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«What is in this leaflet: 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 ...»

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Package leaflet: Information for the user

Sunveniz XL 37.5 mg prolonged-release tablets

Sunveniz XL 75 mg prolonged release tablets

Sunveniz XL 150 mg prolonged release tablets

Venlafaxine

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

What is in this leaflet:

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

1. What Sunveniz XL is and what it is used for Sunveniz 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 noradrenalin in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenalin in the brain.

Sunveniz XL is a medicine to treat adults with depression. Sunveniz is also used to treat adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks). Treating depression or anxiety disorders properly is important to help you get better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.

2. What you need to know before you take Sunveniz XL Do not take Sunveniz XL

- if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6)

- if you are also taking or have taken any time within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (irreversible 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 irreversible MAOI (see also “Taking other medicines”).

If you think any of these apply to you, do not take the tablets. Talk to your doctor first and follow the advice given.

Warnings and precautions Talk to your doctor or pharmacist before taking Sunveniz XL V010 UK-PL

- if you use other medicines that taken concomitantly 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 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 (feeling over-excited or euphoric) or bipolar disorder

- if you have a history of aggressive behaviour

- if you have liver or kidney problems.

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

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 first starting 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 or harming yourself.

- If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years 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.

Dental hygiene Dry mouth is reported in 10% of patients treated with Sunveniz XL. This may increase the risk of caries.





Therefore, you should take special care in your dental hygiene.

Children and adolescents Sunveniz XL should normally not be used for children and adolescents under 18 years. The long-term safety effects concerning growth, maturation and behavioural development of Sunveniz XL in this age group have not yet been demonstrated. Also, you should know that patients under 18 have an increased risk of sideeffects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take medicines such as Sunveniz XL. Despite this, your doctor may prescribe Sunveniz XL for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Sunveniz 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 Sunveniz XL.

Other medicines and Sunveniz XL 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. When Sunveniz XL is taken in combination with other medicines, this may lead to the so-called 'serotonin syndrome'. For information about the symptoms of this syndrome, see section 4 under 'Other serious side effects'. The serotonin syndrome is a potentially life-threatening condition which may be caused when

Sunveniz XL is used in combination with other medicines such as:

irreversible monoamine oxidase inhibitors (see also under “Do not take Sunveniz XL”) V010 UK-PL

- medicines containing moclobemide, which is a newer, reversible MAOI (used to treat depression)

- triptans (used for migraine)

- medicines to treat depression, for instance SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium

- medicines containing linezolid, an antibiotic (used to treat infections)

- 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).

Certain other 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 with food, drink and alcohol Take Sunveniz XL with food. Do not drink alcohol during treatment with Sunveniz 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.

Pregnancy Tell your doctor if you are 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.

Breast-feeding Sunveniz XL passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss breast-feeding with your doctor, and he/she will decide whether you should stop breast-feeding or stop taking Sunveniz XL.

Driving and using machines Sunveniz XL may impair mental concentration and alertness. Therefore, you should be careful when driving motor vehicles or operating machinery. Your doctor will evaluate your ability to drive or use machines by taking into account the degree of the underlying disease, response to treatment and possible undesirable effects.

Sunveniz XL contains lactose 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.

–  –  –

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

V010 UK-PL It may take several days or more before you feel your medicine is working. You may need to take Sunveniz XL for several months.

Dosage The 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.

Method of administration 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.

If you take more Sunveniz XL than you should If you may have taken more Sunveniz XL than you should you must seek immediate medical attention.

Remember to take the packet with you.

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 forget to take Sunveniz 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 Sunveniz XL that has been prescribed for you in one day.

If you stop taking Sunveniz XL 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 Sunveniz XL, especially when Sunveniz 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 Sunveniz XL. 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 medicine, ask your doctor or pharmacist.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious allergic reactions If you notice any of the following symptoms, stop taking Sunveniz 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, tongue, throat, hands, or feet

- feeling nervous or anxious, dizziness, throbbing sensations in the head, 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)

Other serious side effects

V010 UK-PL If you notice any of the following symptoms, you may need urgent medical attention as this may be an

indication of very serious conditions, such as the serotonin syndrome or the neuroleptic malignant syndrome:

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

- eye problems, such as blurred vision, dilated pupils, sustained rapid eye movements

- nerve problems, such as dizziness, pins and needles, movement disorder, seizures or fits

- other physical symptoms, such as high temperature, sweating, feeling of being drunk, rigid muscles or jerky muscle movements

- psychiatric problems, such as euphoric feelings, confusion, agitation, or restlessness

- treatment withdrawal (see the information under 'If you stop taking Sunveniz XL ' in the section “How to take Sunveniz XL ”).

Other side effects If any of the following side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Very common: may affect more than 1 in 10 people

- dry mouth

- headache

- nausea



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