- venlafaxine hydrochloride
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet are: PL14017/0122, PL14017/0123.
Venladex XL 75,150 mg Prolonged-Release Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENLADEX® XL 75 mg PROLONGED-RELEASE TABLETS
VENLADEX® XL 150 mg PROLONGED-RELEASE TABLETS
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 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 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 - see in section 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.
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 norepinephrine in the brain. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and norepinephrine 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 TAKE VENLADEX XL
Do not take VENLADEX XL
Warnings and precautions
Talk to your doctor or pharmacist before taking VENLADEX XL:
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 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 Venladex XL.
You may be more likely to think like this:
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 VENLADEX XL. Therefore, the dosage of your diabetes medicines may need to be adjusted.
Medicines like VENLADEX XL (so called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
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
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 Venladex 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.
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:
Signs and symptoms of serotonin syndrome may include a combination of the following:
involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, excessive sweating, tremor, increased muscle tension, restlessness, hallucinations, loss of coordination, fast heartbeat, body temperature above 38°C, fast changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting. Contact your doctor when experiencing such symptoms.
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).
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:
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 pharmacist if you are taking medicines containing:
VENLADEX XL with food, drink and alcohol
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 knows 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, 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.
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.
If you take Venladex 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 Venladex XL so they can advise you.
Driving and using machines
Do not drive or use any tools or machines until you know how this medicine affects you.
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 heartbeat, 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 a double dose to make up for a forgotten one. 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 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 VENLADEX 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.
If you have any further questions on the use of this medicine, 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)
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):
Other side effects that may occur
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)
VENLADEX 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, 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.
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 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.
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.
Do not store above 25°C.
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 XL 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:
This leaflet was last revised in February 2021.
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+44 (0) 1748 828 784
+44 (0) 1748 828 784