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Bupropion HCl Sandoz retard 150 mg, tabletten met gereguleerde afgifte

RegistratienummerRVG 114395
ProcedurenummerNL/H/3042/001
Farmaceutische vormTablet met gereguleerde afgifte
ToedieningswegOraal gebruik
ATCN06AX12 - Bupropion
AfleverstatusUitsluitend recept
Registratiedatum16 april 2015
RegistratiehouderSandoz B.V.
Veluwezoom 22
1327 AH ALMERE
Werkzame stof(fen)BUPROPIONHYDROCHLORIDE
SAMENSTELLING
overeenkomend met
BUPROPION
Hulpstof(fen)AMMONIA (E 527)
COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1)
ETHYLCELLULOSE (E 462)
HYPROLOSE (E 463)
HYPROMELLOSE (E 464)
IJZEROXIDE ZWART (E 172)
MACROGOL 1500
MACROGOL 400
MACROGOL 8000
NATRIUMSTEARYLFUMARAAT
POVIDON K 90 (E 1201)
PROPYLEENGLYCOL (E 1520)
SCHELLAK GLAZE, GEDEELTELIJK VERESTERD
SILICIUMDIOXIDE (E 551)
TRIETHYLCITRAAT (E 1505)
ZOUTZUUR (E 507)
Download: Bijsluiter PDF


 
Package leaflet: Information for the user 
 
Bupropion HCl Sandoz retard 150 mg, tabletten met gereguleerde afgifte  
Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte
 
 
Bupropion hydrochloride 
 
Read all of this leaflet carefully before you start taking this medicine because it contains 
important information for you. 
 

Keep this leaflet. 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 pass it on to others. It may harm them, 
even if their signs of illness are the same as yours.  

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 
effects not listed in this leaflet. See section 4. 
 
 
What is in this leaflet  
 
1. What [nationally completed name]  is and what it is used for  
2. What you need to know before you take [nationally completed name] 
3. How to take [nationally completed name] 
4. Possible side effects  
5. How to store [nationally completed name] 
6. Contents of the pack and other information  
 
 
1. What [nationally completed name] is and what it is used for  
 
[nationally completed name] is used to treat depression. It interacts with chemicals in the brain called 
noradrenaline and dopamine, which are linked to depression. 
 
 
2. What you need to know before you take [nationally completed name] 
 
Do not take [nationally completed name]:  
 
if you are/have: 
 
allergic to bupropion or any of the other ingredients of this medicine (listed in section 6)  
 
taking any other medicines which contain bupropion  
 
epilepsy or a history of fits 
 
a brain tumour 
 
undergoing abrupt withdrawal from alcohol or any medicines known to be associated with a 
risk of withdrawal, particularly 

medicines which calm, induce sleep or relax muscles with active substance names ending 
with "azepam" 
- or 
similar 
sedatives 

 
severe long-lasting liver disease marked by degeneration and thickening of liver tissue 
 
an eating disorder or have had one, such as bulimia or anorexia nervosa 
 
taking  or have been taking other medicines to treat  depression called monoamine oxidase 
inhibitors
 
 A gap of  at least 14 days is required following discontinuation of certain monoamine oxidase 
inhibitors (called irreversible monoamine oxidase inhibitors) and taking [nationally completed 
name]. For some other monoamine oxidase inhibitors (which are called reversible monoamine 
oxidase inhibitors), a gap of 24 hours could be sufficient. Ask your doctor for advice.  
 
Warnings and precautions 
 
Talk to your doctor before taking [nationally completed name] if you are/have: 
 
regularly drinking a lot of alcohol 
Please consider the previous section: “Do not take [nationally completed name]” if you are 
undergoing abrupt withdrawal from alcohol. 
 
diabetes for which you use insulin or tablets 
 
a history of a head injury 
 
extreme mood swings or mental problems 
Prior to treatment, patients should be checked for risk of disorders with episodes of elevated or 
agitated mood. 
 
reduced kidney or mild to moderate reduced liver function 
Patients with reduced liver or kidney function will be monitored by the doctor for possible side 
effects. Do not use [nationally completed name] if you have the severe liver disease listed in the 
sixth bullet point under “Do not take [nationally completed name]”. 
 
require a urine test  
Tell your doctor that you are taking [nationally completed name] as it may interfere with some 
urine tests to detect other medicines. 
 
[nationally completed name] has been shown to cause fits. This side effect is more likely in people: 
 
affected by a condition listed in the first three bullet points under “Warnings and precautions” in 
section 2 or 
 
taking a medicine listed in the second to twelfth bullet point under “Other medicines and 
[nationally completed name]” in section 2 
All patients should be assessed for existing risk factors. Stop taking [nationally completed name] 
and contact your doctor
 if fits occur during treatment. 
 
Thoughts of harming or killing yourself are associated with depression. These may be increased 
when starting treatment as medicines to treat depression take time to work. This can usually be about 
two weeks but sometimes longer.  
You are more likely to have such thoughts if you:  
 
have previously had these thoughts 
 
are a young adult 
Studies show an increased risk of suicidal behavior in adults aged under 25 years with mental 
problems and using medicines to treat depression.  
 
Contact your doctor or go to a hospital immediately, if you have thoughts of harming or killing 
yourself. Tell a relative or close friend that you are depressed, and ask them to read this leaflet. Ask 
them to tell you if they think your depression is getting worse or changes in your behavior occur. 
 

Children under 18 years 
 
[nationally completed name] is not recommended for this age group. An increased risk of suicidal 
thoughts and behaviour exists in children using medicines to treat depression. 
 
Other medicines and [nationally completed name]  
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines
.  
 
The following medicines can affect or be affected by [nationally completed name],  but it is not a 
complete list. Tell your doctor if you take any of these medicines so that your treatment can be altered 
if necessary: 
 
certain medicines to treat depression or Parkinson’s disease called monoamine oxidase 
inhibitors
 
Consider the last bullet point under “Do not take [nationally completed name]” in section 2. 
 
medicines to treat  depression, such as amitriptyline, fluoxetine, paroxetine, dosulepin, 
desipramine, imipramine, citalopram  
 
medicines to treat mental diseases, such as clozapine, risperidone, thioridazine, olanzapine 
 
theophylline: a medicine to treat asthma and other breathing diseases 
 
tramadol: a medicine to treat pain 
 
sedatives 
Consider the fifth bullet point under “Do not take [nationally completed name]” in section 2 
if you intend to stop taking sedatives. 
 
medicines to prevent and treat malaria, such as mefloquine, chloroquine 
 
stimulants or other medicines to control your weight or appetite 
 
steroids, administered by mouth or injection 
 
medicines to treat bacterial infection with active substance names ending in “oxacin” 
 
anti-histamines that can cause sleepiness: used to treat allergies, sleep disturbances or colds; or 
prevent and treat nausea and vomiting 
 
medicines to treat diabetes 
 
levodopa, amandatine: medicines to treat Parkinson’s disease 
 
orphenadrine: a medicine to treat painful muscle tension 
 
carbamazepine, phenytoin, valproate: medicines to treat epilepsy and certain pain conditions 
 
certain medicines to treat cancer, such as cyclophosphamide, ifosfamide 
 
ticlopidine, clopidogrel: medicines to inhibit blood clotting 
 
medicines to treat high blood pressure, heart or other diseases, with active substance names 
ending with “lol”, such as metoprolol 
 
propafenone, flecainide: medicines to treat heart rhythm disorders 
 
nicotine patches: medicines to stop smoking 
 
ritonavir, efavirenz: medicines to treat HIV infection 
 
tamoxifen: a medicine to treat breast cancer 
Tell your doctor if you take tamoxifen as it may be necessary to change to another treatment for 
depression.  
 
[nationally completed name] with alcohol 
 

Drinking alcohol is not recommended while taking [nationally completed name]. But if you drink a 
lot now, do not stop suddenly as it may put you at risk of having a fit.  
 
Talk to the doctor about drinking and withdrawal from alcohol before you take [nationally completed 
name].  
 
Pregnancy and breast-feeding 
 
Do not take  [nationally completed name] if you are pregnant, think you may be pregnant or are 
planning to have a baby, unless your doctor recommends it. Some clinical studies have reported an 
increase in the risk of birth defects, particularly heart defects, in babies whose mothers were taking 
[nationally completed name]. It is not known if these are due to the use of [nationally completed 
name]. 
The ingredients of [nationally completed name] can pass into breast milk. If you are breast-feeding, 
ask your doctor or pharmacist for advice before taking [nationally completed name].  
 
Driving and using machines 
 
 
Do not drive or operate any tools or machines as [nationally completed name] makes you dizzy or 
light-headed. 
 
 
3. How to take [nationally completed name] 
 
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor 
or pharmacist if you are not sure. 
 
The recommended dose is
 
 
1 tablet once daily 
 
Your doctor may increase your dose to 
2 tablets once daily if your depression does not improve 
after several weeks.  
 
Patients with reduced liver or kidney function 
 
The recommended dose is one tablet once daily if you have reduced kidney or mild to moderate 
reduced liver function. 
Do not use [nationally completed name] if you have the severe liver disease listed in the sixth bullet 
point under “Do not take [nationally completed name]” in section 2. 
 
[nationally completed name 300 mg modified-release tablets] 
The recommended dose is 
 
 
1 tablet once daily of [nationally completed name 150 mg modified-release tablets] 
 
Your doctor may increase your dose to 1 tablet once daily of [nationally completed name 300 
mg modified-release tablets] if your depression does not improve after several weeks.  
 

Patients with reduced liver or kidney function 
 
The recommended dose is one tablet once daily of [nationally completed name 150 mg modified-
release tablets], if you have reduced kidney or mild to moderate reduced liver function. 
Do not use [nationally completed name] if you have the severe liver disease listed in the sixth bullet 
point under “Do not take [nationally completed name]” in section 2. 
 
Method of use 
 
Take your tablets whole, in the morning with a glass of water. The tablets can be taken with or without 
food. 
 
The tablet is covered by a shell that slowly releases the active substance inside your body. You may 
notice something in your stool that looks like a tablet. This is the empty shell passing from your body.  
 
You must not chew, crush or split the tablets
 as you could overdose, because the medicine will 
release too quickly. This increases the possibility of side effects, including fits. 
 
Duration of use 
 
Your doctor decides how long you should take [nationally completed name]. 
 
It may take a while before you start feeling better and have the full effect, sometimes weeks or months. 
Your doctor may advise you to keep taking [nationally completed name] when you start feeling better, 
so as to stop depression returning. 
 
If you take more [nationally completed name] than you should 
 
 
Contact your doctor immediately or your nearest hospital if an overdose occurs, as this may increase 
the risk of fits. 
 
If you forget to take [nationally completed name]
 
 
If you miss a dose, wait and take your next tablet at the usual time. Do not take a double dose to make 
up for a forgotten tablet.  
 
If you stop taking [nationally completed name]
 
 
Do not stop [nationally completed name] use or reduce the dose without your doctor’s permission. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
4. Possible side effects  
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
Fits or seizures  
 

Approximately 1 in every 1000 people taking [nationally completed name] is at risk of a fit (a seizure 
or convulsion). The chance of this happening is higher if you take too much, if you take certain 
medicines, or if you are at higher than usual risk of fits. If you are worried, talk to your doctor.  
 
If you have a fit, 
tell your doctor when you have recovered. Don’t take any more tablets.  
 
Allergic reactions  
 
Some people may get allergic reactions to bupropion. These include  

Red skin or rash (like nettle rash), blisters or itchy lumps (hives) on the skin. 
Some skin rashes may need hospital treatment, especially if you also have a sore mouth or 
sore eyes. 

Unusual wheezing or difficulty in breathing 

Swollen eyelids, lips or tongue 

Pains in muscles or joints 

Collapse or blackout. 
 
If you have any signs of an allergic reaction contact a doctor at once. Don’t take any more tablets.  
 
Allergic reactions can last a long time. 
If your doctor prescribes something to help with allergic 
symptoms, make sure you finish the course.  
 
Other side effects  
 
Very common side effects: 
these may affect more than one in 10 people 
• 
Difficulty in sleeping. Make sure you take [nationally completed name] in the morning.  
• 
Headache 
• 
Dry mouth 
• 
Feeling sick, vomiting 
 
Common side effects: 
these may affect up to one in 10 people 
• 
Fever, dizziness, itching, sweating and skin rash (sometimes due to an allergic reaction) 
• 
Shakiness, tremor, weakness, tiredness, chest pain 
• 
Feeling anxious or agitated 
• 
Tummy pain or other upsets (constipation), changes in the taste of food, loss of appetite (anorexia) 
• 
Increase in blood pressure sometimes severe, flushing 
• 
Ringing in the ears, visual disturbances. 
 
Uncommon side effects: may affect up to one in 100 people  
• 
Feeling depressed (see also section 2 ‘Take special care with [nationally completed name]´, under 
‘Thoughts of suicide and worsening of your depression’) 
• 
Feeling confused 
• 
Difficulty concentrating 
• 
Raised heart rate 
• 
Weight loss 
 
Rare side effects: may affect up to one in 1,000 people  
• 
Seizures 
 

Very rare side effects: may affect up to one in 10,000 people 
• 
Palpitations, fainting 
• 
Twitching, muscle stiffness, uncontrolled movements, problems with walking or coordination 
• 
Feeling restless, irritable, hostile, aggressive, strange dreams, tingling or numbness, loss of 
memory 
• 
Yellowing of skin or the whites of your eyes (jaundice) which may be caused by raised liver 
enzymes, hepatitis 
• 
Severe allergic reactions; rash together with joint and muscle pains 
• 
Changes in blood sugar levels 
• 
Urinating more or less than usual 
• 
Severe skin rashes that may affect the mouth and other parts of the body and can be life 
threatening 
• 
Worsening of psoriasis (thickened patches of red skin) 
• 
feeling unreal or strange (depersonalisation); seeing or hearing things that are not there 
(hallucinations); sensing or believing things that are not true (delusions); severe suspiciousness 
(paranoia). 
 
Other side effects 
Other side effects have occurred in a small number of people but their exact frequency is unknown: 
 
• 
thoughts of harming or killing themselves while taking [nationally completed name] or soon 
after stopping treatment (see section 2, ’What you need to know before you take [nationally 
completed name]´). If you have these thoughts, contact your doctor or go to a hospital 
straight away

• 
loss of contact with reality and unable to think or judge clearly (psychosis); other symptoms may 
include hallucinations and/or delusions. 
• 
reduced numbers of red blood cells (anaemia), reduced numbers of white blood cells (leucopenia) 
and reduced numbers of platelets (thrombocytopenia). 
 
Reporting of side effects 
If  you  get  any  side  effects,  talk  to  your doctor or pharmacist.  This  includes  any possible side 
effects not listed in this leaflet. 
You can also report side effects directly via the national reporting system listed in Appendix V. By 
reporting side effects you can help provide more information on the safety of this medicine. 
 
 
5. How to store [nationally completed name] 
 
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 bottle after EXP. The expiry date 
refers to the last day of that month. 
  
Do not store above 25°C. 
 
Store in the original pack in order to protect from moisture and light. 
 
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines 
you no longer use. These measures will help protect the environment. 

 
 
6. Contents of the pack and other information  
 
What [nationally completed name] contains  
 
 
The active substance is bupropion hydrochloride. 
 
Each modified-release tablet contains 150 mg of bupropion hydrochloride. 
Each modified-release tablet contains 300 mg of bupropion hydrochloride. 
 
 
The other ingredients are povidone, hydrochloric acid, sodium stearyl fumarate, ethylcellulose, 
hydroxy propylcellulose, methacrylic acid-ethyl acrylate copolymer (1:1) Type A, silica 
colloidal anhydrous, macrogol 1500, triethyl citrate, hypromellose, macrogol 400, macrogol 
8000,  shellac glaze, iron oxide black, propylene glycol, ammonium hydroxide 
 
What [nationally completed name] looks like and contents of the pack  
 
NL/H/3042/001 
White to pale yellow, round tablets, rounded on the upper and lower side, printed with ‘A 151’ on one 
side and plain on other side. 
10, 30 or 90 tablets in a white light-tight plastic bottle 
 
NL/H/3042/002 
White to pale yellow, round tablets, rounded on the upper and lower side, printed with ‘A 152’ on one 
side and plain on other side. 
10, 30 or 90 tablets in a white light-tight plastic bottle 
 
Marketing Authorisation Holder and Manufacturer 
 
Marketing Authorisation Holder
 
Sandoz B.V. 
Veluwezoom 22 
1327 AH Almere 
Nederland 
 
Manufacturer 
Lek Pharmaceuticals d.d. 
Verovškova ulica 57 
1526 Ljubljana 
Slovenië 
 
Lek Pharmaceuticals d.d. 
Trimlini 2D 
9220 Lendava 
Slovenië 
 
LEK S.A. 

ul. Domaniewska 50 C 
02-672 Warschau 
Polen 
 
Salutas Pharma GmbH 
Otto-von-Guericke Allee 1 
39179 Barleben 
Duitsland  
 
S.C. Sandoz, S.R.L. 
Str. Livezeni nr. 7A 
RO-540472 Targu-Mures 
Roemenië 
 
In het register ingeschreven onder:  
Bupropion HCl Sandoz retard 150 mg, tabletten met gereguleerde afgifte  
RVG 114395. 
Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte  
RVG 114396. 
 
This medicinal product is authorised in the Member States of the EEA under the following 
names: 
Nederland:  
Bupropion HCl Sandoz retard 150 mg, tabletten met gereguleerde afgifte 
Bupropion HCl Sandoz retard 300 mg, tabletten met gereguleerde afgifte 
Oostenrijk:  
Bupropion 1A Pharma 150 mg - Tablette mit veränderter Wirkstofffreisetzung 
Bupropion 1A Pharma 300 mg - Tablette mit veränderter Wirkstofffreisetzung 
Duitsland:  
Bupropionhydrochlorid HEXAL 150 mg Tabletten mit veränderter 
Wirkstofffreisetzung 
Bupropionhydrochlorid HEXAL 300 mg Tabletten mit veränderter 
Wirkstofffreisetzung 
Italië:    
BUPROPIONE SANDOZ 
BUPROPIONE SANDOZ 
 
This leaflet was last revised in 04-2015 






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