Sunveniz XL 37.5 mg prolonged release tablets

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

• Sunveniz 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)
• Sunveniz 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.

• Sunveniz 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 Sunveniz XL or change your dose without the advice of your doctor even if you feel better. If you stop taking Sunveniz XL abruptly you may get withdrawal reactions – see in section 3 ‘If you stop taking Sunveniz 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 Sunveniz XL – see in section 2 ‘Before you take Sunveniz XL’
• Taking certain other medicines with Sunveniz 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 Sunveniz 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 Sunveniz XL is and what it is used for
2. What you need to know before you take Sunveniz XL
3. How to take Sunveniz XL
4. Possible side effects
5. How to store Sunveniz 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 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 Sunveniz XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Sunveniz XL before you take any MAOI (see also “Other medicines and Sunveniz XL” and the information in the section about “Serotonin Syndrome”).

If any of the following apply to you, please tell your doctor or pharmacist before taking Sunveniz XL

• if you use other medicines that taken together with Sunveniz XL could increase the risk of developing serotonin syndrome (see the section “ Other medicines and Sunveniz 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 (used to prevent blood clots), or if you are pregnant (see ‘Pregnancy’)
• 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.

Sunveniz 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 Venlafaxine SUN 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.

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. These thought may also occur when your dose is decreased or during discontinuation of treatment with Sunveniz XL.

You may be more likely to think like this:

• If you have previously had thoughts about killing or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in 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 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.

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

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

Sunveniz 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 Sunveniz XL. Also, the long-term safety 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 Sunveniz 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 Sunveniz 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 Sunveniz 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 to treat migraine)
  • other medicines used 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 tramadol, 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 the 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 Sunveniz 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).

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

Do not drink alcohol while being treated with Venlafaxine SUN. 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.

Pregnancy

Tell your doctor if you become pregnant, or if you are trying to become pregnant. You should use Sunveniz 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 Sunveniz 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 this medicine 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.

If you take Sunveniz 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 Sunveniz XL so they can advise you.

Breast-feeding

Sunveniz 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.

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.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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 this medicine at approximately the same time each day, either in the morning or in the evening. Tablets must be swallowed whole with fluid and not crushed, chewed or dissolved.

Sunveniz 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 Sunveniz XL”).

PEEL INSTRUCTION:

The unsealed area for peel-off is along the middle of the blister strip.

1. Tear the blister at the perforations to separate the individual tablet pocket
2. Peel the printed backing off to expose the foil
3. Push the tablet through the foil
4. Put the tablet in your mouth

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 Venlafaxine SUN”).

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.

Do not take a double dose to make up a forgotten tablet. 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 Sunveniz XL that has been prescribed for you in one day.

Do not stop taking this medicine or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Sunveniz XL, he/she may 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 Sunveniz XL. 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, rash, 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: frequency 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 Sunveniz XL”)
• aggression
• vertigo
• heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy in section 2 for more information.

Sunveniz 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, Sunveniz 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 Sunveniz XL for a long time.

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 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 37.5 mg, 75 mg or 150 mg venlafaxine (as venlafaxine hydrochloride).

The other ingredients are:

For 37.5 mg

Tablet core

Sustained release layer:

methyl hydroxypropyl cellulose,

povidone K30,

lactose monohydrate,

methacrylic acid-ethyl acrylate copolymer (1:1),

talc,

magnesium stearate.

Openable layer:

microcrystalline cellulose silicified,

crospovidone Type A,

silica, colloidal anhydrous,

sodium lauryl sulfate,

allura red AC aluminium lake (E129),

talc,

magnesium stearate.

Coating

ethylcellulose aqueous dispersion,

mannitol,

povidone K30,

dibutyl sebacate,

triethyl citrate,

polysorbate 20,

opadry II 85F19250 clear, which consists of

talc,

macrogol 3350,

polysorbate 80,

polyvinyl alcohol.

Printing ink (opacode-s-1-17823 black ink)

shellac,

iron oxide black (E172),

propylene glycol.

For 75 mg and 150 mg

Tablet core

Sustained release layer:

methyl hydroxypropyl cellulose,

povidone K30,

lactose monohydrate,

methacrylic acid-ethyl acrylate co-polymer (1:1),

talc,

magnesium stearate.

Openable layer:

microcrystalline cellulose silicified,

crospovidone Type A,

silica, colloidal anhydrous,

sodium lauryl sulfate,

allura red AC aluminium lake (E129),

talc,

magnesium stearate.

Coating

ethylcellulose aqueous dispersion,

mannitol,

povidone K30,

dibutyl sebacate,

triethyl citrate,

polysorbate 20,

talc

opadry II 85F19250 clear, which consists of

talc,

macrogol 3350,

polysorbate 80,

polyvinyl alcohol.

Printing ink (opacode-s-1-17823 black ink)

shellac,

iron oxide black (E172),

propylene glycol.

Sunveniz XL 37.5 mg: This medicinal product is presented as a round, pink and white coloured biconvex, 5.9 mm in diameter bilayer coated prolonged-release tablet imprinted with “760” with black ink on one side and plain on the other side.

Sunveniz XL 75 mg: This medicinal product is presented as a round, pink and white coloured biconvex, 8.4 mm in diameter bilayer coated prolonged-release tablet imprinted with “759” with black ink on one side and plain on the other side.

Sunveniz XL 150 mg: This medicinal product is presented as an oval, pink and white coloured biconvex, 16.35 mm x 7.85 mm bilayer coated tablet imprinted with “758” with black ink on one side and plain on the other side.

Blister: Pack sizes 14, 15, 20, 28, 30, 50 or 100 prolonged-release tablets.

Tablet container: Pack sizes: 30 and 1000 (for dispensing only) prolonged-release tablets.

Not all pack sizes may be marketed.

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Spain: Venlafaxina SUN 75 mg / 150 mg, comprimido de liberación prolongada

The Netherlands: Venlafaxine SUN 37,5 mg / 75 mg / 150 mg, tablet met verlengde afgifte

United Kingdom (Northern Ireland): Sunveniz XL 37.5 mg / 75 mg / 150 mg, prolonged-release tablets