ViePax XL 150 mg Prolonged-Release Tablets

Please read all of this leaflet before you start to take your medicine as it contains important information about ViePax XL prolonged-release tablets (referred to as ViePax XL throughout this leaflet.)

• ViePax 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)
• ViePax 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.

• ViePax 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 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 ViePax XL or change your dose without the advice of your doctor even if you feel better. If you stop taking ViePax XL abruptly you may get withdrawal reactions – see in section 3 ‘If you stop taking ViePax 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 ViePax XL – see in section 2 ‘Before you take ViePax XL’
• Taking certain other medicines with ViePax 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 ViePax 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.

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

1. What ViePax XL is and what it is used for
2. What you need to know before you take ViePax XL
3. How to take ViePax XL
4. Possible side effects
5. How to store ViePax XL
6. Contents of the pack and other information

• 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 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 ViePax XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking ViePax XL before you take any MAOI (see also the section entitled “Other medicines and ViePax XL” and the information in that section about ‘Serotonin Syndrome’).

Talk to your doctor or pharmacist before taking ViePax XL:

• If you use other medicines that taken together with ViePax XL could increase the risk of developing serotonin syndrome (see the section “Other medicines and ViePax 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 history of bleeding disorders (tendency to develop bruises or a tendency to bleed easily), or if you are taking other medicines that may increase the risk of bleeding e.g., warfarin (used to prevent blood clots), or if you are pregnant (see ‘Pregnancy and breast-feeding’).
• 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.

ViePax 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.

Do not drink alcohol while being treated with ViePax XL as it can lead to extreme tiredness and unconsciousness. Concomitant use with alcohol and/or certain medicines can make your symptoms of depression and other conditions, such as anxiety disorders worse.

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 thoughts may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is decreased or during discontinuation of treatment with ViePax XL.

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 ViePax XL. Therefore, the dosage of your diabetes medicines may need to be adjusted.

Sexual problems

Medicines like ViePax XL (so called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

ViePax 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 ViePax XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of this medicine in this age group has not yet been demonstrated.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor should decide whether you can take ViePax 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 ViePax 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 ViePax XL”).
• 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 SNRIs, SSRIs, tricyclics, or medicines containing lithium
• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity)
• Medicines containing linezolid, an antibiotic (used to treat infections)
• Medicines containing moclobemide, a MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing opioids [e.g., tramadol, fentanyl, tapentadol, pethidine, pentazocine, buprenorphine (used to treat severe pain), buprenorphine/naloxone (used to treat dependence to opioid drugs)]
• 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 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 (determined by a blood test).

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 ViePax 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)
• Oral contraceptives

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

Do not drink alcohol while being treated with ViePax XL. Concomitant use with alcohol can lead to extreme tiredness and unconsciousness and can make your symptoms of depression and other conditions, such as anxiety disorders worse.

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 ViePax 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 ViePax 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 take ViePax XL near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking ViePax XL so they can advise you.

If you are taking this medicine during pregnancy, in addition to having trouble breathing, another symptom your baby might have when it is born is 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.

ViePax 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.

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

One of the excipients of ViePax XL, polyvinyl acetate dispersion 30 per cent, contains sodium. Each tablet contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

Call your doctor or pharmacist immediately if you take more of this medicine than the amount prescribed by your doctor. Overdose can be life-threatening, especially with concomitant use of alcohol and/or certain medicines (see “Other medicines and ViePax XL”).

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 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 a double dose to make up for a forgotten dose. Do not take more than the daily amount of ViePax XL that has been prescribed for you in one day.

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 ViePax 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 this medicine, especially when it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggressiveness, 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, problems with eyesight and increase in blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc).

Your doctor will advise you on how you should gradually discontinue ViePax XL treatment. This can take a period of several weeks or months. In some patients, discontinuation may need to occur very gradually over periods of months or longer. If you experience any of these or other symptoms that are troublesome, ask your doctor for further advice.

Very common (may affect more than 1 in 10 people)

• Dizziness; headache; drowsiness
• Insomnia
• Nausea; dry mouth; constipation
• 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; agitation; nervousness; abnormal dreams
• 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
• Mild rash; itching
• 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 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)

• Aggression
• Vertigo
• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see `Pregnancy and breast-feeding' in section 2 for more information

ViePax XL sometimes causes unwanted effects that you may not be aware of, such as increases in blood pressure or abnormal heartbeat; slight changes in blood levels of liver enzymes, sodium or cholesterol. More rarely, ViePax 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 ViePax XL for a long time.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is venlafaxine.

Each prolonged-release tablet contains 169.7 mg of venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine free base.

The other ingredients are: calcium hydrogen phosphate dehydrate, hypromellose, polyacrylate dispersion 30 per cent, silica, colloidal anhydrous, magnesium stearate, polyvinyl acetate dispersion 30 per cent, triethyl citrate, macrogol polyvinyl alcohol grafted copolymer, talc, carnauba wax.

ViePax XL 150 mg prolonged-release tablets are 11 mm diameter white to off white, mottled round coated tablets.

The tablets are packed in PVC/PE/PVdC blister strips, sealed with Aluminium foil.

The blister strips are packed in cartons of 28 tablets.