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SIVION XL 225 MG PROLONGED-RELEASE TABLETS

Active substance(s): VENLAFAXINE

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Package leaflet - Information for the user

Sivion XL 225mg Prolonged-Release Tablets
Venlafaxine hydrochloride
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again
If you have 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
Your medicine is called Sivion XL 225mg Prolonged-Release Tablets but will be referred to as Sivion XL throughout
this leaflet.
What is in this leaflet:
1. What Sivion XL is and what it is used for
2. What you need to know before you take Sivion XL
3. How to take Sivion XL
4. Possible side effects
5. How to store Sivion XL
6. Contents of the pack and other information

1. What Sivion XL is and what it is used for
Sivion 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.
Sivion XL is a treatment for adults with depression. Sivion 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. What you need to know before you take Sivion XL
Do not take Sivion 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
Sivion XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking
Sivion XL before you take any MAOI (see also the sections entitled "Other medicines and Sivion XL" and the information in
that section about “Serotonin syndrome”).
Warnings and precautions
Talk to your doctor before taking Sivion XL
If you use other medicines that taken concomitantly with Sivion XL could increase the risk of developing serotonin
syndrome (see the section "Other medicines and Sivion XL")
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.
Sivion 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 Sivion 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 Sivion XL. Therefore, the dosages of your diabetes medicines may need to
be adjusted.
Use in children and adolescents under 18 years of age
Sivion 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 Sivion
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 Sivion XL. Also, the long-term safety effects
concerning growth, maturation and cognitive and behavioural development of Sivion XL in this age group has not yet been
demonstrated.
Other medicines and Sivion XL
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Your doctor should decide whether you can take Sivion 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 Sivion
XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “Before you take
Sivion 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 Sivion 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)
Sivion XL with food, drink and alcohol
Sivion XL should be taken with food (see section 3 "How to take Sivion XL").
You should avoid alcohol while you are taking Sivion XL.
Pregnancy, breast-feeding and fertility
Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use Sivion 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 Sivion 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 Sivion 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 Sivion XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Sivion XL affects you.
Important information about some of the ingredients of Sivion 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 Sivion 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, generalised anxiety disorder and social anxiety disorder is
75mg per day. The dose can be raised by your doctor gradually, and if needed, even up to a maximum dose of 375mg daily
for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5mg) and then increase
the dose gradually. The maximum dose for generalised anxiety disorder, social anxiety disorder and panic disorder is
225mg/day.
(Continued overleaf)

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

070116-XXXX-PIL-02
Sivion XL PIL - Italy + Greece - Side 1
540 x 140mm
7 January 2016
14166/02 PIL S1.ai
1 Colour - Black

M1X

Take Sivion 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.
Sivion XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Sivion XL may need to be different.
Do not stop taking Sivion XL without talking to your doctor (see the section "If you stop taking Sivion XL")
If you take more Sivion XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Sivion 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 Sivion 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 Sivion XL that has been prescribed for you in one day.
If you stop taking Sivion 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 Sivion 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 Sivion XL, especially when Sivion 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.
Your doctor will advise you on how you should gradually discontinue Sivion 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, Sivion XL can cause side effects, although not everybody gets them.
Do not be concerned if you see a tablet in your stools after taking Sivion 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 Sivion 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 Sivion XL, if you stop taking Sivion 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; inabiity 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 (particulary 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 Sivion 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
Sivion 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, Sivion 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 Sivion XL for a long time.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side
effects, you can provide more information on the safety of this medicine.

5. How to store Sivion XL
Keep out of the sight and reach of children.
Do not use Sivion 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 in order to protect from moisture.
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.
Do not use if any signs of deterioration are seen.

6. Contents of the pack and other information
What Sivion XL contains
The active substance is venlafaxine.
Each prolonged-release tablet contains 225mg venlafaxine (as hydrochloride).
The other ingredients are
Core: mannitol (E421), povidone K-90, macrogol 400, cellulose microcrystalline, colloidal anhydrous silica, magnesium
stearate.
Coat: cellulose acetate, macrogol 400, hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin.
What Sivion XL looks like and contents of the pack
White round tablets, plain on one side with a laser hole on the reverse.
Sivion XL is available in pack sizes of 14 or 30 tablets.
PL holder:
Manx Pharma Ltd, Taylor Group House, Wedgnock Lane, Warwick, CV34 5YA, UK
PL 15833/0072 and PL 15833/0074
POM
Procured from within the EU.
Manufacturer:
Laboratorios LICONSA S.A, Avada.
Miralcampo, No 7, Poligono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN
To request a copy of this leaflet in large print, audio or Braille please call 01926 482511.
This leaflet was last revised on 7/1/16

WIP URN: 070116-XXXX-PIL-02

WIP URN
APPROVED URN
Job
Size
Date
BOH Approval Date
Saved as
Prints

070116-XXXX-PIL-02
Sivion XL PIL - Italy + Greece - Side 2
540 x 140mm
7 January 2016
14166/02 PIL S2.ai
1 Colour - Black

M1X

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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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