Venlafaxine Bluefish Xl

Leaflet accompanying the packaging: information for the user

Venlafaxine Bluefish XL, 75 mg, prolonged-release hard capsules

Venlafaxine Bluefish XL, 150 mg, prolonged-release hard capsules

Venlafaxine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

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

1. What is Venlafaxine Bluefish XL and what is it used for

Venlafaxine Bluefish XL is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). These medicines are used to treat depression and other conditions, such as anxiety disorders. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the levels of serotonin and norepinephrine in the brain.

Venlafaxine Bluefish XL is used to treat depression in adults. Venlafaxine Bluefish XL 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). For the patient to feel better, it is essential that the treatment of depression and anxiety disorders is carried out correctly. If the treatment is not started, the patient's condition may not improve, worsen, and become more difficult to treat.

2. Important information before taking Venlafaxine Bluefish XL

When not to take Venlafaxine Bluefish XL

• 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 irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOIs with Venlafaxine Bluefish XL may cause serious or life-threatening side effects. Also, before starting to take any MAOI, the patient should wait at least 7 days after stopping Venlafaxine Bluefish XL (see also the section "Venlafaxine Bluefish XL and other medicines" and the information in the section "Serotonin syndrome").

Bluefish XL (see also the section "Venlafaxine Bluefish XL and other medicines" and the information in the section "Serotonin syndrome").

Warnings and precautions

Before starting treatment with Venlafaxine Bluefish XL, the patient should discuss it with their doctor, pharmacist, or nurse.

• If the patient is taking other medicines that may increase the risk of serotonin syndrome, a potentially life-threatening condition (see the section "Venlafaxine Bluefish XL and other medicines").
• If the patient has eye diseases, such as certain types of glaucoma (increased pressure in the eyeball).
• If the patient has a history of high blood pressure.
• If the patient has a history of heart disease.
• If the patient has a history of seizures (epilepsy).
• If the patient has a history of low sodium levels in the blood (hyponatremia).
• If the patient has a tendency to bruise or bleed (bleeding disorders in the past) or if the patient is pregnant (see "Pregnancy and breastfeeding") or if they are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots).
• If the patient or anyone in their family has a history of mania or bipolar disorder (feeling excessively excited or euphoric).
• If the patient has a history of aggressive behavior.

Before starting treatment with Venlafaxine Bluefish XL, the patient should discuss it with their doctor or pharmacist, especially if they have:

• Serotonin syndrome (excessive serotonin levels caused by increased neuronal activity).
• Malignant neuroleptic syndrome (symptoms include fever, muscle stiffness, changes in mental status, and autonomic dysfunction).

These disorders may occur when taking:

• other serotonergic medicines (especially antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and triptans);
• monoamine oxidase inhibitors (MAOIs) (medicines used to treat depression, such as methylene blue);
• antipsychotic medicines (medicines used to treat schizophrenia and bipolar disorder).

It is recommended to closely monitor the patient during treatment, especially if the patient is taking these medicines with venlafaxine, as this combination may have an undesirable effect on serotonin and dopamine levels.

During the first few weeks of treatment with Venlafaxine Bluefish XL, the patient may experience restlessness or an inability to sit or stand still. If such symptoms occur, the patient should inform their doctor.

Suicidal thoughts and worsening of depression or anxiety disorders

Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such symptoms or behavior may worsen at the beginning of treatment with antidepressants, as these medicines usually start working after 2 weeks, and sometimes later.

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

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

If the patient experiences suicidal thoughts or self-harm, they should immediately contact their doctor or go to the emergency room.

It may be helpful to inform relatives or friends about the depression or anxiety disorder and ask them to read this leaflet. The patient may ask their 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 any worrying changes in behavior.

Medicines like Venlafaxine Bluefish XL (so-called SSRIs or SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persisted after stopping treatment.

Dry mouth

Dry mouth is reported by 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, it is essential to take good care of oral hygiene.

Diabetes

Venlafaxine Bluefish XL may affect blood sugar levels. There may be a need to adjust the dose of antidiabetic medicines.

Children and adolescents

Venlafaxine Bluefish XL should not be used in children and adolescents under 18 years of age. It should also be noted that patients under 18 years of age who take medicines from this group are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). However, the doctor may prescribe Venlafaxine Bluefish XL to a patient under 18 years of age if they consider it beneficial. If the doctor has prescribed Venlafaxine Bluefish XL to a patient under 18 years of age, in case of any doubts, the patient should consult their doctor to discuss it. The patient should inform their doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Venlafaxine Bluefish XL.

So far, there is no evidence of long-term safety regarding the effects on growth, maturation, and cognitive and behavioral development in this age group.

Venlafaxine Bluefish XL and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.

The doctor will decide whether to use Venlafaxine Bluefish XL with other medicines.

The patient should not start or stop taking other medicines, including those available without a prescription, herbal, or natural remedies, without consulting their doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors, which are used to treat depression or Parkinson's disease, must not be taken with Venlafaxine Bluefish XL. The patient should tell their doctor if they have taken these medicines in the last 14 days (MAOIs; see the section "Important information before taking Venlafaxine Bluefish XL").

Serotonin syndrome:

During treatment with venlafaxine, a potentially life-threatening or malignant neuroleptic syndrome-like reaction (see the section "Possible side effects") may occur, especially when taking medicines such as:

• triptans (substances used to treat migraine headaches)
• other antidepressants, such as selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and tricyclic antidepressants or lithium-containing medicines
• medicines containing the antibiotic linezolid (substance used to treat infections)
• medicines containing the reversible MAOI, moclobemide (substance used to treat depression)
• medicines containing sibutramine (substance 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 addiction or severe or moderate 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 for sleep problems and depression)
• antipsychotic medicines (used to treat schizophrenia and bipolar disorder)

Subjective and objective symptoms of serotonin syndrome may include a combination of the following symptoms: restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.

The most severe form of serotonin syndrome may resemble malignant neuroleptic syndrome. Its subjective and objective symptoms include: fever, rapid heart rate, sweating, muscle stiffness, disorientation, increased levels of muscle enzymes in the blood (detected in a blood test).

In case of suspected serotonin syndrome, the patient should immediately inform their doctor or go to the emergency room.

The following medicines may also interact with Venlafaxine Bluefish XL, and therefore, the patient should take them 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)

Venlafaxine Bluefish XL with food, drink, and alcohol

Venlafaxine Bluefish XL should be taken with food (see section 3).

During treatment with Venlafaxine Bluefish XL, the patient should avoid consuming alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Venlafaxine Bluefish XL should only be used after discussing the potential benefits and risks to the unborn child with the doctor.

The patient should ensure that their midwife and/or doctor know that they are taking Venlafaxine Bluefish.

Similar medicines (selective serotonin reuptake inhibitors), taken during pregnancy, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), characterized by rapid breathing and bluish skin color in the baby. Symptoms usually appear within the first day of life. If the baby has any of these symptoms, the patient should immediately contact their midwife and/or doctor.

If the patient takes Venlafaxine Bluefish XL during pregnancy, after birth, the baby may experience difficulties breathing, in addition to other symptoms, such as difficulty feeding.

If the patient is concerned about such symptoms in their newborn, they should contact their doctor and/or midwife, who will be able to provide appropriate advice.

Taking Venlafaxine Bluefish XL at the end of pregnancy may increase the risk of severe postpartum hemorrhage, occurring shortly after delivery, especially if the patient has a history of bleeding disorders. If the patient is taking Venlafaxine Bluefish XL, they should inform their doctor or midwife so that they can provide appropriate advice.

Venlafaxine Bluefish XL passes into breast milk. There is a risk of affecting the baby. Therefore, the patient should discuss this with their doctor, and the doctor will decide whether to stop breastfeeding or stop treatment with Venlafaxine Bluefish XL.

Driving and using machines

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

Venlafaxine Bluefish XL, 150 mg contains colorants, Allura Red, Orange Yellow

and Brilliant Blue, which may cause allergic reactions.

3. How to take Venlafaxine Bluefish XL

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

Usually, the recommended initial dose for the treatment of depression, generalized anxiety disorder, and social phobia is 75 mg per day. This dose may be gradually increased by the doctor if necessary, up to a maximum dose of 375 mg per day, in the case of depression.

In the case of panic disorder, treatment should be started with a lower dose (37.5 mg) and then gradually increased. The maximum dose for the treatment of generalized anxiety disorder, social phobia, and panic disorder is 225 mg per day.

Venlafaxine Bluefish XL should be taken once a day, at approximately the same time, regardless of whether the medicine is taken in the morning or evening. The capsules should be swallowed whole, with a drink of water. They should not be opened, crushed, chewed, or dissolved. Chewing, crushing, or dissolving the capsule contents may damage the tablet coating, which changes the release of the medicine.

Venlafaxine Bluefish XL should be taken with food.

Patients with liver or kidney problems:

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

The patient should not stop taking Venlafaxine Bluefish XL without consulting their doctor (see the section "Stopping treatment with Venlafaxine Bluefish XL").

Taking a higher dose of Venlafaxine Bluefish XL than recommended

In case of taking a higher dose of Venlafaxine Bluefish XL than recommended, the patient should immediately contact their doctor.

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

Missing a dose of Venlafaxine Bluefish XL

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

Stopping treatment with Venlafaxine Bluefish XL

The patient should not stop treatment or reduce the dose without consulting their doctor, even if they feel better. If the doctor decides that it is possible to stop taking Venlafaxine Bluefish XL, they will inform the patient how to gradually reduce the dose before completely stopping treatment. In patients stopping venlafaxine, especially when stopping treatment abruptly or reducing the dose too quickly, side effects may occur, such as fatigue, dizziness, feeling empty-headed, 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 the patient on how to gradually stop taking Venlafaxine Bluefish XL. If any of the above symptoms occur or are troublesome for the patient, they should consult their doctor.

In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the following side effects, they should stop taking Venlafaxine Bluefish XL and immediately contact their doctor or go to the emergency room.

• Chest pain, wheezing, difficulty swallowing or breathing.
• Swelling of the face, throat, hands, or feet.
• Feeling nervous or anxious, dizziness, feeling of pulsation, sudden flushing, and/or feeling of heat.
• Severe rash, itching, hives (elevated red or pale patches, often accompanied by itching).
• Symptoms of serotonin syndrome, which may include restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting. The most severe form of serotonin syndrome may resemble malignant neuroleptic syndrome (NMS). Symptoms of NMS may include fever, rapid heart rate, sweating, muscle stiffness, disorientation, increased levels of muscle enzymes in the blood (detected in a blood test).

Other side effects that the patient should tell their doctor aboutinclude:

• Cough, wheezing, shortness of breath, and high fever.
• Black (tar-like) stools or blood in stools, which may be a sign of internal bleeding.
• Yellowing of the skin or eyes, itching, or dark urine, which may be signs of liver inflammation.
• Heart problems, such as rapid or irregular heartbeat, high blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems, such as dizziness, tingling, coordination problems, seizures, or convulsions.
• Psychiatric problems, such as excessive restlessness and euphoria (feeling unnatural excitement).
• Withdrawal symptoms (see the sections "How to take Venlafaxine Bluefish XL" and "Stopping treatment with Venlafaxine Bluefish XL").
• Prolonged bleeding - after a cut or injury, bleeding stops after a longer time than usual.

The patient should not worry if, while taking Venlafaxine Bluefish XL, they notice small, white granules or balls in their stool. Inside the capsules of Venlafaxine Bluefish XL, there are granules or small, white balls that contain the active substance, venlafaxine. These granules are

released from the capsule into the gastrointestinal tract. As they pass through the entire length of the gastrointestinal tract, venlafaxine is slowly released from the granules. The "skeleton" of the granule is insoluble and is excreted in the stool. Therefore, even if the patient sees granules in their stool, the venlafaxine dose has been absorbed.

Full list of side effects

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

• Dizziness, headache
• Nausea, dry mouth
• Sweating (including night sweats)

Common (may affect up to 1 in 10 people)

• Decreased appetite
• Disorientation, feeling of detachment (or lack of involvement) from oneself, lack of orgasm, decreased libido, nervousness, insomnia, unusual dreams
• Somnolence, tremors, tingling, increased muscle tone
• Visual disturbances, including blurred vision, dilated pupils
• Tinnitus (ringing in the ears)
• Palpitations (feeling of heartbeat)
• Increased blood pressure, hot flashes
• Yawning
• Vomiting, constipation, diarrhea
• Increased frequency of urination, difficulty urinating
• Menstrual disturbances, such as increased bleeding or irregular bleeding, ejaculation or orgasm disorders (men), erectile dysfunction (impotence)
• Weakness (asthenia), feeling of fatigue, chills
• Increased cholesterol levels

Uncommon (may affect up to 1 in 100 people)

• Hallucinations, feeling of detachment (or lack of involvement) from reality, agitation, orgasm disorders (women), lack of feelings or emotions, feeling of excessive excitement, teeth grinding
• Feeling of restlessness or inability to sit or stand still, fainting, involuntary muscle movements, coordination and balance problems, taste disturbances
• Rapid heartbeat, dizziness (especially when standing up too quickly)
• Shortness of breath
• Bloody vomiting, black, tar-like stools, or blood in stools, which may be signs of internal bleeding
• Generalized swelling of the skin, especially of the face, lips, tongue, throat, or hands and feet, and/or swollen, itchy rash (hives), increased sensitivity to sunlight, bruising, rash, hair loss
• Urinary retention
• Weight gain, weight loss

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

• Seizures or convulsions
• Urinary incontinence
• Overactivity, racing thoughts, and decreased need for sleep (mania)

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

• Decreased platelet count, leading to increased risk of bruising or bleeding; blood disorders that may increase the risk of infection
• Swelling of the face or tongue, shortness of breath or difficulty breathing, often with a skin rash (may indicate a severe allergic reaction)
• Excessive water retention (known as the syndrome of inappropriate antidiuretic hormone secretion, SIADH)
• Decreased sodium levels in the blood
• Suicidal thoughts or behaviors; during treatment with venlafaxine or soon after stopping treatment, there have been reports of suicidal thoughts and behaviors (see section 2 "Important information before taking Venlafaxine Bluefish XL - Warnings and precautions")
• Disorientation and confusion, often with hallucinations (delirium), aggression
• 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, drowsiness, persistent rapid eye movements, clumsiness, restlessness, sweating, or muscle stiffness, which are symptoms of serotonin syndrome; muscle stiffness, spasms, and involuntary movements
• Severe eye pain and vision problems or blurred vision
• Dizziness of inner ear origin
• Decreased blood pressure; abnormal, rapid, or irregular heartbeat, which may cause fainting, abnormal bleeding, such as bleeding from the gums, blood in the urine, or vomiting, or unexpected bruising or damage to blood vessels (vascular damage)
• 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 intestinal, liver, or pancreatic problems)
• Itching, yellowing of the skin or eyes, dark urine, or flu-like symptoms, which are symptoms of liver inflammation, minor changes in liver enzyme activity in blood tests
• Skin rash that may lead to blistering and peeling; itching; mild rash
• Unexplained muscle pain, tenderness, or weakness (rhabdomyolysis)
• Inappropriate milk production in women
• Severe postpartum hemorrhage, occurring shortly after delivery (postpartum hemorrhage), see additional information in the subsection "Pregnancy and breastfeeding" in section 2.

Venlafaxine Bluefish XL may also cause side effects that the patient may not be aware of, such as increased blood pressure or abnormal heart function; minor changes in sodium, cholesterol, or liver enzyme levels in the blood. In rare cases, Venlafaxine Bluefish XL may affect platelet function, leading to an increased risk of bruising or bleeding. Therefore, the doctor may recommend a blood test from time to time, especially during long-term treatment with Venlafaxine Bluefish XL.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 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. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Venlafaxine Bluefish XL

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after "EXP" or "Expiry date". The expiry date refers to the last day of the month stated.

Do not store above 30°C.

Do not use Venlafaxine Bluefish XL if the patient notices that the capsules are stuck together.

Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Venlafaxine Bluefish XL contains

The active substance is venlafaxine.

75 mg: Each capsule contains venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine.

150 mg: Each capsule contains venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine.

The other ingredients of the medicine are:

Core:microcrystalline cellulose, povidone K 90, talc, colloidal anhydrous silica, magnesium stearate.

Coating:ethylcellulose, copovidone.

75 mg:

Capsule (body and cap): iron oxide black (E172), iron oxide red (E172), titanium dioxide (E171), gelatin.

Printing ink:shellac, iron oxide red (E172).

150 mg:

Capsule (body and cap): Allura Red (E129), Orange Yellow (E110), Brilliant Blue (E133), titanium dioxide (E171), gelatin.

Printing ink:shellac, titanium dioxide (E171).

What Venlafaxine Bluefish XL looks like and contents of the pack

Prolonged-release hard capsule

75 mg:Hard gelatin capsule, orange, size 1, with red, circular bands, thick and thin, on the body and cap of the capsule. The capsule contains 6 white to off-white, round, biconvex, film-coated mini-tablets, each with a strength of 12.5 mg.

150 mg:Hard gelatin capsule, dark orange, size 0, with white, circular bands, thick and thin, on the body and cap of the capsule. The capsule contains 12 white to off-white, round, biconvex, film-coated mini-tablets, each with a strength of 12.5 mg.

Package sizes:

28 capsules in blisters of non-transparent, white PVC/Aclar and aluminum foil and/or non-transparent, white PVC/PVdC and aluminum foil.

Marketing authorization holder and manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden.

Manufacturer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden.

Pharmadox Healthcare Ltd., KW20A Kordin Industrial Park, Paola, PLA 3000, Malta

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet:01/2022