MAALOX
MAALOX NAUSEA "5 MG EFFERVESCENT TABLETS" 20 TABLETS"
MAALOX NAUSEA "5 MG EFFERVESCENT TABLETS" 20 TABLETS"
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Description
Description
Maalox Nausea adults 5 mg effervescent tablets
Maalox Nausea adults 5 mg effervescent granules
Metoclopramide hydrochloride
What is it and what is it for?
Maalox Nausea is a medicine that contains a substance called "metoclopramide" and is used to treat nausea.
Contact your doctor if you do not feel better or if you feel worse after 3 days.
What you need to know before taking the medicine
Do not take Maalox Nausea
- if you are allergic to metoclopramide hydrochloride or any of the other ingredients of this medicine (listed in section 6);
- if you have gastrointestinal haemorrhage (bleeding), obstruction (blockage) or perforation (tear in the stomach or intestine);
- if you have or suspect you have a rare tumor of the adrenal glands, located next to the kidneys (pheochromocytoma);
- if you have ever had involuntary muscle twitches (tardive dyskinesia) after taking certain medicines;
- if you suffer from epilepsy;
- if you suffer from Parkinson's disease;
- if you are taking levodopa or dopamine agonists (medicines for Parkinson's disease and other nervous system diseases) (see "Other medicines and Maalox Nausea");
- if you are being treated with medicines for nervous system diseases (antimonoamine oxidase inhibitors, neuroleptics such as phenothiazines, butyrophenones, thioxanthenes);
- if you have had a disease called "NADH cytochrome-b5 deficiency" or changes in the haemoglobin in your blood (methaemoglobinaemia);
- if you are under 16 years of age (see "Children and adolescents");
- if you are in the first trimester of pregnancy or are breastfeeding (see "Pregnancy and breastfeeding").
Warnings and precautions
Talk to your doctor or pharmacist before taking Maalox Nausea.
Take special caution with Maalox Nausea:
- if you have heart disease (congenital long QT syndrome);
- if you have a slow heartbeat (bradycardia);
- if you have abnormal blood tests for potassium, sodium and magnesium;v - if you take medicines that can affect your heartbeat such as antiarrhythmics (drugs that affect your heartbeat), tricyclic antidepressants (medicines used for depression), macrolides (antibiotics), antipsychotics (medicines used for psychiatric disorders);
- if you have severe liver problems (severe liver failure);
- if you have kidney problems (renal failure);
- if you are being treated at the same time with medicines used to treat nervous system diseases such as phenothiazines (neuroleptic medicines);
- if you suffer from epilepsy;
- if you are between 16 and 18 years old.
You may experience an increase in a hormone called prolactin, particularly if you have breast cancer or a tumor that produces prolactin (pituitary adenoma).
If you have reduced activity of an enzyme (called CYP2D6) involved in the breakdown of the medicine in the body, the risk of side effects, including uncontrolled movements (extrapyramidal symptoms, see section 4), may increase.
An alteration in the hemoglobin content of the blood (methemoglobinemia) has been reported. Your doctor may perform blood tests to check the hemoglobin in your blood.
Treatment should not exceed 3 months due to the risk of involuntary muscle spasms (tardive dyskinesia).
Children and adolescents
Maalox Nausea should not be taken by children and adolescents under 16 years of age.
The use of the medicine in adolescents aged between 16 and 18 years is not recommended.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop treatment and talk to your doctor or pharmacist immediately if you experience any of the following symptoms while taking this medicine:
- uncontrollable movements (often involving the head or neck). These may occur in children or young adults, especially if high doses are used. These symptoms usually appear at the beginning of treatment and may occur even after a single administration. The movements disappear with appropriate treatment;
- high fever, high blood pressure, seizures, sweating, drooling. These may be signs of a disorder called neuroleptic malignant syndrome;
- itching or skin irritation, swelling of the face, lips, or throat, difficulty breathing. These may be signs of an allergic reaction, which could be serious.
Very common (may affect more than 1 in 10 people)
• feeling sleepy.
Common (may affect up to 1 in 10 people)
• depression;
• uncontrollable movements (extrapyramidal disorders);
• Parkinson's disease-like symptoms such as stiffness and tremors (parkinsonism);
• restlessness (akathisia);
• reduction in blood pressure (hypotension);
• diarrhea;
• feeling of weakness (asthenia).
Uncommon (may affect up to 1 in 100 people)
• increased blood levels of a hormone called prolactin (hyperprolactinemia);
• absence of menstruation (amenorrhea);
• hallucinations;
• alteration of muscle or nerve tone (dystonia);
• visual disturbances and involuntary deviation of the eye;
• alteration of movement (dyskinesia);
• reduction in the level of consciousness;
• slow heartbeat (bradycardia);
• hypersensitivity.
Rare (may affect up to 1 in 1,000 people)
• confusional state;
• convulsions (especially in epileptic patients);
• milk production in men and women who are not breastfeeding (galactorrhea).
Frequency not known (frequency cannot be estimated from the available data)
• severe allergic reactions (such as anaphylactic reaction, angioedema and urticaria).
Symptoms may include rash, itching, difficulty breathing, shortness of breath, swelling of the face, lips, throat, or tongue, cold and clammy skin, palpitations, dizziness, weakness, and fainting. Contact your doctor or other healthcare provider immediately or go to the nearest hospital emergency room immediately.
• alterations in hemoglobin, a substance present in the blood;
• abnormal breast development (gynecomastia);
• involuntary muscle spasms (tardive dyskinesias) after prolonged use, particularly in elderly patients;
• high fever, high blood pressure, seizures, sweating, saliva production. These may be symptoms of a disorder called neuroleptic malignant syndrome;
• alterations in heart rhythm (atrioventricular block, sinus arrest, QT interval prolongation, torsade de pointes);
• cardiac arrest;
• shock (severe drop in blood pressure);
• fainting (syncope);
• very high blood pressure;
• increased blood pressure in patients with a rare tumor of the adrenal glands (pheochromocytoma) (see "Do not take Maalox Nausea");
• desire for suicide (suicidal ideation).
Following the instructions in the package leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.
MAALOX
MAALOX NAUSEA "5 MG EFFERVESCENT TABLETS" 20 TABLETS"
MAALOX NAUSEA "5 MG EFFERVESCENT TABLETS" 20 TABLETS"
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