VENLAFAXINE BLUEFISH 225 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Bluefish 225 mg prolonged-release hard 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.
• 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. 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. Storage of Venlafaxine Bluefish
6. Contents of the pack and other information

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

Venlafaxine Bluefish is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. It is not fully understood how antidepressants work, but they may help to increase the levels of serotonin and norepinephrine 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: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks). Treating depressive and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not improve or may worsen and become more difficult to treat.

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

Do not takeVenlafaxine Bluefish

• If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
• If you are also 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 an irreversible MAOI with Venlafaxine Bluefish can cause serious or even life-threatening side effects. Also, you must wait at least 7 days after stopping Venlafaxine Bluefish before taking any irreversible MAOI (see also the section entitled “Other medicines and Venlafaxine Bluefish” and the information in that section on “Serotonin syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Venlafaxine Bluefish.

• If you are taking other medicines that, when taken with Venlafaxine Bluefish, could increase the risk of developing Serotonin syndrome (see the section “Other medicines and Venlafaxine Bluefish”).
• 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 an abnormal heart rhythm.
• 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 history of bleeding disorders (tendency to develop bruises or tendency to bleed easily) or if you are using 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 breastfeeding”).
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.
• Depression or other conditions that are treated with buprenorphine.

Taking venlafaxine with buprenorphine may cause serotonin syndrome, a potentially life-threatening condition.

Venlafaxine Bluefish may cause a feeling of restlessness or difficulty sitting or standing still during the first few weeks of treatment. You should consult your doctor if this happens to you.

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

Suicidal thoughts and worsening of your 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 may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. These thoughts may also occur when your dose is reduced or during the discontinuation of treatment with Venlafaxine Bluefish.

This is more likely to happen:

• If you have previously had thoughts of killing or harming yourself.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric conditions who were treated with antidepressant medicines.

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

You may find it helpful to tell a relative or close friend 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 behavior.

Dry mouth

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

Diabetes

Your blood glucose levels may be altered due to Venlafaxine Bluefish. Therefore, it may be necessary to adjust the dose of your diabetes medicine.

Sexual problems

Some medicines in the same group as Venlafaxine Bluefish (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). 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 old. Also, you should know that in patients under 18 years old, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years old when he decides what is best for the patient. If your doctor has prescribed this medicine to a patient under 18 years old and you wish to discuss this decision, please go back to your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years old are taking Venlafaxine Bluefish. Also, the long-term safety of this medicine in terms of growth, maturation, and cognitive and behavioral 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.

Some medicines may increase the risk of side effects when taken with venlafaxine, and in some cases, may cause serious or even life-threatening reactions. Do not take any other medicines while taking venlafaxine without first consulting your doctor, especially buprenorphine. Venlafaxine may interact with buprenorphine, and you may experience symptoms such as involuntary muscle contractions, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when you experience these symptoms.

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

Do not start or stop taking any medicines, including those that can be bought without a prescription, herbal remedies, and complementary medicines, before consulting your doctor or pharmacist.

• Monoamine oxidase inhibitors, used to treat depression or Parkinson's disease, must not be used withVenlafaxine Bluefish. Tell your doctor if you have taken these medicines in the last 14 days (MAOIs: see section “What you need to know before you take Venlafaxine Bluefish”).
• Serotonin syndrome:

A potentially life-threatening condition, or Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraine)
• Other medicines for treating depression, such as SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder [ADHD], narcolepsy, and obesity)
• Medicines containing the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemide, a reversible MAOI (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing opioids (e.g. buprenorphine, tramadol, fentanyl, tapentadol, pethidine, or pentazocine (used to treat severe pain)
• Medicines containing dextromethorphan (used to treat coughs)
• Medicines containing methadone (used to treat opioid addiction or severe pain)
• Medicines containing methylene blue (used to treat high levels of methemoglobin in the blood)
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a herbal remedy or dietary supplement used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a condition with symptoms of auditory, visual, or perceptual unreality, false beliefs, unusual distrust, confused reasoning, and beginning withdrawal).

The signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.

Serotonin syndrome, in its most severe form, can resemble Neuroleptic Malignant Syndrome (NMS). The symptoms and signs of NMS can include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased levels of muscle enzymes (determined by a blood test).

Tell your doctor immediately or go to the nearest hospital if you think you are suffering from serotonin syndrome.

You must tell your doctor if you are taking medicines that affect heart rhythm.

Examples of these medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythm).
• Antipsychotics such as thioridazine (see also above the section “Serotonin syndrome”).
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections).
• Antihistamines (used to treat allergies).

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

• Ketoconazole (antifungal medicines).
• Haloperidol or risperidone (for treating psychiatric conditions).
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems).

Using Venlafaxine Bluefish with food, drinks, and alcohol

Venlafaxine Bluefish should be taken with food (see section 3 “How to take Venlafaxine Bluefish”).

Do not drink alcohol during treatment with Venlafaxine Bluefish. Taking it with alcohol may cause extreme tiredness and unconsciousness, and worsen 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 or pharmacist for advice before taking this medicine. You should only take Venlafaxine Bluefish after discussing the potential benefits and risks with your doctor.

Make sure your midwife and/or doctor knows you are taking Venlafaxine Bluefish. When similar medicines (called selective serotonin reuptake inhibitors: SSRIs) are taken during pregnancy, there is an increased risk that the baby will suffer from a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually start during the first 24 hours after birth. If this happens to your baby, you must contact a doctor and/or midwife immediately.

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.

If you are taking this medicine during pregnancy, other symptoms that your baby may have when born are feeding problems and breathing problems. If your baby has these symptoms when born and you are worried, contact your doctor and/or midwife who can advise you.

Venlafaxine Bluefish passes into breast milk. There is a risk of an effect on the baby, so you should discuss this with your doctor, and he will decide whether you should stop breastfeeding or stop treatment with this medicine.

Driving and using machines

Do not drive or operate machinery until you know how this medicine affects you.

Venlafaxine Bluefish contains carmoisine (E122).

It may cause allergic reactions.

3. How to Take Venlafaxina Bluefish

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The recommended initial dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose and, if necessary, raise it 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 Venlafaxina Bluefish at approximately the same time each day, either in the morning or evening. The capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxina Bluefish should be taken with food.

If you have liver or kidney problems, talk to your doctor, as it may be necessary for your medication dose to be different.

Do not stop taking this medication without consulting your doctor (see section "If you stop treatment with Venlafaxina Bluefish").

If you take more Venlafaxina Bluefish than you should

Call your doctor or pharmacist immediately if you take more of this medication than prescribed by your doctor.

You can also contact the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Overdose can be life-threatening, especially with the simultaneous intake of certain medications and/or alcohol (see Other medications and Venlafaxina Bluefish).

The symptoms of a possible overdose may include palpitations, changes in the level of alertness (ranging from drowsiness to coma), blurred vision, convulsions or seizures, and vomiting.

If you forget to take Venlafaxina Bluefish

If you have not taken a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only one dose as usual. Do not take a double dose to make up for the missed dose. Do not take more than the daily amount of Venlafaxina Bluefish that has been prescribed for you in one day.

If you stop treatment with Venlafaxina Bluefish

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes you no longer need Venlafaxina Bluefish, they may ask you to gradually reduce the dose before stopping treatment altogether. It is known that adverse effects occur when people stop using Venlafaxina Bluefish, especially when it is stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headache, insomnia, sensation that things are spinning around them or sensation of movement (vertigo), nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, tingling, or, in rare cases, sensations of electric discharge, weakness, sweating, convulsions, or flu-like symptoms, vision problems, and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with Venlafaxina Bluefish. This may take several weeks or months. In some patients, the interruption may need to occur very gradually over months or more. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Venlafaxina Bluefish can cause side effects, although not everyone will experience them.

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

Uncommon (may affect 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands, or feet and/or swollen rash with itching, difficulty swallowing or breathing.

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

• Chest tightness, breathing sounds, difficulty swallowing or breathing.
• Severe skin rash, itching, or hives (elevated areas of reddened or pale skin that often itch).
• Signs and symptoms of serotonin syndrome, which 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 can include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
• Signs of infection, such as increased temperature, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can lead to an increased risk of infection.
• Severe rash, which can lead to the formation of severe blisters and skin peeling.
• Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Frequency not known (cannot be estimated from available data)

• Signs and symptoms of a condition called "stress cardiomyopathy" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeat.

Other side effects that you should report to your doctorinclude (The frequency of these side effects is included in the list below "Other side effects that may occur"):

• Cough, difficulty breathing, respiratory problems that may be accompanied by high temperature.
• Black stools (deposits) or blood in stools.
• Itching, yellow eyes or skin, dark urine, which are symptoms of liver inflammation (hepatitis).
• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems: such as dizziness, tingling, movement disorder (muscle spasms and stiffness) convulsions or seizures.
• Psychiatric problems, such as hyperactivity and unusual sensation of overexcitement.
• Effects of treatment withdrawal (see section "How to take Venlafaxina Bluefish, If you stop treatment with Venlafaxina Bluefish").
• Prolonged bleeding – If you cut or injure yourself, the bleeding may take a little longer than usual to stop.

Do not worry if you notice white granules in your stools after taking this medication. The Venlafaxina Bluefish capsules contain internal microgranules (small white granules) that are the ones that contain the active ingredient (venlafaxine). These microgranules are released from the capsule in the stomach. Venlafaxine is released slowly, as the capsule moves along the length of the gastrointestinal tract. The coating of the microgranules does not dissolve and is eliminated in the stools. Therefore, although you may see microgranules in your stools, your dose of venlafaxine has been absorbed.

Other side effects that may occur

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

• Dizziness, headaches, drowsiness.
• Insomnia.
• Nausea, dry mouth, constipation.
• Sweating (including night sweats).

Common (may affect 1 in 10 patients)

• Decreased appetite.
• Confusion; feeling separated (or detached) from oneself, absence of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremors, a feeling of restlessness or inability to remain seated or still, tingling, altered taste perception, increased muscle tone.
• Eye disorders, including blurred vision, dilated pupils. Inability of the eye to automatically change focus from distant to near objects.
• Ringing in the ears (tinnitus).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased frequency of urination, inability to urinate, difficulty urinating.
• Menstrual irregularities, such as increased bleeding or irregular bleeding; abnormal ejaculation / orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Uncommon (may affect 1 in 100 people)

• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).

• Hallucinations, feeling separated (or detached) from reality, abnormal orgasm (women), lack of feelings or emotions, sensation of overexcitement or euphoria, teeth grinding.
• Fainting, involuntary muscle movements, altered coordination and balance.
• Feeling dizzy (especially when getting up too quickly), decreased blood pressure.
• Vomiting blood, black stools (deposits) or blood in stools, which can be a sign of internal bleeding.
• Sensitivity to sunlight, bruising, abnormal hair loss.
• Inability to control urination.
• Stiffness, spasms, and involuntary muscle movements.
• Mild changes in blood levels of liver enzymes.

Rare (may affect 1 in 1,000 people)

• Seizures or convulsions.
• Cough, breathing sounds, and shortness of breath, which may be accompanied by high temperature.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• Excessive water intake (known as SIADH).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heartbeat, rapid or irregular, which can lead to fainting.
• Severe abdominal or back pain (which can 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).

Very rare (may affect up to 1 in 10,000 people)

• Prolonged bleeding, which may be due to a reduced number of platelets in the blood that leads to an increased risk of bruising or bleeding.
• Abnormal milk production.
• Unexpected bleeding, for example, bleeding from the gums, blood in urine or vomit, or the appearance of unexpected bruising or broken blood vessels (broken veins).

Unknown: cannot be estimated from available data

• Suicidal thoughts and behavior. Cases of suicidal thoughts and behavior have been reported during therapy with venlafaxine or shortly after discontinuation of treatment (see section 2, What you need to know before taking Venlafaxina Bluefish).
• Aggression
• Vertigo.
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

Venlafaxina sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; mild changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, venlafaxina may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to perform occasional blood tests, especially if you have been taking Venlafaxina Bluefish for a long time.

If any of the side effects you suffer from is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Venlafaxina Bluefish

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not throw any medication down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Venlafaxina Bluefish

The active ingredient is venlafaxine.

Each capsule contains 225 mg of Venlafaxina (as hydrochloride).

The other components are:

Core:

Microcrystalline cellulose (Avicel PH 102), povidone (K-90D), talc, colloidal anhydrous silica (Aerosil 200), magnesium stearate.

Coating:

Ethyl cellulose, copovidone.

Capsule:

Carmoisine (E122), titanium dioxide (E171), gelatin.

Printing inks:

Lacquer (E904), indigo carmine (E132)

Appearance of the Product and Package Contents

Hard prolonged-release capsules.

Hard gelatin capsules, opaque, pink, size "00" with a wide and narrow circular band printed in blue ink, both on the body and cap of the capsule, and inside which are the mini-tablets.

Packaging containing aluminum blister packs and CFB; 14, 20, 28, 30, 50, 60, 98, and 100 capsules

Packaging containing aluminum blister packs and white opaque PVC/Aclar; 14, 20, 28, 30, 50, 60, 98, and 100 capsules.

Packaging containing aluminum blister packs and white opaque PVC/PVdC; 14, 20, 28, 30, 50, 60, 98, and 100 capsules.

Not all 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

You can request more information about this medication by contacting the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U,

AP 36007

2832094 Madrid, Sucursal 36

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

Date of the last revision of this leaflet: June 2023

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