VENLAFAXINE RETARD FARMALIDER 75 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Retard Farmalider 75 mg prolonged-release hard capsules

Venlafaxine

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

• 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 and other information

1. What is Venlafaxine Retard Farmalider and what is it used for
2. What you need to know before you take Venlafaxine Retard Farmalider
3. How to take Venlafaxine Retard Farmalider
4. Possible side effects
5. Storing Venlafaxine Retard Farmalider

Contents of the pack and further information

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

Venlafaxine Retard Farmalider 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 noradrenaline in the brain. It is not fully understood how antidepressants work, but they may help to increase the levels of serotonin and noradrenaline in the brain.

Venlafaxine Retard Farmalider 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 adequately is important to help you feel better. If left untreated, your condition may not improve or may get worse and become more difficult to treat.

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

Do not take Venlafaxine Retard Farmalider:

• 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 or even life-threatening side effects. Also, you must wait at least 7 days after stopping venlafaxine before taking any MAOI (see also section “Using other medicines” and the information in that section on “Serotonin Syndrome”).

Warnings and precautionsConsult your doctor or pharmacist before starting to take Venlafaxine Retard Farmalider If any of the following conditions apply to you, tell your doctor beforetaking venlafaxine:

• If you are using other medicines that, when taken with venlafaxine, could increase the risk of developing serotonin syndrome (see section “Using other medicines”).
• 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 (fits).
• If you have a history of low sodium levels in the blood (hyponatremia).
• If you have a tendency to develop bruises or tend to bleed easily (history of bleeding disorders), or 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 (see “Pregnancy”)
• If you have a history of or if someone in your family has had mania or bipolar disorder (feeling overexcited or elated).
• If you have a history of aggressive behavior.

Pregnancy

If you take Venlafaxine Retard Farmalider in the last few months of your pregnancy, you may experience an increased risk of heavy vaginal bleeding after giving birth, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Venlafaxine Retard Farmalider so they can advise you.

Venlafaxine 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.

Some medicines of the same group as Venlafaxine Retard Farmalider (called SSRIs/SNRIs) may cause sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

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

Thoughts of suicide 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 may increase when you first start taking antidepressants, because all these medicines take time to work, usually about two weeks, but sometimes longer.

This is more likely to happen:

• If you have previously had thoughts of suicide or self-harm.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

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

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

Children and adolescents

Venlafaxine should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should know that in patients under 18 years of age, there is an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontation, and irritability) when they take this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 years of age when they decide that it is the best option for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you want to discuss this, please go back to your doctor. You should tell your doctor if any of the above symptoms develop or get worse when these patients under 18 years of age are taking venlafaxine. Also, the long-term effects of this medicine on safety, growth, maturation, and cognitive and behavioral development in this age group have not been established.

Using Venlafaxine Retard Farmalider with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Your doctor will decide whether you can take Venlafaxine Retard Farmalider with other medicines.

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

• Monoamine oxidase inhibitors used to treat depression or Parkinson's disease must not be taken with venlafaxine. Tell your doctor if you have taken any of these medicines in the last 14 days. (MAOI: see section “Before taking Venlafaxine Retard Farmalider”).
• Serotonin Syndrome:

A potentially life-threatening condition, or reactions similar to 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 the antibiotic linezolid (used to treat infections)
• Medicines containing 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 to treat addiction to opiates or to treat severe pain)
• Medicines containing methylthioninium chloride (methylene blue) (used to treat high levels of methaemoglobin in the blood)
• Products containing St. John's Wort (also known as “Hypericum perforatum”, a natural remedy or herbal product 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 are not there, mistaken beliefs, unusual suspiciousness, unclear reasoning, and a 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, 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 may 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 your 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 Farmalider with food, drinks, and alcohol

Venlafaxine should be taken with food (see section 3 “How to take Venlafaxine Retard Farmalider”).

Do not drink alcohol during treatment with Venlafaxine Retard Farmalider. Taking it with alcohol may cause extreme tiredness and unconsciousness, and worsen symptoms of depression and other conditions, such as anxiety disorders.

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 taking this medicine.

Make sure your midwife and/or doctor knows you are taking venlafaxine. When taken during pregnancy, similar drugs (SSRIs) 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 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 are taking this medicine during pregnancy, other symptoms your baby may have when born are feeding problems and breathing problems. If your baby has these symptoms when born and you are worried, 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 they will decide whether you should stop breastfeeding or stop taking this medicine.

Driving and using machines

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

3. How to take Venlafaxine Retard Farmalider

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask 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. Take this medicine at approximately the same time each day, either in the morning or in the evening. The capsules should 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 you may need to take a different dose of this medicine.

Do not stop taking this medicine without talking to your doctor (see section “If you stop taking Venlafaxine Retard Farmalider”).

If you take more Venlafaxine Retard Farmalider than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call 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 Farmalider 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 Farmalider

If you miss 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 a single dose as usual. Do not take more than the daily dose of Venlafaxine Retard Farmalider that your doctor has prescribed for you in one day.

If you stop taking Venlafaxine Retard Farmalider

Do not stop taking your treatment or reduce the dose without the advice of 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 side effects occur when people stop using this medicine, especially when it is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as tiredness, dizziness, unsteadiness, 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.

Your doctor will advise you how to gradually stop taking venlafaxine. If you experience any of these or other symptoms that are troublesome, consult your doctor for further advice.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• Chest tightness, wheezing, difficulty swallowing or breathing.
• Swelling of the face, throat, hands or feet.
• Feeling nervous or anxious, dizziness, tingling sensations, sudden reddening of the skin and/or a feeling of heat.
• Severe skin rash, itching or hives (elevated areas of red or pale skin that often itch).
• Signs and symptoms of serotonin syndrome that may include agitation, 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 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, increased muscle enzymes (determined by a blood test).

Other adverse effects that you should inform your doctor aboutare:

• Cough, wheezing, shortness of breath and high temperature.
• Tarry stools (deposits) or blood in stools.
• Yellow eyes or skin, itching or 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, tingling, movement disorder, seizures or attacks.
• Psychiatric problems, such as hyperactivity and euphoria (unusual feeling of overexcitement).
• Withdrawal effects (see section "How to take Venlafaxina Retard Farmalider, If you stop treatment with Venlafaxina Retard Farmalider").
• Prolonged bleeding - if you cut yourself or get injured, it may take a little longer than usual for the bleeding to stop.

Do not worry if you notice small granules or white balls in your stool after taking this medicine. Inside the Venlafaxina Retard Farmalider capsules, there are spheroids (small white balls) that contain the active ingredient (venlafaxine). These spheroids are released from the capsule in the stomach. As they circulate through the stomach and intestines, venlafaxine is slowly released. The "shell" of the spheroid does not dissolve and is excreted in the stool. Therefore, even if you see spheroids in the stool, the dose of the medicine has been absorbed.The following adverse effects have been reported with the following frequencies:

Complete list of adverse effects

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

• Dizziness; headache.
• Nausea; dry mouth.
• Sweating (including night sweats).

Common (may affect up to 1 in 10 patients)

• Decreased appetite.
• Confusion; feeling detached (or disconnected) from oneself; lack of orgasm; decreased libido; nervousness; insomnia; abnormal dreams.
• Somnolence.
• Tremor; tingling; 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).
• Palpitations.
• Increased blood pressure; hot flashes.
• Yawning.
• Vomiting; constipation; diarrhea.
• Increased frequency of urination; difficulty urinating.
• Menstrual irregularities, such as increased bleeding or irregular bleeding; abnormal ejaculation/orgasm (men); erectile dysfunction (impotence).
• Weakness (asthenia); fatigue; chills.
• Increased cholesterol.

Uncommon (may affect up to 1 in 100 patients)

• Hallucinations; feeling detached (or disconnected) from reality; agitation; abnormal orgasm (women); lack of feelings or emotions; feeling overexcited.
• Teeth grinding.
• A feeling of restlessness or inability to stay seated or still; fainting; involuntary muscle movements; altered coordination and balance; altered taste perception.
• Rapid heartbeat; feeling dizzy (especially when getting up too quickly).
• Difficulty breathing (dyspnea).
• Vomiting blood, tarry stools (deposits) or blood in stools, which may be a sign of internal bleeding.
• Generalized skin swelling, especially the face, mouth, tongue, throat area, or hands and feet, and/or may appear as a raised rash with itching (urticaria); sensitivity to sunlight; bruising; skin rash; abnormal hair loss.
• Inability to urinate.
• Weight gain or loss.

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

• Seizures or attacks.
• Inability to control urination.
• Hyperactivity, accelerated thoughts, and decreased need for sleep (mania).

Frequency not known (cannot be estimated from available data)

• Reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding; blood disorders, which can lead to an increased risk of infection.
• Swelling of the face or tongue, shortness of breath or difficulty breathing, often with skin rashes (this can be a severe allergic reaction).
• Excessive water intake (known as SIADH).
• Decreased sodium levels in the blood.
• 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. "Before taking Venlafaxina Retard Farmalider").
• Disorientation and confusion, often accompanied by hallucinations (delirium); aggression.
• A high temperature with stiff muscles, confusion, or agitation, and sweating, or if you experience jerky muscle movements that you cannot control, may be symptoms of serious conditions known as neuroleptic malignant syndrome; euphoric feelings, somnolence, rapid sustained eye movement, clumsiness, restlessness, feeling drunk, sweating, or stiff muscles, which are symptoms of serotonin syndrome; stiffness; spasms and involuntary muscle movements.
• Severe eye pain and reduced or blurred vision.
• Dizziness.
• Decreased blood pressure; abnormal, rapid, or irregular heartbeat, which can lead to fainting; unexpected bleeding, for example, bleeding gums, blood in stools or vomit, or the appearance of unexpected bruises or broken blood vessels (broken veins).
• Cough, difficult breathing, shortness of breath, and high temperature, which are symptoms of lung inflammation associated with an increase in white blood cells (eosinophilic pneumonia).
• Severe back or abdominal 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), mild changes in blood levels of liver enzymes.
• Skin rash that can lead to severe blistering and peeling of the skin; itching; mild skin rash.
• Unexplained muscle pain, discomfort, or weakness (rhabdomyolysis).
• Abnormal production of breast milk.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Venlafaxine sometimes produces unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; mild changes in blood levels of liver enzymes, sodium, or cholesterol. Less frequently, venlafaxine can 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.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.Reporting of adverse effectsIf you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaRAM.es). By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Venlafaxina Retard Farmalider

Keep this medicine out of sight and reach of children.Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Store in the original packaging to protect it from moisture.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines 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 medicines you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Venlafaxina Retard Farmalider

The active ingredient is venlafaxine. Each prolonged-release capsule contains 84.9 mg of venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine base.

The other components are:

Capsule content:microcrystalline cellulose, povidone, talc, anhydrous colloidal silica, magnesium stearate, ethylcellulose, and copovidone.

Capsule shell:gelatin, titanium dioxide (E171), and red and black iron oxides (E172).

Capsule printing ink:shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, and red iron oxide (E172).

Product appearance and package contents

Venlafaxina Retard Farmalider 75 mg is presented in opaque peach-colored capsules with red printing, hard gelatin capsule, size 1.

Venlafaxina Retard Farmalider 75 mg is available in packs of 30 hard capsules and clinical packs of 500 hard capsules.

Venlafaxina Retard Farmalider 75 mg is available in high-density polyethylene (HDPE) bottles containing 14 hard capsules.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturerMarketing authorization holder:

Farmalider, S.A. C/ La Granja, 1, 3rd floor 28108 Alcobendas (Madrid) Spain Manufacturer:

Edefarm S.L.

Pol. Industrial Enchilagar del Rullo 117

46191 Villamarchante, Valencia Spain

Local representative:

ALLENDA PHARMA S.L

Segundo Mata Nº1

Pozuelo de Alarcon (Madrid) 28224

Spain

Date of the last revision of this prospectus: June 2023

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