150 mg, 300 mg modified- release tablets 
bupropion hydrochloride

What Bupropion Orion is and what it is used for

Bupropion Orion 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 Orion 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.

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

Do not use Bupropion Orion

  • 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 a brain tumor
  • if you have an alcohol addiction that you have recently stopped or plan to stop
  • if you have recently stopped using sedatives (especially benzodiazepines or similar medicines) or should stop taking them while you are taking Bupropion Orion
  • if you have a severe liver disease, such as liver cirrhosis
  • if you have or have had an eating disorder (eg bulimia or anorexia )
  • if you are being treated with or have been treated with medicines for depression or Parkinson’s disease called monoamine oxidase inhibitors ( MAOIs ) for the last 14 days. The time limit may be shorter for certain types of MAO inhibitors , your doctor may advise you.

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

Warnings and cautions

Talk to your doctor before using Bupropion Orion.

Cramps

What your doctor needs to know before using Bupropion Orion:

  • if you regularly drink a lot of alcohol
  • if you have diabetes , which is treated with insulin or tablets
  • if you have or have had a serious head injury
  • if you are taking certain other medicines, see section “Other medicines and Bupropion Orion”.

Bupropion Orion 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 Orion and contact your doctor.

If you have had mental health problems

Some people who have taken Bupropion Orion have had hallucinations or delusions (seeing, hearing or believing things that are not true), confused thoughts or extreme mood swings. This side effect is more likely among patients who have had mental health problems in the past. If this applies to you, talk to your doctor again before taking Bupropion Orion. Your doctor may need to pay extra attention to your treatment, or recommend another treatment.

High blood pressure

Some people taking Bupropion Orion have developed high blood pressure that requires treatment. If you already have high blood pressure , it may get worse. This is more likely if you use nicotine patches to help you quit smoking.

Your blood pressure will be checked before you start taking Bupropion Orion and while you are taking it, especially if you already have high blood pressure .

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.

Liver and kidney problems

If you have liver or kidney disease, you are more likely to get side effects . Talk to your doctor again before using Bupropion Orion. Your doctor may need to pay extra attention to your treatment, or recommend another treatment.

Children and young people

Bupropion Orion should not be used in children and adolescents under 18 years of age. There is an increased risk of suicidal ideation and behavior when children and adolescents under the age of 18 are treated with antidepressants.

Other medicines and Bupropion Orion

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

If you are taking or have been taking other antidepressant medicines called monoamine oxidase inhibitors ( MAOIs ) for the last 14 days, tell your doctor without taking Bupropion Orion (see also “Do not take Bupropion Orion” in section 2).

Some medicines do not work with Bupropion Orion. 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 illness
  • if you are using theophylline for asthma or lung disease
  • if you are using tramadol, a powerful painkiller
  • if you have been taking sedatives, or if you should stop using them while you are taking Bupropion Orion (see also “Do not take Bupropion Orion” in section 2).
  • if you are taking medicines for malaria (such as mefloquine or chloroquine)
  • if you are using stimulants or other appetite and weight control drugs
  • if you are taking steroids (in tablet form or as an injection )
  • if you use the antibiotic that belongs to the quinolone you
  • if you are taking certain antihistamines (used primarily to treat allergies ) that may cause drowsiness
  • if you are taking medicines for diabetes .

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

The risk of other side effects may be 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 Orion (carbamazepine, phenytoin or valproate )
  • if you are taking medicines used to treat cancer (such as cyclophosphamide, ifosfamide)
  • if you are using ticlopidine or clopidogrel which is mainly used for heart disease or to prevent stroke
  • if you are using certain beta-blockers (such as metoprolol ), which are mainly used to treat high blood pressure
  • if you are taking medicines for irregular heartbeat ( propafenone or flecainide )
  • if you use nicotine patches for smoking cessation.

If any of these apply to you, talk to your doctor immediately before using Bupropion Orion. Your doctor will assess the benefits and risks for you when using Bupropion Orion.

Bupropion Orion 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 Orion 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 Orion without asking your doctor as it may lead to an increased risk of side effects , including seizures.

Bupropion Orion 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 Orion with alcohol

Alcohol can affect how Bupropion Orion works in the body and concomitant use can in rare cases affect your nerves or your mental health. Some people experience an increased sensitivity to alcohol when taking Bupropion Orion. Your doctor may advise you not to drink alcohol (beer, wine or spirits) or try to drink very sparingly while using Bupropion Orion. 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 Orion.

Effects on urine tests 

Bupropion Orion 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 Orion.

Pregnancy, breastfeeding and fertility

Do not take Bupropion Orion 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 failure, in children whose mothers took bupropion. It is not known if these are due to the use of Bupropion Orion.

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

Driving and using machines

If Bupropion Orion 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 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.

Bupropion Orion contains excipients

This medicine contains less than 1 mmol (23 mg) sodium per dose unit, ie essentially ‘sodium-free’.

3. How to use Bupropion Orion

Always use 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. As you begin to feel better, your doctor may advise you to continue taking Bupropion Orion to prevent a recurrence of depression.

How much to take

The usual recommended dose for adults 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.

Some people will continue to take a 150 mg tablet per day throughout their treatment. Your doctor may e.g. have prescribed this if you have liver or kidney problems.

How long to take

Only you and your doctor can decide how long to take Bupropion Orion. 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 Orion to prevent recurrence of depression.

Use for children and adolescents

Bupropion Orion should not be used in children and adolescents under 18 years of age.

Administration

Take your dose of Bupropion Orion tablets in the morning. Do not take Bupropion Orion 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.

The tablets can be taken with or without food.

If you take too many tablets, the risk of seizures or other side effects may increase. Do not wait, but consult a doctor for advice or see your nearest hospital immediately.

If you forget to use Bupropion Orion

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 Orion

Do not stop taking Bupropion Orion 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.

Cramps

Approximately 1 in 1,000 people treated with Bupropion Orion may have 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 (see section 2).

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 Orion. 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. 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 user in 10 ):

  • difficulty sleeping. Be sure to take Bupropion Orion 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 other stomach upset (constipation), taste changes, loss of appetite ( anorexia )
  • high blood pressure (sometimes severe), flushing
  • tinnitus, visual disturbance.

Uncommon (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
  • concentration difficulties
  • increased heart rate
  • weight loss.

Rare  (may affect up to 1 in 1000 users ):

  • cramps.

Very rare  (may affect up to 1 in 10 000 users ):

  • palpitation er (palpitations), fainting
  • twitching, muscle stiffness, uncontrolled movements, difficulty walking 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)
  • feeling of being out of reality or feeling strange (depersonalization), seeing or hearing unreal things (hallucinations), feeling or believing things that are not true (delusions), severe suspicion ( paranoia ).

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

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 Orion or shortly after stopping treatment (see section 2 “What you need to know before you take Bupropion Orion”). 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 assessments ( 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 ar

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. You can also report side effectsdirectly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

SE-751 03 Uppsala

Website: www.lakemedelsverket.se

5. How to store Bupropion Orion

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

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is bupropion hydrochloride. Each tablet contains 150 mg or 300 mg of bupropion hydrochloride.
  • Other ingredients are:Tablet core: povidone, hydrochloric acid , sodiumstearyl fumarate. Tablet coating: ethylcellulose, hydroxypropylcellulose, methacrylic acid-ethyl acrylate copolymer, anhydrous colloidal silica, macrogol, triethyl citrate, hypromellose.

What the medicine looks like and contents of the pack

150 mg tablet: white to light yellow, round, biconvex tablets without label. The diameter of the tablets is 7.1 mm to 7.7 mm.

300 mg tablet: white to light yellow, round, biconvex tablets without label. The diameter of the tablets is 9.6 mm to 10.0 mm.

The tablets are available in plastic cans (HDPE) with 30 and 90 tablets with child-resistant lids. The jars contain a bag with silica gel / activated carbon and one with oxygen / moisture absorber.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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