Bupropion Teva: detailed information

Package leaflet: Information for the patient

Bupropione Teva 150 mg modified-release tablets

bupropion hydrochloride
Generic medicine
Please read this entire 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, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Bupropione Teva is and what it is used for
What you need to know before taking Bupropione Teva
How to take Bupropione Teva
Possible side effects
How to store Bupropione Teva
Contents of the pack and other information

1. What Bupropione Teva is and what it is used for

Bupropione Teva is a medicine prescribed by a doctor to treat depression. It is thought to
interact with certain chemical substances in the brain called noradrenaline and dopamine.

2. What you should know before taking Bupropione Teva

Do not take Bupropione Teva

If you are allergic to bupropione or to any of the other ingredients of this medicine (listed in section 6)
If you are currently taking any other medicine containing bupropione
If you have been diagnosed with epilepsy or have had seizures in the past
If you have, or have had, an eating disorder (for example, bulimia or anorexia nervosa)
If you have a brain tumour
If you are a heavy drinker who has recently stopped or is about to stop drinking
If you have severe liver problems
If you have recently stopped taking sedatives, or if you are about to discontinue them while taking Bupropione Teva
If you are taking or have taken other medicines for depression called monoamine oxidase inhibitors (MAOIs) within the last 14 days. If any of the above apply to you, speak to your doctor immediately, without taking Bupropione Teva.

Warnings and precautions
Talk to your doctor or pharmacist before taking Bupropione Teva.
Children and adolescents
Bupropione Teva is not recommended for the treatment of patients under 18 years of age.
There is an increased risk of suicidal thoughts and behaviours in patients under 18 years of age treated with antidepressants.
Adults
Before you take Bupropione Teva, your doctor needs to know

If you regularly drink large amounts of alcohol
If you have diabetes for which you use insulin or tablets
If you have had a serious head injury or past head trauma Bupropione Teva has been shown to cause seizures in about 1 person in 1,000. This side effect is more likely to occur in the individuals described above. If you have a seizure during treatment, you must stop taking Bupropione Teva. Stop taking it immediately and contact your doctor.
If you have bipolar disorder (extreme mood swings), as Bupropione Teva could trigger an episode of this condition
If you have a condition called Brugada syndrome (a rare inherited condition affecting heart rhythm) or if there have been cases of cardiac arrest or sudden death in your family
If you are taking other medicines for depression, using these medicines together with Bupropione Teva may lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Bupropione Teva” in this section)
If you have liver or kidney problems, you are more likely to experience side effects. If any of the above apply to you, discuss them again with your doctor before taking Bupropione Teva. Your doctor may wish to monitor your treatment closely or recommend an alternative therapy.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes have thoughts about harming yourself or taking your life. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines may take some time to work—usually about two weeks, but sometimes longer.
You may be more likely to experience such thoughts:

if you have previously thought about harming yourself or suicide;
if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders who were treated with an antidepressant. If at any time you experience thoughts of self-harm or suicide, contact your doctor or go immediately to a hospital.

You may find it helpful to tell a relative or friend that you suffer from depression and ask them to read this leaflet. You may ask them to let you know if they think your depression is getting worse, or if they are concerned about changes in your behaviour.
Serious skin reactions
Serious skin reactions such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with Bupropione Teva. Stop taking Bupropione Teva and contact your doctor immediately if you notice any symptoms related to these serious skin reactions, described in section 4.
Other medicines and Bupropione Teva
If you are taking or have taken other antidepressants called monoamine oxidase inhibitors (MAOIs) within the last 14 days, inform your doctor without taking Bupropione Teva (see also “Do not take Bupropione Teva” in section 2).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, herbal products or vitamins, even those not requiring a prescription. Your doctor may need to adjust your dose of Bupropione Teva or advise changes to your other medicines.
Some medicines should not be taken together with Bupropione Teva. Some may increase the risk of seizures or convulsions. Other medicines may increase the risk of other side effects. Some examples are listed below, but the list is not complete.
There may be a higher than usual risk of seizures

If you are taking other medicines for depression or other mental illnesses
If you are taking theophylline for asthma or lung disease
If you are taking tramadol, a strong painkiller
If you have taken sedatives, or if you are about to discontinue them while taking Bupropione Teva (see also “Do not take Bupropione Teva” in section 2)
If you are taking medicines for malaria (such as mefloquine or chloroquine)
If you are taking stimulants or other medicines to control weight or appetite
If you are taking steroids (by mouth or injection)
If you are taking antibiotics called quinolones
If you are taking certain types of antihistamines that may cause drowsiness
If you are taking medicines for diabetes. If any of the above apply to you, speak to your doctor immediately before taking Bupropione Teva. Your doctor will assess the benefits and risks of taking Bupropione Teva.

There may be a higher than usual risk of other side effects

If you are taking other medicines for depression (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or for other mental illnesses (such as clozapine, risperidone, thioridazine or olanzapine). Bupropione Teva can interact with some medicines used to treat depression, and you may experience changes in your mental state (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, increased reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
If you are taking medicines for Parkinson’s disease (levodopa, amantadine or orphenadrine)
If you are taking medicines that affect your body’s ability to eliminate bupropione (carbamazepine, phenytoin, valproate)
If you are taking certain medicines used to treat cancer (such as cyclophosphamide, ifosfamide)
If you are taking ticlopidine or clopidogrel, mainly used to prevent stroke
If you are taking certain beta-blockers (such as metoprolol)
If you are taking certain medicines for irregular heart rhythm (propafenone or flecainide)
If you are using nicotine patches to help you stop smoking. If any of the above apply to you, speak to your doctor immediately before taking Bupropione Teva.

Bupropione Teva may be less effective

If you are taking ritonavir or efavirenz, medicines used to treat HIV infection. If this applies to you, talk to your doctor. Your doctor will monitor how Bupropione Teva works for you. It may be necessary to increase the dose or switch to another treatment for depression. Do not increase the dose of Bupropione Teva without medical advice, as this may increase the risk of side effects, including seizures.

Bupropione Teva may make other medicines less effective

If you are taking tamoxifen, used to treat breast cancer. If this applies to you, talk to your doctor. It may be necessary to switch to another treatment for depression.
If you are taking digoxin for heart problems. If this applies to you, talk to your doctor. Your doctor may consider adjusting the dose of digoxin.

Bupropione Teva and alcohol
Alcohol may alter the effect of Bupropione Teva and, when taken together with the medicine, may rarely affect the nervous system and mental state. Some people notice they are more sensitive to alcohol when taking Bupropione Teva. Your doctor may advise you not to drink alcohol (beer, wine or spirits) while taking Bupropione Teva, or to drink only minimal amounts. However, if you currently drink heavily, do not stop suddenly: this could put you at risk of seizures.
Talk to your doctor about alcohol consumption before starting Bupropione Teva.
Effects on urine tests
Bupropione Teva may interfere with certain urine tests used to detect other drugs. If you need to have a urine test, inform your doctor or hospital that you are taking Bupropione Teva.
Pregnancy and breastfeeding
Do not take Bupropione Teva if you are pregnant, think you may be pregnant, or are planning a pregnancy, unless your doctor recommends it. Ask your doctor or pharmacist for advice before using this medicine. Some, but not all, studies have reported an increased risk of birth defects, particularly heart defects, in children whose mothers took Bupropione Teva. It is not known whether these are due to the use of Bupropione Teva.
The components of Bupropione Teva may pass into breast milk.
Driving and using machines
If Bupropione Teva causes you dizziness or a feeling of being lightheaded, do not drive or operate any tools or machinery.

3. How to take Bupropione Teva

Always take this medicine exactly as instructed by your doctor or pharmacist.
These are the usual doses, but your doctor will advise you on the best dosage for you. If you have any doubts,
consult your doctor or pharmacist.
It may take some time before you start to feel better. It takes time for the medicine to have full effect, sometimes weeks or months. When you start to
feel better, your doctor may advise you to continue taking Bupropione Teva to
prevent depression from returning.
How much to take
The usual recommended dose is one 150 mg tablet per day, for adults only.
Your doctor may increase your dose to 300 mg per day if depression does not improve after several
weeks.
Take your dose of Bupropione Teva tablets in the morning. Do not take Bupropione Teva more than
once a day.
The tablet has a coating that slowly releases the medicine into the body. You may notice something in your stool that looks like a tablet. This is the empty coating being eliminated from the body.
Swallow the tablets whole. Do not chew, crush, or divide them – doing so may cause an overdose, as the medicine would be released into your body too quickly. This increases the likelihood of side effects, including seizures.
Some people continue taking one 150 mg tablet per day throughout treatment. Your doctor may have prescribed this dosage if you have liver or kidney problems.
How long to take it
Only you and your doctor can decide how long to take Bupropione Teva. Several weeks or months of treatment may be needed before improvement is seen. Regularly discuss your symptoms with your doctor to determine how long you should continue treatment. When you start to feel better, your doctor may advise you to continue taking Bupropione Teva to prevent depression from returning.
If you take more Bupropione Teva than you should
If you take too many tablets, your risk of seizures or convulsions may increase. Do not delay. Contact your doctor immediately or go to the nearest hospital emergency department.
If you forget to take Bupropione Teva
If you miss a dose, wait and take the next tablet at your usual time.
Do not take a double dose to make up for a forgotten tablet.
If you stop taking Bupropione Teva
Do not stop taking Bupropione Teva or reduce the dose without first talking to your doctor.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects
Inform your doctor immediately if you experience any of the following serious side effects.

Severe skin reactions Stop taking bupropion and contact your doctor immediately if you notice any of the following symptoms:
o Very rare: Flat red spots, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome).
o Frequency not known: Blisters and skin peeling over large areas of skin occur in a severe form of serious skin reaction (toxic epidermal necrolysis).
o Frequency not known: Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). The onset of this syndrome is usually delayed (2–6 weeks after starting treatment).
o Frequency not known: Extensive, red, scaly rash with pustules under the skin and blisters, accompanied by fever. Symptoms usually appear early in treatment (acute generalized exanthematous pustulosis).
Seizures or convulsions
Approximately 1 in 1,000 people taking Bupropione Teva is at risk of seizures (convulsive attacks or epileptic seizures). The likelihood increases if you take too high a dose, take certain other medicines, or have a higher-than-usual risk of seizures. If you are concerned, speak to your doctor. ➔ If you have a seizure, inform your doctor as soon as you feel better. Do not take any more tablets.
Allergic reactions
Some people may experience allergic reactions to Bupropione Teva. These include:
o Reddened skin or rash (similar to hives) and itchy blisters (urticaria) on the skin.
o Unusual wheezing or difficulty breathing.
o Swelling of the eyelids, lips, or tongue.
o Muscle or joint pain.
o Collapse or loss of consciousness.
➔ If you experience any sign of an allergic reaction, contact a doctor immediately. Do not take any more tablets.
Allergic reactions can last a long time. If your doctor prescribes medication to relieve allergy symptoms, make sure you complete the full course of treatment.
Drug-induced lupus rash or worsening of lupus symptoms
Frequency not known (frequency cannot be determined from available data). Lupus is an immune system disorder affecting the skin and other organs. ➔ If you experience lupus flare-ups, skin rashes or lesions (especially on sun-exposed areas) while taking Bupropione Teva, contact your doctor immediately, as treatment may need to be discontinued.

Other side effects
Very common (may affect more than 1 in 10 people)

Difficulty sleeping. Make sure you take Bupropione Teva in the morning.
Headache.
Dry mouth.
Nausea, vomiting.

Common (may affect up to 1 in 10 people)

Fever, dizziness, itching, sweating, and rash (sometimes due to an allergic reaction).
Shaking, tremors, weakness, fatigue, chest pain.
Feelings of anxiety or agitation.
Stomach ache or other gastrointestinal disturbances (constipation), changes in taste, loss of appetite (anorexia).
Increase in blood pressure, sometimes severe, and hot flushes (sudden reddening of the face).
Ringing in the ears, vision disturbances.

Uncommon (may affect up to 1 in 100 people)

Feeling depressed (see also Section 2 “Warnings and precautions”, under “Suicidal thoughts and worsening depression”).
Feeling confused.
Difficulty concentrating.
Increased heart rate.
Weight loss.

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

Seizures.

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

Palpitations, fainting.
Swelling of blood vessels, drop in blood pressure upon standing, causing dizziness, mental confusion, or fainting.
Muscle contractions, muscle stiffness, uncontrolled movements, problems walking or with coordination.
Feelings of restlessness, irritability, hostility, aggression, strange dreams, tingling or numbness, memory loss.
Yellowing of the skin or whites of the eyes ( jaundice ), which may be caused by increased liver enzymes or hepatitis.
Severe allergic reactions; rash associated with muscle and joint pain.
Changes in blood sugar levels.
Urinating more or less than usual.
Urinary incontinence (involuntary urination, urine leakage).
Worsening of psoriasis (thickened, red skin patches).
Unusual hair loss or thinning (alopecia).
Feelings of unreality or detachment ( depersonalization ); seeing or hearing things that are not there ( hallucinations ); having beliefs or thoughts about things that are not real ( delusions ); severe suspiciousness ( paranoia ).

Not known (frequency cannot be determined from available data)

Thoughts of self-harm or suicide while taking Bupropione Teva or immediately after stopping treatment (see Section 2, “What you need to know before taking Bupropione Teva”). If you have these thoughts, contact your doctor or go directly to hospital.
Loss of touch with reality and inability to think or judge clearly ( psychosis ); other symptoms may include hallucinations and/or delusions.
Sudden, intense feeling of fear (panic attack).
Stuttering.
Decreased number of red blood cells (anaemia), decreased number of white blood cells (leucopenia), and decreased number of platelets (thrombocytopenia).
Decreased sodium levels in the blood (hyponatraemia).
Changes in mental state (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, increased reflexes, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea), while taking Bupropione Teva together with medicines used to treat depression (such as paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine).

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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Bupropione Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Do not use this medicine more than three months after first opening.
The intact medicine does not require any special storage temperature.
Store in the original bottle to protect the medicine from moisture and light.
After first opening: do not store at temperatures above 25 °C.
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 Bupropione Teva contains

The active substance is bupropione hydrochloride. Each tablet contains 150 mg of bupropione hydrochloride.
The other components are:
Tablet core: hypromellose (E463) (contains silicon dioxide), silicified microcrystalline cellulose, stearic acid, magnesium stearate, purified water
Tablet coating: ethylcellulose (E462), hypromellose, titanium dioxide (E171), triethyl citrate (E1505), methacrylic acid - ethyl acrylate copolymer, talc (E553b)

Description of the appearance of Bupropione Teva and contents of the pack
Cream-white to pale yellow, round, biconvex tablets, approximately 8.1 mm in diameter.
Bupropione Teva is available in bottles with child-resistant closure containing 7, 30 or 90 tablets.
The bottle has a built-in desiccant in the cap to keep the tablets dry.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
Balkanpharma - Dupnitsa AD
3, Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria