150 mg, 300 mg tablet with modified release
bupropion hydrochloride
What Voxra is and what it is used for
Voxra is a medicine prescribed by your doctor to treat your depression. It is thought to have an effect on brain chemicals called norepinephrine and dopamine.
What you need to know before using Voxra
Do not use Voxra
- if you are allergic to bupropion or any of the other ingredients of this medicine (listed in section 6)
- if you are using any other medicine containing bupropion
- if you have been diagnosed with epilepsy or have previously had seizures
- if you have or have had eating disorders (e.g. 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 sedative medicines or are going to stop using them while you are using Voxra
- if you are being treated with or have been treated with medicines for depression 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 Voxra.
Warnings and precautions
Talk to your doctor or pharmacist before taking Voxra.
Children and adolescents
Voxra is not recommended for the treatment of children under the age of 18. There is an increased risk of suicidal thoughts and behavior when children under the age of 18 are treated with antidepressants.
Adults
Before you start using Voxra, your doctor needs to know:
- if you regularly drink a lot of alcohol
- if you have diabetes and are treated with insulin or tablets
- if you have or have had a serious head injury
Voxra has been shown to cause seizures in about 1 in 1,000 people. The risk of this side effect is greater in people in the aforementioned groups. If you have a seizure during treatment, stop taking Voxra and contact your doctor.
- if you have bipolar disorder (extreme mood swings), Voxra can trigger an episode of the disorder.
- if you take other medicines for depression, these medicines together with Voxra can lead to serotonin syndrome, which is a potentially life-threatening condition (see “Other medicines and Voxra” in this section).
- if you have liver or kidney disease, the risk of side effects is increased.
If any of the above applies to you, talk to your doctor again before you start using Voxra. The doctor may need to pay extra attention to your treatment or recommend another treatment.
If you start to feel worse and have thoughts of harming yourself
You who are depressed may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking anti-depressant drugs because it takes time for drugs of this type to work, 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 antidepressants have an increased risk of suicidal thoughts and thoughts of harming themselves.
Contact a doctor or the nearest hospital immediately if you have thoughts of harming yourself or committing suicide.
It may help to tell a relative or close friend that you are depressed. Please ask them to read this leaflet. You can also ask them to tell you if they think you seem to be feeling worse or if they think your behavior is changing.
Other medicines and Voxra
If you are using or have used other antidepressants called monoamine oxidase inhibitors ( MAOIs ) in the last 14 days, tell your doctor without taking Voxra (see also Do not use Voxra in section 2).
Tell your doctor or pharmacist if you are using, have recently used, or may be thinking about using other medicines, natural remedies or vitamins, or other non-prescription products. The doctor may change your dosage of Voxra or suggest a change to your other medications.
Some medicines do not mix with Voxra. 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 use other medicines for depression or other mental illnesses
- if you use theophylline for asthma or lung disease
- if you are using tramadol, a strong painkiller
- if you have used sedative medicines, or if you are going to stop using them while you are using Voxra (see also “Do not use Voxra” under section 2)
- if you are using anti-malarial medicines (such as mefloquine or chloroquine)
- if you use central stimulating or other appetite and weight-regulating medicines
- if you use steroids, in tablet form or as an injection
- if you use antibiotics that belong to the quinolone group
- if you use certain antihistamines that can cause drowsiness
- if you use medicines for diabetes.
If any of these apply to you, talk to your doctor immediately before using Voxra. The doctor will assess the benefits against the risks for you of using Voxra.
The risk of other side effects is increased:
- if you are using other medicines for depression (such as amitriptyline, fluoxetine, paroxetine, citalopram, escitalopram, venlafaxine, dosulepin, desipramine or imipramine) or other mental illnesses (such as clozapine, risperidone, thioridazine or olanzapine). Voxra can affect or be affected by some medicines used to treat depression, and you may experience changes in mental status (eg agitation, hallucinations, coma ), and other side effects such as body temperature above 38°C, increased heart rate, unstable blood pressure and overactive reflexes, muscle stiffness, lack of coordination, and/or gastrointestinal symptoms (eg, nausea, vomiting, diarrhea).
- if you use medicines for Parkinson’s disease ( levodopa, amantadine, or orphenadrine)
- if you use medicines that affect the body’s breakdown of Voxra (carbamazepine, phenytoin, or valproate )
- if you are using medicines used to treat cancer (such as cyclophosphamide, and ifosfamide)
- if you are using ticlopidine or clopidogrel which are mainly used to prevent stroke
- if you use certain beta-blockers (such as metoprolol )
- if you use medicines against irregular heart rhythm ( 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 Voxra.
Voxra may have less effect:
- if you are taking ritonavir or efavirenz medicine to treat HIV infection.
If this applies to you, tell your doctor. Your doctor will check how well Voxra works for you. It may be necessary to increase your dose or switch to a different treatment for your depression. Do not increase your dose of Voxra without asking your doctor as this may lead to an increased risk of side effects, including seizures.
Voxra can reduce the effect of other medicines:
- if you are using tamoxifen to treat breast cancer. If this applies to you, talk to your doctor. It may be necessary to switch to a different treatment for your depression.
- if you use digoxin for the heart. If this applies to you, talk to your doctor. The doctor may consider changing the dose of digoxin.
Voxra with alcohol
Alcohol can affect how Voxra works in the body and simultaneous use can in rare cases affect your nerves or your mental health. Some people experience increased sensitivity to alcohol when taking Voxra. The doctor may advise you not to drink alcohol (beer, wine, or spirits) or try to drink very sparingly while using Voxra. However, if you currently drink a lot of alcohol, do not stop drinking suddenly, as you may risk a seizure.
Talk to your doctor about your drinking habits before you start using Voxra.
Effects on urine tests
Voxra can affect certain urine tests used to detect other drugs. If you need a urine test, tell your doctor or hospital that you are taking Voxra.
Pregnancy and breastfeeding
Do not use Voxra if you are pregnant, think you may be pregnant, or are planning to have a baby unless your doctor has recommended it. Consult a doctor or pharmacist before using this medicine. Some, but not all, studies have reported an increased risk of birth defects, especially heart defects, in children whose mothers took Voxra. It is not known whether these are due to the use of Voxra
The ingredients in Voxra can pass into breast milk. You should consult a doctor or pharmacist before taking Voxra.
Driving ability and use of machinery
If Voxra makes you dizzy or light-headed, do not drive or operate any tools or machinery.
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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
How to use Voxra
Always use this medicine as directed by your doctor or pharmacist. What is listed below is usuthe al dosage 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 improvement. It takes time, sometimes weeks or months, for the medicine to reach its full effect. When you start to feel better, your doctor may advise you to continue taking Voxra to prevent a recurrence of the depression.
How much to take
The usual recommended dose is one 150 mg tablet per day.
The doctor may increase your dose to 300 mg per day if your depression does not improve after several weeks.
Take your dose of Voxra in the morning. Do not take Voxra more than once a day.
The tablet is covered with a shell that slowly releases the medicine 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
Swallow your tablets whole. The tablets should not be chewed, crushed, or split – if you do, there is a risk of overdose as the medicine will leave your body too quickly. It can lead to an increased risk of side effects, including seizures.
Some people maintain a dosage of 150 mg per day throughout the treatment period. Your doctor may have prescribed this dosage if you have liver or kidney problems.
How long it should be taken
Only you and your doctor can decide how long you should take Voxra. It may take weeks or months of treatment before you notice any improvement. Discuss your symptoms regularly with your doctor to decide how long you should take the medicine. When you start to feel better, your doctor may advise you to continue using Voxra to prevent the depression from returning.
If you have taken too much Voxra
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you take too many tablets, the risk of convulsions is increased. Do not wait, but contact a doctor for advice or visit the nearest hospital immediately.
If you forget to take Voxra
If you have missed a dose, wait until the next dosing occasion and take the next dose as usual. Do not take a double dose to make up for a missed dose.
If you stop using Voxra
Do not stop taking Voxra or reduce the dose without first talking to your doctor.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Seizures
About 1 in 1,000 who are treated with Voxra are at risk of having a seizure. The risk of this is higher if you take too much, if you use certain medicines or if you are more prone to 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 any more tablets.
Allergic reactions
Some people may have allergic reactions to Voxra. Symptoms include:
- skin redness or rashes such as hives, blisters, or itchy swellings. Some types of skin rash may require hospital care, 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 any more tablets.
Allergic reactions can last for a long time. If your doctor has prescribed any medication for your allergy symptoms, be sure to complete the entire regimen.
Lupus skin rash or worsening lupus symptoms
Frequency not known – cannot be estimated from available data in people taking Voxra. Lupus is a disease of the immune system that affects the skin and other organs.
- If you experience lupus flares, skin rashes, or lesions (especially on areas exposed to sunlight) while taking Voxra, contact your doctor immediately, as it may be necessary to stop treatment.
Acute generalized exanthematous pustulosis (AGEP)
Frequency not known – cannot be estimated from available data in people taking Voxra. Symptoms of AGEP include a rash with blisters/blisters.
- If you get a rash with filled pimples/blisters, you should immediately contact a doctor as it may be necessary to stop the treatment.
Other side effects are
Very common which may affect more than 1 in 10 people:
- sleep difficulties. Be sure to take Voxra in the morning.
- headache
- dry mouth
- nausea, vomiting
Common side effects that may affect up to 1 in 10 people:
- fever, dizziness, itching, sweating, and skin rash (which is sometimes due to an allergic reaction )
- shakiness, tremors, weakness, fatigue, chest pain
- anxiety or worry
- abdominal pain or other stomach problems (constipation), taste changes, loss of appetite ( anorexia )
- blood pressure increase, sometimes severe, flushing
- tinnitus, and visual disturbance.
Uncommon side effects that may affect up to 1 in 100 people:
depression (see also section 2 “Take special care with Voxra” under “If you start to feel worse and have thoughts of harming yourself”)
- confusion
- difficulty concentrating
- increased heart rate
- weight loss.
Rare side effects that may affect up to 1 in 1,000 people:
- convulsions.
Very rare side effects that may affect up to 1 in 10,000 people:
- palpitation , fainting
- twitching, muscle stiffness, uncontrolled muscle movements, problems with walking or coordination
- restlessness, irritability, hostility, aggressiveness, strange dreams, numbness or tingling, memory loss
- yellowing of the skin or whites of the eyes which may be due to elevated liver enzyme values, hepatitis
- severe allergic reactions; skin rash together with joint and muscle pain
- blood sugar disorders
- urinating more often or less often than normal
- urinary incontinence (involuntary emptying of the bladder, urine leakage)
- severe rashes in the mouth or on other parts of the body that can be life-threatening
- worsening of psoriasis (circumscribed, reddened thickenings of the skin)
- the feeling of being outside of reality (depersonalization), unreal sensory impressions (hallucinations), feeling or believing things that are not true (delusions), and severe suspiciousness ( paranoia ).
No known frequency
Other side effects have occurred in a few people but their exact frequency is not known:
- thoughts of harming yourself or committing suicide while using Voxra or shortly after finishing treatment (see section 2. “What you need to know before using Voxra”). If you have such thoughts, contact your doctor or go to a hospital immediately.
- loss of contact with reality and inability to think clearly or make clear judgments ( psychosis ); other symptoms may include hallucinations and/or delusions.
- stuttering.
- decreased number of red blood cells ( anemia ), decreased a number of white blood cells ( leukopenia ), and decreased a number of platelets ( thrombocytopenia ).
- decreased sodium levels in the blood ( hyponatremia ).
- changes in mental status (eg agitation, hallucinations, coma ), and other side effects such as body temperature above 38 °C, increased heart rate, unstable blood pressure, and overactive reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms ( eg nausea, vomiting, diarrhea), may occur if you take Voxra together with other medicines used to treat depression (eg paroxetine, citalopram, escitalopram, fluoxetine, and venlafaxine ).
How Voxra should be stored
Store out of sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Store in the original packaging. Moisture sensitive. Light sensitive. The jar contains a small sealed container containing charcoal and silica gel that keeps the tablets dry. Store the container in the jar. Do not swallow it.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is bupropion hydrochloride. One tablet contains 150 mg or 300 mg of bupropion hydrochloride.
Other ingredients are: in the tablet core: polyvinyl alcohol, glyceryl behenate, and in the coating: ethyl cellulose, povidone K-90, macrogol 1450, methacrylic acid-ethyl acrylate copolymer dispersion, silicon dioxide, triethyl citrate.
Printing ink: shellac glaze, black iron oxide (E172), and ammonium hydroxide.
Appearance and package sizes of the medicine
Voxra 150 mg tablet is a cream white to pale yellow round tablet marked “GS 5FV 150” with black ink on one side and unmarked on the other side. The tablets are available in white polyethylene containers with 7, 30, or 90 (3×30) tablets.
Voxra 300 mg tablet is a cream white to pale yellow round tablet marked “GS 5YZ 300” with black ink on one side and unmarked on the other side. The tablets are available in white polyethylene containers with 7, 30, or 90 (3×30) tablets.
Marketing Authorisation Holder:
GlaxoSmithKline AB, Box 516, 169 29 Solna
Tel.: 08-638 93 00
Email: info.produkt@gsk.com
Manufacturer:
Aspen Bad Oldesloe GmbH
Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
or
Glaxo Wellcome SA Avenida de Extremadura, 3 09400 Aranda de Duero, Burgos, Spain.
This medicine is approved in the European Economic Area under the names:
| Wellbutrin XR: | Belgium, Cyprus, Greece, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovenia, Austria |
| Wellbutrin: Elantra: | Italy Estonia, Italy, Lithuania, Netherlands, Portugal, Romania, Slovakia, Spain, Germany, Hungary |
| Wellbutrin Retard: | Iceland, Norway |
| Voxra | Finland, Sweden |