LEVOPRAID 25 mg Tablet

Зміст інструкції

1. Levopraid 25 mg tablets, 25 mg/ml oral drops, solution, 25 mg/2 ml injectable solution
   1. What is Levopraid and what is it used for
   2. What you need to know before taking Levopraid
   3. How to take Levopraid
   4. Possible side effects
   5. How to store Levopraid
   6. Package Contents and Other Information
2. Levopraid 50 mg tablets, 50 mg/2 ml injectable solution, 100 mg tablets
   1. What Levopraid is and what it is used for
   2. What you need to know before taking Levopraid
   3. How to take Levopraid
   4. Possible side effects
   5. How to store Levopraid
   6. Contents of the pack and other information

Levopraid 25 mg tablets, 25 mg/ml oral drops, solution, 25 mg/2 ml injectable solution

Levosulpiride

Read this leaflet carefully before you start to take 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 pass it on to others, even if their symptoms are the same as yours, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Levopraid and what is it used for

Levopraid contains the active substance levosulpiride which belongs to a group of medicines called
“psycholectics, antipsychotics (neuroleptics)”.
It works by stimulating the motility of the stomach and intestines (gastrointestinal prokinetic).
This medicine is indicated for the short-termtreatment of:

• dyspeptic syndrome: this syndrome, that is a set of various symptoms related to poor digestion, which may be due to organic causes, that is to lesions of digestive organs, or to the poor functioning of the same organs, even due to incorrect lifestyles, without lesions detectable in the digestive organs themselves, is predominantly linked to a difficulty of the stomach to empty. Some disorders of the organism (such as delayed gastric emptying in case of diabetes, or some tumors) or psychological disorders (such as anxiety and depression which can determine alterations of visceral function) can make digestion difficult. The stomach struggles to empty and the following symptoms manifest: stomach pain and heartburn, loss of appetite (anorexia), flatulence, stomach bloating and tension, headache after meals, belching, diarrhea and constipation. Levopraid is prescribed by your doctor because you have not previously responded to therapy with other medicines;
• vomitingand nausea, symptoms caused by drugs used for the treatment of tumors. Levopraid is prescribed by your doctor because you have not previously responded to therapy with other medicines.
• dizziness(vertigo), symptoms of a disease affecting the inner ear (Mènière's syndrome) causing balance problems and ear disorders (such as ringing, whistling, crackling), hearing loss and nausea.

2. What you need to know before taking Levopraid

Do not take Levopraid

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you are at risk of developing a tumor of the adrenal glands (pheochromocytoma);
• if you suffer from convulsions (epilepsy);
• if you suffer from mood disorders that can make you feel excited (manic states with hyperactivity, irritation, irritability or decreased need for sleep);
• if you have breast cancer;
• if you have gastrointestinal bleeding, intestinal blockage (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
Consult your doctor or pharmacist before taking Levopraid.
It is very important that you inform your doctor first:

• 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 circulation problems;
• if you or a family member suffers or has suffered from a heart disease that causes irregular heartbeat (“long QT syndrome”);
• if you or someone else in your family has a history of blood clot formation (thrombosis), as medicines like Levopraid have been associated with the formation of blood clots in the veins. Immediately warn your doctorif:

After taking this medicine you experience a combination of symptoms such as fever, severe
muscle stiffness, severe difficulty in movement (akinesia), excessive sweating, if your
heartbeat is accelerated, your blood pressure is altered or if you lose consciousness. These are symptoms of a
very serious and potentially fatal condition called “Neuroleptic Malignant Syndrome”. In
this case you must stop taking Levopraid and immediately contact your
doctorwho will prescribe appropriate therapy.
If you are taking anticholinergic medicines (drugs that block the action of acetylcholine, a substance
involved in the transmission of nerve impulses), narcotics and analgesics (pain relievers) as they
may reduce the effects of Levopraid (see section “Other medicines and Levopraid")

Other medicines and Levopraid
Tell 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 that act on the central nervous system used to treat psychiatric disorders, especially neuroleptics, because the association with Levopraid requires caution;
• medicines that can affect the levels of minerals (electrolytes) in the blood, because the association with Levopraid should be avoided;
• medicines that alter the heartbeat (prolong the QT), because the association with Levopraid increases the risk of developing heart rhythm abnormalities (cardiac arrhythmias).
• Medicines called anticholinergics (used to counteract a substance involved in the transmission of nerve impulses, present in our body called "acetylcholine"), medicines used for sleeping (narcotics) and medicines used for pain (analgesics) as they
  influence the effects of Levopraid on stomach and intestinal motility.

Levopraid with food, drinks and alcohol
DO NOT drink alcoholwhile taking this medicine.

Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy

Do not useLevopraid if you are pregnant or think you might be.
If you are taking antipsychotics (“conventional or atypical”), including Levobren, during the last 3 months of
pregnancy, your baby may experience the following symptoms after birth: tremor, stiffness
and/or muscle weakness, drowsiness, agitation, breathing problems and difficulty taking
food.
Contact your doctor if your baby shows any of these symptoms.
Breastfeeding

Do not useLevopraid during breastfeeding.

Driving and operating machinery
DO NOT drive vehicles, DO NOT use machinery and DO NOT participate in activities that require particular
attention while taking this medicine.
High doses of this medicine can cause drowsiness, a feeling of numbness and make you
make involuntary movements. These effects can impair your ability to drive vehicles or
use machinery.

Levopraid 25 mg tabletscontains lactose:if your doctor has diagnosed you with intolerance to
some sugars, contact him before taking this medicine.

Levopraid 25 mg/ml oral drops, solutioncontains methyl p-hydroxybenzoate and propyl p-
hydroxybenzoate:they may cause allergic reactions (even delayed).

Levopraid 25 mg/2 ml injectable solution for intramuscular and intravenous use containsless
than 1 mmol (23mg) of sodium per dose, i.e. it is practically ‘sodium-free’.

3. How to take Levopraid

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
You must always follow the precise dose that your doctor has prescribed for you. The recommended doses are:

Adults
Levopraid 25 mg tablets
The recommended dose is 1 tablet 3 times a day before meals.

Levopraid 25 mg/ml oral drops, solution
The recommended dose is 15 drops 3 times a day before meals.

Levopraid 25 mg/2 ml injectable solution for intramuscular and intravenous use
The recommended dose is 1 vial 2 or 3 times a day, as prescribed by your doctor, until the symptoms disappear.
The vial can be injected either directly into a vein (intravenously) or into a muscle
(intramuscularly) by authorized healthcare professionals.
If you have nausea and vomiting, you may have difficulty retaining the tablets or the oral solution of
Levopraid. In this case, your doctor will prescribe the injectable solution, until the symptoms
become milder. You can then continue with oral therapy (with tablets
or oral drops of Levopraid) for about 10 – 15 days.
If your doctor should prescribe you to repeat a new cycle of therapy for another 2 or 3 weeks, they will
always have you observe a period of interruption of at least 8 – 10 days between one cycle of therapy and
the other.

Treatment of vomiting caused by anticancer drugs
If the vomiting is caused by some anticancer drugs (cisplatin, anthracyclines), you may be
administered 1-2 vials intravenously (through a vein) slowly or by infusion with fleboclisis,
30 minutes before or during taking the anticancer drug. The same dose may be
repeated 30 minutes after taking the anticancer drug.

Use in the elderly
If you are elderly, your doctor will carefully establish the dosage and assess a possible reduction of the
dosages indicated above.

Use in children and adolescents
This medicine should not be used in children and adolescents because relevant data are not available.

If you take more Levopraid than you should
If you take a dose of Levopraid, higher than that prescribed immediately inform your doctoror
An overdose can cause tremors, difficulty and slowness of movements (extrapyramidal disorders) or
sleep disorders.

If you forget to use Levopraid
Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask 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 of the same class
and/or with prolonged administrations:

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

• heartbeat alterations (prolongation of the QT interval, 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 present in Parkinson's disease such as, e.g., tremor, difficulty and slowing of movements, rigidity and postural instability); involuntary muscle movements (dyskinesias); tremor; repetitive twisting movements or abnormal fixed positions (dystonia); Neuroleptic Malignant Syndrome (see paragraph “ Immediately inform your doctor if”).
• cases of sudden death.

Not known (frequency cannot be estimated based on available data):

• absence of menstruation in women of childbearing potential (amenorrhea), development of breast tissue in men (gynecomastia), feeling of tension in the breasts, spontaneous milk leakage from the breasts not associated with childbirth or breastfeeding (galactorrhea), changes in sexual desire (libido).
• formation of blood clots (venous thrombosis), especially in the legs (symptoms include swelling, pain, redness of the leg), which can reach the lungs and cause chest pain and difficulty breathing.
• neonatal withdrawal symptoms (see section 2 “Pregnancy and breastfeeding”), movement disorders (extrapyramidal symptoms).
• increased levels of a hormone called prolactin in the blood (hyperprolactinemia).

Levopraid is not indicated for the treatment of dementia. In elderly patients with dementia, a small
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 get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the website: http:// www.agenziafarmaco.gov.it/content/come segnalare una sospetta reazione avversa.
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Levopraid

Levopraid 25 mg tablets and Levopraid 25 mg/2 ml injectable solution for intramuscular and intravenous use
These medicines do not require any special storage conditions.

Levopraid 25 mg/ml oral drops, solution
Do not refrigerate or freeze.
Use the product within 90 days of first opening.
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 pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 Levopraid contains
Levopraid 25 mg tablets

• The active ingredient is levosulpiride, one tablet contains 25 mg of levosulpiride.
• The other ingredients are sodium carboxymethylcellulose, microgranular cellulose, lactose, magnesium stearate.

Levopraid 25 mg/ml oral drops, solution

• The active ingredient is levosulpiride, 100 ml of solution contain 2.5 g of levosulpiride.
• The other ingredients are acesulfame K, anhydrous citric acid, purified water, lemon aroma, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate.

Levopraid 25 mg/2 ml injectable solution for intramuscular and intravenous use

• The active ingredient is levosulpiride, one 2 ml vial contains 25 mg of levosulpiride.
• The other ingredients are 2N sulfuric acid, water for injections, sodium chloride.

Description of the appearance of Levopraid and package contents
Levopraid 25 mg tabletsare presented in a package containing 20 tablets in blisters.

Levopraid 25 mg/ml oral drops, solutionis presented in a package containing a dropper bottle made of glass, with child-resistant closure, containing 20 ml of solution.

Levopraid 25 mg/2 ml injectable solution for intramuscular and intravenous useis presented in a package containing 6 vials of 2 ml each.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
Tablets and drops
Teofarma S.r.l.
Viale Certosa, 8/A - 27100 Pavia
Injectable solution
Doppel Farmaceutici S.r.l.
Via Volturno, 48 - 20089 Quinto dè Stampi - Rozzano (MI)

Levopraid 50 mg tablets, 50 mg/2 ml injectable solution, 100 mg tablets

Levosulpiride

Read this leaflet carefully before you start 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Levopraid is and what it is used for

Levopraid contains levosulpiride which belongs to a group of medicines called “psycholeptics, antipsychotics (neuroleptics)”. It works by blocking the effects of dopamine, a substance naturally present in the brain.
Levopraid is indicated for the treatment of mental disorders such as:

• psychiatric alterations characterized by physical symptoms without any underlying bodily disease triggering them ("somatic symptom disorders");
• long-lasting or permanent diseases that cause a severe and persistent alteration of behavior, affect, thinking and perception (feeling, perceiving or seeing things that are not actually there) ("chronic schizophrenia with negative symptoms").

2. What you need to know before taking Levopraid

Do not take Levopraid

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you have a tumor of the adrenal glands (pheochromocytoma);
• if you suffer from convulsions (epilepsy);
• in the presence of mood disorders that can make you feel excited (manic states with hyperactivity, irritation, irritability or decreased need for sleep);
• if you have gastrointestinal bleeding, intestinal blockage (which may be characterized by abdominal cramps, vomiting, constipation) or ulcers (lesions of the stomach/intestinal wall);
• if you have breast cancer;

Warnings and precautions
Consult your doctor or pharmacist before taking Levopraid.

It is very important thatyou inform your doctor before taking this medicine:

• if you suffer from a disease that reduces your ability to remember, speak and reason (dementia);
• if you have a predisposition to stroke or have heart and/or circulation problems;
• if you or a family member suffers or has suffered from a heart disease that causes irregular heartbeat (“long QT syndrome”);
• if you are being treated with other psychotropic drugs (neuroleptics).
• if you or someone else in your family has a history of blood clot formation (thrombosis), as drugs like Levopraid have been associated with the formation of blood clots in the veins.

Pregnancy and breastfeeding
The doctor will prescribe Levopraid only after careful evaluation (see section Pregnancy and

breastfeeding)

Immediately inform your doctor if you experience:

• a combination of symptoms such as fever, severe muscle stiffness, severe difficulty in movements (akinesia), excessive sweating, if you have a rapid heartbeat, altered blood pressure or if you lose consciousness. These are symptoms of a very serious and potentially fatal condition called “Neuroleptic Malignant Syndrome”. In this case you must stop takingLevopraid and immediately contact your doctorwho will prescribe appropriate therapy. If you need to resume treatment with antipsychotics, your doctor will subject you to checks.

Other medicines and Levopraid
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
In particular:

• the doctor will prescribe Levopraid with caution if you are being treated with medicines called “psychotropic drugs” used to treat mental disorders. When you take a type of medicines called “neuroleptics”, including Levopraid, in conjunction with medicines that alter the heartbeat (prolong the QT), the risk of developing heart rhythm abnormalities (cardiac arrhythmias) increases;
• do not take Levopraid in conjunction with medicines that can affect the levels of minerals (electrolytes) in the blood, because the association with Levopraid should be avoided;

Levopraid with food, beverages and alcohol
DO NOT drink alcoholwhile taking this medicine.

Pregnancy and breastfeeding
Levopraid if you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this
medicine.
Pregnancy
If you are pregnant, the medicine will only be administered in cases of recognized and
actual indication, under the direct control of the doctor
The following symptoms have been observed in newborns born to mothers who have taken conventional or atypical antipsychotics, including Levopraid, during the last trimester (last three months of pregnancy):
tremor, stiffness and/or muscle weakness, drowsiness, agitation, breathing problems, and difficulty
in feeding. Contact your doctor if your baby shows any of these
symptoms.
Breastfeeding
If you are breastfeeding, the medicine will only be administered in cases of recognized and
actual indication, under the direct control of the doctor.

Driving and using machines
DO NOT drive vehicles, DO NOT use machinery and DO NOT participate in activities that require particular
attention while taking this medicine.
This medicine can cause a sensation of numbness, dizziness and cause you to make
involuntary movements. These effects can impair your ability to drive vehicles or use machinery.

Levopraid 100 mg tabletscontains lactose:if your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.

Levopraid 50 mg/2 ml injectable solution for intramuscular and intravenous use containsless
than 1 mmol (23 mg) of sodium per dose, i.e. it is practically ‘sodium-free’.

3. How to take Levopraid

Take this medicine following exactly the instructions of your doctor. If you have any doubts, consult your
doctor or pharmacist.
You must always follow the precise dose prescribed by your doctor.

Adults(as prescribed by your doctor)

Acute forms:
The recommended dose is:

• Vials: half a vial or 1 vial 1 - 2 times a day. The vial may be injected either directly into a vein (intravenous route) or into a muscle (intramuscular route) by authorized healthcare personnel; or
• Tablets: 2 - 3 tablets of 100 mg per day.

Maintenance therapy:
The recommended dose is:

• Tablets: 3 tablets of 50 mg per day, or as prescribed by your doctor. The doctor may decide to gradually reduce the dose.

Use in the elderly
If you are elderly, your doctor will prescribe the most appropriate dose for you.

If you take more Levopraid than you should
If you take a dose of Levopraid higher than the prescribed one immediately inform your doctoror go
to the nearest hospital. Taking an excessive dose may cause tremors, difficulty and slowness in
movements (extrapyramidal disorders) or sleep disturbances. The doctor will decide whether to review your dose or
to interrupt the therapy.

If you forget to take Levopraid
Do not take a double dose to make up for a missed dose.

If you stop taking Levopraid
If you have any doubts about the use of 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 of the same class
and/or with prolonged administrations:

Very common(may affect more than 1 in 10 people):

• drowsiness, temporary loss of sensitivity and promptness of reflexes (torpor)

Common (may affect up to 1 in 10 people):

• dizziness, vertigo (feeling a false sense of movement)

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

• heartbeat changes (prolongation of the QT interval, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation), cardiac arrest.

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

• weight gain
• "parkinsonism" (symptoms similar to those present in Parkinson's disease such as, e.g., tremor, difficulty and slowing of movements, rigidity and postural instability); involuntary muscle movements (dyskinesias); tremor; repetitive twisting movements or abnormal fixed positions (dystonia); psychomotor agitation (restlessness and purposeless involuntary movements);
• disorders of the autonomic nervous system (e.g. sweating, pallor, feeling of fainting, especially when getting up from a lying or sitting position, lowering of blood pressure, slowing of the heartbeat).
• cases of sudden death.

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

• "Neuroleptic Malignant Syndrome" (see paragraph “ Special care is required withLEVOPRAID”).
• absence of menstruation in women of childbearing potential (amenorrhea);
• development of breast tissue in men (gynecomastia); feeling of tension in the breasts,
• spontaneous leakage of milk from the breasts not associated with childbirth or breastfeeding (galactorrhea);
• changes in sexual desire (libido);
• formation of blood clots (venous thrombosis), especially in the legs (symptoms include swelling, pain, redness of the leg), which can reach the lungs and cause chest pain and difficulty breathing.
• neonatal withdrawal symptoms (see section 2 “Pregnancy and breastfeeding”), extrapyramidal movement disorders, increased levels of a hormone called prolactin in the blood (hyperprolactinemia).

Levopraid is not indicated for the treatment of dementia. In elderly patients with dementia, a small
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 get any side effects, talk to your doctor or pharmacist. You can also report side effects directly
through the website: http:// www.agenziafarmaco.gov.it/content/come segnalare una sospetta reazione avversa .
By reporting side effects you can help provide more information on the safety
of this medicine.

5. How to store Levopraid

This medicine does not require any particular storage conditions.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the pack after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Levopraid contains
Levopraid 50 mg tablets

• The active ingredient is levosulpiride, one tablet contains 50 mg of levosulpiride.
• The other ingredients are carboxymethylamide, microcrystalline cellulose, magnesium stearate.

Levopraid 50 mg/2 ml injectable solution for intramuscular and intravenous use

• The active ingredient is levosulpiride, one 2 ml vial contains 50 mg of levosulpiride.
• The other ingredients are 2N sulfuric acid, water for injections, sodium chloride.

Levopraid 100 mg tablets

• The active ingredient is levosulpiride, one tablet contains 100 mg of levosulpiride.
• The other ingredients are sodium carboxymethylamide, microcrystalline cellulose, lactose, magnesium stearate.

Description of the appearance of Levopraid and contents of the pack
Levopraid 50 mg tabletsare presented in a pack containing 20 tablets in blisters.

Levopraid 50 mg/2 ml injectable solution for intramuscular and intravenous useis presented in
a pack containing 6 vials of 2 ml each.

Levopraid 100 mg tabletsare presented in a pack containing 20 tablets in blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Teofarma S.r.l.
Via F.lli Cervi, 8
27010 Valle Salimbene (PV)

Manufacturer
Tablets
Teofarma S.r.l.
Viale Certosa, 8/A - 27100 Pavia
Injectable solution
Doppel Farmaceutici S.r.l.
Via Volturno, 48 - 20089 Quinto dè Stampi - Rozzano (MI)