VENLAFAXINE Extended-Release DAVURGAMA 150 mg CAPSULES

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Venlafaxine Retard Davurgama and what is it used for
2. What you need to know before you take Venlafaxine Retard Davurgama
3. How to take Venlafaxine Retard Davurgama
4. Possible side effects
5. Storing Venlafaxine Retard Davurgama
6. Contents of the pack and other information

1. What is Venlafaxine Retard Davurgama and what is it used for

This medicine contains the active substance venlafaxine.

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

Venlafaxine 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 disappear or may become worse and more difficult to treat.

2. What you need to know before you take Venlafaxine Retard Davurgama

Do not take Venlafaxine 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 within the last 14 days, any medicines known as irreversible monoamine oxidase inhibitors (MAOIs), used to treat depression or Parkinson’s disease. Taking an irreversible MAOI with venlafaxine can cause serious side effects or even be life-threatening. Also, you must wait at least 7 days after stopping venlafaxine before taking any irreversible MAOI (see also section “Other medicines and Venlafaxine Retard Davurgama” and the information in that section on “Serotonin syndrome”).

Warnings and precautions

Consult your doctor before starting to take Venlafaxine Retard Davurgama:

• If you are taking other medicines that, when taken with venlafaxine, could increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine 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 told you have an irregular heart rhythm.
• If you have a history of seizures (fits).
• If you have a history of low sodium levels in your blood (hyponatremia).
• If you have a tendency to develop bruises or have a tendency to bleed easily (a history of bleeding disorders), if you are using 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 a family member has had, mania or bipolar disorder (feeling overexcited or elated).
• If you have a history of aggressive behavior.

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

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

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or suicide. These thoughts may be more frequent when you first start taking antidepressants, because all these medicines take time to work, usually around 2 weeks, but sometimes longer. These thoughts also occur when your dose is reduced or when you stop taking venlafaxine.

This is more likely to happen:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (less than 25 years of age) with psychiatric conditions who were treated with antidepressant medicines.

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

You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried 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 (caries). Therefore, you should be careful with your dental hygiene.

Diabetes

Your blood sugar levels may be altered by venlafaxine. Therefore, the doses of your diabetes medicines may need to be adjusted.

Sexual problems

Some medicines of the same group as venlafaxine (SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.

Spheroids in faeces

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

Children and adolescents

This medicine should not normally be used in the treatment of children and adolescents under 18 years of age. Additionally, you should know that in patients under 18 years of age, there is an increased risk of side effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this class of medicines. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age when he decides that it is the most suitable treatment for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor. You should inform your doctor if any of the above symptoms develop or worsen when these patients under 18 years of age are taking venlafaxine. Additionally, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of this medicine in this age group have not yet been demonstrated.

Other medicines and Venlafaxine Retard Davurgama

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

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

Do not start or stop taking any medicines, including those bought without a prescription, herbal or homeopathic remedies, before checking with your doctor or pharmacist.

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

A potentially life-threatening or reaction-like Neuroleptic Malignant Syndrome (NMS) (see section “Possible side effects”), may occur with venlafaxine treatment, particularly when taken with other medicines.

Examples of these medicines include:

• Triptans (used for migraine)
• Other medicines for treating depression, for example, SNRIs, SSRIs, 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 MAOI (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 coughs)
• Medicines containing methadone (used for opioid addiction treatment or for severe pain treatment) and buprenorphine
• Medicines containing methylthioninium chloride (methylene blue) (used to treat high levels of methemoglobin in the blood)
• Medicines containing St. John’s Wort (also known as Hypericum perforatum, a herbal or homeopathic remedy used to treat mild depression)
• Medicines containing tryptophan (used for problems such as sleep and depression)
• Antipsychotics (used to treat a disease with symptoms such as hearing, seeing, or feeling things that are not there, mistaken beliefs, unusual suspicion, unclear reasoning, 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, overactive reflexes, diarrhea, coma, nausea, vomiting.

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

Tell your doctor immediately or go to the casualty department of the nearest hospital if you think you are experiencing serotonin syndrome.

Tell 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 irregular heartbeat)
• 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 containing:

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

Taking Venlafaxine Retard Davurgama with alcohol

Do not drink alcohol while taking venlafaxine. Taking it with alcohol may cause extreme drowsiness and unconsciousness, and worsen symptoms of depression and other conditions, such as anxiety disorders.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should only take venlafaxine after discussing the potential benefits and risks with your doctor.

Make sure your midwife and/or doctor knows you are taking Venlafaxine Retard Davurgama. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in babies called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and/or doctor immediately.

If you take this medicine in the last few months of pregnancy, there may be an increased risk of bleeding in the womb, especially if you have a history of bleeding disorders. Your doctor or midwife should know you are taking Venlafaxine Retard Davurgama so they can advise you.

If you are taking this medicine during pregnancy, in addition to breathing problems, other symptoms your baby may have when born are 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 this with your doctor, and he will decide whether you should stop breast-feeding or stop taking this medicine.

Driving and using machines

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

Venlafaxine Retard Davurgama contains sucrose

If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to take Venlafaxine Retard Davurgama

Follow exactly the instructions for administration of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The usual recommended starting dose for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may gradually increase the dose, and if necessary, 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 gradually increase the dose. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.

Venlafaxine Retard Davurgama is for oral use.

Take this medicine at approximately the same time each day, either in the morning or in the evening. To ensure the complete swallowing of the pellets (spheroids inside the capsules), the capsules should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.

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

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

If you take more Venlafaxine Retard Davurgama than you should

Contact your doctor or pharmacist immediately if you take more of this medicine than prescribed by your doctor.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or contact the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

Overdose can put your life in danger, especially when taken with certain medicines and/or alcohol (see “Taking Venlafaxine Retard Davurgama with other medicines”).

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

If you forget to take Venlafaxine Retard Davurgama

If you miss a dose, take it as soon as you remember. However, if it is already the time for your next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for missed doses. Do not take more than the prescribed daily dose of this medicine in one day.

If you stop treatment with Venlafaxine Retard Davurgama

Do not stop taking your treatment or reduce the dose without your doctor's advice, even if you feel better. If your doctor believes you no longer need Venlafaxine Retard Davurgama, they may ask you to gradually reduce the dose before completely stopping treatment. It is known that adverse effects occur when people stop using this medication, especially when stopped suddenly or if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal 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, sensations of electric shock, weakness, sweating, seizures, or flu-like symptoms, 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 this medication. This may take several weeks or months. In some patients, the discontinuation may need to occur 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 questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

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

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

Uncommon (may affect up to 1 in 100 people)

• Swelling of the face, mouth, tongue, throat, hands, or feet, and/or swollen rash with itching, difficulty swallowing or breathing.

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

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Severe skin rash, itching, or urticaria (elevated areas of red or pale skin, which often itch) severe.
• Signs and 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 signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, elevated muscle enzymes (determined by a blood test)

• Signs of infection, such as increased temperature, chills, shivering, headache, sweating, or flu-like symptoms. This may be due to a blood disorder that can lead to an increased risk of infection.
• Severe 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.

Frequency not known (cannot be estimated from available data)

• Signs and symptoms of so-called "stress cardiomyopathy" which may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

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

• Cough, breathing noise, difficulty breathing that may be accompanied by elevated temperature.
• Black stools (tarry) or blood in stools.
• 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, tingling, movement disorder (muscle spasms and stiffness), seizures, or attacks.
• Psychiatric problems, such as hyperactivity and feeling of unusual overexcitement.
• Withdrawal effects (see section "How to take Venlafaxine Retard Davurgama, If you stop treatment with Venlafaxine Retard Davurgama").
• Prolonged bleeding – if you cut yourself or get injured, 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)

• Decreased appetite.
• Confusion, feeling detached (or disconnected) from oneself, lack of orgasm, decreased libido, agitation, nervousness, abnormal dreams.
• Tremors, a feeling of restlessness or inability to sit still or stay quiet, tingling, 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.
• Ringing 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.
• Menstrual irregularities, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (men), erectile dysfunction (impotence).
• Weakness (asthenia), fatigue, chills.
• Weight gain or loss.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 people)

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

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

• Seizures or attacks.
• Cough, breathing noise, and shortness of breath that may be accompanied by 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, yellowing of the eyes or skin, dark urine, flu-like symptoms, which are symptoms of liver inflammation (hepatitis).
• Disorientation and confusion often accompanied by hallucinations (delirium).
• Abnormal heartbeat, rapid or irregular, which can 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 bruising or bleeding.
• Abnormal production of breast milk.
• Unexpected bleeding, for example, bleeding gums, blood in urine or vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins).

Frequency not known (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 taking Venlafaxine Retard Davurgama").
• Aggression.
• Dizziness.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy and lactation" in section 2 for more information.

This medication sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; mild changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, venlafaxine may reduce the function of blood platelets, leading to an increased risk of bruising or bleeding. Therefore, your doctor may want to perform occasional blood tests, especially if you have been taking venlafaxine for a long time.

Reporting side effects

If you experience any side effects, 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 Pharmacovigilance System for Human Use Website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Venlafaxine Retard Davurgama

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging and blister after CAD. The expiration date is the last day of the month indicated.

Store below 30°C.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Venlafaxine Retard Davurgama 150 mg hard prolonged-release capsules

The active ingredient is venlafaxine.

Each prolonged-release capsule contains venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine.

The other ingredients are:

Capsule content:Sugar spheres (sucrose and cornstarch), hypromellose, ethylcellulose, talc.

Capsule shell:Yellow iron oxide (E172), titanium dioxide (E171), gelatin, red iron oxide (E172).

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

Appearance of the product and package contents

Hard gelatin capsules, with a brown 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 "150" on the body. The capsule measures approximately 16 mm x 6 mm.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura, 11, Edificio Albatros B, 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer

Teva Pharma S.L.U.

C/C, n. 4, Polígono Industrial Malpica

50016 Zaragoza, Spain

This medication is authorized in the Member States of the European Economic Area under the following names:

Germany: Venlafaxin AbZ 150 mg Hartkapseln, retardiert

Ireland: Venlatev 150 mg hard prolonged-release capsules

Portugal: Venlafaxina Salipax

Date of the last revision of this leaflet: May 2023

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