37.5 mg, 75 mg, 150 mg, 225 mg prolonged-release tablet er
venlafaxine
What Venlafaxine 1A Farma is and what it is used for
Venlafaxine 1A Farma contains the active substance venlafaxine.
Venlafaxine 1A Farma 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 1A Farma is a treatment for adults with depression. Venlafaxine 1A Farma 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.
Venlafaxine contained in Venlafaxine 1A Farma may also be approved to treat other diseases 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 taking Venlafaxine 1A Farma
Do not take Venlafaxine 1A Farma
- 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 within 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 1A Farma can cause serious or even life-threatening side effects. In addition, you must wait at least 7 days after you stop taking Venlafaxine 1A Farma before taking an MAO inhibitor (see also the section “Other medicines and Venlafaxine 1A Farma and the information in that section on “Serotonergic syndrome”).
Warnings and precautions
Talk to your doctor or pharmacist before taking Venlafaxine 1A Farma
- if you use other medicines which, if taken together with Venlafaxine 1A Farma, can increase the risk of developing serotonin syndrome (see the section “Other medicines and Venlafaxine 1A Farma”),
- if you have a throat, stomach, or intestinal disorder that reduces your ability to swallow or pass food through normal bowel movements,
- 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 the blood ( hyponatremia )
- if you bruise easily or if you bleed easily (if you have had bleeding disorders) or if you take other medicines that can increase the risk of bleeding, e.g. warfarin (used to prevent blood clots), or if you are pregnant (see “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.
Venlafaxine 1A Pharma 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 also occur when the dose is reduced or when treatment with Venlafaxine 1A Farma is terminated.
These thoughts may be common:
- if you have previously had thoughts of harming yourself or committing suicide,
- if you are a young adult. 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 tooth decay ( caries ). You should therefore be extra careful with dental hygiene.
Diabetes
Venlafaxine 1A Farma can change your blood sugar levels. The dose of your diabetes medication may therefore need to be adjusted.
Sexual dysfunction
Medicines such as Venlafaxine 1A Farma (so-called SSRIs /SNRIs) 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 1A Farma 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 Venlafaxin 1A Farma
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 1A Farma 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 with Venlafaxine 1A Farma. Tell the doctor if you have taken these medicines in the last 14 days. (For MAO inhibitors see the section “What you need to know before taking Venlafaxine 1A Farma”)
- Serotonergic syndrome: A potentially life-threatening condition or reaction similar to 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 )
- other medicines to treat depression e.g. SNRI preparations, SSRI preparations, tricyclic antidepressants, or medicines containing lithium
- medicines containing amphetamines (used to treat attention deficit hyperactivity disorder ( 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 natural or herbal remedy used to treat mild depression)
- products containing tryptophan (used for sleep problems and depression)
- antipsychotic medicines (used to treat an illness with symptoms such as seeing, hearing, or feeling things that are not there, false beliefs, unusual suspiciousness, unclear reasoning, or being withdrawn).
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, palpitations, sweating, severe muscle stiffness, confusion, and increased amounts of muscle enzymes (determined by blood tests).
If you think you have serotonin syndrome, talk to 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 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 1A Farma 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 1A Farma with food, drink, and alcohol
Venlafaxine 1A Farma should be taken with food (see section 3 “How to take Venlafaxine 1A Farma”). Avoid alcohol while taking Venlafaxine 1A Farma.
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 1A Farma until you have discussed the potential benefits and potential risks to your unborn child with the doctor.
Tell your midwife or doctor that you are using Venlafaxine 1A Farma. 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 the 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 1A Farma 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 1A Farma so that they can advise you about this.
Venlafaxine 1A Farma 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 use machines until you know how Venlafaxin 1A Farma 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 a doctor or pharmacist if you are unsure.
Venlafaxine 1A Farma contains lactose
This medicine contains lactose. If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
How to take Venlafaxine 1A Farma
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, 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 1A Farma at about the same time each day, either in the morning or in the evening. The tablets must be swallowed whole with liquid and must not be opened, crushed, chewed, or dissolved.
Venlafaxine 1A Farma should be taken with a meal.
If you have problems with your liver or kidneys, talk to your doctor as your dose of Venlafaxine 1A Farma may need to be changed.
Do not stop taking this medicine without first consulting your doctor (see section “If you stop taking Venlafaxine 1A Farma”).
If you have taken too much Venlafaxin 1A Farma
If you have taken too much of this medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice. 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 1A Farma
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 1A Farma that you have been prescribed per day.
If you stop taking Venlafaxine 1A Farma
You should not stop taking the treatment or reduce the dose without first consulting the doctor, even if you feel better. If the doctor considers that you no longer need Venlafaxin 1A Farma, 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 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, 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 end treatment with Venlafaxine 1A Farma. 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 1A Farma. Talk to a 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 and symptoms of serotonin syndrome, may include restlessness, hallucinations, impaired coordination, palpitations, increased 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, palpitations, sweating, severe muscle stiffness, confusion, or increased amounts 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.
- 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 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 can occur together with a high body temperature
- Black (tarry) stool or blood in the stool
- Itching, yellowing of the 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 spasm or stiffness), seizures
- Mental problems, such as hyperactivity and feeling unusually excited
- Withdrawal symptoms (see section 3 “How to take Venlafaxine 1A Farma”, “If you stop taking Venlafaxine 1A Farma”).
- Prolonged bleeding time – if you cut or injure yourself, it may take a little longer for the bleeding to stop.
Do not be alarmed if you see a tablet in your stool after taking this medicine. While the tablet travels through the gastrointestinal tract, venlafaxine is slowly released. The form of the tablet remains undissolved/unchanged and disappears with your stool. Your dose of venlafaxine has been absorbed, even if you see a tablet 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 detached from oneself, inability to orgasm, decreased libido, agitation, nervousness, abnormal dreams
- Tremors, a feeling of restlessness or an inability to sit or stand still, tingling and numbness, altered sense of taste, increased muscle tension
- Visual disturbances including blurred vision, dilated pupils, and inability of the eye to automatically refocus from distant to near objects
- Ringing in the ears ( tinnitus )
- Rapid heartbeat, palpitations
- Increased blood pressure, flushing
- Shortness of breath, yawning
- Vomiting, diarrhea
- Mild skin rash, itching
- Need to urinate more often than usual, inability to urinate difficulty urinating
- Irregular menstruation such as increased bleeding or increased irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction ( impotence )
- Weakness ( asthenia ), fatigue, chills
- Weight gain, weight loss.
- Elevated cholesterol level.
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, 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 be signs of internal bleeding
- Sensitivity to sunlight, bruising, abnormal hair loss
- Inability to control urine
- 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, may occur along with fever.
- Altered spatial perception and confusion, are 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 can be a sign of a reduced number of platelets in the blood, which leads 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 ideation or suicide attempt: cases of suicidal ideation or suicide attempt have been reported during venlafaxine treatment or soon after stopping treatment (see section 2, What you need to know before taking Venlafaxine 1A Farma)
- Aggression
- Dizziness
- Heavy vaginal bleeding soon after giving birth ( postpartum hemorrhage), see ‘Pregnancy and breast-feeding in section 2 for more information.
Venlafaxine 1A Farma sometimes causes side effects that you may not be aware of, for example, increased blood pressure or abnormal heartbeats, small changes in blood levels of liver enzymes, sodium, or cholesterol. In rare cases, Venlafaxine 1A Farma can affect the function of the blood 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 1A Farma for a long time.
How Venlafaxine 1A Farma should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
No special temperature instructions.
Blister: Store in the original packaging. Moisture sensitive.
Plastic jar: Close the jar tightly. Moisture sensitive.
The medicine 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.
1 prolonged-release tablet contains 37.5 mg, 75 mg, 150 mg, and 225 mg of venlafaxine (as hydrochloride), respectively.
Other ingredients are:
Tablet core: Mannitol (E421), povidone K-90, macrogol 400, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate.
Tablet coating: Cellulose acetate, macrogol 400, hypromellose, lactose monohydrate, titanium dioxide (E171), triacetin.
Appearance and package sizes of the medicine
37.5 mg prolonged-release tablets: 7 mm round, biconvex white tablets
75 mg prolonged-release tablets: 7.5 mm round, biconvex white tablets
150 mg prolonged-release tablets: 9.5 mm round, biconvex white tablets
225 mg prolonged-release tablets: 11 mm round, biconvex white tablets
Venlafaxine 1A Farma is available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 100 and 500 tablets; and in plastic cans of 10, 14, 20, 28, 30, 50, 56, 60, 100, 106 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
1A Farma A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer :
Sandoz A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark