Label: Information for the User

Venlafaxine Bluefish 225 mg Extended-Release Hard Capsules EFG

venlafaxine

Read this label carefully before starting to take this medicine, as it contains important information for you

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

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

3. How to take Venlafaxine Bluefish

4. Possible adverse effects

5. Storage of Venlafaxine Bluefish

6. Contents of the pack and additional information.

Venlafaxina Bluefish is an antidepressant that belongs to a group of medications called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medications is used to treat depression and other conditions such as anxiety disorders. The exact mechanism of how antidepressants work is not fully understood, but they may help increase levels of serotonin and norepinephrine in the brain.

Venlafaxina Bluefish is a treatment for adults with depression. Venlafaxina 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 go away or may worsen and become more difficult to treat.

Do not takeVenlafaxine Bluefish

• If you are allergic to venlafaxine or any of the other ingredients in this medicine (listed in section 6).
• If you are also taking or have taken within the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with Venlafaxine Bluefish may cause severe or potentially fatal side effects. Additionally, you should wait at least 7 days after stopping Venlafaxine Bluefish before taking any IMAO irreversible (see also the section called “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 may 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 (convulsions).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a history of bleeding disorders (tendency to develop ecchymoses or tendency to bleed easily) 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 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.

The use of venlafaxine with buprenorphine may cause serotonin syndrome, a potentially fatal condition.

Venlafaxine Bluefish may cause restlessness or difficulty sitting or staying still during the first weeks of treatment. You should consult your doctor if this happens.

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

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. This may be more likely to happen:

• If you have had thoughts of suicide or self-harm before.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric disorders treated with antidepressants.

If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the hospital immediately.

You may find it helpful to tell a close relative or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned 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 dental decay (tooth caries). You should take good care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by Venlafaxine Bluefish. You may need to adjust the dose of your diabetes medicine.

Sexual problems

Some medicines in the group to which Venlafaxine Bluefish belongs (called ISRS/IRSN) may cause sexual symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Children and adolescents

Venlafaxine Bluefish should not normally be used to treat children and adolescents under 18 years old. You should also know that in patients under 18 years old, there is a higher risk of side effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, the doctor who prescribed this medicine for you may decide that it is the best option for you. If the doctor who prescribed this medicine for you wants to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in patients under 18 years old who are taking Venlafaxine Bluefish. Additionally, the long-term effects of this medicine on growth, maturation, and cognitive and behavioral development are not yet known.

Other medicines and Venlafaxine Bluefish

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Some medicines may increase the side effects of venlafaxine and, in some cases, may cause severe reactions. Do not take any other medicine while taking venlafaxine without first consulting your doctor, especially buprenorphine. Venlafaxine may interact with buprenorphine and you may experience symptoms such as involuntary and rhythmic muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.

Your doctor should decide if you can take Venlafaxine Bluefish with other medicines.

Do not start or stop taking any medicine, including those available over the counter, natural remedies, and herbal products, without consulting your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors, used to treat depression or Parkinson's disease, should not be used with Venlafaxine Bluefish. Inform your doctor if you have taken these medicines within the last 14 days (IMAO: see section “What you need to know before starting to take Venlafaxine Bluefish”).
• Serotonin syndrome:

A potentially fatal condition, or Serotonin Neuroleptic Malignant Syndrome (SNMS), may occur with treatment with venlafaxine, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraines)
• Other medicines for treating depression, such as ISRN, ISRS, 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 IMAO (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 cough)
• 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 natural or herbal remedy used to treat mild depression)
• Products containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a condition with auditory, visual, or perceptual hallucinations, delusions, unusual distrust, confused thinking, and 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, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

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

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

You should inform 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 interact with Venlafaxine Bluefish and should be used with caution. It is especially important to inform your doctor or pharmacist if you are taking medicines that contain:

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

Use of 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 fatigue and loss of consciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before taking this medicine. You should only take Venlafaxine Bluefish after discussing the possible benefits and risks for the unborn child with your doctor.

Make sure your midwife and/or doctor know that you are taking Venlafaxine Bluefish. When taking similar medicines (called selective serotonin reuptake inhibitors: SSRIs) during pregnancy, there may be an increased risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually start within the first 24 hours after birth. If this happens to your baby, you should 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, your baby may have problems with feeding and breathing when born. If your baby has these symptoms when born and you are concerned, 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 they will decide whether you should stop breastfeeding or stop taking this medicine.

Driving and operating machines

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

Venlafaxine Bluefish contains carmoisine (E122).

It may cause allergic reactions.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The normal initial dose recommended for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may increase the dose gradually and, if necessary, raise it 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 increase the dose gradually. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Take Venlafaxina Bluefish approximately at the same time every day, either in the morning or at night. The capsules must 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 you may need a different medication dose.

Do not stop taking this medication without consulting your doctor (see section "If you interrupt 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Overdose can put your life in danger, especially with the simultaneous use of certain medications and/or alcohol (see Other medications and Venlafaxina Bluefish).

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

If you forgot 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 compensate for the missed dose. Do not take more than the daily dose of Venlafaxina Bluefish prescribed in a day.

If you interrupt treatment with Venlafaxina Bluefish

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor thinks you no longer need Venlafaxina Bluefish, they may ask you to reduce the dose gradually before stopping treatment completely. It is known that adverse effects occur when people stop using Venlafaxina Bluefish, especially when stopping suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such assuicidal thoughts, aggression,fatigue, dizziness,instability, headache, insomnia, sensation of things spinning around 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, electric shock sensations, weakness, sweating, seizures, or symptoms similar to the flu,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 be produced 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 doubts about the use of this medication, ask your doctor or pharmacist.

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

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

Rare (may affect 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands, or feetand/or hives with itching, difficulty swallowing or breathing.

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

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 heartbeats.

Other side effects thatyou must inform 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 fever.
• Stool that is tar-like (deposits) or blood in the stool.
• 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, numbness, movement disorder (muscle spasms and rigidity)seizures or attacks.
• Psychiatric problems, such as hyperactivity and unusual feeling of overexcitement.
• Effects of treatment withdrawal (see section "How to take Venlafaxina Bluefish, If you interrupt 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 see white granules in your stool after taking this medication. The Venlafaxina Bluefish capsules contain microgranules (small white granules) inside 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 stool. Therefore, although you may see microgranules in your stool, your venlafaxine dose has been absorbed.

Other side effects that may occur

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

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

Common (may affect 1 in 10 patients)

• Decreased appetite.
• Confusion; feeling disconnected (or detached) from oneself, absence of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremors,a feeling of restlessness or inability to sit or stay still,tingling,altered taste perception,increased muscle tone.
• Eye changes, including blurred vision, dilated pupils. Inability of the eye to automatically change focus from distant to near objects.
• Ear ringing (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.
• Irregular menstrual periods, such as increased bleeding or irregular bleeding; abnormal ejaculation / orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Rare (may affect 1 in 100 people)

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

• Hallucinations, feeling disconnected (or detached) from reality, abnormal orgasm (women), lack of feelings or emotions, feeling overexcited or euphoric, teeth grinding.
• Fainting, involuntary muscle movements, altered coordination and balance.
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
• Vomiting blood, stool that is tar-like (deposits) or blood in the stool, which may be a sign of internal bleeding.
• Sensitivity to sunlight, petechiae, abnormal hair loss.
• Inability to control urination.
• Rigidity, spasms, and involuntary muscle movements.
• Mild changes in liver enzyme levels.

Uncommon (may affect 1 in 1,000 people)

• Seizures or attacks.
• Cough, wheezing, and shortness of breath, which may be accompanied by high fever.
• Disorientation and confusion, often accompanied by hallucinations (delirium).
• Excessive water intake (SIADH).
• Decreased sodium levels in the blood.
• Severe eye pain and reduced or blurred vision.
• Abnormal heartbeat, rapid or irregular, which may lead to fainting.
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas).
• Itching, yellow eyes or skin, dark urine, symptoms similar to the flu, 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 petechiae or bleeding.
• Abnormal milk production.
• Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or the appearance of unexpected petechiae or broken blood vessels (veins).

Unknown: cannot be estimated from available data

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

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

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

Reporting of 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 System for the Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the 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 dispose of any medication through the drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Venlafaxina Bluefish

The active ingredient is venlafaxine.

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

The other components are:

Core:

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

Coating:

Ethyl cellulose, copovidone.

Capsule:

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

Printing inks:

Shellac (E904), indigo carmine (E132)

Appearance of the product and contents of the pack

Prolonged-release hard capsules.

Hard gelatin capsules, opaque, pink, size “00” with a wide and narrow blue band printed in ink, both on the body and the cap of the capsule, and containing mini tablets inside.

Packs containing aluminium blisters and CFB; 14, 20, 28, 30, 50, 60, 98 and 100 capsules

Packs containing aluminium blisters and PVC white opaque/Aclar; 14, 20, 28, 30, 50, 60, 98 and 100 capsules.

Packs containing aluminium blisters and PVC white opaque/PVdC; 14, 20, 28, 30, 50, 60, 98 and 100 capsules.

Only some pack sizes may be marketed.

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

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Bluefish Pharma S.L.U,

AP 36007

2832094 Madrid, Branch 36

Spain

This medicine is authorised in the Member States of the European Economic Area with the following names:

Last review date of this leaflet: June 2023

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/