Package leaflet: Information for the patient

Maalox Nausea adults 5 mg effervescent tablets, effervescent granules

metoclopramide hydrochloride
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you to.

Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Talk to your doctor if you do not notice any improvement or if your symptoms worsen after 3 days.

Contents of this leaflet:

What Maalox Nausea is and what it is used for
What you need to know before taking Maalox Nausea
How to take Maalox Nausea
Possible side effects
How to store Maalox Nausea
Contents of the pack and other information

1. What Maalox Nausea is and what it is used for

Maalox Nausea is a medicine containing a substance called "metoclopramide" and is used to
treat nausea.
Consult your doctor if you do not feel better or if you feel worse after 3 days.

2. What you should know before taking Maalox Nausea

Do not take Maalox Nausea

if you are allergic to metoclopramide hydrochloride or to any of the other ingredients of this medicine (listed in section 6);
if you have gastrointestinal bleeding, obstruction (blockage), or perforation (tear in the stomach or intestine);
if you have or suspect you have a rare tumour of the adrenal glands located next to the kidneys (pheochromocytoma);
if you have ever experienced involuntary muscle twitching (tardive dyskinesia) after taking certain medicines;
if you suffer from epilepsy;
if you suffer from Parkinson's disease;
if you are taking levodopa or dopaminergic agonists (medicines for Parkinson's disease and other nervous system disorders) (see "Other medicines and Maalox Nausea");
if you are being treated with medicines for nervous system disorders (monoamine oxidase inhibitors, neuroleptics such as phenothiazines, butyrophenones, thioxanthenes);
if you have had a condition called "NADH-cytochrome-b5 deficiency" or abnormalities in blood haemoglobin (methaemoglobinaemia);
if you are under 16 years of age (see "Children and adolescents");
if you are in the first trimester of pregnancy or during breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking Maalox Nausea.
Exercise particular caution with Maalox Nausea:

if you have heart diseases (congenital long QT syndrome);
if you have a slow heart rate (bradycardia);
if your blood tests show abnormal levels of potassium, sodium, or magnesium;
if you are taking medicines that may affect heart rhythm, such as antiarrhythmics (medicines acting on heart rhythm), tricyclic antidepressants (medicines used for depression), macrolides (antibiotics), antipsychotics (medicines used for psychiatric disorders);
if you have severe liver problems (severe hepatic insufficiency);
if you have kidney problems (renal insufficiency);
if you are concurrently being treated with medicines used to treat nervous system disorders such as phenothiazines (neuroleptic medicines);
if you suffer from epilepsy;
if you are between 16 and 18 years of age.

An increase in a hormone called prolactin may occur, especially if you have a breast tumour or a tumour producing 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 adverse effects, including uncontrolled movements (extrapyramidal symptoms, see section 4), may increase.
An alteration of haemoglobin in the blood (methaemoglobinaemia) has been reported. Your doctor may perform blood tests to monitor your blood haemoglobin.
Treatment should not exceed 3 months due to the risk of involuntary muscle spasms (tardive dyskinesia).

Children and adolescents
Maalox Nausea must not be taken by children and adolescents under 16 years of age.
Use of this medicine is not recommended in adolescents aged between 16 and 18 years.

Other medicines and Maalox Nausea
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect how Maalox Nausea works, or conversely, Maalox Nausea may affect how other medicines work.
Such medicines include:

levodopa or other medicines used to treat Parkinson's disease (see "Do not use Maalox Nausea");
anticholinergics (medicines used to relieve stomach cramps or spasms);
morphine derivatives (medicines used to treat pain);
sedatives;
any medicine used to treat mental health conditions;
digoxin (a medicine used to treat heart failure);
cyclosporine (an immunosuppressant used in organ transplantation);
mivacurium and suxamethonium (medicines used to relax muscles during surgery);
fluoxetine and paroxetine (medicines used to treat depression);
medicines for nervous system disorders, such as neuroleptics (phenothiazines, butyrophenones, thioxanthenes, etc.);
cisplatin (a medicine used in cancer treatment);
insulin (a medicine used to treat diabetes mellitus);
rifampicin (a medicine used to treat tuberculosis or other infections; it may reduce the amount of metoclopramide in the blood when administered simultaneously). Metoclopramide also reduces the central nervous system effects of apomorphine.

Maalox Nausea and alcohol
Do not consume alcoholic beverages during treatment with Maalox Nausea, as alcohol increases the sedative effect of metoclopramide.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take Maalox Nausea during the first trimester of pregnancy.
Use this medicine after the first three months of pregnancy only if necessary and under direct medical supervision.
Avoid using Maalox Nausea during breastfeeding, as metoclopramide passes into breast milk and adverse effects in the infant cannot be ruled out. As an alternative, consider artificial feeding.

Driving and using machines
Maalox Nausea may cause drowsiness, dizziness, dyskinesia (movement disorders), and dystonia (motor difficulties), which may impair vision and affect your ability to drive vehicles or operate machinery. These symptoms may worsen if alcohol is consumed concurrently.

Maalox Nausea effervescent granules contain sucrose and sodium:

3.95 g of sucrose per sachet; this should be considered in patients with diabetes mellitus. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
157.55 mg of sodium (main component of table salt) per sachet. This corresponds to 7.9% of the maximum recommended daily dietary intake for an adult.

Maalox Nausea effervescent tablets contain sorbitol, sodium, and potassium:

192.0 mg of sorbitol per effervescent tablet. Sorbitol is a source of fructose. If your doctor has told you that you are intolerant to certain sugars, or if you have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which patients cannot metabolize fructose, consult your doctor before taking this medicine.
approximately 66 mg of sodium (main component of table salt) per effervescent tablet. This corresponds to 3.3% of the maximum recommended daily dietary intake for an adult.
6.44 mmol of potassium per effervescent tablet. This should be considered in patients with impaired kidney function or those following a low-potassium diet.

3. How to take Maalox Nausea

Take this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Do not exceed the recommended doses.
This medicine is intended for adult use only. It is contraindicated in children under 16 years of age. Use is not recommended in the 16-18 age group.
The recommended dose is: one sachet of effervescent granules or one effervescent tablet dissolved in half a glass of water, 2-3 times daily, before meals or at the onset of symptoms.
Wait at least 6 hours before taking the next dose of metoclopramide, even if vomiting or rejection of the dose occurs. The maximum recommended daily dose is 30 mg.
If there is no improvement after a maximum of 3 days of treatment, consult your doctor.
The maximum recommended duration of treatment is 5 days.
Caution: Do not exceed the recommended doses without medical advice. In particular, elderly patients should adhere to the minimum dosages indicated above.
Use only for short-term treatment.
Consult your doctor if symptoms recur frequently or if you notice any recent changes in their pattern.

Use in children and adolescents
This medicine is contraindicated in children and adolescents under 16 years of age (see "Do not use Maalox Nausea").
Use is not recommended in the 16-18 age group (see "Warnings and precautions").

Use in the elderly
Your doctor may reduce the dose based on any kidney, liver, or general health problems you may have.
Adhere to the minimum dosages indicated above.

Use in patients with kidney or liver problems
Talk to your doctor if you have kidney or liver problems. The dose should be reduced in cases of moderate or severe kidney impairment and in cases of severe liver problems.

If you take more Maalox Nausea than you should
Extrapyramidal symptoms (involuntary movements), drowsiness, reduced level of consciousness, confusion, hallucinations, and cardiorespiratory arrest may occur.
In case of accidental ingestion or overdose of Maalox Nausea, contact your doctor immediately or go to the nearest hospital.

If you forget to take Maalox Nausea
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop treatment and speak immediately with your doctor or pharmacist if you experience any of the following symptoms during treatment with this medicine:

uncontrollable movements (often affecting the head or neck). These may occur in children or young adults, particularly when high doses are used. These symptoms usually appear at the beginning of treatment and may even occur after a single dose. The movements disappear if appropriately treated.
high fever, high blood pressure, seizures, sweating, salivation. These may be signs of a disorder called neuroleptic malignant syndrome.
itching or skin problems, swelling of the face, lips or throat, difficulty breathing. These may be signs of an allergic reaction, which could be severe.

Very common (may affect more than 1 in 10 people)
drowsiness.
Common (may affect up to 1 in 10 people)
depression;
uncontrollable movements (extrapyramidal disorders);
Parkinson-like symptoms such as stiffness and tremors (parkinsonism);
restlessness (akathisia);
reduction in blood pressure (hypotension);
diarrhoea;
feeling of weakness (asthenia).
Uncommon (may affect up to 1 in 100 people)
increased blood levels of a hormone called prolactin (hyperprolactinaemia);
absence of menstruation (amenorrhoea);
hallucinations;
altered muscle or nerve tone (dystonia);
visual disturbances and involuntary deviation of the eye;
abnormal movements (dyskinesia);
reduced level of consciousness;
slowed heart rate (bradycardia);
hypersensitivity.
Rare (may affect up to 1 in 1,000 people)
confusional state;
seizures (especially in epileptic patients);
milk production in men and women who are not breastfeeding (galactorrhoea).
Frequency not known (frequency cannot be estimated from the available data)
severe allergic reactions (such as anaphylactic reaction, angioedema and urticaria).
Symptoms may include skin 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 another healthcare professional immediately or go immediately to the nearest hospital emergency department;
changes in haemoglobin, a substance present in the blood;
abnormal breast development (gynaecomastia);
involuntary muscle spasms (tardive dyskinesia) after prolonged use, particularly in elderly patients;
high fever, high blood pressure, seizures, sweating, salivation. These may be symptoms of a disorder called neuroleptic malignant syndrome;
changes 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;
increase in blood pressure in patients with a rare tumour of the adrenal glands (pheochromocytoma) (see "Do not take Maalox Nausea");
suicidal thoughts (suicidal ideation).
Following the instructions contained in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those 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/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Maalox Nausea

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp".
The expiry date refers to the last day of that month.
Store the effervescent tablets below 30°C, keeping them in the original packaging, to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Maalox Nausea contains
Effervescent tablets

The active substance is metoclopramide hydrochloride. Each effervescent tablet contains 5 mg of metoclopramide hydrochloride.
The other components are: anhydrous monosodium citrate, potassium bicarbonate, anhydrous citric acid, potassium carbonate, sorbitol (E420), macrogol 6000, leucine, sodium saccharin, lemon flavour.

Effervescent granulate

The active substance is metoclopramide hydrochloride. Each sachet of effervescent granulate contains 5 mg of metoclopramide hydrochloride.
The other components are: tartaric acid, sodium bicarbonate, sucrose, sodium chloride, arabic gum, orange flavour, lemon flavour.

Description of the appearance of Maalox Nausea and contents of the pack
Maalox Nausea 5 mg effervescent tablets for adults are available in a box containing 20 effervescent tablets.
Maalox Nausea 5 mg effervescent granulate for adults is available in a box containing 20 sachets.

Marketing Authorization Holder
Opella Healthcare Italy S.r.l. - Viale L. Bodio, 37/b - IT-20158 Milano (Italy)

Manufacturer
Effervescent tablets
E-Pharma Trento S.p.A. – Via Provina, 2 Trento (TN)
Effervescent granulate
E-Pharma Trento S.p.A. – Via Provina, 2 Trento (TN)
or
Fine Foods NTM S.p.A. – Brembate (BG)