150 mg modified- release tablet 
bupropion hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Bupropion Teva is and what it is used for 
2. What you need to know before you use Bupropion Teva 
3. How to use Bupropion Teva 
4. Possible side effects 
5. How to store Bupropion Teva 
6. Contents of the pack and other information 

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

Bupropion Teva 150 mg modified- release tablet contains 150 mg bupropion and belongs to the pharmacotherapeutic group: Other antidepressants.

Bupropion Teva is a medicine prescribed by your doctor to treat your depression. It is thought to have an effect on chemical substances in the brain called norepinephrine and dopamine, which are linked to depression.

Bupropion contained in Bupropion Teva may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

2. What you need to know before you use Bupropion Teva

Do not take Bupropion Teva

  • if you are allergic to bupropion or any of the other ingredients of this medicine (listed in section 6)
  • if you are taking any other medicine that contains bupropion
  • if you have been diagnosed with epilepsy or have had a seizure before
  • if you have or have had an eating disorder (eg bulimia or anorexia )
  • if you have a brain tumor
  • if you have an alcohol addiction that you have recently stopped or plan to stop
  • if you have severe liver disease
  • if you have recently stopped taking sedatives or should stop taking them while taking Bupropion Teva
  • if you have taken or have been taking antidepressants called monoamine oxidase inhibitors ( MAOIs ) in the last 14 days.

If any of the above apply to you, talk to your doctor immediately without taking Bupropion Teva.

Warnings and cautions

Talk to your doctor or pharmacist before taking Bupropion Teva.

Children and young people

Bupropion Teva is not recommended for the treatment of children under 18 years of age.

There is an increased risk of suicidal ideation and behavior when children under the age of 18 are treated with antidepressants.

Adults

Before you start taking Bupropion Teva, your doctor needs to know:

  • if you regularly drink a lot of alcohol
  • if you have diabetes and are being treated with insulin or tablets
  • if you have or have had a serious head injury.

Bupropion hydrochloride has been shown to cause seizures in approximately 1 in 1,000 people. The risk of this side effect is greater in people in the above groups. If you have a seizure during treatment, stop taking Bupropion Teva and contact your doctor.

  • if you have bipolar disorder (extreme mood swings), Bupropion Teva may cause an episode of the disease.
  • if you have liver or kidney disease, the risk of having side effects is increased.

If any of the above apply to you, talk to your doctor again before you start taking Bupropion Teva. Your doctor may need to pay extra attention to your treatment or recommend another treatment.

Suicidal thoughts and worsening of your depression

You who are depressed can sometimes have thoughts of harming yourself or committing suicide. These symptoms can worsen when you start taking antidepressants because it takes time for drugs of this type to take effect, usually about 2 weeks, sometimes longer.

These thoughts may be common:

  • If you have previously had thoughts of harming yourself or committing suicide.
  • If you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.

Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.

It can be helpful to tell a relative or close friend that you are depressed. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.

Other medicines and Bupropion Teva

If you are taking or have taken other antidepressant medicines called monoamine oxidase inhibitors ( MAOIs ) in the last 14 days, tell your doctor before taking Bupropion Teva (see also “Do not take Bupropion Teva” in section 2).

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, herbal remedies or vitamins or other over-the-counter products. Your doctor may change your dose of Bupropion Teva or suggest a change in your other medicines.

Some medicines do not work with Bupropion Teva. Some of them may increase the risk of seizures while others may increase the risk of other side effects. Below are some examples of this, but it is not a complete list.

The risk of seizures is increased:

  • 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 powerful painkiller
  • if you are taking sedatives, or if you should stop taking them while you are taking Bupropion Teva (see also “Do not take Bupropion Teva” in section 2)
  • if you are taking medicines for malaria (such as mefloquine or chloroquine)
  • if you are taking stimulants or other appetite and weight control drugs
  • whether you are taking steroids, in tablet form or as an injection
  • if you take the antibiotic that belongs to the quinolone you
  • if you are taking certain antihistamines that may cause drowsiness
  • if you are taking medicines for diabetes.

If any of these apply to you, talk to your doctor immediately before taking Bupropion Teva. Your doctor will assess the benefits against the risks for you to take Bupropion Teva.

The risk of other side effects is increased:

  • if you are taking other medicines for depression (eg amitriptyline, fluoxetine, paroxetine, dosulepin, desipramine, or imipramine) or for other mental illnesses (such as clozapine, risperidone, thioridazine, or olanzapine)
  • if you are taking medicines for Parkinson’s disease ( levodopa, amantadine, or orphenadrine)
  • if you are taking medicines that affect the body’s breakdown of Bupropion Teva (carbamazepine, phenytoin, or valproate )
  • if you are taking medicines used to treat cancer (such as cyclophosphamide, ifosfamide)
  • if you are taking ticlopidine or clopidogrel which is mainly used to prevent stroke
  • if you are taking certain beta-blockers (such as metoprolol )
  • if you are taking medicines for irregular heartbeat ( propafenone or flecainide )
  • if you are taking nicotine patches for smoking cessation.

If any of these apply to you, talk to your doctor immediately before using Bupropion Teva.

Bupropion Teva may have less effect:

  • if you take ritonavir or efavirenz, medicines to treat HIV – infection.

If this applies to you, tell your doctor. Your doctor will check how good Bupropion Teva is for you. It may be necessary to increase your dose or switch to another treatment for your depression. Do not increase your dose of Bupropion Teva without asking your doctor as it may lead to an increased risk of side effects, including seizures.

Bupropion Teva may reduce the effect of other medicines:

  • if you are using tamoxifen for the treatment of breast cancer.

If this applies to you, talk to a doctor. It may be necessary to switch to another treatment for your depression.

  • if you use digoxin for the heart.

If this applies to you, talk to a doctor. Your doctor may consider changing your dose of digoxin.

Bupropion Teva with alcohol

Alcohol can affect how Bupropion Teva works in the body and concomitant use can in rare cases affect your nerves or your mental health. Some people experience increased sensitivity to alcohol when taking Bupropion Teva. Your doctor may advise you not to drink alcohol (beer, wine, or spirits) or try to drink very sparingly while using Bupropion Teva. However, if you currently have a high alcohol consumption, do not abruptly stop drinking, as you may have a seizure.

Talk to your doctor about your drinking habits before using Bupropion Teva.

Effects on urine tests

Bupropion Teva may affect some urine tests used to detect other drugs. If you need to have a urine test tell your doctor or hospital that you are taking Bupropion Teva.

Pregnancy and breastfeeding

Do not take Bupropion Teva if you are pregnant, think you may be pregnant, or are planning to have a baby unless your doctor tells you to. Ask your doctor or pharmacist for advice before taking this medicine. Some, but not all, studies have reported an increased risk of birth defects, especially heart defects, in children whose mothers took bupropion hydrochloride. It is not known if these are due to the use of bupropion hydrochloride.

The ingredients in Bupropion Teva can pass into breast milk. You should consult your doctor or pharmacist before taking Bupropion Teva.

Driving and using machines

If Bupropion Teva makes you dizzy or dizzy, do not drive or use any tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Bupropion Teva

Always take this medicine exactly as your doctor or pharmacist has told you. What is stated below are normal dosages while the doctor’s prescription is personal to you. Ask your doctor or pharmacist if you are unsure. 

It may take some time before you feel better. It takes time, sometimes weeks or months, before the drug reaches full effect. When you start to feel better, your doctor may advise you to continue taking Bupropion Teva to prevent the recurrence of depression.

How much medicine to take

The usual recommended dose is one 150 mg tablet per day.

Your doctor may increase your dose to 300 mg per day if your depression does not improve after several weeks.

Take your dose of Bupropion Teva in the morning. Do not take Bupropion Teva more than once a day.

The tablet is covered with a shell that slowly releases the drug inside your body. You may notice something in your stool that looks like a tablet. This is the empty shell that has passed your body.

Swallow your tablets whole. The tablets should not be chewed, crushed, or divided – if you do, there is a risk of overdose as the drug gets into your body too quickly. This can lead to an increased risk of side effects, including seizures.

Some people keep the dosage at 150 mg per day throughout the treatment period. Your doctor may have prescribed this dosage if you have liver or kidney problems.

How long to take the medicine

Only you and your doctor can decide how long to take Bupropion Teva. It may take weeks or months of treatment before you notice any improvement. Discuss your symptoms regularly with your doctor to determine how long you should take the medicine. As you begin to feel better, your doctor may advise you to continue using Bupropion Teva to prevent the recurrence of depression.

If you forget to take Bupropion Teva

If you miss a dose, wait until the next dose and take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop using Bupropion Teva

Do not stop taking Bupropion Teva or reduce the dose without first talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Seizures

About 1 in 1,000 people treated with bupropion hydrochloride are at risk of having a seizure. The risk of this is higher if you take too much, if you take certain medicines or if you have a greater tendency for seizures than normal. Discuss with your doctor if this worries you.

If you have a seizure, tell your doctor when you have recovered. Do not take more tablets.

Allergic reactions

Some people may have allergic reactions to Bupropion Teva. Symptoms include:

  • redness or rash such as hives, blisters, or itchy swelling. Some types of rash may require hospitalization, especially if you also have mouth or eye irritation.
  • abnormal breathing with wheezing or wheezing or difficulty breathing
  • swelling of the eyelids, lips or tongue
  • muscle or joint pain
  • collapse or temporary unconsciousness (blackout).

If you have any signs of an allergic reaction, contact a doctor immediately. Do not take more tablets. Allergic reactions can last for a long time. If your doctor has prescribed any remedy for your allergic symptoms, be sure to complete the entire course.

Other side effects are

Very common (may affect more than 1 in 10 people):

  • difficulty sleeping. Be sure to take Bupropion 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, tremor, weakness, fatigue, chest pain
  • anxiety or worry
  • abdominal pain or another stomach upset (constipation), taste changes, loss of appetite ( anorexia )
  • high blood pressure, sometimes severe, redness
  • tinnitus, visual disturbance.

Uncommon (may affect up to 1 in 100 people)

  • depression (see also section 2 “Take special care with Bupropion Teva” under “Suicidal thoughts and worsening of your depression”)
  • confusion
  • 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):

  • palpitation er (palpitations), fainting
  • twitching, muscle stiffness, uncontrolled muscle movements, gait problems or coordination
  • restlessness, irritability, hostility, aggression, strange dreams, numbness or tingling, memory loss
  • yellowing of the skin or whites of the eyes that may be due to elevated liver enzyme levels, hepatitis
  • severe allergic reactions; skin rash along with joint and muscle pain
  • blood sugar disorders
  • urination more often or less frequently than normal
  • urinary incontinence (involuntary emptying of the bladder, urine leakage)
  • severe rash in the mouth or on other parts of the body that can be life-threatening
  • worsening of psoriasis (limited, reddening thickening of the skin)
  • the feeling of being out of reality (depersonalization), unreal sensory impressions (hallucinations), feeling or believing things that are not true (delusions), severe suspicion ( paranoia ).

Other side effects are

Other side effects have been reported in a few people but their exact frequency is unknown:

  • thoughts of self-harm or suicide while using bupropion hydrochloride or shortly after stopping treatment (see section 2. “What you need to know before you take Bupropion Teva”). If you have such thoughts, contact your doctor or go to a hospital immediately.
  • lost contact with reality and inability to think clearly or make clear judgments ( psychosis ); Other symptoms may include hallucinations and/or delusions
  • decreased number of red blood cells ( anemia ), decreased number of white blood cells ( leukopenia ), and decreased number of platelets ( thrombocytopenia )
  • decreased sodium levels in the blood ( hyponatremia ).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Bupropion Teva

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 carton and blister after EXP.

The expiration date is the last day of the specified month.

Use within 3 months after first opening.

Unopened jar: No special temperature instructions. Store in the original package. Moisture sensitive. Sensitive to light.

After first opening: Do not store above 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Can

The jar has an integrated desiccant in the lid to keep the tablets dry.

6. Contents of the packaging and other information

Content declaration

The active substance is bupropion hydrochloride. One tablet contains 150 mg of bupropion hydrochloride.

Other ingredients are:

Tablet core: hydroxypropyl cellulose (E463) (contains silicon dioxide), silicon modified microcrystalline cellulose, stearic acid, magnesium stearate, purified water.

Tablet coating: ethylcellulose (E462), hydroxypropylcellulose, titanium dioxide (E171), triethyl citrate (E1505), methacrylic acid-ethyl acrylate copolymer, talc (E553b).

What the medicine looks like and the contents of the pack

Bupropion Teva 150 mg is a creamy white to pale yellow round, biconvex tablet with a diameter of about 8.1 mm

Bupropion Teva is available in jars with a child-resistant closure containing 7, 30, or 90 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Teva BV

Swensweg 5

2031 GA Haarlem

Netherlands

Manufacturer

Teva BV

Swensweg 5

2031 GA Haarlem

Netherlands

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

Muhammad Nadeem

Leave a Reply