CONVALEMIN XL 150 MG PROLONGED RELEASE CAPSULES

Active substance: VENLAFAXINE HYDROCHLORIDE

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CONVALEMIN XL 37.5 mg, 75 mg & 150 mg
Prolonged Release Capsules
(venlafaxine hydrochloride)
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 further questions, please ask your doctor or your 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. What Convalemin XL Prolonged Release Capsules are and what they are
used for
2. Before you take Convalemin XL Prolonged Release Capsules
3. How to take Convalemin XL Prolonged Release Capsules
4. Possible side effects
5. How to store Convalemin XL Prolonged Release Capsules
6. Further information
1. WHAT CONVALEMIN XL PROLONGED RELEASE CAPSULES ARE AND WHAT
THEY ARE USED FOR
Convalemin XL Prolonged Release Capsules contain the active ingredient venlafaxine hydrochloride. Venlafaxine hydrochloride 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.
Convalemin XL Prolonged Release Capsules are used to treat adults with depression. Convalemin XL Prolonged Release Capsules are also a treatment for adults
with the following anxiety disorders: generalised anxiety disorder, social anxiety
disorder (fear or avoidance of social situations) and panic disorder (panic attacks).
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 CONVALEMIN XL PROLONGED RELEASE CAPSULES
Do not take Convalemin XL Prolonged Release Capsules if:
• You are allergic (hypersensitive) to venlafaxine hydrochloride, or to any of the
other ingredients of Convalemin XL Prolonged Release Capsules.
• 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 Convalemin XL Prolonged Release Capsules, can
cause serious or even life-threatening side effects. Also, you must wait at least 7
days after you stop taking Convalemin XL Prolonged Release Capsules before
you take any MAOI (see also the sections “Serotonin syndrome” and “Taking
other medicines”).
Take special care with Convalemin XL Prolonged Release Capsules
• If you use other medicines that taken concomitantly with Convalemin XL
Prolonged Release Capsules 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.
• If you have been told by your doctor that you have an intolerance to some
sugars (e.g. sucrose).
Convalemin XL Prolonged Release Capsules 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
Convalemin XL Prolonged Release Capsules.
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 start
taking 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 yourself 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.
Use in children and adolescents under 18 years of age
Convalemin XL Prolonged Release Capsules 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 Convalemin XL Prolonged Release Capsules for patients under 18 because he/she decides

that this is in their best interests. If your doctor has prescribed Convalemin
XL Prolonged Release Capsules 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 Convalemin XL Prolonged Release Capsules. Also, the
long-term safety effects concerning growth, maturation and cognitive and
behavioural development of Convalemin XL Prolonged Release Capsules in
this age group has not yet been demonstrated.
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.
Your doctor should decide whether you can take Convalemin XL Prolonged
Release Capsules 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
Convalemin XL Prolonged Release Capsules”).
• 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 (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 Convalemin XL Prolonged
Release Capsules 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 your medicine with food and alcohol
Convalemin XL Prolonged Release Capsules should be taken with food (see
section 3 “HOW TO TAKE CONVALEMIN XL PROLONGED RELEASE
CAPSULES”).
You should avoid alcohol while you are taking Convalemin XL Prolonged
Release Capsules.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or you are trying to become
pregnant. You should take Convalemin XL Prolonged Release Capsules only
after discussing the potential benefits and the potential risks to your unborn
child with your doctor.
If you are taking Convalemin XL Prolonged Release Capsules during
pregnancy, let your midwife and/or doctor know, as your baby might have
some symptoms when it is born. These symptoms usually begin during the
first 24 hours after the baby is born. They include not feeding properly and
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.
Make sure your midwife and/or doctor know you are on Convalemin XL
Prolonged Release 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 immediately.
Venlafaxine hydrochloride 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 Convalemin XL Prolonged Release Capsules.
Driving and using machines
Do not drive or use any tools or machines until you know how Convalemin
XL Prolonged Release Capsules affect you.
Important information about some of the ingredients of Convalemin XL
Prolonged Release Capsules
Some of the colourants in Convalemin XL Prolonged Release Capsules may
cause allergic reactions. If you have been told by your doctor that you have
an intolerance to some sugars, contact your doctor before taking this
medicinal product.
3. HOW TO TAKE CONVALEMIN XL PROLONGED RELEASE CAPSULES
Dosage
Always take Convalemin XL Prolonged Release Capsules exactly as your
doctor has told you. You should check with your doctor or pharmacist if you
are not sure.
Take Convalemin XL Prolonged Release Capsules 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.
Convalemin XL Prolonged Release Capsules should be taken with food.
The usual adult doses for different conditions are as follows:
Depression:
• The usual recommended starting dose for treatment of depression 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 per day.

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PATIENT INFORMATION LEAFLET

PACKAGING DEVELOPMENT
Product Name : Convalemin 37.5mg, 75mg & 150mg (PIL)
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4. POSSIBLE SIDE EFFECTS
Like all medicines, Convalemin XL Prolonged Release Capsules 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 Convalemin XL Prolonged Release Capsules. Inside Convalemin XL
Prolonged Release 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.
Allergic reactions
If any of the following happen, do not take more Convalemin XL Prolonged
Release Capsules. 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 CONVALEMIN XL
PROLONGED RELEASE CAPSULES, if you stop taking Convalemin XL
Prolonged Release Capsules”).
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 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
• Metabolism/nutritional 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
• 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 over-excited 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
• Sight and hearing disorders
Common: blurred vision
Uncommon: altered taste sensation; ringing in the ears (tinnitus)
Not known: severe eye pain and decreased or blurred vision
• Heart or circulation disorders
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
• Breathing disorders
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)
• Digestive disorders
Very common: nausea
Common: appetite decreased; constipation; vomiting
Uncommon: grinding of the teeth; diarrhoea
Not known: severe abdominal or back pains (which could indicate a serious
problem in the gut, liver or pancreas)
• Skin disorders
Very common: sweating (including night sweats)
Uncommon: rash; abnormal hair loss
Not known: skin rash, which may lead to severe blistering and peeling of the
skin; itching; mild rash
• Muscle disorders
Not known: unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Urinary system disorders
Common: difficulties passing urine; increased frequency in urination
Uncommon: inability to pass urine
• Reproductive and sexual disorders
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
Common: weakness (asthenia); chills
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)
Convalemin XL Prolonged Release Capsules 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, Convalemin XL Prolonged Release Capsules 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 Convalemin XL Prolonged
Release Capsules 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 CONVALEMIN XL PROLONGED RELEASE CAPSULES
Keep your capsules in the pack in which they are supplied to protect them from
moisture. Store the pack below 30ºC. Do not use them after the expiry date
which is shown on the pack after EXP. The expiry date refers to the last day of
that month.
Keep all medicines out of the reach and sight of children.
Medicines should not be disposed of via waste water or household waste. Ask
your pharmacist how to dispose of medicines no longer required. These
measures will help protect the environment.
6. FURTHER INFORMATION
What Convalemin XL Prolonged Release Capsules contain:
The active ingredient in Convalemin XL Prolonged Release Capsules is
venlafaxine hydrochloride.
The inactive ingredients are: sucrose, maize starch, hydroxypropyl cellulose,
hydroxypropylmethyl cellulose, talc, ethyl cellulose, dibutyl sebacate,
oleic acid, colloidal anhydrous silica, sodium lauryl sulphate and gelatin
(capsule shell only). Colouring agents included in the 37.5 mg capsule shells
are Ponceau 4R (E124), quinoline yellow (E104) and titanium dioxide (E171).
Colouring agents included in the 75 mg capsule shells are sunset yellow
(E110), quinoline yellow and titanium dioxide. Colouring agents included in the
150 mg shells are sunset yellow, quinoline yellow, patent blue (E131) and
titanium dioxide.
What Convalemin XL Prolonged Release Capsules look like and contents of
the pack:
Convalemin XL Prolonged Release Capsules come in three strengths.
Convalemin XL 37.5 mg Capsules are orange/clear capsules. Convalemin XL
75 mg Capsules are yellow/clear capsules. Convalemin XL 150 mg Capsules
are buff/clear capsules. All three strengths of capsules are filled with white to
off-white pellets. Your medicine is available in blister packs containing 14 or 28
capsules. Not all pack sizes may be marketed
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Generalised Anxiety Disorder and Social Anxiety Disorder:
• The usual recommended starting dose for treatment of generalised anxiety
disorder and social anxiety disorder is 75 mg per day. The maximum dose
is 225 mg per day.
Panic Disorder:
• If you are being treated for panic disorder, your doctor will start with a lower
dose (37.5 mg) and then increase the dose gradually. The maximum dose is
225 mg per day.
If you have liver or kidney problems, talk to your doctor, since your dose of
Convalemin XL Prolonged Release Capsules may need to be different.
Do not stop taking Convalemin XL Prolonged Release Capsules without talking
to your doctor (see the section “If you stop taking Convalemin XL Prolonged
Release Capsules”).
If you take more Convalemin XL Prolonged Release Capsules than you
should:
Call your doctor or pharmacist immediately if you take more Convalemin XL
Prolonged Release Capsules than prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat, changes
in level of alertness (ranging from sleepiness to coma), blurred vision, seizures
or fits, and vomiting.
If you forget to take Convalemin XL Prolonged Release Capsules:
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 a double dose to make up for a forgotten dose. Do not take more than
the daily amount of Convalemin XL Prolonged Release Capsules that have been
prescribed for you in one day.
If you stop taking Convalemin XL Prolonged Release Capsules:
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 to
take Convalemin XL Prolonged Release Capsules, he/she may ask you to reduce
your dose slowly before stopping treatment altogether. Side effects are known
to occur when people stop taking Convalemin XL Prolonged Release Capsules,
especially when treatment 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 treatment
with Convalemin XL Prolonged Release Capsules. 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 product, ask your doctor or
pharmacist.

Marketing Authorisation Holder and Manufacturer:
The Product Licence holder is STD Chemicals Ltd, Hillbrow House,
Hillbrow Road, Esher, Surrey, KT10 9NW.
The manufacturer responsible for batch release is Neolab Ltd, 57 High Street,
Odiham, Hants, RG29 1LF.
This leaflet was last revised in MM/YYYY.

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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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