75 mg hard prolonged-release capsules, 150 mg hard prolonged-release capsules
venlafaxine
What Venlafaxine Mylan is and what it is used for
Venlafaxine Mylan contains the active substance venlafaxine, which 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.
Venlafaxine Mylan is a treatment for adults with depression or to prevent the recurrence of depression. Venlafaxine Mylan is also a treatment for adults with the following anxiety disorders: generalized anxiety, social phobia (fear of or avoidance of social situations), and panic disorder (panic attacks). 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 Mylan may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Venlafaxine Mylan
Do not take Venlafaxine Mylan
- 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 Mylan can cause serious or even life-threatening side effects. In addition, you must wait at least 7 days after you stop taking Venlafaxine Mylan before taking an MAO inhibitor (see also sections “Serotonergic syndrome” and “Other medicines and Venlafaxine Mylan”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine Mylan:
- if you use other medicines which, if taken together with venlafaxine, can increase the risk of developing serotonin syndrome (see section “Other medicines and Venfalaxin Mylan”).
- if you have eye problems, for example, certain types of glaucoma (increased pressure in the eye), or if your optician has told you that you are at increased risk of developing glaucoma.
- if you have previously had high blood pressure or if you have recently had a heart attack.
- if you or someone in your family previously had heart problems.
- if you have been told that you have an abnormal heart rhythm.
- if you have previously had seizures (epileptic seizures).
- if you previously had low sodium levels in the blood ( hyponatremia ). Also, talk to your doctor or pharmacist if you are elderly, take diuretics (water-reducing medicines that increase urine production), or are dehydrated (e.g. due to severe diarrhea or vomiting).
- if you bruise easily or if you bleed easily (if you have had bleeding disorders), or if you are taking other medicines that thin the blood and may increase the risk of bleeding, or if you are pregnant (see section “Pregnancy and breast-feeding”).
- 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. You may feel aggressive especially at the start of venlafaxine treatment, if the dose is changed or when treatment is stopped.
- if you have diabetes (this medicine can affect blood sugar levels).
- if you use any medicine for weight loss.
During treatment
- This medicine may cause an increase in blood pressure et or cholesterol levels. The doctor may want to check your blood pressure and cholesterol level regularly.
- If you feel restless or unable to stand or sit still (which may occur at the beginning of treatment), talk to your doctor or pharmacist.
- If you need to provide a urine sample to check the use of certain medicines, this medicine may affect the results. Tell the doctor or hospital staff that you are taking this medicine.
- Venlafaxine Mylan contains granules. The undissolved part of these granules is eliminated and can be seen in the feces.
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 thoughts can get worse when you start using anti-depressant drugs because it takes time for drugs of this type to take effect, usually about 2 weeks, sometimes longer. These thoughts may also occur when the dose is reduced or when treatment with Venlafaxine is stopped.
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 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.
Dry mouth
Dry mouth has been reported in 10% of patients treated with venlafaxine. This can increase the risk of caries (cavities in the teeth). You should therefore be extra careful with dental hygiene.
Diabetes
Venlafaxine can change your blood sugar levels. The dose of your diabetes medication may therefore need to be adjusted.
Sexual problems
Medicines such as Venlafaxine Mylan (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.
Children and young people
Venlafaxine Mylan 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, this medicine can be prescribed by doctors to patients under 18 years of age, if the doctor considers this to be 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 in patients under 18 years of age taking Venlafaxine. The long-term effects of this drug on growth, maturation, and cognitive and behavioral development have yet to be determined for this age group.
Other medicines and Venlafaxine Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or may be taking other medicines, including over-the-counter medicines and natural and herbal medicines.
Your doctor will decide whether you can take Venlafaxine Mylan together with other medicines.
- Do not take monoamine oxidase inhibitors ( MAOIs ) used to treat depression or Parkinson’s disease together with venlafaxine. Tell your doctor if you have taken any such medicine in the last 14 days. (MAOIs: see section “Do not take Venlafaxine Mylan”)
Serotonergic syndrome:
A potentially life-threatening condition or reactions 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 migraine , eg sumatriptan, zolmitriptan)
- other medicines to treat depression, such as SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
- Medicines containing amphetamines (used in the treatment of ADHD, narcolepsy, and obesity)
- medicines containing linezolid, an antibiotic (used to treat infections )
- medicines containing moclobemide, an MAO inhibitor (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 (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 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 heart rate, increased sweating, severe muscle stiffness, confusion, altered mental status, and elevated levels of muscle enzymes (determined by blood tests).
Tell your doctor immediately, or go to the nearest emergency room, if you think you have serotonin syndrome or NMS.
You must tell your doctor if you are taking medicines that can affect your heart rhythm.
Examples of these medicines are:
- antiarrhythmics e.g. quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythms)
- antipsychotic drugs e.g. thioridazine (see also Serotonergic syndrome above)
- antibiotics e.g. erythromycin and moxifloxacin (used to treat infections caused by bacteria)
- antihistamines (used to treat allergies )
The following medicines can also affect or be affected by ( interact ) Venlafaxine Mylan and should be used with caution. You must tell your doctor or pharmacist if you are taking medicines containing:
- drugs that inhibit certain enzymes (CYP3A4) such as
- atazanavir, indinavir, nelfinavir, ritonavir, saquinavir (medicines used to treat HIV )
- ketoconazole , itraconazole, voriconazole, posaconazole (antifungal medicine)
- clarithromycin and telithromycin ( antibiotics )
- haloperidol or risperidone (to treat psychiatric conditions)
- metoprolol (a beta blocker to treat high blood pressure and heart problems)
Venlafaxine Mylan with food, drink, and alcohol
Venlafaxine should be taken with a meal (see section 3 “How to take Venlafaxine”).
Avoid alcohol while taking Venlafaxine.
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 using this medicine. Do not use venlafaxine until you have discussed the potential benefits and potential risks to your unborn baby with the doctor.
Tell your midwife and/or doctor that you are using Venlafaxine Mylan. 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.
Another symptom, in addition to breathing difficulties, that your baby may have at birth if you take this medicine during pregnancy is that the baby does not eat properly. 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 Mylan 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 told that you are taking Venlafaxine Mylan so that they can advise you about this.
If you are breastfeeding, consult a doctor. Venlafaxine Mylan 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 Mylan.
Driving ability and use of machinery
Do not drive or use machines until you know how Venlafaxine Mylan affects you. This medicine may affect your judgment, thoughts, and ability to drive or use machines. 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. The 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.
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost “sodium-free”.
How to take Venlafaxine Mylan
Always take this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The usual recommended starting dose for the treatment of depression, generalized anxiety, 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. If you are being treated for panic disorder, the doctor will start with a lower dose (37.5 mg) and then increase the dose step by step. The highest dose for generalized anxiety disorder, social phobia, and panic disorder is 225 mg daily. The doctor may recommend that you take this medicine for several months depending on your condition. The doctor may want to examine you regularly during treatment.
Take Venlafaxine Mylan 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.
Venlafaxine Mylan should be taken with a meal.
If you have liver or kidney problems, talk to your doctor as your dose of this medicine may need to be changed.
Do not stop taking Venlafaxine Mylan without first talking to your doctor (see section “If you stop taking Venlafaxine Mylan”).
Use for children and adolescents
Venlafaxine Mylan is not normally recommended for the treatment of children and adolescents (see section 2).
If you have taken too much Venlafaxine Mylan
If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for an assessment of the risk and advice.
The symptoms of a possible overdose can be fast or slow heart rhythm or changes in the heart’s electrical activity which can be seen during examinations, low blood pressure, dizziness, changes in the level of alertness (from drowsiness to coma ), blurred vision, seizures, and vomiting.
If you forget to take Venlafaxine Mylan
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. Do not take more than the amount of Venlafaxine that you have been prescribed per day.
If you stop taking Venlafaxine Mylan
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 Mylan, he/she may ask you to reduce the dose slowly before stopping the treatment completely. It is known that you can get side effects when you stop taking this medicine, especially if you stop taking Venlafaxine Mylan suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggressiveness, fatigue, dizziness, intoxication, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, anxiety, nervousness, restlessness, confusion, ringing in the ears, crawling or in rare cases feeling like electric shocks, weakness, sweating, seizures, tremors or flu-like symptoms, vision problems and increased blood pressure (which can cause headache, dizziness, ringing in the ears, sweating, etc.).
The doctor will tell you how to gradually stop treatment with Venlafaxine Mylan. This may take a few weeks or months. In some patients, it may need to be done gradually over several months or longer. 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. Tell a doctor immediately, or go to the emergency department of the nearest hospital, if you experience any of the following:
Uncommon (may affect up to 1 in 100 users)
- Swelling of the face, mouth, tongue, throat, hands, or feet and/or a raised itchy rash ( hives ), difficulty swallowing or breathing.
Rare (may affect up to 1 in 1,000 users)
- Chest tightness, wheezing, difficulty swallowing, or breathing.
- Severe skin rash, itching, or hives (raised patches of red or pale skin that often itch).
- Severe rashes, can lead to severe blistering and peeling of the skin.
- Signs and symptoms of serotonergic symptoms such as restlessness, hallucinations, loss of coordination, rapid pulse, 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 (determined by blood tests).
- Signs of infection, such as fever, chills, shaking, headache, sweating, and flu-like symptoms. This may be due to a blood disorder that leads to an increased risk of infection.
- Unexplained muscle pain, soreness, or weakness. This may be a sign of rhabdomyolysis.
Has been reported (occurring in an unknown number of users)
- Signs and symptoms of a condition called “stress cardiomyopathy” which may include chest pain, shortness of breath, dizziness, fainting, and irregular heartbeat.
Other side effects that you should tell your doctor are (the frequency of these side effects is included in the “Other side effects that may occur” list below):
- Coughing, wheezing and shortness of breath, may occur along with fever.
- Black (tarry) stool or blood in the stool.
- Itching, yellowish skin or yellow eyes, or dark urine, can be symptoms of an inflammation of the liver ( hepatitis ).
- Heart problems, for example, fast or irregular heart rate, and high blood pressure.
- Eye problems, such as blurred vision, and dilated pupils.
- Nerve problems, such as dizziness, tingling, and numbness, movement disorder (muscle spasms or stiffness), and seizures.
- Mental problems, such as hyperactivity and feeling unusually excited.
- Withdrawal symptoms (see section 3 “How to take Venlafaxine, If you stop taking Venlafaxine”).
- Prolonged bleeding – if you cut or injure yourself, it may take a little longer than that. usually for the bleeding to stop.
Do not be alarmed if you see small white grains in your stool after taking Venlafaxine. Inside the Venlafaxine 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.
Other possible side effects:
Very common (may affect more than 1 in 10 users)
- Dizziness, headache
- Nausea, dry mouth
- Somnolence
- Heavy sweating (even at night)
- Difficulty sleeping ( insomnia )
- Constipation
Common (may affect up to 1 in 10 users)
- Loss of appetite
- Confusion, feeling detached, failure to orgasm, decreased sexual desire, agitation, nervousness, abnormal dreams, agitation
- Visual disturbances including blurred vision, dilated pupils, inability to automatically change focus between objects near or far from the eye
- Ringing in the ears ( tinnitus )
- Increased blood pressure, flushing.
- Yawns
- Vomiting, diarrhea
- Need to urinate more often than usual, inability to urinate, difficulty urinating.
- Menstrual disorders such as increased bleeding or increased irregular bleeding, abnormal ejaculation/orgasm (in men), erectile problems ( impotence )
- Weakness ( asthenia ), fatigue, chills
- Elevated cholesterol levels in the blood
- Respiratory distress
- Mild skin rash, itching
- Weight gain, weight loss
- Tremors, a feeling of restlessness or an inability to sit or stand still, numbness and tingling, altered sense of taste, and increased muscle tension.
- Rapid heartbeat, palpitations
Uncommon (may affect up to 1 in 100 users)
- Overactivity, flight of mind, and reduced need for sleep (mania)
- Hallucinations, feeling detached from reality, abnormal orgasm, lack of emotion, feeling overly excited, teeth grinding
- Fainting, involuntary muscle movements, uncontrollable muscle spasms, twitching or twisting movements, impaired coordination, and balance
- Dizziness (especially if you stand up too quickly), decreased blood pressure
- Vomiting blood, black tarry stools, or blood in the stool, which may indicate internal bleeding
- Sensitivity to sunlight, bruising, abnormal hair loss, hives (urticaria)
- Low blood pressure
- Some changes in the level of liver enzymes in the blood can be seen in blood tests
- Inability to control urine
- Stiffness, spasms, and involuntary muscle movements
Rare (may affect up to 1 in 1,000 users)
- Reduced sodium levels in the blood which can be seen in blood tests
- Disorientation and confusion, often combined with hallucinations ( delirium )
- Coughing, wheezing, and shortness of breath, may occur along with fever.
- Excessive fluid intake (so-called SIADH)
- Severe pain in the eyes and impaired or blurred vision
- Abnormal, fast, or irregular heartbeat, which can lead to fainting
- Severe pain in the stomach or back (which may indicate a serious disease in the abdomen, liver, or pancreas)
- Itching, yellow skin or eyes, dark urine, or flu-like symptoms, which are signs of liver inflammation ( hepatitis )
Very rare (may affect up to 1 in 10,000 users)
- Abnormal production of breast milk
- Prolonged bleeding may be a sign of a reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding
- Unexpected bleeding, e.g. bleeding gums, blood in the urine or vomiting blood, or the appearance of unexpected bruises or burst blood vessels
Has been reported (occurring in an unknown number of users)
- Suicidal thoughts and suicidal tendencies, cases of suicidal thoughts and suicidal tendencies have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2, What you need to know before you take Venlafaxine )
- Aggression
- Dizziness
- Heavy vaginal bleeding soon after giving birth ( postpartum hemorrhage), see ‘Pregnancy and breast-feeding in section 2 for more information.
Venlafaxine sometimes causes side effects that you may not be aware of, such as increased blood pressure or abnormal heartbeats, and small changes in blood levels of liver enzymes, sodium, or cholesterol. In rare cases, Venlafaxine can impair the function of the platelets (thrombocytes) in the blood, leading to an increased risk of bruising or bleeding. Therefore, the doctor may want to take blood tests from time to time, especially if you have been taking Venlafaxine for a long time.
Additional side effects in children and adolescents
Although this drug is not normally recommended for children and adolescents, hostility, self-injurious behavior, stomach pain, indigestion and heartburn, and muscle pain have also been reported.
How to store Venlafaxine Mylan
Keep this medicine out of the sight and reach of children.
Use before the expiry date which is stated on the label/carton after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
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.
Each prolonged-release capsule contains venlafaxine hydrochloride equivalent to 75 mg or 150 mg of venlafaxine (as hydrochloride). Other ingredients are hypromellose, ammonium methacrylate copolymer, sodium lauryl sulfate, magnesium stearate, and basic butylated methacrylate copolymer. The capsule shell contains titanium dioxide E171, gelatin, red iron oxide E172 (only for 75 mg), erythrosine E127, and indigo carmine E132 (only for 150 mg). Printing ink: glossy shellac, black iron oxide.
Appearance and package sizes of the medicine
75 mg: Opaque, skin-colored hard capsule, marked with “VEN” on the top of the capsule and “75” on the bottom of the capsule.
150 mg: Opaque, scarlet hard capsule, marked with “VEN” on the top of the capsule and “150” on the bottom of the capsule.
Venlafaxine Mylan prolonged-release capsules are available in blister packs of 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100, 500, 1000 and multipacks of 90 (3 cartons of 30) or 100 (2 cartons with 50) capsules and in cans containing 7, 10, 14, 20, 25, 28, 30, 50, 56, 70, 90, 100 and 250 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Pharmathen International SA, Sapes Industrial Park, Block 5, 69300 Rodopi, Greece
Pharmathen Pharmaceutics SA, Dervenakion 6, Pallini 153 51 Attikis, Greece
Mylan Hungary Kft, H-2900 Komárom, Mylan utca 1, Hungary
Viatris Santé, 360 Avenue Henri Schneider, 69330 Meyzieu, France.
Viatris Santé, 1 Rue de Turin, 69007 Lyon, France.