Levosulpiride Eg
Italy
Table of Contents
Package leaflet: information for the patient
Levosulpiride EG 25 mg/ml oral drops, solution
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 other people, 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, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
-
What Levosulpiride EG is and what it is used for
-
What you need to know before taking Levosulpiride EG
-
How to take Levosulpiride EG
-
Possible side effects
-
How to store Levosulpiride EG
-
Contents of the pack and other information
1. What Levosulpiride EG is and what it is used for
Levosulpiride EG contains the active substance levosulpiride, which belongs to a group of medicines called "neuroleptics, antipsychotics, benzamides". It acts as a prokinetic agent, stimulating gastric and intestinal motility, and as an antiemetic, reducing nausea and vomiting.
Levosulpiride EG is used in adults for the short-term treatment of:
- disorders related to slow and difficult digestion (dyspeptic syndrome), such as loss of appetite, excessive intestinal gas (meteorism), feeling of fullness in the upper abdomen, headache after meals, heartburn, belching, diarrhoea, constipation due to concomitant diseases (diabetic gastroparesis, tumours, etc.) and/or functional factors (digestive disorders of psychosomatic origin in anxious-depressive subjects) in patients who have not responded to other therapies;
- vomiting and nausea induced by antineoplastic drugs following failure of first-line medications;
- vertigo, tinnitus, hearing loss and nausea associated with Ménière's syndrome, a rare disease affecting the inner ear.
2. What you need to know before taking Levosulpiride EG
Do not take Levosulpiride EG
- if you are allergic to levosulpiride or to any of the other ingredients of this medicine (listed in section 6);
- if you have a tumour of the adrenal gland called phaeochromocytoma;
- if you suffer from seizures (epilepsy);
- if you have psychiatric disorders (manic states, manic phases of manic-depressive psychosis);
- if you have malignant mastopathy (breast cancer);
- 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 Levosulpiride EG.
Avoid taking Levosulpiride EG if you have bleeding due to stomach or intestinal lesions (gastrointestinal haemorrhage), mechanical obstructions, or perforations.
Avoid taking Levosulpiride EG concurrently with other psychotropic medicines (neuroleptics).
If you are being treated with medicines used for psychiatric disorders (neuroleptics), Neuroleptic Malignant Syndrome may occur (see "Other medicines and Levosulpiride EG"), a condition that can be life-threatening. Symptoms of this syndrome include: high fever, muscle rigidity, movement difficulties, irregular pulse and blood pressure, sweating, increased heart rate, changes in heart rhythm, and alterations in consciousness which may progress to confusion and coma. If you experience any of these symptoms, stop treatment immediately and contact your doctor, who will initiate symptomatic treatment and monitor you closely.
Levosulpiride EG is not indicated for the treatment of dementia. It has been observed that in some elderly patients with dementia, the use of certain antipsychotics increases the risk of cerebrovascular disorders and death.
Exercise special caution with Levosulpiride EG:
- If you have risk factors for stroke.
- If you suffer from heart and/or circulatory disorders (cardiovascular diseases) or have a family history of irregular heartbeat (QT prolongation).
- 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 Levosulpiride EG.
- If you or someone in your family has or has had a history of blood clots (thrombi), as Levosulpiride EG may cause blood clot formation.
Other medicines and Levosulpiride EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Exercise particular caution and inform your doctor if you are taking the following medicines:
- medicines acting on the central nervous system used to treat psychiatric disorders, particularly neuroleptics, as combination with levosulpiride requires caution.
- medicines that affect heart rhythm (prolong QT interval), as the risk of developing abnormal heart rhythms (cardiac arrhythmias) increases.
- medicines that cause imbalances in substances in the body known as "electrolytes".
Levosulpiride EG and alcohol
Do not consume alcohol during treatment with Levosulpiride EG.
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 taking this medicine.
Pregnancy
Do not use Levosulpiride EG if you are pregnant or think you might be.
If you take conventional or atypical antipsychotics, including Levosulpiride EG, during the last three months of pregnancy, your newborn 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 Levosulpiride EG during breastfeeding.
Driving and using machines
The use of Levosulpiride EG may affect your ability to drive vehicles or operate machinery.
Indeed, with high doses of levosulpiride, drowsiness, lethargy, and involuntary movements (dyskinesias) may occur. Therefore, if you experience these symptoms, do not drive or operate machinery.
Levosulpiride EG contains parahydroxybenzoates and sodium:
This medicine contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions (including delayed reactions).
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially sodium-free.
3. How to take Levosulpiride EG
Take this medicine exactly as directed 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 doses are:
Adults
The recommended dose is 15 drops three times daily before meals (one drop contains 1.6 mg of
levosulpiride).
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.
Instructions for use:
- To open the bottle: press on the cap and unscrew it simultaneously (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. 1 Fig. 2 Fig. 3
If you take more Levosulpiride EG than you should
In case of accidental ingestion/overdose of Levosulpiride EG, contact your doctor immediately or go to the nearest hospital.
An overdose may cause movement disorders and sleep disturbances, which resolve upon discontinuation of treatment or dose reduction.
If you forget to take Levosulpiride EG
Do not take a double dose to make up for the missed dose.
If you stop using Levosulpiride EG
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.
During prolonged treatment with this medicine, certain side effects may occur, typical of medicines
that act similarly to levosulpiride, such as increased prolactin levels in the blood (hyperprolactinaemia).
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 heartbeat (prolongation of QT interval, ventricular arrhythmias such as torsade 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 present in Parkinson's disease such as, e.g., tremor, difficulty and slowness of movement, rigidity and postural instability),
movement disorders (dyskinesias), tremor, movement disturbances (dystonia), neuroleptic malignant syndrome (see section “Warnings and precautions”). -
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), spontaneous milk discharge from the breasts not associated with childbirth or breastfeeding (galactorrhoea), changes in sexual desire (libido).
- 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.
- neonatal withdrawal symptoms (see section 2, “Pregnancy and breastfeeding”), movement disorders (extrapyramidal symptoms).
Reporting of side effects
If you experience any side effects, 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 Levosulpiride EG
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after “Exp”.
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 no longer required. This will help protect the environment.
6. Package contents and other information
What Levosulpiride EG contains
- The active substance is levosulpiride. 100 ml of solution contain 2.5 g of levosulpiride.
- The other components are: anhydrous citric acid, sodium saccharin, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, lemon flavour, purified water.
Description of the appearance of Levosulpiride EG and package contents
Levosulpiride EG 25 mg/ml oral drops, solution is supplied in a pack containing a glass bottle with dropper, closed with a child-resistant cap (child-proof), containing 20 ml of a clear, colourless solution with a characteristic lemon odour.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Epifarma S.r.l.
Via San Rocco, 6
85033 Episcopia (PZ)
Manufacturers
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)
Patient Information Leaflet
Levosulpiride EG 25 mg tablets
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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Levosulpiride EG is and what it is used for
- What you need to know before taking Levosulpiride EG
- How to take Levosulpiride EG
- Possible side effects
- How to store Levosulpiride EG
- Contents of the pack and other information
1. What Levosulpiride EG is and what it is used for
Levosulpiride EG contains the active substance levosulpiride, which belongs to a group of medicines called "neuroleptics, antipsychotics, benzamides". It acts as a prokinetic agent, stimulating gastric and intestinal motility, and as an antiemetic, reducing nausea and vomiting.
Levosulpiride EG is used in adults for the short-term treatment of:
- disorders related to slow and difficult digestion (dyspeptic syndrome), such as loss of appetite, excessive intestinal gas (meteorism), feeling of fullness in the upper abdomen, headache after meals, heartburn, belching, diarrhoea, constipation due to concomitant diseases (diabetic gastroparesis, tumours, etc.) and/or functional factors (digestive disorders of psychosomatic origin in anxious-depressive subjects) in patients who have not responded to other therapies;
- vomiting and nausea induced by antineoplastic drugs following failure of first-line medications;
- vertigo, tinnitus, hearing loss and nausea associated with Ménière's syndrome, a rare disease affecting the inner ear.
2. What you need to know before taking Levosulpiride EG
Do not take Levosulpiride EG
- if you are allergic to levosulpiride or to any of the other ingredients of this medicine (listed in section 6);
- if you have a tumor of the adrenal gland called phaeochromocytoma;
- if you suffer from seizures (epilepsy);
- if you have psychiatric disorders (manic states, manic phases of manic-depressive psychosis);
- if you have malignant mastopathy (breast cancer);
- 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 Levosulpiride EG.
Avoid taking Levosulpiride EG if you have gastrointestinal bleeding due to stomach or intestinal lesions (gastrointestinal hemorrhage), mechanical obstructions, or perforations.
Avoid taking Levosulpiride EG concomitantly with other psychotropic drugs (neuroleptics). If you are being treated with medicines used for psychiatric disorders (neuroleptics), you may develop Neuroleptic Malignant Syndrome (see "Other medicines and Levosulpiride EG"), a condition that can be life-threatening. Symptoms of this syndrome include: high fever, muscle rigidity, movement difficulties, irregular pulse and blood pressure, sweating, increased heart rate, heart rhythm disturbances, and changes in consciousness that may progress to confusion and coma. If you experience any of these symptoms, stop treatment immediately and contact your doctor, who will initiate symptomatic treatment and monitor you closely.
Levosulpiride EG is not indicated for the treatment of dementia. It has been observed that in some elderly patients with dementia, the use of certain antipsychotics increases the risk of cerebrovascular disorders and death.
Exercise particular caution with Levosulpiride EG:
- If you have risk factors for stroke.
- If you suffer from heart and/or circulatory disorders (cardiovascular diseases) or have a family history of heart rhythm abnormalities (QT prolongation).
- 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 these may reduce the effects of Levosulpiride EG.
- If you or someone in your family has or has had a history of blood clots (thrombi), as Levosulpiride EG may cause blood clot formation.
Other medicines and Levosulpiride EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay particular attention and inform your doctor if you are taking the following medicines:
- medicines acting on the central nervous system used to treat psychiatric disorders, particularly neuroleptics, as combination with levosulpiride requires caution.
- medicines that affect heart rhythm (prolong the QT interval), as the risk of developing heart rhythm abnormalities (cardiac arrhythmias) increases.
- medicines that cause changes in substances in the body known as "electrolytes".
Levosulpiride EG and alcohol
Do not consume alcohol during treatment with Levosulpiride EG.
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 taking this medicine.
Pregnancy
Do not use Levosulpiride EG if you are pregnant or think you might be pregnant.
If you take conventional or atypical antipsychotics, including Levosulpiride EG, during the last 3 months of pregnancy, your baby may develop 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 Levosulpiride EG while breastfeeding.
Driving and using machines
The use of Levosulpiride EG may affect your ability to drive or operate machinery.
Indeed, at high doses of levosulpiride, drowsiness, lethargy, and involuntary movements (dyskinesias) may occur. Therefore, if you experience these symptoms, do not drive or operate machinery.
Levosulpiride EG contains lactose and sodium:
This medicine contains lactose: If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially sodium-free.
3. How to take Levosulpiride EG
Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
You must always follow the exact dose prescribed by your doctor. The recommended doses are:
Adults
The recommended dose is 1 tablet three times daily before meals.
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 EG than you should
In case of accidental ingestion/overdose of Levosulpiride EG, inform your doctor immediately or go to the nearest hospital.
An overdose may cause movement disorders and sleep disturbances, which resolve upon discontinuation of therapy or reduction of the dose.
If you forget to take Levosulpiride EG
Do not take a double dose to make up for the missed dose.
If you stop taking Levosulpiride EG
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 will experience them.
During prolonged treatment with this medicine, certain side effects may occur, typical of medicines acting similarly to levosulpiride, such as increased prolactin levels in the blood (hyperprolactinaemia).
The following side effects have also been observed with other medicines of 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, 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, for example, tremor, difficulty and slowness of movement, rigidity and postural instability), movement disorders (dyskinesias), tremor, movement disturbances (dystonia), neuroleptic malignant syndrome (see section “Warnings and precautions”).
- 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), spontaneous milk discharge from the breasts unrelated to childbirth or breastfeeding (galactorrhoea), changes in sexual desire (libido).
- formation of blood clots (venous thrombosis), particularly 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).
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.
Reporting side effects can help provide more information on the safety of this medicine.
5. How to store Levosulpiride EG
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.
This medicine requires no special storage conditions.
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 Levosulpiride EG contains
- The active substance is levosulpiride. Each tablet contains 25 mg of levosulpiride.
- The other ingredients are microcrystalline cellulose, lactose monohydrate, magnesium stearate, sodium starch glycolate.
Description of the appearance of Levosulpiride EG and contents of the pack
Levosulpiride EG 25 mg is presented as white or almost white, round tablets,
in a pack containing 20 tablets in blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Epifarma S.r.l.
Via San Rocco, 6
85033 Episcopia (PZ)
Manufacturers
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)