DOBREN 50 mg Film-Coated Tablets

Зміст інструкції

1. Dobren 50 mg tablets, 100 mg tablets, 200 mg tablets
   1. What is Dobren and what is it used for
   2. What you need to know before you take Dobren
   3. How to take DOBREN
   4. Possible side effects
   5. How to store Dobren
   6. Contents of the pack and other information

Dobren 50 mg tablets, 100 mg tablets, 200 mg tablets

sulpiride
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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Dobren and what is it used for

Dobren contains the active ingredient sulpiride and belongs to a group of medicines called antipsychotics,
Dobren is used to treat

• psychiatric illnesses (chronic and acute psychoses)
• a mood disorder of an anxious-depressive type (anxiety and depression with psychosomatic disorders) called “Distimia”.

2. What you need to know before you take Dobren

DO NOT take Dobren

• if you are allergic to sulpiride, or to any of the other ingredients of this medicine (listed in section 6);
• if you have a tumor of the adrenal gland called pheochromocytoma;
• if you have a tumor of a gland in the brain called the pituitary gland, associated with an increase in the secretion of a hormone called prolactin (prolactinoma);
• if you have breast cancer;
• if you are pregnant or if you are breastfeeding (see Pregnancy and breastfeeding);
• if the patient is a child or an adolescent
• if you are using a medicine for Parkinson's disease such as levodopa or ropinirole (see Other medicines)
• if you have a disease called "acute porphyria".

Warnings and precautions
Talk to your doctor or pharmacist before taking Dobren.
Go to your doctor immediately if you have:

• muscle rigidity, loss or reduction of movements (akinesia),
• irregularities in blood pressure, sweating, fast or irregular heartbeat,
• changes in state of consciousness that may progress to stupor and coma, as these may be symptoms of a serious syndrome called Neuroleptic Malignant Syndrome, which can lead to death.

Take special care with Dobren:

• if you have a severe kidney disease. In this case, your doctor will reduce the dose or tell you to take the medicine intermittently;
• if you suffer from manic states or if you are in the manic phase (of excitement) of manic-depressive psychosis. In this case, your doctor may also prescribe a tranquilizer (sedative);
• if you suffer from aggressive or agitated behavior with impulsivity. In this case, your doctor may also prescribe a tranquilizer (sedative);
• if you have Parkinson's disease;
• if you have epilepsy;
• if you have high blood pressure or have heart failure;
• if you or someone in your family has or has had heart disease (ventricular arrhythmia, such as torsade de pointes), blood vessel disease, or disturbances in the electrical activity of the heart (prolongation of the QT interval on the electrocardiogram); in this case, your doctor will check the factors that could favor the manifestation of these heart rhythm disturbances;
• if you or someone in your family has or has had thrombosis (blood clots in blood vessels), because this medicine can cause the formation of thrombi;
• if you are at risk of stroke;
• if you suffer from diabetes mellitus or have risk factors for diabetes. In this case, your doctor will check your blood sugar levels (glycemic monitoring);
• if you have leukopenia, neutropenia and agranulocytosis, as unexplained infections or fever may indicate a blood disease called "blood dyscrasia" (see "Possible side effects");
• if you suffer from a blood disease called "severe neutropenia" (absolute neutrophil count <1000/mmc). In this case, your doctor will stop the treatment with Dobren and keep you under control until the normal values of some tests are restored (white blood cell count);
• if you have suffered from high pressure in the eye (glaucoma), alterations in the stomach and intestines (ileus, congenital digestive stenosis), urinary retention and enlargement (hyperplasia) of the prostate;
• if you are an elderly patient with mental illnesses such as dementia-related psychosis because it may increase the risk of death. The causes of death in patients taking antipsychotics appear to be due to heart and blood circulation disorders (cardiovascular in nature; for example, heart failure, sudden death) or infections (e.g., pneumonia). In addition, you have a greater risk of having a sudden drop in blood pressure when suddenly moving from a sitting or lying position to an upright position (postural hypotension), excessive drowsiness (sedation), tremors, rigidity, increased salivation, movement disorders (extrapyramidal symptoms). Dobren is not authorized for the treatment of behavioral disorders related to dementia;
• if you or someone in your family has had breast cancer. In this case, your doctor will monitor you carefully during therapy with Dobren as Dobren can increase the levels of a hormone called "prolactin".

Children and adolescents
Dobren is contraindicated in children and adolescents.

Other medicines and Dobren
Contraindicated combinations

• medicines for Parkinson's disease such as levodopa or ropinirole.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines and in particular:

• medicines that can cause alterations in the electrical activity of the heart (prolongation of the QT interval) because it increases the risk of heart rhythm disturbances;
• medicines that cause changes in the levels of salts and fluids in the body. In this case, the simultaneous intake with Dobren should be avoided;

The sulpiride contained in Dobren increases the action of the following medicines:

• medicines to lower blood pressure (hypotensives, anti-hypertensives);
• medicines that depress the central nervous system such as tranquilizers, hypnotics, anesthetics, analgesics;
• other psychotropic drugs. Your doctor will monitor you carefully to avoid unexpected side effects due to the interaction.

Dobren with alcohol
Alcohol increases the sedative effect of medicines of the same class as Dobren (neuroleptics).
Avoid the simultaneous intake of alcoholic beverages and medicines containing alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant or are breastfeeding,
ask your doctor or pharmacist for advice before using this medicine.

Pregnancy
Do not use Dobren if you are pregnant, think you may be pregnant or are of childbearing potential and are not using effective contraception.
Dobren is contraindicated throughout the period of pregnancy (see What you need to know before you take
Dobren).
Babies born to mothers who have taken Dobren during the last 3 months of pregnancy have shown
agitation, alteration of muscle tone, withdrawal symptoms (which present with restlessness and insomnia), tremor,
drowsiness, breathing problems and sucking problems

Breastfeeding
Dobren is excreted in breast milk.
If you are breastfeeding, DOBREN should not be used (see What you need to know before
you take DOBREN). If you are prescribed DOBREN, breastfeeding should be stopped.

Driving and using machines
Dobren can cause drowsiness, dizziness and movement disorders (dyskinesias) therefore you should avoid
driving vehicles and using machinery.

Dobren 100 mg tablets contains lactose
Dobren 100 mg contains lactose: if your doctor has diagnosed you with an intolerance to some sugars, contact
them before taking this medicine.

3. How to take DOBREN

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Dobren 50 mg tablets
In the therapy of psychoneuroses, the recommended dose is 3-6 tablets per day.

Dobren 100 mg tablets
In the maintenance therapy of psychoses, the recommended dose is 3 tablets per day.

Dobren 200 mg tablets
In the acute phase of psychoses, the recommended dose is 2-3 tablets per day.
Your doctor will indicate the optimal dose based on your response to treatment. Do not exceed the dose of 1 g per
day.

Use in elderly patients
If you are an elderly patient, your doctor may prescribe a reduced dose. Do not exceed the dose of 300 mg per
day.

If you take more DOBREN than you should
In case of accidental ingestion of an excessive dose of Dobren, inform your doctor immediately or
go to the nearest hospital.
In case of ingestion of an excessive dose of Dobren, movement and sleep disturbances may occur. If you experience these symptoms, your doctor will assess whether to discontinue treatment or reduce the dose
of Dobren.

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

If you stop taking DOBREN
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Dobren can cause side effects, although not everybody gets them.

• 1)Neurological: sedation or drowsiness, sleep disturbances. Early dyskinesias (spasmodic torticollis, oculogyric crises, trismus) reversible with the administration of antiparkinson-anticholinergic drugs. Extrapyramidal syndrome partially reversible with antiparkinson-anticholinergic drugs. Tardive dyskinesias that may be observed, as with all neuroleptics, in cases of very prolonged treatments; antiparkinson-anticholinergic drugs either do not modify or may worsen such symptoms.
• 2)Endocrine and metabolic: impotence, frigidity. Amenorrhea, galactorrhea, gynecomastia, hyperprolactinemia. Cases of weight gain following prolonged treatments.
• 3)Cardiac: Cases of QT prolongation, ventricular arrhythmias such as torsade de pointes, ventricular tachycardia, ventricular fibrillation, and cardiac arrest have been observed with Dobren or other drugs of the same class. Very rare cases of sudden death.
• 4)Various: allergic reactions. Rarely neurovegetative manifestations (dry mouth, nausea, sialorrhea), alteration of some blood cells (leukopenia, see “Warnings and precautions”).

Venous blood clots, especially in the legs (symptoms are swelling, pain and redness of the legs)
can reach the lungs through the blood vessels and cause chest pain and difficulty breathing.
If you notice any of these symptoms, consult a doctor immediately.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at http://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 Dobren

This medicine does not require any particular storage conditions.
Keep this medicine out of the 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 dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dobren contains
Dobren 50 mg tablets

• The active ingredient is sulpiride. Each tablet contains 50 mg of sulpiride.
• The other ingredients are carboxymethylamide, microcrystalline cellulose, dimethylaminoethyl methacrylate, magnesium stearate, povidone.

Dobren 100 mg tablets

• The active ingredient is sulpiride. Each tablet contains 100 mg of sulpiride.
• The other ingredients are carboxymethylamide, microcrystalline cellulose, dimethylaminoethyl methacrylate, lactose, magnesium stearate, povidone.

Dobren 200 mg tablets

• The active ingredient is sulpiride. Each tablet contains 200 mg of sulpiride.
• The other ingredients are: carboxymethylamide, microcrystalline cellulose, dimethylaminoethyl methacrylate, magnesium stearate, povidone.

Description of the appearance of Dobren and contents of the pack
Dobren 50 mg tablets
Each pack contains 30 tablets for oral use of 50 mg

Dobren 100 mg tablets
Each pack contains 24 tablets for oral use of 100 mg

Dobren 200 mg tablets
Each pack contains 20 tablets for oral use of 200 mg.

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

Manufacturer
TEOFARMA S.r.l.
Viale Certosa, 8/A
27100 Pavia