VENLALIC XL 150MG PROLONGED RELEASE TABLETS

Active substance: VENLAFAXINE

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Pg 4

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

VENLALIC XL 75mg 150mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

06464/2982 2983G

DATE OF PROOF:

16/05/13

DATE:

PROOF HISTORY:
v.2 - waymade - 16/05/13

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2012

Pg 1

Pg 4

Venlalic 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, Venlalic 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 Venlalic XL for a long time.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.

5. How to store Venlalic XL
Keep out of the sight and reach of children.
Do not use Venlalic XL after the expiry date which is stated on the packaging. The expiry date refers to the last
day of that month.
Do not store above 30ºC.
Store in the original package.
Protect from moisture.
If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will
tell you what to do.
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. Contents of the pack and other information
What Venlalic XL contains
The active substance is venlafaxine.
Each Venlalic XL 75mg prolonged release tablet contains venlafaxine hydrochloride equivalent to 75mg of
venlafaxine.
Each Venlalic XL 150mg prolonged release tablet contains venlafaxine hydrochloride equivalent to 150mg of
venlafaxine.
The other ingredients are:

Core: mannitol (E421), povidone K-90, macrogol 400, microcrystalline cellulose, colloidal
anhydrous silica and magnesium stearate.

Coat: cellulose acetate, macrogol 400, hypromellose, lactose monohydrate, titanium dioxide (E171)
and triacetin.
What Venlalic XL looks like and contents of the pack
Venlalic XL (both strengths) are white, round, biconvex, prolonged-release tablets without any markings on
either side.
Venlalic XL is available in blister packs of 28 tablets.
POM

PL No: 06464/2982 75mg
PL No: 06464/2983 150mg

These products are manufactured by: Laboratorios LICONSA, S.A. Avda. Miralcampo, Nº 7, Polígono
Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara), Spain, and are procured from within the EU
and repackaged by the Product Licence holder:
WAYMADE PLC, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 16.5.2013
Venlalic® is a registered trademark of Dallas Burston Ashbourne Holdings Limited.

VENLALIC® XL 75mg PROLONGED-RELEASE TABLETS
VENLALIC® XL 150mg PROLONGED-RELEASE TABLETS
(venlafaxine hydrochloride)
Patient Information Leaflet
This product is known as the above names but will be referred to as Venlalic XL throughout this leaflet. Other
strengths (37.5mg and 225mg) are also available.
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 please 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 signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet.
What is in this leaflet:
1. What Venlalic XL is and what it is used for
2. What you need to know before you take Venlalic XL
3. How to take Venlalic XL
4. Possible side effects
5. How to store Venlalic XL
6. Contents of the pack and other information

1. What Venlalic XL is and what it is used for
Venlalic 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.
Venlalic XL is a treatment for adults with depression 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. What you need to know before you take Venlalic XL
Do not take Venlalic XL

If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).

If you are also taking or have taken 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 Venlalic XL, can cause serious or even
life-threatening side effects. Also, you must wait at least 7 days after you stop taking Venlalic XL
before you take any MAOI (see also the sections entitled “Taking other medicines” and the
information in that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Venlalic XL

If you use other medicines that taken concomitantly with Venlalic XL could increase the risk of
developing serotonin syndrome (see the section “Taking other medicines”).

If you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass
foods by normal bowel movements.

If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).

If you have a history of high blood pressure.

If you have a history of heart problems.

If you have a history of fits (seizures).

If you have a history of low sodium levels in your blood (hyponatraemia).

If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding
disorders), or if you are taking other medicines that may increase the risk of bleeding e.g. warfarin
(used to prevent blood clots).

If your cholesterol levels get higher.

If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling
over-excited or euphoric).

If you have a history of aggressive behaviour.
Venlalic XL 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.
If any of these conditions apply to you, please talk with your doctor before taking Venlalic XL.
Thoughts of suicide and worsening of your depression or feelings of anxiety
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.
Diabetes
Your blood glucose levels may be altered due to Venlalic XL. Therefore, the dosages of your diabetes
medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Venlalic 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 this medicine for patients under 18 because he/she decides that this is
in their best interests. If your doctor has prescribed Venlalic 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 Venlalic XL. Also, the long-term safety effects concerning growth,
maturation and cognitive and behavioural development of Venlalic XL in this age group has not yet been
demonstrated.

Pg 2

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

VENLALIC XL 75mg 150mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

06464/2982 2983G

DATE OF PROOF:

16/05/13

DATE:

PROOF HISTORY:
v.2 - waymade - 16/05/13

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2012

Pg 2

Pg 3

Other medicines and Venlalic XL
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines.

Your doctor will advise you on how you should gradually discontinue Venlalic XL treatment. If you experience
any of these or other symptoms that are troublesome, ask your doctor for further advice.

Your doctor should decide whether you can take Venlalic XL with other medicines.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

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

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)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products containing St. John’s Wort (also called Hypericum perforatum, a natural or herbal
remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or sensing things
which are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and becoming
withdrawn)
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 Venlalic 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, Itraconazole, Voriconazole, Posaconazole (antifungal medicines)

Clarithromycin, telithromycin (antibiotics used to treat infections)

Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection)

Haloperidol or risperidone (to treat psychiatric conditions)

Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Venlalic XL with food, drink and alcohol
Venlalic XL should be taken with food (see section 3 “How to take Venlalic XL”).
You should avoid alcohol while you are taking Venlalic XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Venlalic XL
only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Venlalic XL. When taken during pregnancy, similar
drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension
of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin
during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife
and/or doctor immediately.
If you are taking Venlalic XL 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 irritability, tremor, hypotonia, constant crying, sleeping difficulties and, not feeding properly.
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.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby, which may cause symptoms such
as crying, irritability and abnormal sleep patterns. Symptoms consistent with venlafaxine drug discontinuation
can also occur after stopping breast-feeding. 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 Venlalic XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Venlalic XL affects you.
Important information about some of the ingredients of Venlalic XL
This medicine 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 Venlalic XL
Always take this medicine 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 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.
Take Venlalic XL at approximately the same time each day, either in the morning or in the evening. Tablets
must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Venlalic XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Venlalic XL may need to be
different.
Do not stop taking Venlalic XL without talking to your doctor (see the section “If you stop taking Venlalic XL”).
If you take more Venlalic XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Venlalic XL 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 Venlalic 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 Venlalic XL that has
been prescribed for you in one day.
If you stop taking Venlalic XL
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better.
If your doctor thinks that you no longer need Venlalic XL, he/she may ask you to reduce your dose slowly
before stopping treatment altogether. Side effects are known to occur when people stop using Venlalic XL,
especially when Venlalic XL is stopped suddenly or the dose is reduced too quickly. Some patients may
experience symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, sensation
that everything around you is spinning or moving (vertigo), 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.
Pg 3

4. Possible side effects
Like all medicines, Venlalic XL can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Venlalic XL. As the tablet travels the length
of your gastrointestinal tract, venlafaxine is slowly released. The shape of the tablet remains undissolved and
is eliminated in your stools. Therefore, even though you may see a tablet in your stools, your dose of
venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Venlalic 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)

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 Venlalic XL, if you stop taking Venlalic XL”)

Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding
to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)

Dizziness; headache

Nausea; dry mouth

Sweating (including night sweats)
Common (may affect up to 1 in 10 people)

Appetite decreased

Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido

Nervousness; insomnia; abnormal dreams

Drowsiness; tremor; pins and needles; increased muscle tonus

Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically
change focus from distant to near objects

Ringing in the ears (tinnitus)

Palpitations

Increase in blood pressure; flushing

Yawning

Vomiting; constipation; diarrhoea

Increased frequency in urination; difficulties passing urine

Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal
ejaculation/orgasm (males); erectile dysfunction (impotence)

Weakness (asthenia); fatigue; chills

Increased cholesterol
Uncommon (may affect up to 1 in 100 people)

Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females);
lack of feeling or emotion; feeling over-excited; grinding of the teeth

A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the
muscles; impaired coordination and balance; altered taste sensation

Fast heartbeat; feeling dizzy (particularly when standing up too quickly)

Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal
bleeding

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; sensitivity to sunlight; bruising; rash; abnormal
hair loss

Inability to pass urine

Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)

Seizures or fits

Inability to control urination

Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)

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

Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may
be a serious allergic reaction)

Excessive water intake (known as SIADH)

Decrease in blood sodium levels

Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have
been reported during venlafaxine therapy or early after treatment discontinuation (see section 2,
Before you take Venlalic XL)

Disorientation and confusion often accompanied by hallucination (delirium); aggression

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; stiffness, spasms and involuntary movements of the muscles

Severe eye pain and decreased or blurred vision

Vertigo

Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting;
unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of
unexpected bruises or broken blood vessels (broken veins)

Coughing, wheezing, shortness of breath and a high temperature, which are symptoms of
inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)

Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or
pancreas)

Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation
of the liver (hepatitis); slight changes in blood levels of liver enzymes

Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash

Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

Abnormal breast milk production

Pg 4

Pg 4

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Waylic XL 75mg 150mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CODE:

06464/2982 2983G

DATE OF PROOF:

16/05/13

DATE:

PROOF HISTORY:
v.2 - waymade - 16/05/13

CUSTOMER
APPROVED:
DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2012

Pg 1

Pg 4

Waylic 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, Waylic 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
Waylic XL for a long time.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not
listed in this leaflet.

5. How to store Waylic XL
Keep out of the sight and reach of children.
Do not use Waylic XL after the expiry date which is stated on the packaging. The expiry date refers to the last
day of that month.
Do not store above 30ºC.
Store in the original package.
Protect from moisture.
If the tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will
tell you what to do.
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. Contents of the pack and other information
What Waylic XL contains
The active substance is venlafaxine.
Each Waylic XL 75mg prolonged release tablet contains venlafaxine hydrochloride equivalent to 75mg of
venlafaxine.
Each Waylic XL 150mg prolonged release tablet contains venlafaxine hydrochloride equivalent to 150mg of
venlafaxine.
The other ingredients are:

Core: mannitol (E421), povidone K-90, macrogol 400, microcrystalline cellulose, colloidal
anhydrous silica and magnesium stearate.

Coat: cellulose acetate, macrogol 400, hypromellose, lactose monohydrate, titanium dioxide (E171)
and triacetin.
What Waylic XL looks like and contents of the pack
Waylic XL (both strengths) are white, round, biconvex, prolonged-release tablets without any markings on
either side.
Waylic XL is available in blister packs of 28 tablets.
POM

PL No: 06464/2982 75mg
PL No: 06464/2983 150mg

These products are manufactured by: Laboratorios LICONSA, S.A. Avda. Miralcampo, Nº 7, Polígono
Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara), Spain, and are procured from within the EU
and repackaged by the Product Licence holder:
WAYMADE PLC, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 16.5.2013

WAYLIC® XL 75mg PROLONGED-RELEASE TABLETS
WAYLIC® XL 150mg PROLONGED-RELEASE TABLETS
(venlafaxine hydrochloride)
Patient Information Leaflet

This product is known as the above names but will be referred to as Waylic XL throughout this leaflet.
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 please 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 signs
of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet.
What is in this leaflet:
1. What Waylic XL is and what it is used for
2. What you need to know before you take Waylic XL
3. How to take Waylic XL
4. Possible side effects
5. How to store Waylic XL
6. Contents of the pack and other information

1. What Waylic XL is and what it is used for
Waylic 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.
Waylic XL is a treatment for adults with depression 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. What you need to know before you take Waylic XL
Do not take Waylic XL

If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).

If you are also taking or have taken 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 Waylic XL, can cause serious or even
life-threatening side effects. Also, you must wait at least 7 days after you stop taking Waylic XL
before you take any MAOI (see also the sections entitled “Taking other medicines” and the
information in that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Waylic XL

If you use other medicines that taken concomitantly with Waylic XL could increase the risk of
developing serotonin syndrome (see the section “Taking other medicines”).

If you have a swallowing, stomach or intestinal disorder that reduces your ability to swallow or pass
foods by normal bowel movements.

If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).

If you have a history of high blood pressure.

If you have a history of heart problems.

If you have a history of fits (seizures).

If you have a history of low sodium levels in your blood (hyponatraemia).

If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding
disorders), or if you are taking other medicines that may increase the risk of bleeding e.g. warfarin
(used to prevent blood clots).

If your cholesterol levels get higher.

If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling
over-excited or euphoric).

If you have a history of aggressive behaviour.
Waylic XL 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.
If any of these conditions apply to you, please talk with your doctor before taking Waylic XL.
Thoughts of suicide and worsening of your depression or feelings of anxiety
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.
Diabetes
Your blood glucose levels may be altered due to Waylic XL. Therefore, the dosages of your diabetes
medicines may need to be adjusted.
Use in children and adolescents under 18 years of age
Waylic 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 this medicine for patients under 18 because he/she decides that this is
in their best interests. If your doctor has prescribed Waylic 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 Waylic XL. Also, the long-term safety effects concerning growth,
maturation and cognitive and behavioural development of Waylic XL in this age group has not yet been
demonstrated.

Pg 2

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Waylic XL 75mg 150mg tabs

ARTWORKER:

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

CODE:

06464/2982 2983G

DATE OF PROOF:

16/05/13

DATE:

PROOF HISTORY:
v.2 - waymade - 16/05/13

DATE:

Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2012

Pg 2

Pg 3

Other medicines and Waylic XL
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines.

Your doctor will advise you on how you should gradually discontinue Waylic XL treatment. If you experience
any of these or other symptoms that are troublesome, ask your doctor for further advice.

Your doctor should decide whether you can take Waylic XL with other medicines.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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

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

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)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products containing St. John’s Wort (also called Hypericum perforatum, a natural or herbal
remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or sensing things
which are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and becoming
withdrawn)
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 Waylic 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, Itraconazole, Voriconazole, Posaconazole (antifungal medicines)

Clarithromycin, telithromycin (antibiotics used to treat infections)

Atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (used to treat HIV infection)

Haloperidol or risperidone (to treat psychiatric conditions)

Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Waylic XL with food, drink and alcohol
Waylic XL should be taken with food (see section 3 “How to take Waylic XL”).
You should avoid alcohol while you are taking Waylic XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Waylic XL
only after discussing the potential benefits and the potential risks to your unborn child with your doctor.
Make sure your midwife and/or doctor knows you are on Waylic XL. When taken during pregnancy, similar
drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension
of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin
during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife
and/or doctor immediately.
If you are taking Waylic XL 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 irritability, tremor, hypotonia, constant crying, sleeping difficulties and, not feeding properly.
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.
Venlafaxine passes into breast milk. There is a risk of an effect on the baby, which may cause symptoms such
as crying, irritability and abnormal sleep patterns. Symptoms consistent with venlafaxine drug discontinuation
can also occur after stopping breast-feeding. 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 Waylic XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Waylic XL affects you.
Important information about some of the ingredients of Waylic XL
This medicine 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 Waylic XL
Always take this medicine 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 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.
Take Waylic XL at approximately the same time each day, either in the morning or in the evening. Tablets
must be swallowed whole with fluid and not opened, crushed, chewed or dissolved.
Waylic XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Waylic XL may need to be different.
Do not stop taking Waylic XL without talking to your doctor (see the section “If you stop taking Waylic XL”).
If you take more Waylic XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Waylic XL 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 Waylic 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 Waylic XL that has been
prescribed for you in one day.
If you stop taking Waylic XL
Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better.
If your doctor thinks that you no longer need Waylic XL, he/she may ask you to reduce your dose slowly before
stopping treatment altogether. Side effects are known to occur when people stop using Waylic XL, especially
when Waylic XL is stopped suddenly or the dose is reduced too quickly. Some patients may experience
symptoms such as tiredness, dizziness, light-headedness, headache, sleeplessness, sensation that everything
around you is spinning or moving (vertigo), 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.
Pg 3

4. Possible side effects
Like all medicines, Waylic XL can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Waylic XL. As the tablet travels the length
of your gastrointestinal tract, venlafaxine is slowly released. The shape of the tablet remains undissolved and
is eliminated in your stools. Therefore, even though you may see a tablet in your stools, your dose of
venlafaxine has been absorbed.
Allergic reactions
If any of the following happen, do not take more Waylic 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)

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 Waylic XL, if you stop taking Waylic XL”)

Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding
to stop
Complete side effect listing
Very common (may affect more than 1 in 10 people)

Dizziness; headache

Nausea; dry mouth

Sweating (including night sweats)
Common (may affect up to 1 in 10 people)

Appetite decreased

Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido

Nervousness; insomnia; abnormal dreams

Drowsiness; tremor; pins and needles; increased muscle tonus

Visual disturbance including blurred vision; dilated pupils; inability of the eye to automatically
change focus from distant to near objects

Ringing in the ears (tinnitus)

Palpitations

Increase in blood pressure; flushing

Yawning

Vomiting; constipation; diarrhoea

Increased frequency in urination; difficulties passing urine

Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal
ejaculation/orgasm (males); erectile dysfunction (impotence)

Weakness (asthenia); fatigue; chills

Increased cholesterol
Uncommon (may affect up to 1 in 100 people)

Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females);
lack of feeling or emotion; feeling over-excited; grinding of the teeth

A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the
muscles; impaired coordination and balance; altered taste sensation

Fast heartbeat; feeling dizzy (particularly when standing up too quickly)

Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal
bleeding

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; sensitivity to sunlight; bruising; rash; abnormal
hair loss

Inability to pass urine

Weight gain; weight loss
Rare (may affect up to 1 in 1,000 people)

Seizures or fits

Inability to control urination

Over activity, racing thoughts and decreased need for sleep (mania)
Not known (frequency cannot be estimated from the available data)

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

Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may
be a serious allergic reaction)

Excessive water intake (known as SIADH)

Decrease in blood sodium levels

Suicidal ideation and suicidal behaviours; cases of suicidal ideation and suicidal behaviours have
been reported during venlafaxine therapy or early after treatment discontinuation (see section 2,
Before you take Waylic XL)

Disorientation and confusion often accompanied by hallucination (delirium); aggression

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; stiffness, spasms and involuntary movements of the muscles

Severe eye pain and decreased or blurred vision

Vertigo

Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting;
unexpected bleeding, e.g. bleeding gums, blood in the urine or in vomit, or the appearance of
unexpected bruises or broken blood vessels (broken veins)

Coughing, wheezing, shortness of breath and a high temperature, which are symptoms of
inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)

Severe abdominal or back pains (which could indicate a serious problem in the gut, liver or
pancreas)

Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation
of the liver (hepatitis); slight changes in blood levels of liver enzymes

Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash

Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

Abnormal breast milk production

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Expand view ⇕

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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