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VENLABLUE XL 150 MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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Bluefish Pharmaceuticals
Reason of change
Product name

Revised text received on 20.06.16

Venlablue XL Capsules

Strength

37.5/75/150 mg

Country

UK

Dimension

Packs

Artwork code

-

Manufacturer

Revision
History

No. of colours

01

Pantone Shades
Alembic

Black

Leaflet

Artwork made to

100%
Blister Layout No.:

NA

Reviewed
&
Approved by

M/VEN/UK/P01

02

200 x 600 mm

Component
Braille

Revision no.

NA
PDC

QA

Remarks Font Size - Heading 15, 12 pts.
Rest all 9 pts.

RA

Date: 20.06.2016
R1 - Initial Mock-up Artwork (AM-16-042) - 10.05.16

200 mm

United Kingdom

PACKAGE LEAFLET: INFORMATION FOR THE USER
Venlablue XL 37.5 mg, prolonged-release capsules, hard
Venlablue XL 75 mg, prolonged-release capsules, hard
Venlablue XL 150 mg, prolonged-release capsules, hard
Venlafaxine
Read all of this leaflet carefully before you start taking this
medicine.





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. Do not pass it on to
others. It may harm them, even if their symptoms are the same as
yours.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor or
pharmacist.

In this leaflet:
1.
2.
3.
4.
5.
6.

What Venlablue XL is and what it is used for
Before you take Venlablue XL
How to take Venlablue XL
Possible side effects
How to store Venlablue XL
Further information

1. WHAT VENLABLUE XL IS AND WHAT IT IS USED FOR
Venlablue XL 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.
Venlablue XL is a treatment for adults with depression.
Venlablue 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. BEFORE YOU TAKE VENLABLUE XL

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Do not take Venlablue XL
- if you are allergic to venlafaxine or any of the other
ingredients of Venlablue XL
- If you are also taking or have taken 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 Venlablue XL, can cause
serious or even life-threatening side effects. Also, you must
wait at least 7 days after you stop taking Venlablue XL
before you take any MAOI (see also the sections “Serotonin
syndrome” and “Taking other medicines”).
Take special care with Venlablue XL
• If you use other medicines that taken concomitantly with
Venlablue XL could increase the risk of developing serotonin
syndrome (see the section “Taking other medicines”).
• 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.
• 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.
Venlablue 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.

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 (a pain-killer)
• 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)
Signs and symptoms of serotonin syndrome may include a
combination of the following:
restlessness, hallucinations, loss of coordination, fast heart beat,
increased body temperature, fast changes in blood pressure,
overactive reflexes, diarrhoea, coma, nausea, vomiting. Get
medical care right away if you think serotonin syndrome is
happening to you.
The following medicines may also interact with Venlablue 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)
Taking Venlablue XL with food and drink
Venlablue XL should be taken with food (See section 3).
You should avoid alcohol while you are taking Venlablue XL.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or you are trying to
become pregnant. You should use Venlablue XL only after
discussing the potential benefits and the potential risks to your
unborn child with your doctor.
If you are taking Venlablue XL during pregnancy, your baby
might present difficulties in feeding properly when it is born.
These symptoms usually begin during the first 24 hours after the
baby is born. They include trouble with 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.
Venlablue 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 Venlablue XL.
Make sure your midwife and/or doctor knows you are on
Venlablue XL. When taking 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.
Driving and using machines
Do not drive or use any tools or machines until you know how
Venlablue XL affects you.
Important information about some of the ingredients of
Venlablue XL
Venlablue XL 150 mg contains the colouring agents allura red
and sunset yellow which may cause allergic reactions.
3. HOW TO TAKE VENLABLUE XL

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

Always take Venlablue XL exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not
sure.

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 you first starting antidepressants, since
these medicines all take time to work, usually about two weeks,
but sometimes longer.

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/day.

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 young adults
(less than 25 years old) with psychiatric conditions who were
treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
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.
Dry mouth
Dry mouth is reported in 10% of patients treated with
venlafaxine. This may increase the risk of caries. Therefore, you
should take special care in your dental hygiene.

Take Venlablue 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. Chewing, crushing or dissolving the content of the
capsule may damage the film coating that modifies the release of
the drug.
Venlablue XL should be taken with food.
Do not be concerned if you see small white granules or balls in
your stools after taking Venlablue XL. Inside Venlablue 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.
If you have liver or kidney problems, talk to your doctor, since
your dose of Venlablue XL may need to be different.

Use in children and adolescents under 18 years of age
Venlablue 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
Venlablue XL for patients under 18 because he/she decides that
this is in their best interests. If your doctor has prescribed
Venlablue 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 above develop or worsen
when patients under 18 are taking Venlablue XL. Also, the
long-term safety effects concerning growth, maturation and
cognitive and behavioural development of Venlablue XL in this
age group has not yet been demostrated.

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

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription.

If you stop taking Venlablue XL
Do not stop taking your treament or reduce the dose without the
advice of your doctor even if you feel better. If your doctor thinks
that you no longer need Venlablue XL he/she will ask you to
reduce your dose slowly before stopping treatment altogether.
Side effects are known to occur whe people stop using Venlablue
XL, especially when Venlablue XL is stopped suddenly or the
dose 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 should decide whether you can take Venlablue XL
with other medicines.
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 (MAOIs: see the section
“Before you take Venlablue XL”).
• Serotonin syndrome:
• Serotonin syndrome, a potentially life-threatening condition
(see the section “Possible Side Effects”), may occur with

If you take more Venlablue XL than you should
Call your doctor or pharmacist immediately if you take more than
the amount of Venlablue 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 Venlablue 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
Venlablue XL that has been prescribed for you in one day.

Your doctor will advise you on how you should gradually
discontinue Venlablue XL treatment. If you experience any of

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these or other symptoms that are troublesome, ask your doctor
for further advice.
If you have any further questions on the use of this product, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Venlablue XL can cause side effects,
although not everybody gets them.
Allergic reactions
If any of the following happen, do not take more Venlablue XL.
Tell your doctor immediately, or go to the casualty department at
your nearest hospital:
• Chest tightness, wheezing, trouble swallowing or breathing
• Swelling of the face, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations,
sudden reddening of the skin and/or a warm feeling
• Severe rash, itching, or hives (elevated patches of red or pale
skin that often itch)
Serious side effects
If you notice any signs of the following, you may need urgent
medical attention:
• Heart problems, such as fast or irregular heart rate, increased
blood pressure
• Eye problems, such as blurred vision, dilated pupils
• Nerve problems, such as dizziness, pins and needles,
movement disorder, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria
• Treatment withdrawal (see the section “How to take
Venlablue XL, if you stop taking Venlablue XL”).
Complete side effect listing
The frequency (likelihood of occurring) of side effects is
classified as follows:
Very common
Common
Uncommon
Rare
Not known


Affects more than 1 user in 10
Affects 1 to 10 users in 100
Affects 1 to 10 users in 1,000
Affects 1 to 10 users in 10,000
Frequency cannot be estimated from the
available data

Blood and lymphatic system disorders
Uncommon: bruising; black tarry stools (faeces) or blood in
stools, which can be a sign of internal bleeding
Not known: reduced number of platelets in your blood,
leading to an increased risk of bruising or bleeding; blood
disorders which may lead to an increased risk of infection



Immune system disorders
Uncommon: Photosensitivity reaction
Not known: Anaphylaxis



Metabolism and nutrition disorders
Common: weight loss; increased cholesterol
Uncommon: weight gain
Not known: slight changes in blood levels of liver enzymes;
decrease in blood sodium levels; itchiness, yellow skin or eyes,
dark urine, or flu-like symptoms, which are symptoms of
inflammation of the liver (hepatitis); confusion, excessive water
intake (known as SIADH); abnormal breast milk production

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Nervous system disorders
Very common: dry mouth; headache
Common: abnormal dreams; decreased libido; dizziness;
increased muscle tonus; insomnia; nervousness; pins and
needles; sedation; tremor; confusion; feeling separated (or
detached) from yourself and reality.
Uncommon: lack of feeling or emotion; hallucinations;
involuntary movement of the muscles; agitation; impaired
coordination and balance.
Rare: a sensation of restlessness or an inability to sit or stand
still; seizures or fits; feeling overexcited or euphoric.
Not known: 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; euphoric feelings, drowsiness, sustained rapid eye
movement, clumsiness, restlessness, feeling of being drunk,
sweating or rigid muscles, which are symptoms of
serotonergic syndrome; disorientation and confusion often
accompanied by hallucination (delirium); stiffness, spasms
and involuntary movements of the muscles; thoughts of
harming or killing yourself
Eye disorders
Common: blurred vision
Not known: severe eye pain and decreased or blurred vision



Ear and labyrinth disorders
Uncommon: ringing in the ears (tinnitus)



Cardiac disorder
Common: increase in blood pressure; flushing; palpitations
Uncommon: feeling dizzy (particularly when standing up too
quickly), fainting, fast heartbeat Not known: decrease in
blood pressure; abnormal, rapid or irregular heart beat, which
could lead to fainting



Respiratory, thoracic and mediastinal disoreder
Common: yawning
Not known: 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)



Gastrointestinal disorders
Very common: nausea
Common: appetite decreased; constipation; vomiting
Uncommon: grinding of the teeth; diarrhoea, altered taste
sensation
Not known: severe abdominal or back pains (which could
indicate a serious problem in the gut, liver or pancreas)



Skin and subcutaneous tissue disorders
Very common: sweating (including night sweats)
Common: chills
Uncommon: rash; abnormal hair loss
Not known: skin rash, which may lead to severe blistering
and peeling of the skin; itching; mild rash



Musculoskeletal and connective tissue disorders
Not known: unexplained muscle pain, tenderness or
weakness (rhabdomyolysis)



Renal and urinary disorders
Common: difficulties passing urine; increased frequency in
urination
Uncommon: inability to pass urine



Reproductive system and breast disorder
Common: abnormal ejaculation/orgasm (males); lack of
orgasm; erectile dysfunction (impotence); menstrual
irregularities such as increased bleeding or increased irregular
bleeding
Uncommon: abnormal orgasm (females)



General disorders and administration site conditions
Common: weakness (asthenia)
Uncommon: sensitivity to sunlight
Not known: swollen face or tongue, shortness of breath or
difficulty breathing, often with skin rashes (this may be a
serious allergic reaction)

Venlablue XL sometimes causes unwanted effects that you may
not be aware of, such as increases in blood pressure or abnormal
heart beat; slight changes in blood levels or liver enzymes,

sodium or cholesterol. More rarely, Venlablue XL 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
Venlablue XL for a long time.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE VENLABLUE XL
Keep out of the reach and sight of children.
Do not use Venlablue XL after the expiry date which is stated on
the carton after EXP. The expiry date refers to the last day of that
month.
Do not store above 30°C.
Do not use Venlablue XL if you notice that the capsules are sticky.
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. FURTHER INFORMATION
What Venlablue XL contains
The active substance is venlafaxine.
Each capsule contains: Venlafaxine hydrochloride, corresponding
to 37,5 mg Venlafaxine.
Each capsule contains: Venlafaxine hydrochloride, corresponding
to 75 mg Venlafaxine.
Each capsule contains: Venlafaxine hydrochloride, corresponding
to 150 mg Venlafaxine.
The other ingredients are
Tablet core:
microcrystalline cellulose, povidone, talc, silica, colloidal
anhydrous, magnesium stearate
Tablet film coat:
ethyl cellulose, copovidone
37.5 mg
Capsule:
black iron oxide (E172), red iron oxide (E172), yellow iron oxide
(E172), titanium dioxide (E171), gelatin
Printing Inks:
Shellac, red iron oxide
75 mg:
Capsule:
black iron oxide (E172), red iron oxide (E172), titanium dioxide
(E171), gelatin
Printing Inks:
Shellac, red iron oxide
150 mg:
Capsule:
allura red (E129), sunset yellow FCF (E110), brilliant blue FCF
(E133), titanium dioxide (E171), gelatin
Printing Inks:
Shellac, titanium dioxide
What Venlablue XL looks like and contents of the pack
Prolonged release capsule, hard
37,5 mg: Light grey opaque / peach opaque, size ‘3’ hard gelatin
capsules having thick and thin radial circular band on the body in
red ink and thick and thin radial circular band on the cap in red
ink. The capsule is filled with 3 white to off-white, round,
biconvex, film coated mini tablets of 12.5 mg each.
75 mg: Peach opaque / peach opaque, size ‘1’ hard gelatin
capsules having thick and thin radial circular band on the body in
red ink and thick and thin radial circular band on the cap in red
ink. The capsule is filled with 6 white to off-white, round,
biconvex, film coated mini tablets of 12.5 mg each.
150 mg: Dark orange / dark orange opaque, size ‘0’ hard gelatin
capsules having thick and thin radial circular band on the body in
white ink and thick and thin radial circular band on the cap in
white ink. The capsule is filled with 12 white to off-white, round,
biconvex, film coated mini tablets of 12.5 mg each.
Blister packs of PVC/Aclar film and aluminium foil; 10, 14, 28,
30, 50 & 100 capsules
Blister packs of PVC/PVdC film and aluminium foil; 10, 14, 28,
30, 50 & 100 capsules
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm, Sweden
Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm, Sweden
This medicinal product is authorised in the Member States of
the EEA under the following names:
Name of the
Member State
Name of the medicinal product
Austria
Venlafaxin Bluefish 75 mg/150 mg
Hartkapseln, retardiert
Czech Republic
Venlafaxine Bluefish 75 mg/150 mg Tvrdá
tobolka s prodlouženým uvolnováním
Denmark
Venlafaxin Bluefish XR 75 mg/150 mg
Finland
Venlafaxine Bluefish 75 mg/150 mg
depotkapseli, kova
Venlafaxine Bluefish 75 mg/150 mg
depotkapsel, hård
France
Venlafaxine Bluefish LP 37.5 mg/75 mg/
150 mg gélules à libération prolongée
Germany
Venlafaxin Bluefish 75/150 mg
Hartkapseln, retardiert
Greece
Venlafaxine Bluefish XR 75 mg/150 mg
Κάψουλες παρατεταμένης αποδέσμευσης
Hungary
Venlafaxine Bluefish XR 75 mg/150 mg
Nyújtott hatóanyagleadású kapszulák
Ireland
Venlablue XL 75 mg/150 mg
prolonged-release capsules, hard
Italy
Venlafaxina ABC 75 mg/150 mg Capsule a
rilascio prolungato
Netherlands
Venlafaxine Bluefish XR 37.5 mg/75 mg/
150 mg Capsules met verlengde afgifte
Norway
Venlafaxine Bluefish XR
Poland
Venlafaxine Bluefish XL
Portugal
Venlafaxina Bluefish XR
Slovakia
Venlafaxine Bluefish XR 75 mg/150 mg
tvrdé kapsuly s predĺženým uvoľňovaním
Spain
Venlafaxina Bluefish 75 mg/150 mg
Cápsulas de liberación prolongada
Sweden
Venlafaxine Bluefish 37.5 mg/75 mg/
150 mg depotkaplar, hårda
United Kingdom Venlablue XL 37.5mg/75 mg/150 mg
(RMS)
prolonged-release capsules, hard
This leaflet was last approved in 06/2016

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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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