Argopro

Package leaflet: Information for the patient

ARGOPRO 25 mg tablets

Generic Medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ARGOPRO is and what it is used for
2. What you need to know before taking ARGOPRO
3. How to take ARGOPRO
4. Possible side effects
5. How to store ARGOPRO
6. Contents of the pack and other information

1. What ARGOPRO is and what it is used for

ARGOPRO contains the active substance levosulpiride, which belongs to a group of medicines known as “psycholytics, antipsychotics (neuroleptics)”.
It works by stimulating gastric and intestinal motility (gastrointestinal prokinetic effect).
This medicine is indicated for the short-term treatment of:

• Dyspeptic syndrome: this syndrome, i.e. a group of various symptoms related to poor digestion, may be due to organic causes—such as lesions in digestive organs—or to impaired function of these organs, even in the absence of detectable lesions, often linked to unhealthy lifestyle habits. It is mainly associated with delayed gastric emptying. Certain medical conditions (such as delayed gastric emptying due to diabetes or certain tumours) or psychological disorders (such as anxiety and depression, which may cause visceral functional disturbances) can make digestion difficult. The stomach has trouble emptying, leading to symptoms such as stomach pain and heartburn, loss of appetite (anorexia), flatulence, bloating and abdominal fullness, headache after meals, belching, diarrhoea, and constipation. Your doctor has prescribed ARGOPRO because you did not respond adequately to previous treatments with other medicines;
• Vomiting and nausea, symptoms caused by drugs used in cancer treatment. Your doctor has prescribed ARGOPRO because you did not respond adequately to previous treatments with other medicines;
• Vertigo (dizziness), symptoms of a disease affecting the inner ear (Ménière’s syndrome), causing balance problems and ear disturbances (such as ringing, whistling, or crackling noises), hearing loss, and nausea.

2. What you need to know before taking ARGOPRO

Do not take ARGOPRO

• if you are allergic to levosulpiride or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from seizures (epilepsy);
• if you have mood disorders that may cause feelings of excitement (manic states with hyperactivity, irritability, irritability, or reduced need for sleep);
• if you are at risk of developing a tumor of the adrenal glands (pheochromocytoma);
• if you have a breast tumor;
• if you have gastrointestinal bleeding, intestinal obstruction (which may be characterized by abdominal cramps, vomiting, constipation), or ulcers (lesions of the stomach/intestinal wall);
• if you are pregnant or suspect you may be pregnant, or if you are breastfeeding (see “Pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor or pharmacist before taking ARGOPRO.
It is very important that you inform your doctor beforehand:

• if you suffer from a disease that reduces your ability to remember, speak, and reason (dementia);
• if you are elderly;
• if you have a predisposition to stroke, or have heart and/or circulatory disorders;
• if you or a family member suffers or has suffered from a heart disease causing irregular heartbeat (“long QT syndrome”);
• if you or someone in your family has a history of blood clots (thrombosis), as medicines like ARGOPRO have been associated with the formation of blood clots in veins.

Contact your doctor immediately if:
After taking this medicine you experience a combination of symptoms such as
fever, severe muscle stiffness, severe movement difficulties (akinesia), excessive
sweating, rapid heartbeat, altered blood pressure, or loss of consciousness. These are symptoms of a very serious and potentially life-threatening condition
called “Neuroleptic Malignant Syndrome”. In this case, you must stop taking ARGOPRO and contact your doctor immediately, who will prescribe appropriate treatment.
If you are taking anticholinergic medicines (medicines that block the action of acetylcholine, a substance involved in nerve impulse transmission), narcotics, and analgesics (painkillers), as they may reduce the effects of ARGOPRO (see section “Other medicines and ARGOPRO”).

Other medicines and ARGOPRO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, before taking this medicine, tell your doctor if you are already taking:

• medicines acting on the central nervous system used to treat psychiatric disorders, especially neuroleptics, as combination with ARGOPRO requires caution;
• medicines that affect heart rhythm (prolong QT interval), as combination with ARGOPRO increases the risk of developing heart rhythm abnormalities (cardiac arrhythmias);
• medicines that may affect blood mineral levels (electrolytes), as combination with ARGOPRO should be avoided;
• medicines called anticholinergics (used to counteract a substance involved in nerve impulse transmission in the body called "acetylcholine"), medicines used for sleep (narcotics), and medicines used for pain relief (analgesics), as they may influence the effects of ARGOPRO on stomach and intestinal motility.

ARGOPRO with food, drinks and alcohol
DO NOT drink alcohol while taking this medicine.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use ARGOPRO if you are pregnant or think you might be pregnant.
If you take antipsychotics (“conventional or atypical”), including ARGOPRO, during the last 3
months of pregnancy, your baby may experience the following symptoms after birth:
tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
Contact your doctor if your baby shows any of these symptoms.

Breastfeeding
Do not use ARGOPRO during breastfeeding.

Driving and use of machines
DO NOT drive vehicles, DO NOT operate machinery, and DO NOT engage in activities requiring special attention while taking this medicine.
High doses of this medicine may cause drowsiness, numbness, and involuntary movements. These effects may impair your ability to drive or operate machinery.

ARGOPRO tablets contain lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

ARGOPRO tablets contain sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

3. How to take ARGOPRO

Take this medicine exactly as your doctor or pharmacist has told you. If you have any doubts, consult your doctor or pharmacist.
You must always follow the exact dose prescribed by your doctor. The recommended dose for adults is: 1 tablet three times daily, before meals.

Use in children and adolescents
This medicine must not be used in children and adolescents, as relevant data are not available.

Use in the elderly
If you are elderly, your doctor will carefully determine the dosage and may consider reducing the doses indicated above.

If you take more ARGOPRO than you should
If you take a dose of ARGOPRO higher than prescribed, contact your doctor immediately or go to the nearest hospital. Take this Patient Information Leaflet with you.
An overdose may cause tremors, movement difficulties and slowness (extrapyramidal disorders), or sleep disturbances.

If you forget to take ARGOPRO
Do not take a double dose to make up for the missed tablet.
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 gets them.
The following side effects have also been observed with the use of other medicines in the same class and/or with prolonged administration:
Rare (may affect up to 1 in 1,000 people):

• changes in heart rhythm (prolongation of the QT interval on electrocardiogram, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation), cardiac arrest.
  Very rare (may affect up to 1 in 10,000 people):

• drowsiness, "parkinsonism" (symptoms similar to those of Parkinson's disease such as, e.g., tremor, difficulty and slowness of movement, stiffness and postural instability); involuntary muscle movements (dyskinesias); tremor; repetitive twisting movements or abnormal fixed postures (dystonia); Neuroleptic Malignant Syndrome (see section “Contact your doctor immediately if”).

• cases of sudden death.

Not known (frequency cannot be estimated from the available data):

• absence of menstruation in women of childbearing age (amenorrhoea), breast tenderness, spontaneous flow of milk from the breasts not related to childbirth or breastfeeding (galactorrhoea), breast development in men (gynaecomastia), changes in sexual desire (libido).
• neonatal withdrawal syndrome, movement disorders (extrapyramidal symptoms) (see section 2, “Pregnancy and breastfeeding”).
• formation of blood clots (venous thrombosis), especially in the legs (symptoms include swelling, pain, redness of the leg), which may travel to the lungs and cause chest pain and breathing difficulties.
• increased levels of a hormone called prolactin in the blood (hyperprolactinaemia).

ARGOPRO is not indicated for the treatment of dementia. In elderly patients with dementia, a slight increase in the number of deaths has been observed in patients taking antipsychotics compared to those not taking antipsychotics.
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 ARGOPRO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 ARGOPRO contains

• The active substance is levosulpiride. One tablet contains 25 mg of levosulpiride.
• The other components are: microcrystalline cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate.

Description of the appearance of ARGOPRO and package contents
Carton pack containing 20 tablets
Marketing Authorization Holder
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milano
Manufacturer:
Doppel Farmaceutici S.r.l. - Via Volturno, 48, 20089 Quinto De’ Stampi – Rozzano (MI)
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 29016 Cortemaggiore (PC)
Package leaflet: information for the patient

ARGOPRO 25 mg/ml oral drops solution

Levosulpiride
Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What ARGOPRO is and what it is used for
2. What you need to know before taking ARGOPRO
3. How to take ARGOPRO
4. Possible side effects
5. How to store ARGOPRO
6. Package contents and other information

1. What ARGOPRO is and what it is used for

ARGOPRO contains the active substance levosulpiride, which belongs to a group of medicines called "psychotropic, antipsychotics (neuroleptics)".
It works by stimulating gastric and intestinal motility (gastrointestinal prokinetic effect).
This medicine is used for short-term treatment of:

• dyspeptic syndrome : this syndrome, i.e. a set of various symptoms related to poor digestion, may be due to organic causes, such as lesions in digestive organs, or to impaired function of these organs—even due to incorrect lifestyle habits—without detectable lesions in the digestive organs themselves. It is mainly related to difficulty in gastric emptying. Certain medical conditions (such as delayed gastric emptying due to diabetes or certain tumours) or psychological disorders (such as anxiety and depression, which may cause alterations in visceral function) can make digestion difficult. The stomach has trouble emptying, resulting in: stomach pain and heartburn, loss of appetite (anorexia), flatulence, bloating and stomach distension, headache after meals, belching, diarrhoea, and constipation. Your doctor has prescribed ARGOPRO because you did not respond adequately to previous treatment with other medicines;
• nausea and vomiting , symptoms caused by medications used in cancer treatment. Your doctor has prescribed ARGOPRO because you did not respond adequately to previous treatment with other medicines;
• dizziness (vertigo) , symptoms of a disease affecting the inner ear (Ménière's syndrome), causing balance problems and ear disturbances (such as noises, ringing, crackling sounds), hearing loss, and nausea.

2. What you need to know before taking ARGOPRO

Do not take ARGOPRO

• if you are allergic to levosulpiride or to any of the other ingredients of this medicine (listed in section 6);
• if you are at risk of developing a tumour of the adrenal glands (pheochromocytoma);
• if you suffer from seizures (epilepsy);
• if you have mood disorders that may cause feelings of excitement (manic states with hyperactivity, irritability, irritability, or reduced need for sleep);
• if you have a breast tumour;
• if you have gastrointestinal bleeding, intestinal obstruction (which may be characterized by abdominal cramps, vomiting, constipation), or ulcers (lesions of the stomach/intestine wall);
• if you are pregnant or suspect you might be pregnant, or if you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
Talk to your doctor or pharmacist before taking ARGOPRO.
It is very important that you inform your doctor beforehand:

• if you suffer from a disease that reduces your ability to remember, speak, and reason (dementia);
• if you are elderly;
• if you have a predisposition to stroke, or have heart and/or circulatory disorders;
• if you or a family member has or has had a heart condition causing irregular heartbeat ("long QT syndrome");
• if you or someone in your family has a history of blood clots (thrombosis), as medicines like ARGOPRO have been associated with the formation of blood clots in veins.

Contact your doctor immediately if:
After taking this medicine you experience a combination of symptoms such as
fever, severe muscle stiffness, severe movement difficulties (akinesia), excessive
sweating, rapid heartbeat, altered blood pressure, or loss of consciousness. These are symptoms of a very serious and potentially life-threatening condition
called "Neuroleptic Malignant Syndrome". In this case, you must stop taking ARGOPRO immediately and contact your doctor right away, who will prescribe appropriate treatment.
If you are taking anticholinergic medicines (drugs that block the action of acetylcholine, a substance involved in nerve impulse transmission), narcotics, and analgesics (painkillers), as they may reduce the effects of ARGOPRO (see section "Other medicines and ARGOPRO").

Other medicines and ARGOPRO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, before taking this medicine, tell your doctor if you are already taking:

• medicines acting on the central nervous system used to treat psychiatric disorders, especially neuroleptics, as combination with ARGOPRO requires caution;
• medicines that affect heart rhythm (prolong QT interval), because combining them with ARGOPRO increases the risk of developing heart rhythm abnormalities (cardiac arrhythmias);
• medicines that may affect mineral levels (electrolytes) in the blood, because combination with ARGOPRO should be avoided;
• medicines called anticholinergics (used to counteract a substance involved in nerve impulse transmission in the body called "acetylcholine"), medicines used to induce sleep (narcotics), and pain-relieving medicines (analgesics), as they may influence the effects of ARGOPRO on stomach and intestinal motility.

ARGOPRO with food, drinks and alcohol
DO NOT drink alcohol while taking this medicine.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Pregnancy
Do not use ARGOPRO if you are pregnant or think you might be.
If you take antipsychotics ("conventional or atypical"), including ARGOPRO, during the last 3 months of pregnancy, your baby may experience the following symptoms after birth:
tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems.
Contact your doctor if your baby shows any of these symptoms.

Breastfeeding
Do not use ARGOPRO while breastfeeding.

Driving and using machines
DO NOT drive, DO NOT operate machinery, and DO NOT engage in activities requiring special attention while taking this medicine.
High doses of this medicine may cause drowsiness, numbness, and involuntary movements. These effects may impair your ability to drive or operate machinery.

ARGOPRO contains p-hydroxybenzoates
This medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).

ARGOPRO contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially 'sodium-free'.

3. How to take ARGOPRO

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You must always follow the dose prescribed by your doctor. The recommended dose for adults is: 15 drops three times daily, before meals (one drop contains 1.6 mg of levosulpiride).

Use in children and adolescents
This medicine must not be used in children and adolescents, as relevant data are not available.

Use in the elderly
If you are elderly, your doctor will carefully determine the dosage and may consider reducing the doses indicated above.

Instructions for use:

• To open the bottle: press on the cap and unscrew at the same time (Fig. 1).
• Let the drops fall into a glass, holding the bottle in an upright position with the opening facing downwards (Fig. 2).
• To close the bottle: screw the cap until tightly sealed (Fig. 3).

Fig. 1 Fig. 2 Fig. 3
If you take more ARGOPRO than you should
If you take a dose of ARGOPRO higher than prescribed, contact your doctor immediately
or go to the nearest hospital. Take this Patient Information Leaflet with you.
An overdose may cause tremors, movement difficulties or slowness (extrapyramidal disorders), or sleep disturbances.
If you forget to use ARGOPRO
Do not use a double dose to make up for the forgotten dose.
If you have any doubts about the use of this medicinal product, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have also been observed with the use of other medicines in the same class and/or with prolonged administration:

Rare (may affect up to 1 in 1,000 people):

• changes in heart rhythm (prolongation of the QT interval on electrocardiogram, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation), cardiac arrest.

Very rare (may affect up to 1 in 10,000 people):

• drowsiness, "parkinsonism" (symptoms similar to those seen in Parkinson's disease such as, e.g., tremor, difficulty and slowness of movement, rigidity, and postural instability); involuntary muscle movements (dyskinesias); tremor; repetitive twisting movements or abnormal fixed postures (dystonia); Neuroleptic Malignant Syndrome (see section "Contact your doctor immediately if").
• cases of sudden death.

Not known (frequency cannot be estimated from the available data):

• absence of menstruation in women of childbearing age (amenorrhoea), breast tenderness, spontaneous milk discharge from the breasts unrelated to childbirth or breastfeeding (galactorrhoea), breast development in men (gynaecomastia), changes in sexual desire (libido).
• neonatal withdrawal syndrome, movement disorders (extrapyramidal symptoms) (see section 2, “Pregnancy and breastfeeding”).
• formation of blood clots (venous thrombosis), especially in the legs (symptoms include swelling, pain, redness of the leg), which may travel to the lungs and cause chest pain and breathing difficulties.
• increased levels of a hormone called prolactin in the blood (hyperprolactinaemia).

ARGOPRO is not indicated for the treatment of dementia. In elderly patients with dementia, a small increase in the number of deaths has been observed among patients taking antipsychotics compared to those not taking antipsychotics.

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 the following website: 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 ARGOPRO

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
No special storage precautions are required.
Use the medicine within 4 weeks after first opening the bottle. After this period, discard any remaining product.
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 ARGOPRO contains

• The active substance is levosulpiride. 2.5 g of levosulpiride are contained in 100 ml of solution.
• The other components are: anhydrous citric acid, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, lemon flavour, purified water.

Description of the appearance of ARGOPRO and contents of the pack
Carton pack containing a 20 ml dropper bottle
Marketing Authorization Holder
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milan
Manufacturer:
Doppel Farmaceutici S.r.l. - Via Volturno, 48 20089 Quinto De’ Stampi – Rozzano (MI)
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe, 1 29016 Cortemaggiore (PC)