Velafax

Leaflet accompanying the packaging: information for the user

Velafax, 37.5 mg, tablets
Velafax, 75 mg, tablets
Venlafaxine

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Velafax and what is it used for
• 2. Important information before taking Velafax
• 3. How to take Velafax
• 4. Possible side effects
• 5. How to store Velafax
• 6. Contents of the packaging and other information

1. What is Velafax and what is it used for

Venlafaxine is an antidepressant with a different chemical structure from previously used tricyclic, tetracyclic, and other available antidepressants.
The mechanism of antidepressant action of venlafaxine in humans is related to its ability to increase the activity of neurotransmitters in the central nervous system.
It is believed that in people with depression and/or anxiety, there is a lower concentration of serotonin and norepinephrine in the brain. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the concentration of serotonin and norepinephrine in the brain.

Indications for use:

Velafax in tablet form is indicated for the treatment of depressive disorders, including depressive disorders with anxiety, in both hospitalized and ambulatory patients.
Velafax is indicated for the prevention of relapse of depression and the occurrence of new depressive episodes.

2. Important information before taking Velafax

When not to take Velafax:

• if the patient is allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6);
• if the patient is taking or has taken within the last 14 days any monoamine oxidase inhibitor (MAOI) medicine. Taking MAOIs with Velafax may cause serious or life-threatening side effects. Before starting any MAOI medicine, the patient should also wait at least 7 days after stopping Velafax (see also "Velafax and other medicines" and "Serotonin syndrome").

Warnings and precautions

Before starting Velafax, the patient should discuss with their doctor or pharmacist if:

• •the patient is taking other medicines that may increase the risk of serotonin syndrome when taken with Velafax (see "Velafax and other medicines");
• •the patient has eye diseases, such as certain types of glaucoma (increased pressure in the eyeball);
• •the patient has a history of high blood pressure;
• •the patient has a history of heart disease;
• •the patient has a history of heart rhythm disorders;
• •the patient has a history of seizures (epilepsy);
• •the patient has a history of low sodium levels in the blood (hyponatremia);
• •the patient has a tendency to bruise or bleed (bleeding disorders in the past), or if they are taking other medicines that may increase the risk of bleeding, or if the patient is pregnant (see "Pregnancy, breastfeeding, and fertility");
• the patient has high cholesterol levels;
• •the patient or anyone in their family has a history of mania (feeling overly excited or euphoric) or bipolar disorder;
• •the patient has a history of aggressive behavior.

Velafax may cause feelings of restlessness or inability to sit or stand still during the first few weeks of treatment. If such symptoms occur, the patient should inform their doctor.
Medicines like Velafax (so-called SSRIs, i.e., selective serotonin reuptake inhibitors, or SNRIs, i.e., serotonin and norepinephrine reuptake inhibitors) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after treatment was discontinued.
Suicidal thoughts and worsening of depression or anxiety
People with depression and/or anxiety may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the start of treatment with antidepressants, as these medicines usually start working after 2 weeks, sometimes later.
The occurrence of suicidal thoughts is more likely if:

• the patient has had suicidal thoughts or self-harm in the past;
• the patient is a young adult; data from studies indicate an increased risk of suicidal behavior in people under 25 with mental disorders who were treated with antidepressants.

If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the hospital.
It may be helpful to inform relatives or friends about the depression or anxiety and ask them to read this leaflet. The patient may ask relatives or friends for help and ask them to inform them if they notice that the depression or anxiety has worsened or if there are worrying changes in behavior.
Dry mouth
Dry mouth is reported by 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, special attention should be paid to oral hygiene.
Diabetes
Velafax may cause changes in blood sugar levels, and therefore, there may be a need to adjust the dose of antidiabetic medicines.
Withdrawal symptoms of venlafaxine
Withdrawal symptoms of venlafaxine (so-called withdrawal symptoms) are common, especially when treatment is stopped abruptly. The risk of such symptoms may depend on several factors, including the duration of therapy, the dose used, and the rate of dose reduction.
The most commonly reported symptoms include dizziness, sensory disturbances (including paresthesia, i.e., a feeling of tingling, and a sensation of electric shock), sleep disturbances (including insomnia, intense dreams), agitation or anxiety, nausea and/or vomiting, tremors, headache, and flu-like symptoms. These symptoms are usually mild to moderate, but in some patients, they may be severe. They usually occur within a few days of stopping the medicine, but there are very rare reports of such symptoms in patients who have missed a dose of the medicine. These symptoms usually resolve on their own within 2 weeks, although in some people, they may persist (2-3 months or longer). Therefore, when stopping venlafaxine, it is recommended to gradually reduce the dose over a period of several weeks or months, depending on the patient's needs.

Children and adolescents

Velafax should not be used in children and adolescents under 18 years of age. It should also be noted that during treatment with medicines of this class, patients under 18 are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and manifestations of anger). Nevertheless, the doctor may prescribe Velafax to patients under 18 if they believe it is in the patient's best interest. If the doctor has prescribed Velafax to a patient under 18, in case of any doubts, the doctor should be consulted again. If the above-mentioned symptoms worsen in patients under 18 taking Velafax, the doctor should be informed. There is also no evidence of long-term safety regarding the effect on growth, maturation, and development of cognitive and behavioral functions in this age group.

Velafax and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The doctor will decide whether to use Velafax with other medicines.
The patient should not start or stop taking other medicines, including over-the-counter medicines, herbal or natural remedies, without first consulting their doctor or pharmacist.

Monoamine oxidase inhibitors

Monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with Velafax. The patient should tell their doctor if they have taken these medicines within the last 14 days (MAOIs; see "When not to take Velafax").

Serotonin syndrome

During treatment with venlafaxine, a life-threatening condition called serotonin syndrome may occur.
Symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity (exaggerated reflexes), diarrhea, coma, nausea, vomiting.
The most severe form of serotonin syndrome may resemble malignant neuroleptic syndrome. Its symptoms include fever, rapid heart rate, sweating, muscle stiffness, disorientation, increased muscle enzyme activity (detected in blood tests). It may occur especially when venlafaxine is taken with medicines such as:

• •triptans (used to treat migraine headaches);
• •other medicines used to treat depression, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or medicines containing lithium;
• •medicines containing the antibiotic linezolid (used to treat infections);
• •medicines containing moclobemide, MAOIs (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 dependence or severe pain);
• •medicines containing methylene blue (used to treat high levels of methemoglobin in the blood)
• •medicines containing St. John's Wort (Hypericum perforatum, herbal or natural remedies used to treat mild depression);
• •medicines containing tryptophan (used to treat sleep disorders and depression)
• •antipsychotic medicines (used to treat diseases with symptoms such as hearing, seeing, or feeling things that do not exist, delusions, unnatural suspicion, disordered reasoning, withdrawal).

In case of suspected serotonin syndrome, the doctor or the emergency department of the nearest hospital should be contacted immediately.

Medicines affecting heart rhythm

If the patient is taking medicines that may affect heart rhythm, they should inform their doctor.
Examples of such medicines include:

• antiarrhythmic medicines, such as quinidine, amiodarone, sotalol, or dofetilide (used to treat heart rhythm disorders);
• antipsychotic medicines, such as thioridazine (see above - serotonin syndrome);
• antibiotics, such as erythromycin or moxifloxacin (used to treat bacterial infections);
• antihistamines (used to treat allergies).

The above list is not exhaustive, and the patient should also avoid taking other medicines that affect heart rhythm.
The following medicines may also interact with Velafax, so they should be used with caution. It is especially important to inform the doctor if the patient is taking medicines containing:

• ketokonazole (an antifungal medicine);
• haloperidol or risperidone (medicines used to treat mental disorders);
• metoprolol (a beta-blocker used to treat high blood pressure and heart disease).

Velafax with food, drink, and alcohol

Velafax should be taken with food (see section 3 "How to take Velafax").
During treatment with Velafax, the patient should not drink alcohol.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. Velafax can only be used after discussing the potential benefits and risks to the unborn child with the doctor.
The patient should inform their doctor and/or midwife if they are taking Velafax. Similar medicines taken during pregnancy may increase the risk of a serious condition called persistent pulmonary hypertension in newborns, causing rapid breathing and bluish discoloration. These symptoms usually occur within 24 hours of birth. If the patient notices such symptoms in their child, they should immediately contact their midwife and/or doctor.
If the patient takes this medicine during pregnancy, the following symptoms may occur in the child after birth: abnormal sucking and breathing difficulties. If the patient is concerned about such symptoms in their child after birth, they should contact their doctor and/or midwife, who will be able to provide appropriate advice.
Taking Velafax at the end of pregnancy may increase the risk of severe bleeding from the uterus, occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Velafax, they should inform their doctor or midwife so that they can provide appropriate advice.
Velafax passes into breast milk. There is a risk of affecting the child. Therefore, the patient should discuss this with their doctor, and the doctor will decide whether to stop breastfeeding or discontinue Velafax treatment.

Driving and operating machinery

The patient should not drive or operate machinery until they know how the medicine affects them.

Velafax contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

3. How to take Velafax

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.

Recommended dose

The usual recommended dose of venlafaxine is 75 mg per day, divided into two doses (37.5 mg twice a day). If necessary, the daily dose can be increased to 150 mg, divided into two doses (75 mg twice a day), after a few weeks of treatment.
If a higher dose of the medicine is required, e.g., in patients with severe depression or hospitalized patients, the initial dose of 150 mg per day may be administered in two divided doses (75 mg twice a day). The daily dose can then be increased by 75 mg every two or three days until the desired clinical effect is achieved. The maximum daily dose is 375 mg.
The dose should then be gradually reduced to the usual recommended dose, taking into account the patient's clinical condition and tolerance to the medicine.
The doctor should regularly monitor the patient's condition (every three months) to assess the benefits of long-term therapy.
Velafax tablets should be taken with food, swallowed with water. They should not be chewed or crushed.

Dosing in patients with renal or hepatic impairment

The patient should inform their doctor about any kidney or liver disorders, as there may be a need to adjust the dose.

Dosing in elderly patients

In elderly patients, it is not recommended to change the usual dosing. However, as with any therapy, caution should be exercised when treating elderly patients (e.g., due to the possibility of renal impairment). See also the recommendations for dosing in renal impairment.
The smallest effective dose should always be used, and if it is necessary to increase the dose, the patient's condition should be carefully monitored.
The patient should not stop taking Velafax without consulting their doctor (see "Stopping Velafax treatment").

Taking a higher dose of Velafax than recommended

In case of taking a higher dose of the medicine than recommended, the patient should immediately contact their doctor.
Symptoms of overdose may include rapid heart rate, disturbances of consciousness (from drowsiness to coma), visual disturbances, seizures, and vomiting.

Missing a dose of Velafax

In case of missing a dose, the patient should take it as soon as possible. However, if it is close to the time for the next dose, the missed dose should be skipped, and only one dose should be taken at the usual time.
The patient should not take a double dose to make up for the missed dose.

Stopping Velafax treatment

The patient should not stop treatment or reduce the dose without consulting their doctor, even if they feel better. If the doctor decides that Velafax can be discontinued, they will inform the patient how to gradually reduce the dose before completely stopping treatment. In patients stopping Velafax, especially after abrupt discontinuation or too rapid dose reduction, side effects may occur, such as fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms.
The doctor will advise on how to gradually stop taking Velafax. If any of the above symptoms or other symptoms that are bothersome to the patient occur, they should consult their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Velafax can cause side effects, although not everybody gets them.
If any of the following side effects occur, the patient should stop taking Velafax and immediately contact their doctor or go to the emergency department of the nearest hospital.

• Swelling of the face, lips, tongue, throat, hands, or feet, and/or a raised, itchy rash (hives), difficulty swallowing or breathing - symptoms of hypersensitivity.
• •Feeling nervous or anxious, dizziness, feeling of pulsation, sudden flushing of the skin, and/or a feeling of heat.
• •Severe rash, itching, or hives (a red or pale rash, often with itching) - symptoms of skin reactions.
• •Restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity (exaggerated reflexes), diarrhea, coma, nausea, vomiting - symptoms of serotonin syndrome.
• •Fever, rapid heart rate, sweating, muscle stiffness, disorientation, increased muscle enzyme activity (detected in blood tests) - the most severe form of serotonin syndrome, resembling malignant neuroleptic syndrome.
• •Muscle pain of unknown origin, tenderness, or weakness. These may be symptoms of rhabdomyolysis.

If any of the following side effects occur, the patient should contact their doctor:

• cough, wheezing, shortness of breath, and high fever;
• black (tar-like) stools or blood in the stool;
• yellowing of the skin or whites of the eyes, itching, or dark urine, which may be symptoms of liver inflammation;
• heart rhythm disorders, such as rapid or irregular heartbeat, high blood pressure;
• vision disturbances, such as blurred vision, dilated pupils;
• nervous system disorders, such as dizziness, tingling, coordination disorders, seizures, or convulsions;
• psychiatric disorders, such as excessive restlessness and euphoria (feeling unnatural excitement);
• withdrawal symptoms (see "How to take Velafax" and "Stopping Velafax treatment");
• prolonged bleeding time - in case of injury, the time to stop bleeding may be slightly longer than usual.

Full list of side effects

Very common (may occur in more than 1 in 10 patients)

• dizziness; headache
• nausea; dry mouth
• excessive sweating (including night sweats)

Common (may occur in up to 1 in 10 patients)

• decreased appetite
• disorientation; feeling of detachment (or separation) from oneself; lack of orgasm; decreased libido; nervousness; insomnia; nightmares
• sleepiness; tremors; tingling; increased muscle tone
• vision disturbances, including blurred vision; dilated pupils; inability of the eye to accommodate (automatic change of focus from distant to near objects)
• ringing in the ears (tinnitus)
• palpitations
• increased blood pressure; flushing
• yawning
• vomiting; constipation; diarrhea
• increased frequency of urination; difficulty urinating
• menstrual irregularities, such as heavy bleeding or more frequent irregular bleeding; ejaculation disorders; erectile dysfunction (impotence)
• weakness; fatigue; chills
• increased cholesterol levels in the blood

Uncommon (may occur in up to 1 in 100 patients)

• hallucinations; feeling of detachment (or separation) from reality; agitation; orgasm disorders (in women); apathy; feeling of excessive excitement; teeth grinding
• feeling of restlessness or inability to sit or stand still; fainting; uncontrolled movements; coordination disorders; taste disturbances
• rapid heart rate; dizziness (especially when standing up too quickly)
• shortness of breath
• dizziness when standing up from a sitting or lying position
• vomiting blood; black (tar-like) stools or blood in the stool, which may be a sign of internal bleeding
• generalized skin swelling, especially of the face, lips, tongue, throat, hands, and feet, and/or a raised, itchy rash; hypersensitivity to light; bruising; rash; excessive hair loss
• urinary retention
• weight gain; weight loss

Rare (may occur in up to 1 in 1000 patients)

• excessive excitement, racing thoughts, and decreased need for sleep (mania)
• seizures
• urinary incontinence

Frequency not known (cannot be estimated from the available data)

• decreased platelet count, which may increase the risk of bruising or bleeding; blood disorders that may increase the risk of infection
• swelling of the face or tongue, difficulty breathing, or rash, which may indicate a severe allergic reaction
• excessive water retention in the body
• decreased sodium levels in the blood
• suicidal thoughts and behaviors; (see section 2 "Important information before taking Velafax")
• disorientation with frequent hallucinations (delirium); aggressive behavior
• high fever with muscle stiffness, disorientation, or agitation, and sweating or involuntary muscle movements that cannot be controlled, which may be symptoms of a serious condition called malignant neuroleptic syndrome; feeling of euphoria, sleepiness, persistent rapid eye movements, clumsiness, restlessness, feeling of being drunk, sweating, or muscle stiffness, which are symptoms of serotonin syndrome; stiffness, muscle spasms, and uncontrolled movements
• severe eye pain and vision disturbances or blurred vision
• dizziness
• abnormal, rapid, or irregular heart rate, which may cause fainting;
• decreased blood pressure
• unexpected bleeding, e.g., bleeding from the gums, blood in the urine or vomit, or unexpected appearance of bruises or broken blood vessels (broken veins)
• cough, wheezing, shortness of breath, and high fever, which are symptoms of pneumonia associated with an increased number of white blood cells in the blood (eosinophilic pneumonia)
• severe abdominal or back pain (which may indicate serious problems with the intestines, liver, or pancreas)
• itching; yellowing of the skin or whites of the eyes; dark urine; flu-like symptoms, which are symptoms of liver inflammation; mild changes in liver enzyme activity in the blood
• skin rash that may lead to blistering and peeling of the skin; itching; mild rash
• unexplained muscle pain, tenderness, or weakness (rhabdomyolysis)
• abnormalities in the ECG recording; prolonged bleeding time
• abnormal milk secretion in women
• severe bleeding from the uterus, occurring shortly after delivery (postpartum hemorrhage), see additional information in subsection "Pregnancy, breastfeeding, and fertility" in section 2.

Velafax may sometimes cause side effects that the patient is not aware of, such as increased blood pressure or abnormal heart rate; mild changes in liver enzyme activity in the blood, sodium or cholesterol levels. In rare cases, Velafax may affect platelet function, increasing the risk of bruising or bleeding. In this regard, the doctor may recommend a blood test from time to time, especially during long-term treatment with Velafax.

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Velafax

Store at a temperature below 25°C.
The medicine should be stored in a place that is out of sight and reach of children.
Velafax should not be used after the expiry date stated on the packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Velafax contains

• The active substance of the medicine is venlafaxine in the form of hydrochloride, in amounts of 37.5 mg or 75 mg, respectively;
• Other ingredients are: microcrystalline cellulose, cornstarch, yellow iron oxide (E 172), sodium carboxymethylcellulose (type A), talc, anhydrous colloidal silica, magnesium stearate.

What Velafax looks like and contents of the pack

Velafax 37.5 mg - yellow to light yellow, oblong tablets with a dividing line on both sides.
Velafax 75 mg - yellow to light yellow, round tablets with the name PLIVA embossed on one side and a dividing line on the other side.
Velafax tablets are packaged in blisters of 28 or 56 tablets, in a cardboard box.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53, 00-113 Warsaw

Manufacturer:

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80,
31-546 Kraków
Pliva Croatia Ltd. (Pliva Hrvatska d.o.o.)
Prilaz Baruna Filipoviča 25, 10000 Zagreb
Croatia

Date of last revision of the leaflet: