VENLAFAXINE BLUEFISH 150 mg PROLONGED-RELEASE CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Bluefish 150 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 get 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 and other information

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

1. Contents of the pack and further 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.

Venlafaxine Bluefish is a treatment for adults with depression. Venlafaxine Bluefish is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear of social or performance situations), panic disorder (panic attacks). It is important to treat depression or anxiety disorders properly for you to get better. If they are not treated, 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 or even life-threatening reactions. Also, you must wait at least 7 days after stopping Venlafaxine Bluefish before you take any MAOI (see also section “Using Venlafaxine Bluefish with other medicines” and the information in that section on “Serotonin Syndrome”).

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting treatment with Venlafaxine Bluefish

• if you are taking other medicines that, when taken with Venlafaxine Bluefish, may increase the risk of developing Serotonin Syndrome, a potentially life-threatening condition (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 the blood (hyponatremia).
• if you have a tendency to develop bruises or bleed easily (history of bleeding disorders), or if you are pregnant (see “Pregnancy and breastfeeding”) or if you are taking other medicines that may increase the risk of bleeding, e.g. warfarin (used to prevent blood clots)
• if you have a history of, or if a family member has had, bipolar disorder or mania (feeling overexcited or elated).
• if you have a history of aggressive behavior.

Consult your doctor or pharmacist before starting treatment with Venlafaxine Bluefish, especially if you suffer from:

• Serotonin Syndrome (excessive levels of serotonin caused by an increase in nerve cell activity)
• Neuroleptic Malignant Syndrome (characterized by symptoms such as fever, muscle stiffness, 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)

It is advised to carefully monitor the patient during treatment, 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 a need to be in motion, often accompanied by difficulty sitting or standing still, during the first few weeks of treatment. If this happens, you should inform your doctor.

Overdose can put your life in danger, especially when taking certain medicines and/or alcohol (see “Taking Venlafaxine Bluefish with other medicines”).

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have suicidal thoughts or thoughts of self-harm. This risk may increase at the start of treatment with antidepressants, because all these medicines take time to work, usually around 2 weeks, but sometimes longer.

You are more likely to think this way:

• if you have previously had thoughts of self-harm or suicide.
• if you are a young adult. Clinical trials have shown an increased risk of suicidal behavior in young adults (less than 25 years) with psychiatric conditions who were treated with antidepressants.

If you have thoughts of suicide or self-harm, contact your doctor or go directly to a hospital.

Tell a family member or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. This could be helpful to them and to you.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This can increase the risk of tooth decay (caries). Therefore, you should take special care with your dental hygiene.

Diabetes

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

Some medicines in the same group as Venlafaxine Bluefish (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4.8). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxine Bluefish should not normally be used in the treatment of children and adolescents under 18 years. Also, you should know that in patients under 18 years, there is an increased risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Venlafaxine Bluefish to patients under 18 years when he decides what is best for the patient. If the doctor who is treating you has prescribed Venlafaxine Bluefish to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms described above get worse or if you experience complications when patients under 18 years are taking Venlafaxine Bluefish. Also, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of Venlafaxine Bluefish in this age group have not yet been demonstrated.

Other medicines and Venlafaxine Bluefish

Tell your doctor or pharmacist if you are taking or 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 medicine, including those bought without a prescription, herbal remedies, and supplements, without first talking to 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 in the last 14 days (MAOIs: see section “Before taking Venlafaxine Bluefish”).
• Serotonin Syndrome:
• A potentially life-threatening or similar reaction to Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”), may occur with treatment with venlafaxine, particularly when taken at the same time as other medicines,

Examples of these medicines include:

• Triptans (anti-migraine medicines)
• Other medicines for treating depression, e.g. SNRIs, SSRIs, tricyclics (antidepressants), or medicines that contain lithium
• Medicines that contain linezolid (an antibiotic used to treat infections)
• Medicines that contain moclobemide, a reversible MAOI (antidepressants)
• Medicines that contain sibutramine (used for weight loss)
• Medicines that contain tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
• Medicines that contain dextromethorphan (used to treat coughs)
• Medicines that contain methadone or buprenorphine (used to treat addiction to opioids or to treat severe/moderate pain).
• Medicines that contain methylene blue (used to treat high levels of methemoglobin in the blood)
• Products that contain St. John's Wort (also known as Hypericum perforatum, a herbal remedy used to treat mild depression)
• Products that contain tryptophan (used for insomnia and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing, or feeling things that do not exist, mistaken beliefs, unusual suspicion, unclear reasoning, and a tendency to withdraw)

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

Tell your doctor immediately or go to the emergency 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 inform your doctor or pharmacist if you are taking medicines that contain:

• ketoconazole (an antifungal medicine)
• haloperidol or risperidone (for treating psychiatric conditions)
• metoprolol (β-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 during treatment with 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 breastfeeding

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

Tell your doctor/midwife that you are taking Venlafaxine Bluefish. During pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in newborns, persistent pulmonary hypertension in newborns (PPHN), which causes the newborn to breathe faster and have a bluish appearance. These symptoms start in the first 24 hours after birth. If this happens to your baby, contact your doctor/midwife immediately.

If you are taking Venlafaxine Bluefish during pregnancy, other symptoms your baby may have when born are feeding problems and breathing problems. If your baby has these symptoms at birth and you are concerned, consult your doctor.

If you take Venlafaxine Bluefish in the final stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know 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 breastfeeding your child. 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 breastfeeding or stop Venlafaxine Bluefish therapy.

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

Follow exactly the instructions for taking this medicine given by your doctor. Consult your doctor or pharmacist if you have any doubts.

The recommended initial daily dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg in a single dose. Your doctor may consider it appropriate to increase the dose up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose for generalized 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 liquid, without opening, crushing, chewing, or dissolving. Chewing, crushing, or dissolving the capsule contents can damage the coating and alter the release of the medicine.

Venlafaxine Bluefish should be taken with food.

Patients with liver and 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 treatment with Venlafaxine Bluefish without consulting your doctor (see section “If you stop taking Venlafaxine Bluefish”).

If you take more Venlafaxine Bluefish than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 562 0420, indicating the medicine and the amount taken.

Overdose can put your life in danger, especially when taking certain medicines and/or alcohol (see “Taking Venlafaxine Bluefish with other medicines”).

The symptoms of a possible overdose are: rapid heartbeat, changes in the level of consciousness (from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Venlafaxine Bluefish

If you have forgotten to take a capsule, simply 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 forgotten doses.

If you stop taking Venlafaxine Bluefish

Do not stop your treatment or reduce the dose without first consulting your doctor, even if you feel better. If your doctor considers that you no longer need Venlafaxine Bluefish, they will tell you to gradually reduce the dose before stopping treatment completely. It is known that there are side effects when stopping treatment with this medicine, particularly if it is stopped abruptly or when the dose is reduced too quickly. Some patients may experience symptoms such as: fatigue, dizziness, sensory disturbances, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, numbness or tingling, tremor, weakness, sweating, seizures, or fever and chills.

Your doctor will tell you how to gradually stop taking Venlafaxine Bluefish. If you experience any of these or other bothersome symptoms, consult 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 difficulties
• 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 is excreted 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.
• Somnolence, 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 (deposits), or blood in stools, which can be a sign of internal bleeding.
• Generalized skin swelling, especially 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.
• High temperature with rigid 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, somnolence, rapid sustained eye movement, clumsiness, restlessness, feeling drunk, sweating, or rigid muscles, which are symptoms of serotonin syndrome; rigidity; spasms and involuntary muscle movements.
• Severe eye pain and reduced or blurred vision.
• Dizziness.
• Decreased blood pressure; abnormal, rapid, or irregular heartbeat, which can lead to fainting; unexpected bleeding, for example, bleeding gums, blood in stools or vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins).
• 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), mild 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.
• Excessive 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; mild 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; particularly 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 the 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 you no longer need at the SIGRE collection point in your pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines 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 150 mg of venlafaxine.

The other ingredients are:

Core

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

Coating

Ethyl cellulose, copovidone.

Capsule

Allura red (E129), sunset yellow FCF (E110), brilliant blue FCF (E133), titanium dioxide (E171), and gelatin.

Printing inks

Shellac and titanium dioxide

Product appearance and package contents

Hard gelatin capsule of prolonged release.

150 mg: Hard gelatin capsules of orange dark / orange dark opaque body and cap, size "0", with thick and thin white circular radial bands on the body, and thick and thin white circular radial bands on the cap. Each capsule contains 12 mini-tablets of 12.5 mg each, white to white opaque, round, biconvex, film-coated.

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