37.5 mg prolonged-release capsules, hard
venlafaxine
What Venlafaxine Hexal is and what it is used for
Venlafaxine Hexal 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 thought that people who are depressed and/or have anxiety have lower levels of serotonin and norepinephrine in the brain. It is not fully understood how antidepressants work, but they may help by increasing levels of serotonin and norepinephrine in the brain.
Venlafaxine Hexal is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorder: 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 Hexal may also be approved to treat other conditions not mentioned in this product information. 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 Hexal
Do not take Venlafaxine Hexal:
- 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 other medicines, including Venlafaxine Hexal, can cause serious or even life-threatening side effects. In addition, you must wait at least 7 days after you stop taking Venlafaxine Hexal before taking an MAO inhibitor (see also the section “Other medicines and Venlafaxine Hexal” and the subsection “Serotonergic syndrome”).
Warnings and precautions
Talk to your doctor or pharmacist before using Venlafaxine Hexal.
- if you use other medicines which, if taken together with Venlafaxine Hexal, can increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine Hexal.”)
- 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 a history of bleeding disorders), or if you take other medicines that may increase the risk of bleeding (eg 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 Hexal 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.
Medicines such as Venlafaxine Hexal (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.
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 Hexal 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 caries (cavities in the teeth). You should therefore be extra careful with dental hygiene.
Diabetes
Venlafaxine Hexal can change your blood sugar levels. The dose of your diabetes medication may therefore need to be adjusted.
Children and young people
Venlafaxine Hexal 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 the doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age taking Venlafaxine Hexal. 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 Hexal
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 Hexal together with other medicines.
- Monoamine oxidase inhibitors, which are used to treat depression or Parkinson’s disease, must not be used together with Venlafaxine Hexal. 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 taking Venlafaxine Hexal”).
- Serotonergic syndrome: A potentially life-threatening condition or reactions 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 migraines )
- other medicines to treat depression, such as 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 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)
- 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 (determined by blood tests).
Tell your doctor immediately, or go to the nearest emergency room, if you think you have serotonin syndrome.
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 or 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 Hexal 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 Hexal with food, drink, and alcohol
Venlafaxine Hexal should be taken with a meal (see section 3 “How to take Venlafaxine Hexal”).
Avoid alcohol while taking Venlafaxine Hexal.
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 Hexal 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 Hexal. 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 Hexal 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 Hexal so that they can advise you about this.
Venlafaxine Hexal 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 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 Hexal hard prolonged-release capsules contain sodium, sucrose, and azo dyes
This medicine contains less than 1 mmol (23 mg) of sodium per hard prolonged-release capsule , i.e. it is almost “sodium-free”.
If you have an intolerance to certain sugars, you should consult your doctor before taking this medicine.
This medicine contains azo dyes nycoccin which can cause allergic reactions.
How to take Venlafaxine Hexal
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 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 Hexal 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 Hexal 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 Hexal”).
If you have taken too much Venlafaxine Hexal
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 Hexal
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 Hexal that you have been prescribed per day.
If you stop taking Venlafaxine Hexal
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 Venlafaxine Hexal, 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 Venlafaxine Hexal, especially if you stop taking Venlafaxine Hexal 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 Hexal. 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 any further questions about this medicine, ask 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 Hexal. Tell the doctor immediately, or visit the nearest emergency department :
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 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 (determined by blood tests). - signs of infection, eg fever, chills, chills, headache, sweating, flu-like symptoms. This may be due to a blood disorder that causes an increased risk of infection.
- severe rash that can cause severe blistering and scaly skin
- unexplained muscle pain, tenderness, 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 listed in the “Other side effects that may occur”):
- cough, wheezing, and shortness of breath, which may occur together with fever
- black (tarry) stools or blood in the stools
- itching, yellowish skin or yellow eyes, 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, such as dizziness, tingling and numbness, movement disorder (muscle spasms or stiffness), seizures
- psychological problems, such as hyperactivity and feelings of elation
- withdrawal symptoms (see section 3 “How to take Venlafaxine Hexal”, subsection “If you stop taking Venlafaxine Hexal”)
- 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 balls or grains in your stool after taking this medicine. Inside the Venlafaxin Hexal prolonged-release 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 is removed 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
- sweating (even at night).
Common (may affect up to 1 in 10 users)
- loss of appetite
- confusion, feeling detached from oneself, lack of orgasm, decreased libido, 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 including blurred vision, dilated pupils, and inability of the eye to automatically change focus from distant to near objects
- ringing in the ears ( tinnitus )
- fast heartbeat, palpitations
- increased blood pressure, flushing
- shortness of breath, yawning
- vomiting, diarrhea
- light skin rash, itching
- need to urinate more often than usual, inability to urinate, difficulty urinating
- irregular periods such as increased bleeding or more irregular bleeding, abnormal ejaculation/orgasm (in 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
- feeling dizzy (especially if you get 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
- 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)
- convulsions
- cough, wheezing, and shortness of breath, which may occur together 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 reduced 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 time which 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 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 Hexal).
- 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 affect 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 samples from time to time, especially if you have been taking Venlafaxine Hexal for a long time.
How to store Venlafaxine Hexal
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton and the blister card/can 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 hard prolonged-release capsule contains venlafaxine hydrochloride equivalent to 37.5 mg of venlafaxine.
- Other ingredients are sugar spheres (contains sucrose and corn starch), hydroxypropyl cellulose, hypromellose (E464), talc (E553b), ethyl cellulose (E462), dibutyl sebacate, oleic acid, colloidal anhydrous silica in pellet core; gelatin, sodium lauryl sulfate, nycoccin (E124), quinoline yellow (E104), titanium dioxide (E171) in the capsule shell.
Appearance and package sizes of the medicine
White to off-white granules in a hard prolonged-release capsule ‘size 3’ with an orange top and a transparent bottom.
Venlafaxine Hexal 37.5 mg prolonged-release hard capsules are available in the following pack sizes:
PVC/Aluminium blisters: 7, 20, 28, 30, 50, 56, 98, 100 and 112 hard prolonged-release capsules.
HDPE jar with HDPE screw cap and bag of silica gel (desiccant): 50 and 100 hard prolonged-release capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
HEXAL A/S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Dragenopharm Apotheker Püschl GmbH, Göllstrasse 1, 84529 Tittmoning, Germany
or
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
Lek Pharmaceuticals dd, Trimline 2 D, 9220 Lendava, Slovenia