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ALVENTA XL 150 MG PROLONGED RELEASE CAPSULE HARD

Active substance(s): VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE / VENLAFAXINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CONSI1INT HEALTH

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Alventa XL 37.5 mg prolonged-release capsules, hard
Alventa XL 75 mg prolonged-release capsules, hard
Alventa XL 150 mg prolonged-release capsules, hard
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 effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Alventa XL is and what it is used for
2. What you need to know before you take Alventa XL
3. How to take Alventa XL
4. Possible side effects
5. How to store Alventa XL
6. Contents of the pack and other information

1. What Alventa XL is and what it is used for
Alventa 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.
Alventa XL is a treatment for adults with depression. Alventa 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 Alventa XL
Do not take Alventa 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 (MAOIs), used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with other medicines,
including Alventa XL, can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after you stop
taking Alventa XL before you take any MAOI (see also the sections “Serotonin syndrome” and “Other medicines and Alventa XL”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Alventa XL.
• If you use other medicines that taken concomitantly with Alventa XL could increase the risk of developing serotonin syndrome
(see the section “Other medicines and Alventa 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 been told you have an abnormal heart rhythm.
• 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 e.g., warfarin (used to prevent blood clots).
• If your cholesterol levels get higher.
• 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.
• If you have diabetes.
Alventa XL may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.
If any of these conditions apply to you, please talk with your doctor before taking Alventa 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 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 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 (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 venlafaxine. This may increase the risk of caries. Therefore, you should take
special care in your dental hygiene.
Children and adolescents under 18 years of age
Alventa 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 Alventa XL for
patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Alventa 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 Alventa XL. Also, the long-term safety effects concerning growth,
maturation and cognitive and behavioural development of Alventa XL in this age group has not yet been demonstrated.
Other medicines and Alventa XL
Tell your doctor or pharmacist if you are taking or have recently taken or might any other medicines, including medicines obtained
without a prescription.
Your doctor should decide whether you can take Alventa 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 Alventa XL. Tell
your doctor if you have taken these medicines within the last 14 days (MAOIs: see the section “Before you take Alventa XL”).
• Serotonin syndrome: Serotonin syndrome, a potentially life-threatening condition (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)
- Medicines to treat depression, for instance SNRI, SSRIs, tricyclics, or medicines containing lithium
- Medicines containing linezolid, an antibiotic (used to treat infections)
- Medicines containing moclobemide, a reversible 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) (a pain-killer)
- 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 notDPMockUp065222_1
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. Get medical care right away if you think serotonin syndrome is happening to you.
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 Alventa 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)
Taking Alventa XL with food and drink and alcohol
Alventa XL should be taken with food (see section 3 “How to take Alventa XL”).
You should avoid alcohol while you are taking Alventa XL.
Pregnancy and breast-feeding and fertility
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 Alventa 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 Alventa 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 Alventa XL during pregnancy, let your midwife and/or doctor know, as your baby might have some symptoms
when it is born. These symptoms usually begin during the first 24 hours after the baby is born. They include not feeding properly
and trouble with 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.
Alventa 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 Alventa XL.
Driving and using machines
Do not drive or use any tools or machines until you know how Alventa XL affects you.
Alventa XL contains sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal
product.

3. How to take Alventa XL
Always take this medicine exactly as your doctor or pharmacist has told you. 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.

CONFIDENTIAL

Take Alventa 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.
Alventa XL should be taken with food.
If you have liver or kidney problems, talk to your doctor, since your dose of Alventa XL may need to be different.
Do not stop taking Alventa XL without talking to your doctor (see the section “If you stop taking Alventa XL”).
If you take more Alventa XL than you should
Call your doctor or pharmacist immediately if you take more than the amount of Alventa XL prescribed by your doctor.
The symptoms of a possible overdose may include a rapid heart beat, changes in level of alertness (ranging from sleepiness to
coma), blurred vision, seizures or fits, and vomiting.
If you forget to take Alventa 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 Alventa XL that has been prescribed for you in one day.
If you stop taking Alventa 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 Alventa 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 Alventa XL, especially when Alventa 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 Alventa 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 medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, do not take more Alventa 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, throat, hands, or feet
• Feeling nervous or anxious, dizziness, throbbing sensations, 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)
• 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 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).
Other side effects that you should tell your doctor about include:
• Coughing, wheezing, shortness of breath and 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, seizures or fits
• Psychiatric problems, such as hyperactivity and euphoria (feeling unusually overexcited).
• Withdrawal effects (see the section “How to take Alventa XL, If you stop taking Alventa XL”).
• Prolonged bleeding - if you cut or injure yourself, it may take slightly longer than usual for bleeding to stop.
Complete side effect listing
Very common (may affect more than 1 in 10 people)
• Dizziness; headache
• Nausea; dry mouth
• Sweating (including night sweats)
Common (may affect up 1 in 10 people)
• Appetite decreased
• Confusion; feeling separated (or detached) from yourself; lack of orgasm; decreased libido; nervousness; insomnia;
abnormal dreams
• Drowsiness; tremor; pins and needles; 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)
• Palpitations
• Increase in blood pressure; flushing
• Yawning
• Vomiting; constipation; diarrhoea
• Increased frequency in urination; difficulties passing urine
• Menstrual irregularities such as increased bleeding or increased irregular bleeding; abnormal ejaculation/orgasm (males);
erectile dysfunction (impotence)
• Weakness (asthenia); fatigue; chills
• Increased cholesterol
Uncommon (may affect 1 in 100 people)
• Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feeling or
emotion; feeling over-excited; grinding of the teeth
• A sensation of restlessness or an inability to sit or stand still; fainting; involuntary movements of the muscles; impaired
coordination and balance; altered taste sensation
• Fast heartbeat; feeling dizzy (particularly when standing up too quickly)
• Shortness of breath
• Vomiting blood, black tarry stools (faeces) or blood in stools; which can be a sign of internal bleeding
• General swelling of the skin especially the face, mouth, tongue, throat area or hands and feet and/or a raised itchy rash
(hives) may be present; sensitivity to sunlight; bruising; rash; abnormal hair loss
• Inability to pass urine;
• Weight gain; weight loss
Rare (may affect 1 in 1,000 people)
• Seizures or fits
• Inability to control urination
• Over activity, racing thoughts and decreased need for sleep (mania)
Frequency not known (frequency cannot be estimated from the available data)
• Reduced number of platelets in your blood, leading to an increased risk of bruising or bleeding; blood disorders which may
lead to an increased risk of infection
• Swollen face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this may be a serious allergic
reaction)
• Excessive water intake (known as SIADH)
• Decrease in blood sodium levels
• 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, Before you take Alventa XL)
• Disorientation and confusion often accompanied by hallucination (delirium); aggression
• A high temperature with rigid muscles, confusion or agitation, and sweating, or if you experience jerky muscle movements
which you can’t control, these may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric
feelings, drowsiness, sustained rapid eye movement, clumsiness, restlessness, feeling of being drunk, sweating or rigid
muscles, which are symptoms of serotonin syndrome; stiffness, spasms and involuntary movements of the muscles
• Severe eye pain and decreased or blurred vision
• Vertigo
• Decrease in blood pressure; abnormal, rapid or irregular heart beat, which could lead to fainting; 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)
• Coughing, wheezing, shortness of breath and a high temperature, which are symptoms of inflammation of the lungs
associated with an increase in white blood cells (pulmonary eosinophilia)
• 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);
slight changes in blood levels of liver enzymes
• Skin rash, which may lead to severe blistering and peeling of the skin; itching; mild rash
• Unexplained muscle pain, tenderness or weakness (rhabdomyolysis)
• Abnormal breast milk production
Alventa 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, Alventa 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 Alventa XL for a long time.
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: Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Alventa XL
Keep this medicine out of the sight and reach of children.
Do not use Alventa XL after the expiry date which is stated on the package. The expiry date refers to the last day of that
month.
This medicinal product does not require any special storage conditions.
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 Alventa XL contains
• The active substance is venlafaxine.
Alventa XL 37.5 mg: Each prolonged release capsule, hard, contains 37.5 mg venlafaxine (as 42.43 mg venlafaxine
hydrochloride).
Alventa XL 75 mg: Each prolonged release capsule, hard, contains 75 mg venlafaxine (as 84.85 mg venlafaxine hydrochloride).
Alventa XL 150 mg: Each prolonged release capsule, hard, contains 150 mg venlafaxine (as 169.70 mg venlafaxine
hydrochloride).
• The other ingredients are:
Capsule contents:
Sugar spheres (saccharose, maize starch), hydroxypropylcellulose, povidone K 30, ethylcellulose, dibutyl sebacate, talc.
37.5 mg capsules contain gelatin, titanium dioxide (E171), red iron oxide (E172)
75 mg capsules contain gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)
150 mg capsules contain gelatin, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172)
What Alventa XL looks like and contents of the pack
Alventa XL 37.5 mg prolonged release capsules, hard: opaque capsules, the upper part is brownish-pink, the lower part is white.
Alventa XL 75 mg prolonged release capsules, hard: opaque, light pink capsules.
Alventa XL 150 mg prolonged release capsules, hard: opaque, brownish-orange colored capsules.
Pack sizes:
Boxes of 10, 14, 20, 28, 30, 50, 98, 100, 100x1 prolonged-release, capsules, hard, in blister packs.
Boxes of 50, 100 and 250 prolonged-release capsules, hard, in HDPE capsule container.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer:
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Distributed by: Consilient Health (UK) Limited. No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE
This leaflet was last revised in 05/2017
P0613

CONFIDENTIAL

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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