Package leaflet:

Information for the patient
Levosulpiride Ferrer 25 mg injection solution or for infusion
Levosulpiride
Equivalent medicine
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

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

Contents of this leaflet

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

1. What Levosulpiride Ferrer is and what it is used for

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

dyspeptic syndrome: this syndrome, a combination of various symptoms related to poor digestion, may result from organic causes, i.e. lesions of digestive organs, or from impaired function of these organs—even due to unhealthy lifestyle habits—without detectable lesions in the digestive organs themselves, and is primarily associated with delayed gastric emptying. Certain medical conditions (such as delayed gastric emptying due to diabetes or certain tumors) or psychological disorders (such as anxiety and depression, which may cause visceral functional disturbances) can impair digestion. The stomach has difficulty emptying, leading to symptoms such as stomach pain and heartburn, loss of appetite (anorexia), flatulence, bloating and abdominal fullness, headache after meals, belching, diarrhea, and constipation. Levosulpiride has been prescribed for you because you did not respond to previous treatment with other medicines;
vomiting and nausea caused by drugs used in cancer treatment. Levosulpiride has been prescribed for you because you did not respond to previous treatment with other medicines;
vertigo (dizziness), symptoms of a disease affecting the inner ear (Ménière's syndrome), causing balance problems and ear disturbances (such as tinnitus, ringing, crackling sounds), hearing loss, and nausea.

2. What you need to know before taking Levosulpiride Ferrer

Do not take Levosulpiride Ferrer

if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6);
if you have or suspect you have a tumor of the adrenal glands (pheochromocytoma);
if you suffer from seizures (epilepsy);
if you suffer from mood disorders that may cause feelings of excitement (manic states with hyperactivity, agitation, irritability, or reduced need for sleep);
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 or suspect you are pregnant or are breastfeeding (see "Pregnancy and breastfeeding").

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

if you suffer from a disease that reduces your ability to remember, speak, and think (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 suffer or have suffered from 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 Levosulpiride Ferrer 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,
changes in 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 Levosulpiride Ferrer and contact your doctor immediately, who will prescribe appropriate treatment.
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 Levosulpiride Ferrer (see section "Other medicines and Levosulpiride Ferrer").

Children and adolescents
Do not administer this medicine to children and adolescents, as relevant data are not available.

Other medicines and Levosulpiride Ferrer
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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, particularly neuroleptics, as combination with Levosulpiride Ferrer requires caution;
medicines that may affect blood levels of minerals (electrolytes), as combination with Levosulpiride Ferrer should be avoided;
medicines that alter heart rhythm (prolong QT interval), as combination with Levosulpiride Ferrer increases the risk of developing heart rhythm abnormalities (cardiac arrhythmias);
anticholinergic medicines (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 Levosulpiride Ferrer on stomach and intestinal motility.

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

Pregnancy, breastfeeding, and fertility
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 take Levosulpiride Ferrer if you are pregnant or planning to become pregnant.
If you take antipsychotics ("conventional or atypical"), including Levosulpiride Ferrer, during the last
three 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 take Levosulpiride Ferrer while breastfeeding.

Driving and using machines
DO NOT drive, operate machinery, or engage in activities requiring alertness 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.

Levosulpiride Ferrer 25 mg injectable solution for intramuscular and intravenous use contains less than 1 mmol (23 mg) of sodium per dose, i.e., it is essentially "sodium-free".

3. How to take Levosulpiride Ferrer

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
You must always take the exact dose prescribed by your doctor. The recommended doses are:
Adults
If you have nausea and vomiting, you may have difficulty retaining levosulpiride tablets or oral solution.
In this case, your doctor will prescribe the injectable solution until symptoms become milder.
The recommended dose is: 1 vial 2 or 3 times a day, as prescribed by your doctor. The vial can be administered either directly into a vein (intravenous route) or into a muscle (intramuscular route) by authorized healthcare personnel.
Subsequently, you may continue treatment orally (with levosulpiride tablets or oral drops) for approximately 10–15 days.
If your doctor prescribes repeating another treatment cycle for an additional 2 or 3 weeks, you will always be required to observe a break period of at least 8–10 days between one treatment cycle and the next.
Management of vomiting caused by antitumor medicines
If vomiting is caused by certain antitumor medicines (cisplatin, anthracyclines), 1–2 vials may be administered intravenously (through a vein) slowly or by infusion via intravenous drip, 30 minutes before or during administration of the antitumor medicine. The same dose may be repeated 30 minutes after administration of the antitumor medicine.
Use in the elderly
If you are elderly, your doctor will carefully determine the dosage and may consider reducing the doses indicated above.
Use in children and adolescents
This medicine must not be used in children and adolescents, as relevant data are not available.
If you take more Levosulpiride Ferrer than you should
If you take a dose of levosulpiride higher than prescribed, contact your doctor immediately or go to the nearest hospital. Bring this leaflet with you.
An overdose may cause tremors, difficulty or slowness in movement (extrapyramidal disorders), or sleep disturbances.
If you forget to take Levosulpiride Ferrer
Do not take a double dose to make up for the forgotten 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 everybody 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 (QT interval prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation), cardiac arrest.

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

somnolence, "parkinsonism" (symptoms similar to those of Parkinson's disease such as, for example, 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 (a potentially fatal reaction, symptoms include hyperpyrexia, muscle rigidity, akinesia, irregular pulse or blood pressure, sweating, tachycardia, arrhythmias, alterations in mental status which may progress to stupor and coma). (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 development in men (gynaecomastia), breast tension, spontaneous milk discharge from the breasts not associated with childbirth or breastfeeding (galactorrhoea), changes in sexual desire (libido).
formation of blood clots (venous thrombi), 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.
neonatal withdrawal symptoms (see section 2, “Pregnancy and breastfeeding”), movement disorders (extrapyramidal symptoms).
increased levels of a hormone called prolactin in the blood (hyperprolactinaemia). Levosulpiride Ferrer 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 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 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 Levosulpiride Ferrer

Levosulpiride Ferrer 25 mg injection solution or for intramuscular and
intravenous infusion
Before opening: this medicinal product requires no special storage conditions.
After dilution: Physical and chemical stability in use has been demonstrated for 6 hours at room
temperature when diluted with 0.9% sodium chloride solution or 5% glucose solution.
From a microbiological standpoint, the product should be used immediately. If not used
immediately, the duration and conditions of in-use storage prior to use are the responsibility of the
user and generally should not exceed 24 hours at 2-8°C, unless dilution has been carried out under
controlled and validated aseptic conditions.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the carton after “Exp.”. The expiry
date refers to the last day of that month.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What Levosulpiride Ferrer contains
Levosulpiride Ferrer 25 mg solution for injection or infusion for intramuscular and
intravenous use

The active substance is levosulpiride. Each 2 ml vial contains 25 mg of levosulpiride.
The other components are sulfuric acid 2 N, water for injections, sodium chloride.

Description of the appearance of Levosulpiride Ferrer and contents of the pack
Levosulpiride Ferrer 25 mg solution for injection or infusion for intramuscular and
intravenous use is supplied in a pack containing 6 glass vials of 2 ml each.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Ferrer Internacional S.A.
Gran Via Carlos III, 94
Barcelona – 08028
Spain
Manufacturer
Doppel Farmaceutici S.r.l.
Via Volturno, 48 - 20089 Quinto de' Stampi - Rozzano (MI)