Package Leaflet: Information for the User

venlafaxine prolonged-release hard capsules 75 mg cinfamedEFG

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4

venlafaxina retardcinfamedis 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 noradrenaline in the brain. The exact mechanism of how antidepressants work is not fully understood, but they may help increase the levels of serotonin and noradrenaline in the brain.

venlafaxina retardcinfamedis a treatment for adults with depression. It is also a treatment foradults 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 venlafaxine retard cinfamed

• If you are allergic to venlafaxine or any of the other ingredients in 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 other medicines, such as venlafaxine, may cause serious or potentially life-threatening side effects. You must wait at least 7 days after stopping venlafaxine before taking any IMAO (see also the sections "Serotonin syndrome" and "Other medicines and venlafaxine retard cinfamed").

Warnings and precautions

Consult your doctor or pharmacist before starting to take venlafaxine retard cinfamed

• If you are taking other medicines that may increase the risk of developing serotonin syndrome (see the section "Other medicines and venlafaxine retard cinfamed").
• 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 told that your heart rhythm is abnormal.
• 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 bleeding or bruising easily (history of bleeding disorders), or if you are taking other medicines that may increase the risk of bleeding, such as warfarin (used to prevent blood clots), or if you are pregnant (see "Pregnancy and breastfeeding").
• If you have a history of mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

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

Venlafaxine may cause restlessness or difficulty sitting or staying still during the first few weeks of treatment. You should consult your doctor if this happens.

Do not drink alcohol during treatment with venlafaxine retard cinfamed, as it may cause extreme drowsiness 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. This may increase when starting to take antidepressants, as 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 venlafaxine.

This is more likely to happen:

• If you have had previous thoughts of suicide or self-harm.
• 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.

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

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.

Children and adolescents

Venlafaxine should not be used normally in the treatment of children and adolescents under 18 years old. You should also know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal thoughts, suicidal behavior, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, your doctor may prescribe this medicine to patients under 18 years old if they decide it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years old and you want 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. Additionally, the long-term safety in relation to growth, maturation, and cognitive and behavioral development has not been demonstrated.

Other medicines and venlafaxine retard cinfamed

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 available over the counter, natural remedies, and herbal remedies, without checking with your doctor or pharmacist.

• Irreversible monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be taken with venlafaxine. Tell your doctor if you have taken any of these medicines in the last 14 days (IMAO: see section "What you need to know before starting to take venlafaxine retard cinfamed").
• Serotonin syndrome:

A potentially life-threatening state or reactions similar to Neuroleptic Malignant Syndrome (NMS) (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, ISRN, ISRS, 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 moclobemide, an irreversible MAO-A 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 known as Hypericum perforatum, a natural remedy or herbal remedy used to treat mild depression),
• Products 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 do not exist, false beliefs, unusual suspicion, unclear thinking, and tendency to withdraw).

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 Neuroleptic Malignant Syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).

Inform your doctor immediately or go to the nearest hospital emergency department 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 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 conditions).
• Metoprolol (a beta-blocker used to treat high blood pressure and heart problems).

Taking venlafaxine retard cinfamed with food, drinks, and alcohol

Venlafaxine should be taken with food (see section 3).

Do not drink alcohol during treatment with venlafaxine retard cinfamed. Taking it with alcohol may cause extreme drowsiness 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 know that you are taking venlafaxine. When taken during pregnancy, similar medicines (ISRS) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

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

If you take venlafaxine retard in the final stages of pregnancy, there may be an increased 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 venlafaxine so they 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 you should stop breastfeeding or stop taking this medicine.

Driving and using machines

During treatment with venlafaxine, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how venlafaxine affects you.

venlafaxine retard cinfamed contains saccharose.

This medicine contains saccharose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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.

Take venlafaxine approximately at the same time every day, either in the morning or at night. The capsules must be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

Venlafaxine should be taken with food.

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

Do not stop taking this medication without consulting your doctor (see section "If you interrupt treatment with venlafaxine retard cinfamed").

If you take more venlafaxine retard cinfamed than you should

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

Overdose can put your life in danger, especially with the simultaneous taking of certain medications and/or alcohol (see Taking venlafaxine retard cinfamed with other medications).

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

If you forgot to take venlafaxine retard cinfamed

If you have not taken a dose, 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 venlafaxine prescribed to you in a day.

If you interrupt treatment with venlafaxine retard cinfamed

Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor thinks you no longer need venlafaxine, 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 assuicidal thoughts, aggression,fatigue, dizziness, instability, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, ringing in the ears, 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 headache, dizziness, ringing in the ears, sweating, etc.).

Your doctor will advise you on how to gradually stop treatment with venlafaxine. 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 advice.

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

Like all medications, this medication may cause side effects, although not everyone will experience them.

If any of the following effects occur, do not take more venlafaxine.Inform your doctor immediately, or go to the nearest hospital emergency room:

Rare (may affect up to 1 in 100 patients)

• 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 patients)

• Pressure in the chest, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching, or urticaria (raised, red, or pale areas of skin that often itch).
• Signs and symptoms of serotonin syndrome, which may include agitation, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, and vomiting.
• In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). NMS symptoms may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (determined by blood tests).
• Signs of infection, such as increased temperature, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that may increase the risk of infection.
• Severe rash, which may lead to the formation of severe blisters and skin peeling.
• Muscle pain, aches, or weakness. This may be a sign of rhabdomyolysis.

Unknown frequency (cannot be estimated from available data)

• Signs and symptoms of a condition called "stress cardiomyopathy" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeat.

Other side effects that you should inform your doctor are (the frequency of these side effects are included in the lower list "Other side effects"):

• Cough, wheezing, and difficulty breathing that may be accompanied by an increased temperature.
• Stool (deposits) that are tar-like or blood in stool.
• Itching, yellow eyes or skin, dark urine, which are 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 (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take venlafaxine retard cinfamed. If you interrupt treatment with venlafaxine retard cinfamed").
• Prolonged bleeding, if you cut or get a wound, it may take a little longer than usual for bleeding to stop.

Do not worry if you observe small white grains or beads in your stool after taking this medication. Inside the venlafaxine capsules, there are spheres or small white beads that contain the active ingredient (venlafaxine). These spheres are released from the capsule in the stomach. As they circulatethroughthestomach and intestines, venlafaxina is releasedcompletely. The "shell" of the spheredoes not dissolveand isimine in the stool. Therefore, although you seespheres inthestool,thedissolution of the medicationhas beenabsorbed.

Other side effects that may occur:

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

• Dizziness, headache, somnolence.
• Insomnia.
• Nausea, dry mouth, constipation.
• Excessive sweating (including nocturnal sweating).

Common (may affect up to 1 in 10 patients)

• Decreased appetite.
• Confusion, feeling strange, 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 change focus from distant to near objects.
• Tinnitus (ringing in the ears).
• Rapid heartbeat, palpitations.
• Increased blood pressure, hot flashes.
• Difficulty breathing, yawning.
• Vomiting, diarrhea.
• Mild skin rash, itching.
• Increased 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 patients)

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

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

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

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

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

Unknown frequency (cannot be estimated from available data)

• Suicidal ideation and behavior; cases of suicidal ideation and behavior have been reported during treatment with venlafaxine or shortly after discontinuation of treatment (see section 2. "What you need to know before starting to take venlafaxine retard cinfamed").
• Aggression.
• Dizziness.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

Venlafaxine may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; mild changes in liver enzyme levels, sodium, or cholesterol. Less frequently, venlafaxine may reduce the function of platelets in the blood, leading to an increased risk of petechiae or bleeding. Therefore, 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 Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

Store below 30°C.

Store in a dry place.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of venlafaxine retard cinfamed

• The active ingredient isvenlafaxine (as hydrochloride). Each capsule contains75 mg of venlafaxine (as venlafaxine hydrochloride).
• The other components aresugar spheres 20 (saccharose and cornstarch), stearic acid, ethylcellulose, and talc. The capsule components are: gelatin and titanium dioxide (E-171)

Appearance of the product and contents of the package

venlafaxine retard cinfamed is presented in the form of hard, prolonged-release capsules. The capsules with a cap and a white opaque body are made of hard gelatin and contain white or off-white pellets.

venlafaxine retard cinfamed is presented in Al/PVDC-PVC/PVDC blisters.

Each package contains 30 or 500 (clinical package) hard, prolonged-release capsules.

Only some package sizes may be commercially available

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Farmalider S.A.

Aragoneses, 2

28108 (Alcobendas) Madrid

Spain

Or

StarpharmaLtd.

Industrial State

Half Far - Malta

Or

VALPHARMA INTERNATIONAL S.p.A.

Via G. Morgagni, 2

61016 Pennabilli (Pesaro-Urbino)

Italy

Or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10.

Areta Industrial Estate

31620 Huarte (Navarra) - Spain

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/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/69162/P_69162.html

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