XENALVEN XL 150 MG PROLONGED-RELEASE CAPSULE - patient leaflet, side effects, dosage

Patient leaflet - XENALVEN XL 150 MG PROLONGED-RELEASE CAPSULE

2. what you need to know before you take xenalven xl capsules.

Do not take Xenalven XL

if you are allergic to venlafaxine or any other ingredients of this medicine (listed in section 6).
if you are also taking or have taken 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 venlafaxine can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop taking Xenalven XL before you take any MAOI (see also the section „Other medicines and Xenalven XL " and the information in that section about "Serotonin Syndrome“)

Warnings and precautions

Talk to your doctor or pharmacist before taking Xenalven XL

if you use other medicines that taken together with Xenalven XL could increase the risk of developing serotonin syndrome (see the section “Other medicines and Xenalven 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 pregnant (see ‘Pregnancy and breast-feeding’) or if you are taking other medicines that may increase the risk of bleeding eg.warfarin (used to prevent blood clot)
if your cholesterol levels get higher
if you have been told you have an abnormal heart rhythm.
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.

Xenalven 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 venlafaxine.

You may be more likely to think like this:

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

Dry mouth is reported in 10% of patients treated with Xenalven XL. This may increase the risk of tooth decay (caries). Therefore, you should take special care in your dental hygiene

Diabetes

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

Sexual dysfunction

Medicines like Xenalven 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

Xenalven 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 Xenalven XL for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Xenalven 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 Xenalven XL. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Xenalven XL in this age group has not yet been demonstrated.

Other medicines and Xenalven XL

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 Xenalven 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 Xenalven XL capsules. 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 Xenalven XL Capsules”).
Serotonin syndrome: A potentially life-threatening condition or Neuroleptic Malignant Syndrome (NMS)-like reactions (see the section „Possible Side Effects“), may occur with Xenalven XL treatment, particularly when taken with other medicines. Examples of these medicines include:
– triptans (used for migraine)
– medicines to treat depression, for instance SNRI, 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 methadone (used to treat opioid drug addiction or severe pain)
– Medicines containing dextromethorphan (used to treat coughing)
– 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 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 Xenalven 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)

Xenalven XL with food, drink and alcohol

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

You should avoid alcohol while you are taking Xenalven 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 Xenalven 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 Xenalven 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, in addition to having trouble breathing, another symptoms 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.

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

Xenalven 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 Xenalven XL.

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Driving and using machines

Venlafaxine can cause impaired judgement, thinking, and movement and coordination as well as problems with vision. If you are affected by any of these you should not drive, operate machinery or take part in any activities where such effects could put you or others at risk.

Xenalven XL contains sunset yellow, ponceau 4R red and sucrose.

sunset yellow as a colouring agent – is contained in the 75 mg and 150 mg strength capsules. It may cause an allergic reaction.
ponceau 4R red as a colouring agent – is contained in the 37.5 mg capsules. It may cause as allergic reaction.
sucrose – is contained in all strengths capsules. 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 capsule, that is to say essentially ‘sodium-free’.

3. how to take xenalven xl capsules

Always take Xenalven 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 Xenalven 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.

Xenalven XL should be taken with food.

If you have liver or kidney problems, talk to your doctor, since your dose of Xenalven XL may need to be different.

Do not stop taking Xenalven XL without talking to your doctor (see the section “If you stop taking Xenalven XL”).

If you take more Xenalven XL than you should

Call your doctor or pharmacist immediately if you take more than the amount of Xenalven 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 Xenalven 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 dose. Do not take more than the daily amount of Xenalven XL that has been prescribed for you in one day.

If you stop taking Xenalven 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 Xenalven 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 Xenalven XL, especially when Xenalven 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 Xenalven 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, this medicine can cause side effects, although not everybody gets them.

Do not be concerned if you see small white granules or balls in your stools after taking Xenalven XL. Inside Xenalven XL capsules are spheroids or small white balls that contain the Xenalven XL active ingredient. These spheroids are released from the capsules into your gastrointestinal tract. As the spheroids travel the length of your gastrointestinal tract, Xenalven XL is slowly released.

The spheroid “shell” remains undissolved and is eliminated in your stools. Therefore, even though you may see spheroids in your stools, your dose of Xenalven XL has been absorbed

Allergic reactions

If any of the following happen, do not take more Xenalven 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 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 Neutroleptic 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).

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.

Not known (frequency cannot be estimated from the available data)

Signs and symptoms of a condition called “stress cardiomyopathy” which may include chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.
Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy and breast-feeding in section 2 for more information.

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
Yellow skin or eyes, itchiness 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 Xenalven XL Capsules, if you stop taking Xenalven XL)
Prolonged bleeding – if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.

Other reported side effects

Very common (may affect more than 1 in 10 people)

Headache; dry mouth; sweating (including night sweats)
Nausea
Dizziness
Insomnia
Constipation
Drowsiness

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)

Hallucinations; feeling separated (or detached) from reality; abnormal orgasm; lack of feeling or emotion; feeling over-excited; grinding of the teeth
Over activity, racing thoughts and decreased need for sleep (mania)
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 urination
Stiffness, spasms and involuntary movements of the muscles
Slight changes in blood levels of liver enzymes

Rare (may affect up to 1 in 1000 people)

Seizures or fits
Coughing, wheezing and shortness of breath which may be accompanied by a high temperature
Excessive water intake (known as SIADH)
Severe eye pain and decreased or blurred vision
abnormal, rapid or irregular heart beat, which could lead to fainting
decrease in blood sodium level
disorientation and confusion often accompanied by hallucination (delirium)
Itchiness, yellow skin or eyes, dark urine, or flu-like symptoms, which are symptoms of inflammation of the liver (Hepatitis)
severe abdominal or back pains (which could indicate a serious problem in the gut, liver or pancreas).

Very rare (may affect up to 1 in 10,000 people):

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),
Abnormal breast milk production,
Prolonged bleeding, which may be a sign of reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding

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).
Vertigo
Aggression

Xenalven 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 of liver enzymes, sodium or cholesterol. More rarely, Xenalven 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 Xenalven XL for a long time.

Reporting of side effects

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 Website: 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 xenalven xl capsules

Keep this medicine out of the sight and reach of children.

Do not use Xenalven XL after the expiry date which is stated on the carton after “EXP”. The expiry date refers to the last day of that month.

Store below 30°C and store in the original container to protect from moisture.

Do not use Xenalven XL after 100 days of opening the bottle.

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.

6. contents of the pack and other information

What Xenalven XL contains

– The name of your medicine is Xenalven XL 37.5 mg or 75 mg or 150 mg prolonged release capsules. It will be referred to as Xenalven XL Capsules throughout this leaflet. Each prolonges release capsules contains either 37.5 mg or 75 mg or 150 mg venlafaxine hydrochloride as an active substance.
– The other contents of the capsules are Sugar Spheres (contains sucrose), Ethyl cellulose (E462), Hydroxy propyl cellulose, Hypromellose (E464), Talc (E553b), Dibutyl sebacate, Oleic acid and Colloidal anhydrous silica.
– The capsules shell contains: Gelatin, Sodium Lauryl sulphate, Ponceau 4R (E124), Quinoline yellow (E104) and Titanium dioxide (E171) for 37.5 mg, Sunset yellow (E110), Quinoline yellow (E104) and Titanium dioxide (E171) for 75 mg, Sunset yellow (E110), Quinoline yellow (E104), Patent blue (E131) and Titanium dioxide (E171) for 150 mg.

Remember : This medicine is for you. Only a doctor can prescribe it for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours.

What Xenalven XL looks like and contents of the pack

Xenalven XL prolonged release capsules is available in three strengths

– 37.5 mg: White to off-white pellets filled in hard gelatin capsules shells ‘size 3’ with orange cap and clear transparent body
– 75 mg: White to off-white pellets filled in hard gelatin capsules shells ‘size 1’ with yellow cap and clear transparent body
– 150 mg: White to off-white pellets filled in hard gelatin capsules shells ‘size 0’ with buff cap and clear transparent body.

Cipla I

Date: 17/01/2022

safety variation