Dobren

Package leaflet: Information for the patient

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

sulpiride
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 other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, 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 taking 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 Dobren is and what it is used for

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

• psychiatric disorders (chronic and acute psychoses)
• an anxious-depressive mood disorder (anxiety and depression with psychosomatic symptoms) known as "Dysthymia".

2. What you should know before taking 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 tumour of the adrenal gland called phaeochromocytoma;
• if you have a tumour of a gland in the brain called the pituitary, associated with increased secretion of a hormone called prolactin (prolactinoma);
• if you have a tumour of the breast;
• if you are pregnant or breastfeeding (see Pregnancy and breastfeeding);
• if the patient is a child or adolescent;
• if you are taking 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.
Seek immediate medical attention if you experience:

• muscle rigidity, absence or reduction of movement (akinesia),
• irregular blood pressure, sweating, rapid or irregular heartbeat,
• changes in consciousness that may progress to stupor and coma, as these may be symptoms of a serious condition called Neuroleptic Malignant Syndrome, which can be fatal.

Use particular caution with Dobren:

• if you have severe kidney disease. In this case, your doctor will reduce your dose or advise you to take the medicine intermittently;
• if you suffer from manic states or are in the manic (excited) phase of manic-depressive psychosis. In this case, your doctor may also prescribe a tranquilizer (sedative);
• if you suffer from aggressive behaviour or agitation 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 heart failure;
• if you or someone in your family has or has had heart diseases (ventricular arrhythmia, such as torsades de pointes), blood vessel disorders, or disturbances in the heart's electrical activity (prolongation of the QT interval on electrocardiogram); in such cases, your doctor will monitor factors that could promote these heart rhythm disturbances;
• if you or someone in your family has or has had thrombosis (blood clots in blood vessels), because this medicine may cause blood clots to form;
• if you are at risk of stroke;
• if you have diabetes mellitus or risk factors for diabetes. In this case, your doctor will monitor your blood sugar levels (glycaemic monitoring);
• if you have leukopenia, neutropenia, or agranulocytosis, as unexplained infections or fever may indicate a blood disorder called "haematological dyscrasia" (see "Possible side effects");
• if you have a blood disorder called "severe neutropenia" (absolute neutrophil count <1000/mm³). In this case, your doctor will discontinue treatment with Dobren and monitor you until normal values are restored in certain tests (white blood cell count);
• if you have previously suffered from high pressure in the eye (glaucoma), stomach or intestinal disorders (ileus, congenital digestive stenosis), urinary retention, or enlargement of the prostate (prostatic hyperplasia);
• if you are an elderly patient with mental disorders such as dementia-related psychosis, as this may increase the risk of death. Causes of death in patients taking antipsychotics appear to be due to heart and circulation problems (cardiovascular nature; e.g. heart failure, sudden death) or infections (e.g. pneumonia). Furthermore, you have an increased risk of sudden drop in blood pressure upon rapidly standing up from a sitting or lying position (postural hypotension), excessive drowsiness (sedation), tremors, rigidity, increased salivation, and movement disorders (extrapyramidal symptoms). Dobren is not authorized for the treatment of behavioural disorders related to dementia;
• if you or someone in your family has had breast cancer. In this case, your doctor will monitor you closely during treatment with Dobren, as Dobren may increase levels of a hormone called "prolactin".

Children and adolescents
Dobren is contraindicated in children and adolescents.
Other medicines and Dobren
Combinations contraindicated

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

Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other
medicine, and especially:

• medicines that can cause disturbances in the heart's electrical activity (prolongation of the QT interval), as this increases the risk of heart rhythm disturbances;
• medicines that alter the levels of salts and fluids in the body. In such cases, concomitant use with Dobren should be avoided.

Sulpiride contained in Dobren increases the effect of the following medicines:

• medicines to lower blood pressure (hypotensives, antihypertensives);
• medicines that depress the central nervous system, such as tranquilizers, hypnotics, anaesthetics, and analgesics;
• other psychotropic medicines. Your doctor will monitor you closely to avoid unexpected adverse effects due to interactions.

Dobren and alcohol
Alcohol increases the sedative effect of medicines of the same class as Dobren (neuroleptics).
Avoid consuming alcoholic beverages and medicines containing alcohol simultaneously.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not use Dobren if you are pregnant, think you may be pregnant, or are of childbearing age and not using effective contraception.
Dobren is contraindicated throughout pregnancy (see What you should know before taking Dobren).
Newborns whose mothers took Dobren during the last three months of pregnancy have shown symptoms such as agitation, muscle tone disturbances, withdrawal symptoms (manifested by restlessness and insomnia), tremor, drowsiness, breathing difficulties, and sucking problems.
Breastfeeding
Dobren is excreted in breast milk.
Dobren must not be used during breastfeeding (see What you should know before taking Dobren). If Dobren is prescribed to you, breastfeeding must be discontinued.
Driving and using machines
Dobren may cause drowsiness, dizziness, and movement disorders (dyskinesias); therefore, you should avoid driving vehicles or operating machinery.
Dobren 100 mg tablets contain lactose
Dobren 100 mg contains lactose: if your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take DOBREN

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Dobren 50 mg tablets
In the treatment 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 determine the optimal dose based on your response to treatment. Do not exceed 1 g per
day.
Use in elderly patients
If you are an elderly patient, your doctor may prescribe a reduced dose. Do not exceed 300 mg per
day.
If you take more Dobren than you should
If you accidentally take an excessive dose of Dobren, inform your doctor immediately or go to the nearest
hospital.
An overdose of Dobren may cause disturbances in movement and sleep. If you experience these symptoms,
your doctor will assess whether treatment should be discontinued or the dose of Dobren reduced.
If you forget to take Dobren
Do not take a double dose to make up for a forgotten dose.
If you stop taking Dobren
If you have any doubts about using this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, Dobren can cause side effects, although not everybody will experience them.
1) Neurological: sedation or drowsiness, sleep disturbances. Early dyskinesias (spasmodic torticollis, oculogyric crisis, trismus) which may resolve with administration of antiparkinsonian-anticholinergic drugs. Extrapyramidal syndrome, partially reversible with antiparkinsonian-anticholinergic drugs. Late dyskinesias, which may occur, as with all neuroleptics, after prolonged treatment; antiparkinsonian-anticholinergic drugs either do not modify or may worsen these symptoms.
2) Endocrine and metabolic: impotence, frigidity. Amenorrhea, galactorrhea, gynecomastia, hyperprolactinemia. Cases of weight gain following prolonged treatment.
3) Cardiac: Rare cases of QT prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, ventricular fibrillation, and cardiac arrest have been observed with Dobren or other drugs in the same class. Very rare cases of sudden death have also been reported.
4) Miscellaneous: allergic reactions. Rarely, autonomic nervous system manifestations (dry mouth, nausea, salivation), changes in certain blood cells (leukopenia, see “Warnings and precautions”). Venous thrombosis, especially in the legs (symptoms include swelling, pain, and redness of the legs), which may travel through blood vessels to the lungs and cause chest pain and breathing difficulties.
If you notice any of these symptoms, consult your doctor immediately.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly via 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 special storage conditions.
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 packaging after "Exp." The expiry date refers to the last day of that month.
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 Dobren contains
Dobren 50 mg tablets

• The active substance is sulpiride. Each tablet contains 50 mg of sulpiride.
• The other components are carboxymethyl starch, microcrystalline cellulose, dimethylaminoethyl methacrylate, magnesium stearate, povidone.

Dobren 100 mg tablets

• The active substance is sulpiride. Each tablet contains 100 mg of sulpiride.
• The other components are carboxymethyl starch, microcrystalline cellulose, dimethylaminoethyl methacrylate, lactose, magnesium stearate, povidone.

Dobren 200 mg tablets

• The active substance is sulpiride. Each tablet contains 200 mg of sulpiride.
• The other components are: carboxymethyl starch, 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 oral tablets of 50 mg
Dobren 100 mg tablets
Each pack contains 24 oral tablets of 100 mg
Dobren 200 mg tablets
Each pack contains 20 oral tablets of 200 mg.

Marketing Authorization 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