37.5 mg, 75 mg, 150 mg prolonged-release capsule, hard
venlafaxine
What Venlafaxine Bluefish is and what it is used for
Venlafaxine Bluefish is an antidepressant that belongs to a group of drugs called serotonin and norepinephrine reuptake inhibitors ( SNRIs ). This group of drugs is used to treat depression and other conditions such as anxiety disorders. It is not fully understood how antidepressants work, but they may help by increasing 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 social phobia (fear of or avoidance of social situations). It is important to treat depression or anxiety disorders properly to help you feel better. If the condition is not treated, it may not go away but become more serious and difficult to treat.
The venlafaxine contained in Venlafaxine Bluefish may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
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 also taking or at any time in the last 14 days have taken any medicine called an irreversible monoamine oxidase inhibitor ( MAO inhibitor ) used to treat depression or Parkinson’s disease. Taking an irreversible MAOI together with Venlafaxine Bluefish can cause serious or even life-threatening side effects. In addition, you must wait at least 7 days after you stop taking Venlafaxine Bluefish before taking an MAOI (see also the section entitled “Other medicines and Venlafaxine Bluefish” and the information in this section on “serotonergic syndrome”).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Venlafaxine Bluefish.
- If you use other medicines that if taken together with Venlafaxine Bluefish can increase the risk of developing serotonin syndrome, a condition that can be life-threatening (see section “Other medicines and Venlafaxine Bluefish”).
- If you have eye problems, for example, certain types of glaucoma (increased pressure in the eye).
- If you previously had high blood pressure.
- If you previously had heart problems.
- If you have previously had seizures (epileptic seizures).
- If you previously had low sodium levels in your blood ( hyponatremia ).
- If you bruise easily or if you bleed easily (if you have had bleeding disorders), or if you are pregnant (see “Pregnancy and breast-feeding”), or if you are taking other medicines that can increase the risk of bleeding, e.g. warfarin (used to prevent blood clots).
- If you or someone in your family has had mania or bipolar disorder (feelings of excessive excitement or euphoria ).
- If you have previously had aggressive behavior.
Talk to your doctor or pharmacist before using Venlafaxine Bluefish, especially if you receive:
- Serotonergic syndrome (elevated serotonin levels caused by increased nerve cell activity).
- Neuroleptic malignant syndrome (symptoms such as fever, muscle stiffness, altered mental status, and autonomic dysfunction (impaired functioning of non-volitionally controlled body functions)).
These conditions may occur along with:
- other serotonergic agents (mainly antidepressants, for example, SSRI preparations and SNRI preparations and triptans (used in migraine )).
- MAO inhibitors (substances used to treat depression, eg methylene blue).
- antipsychotic drugs (substances used to treat schizophrenia and bipolar disorder ).
Careful monitoring of the patient is recommended during treatment, especially when drugs are used in combination with venlafaxine. This combination can hurt serotonin and dopamine levels.
Venlafaxine Bluefish may cause a feeling of restlessness or inability to stand or sit still during the first weeks of treatment. Tell your doctor if this happens to you.
If you start to feel worse and have thoughts of harming yourself
You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using anti-depressant drugs, as it takes time for drugs of this type to take effect, usually about 2 weeks, sometimes longer.
These thoughts may be common:
- if you have previously had thoughts of harming yourself or committing suicide,
- if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressants have an increased risk of suicidal thoughts and thoughts of harming themselves.
Contact a doctor or the nearest hospital immediately if you have thoughts of harming yourself or committing suicide.
It may help to tell a relative or close friend that you are depressed and/or suffering from worry/anxiety. Please ask them to read this leaflet. You can also ask them to tell you if they think you seem to be feeling worse or if they think your behavior is changing.
Medicines such as Venlafaxine Bluefish (so-called SSRI -/SNRI preparations) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after discontinuation of treatment.
Dry mouth
Dry mouth has been reported in 10% of patients treated with venlafaxine. This can increase the risk of cavities in the teeth ( caries ). You should therefore be extra careful with dental hygiene.
Diabetes
Venlafaxine Bluefish can change your blood sugar levels. The dose of your diabetes medication may therefore need to be adjusted.
Children and young people
Venlafaxine Bluefish should not normally be used for the treatment of children and adolescents under the age of 18. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under the age of 18 when they take medicines of this type. Despite this, Venlafaxine Bluefish can be prescribed by doctors to patients under the age of 18, if the doctor considers this appropriate. If you are under 18 and want to discuss why you have been given this medicine, you should contact your doctor again. You should also inform your doctor if you notice any of the above symptoms or if they worsen. The long-term effects on growth, maturation and cognitive and behavioral development have not yet been determined for this age group.
Other medicines and Venlafaxine Bluefish
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor will decide whether you can take Venlafaxine Bluefish together with other medicines.
You should not start or stop taking any medicines, including those bought without a prescription, natural and herbal medicines, before you have asked your doctor or pharmacist.
- Monoamine oxidase inhibitors, which are used to treat depression or Parkinson’s disease, must not be used together with Venlafaxine Bluefish. Tell your doctor if you have taken any such medicine in the last 14 days. (MAO inhibitors: see section “What you need to know before you take Venlafaxine Bluefish”).
- Serotonergic syndrome: A potentially life-threatening condition or reaction such as neuroleptic malignant syndrome (NMS), (see section “Possible side effects”) may occur during treatment with venlafaxine, especially when taken together with other drugs.
Examples of such drugs include:
- triptans (used for migraines )
- other medicines to treat depression, such as SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
- medicines containing linezolid, an antibiotic (used to treat infections )
- medicines containing moclobemide, a reversible MAOI (used to treat depression)
- medicines containing sibutramine (used for weight loss)
- medicines containing tramadol, fentanyl, tapentadol, pethidine, and pentazocine (used to treat severe pain)
- medicines containing dextromethorphan (used to treat cough)
- medicines containing methadone or buprenorphine (used to treat opioid addiction or severe/moderate pain)
- medicines containing methylene blue (used to treat high levels of methemoglobin in the blood)
- products containing St. John’s wort (also called Hypericum perforatum, a (traditional) herbal medicine used for mild depression and mild anxiety)
- products containing tryptophan (used for sleep problems and depression)
- antipsychotic medicines (used to treat symptoms of hearing, seeing, or feeling things that are not there, delusions, abnormal suspiciousness, confusion, and withdrawal).
Signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, etc., overactive reflexes, diarrhea, coma, nausea, and vomiting.
In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid pulse, sweating, severe muscle stiffness, confusion, and elevated levels of muscle enzymes (detected by blood tests).
Tell your doctor immediately, or go to the nearest emergency room, if you think you have serotonin syndrome.
The following medicines can also affect or be affected by ( interact ) Venlafaxine Bluefish and should be used with caution. You must tell your doctor or pharmacist if you are taking medicines that contain:
- ketoconazole (an antifungal medicine)
- haloperidol or risperidone (to treat psychiatric conditions)
- metoprolol (a beta blocker to treat high blood pressure and heart problems)
Venlafaxine Bluefish with food, drink, and alcohol
Venlafaxine Bluefish should be taken with a meal (see section 3).
Avoid alcohol while taking Venlafaxine Bluefish.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before using this medicine. Do not use Venlafaxine Bluefish until you have discussed the potential benefits and potential risks to your unborn baby with the doctor.
Tell your midwife or doctor that you are using Venlafaxine Bluefish. When similar drugs ( SSRIs ) are used during pregnancy, the risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN) may increase. This condition causes the child to breathe faster and appear bluish. The symptoms usually appear within 24 hours of the baby being born. If this affects your child, contact your midwife or doctor immediately.
Other symptoms that your baby may have when it is born, if you take this medicine during pregnancy, are that the baby does not eat properly and has breathing difficulties. If your baby has these symptoms at birth and you are worried, contact the doctor and/or midwife who can give you advice.
If you take Venlafaxine Bluefish at the end of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have previously had bleeding disorders. The doctor or midwife should be informed that you are taking Venlafaxine Bluefish so that they can advise you about this.
Venlafaxine Bluefish passes into breast milk. There is a risk that the child will be affected. You should therefore talk to your doctor who will decide whether you should stop breastfeeding or discontinue treatment with Venlafaxine Bluefish.
Driving ability and use of machinery
Do not drive or use machines until you know how Venlafaxine Bluefish affects you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Venlafaxine Bluefish 150 mg contains
allura red (E129), para-orange FCF (E110), and brilliant blue FCF (E133), which may cause allergic reactions.
How to take Venlafaxine Bluefish
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The usual recommended starting dose for the treatment of depression and social phobia is 75 mg per day. The dose can be increased gradually by the doctor and if necessary up to a maximum of 375 mg per day for depression. The highest dose for social phobia is 225 mg daily.
Take Venlafaxine Bluefish at about 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. Chewing, crushing, or dissolving the contents of the capsule can damage the coating, which modifies the release of the drug in the body.
Venlafaxine Bluefish should be taken with a meal.
Patients with liver or kidney problems:
If you have liver or kidney problems, talk to your doctor as your dose of Venlafaxine Bluefish may need to be changed.
Do not stop taking Venlafaxine Bluefish without first talking to your doctor (see section “If you stop taking Venlafaxine Bluefish”).
If you have taken too much Venlafaxine Bluefish
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
The symptoms of a possible overdose can be a rapid heartbeat, changes in the level of alertness (from drowsiness to coma ), blurred vision, convulsions, and vomiting.
If you forget to take Venlafaxine Bluefish
If you miss a dose, take it as soon as you remember. However, if it is time for your next dose, skip the missed dose and just take one dose as usual. Do not take a double dose to make up for a missed dose.
If you stop taking Venlafaxine Bluefish
You should not stop taking the treatment or reduce the dose without first consulting the doctor, even if you feel better. If the doctor thinks that you no longer need Venlafaxine Bluefish, he/she may ask you to reduce the dose slowly before stopping the treatment completely. It is known that side effects can occur when stopping this medicine, especially if it is stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, intoxication, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, restlessness, confusion, ringing in the ears, goosebumps or, rarely, feeling like electric shocks, weakness, sweating, seizures or flu-like symptoms.
The doctor will tell you how to gradually stop treatment with Venlafaxine Bluefish. If you experience any of these or other symptoms that bother you, consult your doctor.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
- If any of the following occur, do not take more Venlafaxine Bluefish. Tell the doctor immediately, or go to the nearest emergency room.
- Chest tightness, wheezing, difficulty swallowing or breathing
- Swelling of the face, throat, hands, or feet
- Feeling of nervousness or worry/anxiety, dizziness, throbbing sensation, sudden flushing, and/or feeling of warmth
- Severe skin rash, itching, or hives (raised patches of red or pale skin that often itch)
- Signs and symptoms of serotonergic symptoms such as restlessness, hallucinations, loss of coordination, rapid heartbeat, elevated body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, and vomiting. In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid pulse, sweating, severe muscle stiffness, confusion, and elevated levels of muscle enzymes (detected by blood tests).
Other side effects that you should talk to your doctor about are:
- cough, wheezing, shortness of breath, and fever
- black (tarry) stools or blood in the stools
- yellowish skin or eyes, itching, or dark urine, which may be symptoms of an inflammation of the liver ( hepatitis )
- heart problems, for example, fast or irregular heart rate, high blood pressure
- eye problems, such as blurred vision, dilated pupils
- nerve problems: for example, dizziness, tingling and numbness, movement disorder, seizures
- mental health problems, such as hyperactivity and euphoria (feelings of unusual excitement)
- withdrawal symptoms (see section 3 “How to take Venlafaxine Bluefish”, “If you stop taking Venlafaxine Bluefish”).
- prolonged bleeding – if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.
Do not be alarmed if you see small white grains in your stool after taking Venlafaxine Bluefish. Inside Venlafaxine Bluefish capsules are small white grains that contain the active substance venlafaxine. These grains are released from the capsule in your stomach. As the grains pass through the gastrointestinal tract, venlafaxine is slowly released. The coating of the grain remains undissolved and disappears with your stool. Your dose of venlafaxine has been taken, even if you see grains in your stool.
Complete the side effects list
Very common (may affect more than 1 in 10 users)
- Dizziness, headache
- Nausea, dry mouth
- Sweats (even at night)
Common (may affect up to 1 in 10 users)
- Decreased appetite
- Confusion, feeling detached from oneself, failure to orgasm, decreased libido, nervousness, difficulty sleeping, abnormal dreams
- Drowsiness, tremors, numbness, and tingling, increased muscle tension
- Visual disturbances including blurred vision, dilated pupils, and inability of the eye to automatically change focus from distant to near objects
- Ringing in the ears ( tinnitus )
- Palpitation
- Increased blood pressure, flushing
- Yawns
- Vomiting, constipation, diarrhea
- Need to urinate more often than usual, difficulty urinating
- Irregular periods such as increased bleeding or more irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction ( impotence )
- Weakness ( asthenia ), fatigue, chills
- Elevated cholesterol level
Uncommon (may affect up to 1 in 100 users)
- Hallucinations, feeling detached from reality, agitation, abnormal orgasm (in women), lack of emotion, feeling overly excited, teeth grinding
- A feeling of restlessness or an inability to sit or stand still, fainting, involuntary muscle movements, impaired coordination and balance, altered sense of taste
- Fast heartbeat, feeling dizzy (especially if you stand up too quickly)
- Respiratory distress
- Vomiting blood, black tarry stools, or blood in the stool, which may indicate internal bleeding
- General swelling of the skin especially in the face, mouth, tongue, neck or hands and feet, and/or a raised itchy rash ( hives ) may occur, sensitivity to sunlight, bruising, rash, abnormal hair loss
- Inability to urinate
- Weight gain, weight loss
Rare (may affect up to 1 in 1,000 users)
- Seizures
- Inability to control urine
- Overactivity, flight of mind, and reduced need for sleep (mania)
Has been reported (occurring in an unknown number of users)
- Decreased number of platelets in the blood, which leads to an increased risk of bruising or bleeding, blood disorders that can lead to an increased risk of infection
- Swollen face or tongue, shortness of breath, or difficulty breathing, often with a rash (this may be a serious allergic reaction )
- Excessive fluid intake (so-called SIADH)
- Decreased sodium levels in the blood
- Suicidal thoughts and suicidal tendencies, cases of suicidal thoughts and suicidal tendencies have been reported during treatment with venlafaxine or immediately after stopping treatment (see section 2, What you need to know before you take Venlafaxine Bluefish).
- Altered spatial perception and confusion, often combined with hallucinations ( delirium ), aggression
- Fever with muscle stiffness, confusion or severe restlessness and sweating, or uncontrollable jerky muscle movements. These may be symptoms of a serious condition called a neuroleptic malignant syndrome, feelings of euphoria, drowsiness, persistent rapid eye movements, clumsiness, restlessness, feeling drunk, sweating or stiff muscles, which are symptoms of serotonin syndrome, stiffness, spasms, and involuntary muscle movements
- Severe pain in the eyes and impaired or blurred vision
- Dizziness
- Lowered blood pressure, abnormal, fast, or irregular pulse, which can lead to fainting, or unexpected bleeding e.g. bleeding gums, blood in the urine or vomiting blood, or the appearance of unexpected bruises or broken blood vessels.
- Coughing, wheezing, shortness of breath, and fever, are symptoms of inflammation of the lungs associated with an increased number of white blood cells ( pulmonary eosinophilia )
- Severe pain in the stomach or back (which may indicate a serious disease in the abdomen, liver, or pancreas)
- Itching, yellowish skin or eyes, dark urine or flu-like symptoms of inflammation of the liver ( hepatitis ), minor changes in liver enzyme levels in the blood
- Skin rash that can lead to severe blistering and scaling, itching, mild skin rash
- Unexplained muscle pain, tenderness, or weakness ( rhabdomyolysis )
- Abnormal production of breast milk
- Heavy vaginal bleeding soon after giving birth ( postpartum hemorrhage), see ‘Pregnancy and breast-feeding in section 2 for more information
Venlafaxine Bluefish sometimes causes side effects that you may not be aware of, such as increased blood pressure or abnormal heartbeats, small changes in blood levels of liver enzymes, sodium, or cholesterol. In rarer cases, Venlafaxine Bluefish can affect the function of the platelets (platelets) in the blood, leading to an increased risk of bruising or bleeding. Therefore, the doctor may want to take blood samples from time to time, especially if you have been taking Venlafaxine Bluefish for a long time.
How to store Venlafaxine Bluefish
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton after Expiration. dat. The expiration date is the last day of the specified month.
Store at a maximum of 30 ºC.
Do not use this medicine if you notice that the capsules are sticky.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is venlafaxine.
37.5 mg: Each prolonged-release capsule contains venlafaxine hydrochloride equivalent to 37.5 mg venlafaxine.
75 mg: Each prolonged-release capsule contains venlafaxine hydrochloride equivalent to 75 mg venlafaxine.
150 mg: Each prolonged-release capsule contains venlafaxine hydrochloride equivalent to 150 mg venlafaxine.
Other ingredients are
Tablet core:
microcrystalline cellulose, povidone, talc, anhydrous colloidal silicon dioxide, magnesium stearate
Tablet case:
Ethyl cellulose, copovidone
Capsules:
37.5 mg: Black iron oxide (E172), red iron oxide (E172), yellow iron oxide (E172), titanium dioxide (E171), gelatin
75 mg: Black iron oxide (E172), red iron oxide (E172), titanium dioxide (E171), gelatin
150 mg: Allura red, (E129), para-orange FCF (E110), brilliant blue FCF (E133), titanium dioxide (E171), gelatin
Ink:
37.5 mg and 75 mg: Shellac, red iron oxide
150 mg: Shellac, titanium dioxide
Appearance and package sizes of the medicine
Prolonged-release capsules, hard.
37.5 mg: Light gray/peach-colored opaque, size “3” hard gelatin capsules with thick and narrow bands in red ink on the center and top of the capsule. The capsule is filled with 3 white to off-white round, biconvex mini-tablets each containing 12.5 mg.
75 mg: Peach-colored opaque, size “1” hard gelatin capsules with thick and narrow bands in red ink on the center and top of the capsule. The capsule is filled with 6 white to off-white round, biconvex mini-tablets each containing 12.5 mg.
150 mg: Dark orange opaque, size “0”, hard gelatin capsules with thick and narrow stripes in white ink on the center and top of the capsule. The capsule is filled with 12 white to off-white round, biconvex mini-tablets each containing 12.5 mg.
Blister made of PVC/Aclar film and aluminum foil: Package sizes: 10, 14, 28, 30, 50, and 100 prolonged-release tablets.
Blister made of PVC/PVdC film and aluminum foil: Pack sizes: 10, 14, 28, 30, 50, and 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Paradox Healthcare Ltd.
KW20A Kordin Industrial Park,
Paola, PLA 3000
Malta
This medicine is approved within the European Economic Area
and in the United Kingdom (Northern Ireland) under the names:
| Member country | Name of the medicine |
| AT | Venlafaxin Bluefish 75 mg/150 mg Resin capsule, delayed release |
| THE | Venlafaxin Bluefish 75/150 mg Resin capsule, delayed release |
| DK | Venlafaxine Bluefish 75 mg/150 mg |
| ES | Venlafaxine Bluefish 75 mg/150 mg Cápsulas de liberación prolongedada |
| FI | Venlafaxine Bluefish 75 mg/150 mg prolonged-release capsules, covaVenlafaxine Bluefish 75 mg/150 mg prolonged-release capsule, hard |
| FR | Venlafaxine Bluefish LP 37.5 mg/75 mg/150 mg gélules à libération protracted |
| IE | Venlablue XL 75 mg/150 mg prolonged-release capsules |
| IT | Venlafaxine ABC 75 mg/150 mg Capsule a rilascio prolungato |
| NO | Venlafaxine Bluefish |
| PL | Venlafaxine Bluefish XL |
| PT | Venlafaxine Bluefish XR |
| SEE | Venlafaxine Bluefish 37.5 mg/75 mg/150 mg prolonged-release capsule, hard |
| UK (NI) | Venlablue XL 75 mg/150 mg prolonged-release capsules |
| IS | Venlafaxine Bluefish 37.5 mg/75 mg/150 mg hard capsules. |