VENLAFAXINE BLUEFISH 75 mg PROLONGED-RELEASE CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Bluefish 75 mg prolonged-release capsules EFG

venlafaxine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Venlafaxine Bluefish and what is it used for
2. What you need to know before you take Venlafaxine Bluefish
3. How to take Venlafaxine Bluefish
4. Possible side effects
5. Storing Venlafaxine Bluefish
6. Contents of the pack and other information.

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

Venlafaxine Bluefish belongs to a group of medicines called antidepressants, selective serotonin and noradrenaline reuptake inhibitors (SSNRIs). It is used in the treatment of depression and other conditions such as anxiety disorders. It is not fully understood how antidepressants work, but they may help by increasing the levels of serotonin and noradrenaline in the brain.

Venlafaxine Bluefish is a treatment for adults with depression. Venlafaxine Bluefish is also a treatment for adults with the following anxiety disorders: generalised anxiety disorder, social anxiety disorder (fear of social or performance situations), panic disorder (recurring panic attacks). It is important to treat depression or anxiety disorders properly to improve your condition. If left untreated, your condition will persist and may become worse and more difficult to treat.

2. What you need to know before you take Venlafaxine Bluefish

Do not take Venlafaxine Bluefish

• if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6)
• if you are taking or have taken within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease. Taking irreversible MAOIs with Venlafaxine Bluefish can cause serious reactions. Also, you must wait at least 7 days after stopping Venlafaxine Bluefish before you start taking any MAOI (see also section “Using Venlafaxine Bluefish with other medicines” and the information in that section about “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor, pharmacist or nurse before you start taking Venlafaxine Bluefish

• if you are taking any other medicines that may increase the risk of developing Serotonin Syndrome when taken with Venlafaxine Bluefish (see section “Using Venlafaxine Bluefish with other medicines”).
• if you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• if you have a history of high blood pressure.
• if you have a history of heart problems.
• if you have a history of seizures (fits).
• if you have a history of low sodium levels in your blood (hyponatraemia).
• if you have a tendency to develop bruises or bleeding easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots), or if you are pregnant (see “Pregnancy and breast-feeding”) or if you are taking other medicines that may increase the risk of bleeding.
• if you have a history of, or if someone in your family has had, bipolar disorder or mania (feeling overexcited or elated).
• if you have a history of aggressive behaviour.

Tell your doctor or pharmacist before you start taking Venlafaxine Bluefish, especially if you suffer from:

• Serotonin Syndrome (excessive levels of serotonin caused by an increase in the activity of nerve cells)
• Neuroleptic Malignant Syndrome (characterised by symptoms such as fever, muscular rigidity, altered mental status and autonomic dysfunction)

These conditions can occur with:

• Other serotonergic agents (essentially antidepressants such as SSRIs, SNRIs and triptans)
• MAOIs (medicines used to treat depression, e.g. methylene blue)
• Antipsychotics (medicines used to treat schizophrenia and bipolar disorder)

Careful observation of the patient during treatment is advised, particularly when combining other agents with venlafaxine, as this combination may have an undesired effect on serotonin and dopamine levels.

Venlafaxine Bluefish may cause a feeling of restlessness and an urgent need to move, often accompanied by difficulty sitting or standing still, during the first few weeks of treatment. If this happens, you should tell your doctor.

Do not drink alcohol while taking Venlafaxine Bluefish. Taking it with alcohol may cause extreme tiredness and unconsciousness. Taking it with certain medicines or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These thoughts may be more likely when you first start taking antidepressants, since these medicines all take time to work, usually about 2 weeks, but sometimes longer.

You are more likely to think this way:

• if you have previously had thoughts about killing or harming yourself.
• if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to hospital straight away.

Tell a friend or relative that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.

Dry mouth

Dry mouth has been reported in approximately 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should be careful with your dental hygiene.

Diabetes

Your blood glucose levels may be altered due to Venlafaxine Bluefish. Therefore, the doses of your diabetes medicines may need to be adjusted.

Some medicines in the same class as Venlafaxine Bluefish (so-called SSRIs/ SNRIs) may cause sexual dysfunction (see section 4.8). In some cases, these symptoms have persisted after stopping treatment.

Children and adolescents

Venlafaxine Bluefish should not normally be used in the treatment of children and adolescents under 18 years. Furthermore, you should know that in patients under 18 years, there is an increased risk of adverse reactions such as suicide attempt, suicidal ideation and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Nevertheless, your doctor may prescribe Venlafaxine Bluefish to patients under 18 years when it is decided that it is the best option for the patient. If the doctor who prescribed Venlafaxine Bluefish to a patient under 18 years decides to do so, please go back to see the doctor. You should tell your doctor if any of the symptoms described above get worse or if you experience any difficulties when patients under 18 years are taking Venlafaxine Bluefish. Furthermore, the long-term safety of Venlafaxine Bluefish in this age group concerning growth, maturation and cognitive and behavioural development has not yet been demonstrated.

Other medicines and Venlafaxine Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor will decide whether you can take Venlafaxine Bluefish with other medicines.

Do not start or stop taking any medicines, including those bought without a prescription, herbal or homeopathic remedies, without first checking with your doctor or pharmacist.

• MAOIs used to treat depression or Parkinson’s disease must not be taken with Venlafaxine Bluefish. Tell your doctor if you have taken any of these medicines within the last 14 days (MAOIs: see section “Before you take Venlafaxine Bluefish”).
• Serotonin Syndrome:
• A potentially life-threatening or a reaction similar to Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”) may occur with venlafaxine treatment, particularly when taken in combination with other medicines.

Examples of these medicines include:

• Triptans (antimigraine medicines)
• Other medicines for treating depression, for example, SNRIs, SSRIs, tricyclics (antidepressants), or medicines containing lithium
• Medicines containing linezolid (an antibiotic used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (antidepressant)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol, fentanyl, tapentadol, pethidine or pentazocine (used for severe pain)
• Medicines containing dextromethorphan (used to treat coughs)
• Medicines containing methadone or buprenorphine (used for the treatment of opioid addiction or for the treatment of severe to moderate pain)
• Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood)
• Products containing St John’s Wort (also known as Hypericum perforatum, a herbal or homeopathic remedy used to treat mild depression)
• Products containing tryptophan (used for insomnia and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing or feeling things that are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning and tendency to withdraw from social contact)

The signs and symptoms of serotonin syndrome may include a combination of: agitation, hallucinations, loss of coordination, rapid heart beat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhoea, coma, nausea, vomiting. In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heart beat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

Tell your doctor immediately or go to the casualty department of the nearest hospital if you think you are experiencing serotonin syndrome.

The following medicines may also interact with Venlafaxine Bluefish and should be used with caution. It is very important that you tell your doctor or pharmacist if you are taking medicines that contain:

• ketoconazole (an antifungal medicine)
• haloperidol or risperidone (for treating psychiatric conditions)
• metoprolol (a beta-blocker for treating high blood pressure and heart problems)

Taking Venlafaxine Bluefish with food, drinks and alcohol

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

Do not drink alcohol while taking Venlafaxine Bluefish. Taking it with alcohol may cause extreme tiredness and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should only take Venlafaxine Bluefish after discussing the potential benefits and risks with your doctor.

Tell your doctor or midwife you are taking Venlafaxine Bluefish. During pregnancy, medicines like SSRIs may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and look bluish. These symptoms start during the first 24 hours after birth. If this happens to your baby, contact your doctor or midwife immediately.

If you are taking Venlafaxine Bluefish during pregnancy, other symptoms your baby may have after birth are problems with feeding and breathing. If your baby has these symptoms and you are concerned, contact your doctor.

If you take Venlafaxine Bluefish in the final stages of pregnancy, you may experience an increased risk of heavy vaginal bleeding after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Venlafaxine Bluefish so they can advise you.

Venlafaxine passes into breast milk, so you should not take the medicine if you are breast-feeding your baby. There is a risk of an effect on the baby. Therefore, you should discuss this with your doctor and they will decide whether you should stop breast-feeding or stop Venlafaxine Bluefish treatment.

Driving and using machines

Do not drive or use any tools or machines until you know how Venlafaxine Bluefish affects you.

3. How to take Venlafaxine Bluefish

Take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended starting dose for the treatment of depression, generalised anxiety disorder and social anxiety disorder is 75 mg once daily. Your doctor may gradually increase the dose up to a maximum of 375 mg daily for depression. If you are being treated for panic disorder, your doctor will start you on a lower dose (37.5 mg) and then gradually increase it. The maximum dose for generalised anxiety disorder, social anxiety disorder and panic disorder is 225 mg/day.

Take Venlafaxine Bluefish at approximately the same time each day, either in the morning or in the evening. The capsules should be swallowed whole with a little water, without opening, crushing, chewing or dissolving. Chewing, crushing or dissolving the capsule contents may damage the coating and affect the way the medicine is released.

Venlafaxine Bluefish should be taken with food.

Patients with liver or kidney problems:

If you have liver or kidney problems, consult your doctor as your dose of Venlafaxine Bluefish may need to be adjusted.

Do not stop taking Venlafaxine Bluefish without talking to your doctor (see section “If you stop taking Venlafaxine Bluefish”).

If you take more Venlafaxine Bluefish than you should

If you have taken too much Venlafaxine Bluefish, contact your doctor or pharmacist or go to the casualty department of the nearest hospital immediately. Take the medicine pack with you. Symptoms of overdose are listed below.

Taking too much Venlafaxine Bluefish may lead to severe consequences and may be life-threatening, especially when taken with other medicines and/or alcohol (see “Taking Venlafaxine Bluefish with other medicines”).

Symptoms of overdose may include: rapid heart beat, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, fits or seizures, and vomiting.

If you forget to take Venlafaxine Bluefish

If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and take the next one as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Venlafaxine Bluefish

Do not stop taking your treatment or reduce the dose without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need Venlafaxine Bluefish, your doctor will gradually reduce your dose before stopping treatment completely. It is known that when this medicine is stopped, you may experience side effects. These are usually mild and stop on their own in a few weeks. In some cases, stopping treatment or reducing the dose may cause symptoms such as: dizziness, headache, nausea, vomiting, irritability, agitation, confusion, numbness or tingling, anxiety, fatigue, insomnia, excessive sweating, and vertigo.

Your doctor will advise you on how to stop taking Venlafaxine Bluefish. If you experience any of these or other symptoms that are troublesome, contact your doctor.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If any of the following effects occur, do not take more Venlafaxina Bluefish. Tell your doctor immediately, or go to the emergency department of the nearest hospital:

• Chest oppression, wheezing, swallowing or breathing problems
• Swelling of the face, throat, hands or feet
• Nervousness or anxiety, dizziness, palpitations, sudden reddening of the skin and/or feeling of heat
• Severe rash, itching, or hives (elevated red or pale skin patches that usually itch)
• Signs and symptoms of serotonin syndrome that may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting. In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

Other adverse effects that you should inform your doctor aboutare:

• Cough, wheezing, shortness of breath, and high temperature.
• Tarry stools (deposits) or blood in stools.
• Yellow eyes or skin, itching, or dark urine, which are symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heartbeat, hypertension
• Eye problems, such as blurred vision, dilated pupils
• Nervous system problems, such as dizziness, numbness, movement disorder, convulsions, or seizures
• Psychiatric problems, such as hyperactivity and euphoria (unusual feeling of overexcitement).
• Withdrawal symptoms (see section "How to take Venlafaxina Bluefish, if you stop taking Venlafaxina Bluefish").
• Prolonged bleeding - if you cut yourself or get injured, it may take a little longer than usual for the bleeding to stop.

Do not worry if you notice small granules or white balls in your stools after taking this medicine. Inside the Venlafaxina Bluefish capsules, there are spheroids (small white balls) that contain the active ingredient (venlafaxine). These spheroids are released from the capsule in the stomach. As they circulate through the stomach and intestines, venlafaxine is slowly released. The "shell" of the spheroid does not dissolve and comes out in the stools. Therefore, even if you see spheroids in the stools, the dose of the medicine has been absorbed.

Complete list of adverse effects

Very common (affects more than 1 in 10 patients)

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

Common (affects between 1 and 10 in 100 patients)

• Decreased appetite.
• Confusion; feeling separated (or detached) from oneself; lack of orgasm; decreased libido; nervousness; insomnia; abnormal dreams.
• Drowsiness, tremor; tingling; increased muscle tone.
• Visual disturbances including blurred vision; dilated pupils; inability of the eye to automatically change focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Palpitations.
• Increased blood pressure; hot flashes.
• Vomiting; constipation; diarrhea.
• Increased frequency of urination; difficulty urinating.
• Menstrual irregularities, such as increased bleeding or irregular bleeding; abnormal ejaculation/orgasm (males); erectile dysfunction (impotence).
• Weakness (asthenia); fatigue; chills.
• Increased cholesterol.

Uncommon (affects between 1 and 10 in 1,000 patients)

• Hallucinations; feeling separated (or detached) from reality; agitation; abnormal orgasm (females); lack of feelings or emotions; feeling overexcited; teeth grinding.
• A feeling of restlessness or inability to stay seated or still; fainting; involuntary muscle movements; altered coordination and balance; altered taste perception.
• Rapid heartbeat; feeling dizzy (especially when getting up too quickly).
• Difficulty breathing (dyspnea).
• Vomiting blood, tarry stools, or blood in stools, which can be a sign of internal bleeding.
• Generalized skin swelling, especially on the face, mouth, tongue, throat, or hands and feet, and/or may appear as a raised rash with itching (urticaria); sensitivity to sunlight; bruising; skin rash; abnormal hair loss.
• Inability to urinate.
• Weight gain or loss.

Rare (affects between 1 and 10 in 10,000 patients)

• Seizures or fits.
• Inability to control urination.
• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).

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

• Reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding; blood disorders, which can lead to an increased risk of infection.
• Swelling of the face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this can be a severe allergic reaction).
• Excessive water intake (known as SIADH).
• Decreased sodium levels in the blood.
• Suicidal ideation and behavior; cases of suicidal ideation and behavior have been reported during treatment with venlafaxine or shortly after treatment discontinuation (see section 2. "Before taking Venlafaxina Bluefish").
• Disorientation and confusion, often accompanied by hallucinations (delirium); aggression.
• A high temperature with stiff muscles, confusion, or agitation, and sweating, or if you experience jerky muscle movements that you cannot control, may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, drowsiness, rapid sustained eye movement, clumsiness, restlessness, feeling drunk, sweating, or stiff muscles, which are symptoms of serotonin syndrome; stiffness; spasms and involuntary muscle movements.
• Severe eye pain and reduced or blurred vision.
• Dizziness.
• Cough, difficult breathing, shortness of breath, and high temperature, which are symptoms of lung inflammation associated with an increase in white blood cells (eosinophilic pneumonia).
• Severe back or abdominal pain (which may indicate a serious problem in the intestine, liver, or pancreas).
• Itching, yellow eyes or skin, dark urine, flu-like symptoms, which are symptoms of liver inflammation (hepatitis), slight changes in liver enzyme blood levels.
• Skin rash that can lead to severe blistering and peeling of the skin; itching; mild skin rash.
• Unexplained muscle pain, discomfort, or weakness (rhabdomyolysis).
• Abnormal milk production.
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

Venlafaxina Bluefish sometimes causes undesirable effects that you may not be aware of, such as hypertension or abnormal heartbeat; slight changes in liver enzyme, sodium, or cholesterol blood levels. Rarely, venlafaxine may reduce the function of platelets in the blood, increasing the risk of bruising or bleeding. Therefore, it is best that your doctor performs occasional blood tests; especially if you are taking venlafaxine for a long time.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use http://www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Venlafaxina Bluefish

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after "Cad". The expiration date refers to the last day of that month.

Do not store above 30°C.

Do not use this medicine if you notice that the capsules are sticky.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines that you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Venlafaxina Bluefish composition

The active ingredient is venlafaxine.

Each capsule contains: Venlafaxine hydrochloride, which corresponds to 75 mg of venlafaxine.

The other ingredients are:

Core

Microcrystalline cellulose, povidone, talc, colloidal anhydrous silica, magnesium stearate.

Coating

Ethyl cellulose, copovidone.

Capsule

Black iron oxide (E-172), red iron oxide (E-172), titanium dioxide (E-171), and gelatin.

Printing inks

Shellac and red iron oxide.

Product appearance and package contents

Hard gelatin capsule of prolonged release.

75 mg:hard gelatin capsules with peach-colored opaque body and cap, size "1", with thick and thin radial red bands on the body, and thick and thin radial red bands on the cap. Each capsule contains 6 white to off-white, round, biconvex film-coated mini-tablets.

PVC/Aclar and aluminum blister packs with: 10, 14, 28, 30, 50, and 100 capsules.

PVC/PVdC and aluminum blister packs with: 10, 14, 28, 30, 50, and 100 capsules.

Only some pack sizes may be marketed.

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

Local representative:

Bluefish Pharma S.L.U.,

AP 36007

2832094 Madrid, Sucursal 36

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

Date of last revision of this leaflet: June 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es