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FORAVEN XL 75MG MODIFIED RELEASE CAPSULES
Active substance(s): VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE
75mg and 150mg
MODIFIED RELEASE CAPSULES
The name of your medicine is FORAVEN XL 75mg or 150mg
modified release capsules, referred to as FORAVEN XL Capsules or
venlafaxine throughout this leaflet.
Please read this leaflet carefully before you start to
take this medicine.
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.
• Keep this leaflet. You may need to read it again.
• If you have further questions, please ask your doctor or
• 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. What FORAVEN XL Capsules are and what they are
2. Before you take FORAVEN XL Capsules
3. How to take FORAVEN XL Capsules
4. Possible side effects
5. How to store FORAVEN XL Capsules
6. Further information
1. WHAT FORAVEN XL CAPSULES ARE
AND WHAT THEY ARE USED FOR
The active ingredient in the capsules is venlafaxine which is an
antidepressant. The capsules are a modified release capsule which
means you only need to take your medicine once a day.
Venlafaxine belongs to a group of antidepressant medicines called
serotonin norepinephrine reuptake inhibitors (SNRIs). It is thought
that people who are depressed may have lower levels of serotonin
and norepinephrine in their brain. Venlafaxine may help to relieve
the symptoms of depression by increasing the levels of these
substances in the brain.
You have been given FORAVEN XL Capsules because you are
suffering from the symptoms of depressive illness which may or
may not be accompanied by anxiety. FORAVEN XL Capsules are
a treatment which can relieve these symptoms and help you get
Your doctor may continue to give you FORAVEN XL Capsules when
you are feeling better to prevent your symptoms from returning or
prevent you from becoming depressed in the future.
You may find it helpful to tell a friend or relative that you are
depressed or suffering from symptoms of anxiety, and ask them to
read this leaflet. You might ask them to tell you if they think your
depression is getting worse, or if they are worried about any other
changes in your behaviour.
2. BEFORE YOU TAKE FORAVEN XL CAPSULES
Do not take FORAVEN XL Capsules if you:
• Are allergic to any of the ingredients in FORAVEN XL
• Are taking or have taken within the last 14 days
any medicines known as irreversible monoamine
oxidase inhibitors (also known as MAOIs), used to treat
depression or Parkinson’s disease. If you are prescribed a MAOI
you must discontinue FORAVEN XL and must not start taking
the MAOI for at least 7 days after stopping. Examples of MAOIs
are rasagiline, selegiline, phenelzine, tranylcypromine and
Tell your doctor before taking FORAVEN XL Capsules if you think
any of the above applies to you.
Take special care with FORAVEN XL Capsules and tell
your doctor or pharmacist if you:
• Are taking any other medicines that could increase the risk if
developing serotonin syndrome (see the section “Taking other
• Have liver or kidney disease. Your dose of venlafaxine
capsules may be lowered.
• Have heart problems, such as a previous heart disease (ask
your doctor if you are not sure).
• Have ever had high blood pressure.
• Have had a history of low sodium levels in your blood
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.
Use in children and adolescents under 18
FORAVEN XL Capsules should normally not be used for children
and adolescents under 18 years because it has not been proven to
be an effective medicine in this age-group. Also you should know
that patients under 18 years have an increased risk of side effects
such as suicidal thoughts and hostility (predominantly aggression,
oppositional behaviour and anger) when they take this class of
medicines. Despite this, your doctor may prescribe FORAVEN XL
Capsules for patients under 18 because he/she decides that this is
in their best interest. If your doctor has prescribed FORAVEN XL
Capsules for a patient under 18 (you or your child) 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 a patient under 18 is taking FORAVEN XL
Also the long-term safety effects of venlafaxine concerning growth,
maturation and cognitive and behavioural development in this age
group have not yet been demonstrated.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without
prescription or if you are taking herbal remedies.
• Monoamine oxidase inhibitors (MAOIs). Irreversible
MAOIs must not be taken with FORAVEN XL (see the top of
this section “Before you take FORAVEN XL”). There is a risk of
serotonin syndrome (see below) when venlafaxine is used with
medicines containing reversible MAOIs which include;
- Linezolid, an antibiotic (used to treat infections)
- Moclobemide, a reversible MAOI (used to treat depression)
• Serotonin syndrome is a potentially life-threatening
condition (see the section “Possible side-effects”), and 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 for weight loss such as sibutramine and
- 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
- 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. If you develop any of these signs or
symptoms, tell your doctor immediately or go quickly
to the casualty department of the nearest hospital.
The following medicines may also interact with FORAVEN XL and
so it is important to mention to your doctor or pharmacist if you:
• Are taking cimetidine (to treat stomach problems) and are
elderly or have liver problems, since cimetidine might
increase the effect of venlafaxine.
• Are taking any ketoconazole (for treatment of fungal
infection); since it can effect the way venlafaxine passes
through your body.
• Are taking warfarin (blood thinner).
• Are taking haloperidol, risperidone, clozapine or other drugs
• Are taking metoprolol (a beta blocker) to treat high blood
pressure and heart problems.
• Are taking medication for AIDS or HIV e.g. indinavir.
Similarly, tell your doctor or pharmacist that you are taking
venlafaxine before taking any other drugs or if you enter hospital
• 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 (such as
warfarin to prevent blood clots).
Pregnancy and breast-feeding
• Have had epilepsy or fits (seizures). Your doctor will
supervise you carefully while you are taking venlafaxine
If you are a woman of child-bearing age, you are recommended to
use contraception whilst taking venlafaxine capsules. If, however,
you are pregnant or intend to become pregnant whilst taking
venlafaxine you should talk to your doctor.
• Are having electroconvulsive therapy (ECT) for
• Have ever suffered from, or have a family history of, mania or
bipolar disorder (feeling elated or over-excited).
• Have eye problems or suffer from, or have a history of,
• Have a history of aggressive behaviour.
• Have diabetes.
• Have high cholesterol levels.
• Are being treated for weight-loss.
FORAVEN XL may cause a sensation of restlessness or an inability
to sit or stand still (usually within the first few weeks). You
should tell your doctor if this happens to you at any time during
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
You may be more likely to think like this:
• If you have previously had thoughts about killing or harming
• 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 thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
Ask your doctor or pharmacist for advice before taking any
medicine if you are pregnant; intend to become pregnant or
If you are already taking venlafaxine and have just found out
you are pregnant, you should talk to your doctor immediately.
For some women it would be better to gradually stop taking
venlafaxine, but in some circumstances a woman may agree with
her doctor that she should continue to take venlafaxine.
Make sure your midwife and/or doctor know you are on Foraven XL
Capsules. When taken during pregnancy, similar drugs (SSRIs) may
increase the risk of a serious condition in babies, called persistent
pulmonary hypertension of the new born (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
If you are taking venlafaxine in the last three months of pregnancy
you should let your midwife know as your baby might have some
symptoms. These could appear within the first 24 hours after being
born. Possible effects might include crying a lot, not feeding or
sleeping properly, vomiting, blue-ish skin or they feel too hot or too
cold, difficulty breathing, rigid or floppy muscles, listlessness and
the shakes or fits. If your baby has any of these symptoms or you
are concerned, you should contact your midwife or doctor.
If you are breast-feeding, venlafaxine may get into breast milk
in very small amounts, and you should discuss with your doctor
whether to continue treatment or gradually stop.
Driving and using machines
Possible side effects of venlafaxine include confusion, dizziness
and blurred vision. If you get these side effects do not drive or use
Important information about some of the ingredients
The capsule shells of 150mg FORAVEN XL Capsules contain
sunset yellow (E110) and allura red (E129) colorants which
may sometimes cause allergic reactions. For the complete list of
colorants please refer to section “What your medicine contains”.
3. HOW TO TAKE FORAVEN XL CAPSULES
Method of administration
Do not break open, crush or chew the capsules, or put them in
water before swallowing.
The capsules should be swallowed whole with a drink of water
after food at approximately the same time each day, either in the
morning or in the evening.
You should avoid alcohol while you are taking FORAVEN XL
Common (affects less than 1 person in 10 users):
• weight loss; increased cholesterol
• abnormal dreams; decreased libido; dizziness; increased muscle
tonus; insomnia; nervousness; pins and needles; sedation;
tremor; confusion; feeling separated (or detached) from yourself
• blurred vision
• increase in blood pressure; flushing; palpitations
• decreased appetite; constipation; vomiting
Your doctor will tell you how much you should take and how often.
Always follow you doctor’s instructions exactly and
those printed on the pharmacy label.
• difficulties passing urine; increased frequency in urination
For depression the usual starting dose is one 75mg capsule a day.
However, your doctor may decide a different dose is better for you.
If you are elderly or have liver or kidney problems your doctor may
start with a lower dose. Do not take more than advised by
Also the label on your medicine will tell you how many capsules
to take and how often. If it does not, or you are not sure, ask your
doctor or pharmacist.
Your doctor may have changed your treatment from Venlafaxine
Tablets (which, unlike your capsules, are not of modified release
formulation) to FORAVEN XL Capsules. If so, your doctor will have
decided which dose of FORAVEN XL Capsules is closest to your
total daily dose of Venlafaxine Tablets. This dose of FORAVEN XL
Capsules should only be taken once daily.
• abnormal ejaculation/orgasm (males); lack of orgasm; erectile
dysfunction (impotence); menstrual irregularities such as
increased bleeding or increased irregular bleeding
• weakness (asthenia); chills
Uncommon (affects less than 1 person in 100 users):
• bruising; black tarry stools (faeces) or blood in stools, which can
be a sign of internal bleeding
• weight gain
• lack of feeling or emotion; hallucinations; involuntary movement
of the muscles; agitation; impaired coordination and balance
• altered taste sensation; ringing in the ears (tinnitus)
• feeling dizzy (particularly when standing up too quickly),
fainting, fast heartbeat
• grinding of the teeth; diarrhoea
• rash; abnormal hair loss
• inability to pass urine
It may take a few weeks or more before you feel your medicine is
having an effect and you may need to take venlafaxine for several
months. If so, do not worry – this is not uncommon.
• abnormal orgasm (females)
Your doctor may wish to monitor your blood pressure and heart
rate particularly if you require treatment with high (greater than
200mg a day) doses of FORAVEN XL Capsules.
If your condition does not improve after some time your doctor
may decide that the treatment with FORAVEN XL Capsules should
If you have taken more FORAVEN XL Capsules than you
Always take your medicine as your doctor recommended. If
you take too many capsules you must seek immediate medical
attention, even if you feel well, because of the risk of serious side
effects. Remember to take the pack with you, even if it is empty.
If you forget to take FORAVEN XL Capsules
Do not worry if you forget to take a capsule. You can take it up to
12 hours after you usually take it then take your next capsule at
the usual time. If the period after the missed dose is more than 12
hours, you should miss the dose altogether and just take your next
capsule at the usual time. Do not take a double dose to make up
for a forgotten dose.
If you stop taking FORAVEN XL Capsules
Do not stop taking your capsules or change the dose without the
advice of your doctor even if you feel better. If your doctor thinks
that you no longer need venlafaxine he/she will ask you to reduce
your dose slowly before stopping treatment altogether. This should
help reduce the chance of withdrawal symptoms. If venlafaxine is
stopped suddenly or the dose reduced too quickly, some patients
may experience symptoms such as tiredness, dizziness, lightheadedness, headache, sleeplessness, nightmares, dry mouth, loss
of appetite, feeling or being sick, diarrhoea, nervousness, agitation,
confusion, ringing in the ears, tingling or rarely electric shock
sensations, weakness, poor co-ordination, shaking, sweating, fits
(seizures) or flu-like symptoms.
Around 3 in 10 patients may notice symptoms on stopping
venlafaxine but these symptoms are generally mild and disappear
within a few days. In rare cases they can be more severe, usually
in the first few days of discontinuation, or can last longer.
Your doctor will advise you on how you should gradually
discontinue venlafaxine treatment. If you experience any
of these or other symptoms which are troublesome,
return to your doctor for further advice. Your doctor may
ask you to come off your treatment more slowly.
4. POSSIBLE SIDE EFFECTS
Like all medicines, FORAVEN XL Capsules can cause side effects,
although not everybody gets them.
Very serious side effects
If any of the following happen, stop taking FORAVEN XL
Capsules and tell your doctor immediately, or go to
the casualty department at your nearest hospital.
An allergic reaction which may occur as
• Swollen face, tongue, hands or feet
• Shortness of breath, chest tightness, difficulty breathing or
• Severe skin rash, itching or hives (elevated patches of red or
pale skin that often itch)
Signs and symptoms of serotonin syndrome (see the section
“Taking other medicines”) which can include euphoric feelings
(feeling ‘high’ or over-excited), drowsiness, sustained rapid eye
movement, clumsiness, restlessness, feeling of being drunk,
sweating or rigid muscles.
Serious side effects
Tell your doctor immediately or go to your local hospital emergency
department as you may need medical attention if you experience
any of the following:
• Rapid or irregular heart beat, flushing or fainting.
• Frequent or unusual bruising or bleeding, such as nose bleeds
(this could indicate that venlafaxine has had an effect on your
blood, and this may need to be tested).
• A condition called neuroleptic malignant syndrome (resembling
serotonin syndrome) which can include high temperature with
rigid muscles, confusion or agitation, sweating or experiencing
jerky muscle movements which you cannot control.
• Black tarry stools, which can be a sign of internal bleeding.
• Severe muscle tenderness, stiffness or weakness, especially if
accompanied by dark urine (this can be caused by abnormal
muscle breakdown leading to kidney problems).
• Severe abdominal or back pains (which could indicate a serious
problem in the gut, liver or pancreas).
Side effects on withdrawal
Some side effects can appear after you have stopped taking
FORAVEN XL. Refer to the section “If you stop taking FORAVEN XL
Complete list of side effects
You should tell your doctor as soon as possible if the effects are
becoming troublesome or continue for more than a few days.
Very common (affects more than 1 person in 10 users):
• dry mouth; headache
• sweating (including night sweats)
• sensitivity to sunlight
• swelling of tongue, lips, face or throat (angioedema)
Rare (affects less than 1 person in 1000 users):
• a sensation of restlessness or an inability to sit or stand still;
seizures or fits; feeling overexcited or euphoric
Not known (frequency cannot be estimated from the
• 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
• 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
• 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; a feeling of dizziness or
“spinning” (vertigo); aggression
• severe eye pain and decreased or blurred vision
• decrease in blood pressure; abnormal, rapid or irregular heart
beat, which could lead to fainting
• 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
• severe abdominal or back pains (which could indicate a serious
problem in the gut, liver or pancreas)
• skin rash, which may lead to severe blistering and peeling of the
skin; itching; mild rash
• unexplained muscle pain, tenderness or weakness
• swollen face or tongue, shortness of breath or difficulty
breathing, often with skin rashes (this may be a serious allergic
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.
Effects on laboratory tests
Venlafaxine sometimes causes unwanted effects which you may
not be aware of, such as increases in blood pressure or abnormal
heart beat; slight changes in blood levels of liver enzymes, sodium
or cholesterol. More rarely, venlafaxine may reduce the number
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 venlafaxine for a
5. HOW TO STORE FORAVEN XL CAPSULES
KEEP THIS MEDICINE IN A SAFE PLACE WHERE CHILDREN
CANNOT REACH OR SEE IT. YOUR MEDICINE COULD
You should not use this medicine after the expiry date shown on
Store in the original package to protect from moisture. Do not
store above 25°C.
If your doctor decides to stop treatment, return any leftover
capsules to your pharmacist. Only keep them if your doctor tells
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
needed. These measures will help to protect the environment.
6. FURTHER INFORMATION
What your medicine contains
There are two strengths of FORAVEN XL Capsules. The 75mg
strength contains 75mg of venlafaxine base (as active ingredient)
in form of venlafaxine hydrochloride; the 150mg strength contains
150mg of venlafaxine base. In both strengths the active ingredient
is in a modified release formulation which means you only need to
take your medicine once a day.
Other ingredients in these capsules are: microcrystalline cellulose
(E460), povidone (E1201), talc (E553b), colloidal anhydrous silica,
magnesium stearate (E470b), ethyl cellulose (E462), copovidone,
gelatine, titanium dioxide (E171), black and red iron oxides (E172;
colorants in the 75mg strength only), brilliant blue/sunset yellow/
allura red colorants (E133, E110 and E129, respectively; colorants
in the 150mg strength only) and printing inks.
What your medicine looks like and contents of the
The 75mg capsules are opaque peach coloured and have a thick
and a thin radial circular band on the body and also on the cap
of the capsules in red ink. The 150mg capsules are opaque dark
orange coloured and have a thick and a thin radial circular band on
the body and also on the cap of the capsules in white ink.
The 75mg and 150mg capsules come in packs of 28 capsules.
Marketing authorisation holder and manufacturer
Forum Products Ltd, Crown House, 2-8 Gloucester Road,
Redhill, RH1 1FH
Leaflet approval date: August 2014
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.