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VAXALIN XL 75MG PROLONGED-RELEASE CAPSULES HARD

Active substance(s): VENLAFAXINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Vaxalin XL 75 / 150 mg
prolonged-release capsules, hard
Venlafaxine
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Vaxalin XL is and what it is used for
2. Before you take Vaxalin XL
3. How to take Vaxalin XL
4. Possible side effects
5. How to store Vaxalin XL
6. Further information
1. WHAT VAXALIN XL IS AND WHAT IT IS USED FOR
Vaxalin 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.
Vaxalin XL is a treatment for adults with depression.

Vaxalin XL is 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 VAXALIN XL
Do not take Vaxalin XL
• If you are allergic (hypersensitive) to venlafaxine or any of the other ingredients of Vaxalin
XL (Section 6 contains a full list).
• If you are also taking or have taken any time within the last 14 days any medicines known
as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or
Parkinson’s disease. Taking an irreversible MAOI together with other medicines, including
Vaxalin XL, can cause serious or even life-threatening side effects. Also, you must wait at
least 7 days after you stop taking Vaxalin XL before you take any MAOI (see also the
sections “Serotonin syndrome” and “Taking other medicines”).
Take special care with Vaxalin XL

If any of following conditions apply to you, please talk with your doctor before taking Vaxalin XL

• If you use other medicines that taken concomitantly with Vaxalin XL could increase the risk
of developing serotonin syndrome (see the section “Taking other medicines”).
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems.
• If you have a history of fits (seizures).
• If you have a history of low sodium levels in your blood (hyponatraemia).
• If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding
disorders), or if you are taking other medicines that may increase the risk of bleeding. 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.
• If you have diabetes
Vaxalin XL may cause a sensation of restlessness or an inability to sit or stand still. You
should tell your doctor if this happens to you.
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.
Diabetes
Your blood glucose levels may be altered due to Vaxalin XL .Therefore, the dosages of your
diabetes medicines may need to be adjusted.

Use in children and adolescents under 18 years of age
Vaxalin 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
Vaxalin XL for patients under 18 because he/she decides that this is in their best interests. If
your doctor has prescribed Vaxalin 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 Vaxalin XL. Also, the long-term
safety effects concerning growth, maturation and cognitive and behavioural development of
Vaxalin XL 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 Vaxalin XL with other medicines.
Do not start or stop taking any medicines, including those bought without a prescription,
natural and herbal remedies, before checking with your doctor or pharmacist.
• Monoamine oxidase inhibitors which are used to treat depression or Parkinson’s disease must not
be taken with Vaxalin XL.Tell your doctor if you have taken these medicines within the last 14 days.

(MAOIs: see the section “Before you take Vaxalin XL”).
• Serotonin syndrome:
Serotonin syndrome, a potentially life-threatening condition or Neuroleptic Malignant Syndrome
(NMS)-like reactions (see the section “Possible Side Effects”), may occur with Vaxalin XL
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 heartbeat, 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. 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 heartbeat,
sweating, severe muscle stiffness, confusion, increased muscle enzymes (determination 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 Vaxalin XL and should be used with caution.
It is especially important to mention to your doctor or pharmacist if you are taking medicines
containing:
• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (to treat psychiatric conditions)
• Metoprolol (a beta blocker to treat high blood pressure and heart problems)
Taking Vaxalin XL with food and drink
Vaxalin XL should be taken with food (see section 3 “HOW TO TAKE Vaxalin XL”).
You should avoid alcohol while you are taking Vaxalin XL.
Pregnancy and breast-feeding
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should
use Vaxalin XL only after discussing the potential benefits and the potential risks to your
unborn child with your doctor.
If you are taking Vaxalin 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, muscle weakness,
constant crying, sleeping difficulties, 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 knows you are on Vaxalin 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.
Vaxalin XL passes into breast milk. There is a risk of an effect on the baby. Therefore, you
should discuss the matter with your doctor, and he/she will decide whether you should stop
breast-feeding or stop the therapy with Vaxalin XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Vaxalin XL affects you.
3. HOW TO TAKE VAXALIN XL
Always take Vaxalin XL 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, generalised anxiety
disorder 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. 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 for generalised anxiety disorder, social
anxiety disorder and panic disorder is 225 mg/day.

Take Vaxalin XL at approximately the same time each day, either in the morning or in the
evening. Capsules must be swallowed whole with fluid and not opened, crushed, chewed or
dissolved.
Vaxalin XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Vaxalin XL may
need to be different.
Do not stop taking Vaxalin XL without talking to your doctor (see the section “If you stop
taking Vaxalin XL”).
If you take more Vaxalin XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Vaxalin XL
prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heartbeat, changes in level of
alertness (ranging from sleepiness to coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Vaxalin 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 Vaxalin XL that has been prescribed for you in one day.
If you stop taking Vaxalin 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 Vaxalin 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 Vaxalin XL, especially when Vaxalin XL 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 Vaxalin XL 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, Vaxalin XL can cause side effects, although not everybody gets them.
Do not be concerned if you see small white balls or granules in your stools after taking
this medicine. Inside Vaxalin XL are spheroids (small white balls) that contain the
active ingredient (venlafaxine). These spheroids are released from the capsule into your
stomach. As they travel through your stomach and intestines, venlafaxine is slowly

released. The spheroid “shell” does not dissolve and is passed out in your stools. So,
even though you may see spheroids in your stools, your dose of medicine has been
absorbed.
If any of the following happen, do not take more Vaxalin 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 heartbeat, 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
heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes
(determination by a blood test).
Serious side effects
If you notice any signs of the following, you may need urgent medical attention:
● 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).
• Treatment withdrawal (see the section “HOW TO TAKE Vaxalin XL, if you stop taking
Vaxalin 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 (affects more than 1 in 10 users)
Dizziness; headache
Nausea; dry mouth
Sweating (including night sweats)
Common (affects 1 to 10 users in 100)
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 (affects 1 to 10 users in 1,000)
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)
Ringing in the ears (tinnitus)
Shortness of breath
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 (affects 1 to 10 users in 10,000)
Seizures or fits
Inability to control urination
Over activity, racing thoughts and decreased need for sleep (mania)
Frequency 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
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 Vaxalin 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 heartbeat, 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

rash

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

Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
Abnormal breast milk production
Bone fracture (possible risk for osteoporosis and bone fracture in elderly, especially with
higher doses)
Vaxalin 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, Vaxalin 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 Vaxalin
XL for a long time.
If any of the side effects gets serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE VAXALIN XL

Keep out of the reach and sight of children.
Do not use Vaxalin XL after the expiry date which is stated on the blister and carton. The
expiry date refers to the last day of that month.
These medicinal products do 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 Vaxalin XL contains
The active substance is venlafaxine.
Each prolonged-release capsule, hard contains 75 mg or 150 mg venlafaxine (as
hydrochloride). The exact amount is shown on the carton.
The other ingredients are
Capsule content: Hypromellose, ammonio methacrylate copolymer (type B), basic butylated
metacrylate copolymer, sodium laurilsulfate, magnesium stearate.
Capsule shell: titanium dioxide (E 171), gelatine.
Vaxalin XL 75 mg prolonged-release capsules, hard
Also contains red iron oxide (E 172).
Vaxalin XL 150 mg prolonged-release capsules, hard
Also contains erythrosine (E 127) and indigo carmine (E 132).
What Vaxalin XL looks like and contents of the pack
Vaxalin XL 75 mg prolonged-release capsules, hard
flesh opaque prolonged-release capsules, hard containing two round, biconvex tablets.
Packs of 10, 14, 28, 30, 50, 56, 60, 98, 100 prolonged-release capsules, hard.
Vaxalin XL 150 mg prolonged-release capsules, hard
scarlet opaque prolonged-release capsules, hard containing three round, biconvex tablets.
Packs of 10, 14, 28, 30, 50, 56, 60, 98, 100 prolonged-release capsules, hard.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
ratiophrm GmbH, Graf Arco Strasse 3, 9-89079 Ulm, Germany.
This leaflet was last revised in July 2013

PL 15773/0657-8

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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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