De*rel

pharma

VENLADEX® XL 75 mg PROLONGED-RELEASE TABLETS VENLADEX® XL 150 mg PROLONGED-RELEASE TABLETS

Venlafaxine

IMPORTANT THINGS YOU SHOULD KNOW ABOUT VENLADEX XL

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

Venladex XL is used to treat depression, severe and persistent anxiety known as generalised anxiety disorder (GAD), social anxiety disorder (also known as social phobia) and panic disorder (panic attacks).

Venladex XL is not for use in children and adolescents - see in section 2 'Children and adolescents'.

If you have any concerns about how you feel, or about this medication, 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 medication; it might be useful to show them this leaflet.

Venladex 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 in 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 themselves. 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 tablets 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 Venladex XL or change your dose without the advice of your doctor even if you feel better. If you stop taking Venladex XL abruptly you may get withdrawal reactions - see in section 3 'If you stop taking Venladex XL'.

If you have heart problems such as fast or irregular heart rate or high blood pressure you should talk to your doctor before taking Venladex XL    in 2 'Before you take

Venladex XL'.

Taking certain other medicines with Venladex XL may cause problems. You should tell your doctor if you are taking any other medicines -

see in section 2 'What you need to know before you take Venladex XL'.

See your doctor without delay if you feel restless and feel like you can't keep still, feel 'high' or very over-excited, 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 and breast-feeding'.

More information on all of these points is provided in the rest of this leaflet. Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    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 only. 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. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What VENLADEX XL is and what it is used for

2.    What you need to know before you take VENLADEX XL

3.    How to take VENLADEX XL

4.    Possible side effects

5.    How to store VENLADEX XL

6.    Contents of the pack and other information

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

The name of your medicine is VENLADEX XL 75 mg or VENLADEX XL 150 mg Prolonged-Release Tablets (referred to as VENLADEX XL throughout this leaflet).

VENLADEX XL contains the active substance venlafaxine.

VENLADEX 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.

VENLADEX XL is a treatment for adults with depression. VENLADEX 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 TAKEVENLADEX XL

Do not take VENLADEX XL

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

•    If you are also taking, or have taken within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with VENLADEX XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking VENLADEX XL before you take any MAOI (see also the section entitled “Other medicines and Venladex XL' and the information in that section about “Serotonin syndrome”).

Warnings and precautions

If any of the following apply to you, please tell your doctor before taking VENLADEX XL:

•    If you use other medicines that, if taken concomitantly with VENLADEX XL, could increase the risk of developing serotonin syndrome (see the section “Other medicines and Venladex XL').

•    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 been told you have an abnormal heart rhythm.

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

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

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

•    If your cholesterol levels get higher.

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

•    If you have a history of aggressive behaviour. VENLADEX 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.

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 tooth decay (caries). Therefore, you should take special care in your dental hygiene.

Diabetes

Your blood glucose levels may be altered due to VENLADEX XL. Therefore, the dosage of your diabetes medicines may need to be adjusted.

Children and adolescents

VENLADEX 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 VENLADEX XL for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed VENLADEX 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 VENLADEX XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of VENLADEX XL in this age group has not yet been demonstrated.

Other medicines and Venladex XL

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Do not start or stop taking any medicines, including those bought without a prescription, natural and herbal remedies, before checking with your doctor or pharmacist.

Your doctor should decide whether you can take VENLADEX XL with other medicines, such as:

•    Monoamine oxidase inhibitors which are used to treat depression or Parkinson's disease must not be taken with VENLADEX XL. Tell your doctor if you have taken these medicines within the last 14 days. (MAOIs: see the section “What you need to know before you take VENLADEX XL').

•    Products associated with serotonin syndrome: Serotonin syndrome:

A potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions (see the section “Possible Side Effects”), may occur with venlafaxine treatment, particularly when taken with other medicines. Examples of these medicines include:

•    Triptans (used for migraine)

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

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

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

•    Medicines containing sibutramine (used for weight loss)

•    Medicines containing tramadol (a pain killer), fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)

•    Medicines containing dextromethorphan (used to treat coughing)

•    Medicines containing methadone (used to treat opioid drug addiction or severe pain)

•    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.

You must tell your doctor if you are taking medicines that can affect your heart rhythm.

Examples of these medicines include:

•    Antiarrhythmics such as quinidine, amiodarone, sotalol or dofetilide (used to treat abnormal heart rhythm)

•    Antipsychotics such as thioridazine (See also Serotonin syndrome above)

•    Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)

•    Antihistamines (used to treat allergy)

The following medicines may also interact with VENLADEX XL and should be used with caution. It is especially important to mention to your doctor or

III

ABCDEFG^H

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)

•    Oral contraceptives

Taking VENLADEX XL with food and drink

VENLADEX XL should be taken with food (see section 3 “How to take VENLADEX XL').

You should avoid alcohol while you are taking VENLADEX XL.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should use VENLADEX 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 know you are on VENLADEX 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 VENLADEX XL during pregnancy, other symptoms your baby might have when it is born is not feeding properly, in addition to having trouble breathing. If your baby has these symptoms when it is born and you are concerned, contact your doctor and/or midwife who will be able to advise you.

VENLADEX 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 VENLADEX XL.

Driving and operating machinery

Venlafaxine can cause impaired judgement, thinking, and movement and coordination as well as problems with vision. If you are affected by any of these you should not drive, operate machinery or take part in any activities where such effects could put you or others at risk.

3.    HOW TO TAKE VENLADEX XL

Always take VENLADEX 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 VENLADEX XL at approximately the same time each day, either in the morning or in the evening. The tablets must be swallowed whole with fluid and not crushed, divided, chewed or dissolved. VENLADEX XL should be taken with food.

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

Do not stop taking VENLADEX XL without talking to your doctor (see the section “If you stop taking VENLADEX XL').

If you take more VENLADEX XL than you should

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

If you stop taking VENLADEX 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 VENLADEX 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 VENLADEX XL, especially when VENLADEX 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 VENLADEX 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, VENLADEX XL can cause side effects, although not everybody gets them.

If any of the following happen, do not take more VENLADEX XL. Tell your doctor immediately, or go to the casualty department at your nearest hospital:

Uncommon (may affect up to 1 in 100 people)

•    Swelling of the face, mouth, tongue, throat, hands, or feet and/or a raised itchy rash (hives), trouble swallowing or breathing

Rare (may affect up to 1 in 1,000 people)

•    Chest tightness, wheezing, trouble swallowing or breathing

•    Severe skin 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).

•    Signs of infection, such as high temperature, chills, shivering, headaches, sweating, flu-like symptoms. This may be the result of a blood disorder which leads to an increased risk of infection.

•    Severe rash, which may lead to severe blistering and peeling of the skin.

•    Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.

Other side effects that you should tell your doctor about include (The frequency of these side effects are included in the list “Other side effects that may occur” below):

•    Coughing, wheezing, shortness of breath which may be accompanied by a high temperature

•    Black (tarry) stools or blood in stools

•    Itchiness, yellow skin or eyes, 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 (muscle spasms or stiffness), seizures or fits

•    Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited)

•    Withdrawal effects (see the section “How to take VENLADEX XL, if you stop taking VENLADEX XL').

•    Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.

Other side effects that may occur

Very common: may affect more than 1 in 10 people

•    dizziness; headache, drowsiness

•    insomnia

•    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; abnormal dreams

•    drowsiness; tremor; a sensation of restlessness or an inability to sit or stand still; pins and needles; altered taste sensation; 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)

•    fast heartbeat; palpitations

•    increase in blood pressure; flushing

•    shortness of breath; yawning

•    vomiting; diarrhoea

•    increased frequency in urination; inability to pass urine; difficulties passing urine

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

•    weakness (asthenia); fatigue; chills

•    weight gain, weight loss

•    increased cholesterol

Uncommon: may affect up to 1 in 100 people

•    over activity, racing thoughts and decreased need for sleep (mania)

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

•    fainting; involuntary movements of the muscles; impaired coordination and balance;

•    feeling dizzy (particularly when standing up too quickly); decrease in blood pressure

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

•    sensitivity to sunlight; bruising; abnormal hair loss

•    inability to control pass urination

•    stiffness, spasms and involuntary movements of the muscles

•    slight changes in blood levels of liver enzymes

Rare: may affect up to 1 in 1,000 people

•    seizures or fits

•    coughing, wheezing and shortness of breath which may be accompanied by a high temperature

•    disorientation and confusion often accompanied by hallucination (delirium)

•    excessive water intake (known as SIADH)

•    decrease in blood sodium levels

•    severe eye pain and decreased or blurred vision

•    abnormal, rapid or irregular heartbeat, which could lead to fainting

•    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)

Very rare (may affect up to 1 in 10,000 people)

•    prolonged bleeding, which may be a sign of reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding

•    abnormal breast milk production

•    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)

Frequency not known (cannot be estimated from the available data)

•    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, What you need to know before you take VENLADEX XL)

•    aggression

•    vertigo

VENLADEX 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, VENLADEX 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 VENLADEX 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 help provide more information on the safety of this medicine.

5.    HOW TO STORE VENLADEX XL

Keep out of the sight and reach of children.

Do not use VENLADEX XL after the expiry date, which is stated on the packaging.

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What VENLADEX contains

The active substance is venlafaxine.

Each tablet contains 75 mg or 150 mg venlafaxine as venlafaxine hydrochloride.

Other ingredients in these tablets are: microcrystalline cellulose, hypromellose, ethylcellulose, magnesium stearate, silica colloidal anhydrous, dibutyl sebacate and macrogol 400. VENLADEX XL 150 mg Tablets also contain carnauba wax.

What VENLADEX XL looks like and contents of the pack

VENLADEX XL 75 mg and VENLADEX XL 150 mg are white, convex, capsule-shaped coated tablets. VENLADEX XL 75 mg and VENLADEX XL 150 mg come in calendar packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer:

DEXCEL® -PHARMA LTD., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire,

NN11 8PB, UK.

This leaflet was last revised in August 2016

III

abcdefg^h