Venlafaxine bluefish xl

Package leaflet: Information for the user

Venlafaxine Bluefish XL, 75 mg, prolonged-release capsules, hard
Venlafaxine Bluefish XL, 150 mg, prolonged-release capsules, hard
Venlafaxine
Please 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, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 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, pharmacist, or nurse. See section 4.

Contents of the leaflet:

1. What Venlafaxine Bluefish XL is and what it is used for
2. What you need to know 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 pack and other information

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

Venlafaxine Bluefish XL is an antidepressant medicine belonging to a group of medicines called
serotonin and noradrenaline reuptake inhibitors (SNRIs). Medicines in this group are 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 help by increasing the levels of serotonin and
noradrenaline 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 important that treatment for depression and anxiety disorders is properly managed.
Without treatment, the patient's condition may not improve, may worsen, and become much more
difficult to treat.

2. 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 currently taking or has 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 Venlafaxine Bluefish XL may cause severe or even life-threatening adverse reactions. Also, before starting any MAOI medicine, the patient should wait at least 7 days after stopping Venlafaxine Bluefish XL (see also the section titled “Venlafaxine Bluefish XL and other medicines” and information under “Serotonin syndrome”).

Warnings and precautions

Before starting treatment with Venlafaxine Bluefish XL, discuss this with your doctor, pharmacist, or nurse.

• If the patient is taking other medicines that, when taken together with Venlafaxine Bluefish XL, may increase the risk of serotonin syndrome, a potentially life-threatening condition (see section “Venlafaxine Bluefish XL and other medicines”).
• If the patient has eye disorders such as certain types of glaucoma (increased pressure in the eye).
• If the patient has previously had high blood pressure.
• If the patient has previously had heart disease.
• If the patient has previously had 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 is 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 previously had mania or bipolar disorder (feelings of excessive excitement or euphoria).
• If the patient has previously exhibited aggressive behaviour.

Before starting treatment with Venlafaxine Bluefish XL, discuss this with your doctor or pharmacist, especially if the patient has:

• Serotonin syndrome (excessive serotonin levels caused by increased nerve cell activity).
• Neuroleptic malignant syndrome (symptoms include fever, muscle rigidity, changes in mental status, and autonomic dysfunction).

These conditions may occur when taking Venlafaxine Bluefish XL together with:

• Other serotonergic medicines (especially antidepressants, e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), and triptans);
• MAO inhibitors (medicines used to treat depression, e.g. methylene blue);
• Antipsychotic medicines (used to treat schizophrenia and bipolar disorder).

Close monitoring of the patient is recommended during treatment, particularly if the patient is taking these medicines together with venlafaxine, as such combinations may adversely affect serotonin and dopamine levels.

During the first few weeks of treatment, Venlafaxine Bluefish XL may cause feelings of restlessness or an inability to sit still or remain still. If such symptoms occur, inform your doctor.

Suicidal thoughts and worsening of depression or anxiety disorders

People with depression and/or anxiety disorders may sometimes have thoughts about self-harm or suicide. These symptoms or behaviours may worsen at the beginning of treatment with antidepressants because these medicines usually take about 2 weeks, or sometimes longer, to start working.

The risk of suicidal thoughts, self-harm thoughts, or suicide attempts is higher if:

• The patient has previously had suicidal thoughts or self-harming behaviour;
• The patient is a young adult; clinical data indicate an increased risk of suicidal behaviour in people under 25 years of age with psychiatric disorders who are treated with antidepressants.

If the patient experiences suicidal thoughts or thoughts of self-harm, seek immediate medical advice from a doctor or go to the nearest 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 for help from family or friends and request them to inform the patient if they notice worsening depression or anxiety, or concerning changes in behaviour.

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

Dry mouth

Dry mouth is 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

Venlafaxine Bluefish XL may alter blood glucose levels. Dose adjustments of antidiabetic medicines may be necessary.

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 adverse reactions such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, defiant behaviour, and anger). Nevertheless, a 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, any concerns should be discussed again with the doctor. Inform the doctor if any of the above symptoms occur or worsen in patients under 18 years of age taking Venlafaxine Bluefish XL.

Long-term safety regarding the effects on growth, maturation, and cognitive and behavioural development in this age group has not yet been established.

Venlafaxine Bluefish XL 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 doctor will decide whether Venlafaxine Bluefish XL can be taken together with other medicines.

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

• Monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease, must not be taken with Venlafaxine Bluefish XL. Inform your doctor if the patient has taken any of these medicines within the last 14 days (MAOIs; see section “Information before taking Venlafaxine Bluefish XL”).

• Serotonin syndrome: During treatment with venlafaxine, a potentially life-threatening condition called serotonin syndrome or neuroleptic malignant syndrome-like reactions may occur (see section “Possible side effects”), especially when taken together with medicines such as:

  • Triptans (medicines used for migraine headaches)
  • Other antidepressants, e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, or medicines containing lithium
  • Medicines containing the antibiotic linezolid (used to treat infections)
  • Medicines containing the reversible MAO inhibitor moclobemide (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 addiction or moderate to severe pain)
  • Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
  • Medicines containing St. John’s wort (Hypericum perforatum, natural or herbal remedies used for mild depression)
  • Medicines containing tryptophan (used for sleep problems and depression)
  • Antipsychotic medicines (used to treat conditions with symptoms such as hearing, seeing, or feeling things that are not real, delusions, unusual suspicion, unclear thinking, or social withdrawal)

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

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

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

The following medicines may also interact with Venlafaxine Bluefish XL and should therefore be used with caution. It is especially important to inform your 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 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, alcohol should be avoided.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, thinks she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine. Venlafaxine Bluefish XL should only be used after discussing the potential benefits and potential risks to the unborn child with a doctor.

Ensure that the midwife and/or doctor knows that the patient is taking Venlafaxine Bluefish XL.

Similar medicines (selective serotonin reuptake inhibitors), used during pregnancy, may increase the risk of a serious condition in the newborn called persistent pulmonary hypertension of the newborn (PPHN), which is characterised by rapid breathing and bluish skin in the baby. Symptoms usually appear within the first 24 hours after birth. If the baby shows any of these symptoms, contact the midwife and/or doctor immediately.

If the patient takes Venlafaxine Bluefish XL during pregnancy, especially near delivery, the newborn may experience breathing difficulties and other symptoms such as feeding problems.

If the patient is concerned about such symptoms in the newborn, contact the doctor and/or midwife, who can provide appropriate advice.

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

Venlafaxine Bluefish XL passes into breast milk. There is a risk of effects on the infant. Therefore, discuss this with the doctor, who will decide whether to discontinue breastfeeding or stop treatment with Venlafaxine Bluefish XL.

Driving and using machines

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

Venlafaxine Bluefish XL 150 mg contains colouring agents: Allura Red, Orange Yellow, and Brilliant Blue, which may cause allergic reactions.

3. How to use Venlafaxine Bluefish XL

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, 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 once daily in the treatment of depression.
For panic disorder, treatment should begin with a lower dose (37.5 mg), which should then be gradually increased. The maximum dose for the treatment of generalized anxiety disorder, social phobia, and panic disorder is 225 mg once daily.
Venlafaxine Bluefish XL should be taken daily at approximately the same time, regardless of whether it is taken in the morning or evening. The capsules must be swallowed whole with liquid. Do not open, crush, chew, or dissolve them. Chewing, crushing, or dissolving the capsule contents may damage the coating of the capsule, altering the release of the medicine.
Venlafaxine Bluefish XL should be taken with food.

Patients with liver or kidney function impairment:
Inform your doctor if you have any liver or kidney problems, as your dose may need to be adjusted.
Do not stop taking Venlafaxine Bluefish XL without consulting your doctor (see section "Stopping Venlafaxine Bluefish XL").

Taking more Venlafaxine Bluefish XL than prescribed
If you take more Venlafaxine Bluefish XL than prescribed, contact your doctor immediately.
Symptoms of overdose may include increased heart rate, disturbances in consciousness (ranging from drowsiness to coma), vision disturbances, seizures, and vomiting.

Missing a dose of Venlafaxine Bluefish XL
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 dose.

Stopping Venlafaxine Bluefish XL
Do not stop treatment or reduce the dose of Venlafaxine Bluefish XL without consulting your doctor, even if you feel better. If your doctor decides that you can discontinue Venlafaxine Bluefish XL, they will advise you on how to gradually reduce the dose before stopping completely.
Patients discontinuing venlafaxine, especially those who stop treatment abruptly or reduce the dose too quickly, may experience adverse effects such as fatigue, dizziness, a sensation of emptiness in the head, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, disorientation, tinnitus, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms.
Your doctor will advise you on how to gradually discontinue Venlafaxine Bluefish XL. If you experience any of the symptoms listed above, or any other symptoms that are troublesome, 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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following adverse reactions occur, discontinue the medicine
Venlafaxine Bluefish XL and contact your doctor immediately or go to the
nearest hospital Emergency Department.

• Chest tightness, gasping, difficulty swallowing or breathing.
• Swelling of the face, throat, hands or feet.
• Feeling restless or anxious, dizziness, pulsating sensation, sudden skin flushing and (or) feeling hot.
• Severe rash, itching, urticaria (raised red or pale patches, often accompanied by itching).
• Subjective and objective symptoms of serotonin syndrome, which may include motor restlessness, hallucinations, loss of motor coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, hyperreflexia, diarrhoea, somnolence, nausea, vomiting. The most severe form of serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Symptoms of neuroleptic malignant syndrome may include fever, rapid heartbeat, sweating, muscle rigidity, confusion, increased muscle enzyme levels (detected in blood tests).

Other adverse reactions that should be reported to your doctor include:

• Cough, gasping, shortness of breath, and high temperature.
• Black (tarry) stools or blood in the stool.
• Yellowing of the skin or eyes, itching, or dark-coloured urine, which may be signs of liver inflammation.
• Heart problems such as rapid or irregular heartbeat, elevated blood pressure.
• Eye problems such as blurred vision, dilated pupils.
• Nervous system disorders such as dizziness, tingling sensation, coordination disturbances, seizures or convulsions.
• Psychiatric disorders such as excessive activity and euphoria (feeling of unnatural excitement).
• Withdrawal symptoms (see sections "How to take Venlafaxine Bluefish XL" and "Stopping Venlafaxine Bluefish XL").
• Prolonged bleeding – after a cut or injury, bleeding stops more slowly than usual.

Do not be concerned if, while taking Venlafaxine Bluefish XL, the patient notices small,
white granules or beads in the stool. Inside the Venlafaxine Bluefish XL capsules are
granules or small, white beads containing the active substance, venlafaxine. These granules are
released from the capsule into the gastrointestinal tract. As they move 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 with the stool. Therefore, even if granules are visible
in the stool, the dose of venlafaxine has been absorbed.
Complete list of adverse reactions
Very common (may affect more than 1 in 10 patients)

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

Common (may affect up to 1 in 10 patients)

• Decreased appetite
• Disorientation, feeling detached (or disengaged) from oneself, anorgasmia, decreased libido, restlessness, insomnia, unusual dreams
• Drowsiness, tremor, tingling, increased muscle tension
• Vision disorders, including blurred vision, dilated pupils, inability of the eye to automatically adjust focus when shifting gaze from a distant object to a nearby one
• Ringing in the ears (tinnitus)
• Palpitations (awareness of heartbeat)
• Increased blood pressure, hot flushes
• Yawning
• Vomiting, constipation, diarrhoea
• Increased frequency of urination, difficulty passing urine
• Menstrual disorders such as heavy bleeding or increased, irregular bleeding, ejaculation/orgasm disorders (men), erectile dysfunction (impotence)
• Weakness (asthenia), feeling of fatigue, chills
• Increased cholesterol levels

Uncommon (may affect up to 1 in 100 patients)

• Hallucinations, feeling detached (or disengaged) from reality, agitation, orgasm disorders (women), inability to feel emotions or feelings, feeling excessively stimulated, teeth grinding
• Feeling anxious or inability to sit still or stay in one place, fainting, involuntary muscle movements, disturbances in coordination and balance, taste disturbances
• Rapid heartbeat, dizziness (especially upon standing up too quickly)
• Shortness of breath
• Blood in vomit, black tarry stools or blood in the stool, which may indicate internal bleeding
• Generalized skin swelling, especially of the face, lips, tongue, throat, or hands and feet and (or) raised, itchy rash (urticaria), photosensitivity, bruising, rash, abnormal hair loss
• Urinary retention
• Weight gain, weight loss

Rare (may affect up to 1 in 1000 patients)

• Seizures or convulsions
• Urinary incontinence
• Hyperactivity, racing thoughts, and reduced 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 skin rash (may indicate a severe allergic reaction)
• Excessive water retention (known as syndrome of inappropriate antidiuretic hormone secretion, SIADH)
• Decreased sodium levels in the blood
• Suicidal thoughts or behaviour; suicidal thoughts and behaviours have been reported during treatment with venlafaxine or immediately after discontinuation of treatment (see section 2 "Important information before taking Venlafaxine Bluefish XL – Warnings and precautions")
• Disorientation and confusion with frequent hallucinations (delirium), aggression
• High fever with muscle rigidity, confusion or agitation, sweating, or intermittent uncontrolled muscle movements may be symptoms of a serious condition called neuroleptic malignant syndrome; feelings of euphoria, drowsiness, persistent rapid eye movements, clumsiness, restlessness, feeling drunk, sweating, or muscle stiffness which are symptoms of serotonin syndrome; muscle stiffness, cramps, and uncontrolled muscle movements
• Severe eye pain and visual disturbances or blurred vision
• Vertigo (dizziness of labyrinthine origin)
• Decreased blood pressure; abnormal, rapid or irregular heartbeat, which may lead to fainting, abnormal bleeding, e.g. bleeding from gums, blood in urine or vomit, or occurrence of unexpected bruising or blood vessel damage (venous damage)
• Cough, gasping, breathlessness, and high body temperature, which are symptoms of lung inflammation associated with increased white blood cell count (pulmonary eosinophilia)
• Severe abdominal or back pain (which may indicate serious intestinal, liver, or pancreatic problems)
• Itching, yellowing of the skin or eyes, dark-coloured urine, or flu-like symptoms, which are signs of liver inflammation, minor changes in liver enzyme activity in blood tests
• Skin rash that may lead to blistering and skin peeling; itching; mild rash
• Unexplained muscle pain, tenderness, or weakness (rhabdomyolysis)
• Abnormal milk secretion in women
• Severe vaginal bleeding occurring shortly after childbirth (postpartum haemorrhage), see additional information in subsection "Pregnancy and breastfeeding" in section 2.

Venlafaxine Bluefish XL may sometimes cause adverse reactions that the patient may
not be aware of, such as increased blood pressure or abnormal heart function;
minor changes in blood levels of sodium, cholesterol, or liver enzymes. In even
rarer cases, Venlafaxine Bluefish XL may impair platelet function, leading to an increased risk of petechiae or bleeding. Therefore, your doctor may recommend
periodic blood tests, especially during long-term treatment with Venlafaxine
Bluefish XL.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorisation holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Venlafaxine Bluefish XL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following “EXP” or
“Expiry date”. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Do not use Venlafaxine Bluefish XL if the patient notices that the capsules are stuck together.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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.
Other ingredients are:
Tablet core: microcrystalline cellulose, povidone K 90, talc, colloidal anhydrous silica,
magnesium stearate.
Tablet coating: ethylcellulose, copovidone.
75 mg:
Capsule (body and cap): black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin.
Printing ink: shellac, red iron oxide (E172).
150 mg:
Capsule (body and cap): allura red (E129), sunset 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
Extended-release hard capsule
75 mg: Hard, opaque gelatin capsule with an orange cap and body, size “1”, printed with red circular bands, thick and thin, on the body and cap of the capsule. The capsule contains 6 white to almost white, round, biconvex coated mini-tablets, each with a strength of 12.5 mg.
150 mg: Hard, opaque gelatin capsule with a dark orange cap and body, size “0”, printed with white circular bands, thick and thin, on the body and cap of the capsule. The capsule contains 12 white to almost white, round, biconvex coated mini-tablets, each with a strength of 12.5 mg.

Pack sizes:
28 capsules in blisters made of opaque white PVC/Aclar film and aluminium foil and/or opaque white PVC/PVdC film and aluminium foil.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: