37.5 mg, 75 mg, 150 mg prolonged-release capsule, hard
venlafaxine
What Venlafaxine Actavis is and what it is used for
Venlafaxine Actavis contains the active substance venlafaxine.
Venlafaxine Actavis is an antidepressant that belongs to a group of medicines 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 Actavis is a treatment for adults with depression. It 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 Actavis 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 Actavis
Do not take Venlafaxine Actavis
- 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 other medicines, including Venlafaxine Actavis, can cause serious or even life-threatening side effects. In addition, you must wait at least 7 days after you stop taking Venlafaxine Actavis before taking an MAO inhibitor (see also the section entitled “Other medicines and Venlafaxine Actavis¨ and the information in this section on “serotonergic syndrome¨).
Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine Actavis:
- If you use other medicines that if taken together with Venlafaxine Actavis may increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine Actavis”).
- 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 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 your blood ( hyponatremia ).
- If you bruise easily or if you bleed easily (if you have had bleeding disorders), if you are pregnant (see “Pregnancy and breast-feeding”), or if you are taking other medicines that may increase the risk of bleeding, such as ex. 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.
Venlafaxine Actavis 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 thoughts can be exacerbated when starting anti-depressant medication, as it takes time for this type of medication 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 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.
Dry mouth
Dry mouth has been reported in 10% of patients treated with venlafaxine. This can increase the risk of deteriorating teeth ( caries ). You should therefore be extra careful with dental hygiene.
Diabetes
Your blood glucose levels may change because of Venlafaxine Actavis. Therefore, your dose of diabetes medicine may need to be changed.
Sexual problems
Medicines such as Venlafaxine Actavis (so-called 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 Actavis 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.
The long-term effects of this drug on growth, maturation and cognitive and behavioral development have not yet been established for this age group.
Other medicines and Venlafaxine Actavis
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 Actavis 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 used to treat depression or Parkinson’s disease must not be used together with Venlafaxine Actavis. Tell your doctor if you have used these medicines in the last 14 days (MAO inhibitors: see the section “Do not use Venlafaxine Actavis”).
- Serotonergic syndrome: A potentially life-threatening condition, or reactions similar to Neuroleptic Malignant Syndrome (NMS) (see the section “Possible side effects”) can occur during treatment with venlafaxine, especially when it is taken together with other drugs.
Examples of such drugs include:
- triptans (used for migraines )
- other medicines for the treatment of depression, for example, SNRIs, SSRIs, tricyclic antidepressants, or medicines containing lithium
- drugs containing amphetamines (used to treat 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 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 called Hypericum perforatum, a natural or herbal remedy used to treat mild depression)
- products containing tryptophan (used for sleep problems and depression)
- antipsychotics (used to treat an illness with symptoms such as hearing, seeing, or feeling things that are not there, false perceptions, abnormal suspiciousness, unclear reasoning, and withdrawal) and other dopamine antagonists such as metoclopramide (used for nausea and vomiting )
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, etc., overactive reflexes, diarrhea, coma, nausea, and vomiting. Seek medical attention immediately if you think you have developed serotonin syndrome.
In its most severe form, serotonin syndrome can resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS can be, for example, a combination of fever, fast heartbeat, sweating, severe muscle stiffness, confusion, and elevated muscle enzymes (which can be seen in blood tests).
If you think you have suffered from serotonin syndrome, tell your doctor immediately or go to the emergency department of your nearest hospital.
You must tell your doctor if you are taking medicines that can affect the heart rhythm.
Examples of such drugs are:
– antiarrhythmics such as e.g. quinidine, amiodarone, isolator, or dofetilide (used to treat abnormal heart rhythms)
– antipsychotics such as thioridazine (see also “Serotonergic syndrome” above)
– antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections )
– antihistamines (used to treat allergies )
The following medicines can also affect or be affected by ( interact ) Venlafaxine Actavis 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 Actavis with food, drink, and alcohol
Venlafaxine Actavis should be taken with a meal (see section 3 “How to take Venlafaxine Actavis”).
Avoid alcohol while taking Venlafaxine Actavis.
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.
Pregnancy
Do not use Venlafaxine Actavis 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 Actavis. 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 has breathing difficulties and 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 Actavis 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 Actavis so that they can advise you about this.
Breast-feeding
Venlafaxine Actavis 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 this medicine.
Driving ability and use of machinery
Do not drive or operate machinery until you know how this medicine affects you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 Actavis contains excipients
Sucrose:
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
Sodium :
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. it is almost “sodium-free”.
Venlafaxine Actavis 37.5 mg also contains nycoccin (E124):
May cause allergic reactions.
Venlafaxine Actavis 75 mg and Venlafaxine Actavis 150 mg also contain para-orange (E110):
How to take Venlafaxine Actavis
Always use 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, 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.
Take Venlafaxine Actavis 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 Actavis 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 this medicine without first talking to your doctor (see section “If you stop taking Venlafaxine Actavis”).
If you have used too much Venlafaxine Actavis
Contact your doctor or pharmacist immediately if you have used more of this medicine than was prescribed by your doctor.
The symptoms of a possible overdose can be a rapid heartbeat, changes in the level of alertness (from drowsiness to coma ), blurred vision, seizures, and vomiting.
If you have ingested too much medicine, or if, for example, a child has ingested the medicine by mistake, immediately contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Venlafaxine Actavis
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 Actavis that you have been prescribed per day.
If you stop taking Venlafaxine Actavis
You should not stop 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 Actavis, 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 you stop 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, nervousness, restlessness, confusion, ringing in the ears, goosebumps or, rarely, a feeling of electric shock, weakness, sweating, seizures or flu-like symptoms, vision problems and increased blood pressure (which can cause headaches, dizziness, ringing in the ears, sweating, etc.).
.
The doctor will tell you how to gradually stop treatment with Venlafaxine Actavis. 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 Actavis. Tell the doctor immediately, or go to the nearest emergency room.
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).
- Signs of serotonin syndrome may include 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 can be, for example, a combination of fever, fast heartbeat, sweating, severe muscle stiffness, confusion, and elevated muscle enzymes (which can be seen in 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.
- Severe rashes, can lead to severe blistering and peeling of the skin.
- 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, which may occur along with fever
- Black (tarry) stool or blood in the stool
- Itching, yellow skin or eyes, or dark urine, which may be symptoms of liver inflammation ( hepatitis )
- Heart problems, such as fast or irregular heart rate, high blood pressure
- Eye problems, such as blurred vision, dilated pupils
- Nerve problems, such as dizziness, tingling and numbness, movement disorder (muscle spasms or stiffness), seizures
- Mental problems, such as hyperactivity and feeling abnormally excited
- Withdrawal symptoms (see section “How to take Venlafaxine Actavis, If you stop taking Venlafaxine Actavis”)
- 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 this medicine. Inside the Venlafaxine Actavis, capsules are small white grains that contain the active substance ( venlafaxine ). These grains are released from the capsule into your gastrointestinal tract. As the grains travel through the gastrointestinal tract, venlafaxine is slowly released. The “shell” of the grain remains undissolved and passes out with your stool. Your dose of venlafaxine has therefore been absorbed, even if you see grains in your stool.
Other side effects that may occur
Very common (may affect more than 1 in 10 users)
- Dizziness, headache, drowsiness
- Insomnia
- Nausea, dry mouth, constipation
- Sweats (including night sweats)
Common (may affect up to 1 in 10 users)
- Decreased appetite
- Confusion, feeling outside one’s own body, failure to have orgasms, decreased sexual desire, agitation, nervousness, abnormal dreams
- Tremors, a feeling of restlessness or an inability to sit or stand still, numbness and tingling, altered sense of taste, increased muscle tension
- Visual disturbances with blurred vision, dilated pupils, and inability to automatically change focus between objects near and far from the eye
- Ringing in the ears ( tinnitus )
- Rapid heartbeat, palpitations
- High blood pressure, cramps
- Shortness of breath, yawning
- Vomiting, diarrhea
- Mild skin rash, itching
- More frequent urges to urinate, 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
- Weight gain, weight loss
- Increased cholesterol levels
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 orgasms, lack of emotion, abnormal elation, teeth grinding
- Fainting, involuntary muscle movements, impaired coordination, and balance
- Dizziness (especially when standing up too quickly), and reduced blood pressure.
- Vomiting blood, black tarry stools, or blood in the stool, which may be signs of internal bleeding
- Sensitivity to sunlight, bruising, abnormal hair loss
- Inability to control urination
- Stiffness, spasms, and involuntary muscle movements
- Some changes in the liver enzyme levels in the blood
Rare (may affect up to 1 in 1,000 users)
- Seizures
- Coughing, wheezing, and shortness of breath, which may occur along with fever
- Altered spatial perception and confusion, often combined with hallucinations ( delirium )
- Excessive fluid intake (so-called SIADH).
- Decreased sodium levels in the blood
- 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)
- Prolonged bleeding may be a sign of a reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding
- Abnormal production of breast milk
- 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 behavior. Cases of suicidal thoughts and behavior have been reported in connection with treatment with venlafaxine or shortly after such treatment has been stopped (see section 2 “What you need to know before you take Venfalaxin Actavis”)
- Aggression
- Dizziness
- Heavy vaginal bleeding soon after giving birth ( postpartum hemorrhage), see ‘Pregnancy and breast-feeding in section 2 for more information
Venlafaxine Actavis 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 rarer cases, Venlafaxine Actavis 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 using Venlafaxine Actavis for a long time.
How to store Venlafaxine Actavis
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging. 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.
Venlafaxine Actavis 37.5 mg prolonged-release capsule:
Each capsule contains venlafaxine hydrochloride equivalent to 37.5 mg of venlafaxine.
Other ingredients are:
Capsule contents:
sugar spheres (contains sucrose, corn starch)
ethyl cellulose (E462)
hydroxypropyl cellulose
hypromellose (E464)
talc (E553b)
dibutyl sebacate
oleic acid
colloidal anhydrous silica
Capsule shell:
gelatine
sodium lauryl sulfate
novocaine (E124)
quinoline yellow (E104)
titanium dioxide (E171)
Venlafaxine Actavis 75 mg prolonged-release capsule:
Each capsule contains venlafaxine hydrochloride equivalent to 75 mg of venlafaxine.
Other ingredients are:
Capsule contents:
sugar spheres (contains sucrose, corn starch)
ethyl cellulose (E462)
hydroxypropyl cellulose
hypromellose (E464)
talc (E553b)
dibutyl sebacate
oleic acid
colloidal anhydrous silica
Capsule shell:
gelatine
sodium lauryl sulfate
para-orange (E110)
quinoline yellow (E104)
titanium dioxide (E171)
Venlafaxine Actavis 150 mg prolonged-release capsule:
Each capsule contains venlafaxine hydrochloride equivalent to 150 mg of venlafaxine.
Other ingredients are:
Capsule contents:
sugar spheres (contains sucrose, corn starch)
ethyl cellulose (E462)
hydroxypropyl cellulose
hypromellose (E464)
talc (E553b)
dibutyl sebacate
oleic acid
colloidal anhydrous silica
Capsule shell:
gelatine
sodium lauryl sulfate
para-orange (E110)
quinoline yellow (E104)
patent blue (E131)
Appearance and package sizes of the medicine
Venlafaxine Actavis 37.5 mg prolonged-release capsules, hard:
White to off-white grains in size “3” capsules, the upper part of which is orange and the lower part is transparent.
Venlafaxine Actavis 75 mg prolonged-release capsules, hard:
White to off-white grains in size “1” capsules, the upper part of which is yellow and the lower part is transparent.
Venlafaxine Actavis 150 mg prolonged-release capsules, hard:
White to off-white grains in size “0” capsules, the upper part of which is pale yellow and the lower part is transparent.
The prolonged-release capsules are available in packs of 7, 10, 14, 20, 28, 30, 50, 98, and 100 prolonged-release capsules, packed in PVC/aluminum blisters. 50 and 100 prolonged-release capsules in HDPE cans with HDPE screw caps and a small container with silica gel (desiccant), or with desiccant (silica gel) integrated into PP screw caps.
Not all pack sizes may be marketed.
Marketing authorization holder and manufacturer
Actavis Group PTC EHF.
Reykjavikurvegi 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Balkanpharma- Dupnitsa AD
3 Samokovsko Shosse Str.
Dupnitsa 2600
Bulgaria