Patient leaflet - VENLADEX XL 150 MG PROLONGED-RELEASE TABLETS
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
monoamine oxidase inhibitors which are used to treat depression or parkinson’s disease must not be taken with venladex 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 venladex 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 tramadol (a pain killer), fentanyl, tapentadol, pethidine, pentazocine, buprenorphine (used to treat severe pain), buprenorphine/naloxone (used to treat opioid overdose)
- 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: 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:
- 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 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:
- Ketoconazole (an antifungal medicine)
- Haloperidol or risperidone (to treat psychiatric
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conditions)
- Metoprolol (a beta blocker to treat high blood pressure and heart problems)
- Oral contraceptives
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 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.
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.
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)
- Swelling of the face, mouth, tongue, throat, hands, or feet, and/or a raised itchy rash (hives), trouble swallowing or breathing
Rare (may affect up to 1 in 1,000 people)
- Chest tightness, wheezing, trouble swallowing or breathing
- Severe skin rash, itching or hives (elevated patches of red or pale skin that often itch)
- Signs and symptoms of serotonin syndrome which may include 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).
- Signs of infection, such as high temperature, chills, shivering, headaches, sweating, flu-like symptoms. This may be the result of a blood disorder which leads to an increased risk of infection.
- Severe rash, which may lead to severe blistering and peeling of the skin.
- Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.
Frequency not known (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 Venladex XL)
- Signs and symptoms of a condition called “stress cardiomyopathy” which may include chest pain, shortness of breath, dizziness, fainting, irregular heartbeat
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):
- Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
- Black (tarry) stools or blood in stools
- Itchiness, yellow skin or eyes, or dark urine, which may be symptoms of inflammation of the liver (hepatitis)
- Heart problems, such as fast or irregular heart rate, increased blood pressure
- Eye problems, such as blurred vision, dilated pupils
- Nerve problems, such as dizziness, pins and needles, movement disorder (muscle spasms or stiffness), seizures or fits
- Psychiatric problems, such as hyperactivity and feeling unusually overexcited
- Withdrawal effects (see the section “How to take VENLADEX XL, if you stop taking VENLADEX XL”)
- Prolonged bleeding – if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop
Other side effects that may occur
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 pass 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 (sensation of dizziness or spinning)
- heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see ‚Pregnancy and breast-feeding‘ in section 2 for more information
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:
DEXCEL® -PHARMA LTD., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire,
NN11 8PB, UK.
This leaflet was last revised in June 2021.
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