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1. Venaxx Xl 75 Mg Prolonged-Release Capsules
2. Venaxx Xl 75 Mg Prolonged-Release Capsules

w MercuryPharma	Date of Approval: N/A		PROOF A
	To be implemented by: N/A		1 13/13/2013
Product Description: Venaxx XL® 75mg & 150mg PR Capsules, hard	Originated by Date: KBR 18/1/2012	Tech Approved Date: Yes 19/1/2012
Component: Leaflet	Revised by PAT	Version: 101079/LF/3, 101080/LF/3
Manufacturer: Pharmathen	File Name: 101079_80LF Venaxx 75_150mg v3_1	CRF No.: AMCo.CRF.133.2013
Market: UK	Software Package: Quark Xpress 9	Barcode: N/A
Minimum Font Size & Typeface: 9pt Swiss 721BT	Dimensions: 170 x 500mm	Pharma Code: N/A
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PACKAGE LEAFLET: INFORMATION FOR THE USER

Venaxx XL® 75 mg prolonged-release capsules, hard Venaxx XL® 150 mg prolonged-release capsules, hard Venlafaxine

IMPORTANT THINGS YOU SHOULD KNOW ABOUT Venaxx XL

Please read all of this leaflet before you start to take your medicine as it contains important information about Venaxx XL

•    This medicine is used to treat depression, severe and persistent anxiety known as generalised anxiety disorder (GAD) and social anxiety disorder (also known as social phobia)

•    This medicine is not for use in children and adolescents - see in section 2 ‘Venaxx XL is not recommended for use in Children' This leaflet describes two strengths of the Capsule. For simplicity they will both be referred to as Venaxx XL hereafter.

If you have any concerns about how you feel, or about this medicine, it is important that you talk to your doctor - even if you feel anxious or worried about doing so.

You may find it helpful to tell a friend or relative that you are depressed or suffering from an anxiety disorder, and that you have been prescribed this medicine; it might be useful to show them this leaflet.

•    Venaxx XL may not start to work immediately. Some people taking antidepressants may feel worse before feeling better. Your doctor may ask to see you again a couple of weeks after you start treatment and then regularly until you start to feel well again. Tell your doctor if you do not start to feel better.

•    Some people who are depressed may think of harming or killing themself. If this happens you should see your doctor or go to a hospital straight away - see in section 2 ‘Thoughts of suicide and worsening of your depression or anxiety disorder'

•    If you take too many capsules it is important to seek immediate medical attention, even if you feel well, because of the risk of serious side effects

•    Do not stop taking Venaxx XL or change your dose without the advice of your doctor even if you feel better. If you stop taking this medicine abruptly you may get withdrawal reactions - see in section 3 ‘When and how to stop taking this medicine'

•    If you have heart problems or high blood pressure you should talk to your doctor before taking Venaxx XL -

see in section 2 ‘Before you take this medicine'

•    Taking certain other medicines with Venaxx XL may cause problems. You should tell your doctor if you are taking any other medicines - see in section 2 ‘Before you take Venaxx XL

•    See your doctor without delay if you feel restless and feel like you can't keep still, feel ‘high' or very overexcited, have jerky muscle movements which you can't control. See section 4 - ‘Possible side effects' for other important information

•    If you are pregnant, or intend to become pregnant, or breast feeding, you should talk to your doctor - see in section 2 ‘Pregnancy, breastfeeding and Venaxx XL

More information on all of these points is provided in the rest of the leaflet.

•    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 than yours.

In this leaflet:

1    What Venaxx XL is and what it is used for

2    Before you take Venaxx XL

3    How to take Venaxx XL

4    Possible side effects

5    How to store Venaxx XL

6    Further information

1. WHAT Venaxx XL IS AND WHAT IT IS USED FOR

Venaxx 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.

Venaxx XL is a treatment for adults with depression. This medicine is also a treatment for adults with social anxiety disorder (fear or avoidance of social situations).

Treating depression or social anxiety disorder 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.

Venlafaxine which is contained in Venaxx XL may also be authorised to treat conditions which are not mentioned in further questions.

2. BEFORE YOU TAKE Venaxx XL

Do not take Venaxx XL

•    If you are allergic to this medicine or any of the other ingredients of this medicine.

•    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 this medicine, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking this medicine before you take any MAOI (see also the sections “Serotonin syndrome” and “Taking other medicines”).

Take special care with Venaxx XL

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

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

•    If you have a history of high blood pressure.

•    If you have a history of heart problems.

•    If you have a history of fits (seizures).

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

•    If you have a tendency to develop bruises or a tendency to bleed easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding.

•    If your cholesterol levels get higher.

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

•    If you have a history of aggressive behaviour

Venaxx 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.

If any of these conditions apply to you, please talk with your doctor before taking this medicine.

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 behavior.

Dry mouth is reported in 10% of patients treated with this medicine. This may increase the risk of caries. Therefore, you should take special care in your dental hygiene.

Use in children and adolescents under 18 years of age

Venaxx 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 this medicine 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 this medicine. Also, the longterm safety effects concerning growth, maturation and cognitive and behavioural development of this medicine 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 this medicine with other medicines.

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

•    Monoamine oxidase inhibitors (MAOIs: see the section “Before you take Venaxx XL’).

•    Serotonin syndrome:

•    Serotonin syndrome, a potentially life-threatening condition (see the section “Possible Side Effects”), may occur with this medicine treatment, particularly when taken with other medicines.

Examples of these medicines include:

•    Triptans (used for migraine)

•    Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium

•    Medicines containing linezolid, an antibiotic (used to treat infections)

•    Medicines containing moclobemide, a reversible MAOI (used to treat depression)

•    Medicines containing sibutramine (used for weight loss)

•    Medicines containing tramadol (a pain-killer)

•    Products containing St. John's Wort (also called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)

•    Products containing tryptophan (used for problems such as sleep and depression)

Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, fast heart beat, increased body temperature, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting. Get medical care right away if you think serotonin syndrome is happening to you.

The following medicines may also interact with this medicine 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 Venaxx XL with food and drink

Venaxx XL should be taken with food (see section 3 “HOW TO TAKE Venaxx XL’).

You should avoid alcohol while you are taking this medicine.

Pregnancy and breast-feeding

Tell your doctor if you become pregnant, or you are trying to become pregnant. You should use this medicine 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 this medicine. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of 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.

Venaxx 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 this medicine.

Driving and using machines

Do not drive or use any tools or machines until you know how this medicine affects you.

3. HOW TO TAKE Venaxx 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 this medicine 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.

Venaxx XL should be taken with food.

If you have liver or kidney problems, talk to your doctor, since your dose of this medicine may need to be different.

Do not stop taking this medicine without talking to your doctor (see the section “If you stop taking Venaxx XL’).

If you take more Venaxx XL than you should

Call your doctor or pharmacist immediately if you take more than the amount of this medicine 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 Venaxx 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 this medicine that has been prescribed for you in one day.

If you stop taking Vennax 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 [Venlafaxine], he/she may ask you to reduce your dose slowly before stopping treatment altogether. Side effects are known to occur when people stop using this medicine, especially when this medicine 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 this medicine 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, Venaxx XL can cause side effects, although not everybody gets them.

Allergic reactions

If any of the following happen, do not take more Venaxx 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)

Serious side effects

If you notice any signs of the following, you may need urgent medical attention:

•    Heart problems, such as fast or irregular heart rate, increased blood pressure

•    Eye problems, such as blurred vision, dilated pupils

•    Nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits

•    Psychiatric problems, such as hyperactivity and euphoria

•    Treatment withdrawal (see the section “HOW TO TAKE Venaxx XL, if you stop taking Venaxx XL’).

Complete side effect listing

The frequency (likelihood of occurring) of side effects is classified as follows:

Very common Affects more than 1 user in 10 Common Affects 1 to 10 users in 100 Uncommon Affects 1 to 10 users in 1,000 Rare Affects 1 to 10 users in 10,000 Not known Frequency cannot be estimated from the available data

•    Blood disorders

Uncommon: bruising; black tarry stools (faeces) or blood in stools, which can be a sign of internal bleeding Not known : reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may lead to an increased risk of infection

•    Metabolism/nutritional disorders

Common: weight loss; increased cholesterol Uncommon: weight gain

Not known: slight changes in blood levels of liver enzymes; decrease in blood sodium levels; itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (hepatitis); confusion, excessive water intake (known as SIADH); abnormal breast milk production

•    Nervous system disorders

Very common: dry mouth; headache Common: abnormal dreams; decreased libido; dizziness; increased muscle tonus; insomnia; nervousness; pins and needles; sedation; tremor; confusion; feeling separated (or detached) from yourself and reality Uncommon : lack of feeling or emotion; hallucinations; involuntary movement of the muscles; agitation; impaired coordination and balance Rare: a sensation of restlessness or an inability to sit or stand still; seizures or fits; feeling over excited or euphoric Not known: a high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements which you can't control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid muscles, which are symptoms of serotonergic syndrome; disorientation and confusion often accompanied by hallucination (delirium); stiffness, spasms and involuntary movements of the muscles; thoughts of harming or killing yourself

•    Sight and hearing disorders

Common: blurred vision

Uncommon: altered taste sensation; ringing in the ears (tinnitus)

Not known: severe eye pain and decreased or blurred vision

•    Heart or circulation disorders

Common: increase in blood pressure; flushing; palpitations Uncommon: feeling dizzy (particularly when standing up too quickly), fainting, fast heartbeat Not known: decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting

•    Breathing disorders

Common: yawning

Not known: coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs associated with an increase in white blood cells (pulmonary eosinophilia)

•    Digestive disorders

Very common: nausea

Common: appetite decreased; constipation; vomiting Uncommon: grinding of the teeth; diarrhoea Not known: severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas)

•    Skin disorders

Very common: sweating (including night sweats) Uncommon: rash; abnormal hair loss Not known: skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash

•    Muscle disorders

Not known: unexplained muscle pain, tenderness or weakness (rhabdomyolysis)

•    Urinary system disorders

Common: difficulties passing urine; increased frequency in urination

Uncommon: inability to pass urine

•    Reproductive and sexual disorders

Common: abnormal ejaculation/orgasm (males); lack of orgasm; erectile dysfunction (impotence); menstrual irregularities such as increased bleeding or increased irregular bleeding

Uncommon: abnormal orgasm (females)

•    General

Common: weakness (asthenia); chills

Uncommon: sensitivity to sunlight

Not known: swollen face or tongue, shortness of breath or

difficulty breathing, often with skin rashes (this may be a

serious allergic reaction)

Venaxx 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, this medicine 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 this medicine 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 Venaxx XL

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the packaging.

The expiry date refers to the last day of that month.

Store below 30°C .

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required.

6. FURTHER INFORMATION

What Venaxx XL contains

The active substance is Venlafaxine.

Each prolonged-release capsule, hard contains 75 mg and 150 mg of Venlafaxine as venlafaxine hydrochloride.

The other ingredients are:

75 mg prolonged-release capsules, hard:

Capsule content: Hypromellose, ammonio methacrylate copolymer (type B), sodium larilsulfate, magnesium stearate Coating: Basic butylated methacrylate copolymer 12.5% Capsule shell: Gelatin, titanium dioxide (E 171), red iron oxide (E172)

Printing ink: Shellac, black iron oxide (E172), propylene glycol (E1520)

150 mg prolonged-release capsules, hard:

Capsule content: Hypromellose, ammonio methacrylate copolymer (type B), sodium larilsulfate, magnesium stearate Coating: Basic butylated methacrylate copolymer 12.5%

Capsule shell: Gelatin, titanium dioxide (E 171), erythrosine (E127), indigotin I (E 132)

Printing ink: Shellac, black iron oxide (E172), propylene glycol (E1520)

What Venaxx XL looks like and contents of the pack

75 mg prolonged-release capsules, hard: flesh opaque - flesh opaque size 0 hard gelatin capsules containing two round, bivonvex film-coated tablets, with imprint VEN on cap and 75 on body 150 mg prolonged-release capsules, hard: scarlet opaque - scarlet opaque size 00 hard gelatin capsules containing three round, bivonvex film-coated tablets, with imprint VEN on cap and 150 on body.

75 mg: 14, 28, 30, 56, 98 and 100 prolonged-release capsules, hard

150 mg: 10, 28, 30, 56, 98 and 100 prolonged-release capsules, hard

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Mercury Pharmaceuticals Ltd.,

Capital House, 85 King William Street,

London EC4N 7BL, UK

Manufacturer:

Pharmathen SA, Dervenakion 6, Pallini 15351 Attikis, Greece

This leaflet was last revised in December 2013.

There are a number of organisations that provide help, information and advice for people with depression and their families or carers. You may wish to contact:

Mind

(National Association for Mental Health)

PO Box 277, Manchester M60 3XN

Mind infoline: 0300 123 3393

Depression Alliance 212 Spitfire Studios 63 - 71 Collier Street London N1 9BE

Telephone: 0845 123 23 20

Venaxx is the registered trademark of Mercury Pharma Group Ltd.

101079/LF/3,101080/LF/3