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The product code(s) for this leaflet is: PL 20117/0067.
Vensir XL 75mg prolonged release hard capsules
Vensir XL
75 mg prolonged-release hard capsules
venlafaxine hydrochloride
Please read all of this leaflet before you start to take your medicine as it contains important information about Vensir XL.
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.
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.
1. What Vensir XL is and what it is used for
2. What you need to know before you take Vensir XL
3. How to take Vensir XL
4. Possible side effects
5. How to store Vensir XL
6. Contents of the pack and other information
Vensir XL contains the active substance venlafaxine.
Vensir 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.
Vensir XL is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized 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.
Do not drink alcohol while being treated with Vensir 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.
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:
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 is getting worse, or if they are worried about changes in your behaviour.
Talk to your doctor before taking Vensir XL if you:
Vensir 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.
Medicines like Vensir XL (so called SNRIs/SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
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 Vensir XL. Therefore, the dosage of your diabetes medicines may need to be adjusted.
Vensir 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 Vensir 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, including medicines obtained without a prescription.
Your doctor should decide whether you can take Vensir 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.
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:
The following medicines may also interact with Vensir XL and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines containing:
Food:
The capsules should be taken with food (see section 3 "How to take Vensir XL").
Alcohol:
Do not drink alcohol while being treated with Vensir 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 Vensir 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 Vensir XL. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (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 Vensir 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 Vensir XL so they can advise you.
Vensir XL passes into breast milk. There is a risk of an effect on the baby. Your baby may experience irritability, shaking, floppiness, persistent crying and difficulty in sleeping. 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Vensir XL may make you feel drowsy. Be careful driving or operating dangerous machinery until you know how it affects you.
Always take Vensir XL exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The recommended starting dose for the 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 Vensir XL 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.
Vensir 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 Vensir XL").
The use of Vensir XL in children and adolescents (under the age of 18) is not recommended (see also section 2).
If you suffer from liver or kidney problems, the dosage may be reduced by your doctor.
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 Vensir XL").
Symptoms of overdose: 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 Vensir 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 Vensir 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 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 Vensir 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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, do not take more Vensir XL. Tell your doctor immediately, or go to the casualty department at your nearest hospital:
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Frequency not known (cannot be estimated from the available data)
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):
Do not be concerned if you see small white balls or granules in your stools after taking this medicine. Inside Vensir XL capsules are spheroids (small white balls) that contain the active ingredient (venlafaxine). These spheroids are released from the capsule into your stomach. As they travel through your stomach and intestines, venlafaxine is slowly released. The spheroid "shell" does not dissolve and is passed out in your stools. So, even though you may see spheroids in your stools, your dose of medicine has been absorbed.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Frequency not known (cannot be estimated from the available data)
Vensir 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, Vensir 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 Vensir XL for a long time.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
UK:
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland:
Malta
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blisters after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
Store in the original container to protect from moisture.
Do not use this medicine if you notice that the capsules are sticky or other visible signs of deterioration.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is venlafaxine hydrochloride equivalent to 75 mg venlafaxine.
The other ingredients are: microcrystalline cellulose, copovidone, ethyl cellulose, magnesium stearate, povidone, colloidal silicon dioxide, talc.
The capsule shell contains gelatine, titanium dioxide (E171), black iron oxide (E172), red iron oxide (E172). The printing ink contains: shellac, propylene glycol, red iron oxide (E172).
The active substance and ingredients are used to make white to off-white round biconvex film coated mini tablets of 12.5 mg. The 75 mg capsule contains 6 mini tablets.
The 75 mg capsules are opaque, peach coloured, prolonged release hard capsules having red coloured thick and thin radial circular bands on both ends of the capsules.
Vensir XL capsules are available in blister packs of 10, 14, 15 20, 28, 30, 56, 60 or 100 capsules.
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:
Ireland — Vensir XL 75 mg prolonged-release hard capsules
UK — Vensir XL 75 mg prolonged-release hard capsules & Venlafaxine Morningside 75 mg prolonged-release hard capsules
This leaflet was revised in March 2025.
MPL08350 - P1.2
20044155