Bucidar

SE/H/2459/01-02/IA/004

Package leaflet: Information for the patient

Bucidar, 150 mg, modified-release tablets
Bucidar, 300 mg, modified-release tablets
Bupropioni hydrochloridum
Please read the entire leaflet carefully before taking this medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are similar.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents

1. What Bucidar is and what it is used for
2. Important information before taking Bucidar
3. How to take Bucidar
4. Possible side effects
5. How to store Bucidar
6. Contents of the pack and other information

1. What Bucidar is and what it is used for

Bucidar is a prescription medicine used to treat depression. It works on chemical substances in the brain called noradrenaline and dopamine.

2. Important information before using Bucidar

When not to use Bucidar

• if the patient is allergic to bupropion or any of the other ingredients of this medicine (listed in section 6),
• if the patient is taking any other medicines containing bupropion,
• if the patient has epilepsy or has experienced seizures,
• if the patient currently has or has previously had eating disorders (e.g. bulimia or anorexia nervosa),
• if the patient has a brain tumour,
• if the patient who abuses alcohol has recently stopped drinking alcohol or intends to do so,
• if the patient has severe liver disease,
• if the patient has recently stopped taking sedative medicines or intends to do so during treatment with Bucidar,
• if the patient is taking or has taken within the last two weeks antidepressant medicines called monoamine oxidase inhibitors (MAO inhibitors). If any of the above situations apply to the patient, contact the doctor immediately and do not take Bucidar.

Warnings and precautions
Before starting treatment with Bucidar, discuss this with your doctor or pharmacist.
Brugada syndrome
Before starting treatment with Bucidar, discuss this with your doctor if the patient has been diagnosed with Brugada syndrome (a rare, genetically determined condition affecting heart rhythm) or if there is a family history of cardiac arrest or sudden death.
Serious skin reactions
Serious skin reactions have been reported with the use of Bucidar, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient develops symptoms indicating serious skin reactions listed in section 4, treatment with Bucidar must be stopped immediately and medical advice must be sought without delay.
Children and adolescents
Bucidar is not recommended for use in children and adolescents under 18 years of age.
In children and adolescents under 18 years of age treated with antidepressant medicines, there is an increased risk of suicidal thoughts and behaviour.
Adults
Inform your doctor before starting treatment with Bucidar:

• if the patient regularly drinks large amounts of alcohol,
• if the patient has diabetes and is taking insulin or oral antidiabetic medicines,
• if the patient has previously had a serious head injury or head trauma. Bucidar may cause seizures in approximately 1 in 1000 patients. This adverse effect is more likely to occur in patients from the groups mentioned above. If seizures occur during treatment, stop taking Bucidar immediately. Do not take any more of this medicine and contact your doctor.
• If the patient has bipolar affective disorder (extreme mood swings), because Bucidar may trigger an episode of this condition.
• If the patient is taking other medicines used to treat depression, as concomitant use of these medicines with Bucidar may lead to serotonin syndrome, a potentially life-threatening condition (see "Bucidar with other medicines" in this section).
• If the patient has liver or kidney disease, as adverse reactions may be more likely to occur. If any of the above situations apply to the patient, contact your doctor again before starting treatment with Bucidar. The doctor may decide that treatment should be carried out under close supervision or recommend alternative treatment.

Suicidal thoughts and worsening of depression symptoms
Patients with depression may sometimes experience thoughts of self-harm or suicide. These behaviours may increase when the patient first starts taking antidepressant medicines, as it takes time for these medicines to take effect, usually about two weeks, but sometimes longer.
Such thoughts may be more common:

• If the patient has previously had suicidal thoughts or thoughts of self-harm.
• If the patient is a young adult. Clinical studies have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with antidepressant medicines. If at any time the patient experiences thoughts of self-harm or suicide, contact the doctor immediately or go to hospital.

It may be helpful to inform a relative or friend that the patient has depression and ask them to read this leaflet. The patient may ask them to inform him or her if they notice that the patient's depression worsens or if changes in behaviour become concerning.
Bucidar with other medicines
If the patient is currently taking or has taken within the last fourteen days other antidepressant medicines called monoamine oxidase inhibitors (MAO inhibitors), contact the doctor without taking Bucidar (see also "When not to use Bucidar" in section 2).
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including herbal remedies or vitamins, even those available without a prescription. The doctor may adjust the dose of Bucidar or recommend changing the dosage or discontinuing other medicines.
Some medicines must not be taken at the same time as Bucidar. Some of these may increase the risk of seizures or convulsions. Others may increase the risk of other adverse effects. Examples of such medicines are listed below, but this is not a complete list.
Seizures may occur more frequently than usual:

• if the patient is taking other antidepressants or medicines used to treat psychiatric disorders,
• if the patient is taking theophylline, a medicine for asthma or lung diseases,
• if the patient is taking tramadol, a strong painkiller,
• if the patient has recently taken or is currently taking sedative medicines or intends to stop taking them during treatment with Bucidar (see also "When not to use Bucidar" in section 2),
• if the patient is taking antimalarial medicines (such as mefloquine or chloroquine),
• if the patient is taking stimulant medicines or other medicines used to control body weight or appetite,
• if the patient is taking steroids (orally or by injection),
• if the patient is taking antibiotics called quinolones,
• if the patient is taking certain types of antihistamines that may cause drowsiness,
• if the patient is taking antidiabetic medicines. If any of the above situations apply to the patient, contact your doctor immediately before starting treatment with Bucidar. The doctor will assess the risks and benefits of using Bucidar.

The likelihood of other adverse effects may increase:

• if the patient is taking other antidepressants (such as: amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or medicines for other psychiatric disorders (such as: clozapine, risperidone, thioridazine or olanzapine). Bucidar may interact with medicines used to treat depression, and the patient may experience changes in mental state (e.g. agitation, hallucinations, stupor), and other symptoms such as: body temperature above 38°C, rapid heartbeat, unstable blood pressure, increased reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal disturbances (e.g. nausea, vomiting, diarrhoea),
• if the patient is taking medicines used to treat Parkinson's disease (levodopa, amantadine, orphenadrine),
• if the patient is taking medicines that affect the metabolism of Bucidar (carbamazepine, phenytoin, valproic acid),
• if the patient is taking certain medicines used to treat malignant tumours (such as: cyclophosphamide, ifosfamide),
• if the patient is taking ticlopidine or clopidogrel, mainly used to prevent stroke,
• if the patient is taking beta-blockers (such as metoprolol),
• if the patient is taking certain medicines for irregular heart rhythm (propafenone and flecainide),
• if the patient is using nicotine patches as an aid to stop smoking. If any of the above situations apply to the patient, contact your doctor immediately before starting treatment with Bucidar.

Bucidar may be less effective

• If the patient is taking ritonavir or efavirenz, medicines used to treat HIV infection. If this applies to the patient, inform the doctor. The doctor will assess the effectiveness of Bucidar in the patient. It may be necessary to increase the dose or change the treatment for depression. Do not increase the dose of Bucidar without the doctor's advice, as this may increase the risk of adverse effects, including seizures.

Bucidar may reduce the effectiveness of certain medicines

• If the patient is taking tamoxifen, used in the treatment of breast cancer. If this applies to the patient, inform the doctor. It may be necessary to change the treatment for depression.
• If the patient is taking digoxin for heart problems. If this applies to the patient, inform the doctor. The doctor may consider adjusting the dose of digoxin.

Using Bucidar with alcohol
Alcohol may affect the action of Bucidar, and taking them together may, although rarely, cause nervousness or changes in mental state. Some patients become more sensitive to alcohol while taking Bucidar. The doctor may advise abstaining from alcohol (beer, wine, spirits) or significantly reducing alcohol consumption during treatment with Bucidar.
If the patient currently drinks large amounts of alcohol, do not stop drinking suddenly, as this may trigger a seizure.
Talk to your doctor about drinking alcohol before starting treatment with Bucidar.
Effect on urine tests
Bucidar may affect laboratory test results for the presence of other substances in urine. If the patient undergoes such a test, he or she should inform the doctor or nurse that Bucidar is being taken.
Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to have a child, do not take Bucidar unless advised by a doctor. Consult a doctor or pharmacist before using this medicine during pregnancy. Some, but not all, studies suggest an increased risk of congenital malformations, particularly heart defects, in children whose mothers took Bucidar. It is not known whether this was caused by the medicine itself.
The ingredients of Bucidar may pass into human milk. Consult a doctor or pharmacist before using Bucidar.
Driving and operating machinery
If Bucidar causes dizziness or a feeling of emptiness in the head, do not drive or operate machinery.
Bucidar contains lactose
Bucidar contains lactose (a type of sugar). If the patient has previously been diagnosed with intolerance to certain sugars, contact the doctor before taking this medicine.

3. How to take Bucidar

This medicine should always be taken as directed by the physician or pharmacist. The treating physician will determine the dose individually for each patient. If in doubt, consult the physician or pharmacist.

Improvement in the patient's well-being may occur only after some time. The full effect of the medicine may not become apparent until several weeks or months have passed. Even when the patient begins to feel better, the treating physician may recommend continuing treatment with Bucidar to prevent recurrence of depression.

What doses should be taken

The usual recommended dose for adults is one 150 mg tablet once daily.
The treating physician may recommend increasing the dose to 300 mg once daily if there is no improvement after several weeks of treatment.

The dose of Bucidar should be taken in the morning. Do not take Bucidar more frequently than once daily.

The tablet is coated with a special film that slowly releases the medicine into the gastrointestinal tract. The patient may notice in the stool something that looks like a tablet. This is the empty shell that has been excreted from the body.

Bucidar tablets should be swallowed whole. Do not chew, crush, or divide them. If this occurs, there is a risk of overdose due to too rapid release of the medicine into the body. This may increase the risk of adverse effects, including seizures.

For some patients, a dose of 150 mg once daily may be sufficient throughout the entire treatment period.

The treating physician may recommend such dosing if the patient has liver or kidney disease.

How long to continue treatment

Only the physician together with the patient can decide how long treatment with Bucidar should continue. It may take weeks or even months before any improvement is observed. The patient should regularly discuss depressive symptoms with the treating physician to determine the appropriate duration of treatment. If the patient feels better, the treating physician may still recommend continuing Bucidar to prevent recurrence of depression.

Taking more than the recommended dose of Bucidar

Taking too many tablets may cause seizures or a seizure episode. Do not delay. Contact a physician or the nearest hospital emergency department immediately.

Missing a dose of Bucidar

If a dose is missed, wait and take the next dose at the usual time.
Do not take a double dose to make up for the missed dose.

Stopping treatment with Bucidar

Do not stop treatment with Bucidar or reduce the dose without first consulting the treating physician.

If there are any further doubts regarding the use of this medicine, consult the physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Serious adverse reactions
Seizures or epileptic seizures
Seizures (epileptic seizures or convulsions) may occur in approximately 1 in 1,000 patients taking Bucidar. The likelihood of seizures is higher in patients who take higher than recommended doses, are taking certain other medicines, or belong to a group at increased risk of seizures. If in doubt, contact your treating physician.
→ If a seizure occurs, contact your treating physician immediately.
Do not take the medicine again.
Allergic reactions
Some patients may experience allergic reactions after taking bupropion. These include:

• skin redness or rash (such as maculopapular rash) and itchy skin bumps (urticaria),
• unusual wheezing or difficulty breathing,
• swelling of the eyelids, lips, or tongue,
• muscle or joint pain,
• collapse or brief loss of consciousness. → If any symptoms of an allergic reaction occur, contact your doctor immediately. Do not take the medicine again. Allergic reactions may persist for a long time. If your doctor has prescribed medications to relieve allergic symptoms, complete the full course of treatment.

Severe skin adverse reactions
If any of the following symptoms occur, discontinue bupropion and seek immediate medical attention:

• Very rare: red, flat, target-like or circular spots on the trunk, often with central blisters, peeling of the epidermis, and ulcers in the mouth, throat, nose, genital organs, or eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
• Frequency not known: extensive blistering and widespread peeling of the skin, occurring in the severe form of the skin reaction described above (toxic epidermal necrolysis).
• Frequency not known: widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). Symptoms of DRESS syndrome are usually delayed (occurring 2–6 weeks after starting treatment).
• Frequency not known: red, scaly, widespread rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Lupus-like skin rash or worsening of lupus symptoms
Frequency not known – frequency cannot be determined based on available data from patients taking Bucidar. Lupus is an autoimmune disorder affecting the skin and other organs.
→ If lupus flare-ups, skin rash, or skin lesions occur (especially on skin areas exposed to sunlight) during treatment with Bucidar, contact your doctor immediately, as treatment discontinuation may be necessary.

Other adverse reactions
Very common adverse reactions (may affect more than 1 in 10 patients):

• difficulty sleeping (insomnia) (ensure Bucidar is taken in the morning),
• headache,
• dry mouth,
• nausea, vomiting.

Common adverse reactions (may affect up to 1 in 10 patients):

• fever, dizziness, itching, sweating, and skin rash (sometimes due to allergic reaction),
• chills, tremors, weakness, fatigue, chest pain,
• feelings of anxiety or agitation,
• abdominal pain or other gastrointestinal disturbances (constipation), altered taste perception, loss of appetite (anorexia),
• increased blood pressure (sometimes significant), facial flushing,
• ringing in the ears, visual disturbances.

Uncommon adverse reactions (may affect up to 1 in 100 patients):

• feelings of depression (see also section 2 “Important information before taking Bucidar” under “Suicidal thoughts and worsening of depression symptoms”),
• feelings of disorientation,
• difficulty concentrating,
• increased heart rate,
• weight loss.

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

• seizures.

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

• palpitations, fainting,
• muscle twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination,
• restlessness, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss,
• yellowing of the skin or whites of the eyes (jaundice), which may be due to increased liver enzyme activity or hepatitis,
• severe allergic reactions; rash accompanied by muscle and joint pain,
• changes in blood sugar levels,
• urinating more or less frequently than usual,
• urinary incontinence (involuntary urination, uncontrolled leakage of urine),
• worsening of psoriasis (red, thickened skin patches),
• feelings of unreality or detachment (depersonalization), seeing or hearing things that are not real (hallucinations), experiencing or believing in unreal things (delusions), excessive suspiciousness (paranoia).

Frequency not known
Other adverse reactions have occurred in a small number of patients, but their exact frequency is unknown:

• thoughts of self-harm or suicide during treatment with bupropion or shortly after its discontinuation (see section 2 “Important information before taking Bucidar”). If such thoughts occur, contact your doctor or go to the hospital immediately.
• loss of touch with reality and impaired thinking or judgment (psychosis); other symptoms may include hallucinations and/or delusions,
• stuttering,
• reduced number of red blood cells (anemia), reduced number of white blood cells (leukopenia), and reduced number of platelets (thrombocytopenia),
• low sodium levels in the blood (hyponatremia),
• changes in mental status (e.g., agitation, hallucinations, coma), and other symptoms such as: body temperature above 38°C, rapid heartbeat, unstable blood pressure, increased reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal disturbances (e.g., nausea, vomiting, diarrhea) when bupropion is taken together with medicines used to treat depression (such as: paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Bucidar

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Store in the original packaging to protect from moisture and light.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Bucidar contains
The active substance is bupropion hydrochloride. Each tablet contains either 150 or 300 mg of bupropion hydrochloride.
Other ingredients are:
Tablet core: hydroxypropyl cellulose, glyceryl dibehenate, stearic acid
Tablet coating: hypromellose, ethyl cellulose, povidone K90, lactose monohydrate, triethyl citrate,
methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%, polyethylene glycol 6000 and colloidal anhydrous silica
Printing ink: shellac, iron oxide black (E 172), propylene glycol

What Bucidar looks like and contents of the pack
Bucidar 150 mg: White to pale yellow, round, film-coated tablets, approximately 7.7 mm in diameter, printed with the code "T" in black ink on one side and plain on the other.
Bucidar 300 mg: White to pale yellow, round, film-coated tablets, approximately 9.6 mm in diameter, printed with the code "T1" in black ink on one side and plain on the other.

Bucidar is available in:
White, opaque plastic bottles. The bottle contains at least one desiccant container with activated silica gel and activated carbon. DO NOT EAT the desiccant container or its contents! The bottle is closed with a child-resistant plastic cap containing a sealing liner.
150 mg: 30, 60, 90 tablets.
300 mg: 30, 60, 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego 16 Street
00-710 Warsaw
Phone: +48 22 642 07 75

Manufacturer/Importer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87,
2132 JH Hoofddorp
The Netherlands

Terapia SA
124 Fabricii Street,
400640, Cluj-Napoca,
Romania

This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:
Spain: Bupropión SUN 150 mg, 300 mg comprimidos de liberación modificada EFG
The Netherlands: Bupropion HCl SUN 150 mg, 300 mg tabletten met gereguleerde afgifte
Germany: BUPROPION BASICS 150 mg, 300 mg Tabletten mit veränderter Wirkstofffreisetzung
Romania: AXABAL 150 mg, 300 mg comprimate cu eliberare modificată
Sweden: Bupropion SUN 150 mg, 300 mg Tablett med modifierad frisättning
Italy: Bupropione SUN