Venlafaxine actavis: detailed information

Package leaflet: Information for the user

Venlafaxine Actavis, 37.5 mg, prolonged-release capsules, hard
Venlafaxine Actavis, 75 mg, prolonged-release capsules, hard
Venlafaxine Actavis, 150 mg, prolonged-release capsules, hard
Venlafaxinum

Read all of this leaflet carefully before 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 other people even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Venlafaxine Actavis is and what it is used for
What you need to know before taking Venlafaxine Actavis
How to take Venlafaxine Actavis
Possible side effects
How to store Venlafaxine Actavis
Contents of the pack and other information

1. What Venlafaxine Actavis is and what it is used for

Venlafaxine Actavis contains the active substance venlafaxine.
Venlafaxine Actavis is an antidepressant medicine that belongs to a group of medicines called
serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. The exact mechanism of action of antidepressants is not fully understood, but they may work by increasing the levels of serotonin and noradrenaline in the brain.
Venlafaxine Actavis is used to treat depression in adults. It is also indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social phobia (fear or avoidance of social situations), and panic attacks (panic disorder). Proper treatment of depression and anxiety disorders is important for the patient's well-being. Without appropriate treatment, the patient's condition may not improve, may worsen, and may become much more difficult to treat.

2. Important information before using Venlafaxine Actavis

When not to use Venlafaxine Actavis

if the patient is allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
if the patient is currently taking or has taken within the last 14 days certain medicines belonging to the group of irreversible monoamine oxidase inhibitors (MAOIs), used in the treatment of depression or Parkinson's disease. Taking irreversible MAOIs together with Venlafaxine Actavis may cause severe or even life-threatening adverse reactions. Also, before starting any medicine belonging to the MAOI group, the patient should wait at least 7 days after discontinuing Venlafaxine Actavis.

(see also section "Venlafaxine Actavis and other medicines" and information in this section regarding serotonin syndrome).

Warnings and precautions

Before starting treatment with Venlafaxine Actavis, discuss the following with your doctor or pharmacist:

if the patient is taking other medicines which, when used together with Venlafaxine Actavis, may increase the risk of serotonin syndrome (see section "Venlafaxine Actavis and other medicines")
if the patient has eye disorders, such as certain types of glaucoma (increased pressure in the eyeball)
if the patient has previously had high blood pressure
if the patient has previously had heart diseases
if the patient has been diagnosed with heart rhythm disorders
if the patient has previously experienced seizures (epilepsy)
if the patient has previously had low sodium levels in the blood (hyponatraemia)
if the patient has a tendency to bruise easily or to bleed (bleeding disorders in the past), or if the patient is pregnant (see "Pregnancy and breastfeeding"), or if the patient is taking other medicines which may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots)
if the patient or any family member has previously experienced mania or bipolar disorder (feelings of excessive excitement or euphoria)
if the patient has previously exhibited aggressive behaviour.

Venlafaxine Actavis may cause feelings of restlessness or inability to sit still during the first weeks of treatment. If such symptoms occur, inform your doctor.

Do not consume alcohol during treatment with Venlafaxine Actavis, as this may cause extreme drowsiness and loss of consciousness. Concurrent use with alcohol and (or) certain medicines may worsen symptoms of depression and other medical conditions, such as anxiety disorders.

Suicidal thoughts and worsening of depression or anxiety disorders

Patients with depression and (or) anxiety disorders may sometimes have thoughts about self-harm or suicide. These thoughts may increase at the beginning of treatment with antidepressants, as these medicines usually take about 2 weeks, sometimes longer, to start working. Such thoughts may also occur when reducing the dose or stopping treatment with venlafaxine.

The occurrence of suicidal thoughts, thoughts of self-harm or suicide is more likely if:

the patient has previously had suicidal thoughts or a desire to self-harm
the patient is a young adult. Clinical trial data indicate an increased risk of suicidal behaviour in individuals under 25 years of age with psychiatric disorders who were treated with antidepressant medicines.

If the patient experiences suicidal thoughts or thoughts of self-harm, seek immediate medical help by contacting a doctor or going to hospital.

It may be helpful to inform family members or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask family or friends for support and request them to inform him or her if they notice worsening depression or anxiety, or concerning changes in behaviour.

Dry mouth

Dry mouth was reported by 10% of patients treated with venlafaxine. This may increase the risk of dental caries. Therefore, special attention should be paid to oral hygiene.

Diabetes

Blood glucose levels may change during treatment with Venlafaxine Actavis. Therefore, dosage adjustments of antidiabetic medicines may be necessary.

Sexual dysfunction

Medicines such as Venlafaxine Actavis (so-called SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persisted after discontinuation of treatment.

Children and adolescents

Venlafaxine Actavis should generally not be used in children and adolescents under 18 years of age. It should be emphasized that when taking medicines of this class, patients under 18 years of age are at increased risk of adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and manifestations of anger). Nevertheless, a doctor may prescribe Venlafaxine Actavis to patients under 18 years of age if he or she considers it to be in their best interest. If Venlafaxine Actavis has been prescribed to a patient under 18 years of age and any doubts arise, consult the treating doctor. There is a lack of available data on the long-term safety of this medicine in this age group with regard to growth, puberty, and cognitive and behavioural development.

Venlafaxine Actavis and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

The treating doctor will decide whether Venlafaxine Actavis can be used together with other medicines.

Do not start or stop taking other medicines, including over-the-counter medicines, natural or herbal remedies, without first consulting a doctor or pharmacist.

Monoamine oxidase inhibitors (MAOIs), used in the treatment of depression or Parkinson's disease, must not be taken together with Venlafaxine Actavis. Inform the doctor if the patient has taken these medicines within the last 14 days. (MAOIs: see section "Important information before using Venlafaxine Actavis")
Serotonin syndrome: During treatment with venlafaxine, a life-threatening condition or reactions resembling neuroleptic malignant syndrome (NMS) may occur (see section "Important information before using Venlafaxine Actavis"), particularly when used concomitantly with other medicines.

Examples of such medicines include:

triptans (used for migraine headaches)
other medicines used to treat depression, e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or medicines containing lithium
medicines containing amphetamine derivatives (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
medicines containing the antibiotic linezolid (used to treat infections)
medicines containing moclobemide, an MAO inhibitor (used to treat depression)
medicines containing sibutramine (used for weight loss)
medicines containing buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
medicines containing dextromethorphan (used to treat cough)
medicines containing methadone (used to treat opioid, drug addiction, or severe pain)
medicines containing methylene blue (used to treat high methaemoglobin levels in blood)
medicines containing St. John's wort (Hypericum perforatum, natural or herbal remedies used to treat mild depression)
medicines containing tryptophan (used for sleep problems and depression)
antipsychotic medicines (used to treat illnesses with symptoms such as seeing, hearing, or feeling things that are not there, false beliefs, unclear thinking, and social withdrawal) and other dopamine antagonist medicines, such as metoclopramide (used to treat nausea and vomiting)

Subjective and objective symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, lack of coordination, rapid heart rate, elevated body temperature, fluctuating blood pressure, hyperreflexia, diarrhoea, coma, nausea, vomiting.

The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Symptoms include fever, rapid heart rate, sweating, muscle rigidity, confusion, and increased muscle enzyme levels (detected in blood tests).

If serotonin syndrome is suspected, immediately inform your doctor or go to the emergency department of the nearest hospital.

Inform your doctor if the patient is taking medicines that may affect heart rhythm. Examples of such medicines include:

antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders)
antipsychotics such as thioridazine (see also "Serotonin syndrome" above)
antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
antihistamines (used to treat allergies).

The following medicines may also interact with Venlafaxine Actavis and should therefore be used with caution. It is especially important to inform the doctor if the patient is taking medicines containing:

ketoconazole (an antifungal medicine)
haloperidol or risperidone (medicines used to treat psychiatric disorders)
metoprolol (a beta-blocker used to treat high blood pressure and heart conditions).

Venlafaxine Actavis with food, drink and alcohol

Venlafaxine Actavis should be taken with food (see section 3 "How to use Venlafaxine Actavis").

Do not consume alcohol during treatment with Venlafaxine Actavis. Concurrent use with alcohol may cause extreme drowsiness and loss of consciousness, and may worsen symptoms of depression and other medical conditions such as anxiety disorders.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy

Venlafaxine Actavis should only be used after discussing the potential benefits and risks for the unborn child with a doctor.

Inform your doctor and (or) midwife that you are taking Venlafaxine Actavis. Taking medicines such as Venlafaxine Actavis during pregnancy may increase the risk of serious complications in the newborn, known as persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and cyanosis (bluish skin). These symptoms usually appear within the first 24 hours after birth. If such symptoms occur in the newborn, contact the midwife and (or) doctor immediately.

If the patient takes this medicine during pregnancy, in addition to breathing difficulties, other symptoms such as feeding problems may occur in the newborn. If the patient is concerned about such symptoms in the newborn, she should contact her doctor and (or) midwife, who will be able to provide appropriate advice.

Taking Venlafaxine Actavis late in pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if the patient has a history of blood clotting disorders. If the patient is taking Venlafaxine Actavis, she should inform her doctor or midwife so they can provide appropriate advice.

Breastfeeding

Venlafaxine Actavis passes into breast milk. There is a risk that the medicine may affect the infant. Therefore, this issue should be discussed with the doctor, who will decide whether to discontinue breastfeeding or stop treatment with this medicine.

Driving and operating machinery

Do not drive or operate machinery until the patient knows how this medicine affects them.

Venlafaxine Actavis contains sucrose

If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

Venlafaxine Actavis contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per capsule, meaning the medicine is considered "sodium-free".

Venlafaxine Actavis 37.5 mg also contains carmine red (E 124)

The medicine may cause allergic reactions.

Venlafaxine Actavis 75 mg and 150 mg also contain sunset yellow (E 110)

The medicine may cause allergic reactions.

3. How to take Venlafaxine Actavis

This medicine should always be taken as directed by your doctor. If in doubt, consult your doctor or pharmacist.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social phobia is 75 mg per day. Your doctor may gradually increase this dose if necessary, up to a maximum dose of 375 mg per day in the treatment of depression. For panic disorder, treatment should be initiated at a lower dose (37.5 mg), which may then be gradually increased. The maximum dose for the treatment of generalized anxiety disorder, social phobia, and panic disorder is 225 mg per day.

Venlafaxine Actavis should be taken every day at approximately the same time, regardless of whether it is taken in the morning or evening.

The capsules should be swallowed whole with liquid. Do not divide, crush, chew, or dissolve the capsules.

Venlafaxine Actavis should be taken with food.

If you have liver or kidney problems, inform your doctor, as your dose may need to be adjusted.

Do not stop taking this medicine without consulting your doctor (see section "Stopping Venlafaxine Actavis").

Taking more Venlafaxine Actavis than prescribed

If you take more than the prescribed dose of Venlafaxine Actavis, contact your doctor or pharmacist immediately.

Overdose can be life-threatening, especially when taken with alcohol and/or certain other medicines (see section "Venlafaxine Actavis with other medicines").

Symptoms of overdose may include rapid heartbeat, disturbances in consciousness (from drowsiness to coma), vision disturbances, seizures, and vomiting.

If you miss a dose of Venlafaxine Actavis

If you forget to take your dose, take the next capsule as soon as possible. However, if it is almost time for your next scheduled dose, skip the missed dose and take only the next dose at the usual time. Do not take a double dose to make up for a missed dose. Do not take more than the daily dose of Venlafaxine Actavis prescribed by your doctor within a single day.

Stopping Venlafaxine Actavis

Do not stop treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor decides that you can discontinue Venlafaxine Actavis, they will advise you on how to gradually reduce the dose before stopping treatment completely.

Patients discontinuing this medicine, especially those who stop abruptly or reduce the dose too quickly, may experience adverse effects. Some patients may experience symptoms such as suicidal thoughts, aggressive behavior, fatigue, dizziness, a feeling of emptiness in the head, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, restlessness, agitation, disorientation, tinnitus, tingling or numbness, weakness, sweating, seizures, flu-like symptoms, visual disturbances, and elevated blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue Venlafaxine Actavis. This process may take several weeks or months. In some patients, a very gradual discontinuation over several months or longer may be necessary. If any of the symptoms listed above, or other bothersome symptoms, occur, consult your doctor.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everybody will experience them.
If any of the following adverse reactions occur, stop taking
Venlafaxine Actavis and contact your doctor immediately or go to
the emergency department of the nearest hospital:

Uncommon (may affect up to 1 in 100 people)

swelling of the face, lips, tongue, throat, hands or feet, and (or) raised, itchy rash (urticaria), difficulty swallowing or breathing

Rare (may affect up to 1 in 1,000 people)

chest tightness, gasping, difficulty swallowing or breathing
severe skin rash, itching or urticaria (red or pale raised swellings, often accompanied by itching)
symptoms of serotonin syndrome, such as: agitation, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhoea, drowsiness, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Symptoms of neuroleptic malignant syndrome may include: fever, rapid heartbeat, sweating, muscle rigidity, confusion, increased muscle enzyme levels (detected in blood tests).
signs of infection such as high fever, chills, shivering, headache, sweating, flu-like symptoms. This may result from a blood disorder leading to increased risk of infection.
severe rash, which may lead to formation of serious blisters and peeling of the skin
muscle pain of unknown origin, tenderness or weakness. These may be symptoms of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

Symptoms of a condition known as stress-induced cardiomyopathy (or "broken heart syndrome"), including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

Tell your doctor if you experience any other adverse reactions, such as (the frequency of these adverse reactions is listed below under "Other adverse reactions"):

cough, wheezing and shortness of breath, possibly accompanied by high temperature
black (tarry) stools or blood in the stool
itching, yellowing of the skin or eyes, or dark urine, which may be signs of liver inflammation
heart problems such as rapid or irregular heartbeat, increased blood pressure
eye problems such as blurred vision, dilated pupils
nervous system disorders such as dizziness, tingling sensation, movement coordination problems (muscle spasms or stiffness), seizures or convulsions
psychiatric disorders such as excessive restlessness and feeling of unnatural excitement
withdrawal symptoms (see sections "How to take Venlafaxine Actavis", "Discontinuing Venlafaxine Actavis")
Prolonged bleeding time – in case of injury, the wound may bleed slightly longer than usual.

While taking this medicine, you may notice small white beads or granules in your stool.
Inside the Venlafaxine Actavis capsules are granules (small, white beads) containing the active substance, venlafaxine. These granules are released from the capsule into the gastrointestinal tract. As they pass through the stomach and intestines, venlafaxine is slowly released from them. The granule matrix does not dissolve and is excreted in the stool. Therefore, even if you notice granules in your stool, the dose of medicine has been absorbed.

Other adverse reactions
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)

decreased appetite
confusion, feeling of detachment (or separation) from oneself, anorgasmia, decreased libido, restlessness, nervousness, unusual dreams
tremor, feeling of anxiety or inability to sit still or remain motionless, tingling, taste disturbances, increased muscle tension
visual disturbances, including blurred vision, dilated pupils, inability to adjust focus when viewing objects at varying distances
ringing in the ears (tinnitus)
rapid heartbeat, palpitations
increased blood pressure, hot flushes
shortness of breath, yawning
vomiting, diarrhoea
mild diarrhoea, itching
increased frequency of urination, urinary retention, difficulty passing urine
menstrual disorders such as heavy bleeding or more frequent irregular bleeding; ejaculation and orgasm disorders (in men), erectile dysfunction (impotence)
weakness (asthenia), fatigue, chills
weight gain, weight loss
increased cholesterol levels

Uncommon (may affect up to 1 in 100 people)

excessive activity, racing thoughts and reduced need for sleep (mania)
hallucinations, feeling of detachment (or separation) from reality, orgasm disorders, lack of feelings or emotions, feeling of excessive excitement, teeth grinding
fainting, involuntary muscle movements, coordination and balance disturbances
dizziness (especially when standing up too quickly), decreased blood pressure
blood in vomit, black (tarry) stools or blood in stool, which may indicate internal bleeding
light sensitivity, bruising, excessive hair loss
involuntary urination
stiffness, spasms and uncontrolled muscle movements
slight changes in liver enzyme activity in blood

Rare (may affect up to 1 in 1,000 people)

convulsions
cough, wheezing and shortness of breath, possibly accompanied by high temperature
disorientation with frequent hallucinations (delirium)
excessive water intake (known as SIADH)
decreased sodium levels in blood
severe eye pain and visual disturbances or blurred vision
irregular, rapid or abnormal heartbeat, which may lead to fainting
severe abdominal or back pain (which may indicate serious intestinal, liver or pancreatic disorders)
itching, yellowing of the skin or eyes, dark urine or flu-like symptoms, which are signs of liver inflammation

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

prolonged bleeding, which may be a sign of reduced platelet count, meaning increased risk of bruising or bleeding
unusual milk production in women
unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, or appearance of unexpected bruises or broken blood vessels (ruptured veins)

Not known (frequency cannot be estimated from available data)

suicidal thoughts and behaviour; during treatment with venlafaxine or shortly after stopping treatment, cases of suicidal thoughts and behaviour have been reported (see section 2. Important information before taking Venlafaxine Actavis)
aggressive behaviour
vertigo of vestibular origin
severe vaginal bleeding shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2.

Venlafaxine Actavis may sometimes cause adverse reactions that the patient may not be aware of, such as increased blood pressure or abnormal heart function; slight changes in sodium, cholesterol or liver enzyme levels in blood. Even more rarely, Venlafaxine Actavis may impair platelet function, leading to increased risk of petechiae or bleeding. Therefore, your doctor may recommend periodic blood tests, especially during long-term treatment with Venlafaxine Actavis.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Venlafaxine Actavis

Keep this medicine out of the sight and reach of children.
Do not use Venlafaxine Actavis after the expiry date stated on the cardboard package and blister pack after: EXP. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Venlafaxine Actavis contains

The active substance is venlafaxine. Each capsule contains venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg or 150 mg of venlafaxine.
The other ingredients are: sugar spheres, hydroxypropylcellulose (HPC-LM), hypromellose (6 cps), talc, hypromellose (E-15), dibutyl sebacate, oleic acid, colloidal anhydrous silica, ethylcellulose (20 cP).
Capsule shell:

37.5 mg: gelatin, sodium lauryl sulfate, colourants: carmine red (E 124), quinoline yellow (E 104), titanium dioxide (E 171)
75 mg: gelatin, sodium lauryl sulfate, colourants: orange yellow (E 110), quinoline yellow (E 104), titanium dioxide (E 171)
150 mg: gelatin, sodium lauryl sulfate, colourants: orange yellow (E 110), quinoline yellow (E 104), patent blue (E 131), titanium dioxide (E 171)

What Venlafaxine Actavis looks like and contents of the pack
Venlafaxine Actavis 37.5 mg, prolonged-release hard capsules:
white to almost white pellets in a size "3" capsule with an orange cap and transparent body.
Venlafaxine Actavis 75 mg, prolonged-release hard capsules:
white to almost white pellets in a size "1" capsule with a yellow cap and transparent body.
Venlafaxine Actavis 150 mg, prolonged-release hard capsules:
white to almost white pellets in a size "0" capsule with a pale yellow cap and transparent body.
Prolonged-release hard capsules are available in packs containing PVC/Aluminium blisters.
Pack sizes:
28 capsules packed in blisters (PVC/Aluminium).
30 capsules packed in blisters (PVC/Aluminium).

Marketing Authorisation Holder
Actavis Group PTC ehf.
Dalshraun 1
220 Hafnarfjörður
Iceland

Manufacturer
Balkanpharma – Dupnitsa AD
3 Samokovsko Shosse Str.
2600 Dupnitsa
Bulgaria

For further information about this medicinal product and its trade names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.