150 mg modified- release tablets 
bupropion hydrochloride

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

Bupropion Sandoz is used to treat 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 Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions and always follow their instructions.

What you need to know before you take Bupropion Sandoz

Do not take Bupropion Sandoz

  • 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 epilepsy or have had seizures in the past
  • if you have a brain tumor
  • if you have abruptly stopped using alcohol or taking other medicines that are known to be associated with the risk of abstinence, in particular
    • drugs that are sedative , that induce sleep or cause the muscles to relax, and have an active substance whose name ends in “-azepam”
    • or similar sedatives
  • if you have a severe, long-term liver disease characterized by degradation and thickening of liver tissue
  • if you have or have previously had eating disorders , e.g. bulimia or anorexia
  • if you are taking or have taken other antidepressants called monoamine oxidase inhibitors ( MAOIs )It must be at least 14 days after you stop taking certain monoamine oxidase inhibitors (called irreversible monoamine oxidase inhibitors ) before you start taking Bupropion Sandoz. For some other monoamine oxidase inhibitors (called reversible monoamine oxidase inhibitors ) a 24 hour delay may be sufficient. Consult a doctor.

Warnings and cautions

Talk to your doctor before taking Bupropion Sandoz if you

  • regularly drink a lot of alcohol see previous section: “Do not take Bupropion Sandoz” if you have abruptly discontinued alcohol abuse.
  • have diabetes and are being treated with insulin or tablets
  • has had a serious head injury
  • have extreme mood swings or mental problems.Before treatment, patients should be screened for the risk of diseases involving episodes of high mood or agitation.
  • have impaired renal function or mild to moderate hepatic impairment patients with hepatic or renal impairment should be monitored by a physician for any adverse reactions . Do not use Bupropion Sandoz if you have the severe liver damage listed in the sixth section under “Do not take Bupropion Sandoz”.
  • need to do a urine test tell your doctor that you are taking Bupropion Sandoz as it may affect some urine tests used to detect other drugs.

Bupropion Sandoz has been shown to cause seizures . The risk of this side effect is greater in people:

  • affected by a condition listed in the first three paragraphs of “Warnings and Precautions” in Section 2 or
  • taking any of the medicines listed in the second to twelfth paragraphs of ‘Other medicines and Bupropion Sandoz’ in section 2.

All patients should be examined for pre-existing risk factors. If you have a seizure during treatment, stop taking Bupropion Sandoz and contact your doctor.

If you start to feel worse and have thoughts of harming yourself

You who are depressed can sometimes have thoughts of harming yourself or committing suicide. These symptoms can get worse when you start using 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.

Children under 18 years

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

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

Other medicines and Bupropion Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following medicines may affect or be affected by Bupropion Sandoz, but the list is not exhaustive. Tell your doctor if you are taking any of these medicines so that your treatment can be changed if necessary:

  • certain medicines to treat depression or Parkinson’s disease called monoamine oxidase inhibitors ( MAOIs )See the last point under “ Do not take Bupropion Sandoz ” in section 2.
  • drugs to treat depression , e.g. amitriptyline, fluoxetine , paroxetine , dosulepin, desipramine, imipramine, citalopram
  • drugs for the treatment of mental illness, e.g. clozapine, risperidone , thioridazine, olanzapine
  • theophylline : a drug used to treat asthma and other lung diseases
  • tramadol : a drug used to treat pain
  • tranquilizerSee the fifth point under “ Do not take Bupropion Sandoz ” in section 2 if you intend to stop taking sedatives.
  • drugs to prevent and treat malaria, e.g. mefloquine, chloroquine
  • stimulant or other appetite and weight control drugs
  • Steroids are taken by mouth or given as an injection
  • drug against bacterial infections and has an active substance whose name ends in “-oxacin”
  • antihistamines you can cause sleepiness: used to treat allergy you, sleep disorders or colds, or to prevent and treat nausea and vomiting
  • drugs to treat diabetes
  • levodopa, mandating: medicines to treat Parkinson’s disease
  • orphenadrine : a drug used to treat painful muscle tension
  • carbamazepine, phenytoin, valproate: medicines to treat epilepsy and certain pain conditions
  • certain drugs to treat cancer, e.g. cyclophosphamide, ifosfamide
  • ticlopidine, clopidogrel: medicines to prevent blood clots
  • medicines to treat high blood pressure , heart disease or other diseases and have an active substance whose name ends in “-lol”, e.g. metoprolol
  • propafenone , flecainide: medicines to treat irregular heartbeat
  • nicotine patches : drugs for smoking cessation
  • ritonavir, efavirenz: medicines to treat HIV – infection
  • tamoxifen : a drug used to treat breast cancer cell your doctor if you are taking tamoxifen as you may need to switch to another treatment for depression.
  • digoxin, a heart medicine.Tell your doctor if you are taking digoxin as it may be necessary to adjust someone.

Bupropion Sandoz with alcohol

It is not recommended that you drink alcohol while taking Bupropion Sandoz. However, if you are currently drinking heavily, do not stop suddenly as it poses a risk of seizures.

Talk to your doctor about your drinking habits and alcohol withdrawal before taking Bupropion Sandoz.

Pregnancy and breastfeeding

Do not take Bupropion Sandoz if you are pregnant, think you may be pregnant or are planning to have a baby, unless your doctor tells you to. Some clinical trials have reported an increased risk of malformations, especially heart malformations, in children whose mothers have taken Bupropion Sandoz. It is not known if these are due to the use of Bupropion Sandoz.

The substances contained in Bupropion Sandoz may pass into breast milk. If you are breast-feeding, talk to your doctor or pharmacist before taking this medicine.

Driving and using machines

Do not drive or use any tools or machines if Bupropion Sandoz makes you dizzy or dizzy.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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 take Bupropion Sandoz

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is

One 150 mg tablet once a day.

Your doctor may increase your dose to 300 mg (two 150 mg tablets) once a day unless your depression improves after several weeks.

Patients with hepatic or renal impairment

The recommended dose is 1 tablet of Bupropion Sandoz 150 mg once daily if you have renal impairment or mild to moderate hepatic impairment.

Do not use Bupropion Sandoz if you have the severe liver damage listed in the sixth section under “Do not take Bupropion Sandoz” in section 2.

Method of use

Swallow the tablets whole, in the morning with a glass of water. The tablets can be taken with or without food.

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 through your body.


Do not chew, crush or split the tablets,as this may lead to overdose as the medicine will be released too quickly. This can lead to an increased risk of side effects , including seizures.

How long to take

Your doctor will decide how long you should take Bupropion Sandoz.

It may take a while before you start to feel better and get the full effect of the treatment, sometimes weeks or months. Your doctor may advise you to continue taking Bupropion Sandoz as you begin to feel better to prevent your depression from returning.

If you forget to take Bupropion Sandoz

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

If you stop taking Bupropion Sandoz

Do not stop taking Bupropion Sandoz 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

Approximately 1 in 1,000 people treated with Bupropion Sandoz are at risk of having a seizure. The risk of this is higher if you take too much, if you use certain medications 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. Symptoms include:

  • redness or rash such as hives, blisters, or itchy swelling. Some types of rash may require hospitalization, especially if you also have irritation in your mouth or eyes.
  • 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. T a is not 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, which may affect more than 1 user in 10:

  • difficulty sleeping. Be sure to take Bupropion Sandoz in the morning.
  • headache
  • dry mouth
  • nausea, vomiting.

Common side effect is that may affect up to 1 in 10 people:

  • fever, dizziness, itching, sweating, and rash (sometimes due to an allergic reaction)
  • shaking, trembling, weakness, fatigue, chest pain
  • anxiety or worry
  • abdominal pain or other stomach problems (constipation), taste changes, loss of appetite
  • high blood pressure sometimes severe, redness
  • tinnitus, visual disturbance.

Uncommon side effects that may affect up to 1 in 100 people:

  • depression (see also section 2 “Warnings and precautions” under “If you start to feel worse and have thoughts of harming yourself”)
  • confusion
  • difficulty concentrating
  • increased heart rate
  • weight loss.

Rare side effect is that may affect up to 1 in 1000 users:

  • seizures.

Very rare side effect is that may affect up to 1 in 10 000 users:

  • 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
  • severe skin rash that may affect the mouth or other parts of the body and which may be life-threatening
  • worsening of psoriasis (limited reddening thickening of the skin)
  • feeling of being out of reality (depersonalization); unreal sensory impressions (hallucinations); feel or believe things that are not true (delusions); severe suspicion ( paranoia )

Has been reported: occurs in an unknown number of users:

  • decreased sodium levels in the blood ( hyponatremia )

Other side effects are

Other side effects have been reported in a few users, but the frequency is unknown:

  • thoughts of self-harm or suicide while using Bupropion Sandoz or shortly after stopping treatment (see section 2 “What you need to know before you take Bupropion Sandoz”). If you have similar thoughts , contact a 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 ).

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 Sandoz

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 plastic container after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Store in the original package. Moisture sensitive. Sensitive to light.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is bupropion hydrochloride.One modified-release tablet contains 150 mg of bupropion hydrochloride.
  • The other ingredients are povidone, hydrochloric acid , sodium stearyl fumarate, ethylcellulose, hydroxypropyl cellulose, methacrylic acid-ethyl acrylate copolymer (1: 1) type A, colloidal anhydrous silica, macrogol 1500, triethyl citrate, hypromellose, macrogol 400, macrogol 8000.

What the medicine looks like and the contents of the pack

White to light yellow, round tablets, rounded on the top and bottom.

The tablets are smooth on both sides.

10, 30, 90 or 500 tablets in a white, opaque plastic jar. The jar contains two bags that must not be swallowed. One bag contains silica gel granules and activated carbon and the other contains silica gel granules and a substance that absorbs oxygen.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark

Manufacturer

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

or

Lek Pharmaceuticals dd, Verovškova Ulica 57 1526 Ljubljana, Slovenia

or

Lek Pharmaceuticals dd, Trimline 2D, 9220 Lendava. Slovenia

or

LEK SA, ul. Domaniewska 50 C, 02-672 Warsaw, Poland

or

SC Sandoz, SRL, Str. Livezeni no. 7A, RO-540472 Targu-Mures, Romania

Muhammad Nadeem

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