Package leaflet: Information for the user

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Velaxin ER 150 mg (Velaxin)
Extended-release hard capsules
Venlafaxinum
Velaxin ER 150 mg and Velaxin are different brand names for the same medicine.
Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so you can read it again if needed.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

What Velaxin ER 150 mg is and what it is used for
Important information before taking Velaxin ER 150 mg
How to take Velaxin ER 150 mg
Possible side effects
How to store Velaxin ER 150 mg
Contents of the pack and other information

1. What Velaxin ER is and what it is used for
Velaxin ER contains the active substance – venlafaxine.
Velaxin ER 150 mg is an antidepressant medicine belonging to a group of medicines called
serotonin-norepinephrine reuptake inhibitors (SNRIs). Medicines in this group are used to treat depression and other conditions, such as anxiety disorders. It is believed that people with depression and (or) anxiety have lower levels of serotonin and norepinephrine in the brain. The exact mechanism of action of antidepressant medicines is not fully understood, but they may help by increasing the levels of serotonin and norepinephrine in the brain.
Velaxin ER 150 mg is used to treat depression in adults. Velaxin ER 150 mg 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 disorder (panic attacks). To feel better, treatment of depression and anxiety disorders should be properly managed. If treatment is not initiated, the condition may not improve, may worsen, and become significantly more difficult to treat.

2. Important information before taking Velaxin ER 150 mg

When not to take Velaxin ER 150 mg

if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6);
if you are currently taking or have taken within the last 14 days any medicine from the group of irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease. Taking irreversible MAOIs together with Velaxin ER 150 mg may cause severe or even life-threatening adverse reactions.

Also, before starting any medicine from the group of irreversible MAOIs, you should wait at least 7 days after stopping treatment with Velaxin ER 150 mg (see also section “Velaxin ER 150 mg and other medicines”).

Warnings and precautions
Before starting treatment with Velaxin ER 150 mg, discuss the following with your doctor or pharmacist:

if you are taking other medicines that, when taken together with Velaxin ER 150 mg, may increase the risk of serotonin syndrome (see section “Velaxin ER 150 mg and other medicines”);
if you have eye disorders, such as certain types of glaucoma (increased pressure in the eyeball);
if you have previously had high blood pressure;
if you have previously had heart diseases;
if you have previously had cardiac arrhythmias;
if you have previously had seizures (epilepsy);
if you have previously had low sodium levels in the blood (hyponatremia);
if you are prone to bruising or bleeding (bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, e.g. warfarin (used as an anticoagulant), or if you are pregnant (see “Pregnancy and breastfeeding”);
if you or any of your family members have previously had mania (feelings of excessive excitement or euphoria) or bipolar disorder;
if you have previously exhibited aggressive behavior.

Velaxin ER 150 mg may cause feelings of restlessness or inability to sit still during the first few weeks of treatment. If such symptoms occur, inform your doctor.
Do not consume alcohol during treatment with Velaxin ER 150 mg, as it may cause extreme drowsiness and loss of consciousness. Concurrent use with alcohol and (or) certain medicines may worsen symptoms of depression and other conditions, such as anxiety disorders.

Suicidal thoughts and worsening of depression or anxiety disorders
People with depression and (or) anxiety disorders may sometimes have thoughts of self-harm or suicide. Such thoughts may intensify at the beginning of treatment with antidepressant medicines, as these medicines usually start to work after about 2 weeks, sometimes later.
These thoughts may also occur when reducing the dose or stopping treatment with Velaxin ER 150 mg.
The occurrence of suicidal thoughts, thoughts of self-harm, or suicide attempts is more likely if:

you have previously had suicidal thoughts or self-harming behavior;
you are a young adult; clinical trial data indicate an increased risk of suicidal behavior in individuals under 25 years of age with psychiatric disorders treated with antidepressant medicines.

If you experience suicidal thoughts or thoughts of self-harm, contact your doctor immediately or go to the nearest hospital.
It may be helpful to inform your family members or friends about your depression or anxiety disorder and ask them to read this leaflet. You may ask for help from your family or friends and request them to inform you if they notice worsening of depression or anxiety, or concerning changes in your behavior.

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

Diabetes
Velaxin ER 150 mg may alter blood glucose levels, and therefore, adjustment of antidiabetic medication dosage may be necessary.

Sexual dysfunction
Medicines such as Velaxin ER 150 mg (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
Velaxin ER 150 mg should not be used in children and adolescents under 18 years of age.
It should also be emphasized that patients under 18 years of age taking medicines from this group are at increased risk of adverse effects, such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behavior, and anger).
Nevertheless, your doctor may prescribe Velaxin ER 150 mg to patients under 18 years of age if they consider it beneficial. If your doctor has prescribed Velaxin ER 150 mg to a patient under 18 years of age, discuss any concerns with your doctor. Inform your doctor if any of the above-mentioned symptoms occur or worsen in patients under 18 years of age taking Velaxin ER 150 mg.
Long-term safety regarding the impact on growth, maturation, and cognitive and behavioral development in this age group has not yet been established.

Velaxin ER 150 mg and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Your doctor will decide whether Velaxin ER 150 mg can be taken together with other medicines.
Do not start or stop taking other medicines, including over-the-counter medicines, natural or herbal remedies, without first discussing it with your doctor or pharmacist.

Monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson’s disease must not be taken with Velaxin ER 150 mg. Inform your doctor if you have taken these medicines within the last 14 days (MAOIs: see section “Important information before taking Velaxin ER 150 mg”).
Serotonin syndrome: A life-threatening condition or neuroleptic malignant syndrome-like reactions may occur during treatment with venlafaxine (see section “Possible side effects”), especially 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, a MAO inhibitor (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 dextromethorphan (used to treat cough);
medicines containing methadone or buprenorphine (used to treat opioid dependence or severe pain);
medicines containing methylene blue (used to treat high methemoglobin levels in the blood);
medicines containing St. John’s wort (Hypericum perforatum, herbal or plant-based remedies used to treat mild depression);
medicines containing tryptophan (used for sleep problems and depression);
antipsychotic medicines (used to treat conditions with symptoms such as hearing, seeing, and feeling things that do not exist, delusions, unnatural suspicion, unclear thinking, social withdrawal).

Subjective and objective symptoms of serotonin syndrome may include: motor restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhea, coma, nausea, vomiting.
The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome. Subjective and objective symptoms include: fever, rapid heartbeat, sweating, muscle rigidity, confusion, increased muscle enzyme levels (detected in blood tests).
If serotonin syndrome is suspected, inform your doctor immediately or go to the nearest hospital emergency department.

If you are taking medicines that may affect heart rhythm, inform your doctor. Examples of such medicines:

antiarrhythmics, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat cardiac arrhythmias);
antipsychotics, such as thioridazine (see above – serotonin syndrome);
antibiotics, such as erythromycin or moxifloxacin (used to treat bacterial infections);
antihistamines (used to treat allergies).

The following medicines may also interact with Velaxin ER 150 mg and should therefore be used with caution. It is especially important to inform your doctor if you are taking medicines containing:

ketoconazole (an antifungal medicine);
haloperidol or risperidone (medicines used to treat psychiatric disorders);
metoprolol (a beta-blocker used to treat hypertension and heart diseases).

Taking Velaxin ER 150 mg with food, drink, and alcohol
Velaxin ER 150 mg should be taken with food (see section 3 “How to take Velaxin ER 150 mg”).
Do not consume alcohol during treatment with Velaxin ER 150 mg. Concurrent use with alcohol may cause extreme drowsiness and loss of consciousness and may worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Velaxin ER 150 mg should only be used after discussing with your doctor the potential benefits and risks for the unborn child.
Taking Velaxin ER 150 mg late in pregnancy may increase the risk of serious vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. If you are taking Velaxin ER 150 mg, inform your doctor or midwife so they can provide appropriate advice.
Similar medicines (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn, causing rapid breathing and cyanosis. These symptoms usually occur within 24 hours after birth. If you notice such symptoms in your baby, contact your midwife and (or) doctor immediately.
If you take this medicine during pregnancy, your newborn may experience other symptoms besides breathing difficulties, such as poor feeding. If you are concerned about such symptoms in your newborn, contact your doctor and (or) midwife, who will be able to provide appropriate advice.
Velaxin ER 150 mg passes into human milk. There is a risk of affecting the infant. The infant may become irritable, fussy, and have sleep disturbances. Withdrawal symptoms related to venlafaxine have also been reported after discontinuation of breastfeeding. Therefore, discuss this issue with your doctor, who will decide whether to discontinue breastfeeding or stop treatment with Velaxin ER 150 mg.

Driving and operating machinery
Do not drive or operate machinery until you know how this medicine affects you.

Velaxin ER 150 mg 150 mg contains sodium
Velaxin ER 150 mg contains 36 mg of sodium (the main component of table salt) in each capsule. This corresponds to 1.8% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Velaxin ER 150 mg

This medicine should always be taken exactly as directed by the physician. In case of doubt, consult a doctor or pharmacist.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorders, and social phobia is 75 mg once daily. Your doctor may gradually increase this dose if necessary, up to a maximum dose of 375 mg per day in the case 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 disorders, social phobia, and panic disorder is 225 mg per day.

Velaxin ER 150 mg should be taken every day at approximately the same time, regardless of whether in the morning or evening. The capsules must be swallowed whole with liquid. Do not divide, crush, chew, or dissolve the capsules.

Velaxin ER 150 mg should be taken with food.

Inform your doctor if you have any liver or kidney disorders, as dose adjustment may be necessary.

Do not stop taking this medicine without consulting your doctor (see section "Stopping treatment with Velaxin ER 150 mg").

Taking more Velaxin ER 150 mg than prescribed

If you take more Velaxin ER 150 mg than prescribed, contact your doctor immediately.

Overdose can be life-threatening, especially when taken with alcohol and/or certain other medicines (see section "Velaxin ER 150 mg and other medicines").

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

Missing a dose of Velaxin ER 150 mg

If you miss a dose, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take only your next dose at the usual time. Do not take a double dose to make up for a missed one. Do not take more than the daily dose of Velaxin ER 150 mg prescribed by your doctor during a single 24-hour period.

Stopping treatment with Velaxin ER 150 mg

Do not discontinue treatment or reduce the dose of this medicine without talking to your doctor, even if you feel better. If your doctor decides that treatment with Velaxin ER 150 mg can be discontinued, they will advise you on how to gradually reduce the dose before stopping completely.

Patients who discontinue the medicine, especially after abrupt discontinuation or too rapid dose reduction, may experience adverse effects such as suicidal thoughts, aggressive behavior, feeling of fatigue, dizziness, feeling of emptiness in the head, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling or numbness, weakness, sweating, seizures, flu-like symptoms, visual disturbances, and elevated blood pressure (which may cause headaches, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually discontinue Velaxin ER 150 mg. This process may take several weeks or months. In some patients, very gradual discontinuation over several months or longer may be necessary. If any of the symptoms listed above, or other bothersome symptoms, occur, contact your doctor.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
While taking Velaxin ER 150 mg, patients may notice small, white granules or beads in their
faeces. Inside the Velaxin ER 150 mg capsules are granules or small, white beads that
contain the active substance, venlafaxine. These granules are released from the capsule into the
gastrointestinal tract and travel through its entire length, gradually releasing venlafaxine.
The skeleton of the granules does not dissolve and is excreted in the faeces. Therefore, even if the patient notices
granules in the faeces, the dose of venlafaxine has been absorbed.
If any of the following adverse effects occur, stop taking Velaxin
ER 150 mg immediately and contact your doctor without delay or go to the nearest hospital
Accident and Emergency Department.

Uncommon (may occur in no more than 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 occur in no more than 1 in 1000 people)

Chest tightness, wheezing, difficulty swallowing or breathing;
Severe skin rash, itching or urticaria (swelling with red or pale areas, often accompanied by itching);
Symptoms of serotonin syndrome, which may include: restlessness, 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 that leads to an increased risk of infection.
Severe rash, which may lead to blistering 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 cardiomyopathy (also called broken heart syndrome), including: chest pain, shortness of breath, dizziness, fainting, irregular heartbeat.

If any of the following adverse effects occur, contact your doctor (the frequency of occurrence of these adverse effects is listed below under “Other adverse effects”):

Cough, wheezing and shortness of breath, possibly accompanied by high fever;
Black (tarry) stools or blood in the stool;
Itching, yellowing of the skin or whites of the eyes, or dark urine, which may be symptoms of liver inflammation (hepatitis);
Heart problems such as rapid or irregular heartbeat, increased blood pressure;
Vision disturbances such as blurred vision, dilated pupils;
Nervous system disturbances such as dizziness, tingling sensations, movement coordination problems (muscle spasms or stiffness), seizures or convulsions;
Mental disturbances such as excessive restlessness and feelings of unnatural excitement;
Withdrawal symptoms (see sections “How to take Velaxin ER 150 mg” and “Stopping Velaxin ER 150 mg”);
Prolonged bleeding time – in case of a cut, the wound may bleed slightly longer than usual.

Other adverse effects
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; feelings of detachment (or separation) from oneself; anorgasmia; reduced libido; agitation; nervousness; unusual dreams;
Tremor; feeling of anxiety or inability to sit still or remain motionless; tingling; taste disturbances; increased muscle tension;
Vision disturbances, including blurred vision; dilated pupils; inability of the eye to accommodate (automatic focusing from distant to near objects);
Ringing in the ears (tinnitus);
Rapid heartbeat; palpitations;
Increased blood pressure; sudden flushing;
Shortness of breath; yawning;
Vomiting; diarrhoea;
Mild rash; itching;
Increased frequency of urination; urinary retention; difficulty urinating;
Irregular menstruation, i.e. heavy bleeding or more frequent irregular bleeding;
Ejaculation/orgasm disorders (in men); erectile dysfunction (impotence);
Weakness (asthenia); fatigue; chills;
Increased body weight; decreased body weight;
Increased blood cholesterol levels.

Uncommon (may affect up to 1 in 100 people)

Excessive excitement, racing thoughts and reduced need for sleep (mania);
Hallucinations; feeling of detachment (or separation) from reality; orgasm disorders; apathy; feeling of excessive excitement; teeth grinding;
Fainting; uncontrolled muscle movements; disturbances in coordination and balance;
Dizziness (especially upon standing up too quickly); decreased blood pressure;
Vomiting blood; black, tarry stools (faeces) or blood in the stool, which may indicate internal bleeding;
Light sensitivity; bruising; excessive hair loss;
Urinary incontinence;
Stiffness, spasms and uncontrolled muscle movements;
Minor changes in liver enzyme activity in blood tests.

Rare (may affect up to 1 in 1000 people)

Convulsions;
Cough, wheezing and shortness of breath, possibly accompanied by high fever;
Confusion and disorientation, often with accompanying hallucinations (delirium);
Excessive water retention in the body (known as SIADH, syndrome of inappropriate antidiuretic hormone hypersecretion);
Decreased sodium levels in the blood;
Severe eye pain and worsening or blurred vision;
Irregular, rapid or irregular heartbeat, which may lead to fainting;
Severe abdominal or back pain (which may indicate serious intestinal, liver or pancreatic problems);
Itching, yellowing of the skin or whites of the eyes, dark urine or flu-like symptoms, which are signs of liver inflammation (hepatitis).

Very rare (may affect fewer than 1 in 10,000 people)

Prolonged bleeding, which may be a sign of reduced platelet count, indicating an increased risk of bruising or bleeding;
Unusual milk production in women;
Unexpected bleeding, e.g. bleeding gums, blood in urine or vomit, appearance of unexpected bruises or broken blood vessels (ruptured veins).

Frequency not known (cannot be estimated from available data)

Suicidal thoughts and behaviour; cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after treatment has ended (see section 2. Important information before using Velaxin ER 150 mg);
Aggressive behaviour;
Dizziness;
Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection “Pregnancy and breastfeeding” in section 2.

Velaxin ER 150 mg may sometimes cause adverse effects that the patient may not
be aware of, such as increased blood pressure or abnormal heart function; minor changes in liver enzyme activity, blood sodium or cholesterol levels.
In even rarer cases, Velaxin ER 150 mg may impair platelet function, increasing the risk of petechiae or bleeding. Therefore, your doctor may recommend periodic blood tests, especially during long-term treatment with Velaxin ER 150 mg.

Reporting adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 effects helps to provide more information on the safety of the medicine.

5. How to store Velaxin ER 150 mg

Store below 30°C. Keep in the original packaging to protect from moisture.
Store in a place inaccessible and not visible to children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use this medicine if you notice visible signs of deterioration (e.g. change in colour).
Medicines must 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 packaging and other information

What Velaxin ER 150 mg contains
The active substance is venlafaxine.
Each prolonged-release capsule contains 150 mg of venlafaxine (equivalent to 169.68 mg of venlafaxine hydrochloride).
The other ingredients are:
microcrystalline cellulose, sodium chloride, ethylcellulose, talc, dimethicone, potassium chloride, copovidone, anhydrous colloidal silicon dioxide, xanthan gum, yellow iron oxide (E 172).
Capsule shell composition:
red iron oxide (E 172), titanium dioxide (E 171), yellow iron oxide (E 172), gelatin.

What Velaxin ER 150 mg looks like and contents of the pack
Hard gelatin capsules: red cap, colourless capsule body.
Pack contains 28 (2 x 14) prolonged-release capsules in PVC/PVDC/Aluminium blisters, packed in a cardboard box with patient information leaflet.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturer:
Egis Pharmaceuticals PLC
Bökényföldi út 118-120.
1165 Budapest
Hungary
Egis Pharmaceuticals PLC
Mátyás király u. 65.
9900 Körmend
Hungary

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation number in the Czech Republic, country of export: 30/516/07-C
Parallel Import Licence number: 95/21