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BONILUX XL 75 MG PROLONGED-RELEASE CAPSULES

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Bonilux® XL 75 mg Prolonged-release Capsules
Bonilux® XL 150 mg Prolonged-release Capsules

SZ00000LT000

Venlafaxine

this is in their best interests. If your doctor has
prescribed Bonilux XL for a patient under 18 and
you want to discuss this, please go back to your
doctor. You should inform your doctor if any of the
symptoms listed in this leaflet develop or worsen
when patients under 18 are taking Bonilux XL.
Also, the long-term safety effects concerning
growth, maturation and cognitive and behavioural
development of Bonilux XL in this age group have
not yet been demonstrated.

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.

Other medicines and Bonilux XL:
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
Your doctor should decide whether you can take
Bonilux XL with other medicines.

What is in this leaflet:
1. What Bonilux XL is and what it is used for
2. What you need to know before you take
Bonilux XL
3. How to take Bonilux XL
4. Possible side effects
5. How to store Bonilux XL
6. Contents of the pack and other information

1

Do not start or stop taking any medicines,
including those bought without a prescription,
natural and herbal remedies, before checking with
your doctor or pharmacist.

Monoamine oxidase inhibitors which are used to
treat depression or Parkinson’s disease must not
be taken with Bonilux XL. Tell your doctor if you
have taken these medicines within the last 14
days. (MAOIs: see the section “What you need to
know before you take Bonilux XL”).

What Bonilux XL is and what it is
used for

• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening
condition (see the section “Possible Side
Effects”), may occur with venlafaxine treatment,
particularly when taken with other medicines.
Examples of these medicines include:
- Triptans (used for migraine)
- Medicines to treat depression, for instance
SNRI, SSRIs, tricyclics, or medicines
containing lithium
- Medicines containing linezolid, an antibiotic
(used to treat infections)
- Medicines containing moclobemide, a
reversible MAOI (used to treat depression)
- Medicines containing sibutramine (used for
weight loss)
- Medicines containing tramadol, fentanyl,
tapentadol, pethidine, or pentazocine (used to
treat severe pain)
- Medicines containing dextromethorphan
(used to treat coughing)
- Medicines containing methadone (used to
treat opioid drug addiction or severe pain)
- Medicines containing methylene blue (used to
treat high levels of methaemoglobin in the
blood)
- Products containing St. John’s Wort (also
called Hypericum perforatum, a natural or
herbal remedy used to treat mild depression)
- Products containing tryptophan (used for
problems such as sleep and depression)
- Antipsychotics (used to treat a disease with
symptoms such as hearing, seeing or sensing
things which are not there, mistaken beliefs,
unusual suspiciousness, unclear reasoning
and becoming withdrawn).

Bonilux XL contains the active ingredient
venlafaxine. Venlafaxine is an antidepressant that
belongs to a group of medicines called serotonin
and norepinephrine reuptake inhibitors (SNRIs).
This group of medicines is used to treat
depression and other conditions such as anxiety
disorders. It is thought that people who are
depressed and/or anxious have lower levels of
serotonin and noradrenaline in the brain. It is not
fully understood how antidepressants work, but
they may help by increasing the levels of
serotonin and noradrenaline in the brain.

Bonilux XL is a treatment for adults with
depression. Bonilux XL is also a treatment for
adults with social anxiety disorder (fear or
avoidance of social situations). Treating
depression or anxiety disorders properly is
important to help you get better. If it is not treated,
your condition may not go away and may become
more serious and more difficult to treat.

2

What you need to know before you
take Bonilux XL

Do not take Bonilux XL:
• If you are allergic to venlafaxine or any of the other
ingredients of this medicine (listed in section 6).
• If you are also taking or have taken, at any time
within the last 14 days any medicines known as
irreversible monoamine oxidase inhibitors (MAOIs),
used to treat depression or Parkinson’s disease.
Taking an irreversible MAOI together with other
medicines, including Bonilux XL, can cause
serious or even life-threatening side effects.
Also, you must wait at least 7 days after you
stop taking Bonilux XL before you take any
MAOI (see also the sections “Serotonin
syndrome” and “Other medicines and Bonilux XL”).

Signs and symptoms of serotonin syndrome may
include a combination of the following:
restlessness, hallucinations, loss of coordination,
fast heartbeat, increased body temperature, fast
changes in blood pressure, overactive reflexes,
diarrhoea, coma, nausea, vomiting.

Warnings and precautions:
Talk to your doctor or pharmacist before taking
Bonilux XL
• If you use other medicines that taken
concomitantly with Bonilux XL could increase
the risk of developing serotonin syndrome (see
the section “Other medicines and Bonilux XL”).
• If you have eye problems, such as certain kinds
of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in
your blood (hyponatraemia).
• If you have a tendency to develop bruises or a
tendency to bleed easily (history of bleeding
disorders), or if you are taking other medicines
that may increase the risk of bleeding e.g.
warfarin (used to prevent blood clots).
• If your cholesterol levels get higher.
• If you have a history of, or if someone in your
family has had, mania or bipolar disorder
(feeling over-excited or euphoric).
• If you have a history of aggressive behaviour.

In its most severe form, serotonin syndrome can
resemble Neuroleptic Malignant Syndrome
(NMS). Signs and symptoms of NMS may include
a combination of fever, fast heartbeat, sweating,
severe muscle stiffness, confusion, increased
muscle enzymes (determined by a blood test).

Tell your doctor immediately, or go to the casualty
department at your nearest hospital if you think
serotonin syndrome is happening to you.
The following medicines may also interact with
Bonilux XL and should be used with caution. It is
especially important to mention to your doctor or
pharmacist if you are taking medicines containing:
• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (to treat psychiatric
conditions)
• Metoprolol (a beta blocker to treat high blood
pressure and heart problems).

Bonilux XL may cause a sensation of restlessness
or an inability to sit or stand still. You should tell
your doctor if this happens to you.

If any of these conditions apply to you, please talk
with your doctor before taking Bonilux XL.

Thoughts of suicide and worsening of your
depression or anxiety disorder
If you are depressed and/or have anxiety
disorders you can sometimes have thoughts of
harming or killing yourself. These may be
increased when first starting antidepressants,
since these medicines all take time to work,
usually about two weeks but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about
killing or harming yourself.
• If you are a young adult. Information from
clinical trials has shown an increased risk of
suicidal behaviour in adults aged less than 25
years with psychiatric conditions who were
treated with an antidepressant.
If you have these thoughts of harming or killing
yourself at any time, contact your doctor or go
to a hospital straight away.

Bonilux XL with food and drink:
Bonilux XL should be taken with food (see section
3 “How to take Bonilux XL”).
You should avoid alcohol while you are taking
Bonilux XL.

Pregnancy, breast-feeding and fertility:
If you are pregnant or breast-feeding, think you
may be pregnant or are planning to have a baby,
ask your doctor for advice before taking this
medicine. You should use Bonilux XL only after
discussing the potential benefits and the potential
risks to your unborn child with your doctor.

Make sure your midwife and/or doctor knows you
are on Bonilux XL. When taken during pregnancy,
similar drugs (SSRIs) may increase the risk of a
serious condition in babies, called persistent
pulmonary hypertension of the newborn (PPHN),
making the baby breathe faster and appear
bluish. These symptoms usually begin during the
first 24 hours after the baby is born. If this
happens to your baby you should contact your
midwife and/or doctor immediately.

If you are taking Bonilux XL during pregnancy,
other symptoms your baby might have when it is
born is not feeding properly, in addition to having
trouble breathing. If your baby has these
symptoms when it is born and you are concerned,
contact your doctor and/or midwife who will be
able to advise you.

You may find it helpful to tell a relative or
close friend that you are depressed or have an
anxiety disorder, and ask them to read this leaflet.
You might ask them to tell you if they think your
depression or anxiety is getting worse, or if they
are worried about changes in your behaviour.

Bonilux XL passes into breast milk. There is a risk
of an effect on the baby. Therefore, you should
discuss the matter with your doctor, and he/she
will decide whether you should stop breast-feeding
or stop the therapy with Bonilux XL.

Dry mouth
Dry mouth is reported in 10% of patients treated
with venlafaxine. This may increase the risk of
tooth decay (caries). Therefore, you should take
special care in your dental hygiene.

Driving and using machines:
Do not drive or use any tools or machines until
you know how Bonilux XL affects you.

3

Diabetes
Your blood glucose levels may be altered due to
Bonilux XL. Therefore, the dosage of your
diabetes medicines may need to be adjusted.

Use in children and adolescents under 18
years of age
Bonilux XL should normally not be used for children
and adolescents under 18 years. Also, you should
know that patients under 18 have an increased
risk of side-effects such as suicide attempt,
suicidal thoughts and hostility (predominantly
aggression, oppositional behaviour and anger)
when they take this class of medicines. Despite
this, your doctor may prescribe Bonilux XL for
patients under 18 because he/she decides that

How to take Bonilux XL

Always take this medicine exactly as your doctor
has told you. Check with your doctor or
pharmacist if you are not sure.
The usual recommended starting dose for
treatment of depression and social anxiety
disorder is 75 mg per day. The dose can be raised
by your doctor gradually, and if needed, even up
to a maximum dose of 375 mg daily for
depression. The maximum dose for social anxiety
disorder is 225 mg per day.

Artwork Proof Box
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Date prepared:
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Take Bonilux XL at approximately the same time
each day, either in the morning or in the evening.
Capsules must be swallowed whole with fluid and
not opened, crushed, chewed or dissolved.
Bonilux XL should be taken with food.

If you have liver or kidney problems, talk to your
doctor, since your dose of Bonilux XL may need to
be different.

Do not stop taking Bonilux XL without talking to
your doctor (see the section “If you stop taking
Bonilux XL”).

If you take more Bonilux XL than you should:
Call your doctor or pharmacist immediately if you
take more than the amount of Bonilux XL
prescribed by your doctor.
The symptoms of a possible overdose may
include a rapid heartbeat, changes in level of
alertness (ranging from sleepiness to coma),
blurred vision, seizures or fits, and vomiting.

If you forget to take Bonilux XL:
If you miss a dose, take it as soon as you
remember. However, if it is time for your next
dose, skip the missed dose and take only a single
dose as usual. Do not take more than the daily
amount of Bonilux XL that has been prescribed for
you in one day. Do not take a double dose to
make up for a forgotten dose.

If you stop taking Bonilux XL:
Do not stop taking your treatment or reduce the
dose without the advice of your doctor even if you
feel better. If your doctor thinks that you no longer
need Bonilux XL, he/she may ask you to reduce
your dose slowly before stopping treatment
altogether. Side effects are known to occur when
people stop using Bonilux XL, especially when
Bonilux XL is stopped suddenly or the dose is
reduced too quickly. Some patients may experience
symptoms such as tiredness, dizziness,
light-headedness, headache, sleeplessness,
nightmares, dry mouth, loss of appetite, nausea,
diarrhoea, nervousness, agitation, confusion, ringing
in the ears, tingling or rarely electric shock sensations,
weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how you should
gradually discontinue Bonilux XL treatment. If you
experience any of these or other symptoms that
are troublesome, ask your doctor for further advice.

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.

Do not be concerned if you see small white granules
or balls in your stools after taking Bonilux XL.
Inside Bonilux XL capsules are spheroids or small
white balls that contain the venlafaxine active
ingredient. These spheroids are released from the
capsule into your gastrointestinal tract. As the
spheroids travel the length of your gastrointestinal
tract, venlafaxine is slowly released. The spheroid
“shell” remains undissolved and is eliminated in
your stools. Therefore, even though you may see
spheroids in your stools, your dose of venlafaxine
has been absorbed.

blood in stools; which can be a sign of
gastrointestinal bleeding
• Sensitivity to sunlight, bruising, rash, abnormal
hair loss
• Inability to pass urine
• Weight gain, weight loss

Rare (may affect up to 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased
need for sleep (mania)

Not known (frequency cannot be estimated
from available data)
• Reduced number of platelets in your blood,
leading to an increased risk of bruising or
bleeding
• Blood disorders which may lead to fever, sore
throat, weakness, bruising, an increased risk of
infection
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• Suicidal ideation and suicidal behaviours, cases
of suicidal ideation and suicidal behaviours
have been reported during venlafaxine therapy
or early after treatment discontinuation (see
section 2, What you need to know before you
take Bonilux XL)
• Disorientation and confusion often accompanied
by hallucination (delirium), aggression
• Stiffness, spasms and involuntary movements
of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure, abnormal, rapid or
irregular heartbeat, which could lead to fainting
• Unexpected bleeding (mucous membrane
bleeding), e.g. bleeding gums, blood in the
urine or in vomit, or the appearance of
unexpected bruises or broken blood vessels
(broken veins)
• Coughing, wheezing, shortness of breath and a
high temperature, which are symptoms of
inflammation of the lungs associated with an
increase in white blood cells (pulmonary
eosinophilia)
• Severe abdominal or back pains (which could
indicate a serious problem in the gut, liver or
pancreas)
• Itchiness, yellow skin or eyes, dark urine, or
flu-like symptoms, which are symptoms of
inflammation of the liver (hepatitis), slight
changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering
and peeling of the skin, itching, mild rash
• Unexplained muscle pain, tenderness or
weakness (rhabdomyolysis)
• Prolonged bleeding - if you cut or injure
yourself, it may take slightly longer than usual
for bleeding to stop
• Abnormal breast milk production
Venlafaxine sometimes causes unwanted effects
which you may not be aware of, such as
increases in blood pressure or abnormal
heartbeat; slight changes in blood levels of liver
enzymes, sodium or cholesterol. More rarely,
venlafaxine may reduce the function of 'platelets'
in your blood, leading to an increased risk of
bruising or bleeding. Therefore, your doctor may
wish to do blood tests occasionally, particularly if
you have been taking Bonilux XL for a long time.
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 via the Yellow Card
Scheme (www.mhra.gov.uk/yellowcard). By
reporting side effects you can help provide more
information on the safety of this medicine.

If any of the following happen, do not take more
Bonilux XL. Tell your doctor immediately, or go to
the casualty department at your nearest hospital:

Uncommon (may affect up to 1 in 100 people)
• General swelling of the skin especially the face,
mouth, tongue, throat area or hands and feet
and/or a raised itchy rash (hives) may be
present

5

Not known (frequency cannot be estimated
from available data)
• Difficulty breathing, dizziness (severe allergic
reaction)
• Muscle stiffness, high fever, impaired
consciousness
• A high temperature with rigid muscles,
confusion or agitation, and sweating, or if you
experience jerky muscle movements which you
can't control, these may be symptoms of
serious conditions known as neuroleptic
malignant syndrome.
• Signs and symptoms of serotonin syndrome
which may include restlessness, hallucinations,
loss of coordination, fast heartbeat, increased
body temperature, fast changes in blood
pressure, overactive reflexes, euphoric feelings,
drowsiness, sustained rapid eye movement,
clumsiness, feeling of being drunk, sweating or
rigid muscles, diarrhoea, coma, nausea,
vomiting. In its most severe form, serotonin
syndrome can resemble Neuroleptic Malignant
Syndrome (NMS). Signs and symptoms of NMS
may include a combination of fever, fast
heartbeat, sweating, severe muscle stiffness,
confusion, increased muscle enzymes
(determined by a blood test).

How to store Bonilux XL

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date
which is stated on the carton, on the blister or on
the bottle after EXP. The expiry date refers to the
last day of that month. Use all the capsules within
2 months of opening the bottle.
Do not store above 30°C.

Do not throw away any medicines via wastewater
or household waste. 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 Bonilux XL contains
The active substance is: venlafaxine.

Bonilux XL 75 mg Capsules:
Each prolonged release capsule contains 75 mg
venlafaxine (as venlafaxine hydrochloride).

Bonilux XL 150 mg Capsules:
Each prolonged release capsule contains 150 mg
venlafaxine (as venlafaxine hydrochloride).

Other side effects:

The other ingredients are:
Capsule contents:
Microcrystalline cellulose, hypromellose,
cetostearyl alcohol, ethylacrylate - methyl
methacrylate copolymer, nonoxynol, macrogol, talc.
Capsule shell:
Gelatin, red iron oxide (E172), yellow iron oxide
(E172), titanium dioxide (E171).

Very common (may affect more than 1 in 10
people)
• Dizziness, headache
• Nausea, dry mouth
• Excessive and profuse sweating (including
night sweats)

Common (may affect up to 1 in 10 people)
• Appetite decreased
• Confusion, feeling separated (or detached) from
yourself, lack of orgasm, decreased libido,
nervousness, insomnia, abnormal dreams
• Drowsiness, tremor, pins and needles,
increased muscle tonus
• Visual disturbance including blurred vision,
dilated pupils, inability of the eye to automatically
change focus from distant to near objects
• Ringing in the ears (tinnitus)
• Feeling a strong heartbeat (palpitations)
• Increase in blood pressure, flushing
• Yawning
• Vomiting, constipation, diarrhoea
• Increased frequency in urination, difficulties
passing urine
• Menstrual irregularities such as increased
bleeding or increased irregular bleeding,
abnormal ejaculation/orgasm (males), erectile
dysfunction (impotence)
• Weakness (asthenia), fatigue; chills
• Increased cholesterol

What Bonilux XL looks like and contents of
the pack
Prolonged release capsules, hard.

Bonilux XL 75 mg Capsules are light pink
coloured hard gelatin capsules containing white to
off white pellets.

Bonilux XL 150 mg Capsules are brown-red
coloured hard gelatin capsules containing white to
off white pellets.
Bonilux XL 75 mg Capsules and Bonilux XL
150 mg Capsules are available in:
- Blisters (PVC/PVDC//Aluminium). Pack sizes of
7, 10, 12, 14, 20, 28, 30, 50, 56, 60, 98, 100
and 100 x 1 prolonged release capsules, hard.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz Ltd, Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Uncommon (may affect up to 1 in 100 people)
• Hallucinations, feeling separated (or detached)
from reality, agitation, abnormal orgasm
(females), lack of feeling or emotion,
hyperactivity and euphoria (feeling unusually
over-excited), grinding of the teeth
• A sensation of restlessness or an inability to sit
or stand still, fainting, involuntary movements of
the muscles, impaired coordination and
balance, altered taste sensation
• Fast heartbeat, feeling dizzy (particularly when
standing up too quickly)
• Shortness of breath
• Vomiting blood, black tarry stools (faeces) or

Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee
1, 39179 Barleben, Germany or Salutas Pharma
GmbH, Dieselstrasse 5, 70839 Gerlingen,
Germany or Lek Pharmaceuticals d.d.,
Verovśkova 57, 1526 Ljubljana, Slovenia or
Sandoz GmbH, Biochemiestrasse 10, 6250
Kundl, Austria or Lek Pharmaceuticals d.d.,
Trimlini 2D, 9220 Lendava, Slovenia or
S.C. Sandoz S.R.L, Str. Livezeni nr . 7A, 540472
Targu-Mures, Romania.
This leaflet was last revised in 11/2014.

SZ00000LT000

Artwork Proof Box
Ref: V043 - update texts in line with orginator + national phase
Proof no.
014.1

Date prepared:
17/11/2014

Colours:
Black
Dimensions: 165 x 620 mm

Font size:
9pt
Fonts:
Helvetica

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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