia, respectively. In these patients, long exposures to high doses of aluminum and magnesium salts can lead to encephalopathies, dementia, microcytic anemia or worsening of dialysis osteomalacia.
In the presence of mild and moderate forms of renal insufficiency it is recommended to take the product under the direct supervision of the doctor. Prolonged use of the medicinal product should be avoided in these patients.
Aluminum hydroxide may not be safe in patients with porphyria undergoing hemodialysis (see section 4.3).
MAALOX 3.65% + 3.25% oral suspension contains:
• parahydroxybenzoates: they can cause allergic reactions (even delayed).
• sorbitol: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
MAALOX 400 mg + 400 mg chewable tablets contain sorbitol and sucrose
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase isomaltase insufficiency should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Since the Al and Mg salts reduce the gastrointestinal absorption of tetracyclines, it is recommended to avoid taking Maalox during oral tetracycline therapy.
The use of aluminum-containing antacids may reduce the absorption of drugs such as H2-antagonists, atenolol, cefdinir, cefpodoxime, chloroquine, tetracyclines, diflunisal, digoxin, bisphosphonates, ethambutol, fluoroquinolones, sodium fluoride, glucocorticoids, indomethacine, is ketoconazole, levothyroxine, lincosamides, metoprolol, phenothiazine neuroleptics, penicillamines, propranolol, rosuvastatin, iron salts.
• Polystyrene sulfonate (Kayexalate)
Caution is advised when the medicinal product is taken together with polystyrene sulphonate (Kayexalate) due to the potential risk of the resin's reduced efficacy in binding potassium, of metabolic alkalosis in patients with renal impairment (reported with aluminum hydroxide and magnesium hydroxide), and intestinal obstruction (reported with aluminum hydroxide).
• Aluminum hydroxide and citrates can cause hyperalluminaemia, especially in patients with renal impairment.
Allow at least two hours (4 for fluoroquinolones) before taking MAALOX to avoid interaction with other drugs.
Simultaneous use of quinidine may result in increased serum quinidine levels and lead to quinidine overdose.
The simultaneous use of aluminum hydroxide and citrates can lead to an increase in aluminum levels, particularly in patients with renal insufficiency.
04.6 Pregnancy and lactation
Pregnancy
The medicine should only be used when needed, under direct medical supervision, after evaluating the expected benefit to the mother in relation to the possible risk to the fetus or infant.
Feeding time
Due to limited maternal absorption when taken according to the indicated dosage regimen (see section 4.2), aluminum hydroxide and its combinations with magnesium salts are considered compatible with breastfeeding.
04.7 Effects on ability to drive and use machines
MAALOX does not affect the ability to drive or use machines.
04.8 Undesirable effects
The frequency of side effects listed below is defined using the following conventions:
common (≥1 / 100,
Disorders of the immune system:
Frequency not known (frequency cannot be estimated from the available data): angioedema, anaphylactic reactions, hypersensitivity reactions, urticaria, pruritus.
Gastrointestinal disorders:
Uncommon (≥1 / 1000,:
diarrhea or constipation (see section 4.4).
Metabolism and nutrition disorders:
Frequency not known (frequency cannot be estimated from the available data): hypermagnesaemia, hyperalluminaemia, hypophosphataemia, during prolonged use or at high doses or even at normal doses of the drug in patients with low phosphorus diets or in children (0 to 24 months), which can cause increased bone resorption, hypercalciuria, osteomalacia (see section 4.4).
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions occurring after authorization of the medicinal product is important as it allows continuous monitoring of the benefit / risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system. "address: www.agenziafarmaco.gov.it/it/responsabili.
04.9 Overdose
Experience with deliberate overdose is very limited. Cases of overdose with aluminum salts are more likely to occur in patients with chronic severe renal impairment with the following symptoms: encephalopathy, convulsions and dementia, hypermagnesaemia.
The most frequently reported symptoms of acute overdose with aluminum hydroxide and in combination with magnesium salts include diarrhea, abdominal pain and vomiting.
High doses of this medicinal product may cause or aggravate intestinal obstruction and ileus in patients at risk (see section 4.4).
As in all cases of overdose, treatment should be symptomatic with generic supportive measures.
Aluminum and magnesium are eliminated by urinary excretion; treatment of magnesium overdose involves rehydration and forced diuresis. In case of renal insufficiency, hemodialysis or peritoneal dialysis is required.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: antacids.
ATC code: A02AD01.
Mechanism of action
The antacid activity is expressed in the stomach where, in suitable doses, the magnesium hydroxide and the aluminum hydroxide neutralize the gastric acid production.
The constipating effect of aluminum hydroxide is counteracted by the laxative effect of magnesium hydroxide.
05.2 Pharmacokinetic properties
Absorption
When administered orally, the aluminum hydroxide and magnesium hydroxide react with the hydrochloric acid produced in the stomach to form salts, which are only partially absorbed.
Excretion
The excretion of the absorbed salts occurs mainly via the urine.
05.3 Preclinical safety data
Data from animal studies reveal no risk to humans based on conventional studies of pharmacology, safety, repeated dose toxicity, genotoxicity, carcinogenic potential, reproductive toxicity.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
MAALOX 3.65% + 3.25% oral suspension
Methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid monohydrate, non crystallizable liquid sorbitol, mannitol, mint essence, sodium saccharin, purified water.
MAALOX 400 mg + 400 mg chewable tablets
Sucrose powder with starch, sorbitol, mannitol, magnesium stearate, mint flavoring powder, sodium saccharin, sucrose.
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
MAALOX 3.65% + 3.25% oral suspension:
Do not store below 4 ° C.
Keep the bottle tightly closed.
06.5 Nature of the immediate packaging and contents of the package
Oral suspension: - 200 ml bottle
- 15 sachets of 15 ml
Chewable tablets: - box of 40 tablets
06.6 Instructions for use and handling
No special instructions.
Unused medicine and wastes derived from this medicine must be disposed of in accordance with local regulations.
07.0 MARKETING AUTHORIZATION HOLDER
Sanofi S.p.A.
V.le L. Bodio 37 / b - IT-20158 Milan
08.0 MARKETING AUTHORIZATION NUMBER
Maalox oral suspension, 200 ml bottle AIC 020702015
Maalox oral suspension, 15 sachets of 15 ml AIC 020702027
Maalox 400 mg + 400 mg chewable tablets, 40 tablets AIC 020702054
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 27.05.1967
Date of the most recent renewal: 31.05.2010
10.0 DATE OF REVISION OF THE TEXT
December 2014
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