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VENLADEX 37.5MG TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER

VENLADEX ® 37.5 mg TABLETS
VENLADEX ® 75 mg TABLETS
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.
What VENLADEX is and what it is used for
2.
Before you take VENLADEX
3.
How to take VENLADEX
4.
Possible side effects
5.
How to store VENLADEX
6.
Further information
1. WHAT VENLADEX IS AND WHAT IT IS USED FOR
The name of your medicine is VENLADEX 37.5 mg Tablets or VENLADEX 75 mg Tablets (referred to
as VENLADEX throughout this leaflet).
VENLADEX 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. 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.
VENLADEX is a treatment for adults with depression. Treating depression 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 VENLADEX
Do not take VENLADEX

If you are allergic to venlafaxine or any of the other ingredients of VENLADEX (section 6 contains
a full list).

If you are also taking, or have taken 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 VENLADEX, can cause serious or even life-threatening side
effects. Also, you must wait at least 7 days after you stop taking VENLADEX before you take any
MAOI (see also the section entitled “Taking other medicines” and the information in that section
about “Serotonin syndrome”).
Take special care with VENLADEX
If any of the following apply to you, please tell your doctor before taking VENLADEX:



If you use other medicines that, if taken concomitantly with VENLADEX, 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 e.g., warfarin
(use 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.
VENLADEX may cause a sensation of restlessness or an inability to sit or stand still during the first few
weeks of treatment. You should tell your doctor if this happens to you.

Thoughts of suicide and worsening of your depression or anxiety
If you are depressed and/or anxious, 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 anxious, 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 tooth
decay (caries). Therefore, you should take special care in your dental hygiene.
Diabetes
Your blood glucose levels may be altered due to VENLADEX. Therefore, the dosage of your diabetes
medicines may need to be adjusted.

Use in children and adolescents under 18 years of age
VENLADEX 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 VENLADEX for patients under 18 because
he/she decides that this is in their best interests. If your doctor has prescribed VENLADEX 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 VENLADEX.
Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural
development of VENLADEX 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.
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.
Your doctor should decide whether you can take VENLADEX with other medicines, such as:



Monoamine oxidase inhibitors which are used to treat depression or Parkinson’s disease must not
be taken with VENLADEX. Tell your doctor if you have taken these medicines within the last 14
days. (MAOIs: see the section “Before you take VENLADEX”).
Products associated with serotonin syndrome:
Serotonin syndrome:
A potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions
(see the section “Possible Side Effects, Nervous system disorders”), may occur with venlafaxine
treatment, particularly when taken with other medicines.
Examples of these medicines include:
• Triptans (used for migraine)
• Other 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)
• 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)

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.
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 heart beat, 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 VENLADEX 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 VENLADEX with food and drink
VENLADEX should be taken with food (see section 3 “How to take VENLADEX”).
You should avoid alcohol while you are taking VENLADEX.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use
VENLADEX only after discussing the potential benefits and the potential risks to your unborn child with
your doctor.
Make sure your midwife and/or doctor know you are on VENLADEX. 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 VENLADEX 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.
VENLADEX 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 VENLADEX.
Driving and using machines
Do not drive or use any tools or machines until you know how VENLADEX affects you.
Important information about some of the ingredients of VENLADEX
This product contains lactose. 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 VENLADEX
Always take VENLADEX exactly as your doctor has told you. You should check with your doctor or
pharmacist if you are not sure.
The usual recommended starting dose is 75 mg per day in divided doses. The dose can be raised by your
doctor gradually and, if needed, even up to a maximum dose of 375 mg daily for depression.
Take VENLADEX at approximately the same time each day, in the morning and in the evening.
VENLADEX should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of VENLADEX may need to be
different.
The 37.5mg tablets and 75mg tablets come in special "calendar" packs which help you remember to take
your tablets when you should.
The following instructions will help you:
1. Remove a card.
2. Go to the correct day of the week.

3. Take the tablet from the card or part of the card, marked "AM", in the morning.
4. Your next tablet should be taken in the evening from the card or part of the card, marked "PM".
5. Continue taking a tablet every morning and evening.
6. When you have finished a card, move on to the next one.
Do not stop taking VENLADEX without talking to your doctor (see the section “If you stop taking
VENLADEX”).
If you take more VENLADEX than you should
Call your doctor or pharmacist immediately if you take more than the amount of VENLADEX 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 VENLADEX
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 VENLADEX
that has been prescribed for you in one day.
If you stop taking VENLADEX
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 VENLADEX, he/she may ask you to reduce your
dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using
VENLADEX, especially when VENLADEX 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 VENLADEX 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 product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, VENLADEX can cause side effects, although not everybody gets them.
If any of the following happen, do not take more VENLADEX. 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)

Signs and symptoms of serotonin syndrome which may include restlessness, hallucinations, loss of
coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive
reflexes, 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 heart beat, sweating, severe
muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

Other side effects that you should tell your doctor about include:

Coughing, wheezing, shortness of breath and a high temperature

Black (tarry) stools or blood in stools

Yellow skin or eyes, itchiness or dark urine, which may be symptoms of inflammation of the liver
(hepatitis)

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 (feeling unusually overexcited)

Withdrawal effects (see the section “How to take VENLADEX, if you stop taking VENLADEX”)
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 (tension);
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 serotonin syndrome; disorientation and confusion often accompanied by
hallucination (delirium); stiffness, spasms and involuntary movements of the muscles; thoughts of
harming or killing yourself, aggression, vertigo
Sense 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
Rare: inability to control urination

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, 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
Not known: swollen face or tongue, shortness of breath or difficulty breathing, often with skin
rashes (this may be a serious allergic reaction)
VENLADEX 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, VENLADEX 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 VENLADEX 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 VENLADEX
Keep out of the reach and sight of children.
Do not use VENLADEX after the expiry date, which is stated on the packaging.
This medicinal product does not require any special storage conditions.
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 VENLADEX contains
The active substance is venlafaxine.
Each tablet contains either 37.5 mg or 75 mg venlafaxine as venlafaxine hydrochloride.
Other ingredients in these tablets are: lactose monohydrate, microcrystalline cellulose, sodium starch
glycolate, povidone, magnesium stearate, ferric oxide yellow (E-172), ferric oxide red (E-172) and ferric
oxide black (E-172).

What VENLADEX looks like and contents of the pack
VENLADEX37.5 mg and VENLADEX 75 mg are mottled-beige, round tablets.
VENLADEX 37.5 mg and VENLADEX 75 mg come in calendar packs of 28 and 56 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
®
DEXCEL -PHARMA LTD., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire,
NN11 8PB, UK.
This leaflet was last revised in November 2011

Expand Transcript

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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