Venlafaxine Bluefish 225 mg prolonged-release hard capsules EFG: detailed information

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, talk to your doctor or pharmacist, even if the adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

What Venlafaxine Bluefish is and what it is used for
What you need to know before you take Venlafaxine Bluefish
How to take Venlafaxine Bluefish
Possible side effects
How to store Venlafaxine Bluefish
Contents of the pack and other information

1. What Venlafaxine Bluefish is and what it is 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. The way antidepressants work is not fully understood, but they may help increase levels of serotonin and norepinephrine in the brain.

Venlafaxine Bluefish is a treatment for depression in adults. Venlafaxine Bluefish is also a treatment for the following anxiety disorders in adults: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), and panic disorder (panic attacks). Properly treating depressive and anxiety disorders 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.

2. What you need to know before taking 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 currently taking or have taken within the last 14 days any medicine known as an irreversible monoamine oxidase inhibitor (MAOI) used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with Venlafaxine Bluefish may cause serious or even potentially fatal side effects. In addition, you must wait at least 7 days after stopping Venlafaxine Bluefish before starting any irreversible MAOI (see also the section “Other medicines and Venlafaxine Bluefish” and the information in that section on “Serotonin syndrome”).

Warnings and precautions

Talk to your doctor or pharmacist before taking Venlafaxine Bluefish.

If you are taking other medicines that, when taken together with Venlafaxine Bluefish, could increase the risk of developing serotonin syndrome (see 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 bruise easily or tendency to bleed readily), 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 overly excited or euphoric).
If you have a history of aggressive behavior.
Depression or other conditions treated with buprenorphine.

The use of venlafaxine together with buprenorphine may cause serotonin syndrome, a potentially life-threatening condition.

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

Do not drink alcohol during treatment with Venlafaxine Bluefish, as it may cause extreme drowsiness and unconsciousness. Taking it together with certain medicines and/or 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 yourself or of suicide. This risk may increase when starting antidepressants, as all these medicines take time to work—usually about two weeks, but sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of treatment with Venlafaxine Bluefish.

This is more likely to happen if:

You have previously had thoughts of suicide or self-harm.
You are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years of age) with psychiatric disorders who were treated with antidepressants.

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

It may be helpful to inform a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may also ask them to let you know if they think your depression or anxiety is worsening, 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 problems (cavities). Therefore, you should take care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by Venlafaxine Bluefish. Therefore, a dose adjustment of your diabetes medication may be necessary.

Sexual problems

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

Children and adolescents

Venlafaxine Bluefish should normally not be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. You must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking Venlafaxine Bluefish. In addition, the long-term effects on safety and on growth, maturity, and cognitive and behavioral development have not yet been established.

Other medicines and Venlafaxine Bluefish

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

Some medicines may increase the side effects of venlafaxine and, in some cases, may cause very serious 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 muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tone, body temperature above 38°C. Contact your doctor if you experience these symptoms.

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

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

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

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

Examples of such medicines include:

Triptans (used for migraine)
Other medicines to treat depression, for example, 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, meperidine, 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 symptoms of auditory, visual, or perceptual unreality, false beliefs, unusual distrust, confused thinking, and beginning withdrawal).

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.

In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Symptoms and signs of NMS may include a combination of fever, rapid heart rate, sweating, severe muscle rigidity, confusion, and increased levels of muscle enzymes (detected by a blood test).

Contact your doctor immediately or go to the nearest hospital if you think you are experiencing serotonin syndrome.

You should inform your doctor if you are taking medicines that affect heart rhythm.

Examples of such medicines include:

Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythm).
Antipsychotics such as thioridazine (see also above 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 inform your doctor or pharmacist if you are taking medicines containing:

Ketoconazole (antifungal medicines).
Haloperidol or risperidone (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 together with alcohol may cause extreme drowsiness and unconsciousness, and may worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

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

Make sure your midwife and/or doctor knows that you are taking Venlafaxine Bluefish. When similar medicines (called serotonin reuptake inhibitor antidepressants: SSRIs) are taken during pregnancy, there may be an increased risk of the baby developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact a doctor and/or midwife immediately.

If you take Venlafaxine Bluefish in the late 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 you are taking Venlafaxine Bluefish so they can advise you.

If you take this medicine during pregnancy, other symptoms your baby may have at birth include feeding difficulties and breathing problems. If your baby has these symptoms at birth 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 effects on the baby; therefore, you should discuss this with your doctor, who will decide whether you should stop breastfeeding or stop treatment with this medicine.

Driving and using machines

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

Venlafaxine Bluefish contains carmoisine (E122).

It may cause allergic reactions.

3. How to take Venlafaxine Bluefish

Follow exactly the dosing instructions for this medicine as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase your dose 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 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 must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.

Venlafaxine Bluefish should be taken with food.

If you have liver or kidney problems, speak with your doctor, as your dose of the medicine may need to be adjusted.

Do not stop taking this medicine without consulting your doctor (see section "If you stop taking Venlafaxine Bluefish").

If you take more Venlafaxine Bluefish than you should

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

You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

Overdose can be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see Other medicines and Venlafaxine Bluefish).

Symptoms of a possible overdose may include palpitations, changes in level of consciousness (ranging from drowsiness to coma), blurred vision, seizures or fits, and vomiting.

If you forget to take Venlafaxine Bluefish

If you have missed a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next dose as scheduled. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily amount of Venlafaxine Bluefish prescribed for you in one day.

If you stop taking Venlafaxine Bluefish

Do not stop or reduce your treatment without consulting your doctor, even if you feel better. If your doctor decides that you no longer need Venlafaxine Bluefish, they may instruct you to gradually reduce the dose before stopping treatment completely. Adverse effects are known to occur when people stop taking Venlafaxine Bluefish, especially if it is stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, unsteadiness, headache, insomnia, sensation that things are spinning around or feeling of movement (vertigo), nightmares, dry mouth, loss of appetite, nausea, diarrhea, restlessness, agitation, confusion, tinnitus (ringing in the ears), tingling sensations, or, rarely, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, vision problems, and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with Venlafaxine Bluefish. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for further advice.

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

4. Possible adverse effects

Like all medicines, Venlafaxine Bluefish can cause adverse effects, although not everyone experiences them.

If any of the following effects occur, stop taking Venlafaxine Bluefish immediately and contact your doctor or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

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

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

Chest tightness, noisy breathing, difficulty swallowing or breathing.
Severe skin rash, itching or hives (raised red or pale areas of 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, overactive reflexes, diarrhea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (detected by 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 may progress to serious blistering and peeling of the skin.
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" which may include chest pain, difficulty breathing, dizziness, fainting, or irregular heartbeats.

Other side effects that you should report to your doctor include (the frequency of these adverse effects is included in the list below “Other adverse effects that may occur”):

Cough, difficulty breathing, respiratory problems which may be accompanied by high temperature.
Tarry stools (bowel movements) or blood in the stool.
Itching, yellowing of the 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 disorders (muscle spasms and stiffness), seizures or fits.
Psychiatric problems such as hyperactivity and unusual feelings of overexcitement.
Withdrawal effects (see section “How to take Venlafaxine Bluefish, If you stop taking Venlafaxine Bluefish”).
Prolonged bleeding – If you cut or injure yourself, bleeding may take slightly longer than usual to stop.

Do not be concerned if you notice white granules in your stools after taking this medicine. Venlafaxine Bluefish capsules contain microgranules (small white granules) inside which contain the active substance (venlafaxine). These microgranules are released from the capsule in the stomach. Venlafaxine is released slowly as the capsule moves along the gastrointestinal tract. The coating of the microgranules does not dissolve and is excreted in the stool. Therefore, although you may see microgranules in your stools, your dose of venlafaxine has been absorbed.

Other adverse effects that may occur

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

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

Common (may affect 1 in 10 patients)

Decreased appetite.
Confusion; feeling detached (or separated) from oneself, absence of orgasm, decreased libido, restlessness, nervousness, abnormal dreams.
Tremors, a feeling of restlessness or inability to sit still or remain motionless, tingling, altered taste perception, increased muscle tone.
Eye disturbances, including blurred vision, dilated pupils. Inability of the eye to automatically adjust focus from distant to near objects.
Ringing in the ears (tinnitus).
Rapid heartbeat, palpitations.
Increased blood pressure, hot flushes.
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 increased irregular bleeding; abnormal ejaculation/orgasm (in men), erectile dysfunction (impotence).
Weakness (asthenia), fatigue, chills.
Weight gain or weight loss.
Increased cholesterol.

Uncommon (may affect 1 in 100 people)

Hyperactivity, racing thoughts and reduced need for sleep (mania).
Hallucinations, feeling detached (or separated) from reality, abnormal orgasm (in women), lack of feelings or emotions, feelings of overexcitement or euphoria, teeth grinding.
Fainting, involuntary muscle movements, disturbance of coordination and balance.
Feeling dizzy (especially when standing up too quickly), decreased blood pressure.
Vomiting blood, tarry stools (bowel movements) or blood in the stool, which may be a sign of internal bleeding.
Sensitivity to sunlight, bruising, abnormal hair loss.
Inability to control urination.
Muscle stiffness, spasms and involuntary muscle movements.
Slight changes in blood levels of liver enzymes.

Rare (may affect 1 in 1,000 people)

Seizures or fits.
Cough, noisy breathing 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 levels of sodium in the blood.
Severe eye pain and reduced or blurred vision.
Abnormal, rapid or irregular heartbeat, which may lead to fainting.
Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver or pancreas).
Itching, yellowing of the 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 leading to an increased risk of bruising or bleeding.
Abnormal production of breast milk.
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).

Not known: frequency cannot be estimated from available data

Suicidal thoughts and behaviour. Cases of suicidal thoughts and behaviour have been reported during venlafaxine therapy or shortly after discontinuation of treatment (see section 2, What you should know before starting to take Venlafaxine Bluefish).
Aggression.
Vertigo.
Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy and breastfeeding” in section 2 for more information.

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Venlafaxine Bluefish

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Do not dispose of medicines via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Venlafaxine Bluefish

The active substance 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, colloidal anhydrous silica (Aerosil 200), magnesium stearate.

Coating:

Ethyl cellulose, copovidone.

Capsule shell:

Carmoisine (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.

Opaque pink hard gelatin capsules, size “00”, with a wide and a narrow blue circular band printed on both the body and the cap of the capsule, containing mini-tablets inside.

Pack sizes containing aluminium and CFB blisters: 14, 20, 28, 30, 50, 60, 98 and 100 capsules.

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

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

Only certain 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

For further information on this medicinal product, contact the local representative of the Marketing Authorization Holder:

Bluefish Pharma S.L.U.
P.O. Box 36007
2832094 Madrid, Branch 36
Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Member State Name	Medicinal Product Name
PT (RMS)	venlafaxine Bluefish XR
DE	venlafaxine Bluefish 225 mg prolonged-release hard capsules
ES	venlafaxine Bluefish 225 mg prolonged-release capsules EFG

Date of the latest review of this leaflet: June 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/