Prospect: information for the user

Venlafaxine Extended-Release Davurgama 75 mg hard capsules

Read this entire prospect carefully before starting to take this medication,because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribedonlyto you and should not be given to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

Content of the prospect

This medication contains the active ingredient venlafaxine.

Venlafaxine is an antidepressant that belongs to a group of medications called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medications is used to treat depression and other conditions such as anxiety disorders. It is believed that people who are depressed and/or experience anxiety have lower levels of serotonin and norepinephrine in the brain. The exact mechanism of how antidepressants work is not fully understood, but they may help increase the levels of serotonin and norepinephrine in the brain.

Venlafaxina Retard Davurgama is a treatment for adults with depression. It is also a treatment for adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), panic disorder (panic attacks). Treating depressive and anxiety disorders properly is important to help you feel better. If left untreated, your condition may not go away or may worsen and become more difficult to treat.

Do not take Venlafaxina Retard Davurgama

• 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 have taken in the last 14 days, any medicine known as an irreversible monoamine oxidase inhibitor (IMAO), used to treat depression or Parkinson's disease. Taking an IMAO irreversible with venlafaxine may cause severe or potentially fatal side effects. Also, you should wait at least 7 days after stopping venlafaxine before taking any IMAO irreversible (see also the section “Other medicines and Venlafaxina Retard Davurgama” and the information in that section on “Serotonin syndrome”).

Warnings and precautions

Consult your doctor before starting to take Venlafaxina Retard Davurgama:

• If you are taking other medicines that taken with venlafaxine may increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxina Retard Davurgama”)
• If you have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• If you have a history of high blood pressure.
• If you have a history of heart problems
• If you have been informed that your heart rhythm is altered.
• If you have a history of seizures (convulsions)
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a tendency to develop cardenals or a tendency to bleed easily (history of bleeding disorders), if you are taking other medicines that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots), or if you are pregnant.
• If you have a history of, or if someone in your family has had, mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

This medicine may cause a feeling of restlessness or difficulty sitting or staying still during the first weeks of treatment. You should consult your doctor if this happens.

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme fatigue and unconsciousness. Taking it with certain medicines and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.

Thoughts of suicide and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when you start taking antidepressants, because all these medicines take time to work, usually two weeks but sometimes longer. These thoughts may also occur when your dose is reduced or during the interruption of treatment with venlafaxina.

It is more likely to happen:

• If you have had thoughts of suicide or self-harm before.
• If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (less than 25 years old) with psychiatric illnesses treated with antidepressants.

Immediately contact your doctor or go to the nearest hospital if you have thoughts of harming yourself or committing suicide at any time.

You may find it helpful to tell a close family member or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.

Dry mouth

Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should take good care of your dental hygiene.

Diabetes

Your blood glucose levels may be affected by venlafaxine. Therefore, your doses of diabetes medicines may need to be adjusted.

Sexual problems

Some medicines in the group to which venlafaxine belongs (IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Beads in chains

Do not worry if you see small white grains or beads in your stools after taking this medicine. Inside the capsules of Venlafaxina Retard Davurgama there are beads (small white beads) that contain the active ingredient (venlafaxine). These beads are released from the capsule in the stomach. As they travel through the stomach and intestines, venlafaxine is released slowly. The “shell” of the bead remains undissolved and is eliminated in the stools. Therefore, although you may see beads in your stools, your dose of medicine has been absorbed.

Children and adolescents

This medicine should not be used normally in the treatment of children and adolescents under 18 years old. Also, you should know that in patients under 18 years old there is a higher risk of side effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, the doctor who prescribes it may prescribe it to patients under 18 years old when they decide it is the best option for the patient. If the doctor who prescribes it has prescribed it to a patient under 18 years old and wants to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years old who are taking venlafaxine. Also, the long-term effects on safety, growth, maturity, and cognitive and behavioral development of this medicine in this age group have not yet been demonstrated.

Other medicines and Venlafaxina Retard Davurgama

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

Your doctor must decide if you can take venlafaxine with other medicines.

Do not start or stop taking any medicine, including those sold without a prescription, natural remedies, and herbal remedies, before checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with this medicine. Tell your doctor if you have taken any of these medicines in the last 14 days. (IMAO: see section “Do not take Venlafaxina Retard Davurgama”)
• Serotonin syndrome:

A potentially fatal or reactions similar to Malignant Neuroleptic Syndrome (MNS) (see section “Possible side effects”), may occur with treatment with venlafaxine, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraines)
• Other medicines to treat depression, for example, IRSNs, ISRSs, tricyclic antidepressants, or medicines containing lithium
• Medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy, and obesity)
• Medicines containing the antibiotic linezolid (used to treat infections)
• Medicines containing moclobemida, an IMAO (used to treat depression)
• Medicines containing sibutramine (used for weight loss)
• Medicines containing tramadol, fentanil, 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 to treat severe pain) and buprenorphine
• Medicines containing methylene blue (used to treat high levels of methemoglobin in the blood)
• Medicines containing St. John's Wort (also known as Hypericum perforatum, a natural remedy or herbal remedy used to treat mild depression)
• Medicines containing tryptophan (used for problems such as sleep and depression).
• Antipsychotics (used to treat illnesses with symptoms such as hearing, seeing, or feeling things that are not there, false beliefs, unusual suspicion, unclear thinking, and becoming withdrawn)

The 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, hyperactive reflexes, diarrhea, coma, nausea, vomiting.

In its most severe form, serotonin syndrome may resemble Malignant Neuroleptic Syndrome (MNS). The signs and symptoms of MNS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by blood test).

Inform your doctor immediately or go to the nearest hospital if you think you are experiencing serotonin syndrome.

Inform your doctor if you are taking medicines that may affect your heart rhythm.

Some examples of these medicines include:

• Antiarrhythmics such as quinidine, amiodarone, sotalol, or dofetilide (used to treat abnormal heart rhythm)
• Antipsychotics such as thioridazine (see also Serotonin syndrome above)
• Antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
• Antihistamines (used to treat allergies).

The following medicines may also interact with venlafaxine and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medicines that contain:

• Ketoconazole (an antifungal medicine)
• Haloperidol or risperidone (for treating psychiatric states)
• Metoprolol (a beta-blocker for treating high blood pressure and heart problems)

Taking Venlafaxina Retard Davurgama with alcohol

Do not drink alcohol during treatment with venlafaxine. Taking it with alcohol may cause extreme fatigue and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. You should only take venlafaxine after discussing the possible benefits and risks for the unborn baby with your doctor.

Make sure your midwife and/or doctor knows that you are taking venlafaxine. When taken during pregnancy, similar medicines (ISRs) may increase the risk of a serious illness in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take this medicine in the final stages of pregnancy, there may be a higher risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking venlafaxina to be able to advise you.

If you are taking this medicine during pregnancy, in addition to breathing problems, other symptoms that your baby may have when born include feeding problems. If your baby has these symptoms when born and you are concerned, contact your doctor and/or midwife who can advise you.

Venlafaxine passes into breast milk. There is a risk of an effect on the baby. Therefore, you should discuss the case with your doctor and they will decide whether to stop breastfeeding or stop taking this medicine.

Driving and operating machines

Do not drive or operate tools or machines until you know how this medicine affects you.

Venlafaxina Retard Davurgama contains saccharose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The usual initial dose recommended for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may increase the dose gradually and if necessary, even more up to a maximum of 375 mg per day for depression. If you are being treated for panic disorder, your doctor will start with a lower dose (37.5 mg) and then increase the dose gradually. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Venlafaxina Retard Davurgama is for oral use.

Take this medication approximately at the same time every day, either in the morning or at night. To ensure complete swallowing of the granules (spheres within the capsules), the capsules must be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

This medication should be taken with food. For safety reasons, it is essential to take this medication within 30 minutes after a meal.

If you have liver or kidney problems, talk to your doctor as your dose of this medication may need to be different.

If you take more Venlafaxina Retard Davurgama than you should

Call your doctor or pharmacist immediately if you take more of this medication than prescribed by your doctor.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

Overdose can put your life at risk, especially with the simultaneous taking of certain medications and/or alcohol (see "Taking Venlafaxina Retard Davurgama with other medications").

The symptoms of a possible overdose may include palpitations, changes in alertness level (ranging from drowsiness to coma), blurred vision, seizures, or attacks, and vomiting.

If you forgot to take Venlafaxina Retard Davurgama

If a dose has not been taken, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only one dose as usual. Do not take a double dose to compensate for the missed doses. Do not take more than the daily dose of this medication that you have been prescribed in a day.

If you interrupt treatment with Venlafaxina Retard Davurgama

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor believes you no longer need Venlafaxina Retard Davurgama, they may ask you to reduce the dose gradually before stopping treatment completely. It is known that adverse effects occur when people stop using this medication, especially when it is stopped suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling, or, in rare cases, electric shock sensations, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headaches, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with this medication. This may take several weeks or months. In some patients, the interruption may need to be produced very gradually over months or more. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If any of the following side effects occur, do not take this medicine.Inform your doctor immediately, or go to the nearest hospital emergency department:

Rare (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands, or feet, and/or itchy, swollen, and inflamed skin, difficulty swallowing or breathing.

Uncommon (may affect up to 1 in 1,000 people)

• Chest tightness, wheezing, difficulty swallowing or breathing
• Severe skin rash, itching, or urticaria (raised, red, or pale areas of skin that often itch)
• The symptoms of serotonin syndrome may include restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, exaggerated reflexes, diarrhea, coma, nausea, and vomiting.

In its most severe form, serotonin syndrome can resemble Neuroleptic Malignant Syndrome (NMS). The symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and elevated muscle enzymes (determined by blood tests)

• Symptoms of infection, such as fever, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can increase the risk of infection
• Severe skin rash that can lead to the formation of severe blisters and skin peeling
• Unexplained muscle pain, discomfort, or weakness. This may be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated from available data)

• Symptoms of so-called "stress cardiomyopathy" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

Other side effects that you must inform your doctor are (the frequency of these side effects are included in the list below "Other side effects that may occur"):

• Coughing, wheezing, difficulty breathing that may be accompanied by a high temperature
• Black stools or blood in the stool
• Yellow skin or eyes, dark urine, which may be symptoms of liver inflammation (hepatitis)

• Heart problems, such as rapid or irregular heartbeat, increased blood pressure.
• Eye problems, such as blurred vision, dilated pupils.
• Nervous system problems: such as dizziness, numbness, movement disorders (muscle spasms and rigidity), seizures, or attacks
• Psychiatric problems, such as hyperactivity and unusual feelings of overexcitement
• Withdrawal effects (see section "How to take Venlafaxine Retard Davurgama, If you interrupt treatment with Venlafaxine Retard Davurgama").
• Prolonged bleeding – if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop

Other side effects that may occur

Very common (may affect more than 1 in 10 people)

• Dizziness, headache, drowsiness
• Insomnia
• Nausea, dry mouth, constipation
• Sweating (including night sweats)

Common (may affect up to 1 in 10 people)

• Loss of appetite
• Confusion, feeling disconnected (or detached) from oneself, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams
• Tremor, a feeling of restlessness or inability to sit or stay still, numbness, altered taste perception, increased muscle tone
• Visual disturbances, including blurred vision, dilated pupils, inability of the eye to automatically focus on distant objects
• Ringling in the ears (tinnitus)
• Rapid heartbeat, palpitations
• Increased blood pressure, hot flashes
• Difficulty breathing, yawning
• Vomiting, diarrhea
• Mild skin rash, itching
• Increased frequency of urination, inability to urinate, difficulty urinating
• Irregular menstrual periods, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence)
• Weakness (asthenia), fatigue, chills
• Weight gain or loss
• Increased cholesterol

Rare (may affect up to 1 in 100 people)

• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).
• Hallucinations, feeling disconnected (or detached) from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited; grinding of the teeth
• Fainting, involuntary muscle movements, altered coordination and balance
• Feeling dizzy (especially when standing up too quickly), decreased blood pressure
• Vomiting blood, black stools or blood in the stool, which may be a sign of internal bleeding
• Sensitivity to sunlight, bruises, abnormal hair loss
• Inability to control urination
• Rigidity, spasms, and involuntary muscle movements
• Mild changes in liver enzyme levels in the blood

Rare (may affect up to 1 in 1,000 people)

• Seizures or attacks
• Coughing, wheezing, and shortness of breath that may be accompanied by a high temperature.

• Excessive water intake (known as SIADH)
• Decreased sodium levels in the blood
• Severe eye pain and reduced or blurred vision.
• Severe abdominal or back pain (which may indicate a serious problem in the intestine, liver, or pancreas).
• Itching, yellow skin or eyes, dark urine, flu-like symptoms, which are symptoms of liver inflammation (hepatitis).
• Disorientation and confusion, often accompanied by hallucinations (delirium)
• Abnormal heartbeats, rapid or irregular heartbeat, which may lead to fainting

Very rare (may affect up to 1 in 10,000 people)

• Prolonged bleeding, which may be due to a reduced number of platelets in the blood, leading to an increased risk of cardenales or bleeding
• Abnormal milk production
• Unexpected bleeding, such as bleeding gums, blood in urine or vomit, or the appearance of unexpected bruises or broken blood vessels (veins)

Unknown frequency (cannot be estimated from available data)

• Suicidal thoughts and behavior: cases of suicidal thoughts and behavior have been reported during treatment with venlafaxine or shortly after treatment was stopped (see section 2, "What you need to know before starting to take Venlafaxine Retard Davurgama")
• Aggression
• Dizziness
• Abundant vaginal bleeding after childbirth (postpartum hemorrhage), see "Pregnancy and breastfeeding" in section 2 for more information.

This medicine may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeats; mild changes in liver enzyme levels, sodium, or cholesterol levels. Your doctor may wish to perform occasional blood tests, particularly if you have been taking venlafaxine for a long time.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use Website:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not usethis medication after the expiration date that appears on the packaging and blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Venlafaxina Retard Davurgama 75 mghard prolonged-release capsules

The active ingredient is venlafaxine.

Each prolonged-release capsule contains venlafaxine hydrochloride, equivalent to 75mg of venlafaxine.

The other components are:

Capule content:Sugar spheres (saccharose), hypromellose, ethylcellulose, talc.

Capule coating:Red iron oxide (E172), titanium dioxide (E171), gelatin.

Printing ink:Shellac, propylene glycol (E1520), strong ammonia solution (E527), black iron oxide (E172), potassium hydroxide.

Appearance of the product and contents of the packaging

Hard gelatin capsules, with a pink opaque cap and body, filled with white to beige microgranules. The capsules are marked with black ink with “VNL” on the cap and the number “75” on the body. The capsule measures approximately 20 mm x 7 mm.

Blister packs of 10, 14, 20, 28, 30, 50, 98, 100 prolonged-release hard capsules or perforated single-dose blister packs of 100x1 prolonged-release hard capsules.

Only some packaging sizes may be marketed.

Holder of the Marketing Authorization and Responsible for Manufacturing:

Holder of the marketing authorization

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid (Spain)

Responsible for manufacturing

Teva Pharma S.L.U.

C/C, n. 4, Industrial Estate Malpica

50016 Zaragoza, Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Germany:Venlafaxin AbZ 75 mg Hartkapseln, retardiert

Ireland:Venlatev 75 mg hard prolonged-release capsules

Portugal:VenlafaxinaSalipax

Last review date of this leaflet: May 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)