300 mg modified-release tablets
bupropion hydrochloride
What Bupropion Bluefish is and what it is used for
Bupropion Bluefish 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 Bluefish 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 Bluefish
Do not take Bupropion Bluefish:
- 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 using sedatives or should stop taking them while you are taking Bupropion Bluefish
- if you have been treated with or have been treated with antidepressants called monoamine oxidase inhibitors ( MAOIs ) for the past 14 days.
If any of the above apply to you, talk to your doctor immediately without taking Bupropion Bluefish.
Warnings and cautions
Talk to your doctor or pharmacist before taking Bupropion Bluefish.
Children and young people
Bupropion Bluefish 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.
Adults
Before you start using Bupropion Bluefish, 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 Bluefish 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 Bluefish and contact your doctor.
- if you have bipolar disorder (extreme mood swings), Bupropion Bluefish 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 using Bupropion Bluefish. Your doctor may need to pay extra attention to your treatment or recommend another treatment.
Thoughts of suicide or worsening of your depression
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 a young adult. Studies have shown that young adults (younger than 25 years), with mental illness treated with antidepressants, have an increased risk of suicidal behavior.
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 are worried that your behavior is changing.
Other medicines and Bupropion Bluefish
If you have been or have been taking other antidepressant medicines called monoamine oxidase inhibitors ( MAOIs ) for the last 14 days, tell your doctor without taking Bupropion Bluefish (see also “Do not use Bupropion Bluefish” 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 non-prescription products. Your doctor may change your dose of Bupropion Bluefish or suggest a change in your other medicines.
Some medicines do not work with Bupropion Bluefish. 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 Bluefish (see also “Do not take Bupropion Bluefish” 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
- if you are taking steroids (by mouth or by 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 Bluefish. Your doctor will assess the benefits against the risks for you to take Bupropion Bluefish.
The risk of other side effects may be increased:
- if you are taking other medicines for depression (such as 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 Bluefish (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 use nicotine patches for smoking cessation.
If any of these apply to you, talk to your doctor immediately before using Bupropion Bluefish.
Bupropion Bluefish 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 the effect of Bupropion Bluefish is on you.
It may be necessary to increase your dose or switch to another treatment for your depression. Do not increase your dose of Bupropion Bluefish without asking your doctor as it may lead to an increased risk of side effects, including seizures.
Bupropion Bluefish may reduce the effect of other medicines:
- if you are taking 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 yours
Depression.
- if you are taking digoxin for the heart.
If this applies to you, talk to a doctor. Your doctor may consider changing your dose of digoxin.
Bupropion Bluefish with alcohol
Alcohol can affect the way Bupropion Bluefish 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 Bluefish. Your doctor may advise you not to drink alcohol (beer, wine, or spirits) or try to drink very sparingly while using Bupropion Bluefish. 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 Bluefish.
Effects on urine tests
Bupropion Bluefish 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 Bluefish.
Pregnancy and breastfeeding
Do not use Bupropion Bluefish 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 Bluefish. It is not known if these are due to the use of Bupropion Bluefish.
The ingredients in Bupropion Bluefish can pass into breast milk. You should consult your doctor or pharmacist before taking Bupropion Bluefish.
Driving and using machines
If Bupropion Bluefish 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.
3. How to take Bupropion Bluefish
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 Bluefish to prevent the recurrence of depression.
How much to take
Bupropion Bluefish is only available in strength of 300 mg. For a dose of 150 mg, use an alternative suitable product available on the market.
The usual recommended dose for adults only 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 Bluefish in the morning. Do not take Bupropion Bluefish 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
Only you and your doctor can decide how long you should take Bupropion Bluefish. 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. When you start to feel better, your doctor may advise you to continue using Bupropion Bluefish to prevent the recurrence of depression.
If you take too many tablets, the risk of seizures is increased. Do not wait, but consult a doctor for advice or see your nearest hospital immediately.
If you forget to take Bupropion Bluefish
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 tablet.
If you stop taking Bupropion Bluefish
Do not stop taking Bupropion Bluefish 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 Bluefish 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 Bluefish. These 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 side effects: may affect more than 1 user in 10:
- difficulty sleeping. Be sure to take Bupropion Bluefish in the morning.
- headache
- dry mouth
- nausea, vomiting.
Common side effects: 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.
Less common side effects are: may affect up to 1 in 100 people:
- depression (see also section 2 “Take special care with Bupropion Bluefish” under “If you start to feel worse and have thoughts of harming yourself”)
- confusion
- difficulty concentrating
- increased heart rate
- weight loss.
Rare side effects are: may affect up to 1 in 1000 users:
- seizures.
Very rare side effects: 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)
- a 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 Bluefish or shortly after stopping treatment (see section 2. “What you need to know before you take Bupropion Bluefish”). 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 the number of white blood cells ( leukopenia ), and decreased the 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 Bluefish
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 after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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 300 mg of bupropion hydrochloride.
Other ingredients are:
Tablet core: Povidone, cysteine hydrochloride monohydrate, colloidal anhydrous silica, glycerol dibehenate, magnesium stearate (E 470b)
Coating: Ethylcellulose 100 mPas, povidone, macrogol, methacrylic acid – ethyl acrylate copolymer (1: 1) containing sodium lauryl sulfate and polysorbate 80, colloidal anhydrous silica, triethyl citrate
Ink: Shellac, black iron oxide (E172), and propylene glycol.
What the medicine looks like and the contents of the pack
Bupropion Bluefish is a creamy white to pale yellow, round tablet marked “GS2” on one side and without marking on the other side. The diameter of the tablet is approximately 9.3 mm.
OPA / Alu / PVC-Alu blisters containing 7, 30, 60, and 90 tablets. Also available in OPA / Alu / PVC-Alu perforated unit dose blisters containing 30×1 tablets.
Not all pack sizes may be marketed.
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road, Harrow, Middlesex, HA1 4HF, UK and Northern Ireland
Laboratori Fundació DAU,
C / C, 12-14 Pol. Ind. Zona Franca, Barcelona, 08040, Spain
This medicinal product is authorized under the European Economic Area under the names:
| Germany | Bupropion Bluefish 300 mg tablets with altered active substance release |
| Netherlands | Bupropion hydrochloride Bluefish 300 mg controlled-release tablets |