VENLAFAXINE RETARD STADAGEN 225 mg PROLONGED-RELEASE HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Venlafaxine Retard Stadagen 75 mg prolonged-release hard capsulesEFG

Venlafaxine Retard Stadagen 150 mg prolonged-release hard capsulesEFG

Venlafaxine Retard Stadagen 225 mg prolonged-release hard capsulesEFG

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

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

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

Venlafaxine Retard Stadagen 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 not fully understood how antidepressants work, but they may help to increase the levels of serotonin and norepinephrine in the brain.

Venlafaxine Retard Stadagen 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) and 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 worsen and become more difficult to treat.

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

Do not take Venlafaxine Retard Stadagen

• 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 may 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 sections “Other medicines and Venlafaxine Retard Stadagen” and the information in that section on “Serotonin syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before taking venlafaxine if you:

• are taking other medicines that, when taken with venlafaxine, may increase the risk of developing serotonin syndrome (see section “Other medicines and Venlafaxine Retard Stadagen”)
• have eye problems, such as certain types of glaucoma (increased pressure in the eye).
• have a history of high blood pressure.
• have a history of heart problems.
• have been told you have an abnormal heart rhythm.
• have a history of seizures (fits).
• have a history of low sodium levels in your blood (hyponatremia).
• have a history of bleeding disorders (tendency to develop bruises or tend to bleed easily) 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 section “Pregnancy, breastfeeding and fertility”).
• have a history of, or if a family member has had, mania or bipolar disorder (feeling overexcited or euphoric).
• If you have a history of aggressive behavior.

Venlafaxine Retard Stadagen 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 during treatment with venlafaxine, as it may cause extreme fatigue and unconsciousness. Taking it with certain medicines and/or with 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 anxiety disorders, you may sometimes have thoughts of harming yourself or suicide. These thoughts may increase when you first start taking antidepressants, as these medicines take time to work, usually around 2 weeks, but sometimes longer. These thoughts can also occur when your dose is reduced or during treatment interruption with venlafaxine.

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 young adults (less than 25 years of age) with psychiatric conditions who were treated with antidepressants.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to the 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 can also 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 can 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.

Sexual problems

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

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 a greater risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Despite this, your doctor may prescribe this medicine to patients under 18 years of age when they decide it is the most convenient for the patient. If your doctor has prescribed this medicine to a patient under 18 years of age and you want to discuss this decision, please go back to 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, long-term safety in relation to growth, maturity, and cognitive and behavioral development has not been demonstrated.

Other medicines and Venlafaxine Retard Stadagen

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Do not start or stop taking any medicines, including those that can be bought without a prescription, herbal remedies, and complementary medicines, 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 “What you need to know before you take Venlafaxine Retard Stadagen”)

• 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, e.g., 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 opioids (e.g., buprenorphine, 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 for pain treatment)
• medicines containing methylthioninium chloride (methylene blue) (used to treat high levels of methemoglobin in the blood)
• products containing St. John's Wort (also known as “Hypericum perforatum”, a herbal remedy or supplement used to treat mild depression)
• products 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 do not exist, mistaken beliefs, unusual suspicion, unclear reasoning, and a tendency to withdraw)

The signs and symptoms of serotonin syndrome can 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 emergency 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 Stadagen with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding, and fertility

Pregnancy

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. You should only take venlafaxine after discussing with your doctor the possible benefits and risks to the unborn child.

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 must contact your midwife and/or doctor immediately.

If you take venlafaxine 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.

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

Breastfeeding

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

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

Venlafaxine Retard Stadagen 150 mg contains sodium and the colorants sunset yellow FCF (E110) and allura red AC (E129)

This medicine contains less than 23 mg (1 mmol) of sodium per capsule, so it is considered essentially “sodium-free”.

Sunset yellow FCF (E110) and allura red AC (E129) may cause allergic reactions.

Venlafaxine Retard Stadagen 225 mg contains the colorant carmoisine (E122)

Carmoisine (E122) may cause allergic reactions.

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3. How to take Venlafaxine Retard Stadagen

Take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Dosage

Depression

The recommended initial dose is 75 mg per day. Your doctor may gradually increase the dose and if necessary, up to a maximum of 375 mg per day.

Panic disorder

Your doctor will start with a lower dose (37.5 mg) and then gradually increase the dose. The maximum dose is 225 mg/day.

Generalized anxiety disorder or social anxiety disorder

The recommended initial dose is 75 mg per day. The maximum dose is 225 mg/day.

Liver or kidney problems

Talk to your doctor as you may need to have your dose of this medicine adjusted.

Method of administration

Take venlafaxine 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.

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

If you take more Venlafaxine Retard Stadagen than you should

Contact your doctor or pharmacist immediately if you take more medicine than your doctor prescribed. You can also contact the Toxicology Information Service, phone 91 562 04 20, stating 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 Stadagen 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 Stadagen

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 a double dose to make up for forgotten doses. Do not take more than the daily dose of venlafaxine prescribed by your doctor in one day.

If you stop taking Venlafaxine Retard Stadagen

Do not stop taking your treatment or reduce the dose without your doctor's advice, 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 if the dose is reduced too quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, 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, 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 taking venlafaxine. This may take several weeks or months. In some patients, the discontinuation may need to be very gradual over several months or more. If you experience any of these or other symptoms that bother you, consult your doctor for 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.

Severe Adverse Effects

If any of the following effects occur, do not take more venlafaxine. 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, breathing noise, difficulty swallowing or breathing.
• severe skin rash, itching, or hives (elevated areas of reddened or pale 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, 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 enzyme levels (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, which 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 a condition called "stress cardiomyopathy" that may include chest pain, difficulty breathing, dizziness, fainting, irregular heartbeats.

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

• cough, breathing noise, and difficulty breathing that may be accompanied by a high temperature.
• black stools (deposits) or blood in stools.
• 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, tingling, movement disorder (muscle spasms and stiffness), convulsions, or seizures.
• psychiatric problems, such as hyperactivity (unusual feeling of overexcitement)
• withdrawal effects (see section "How to take Venlafaxine Retard STADAGEN, if you interrupt treatment with Venlafaxine Retard STADAGEN").
• prolonged bleeding, if you cut or injure yourself, it may take a little longer than usual for the bleeding to stop.

Other Adverse Effects That May Occur

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

• dizziness, headache, drowsiness
• insomnia
• nausea, dry mouth, constipation
• excessive sweating (including night sweats)

Common (may affect up to 1 in 10 people)

• 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, 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 urination frequency, inability to urinate, difficulty urinating
• menstrual irregularities, such as increased bleeding or irregular bleeding, abnormal ejaculation/orgasm (males), 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 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 standing up too quickly), decreased blood pressure
• bloody vomiting, black stools (deposits) 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

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

• seizures or convulsions
• cough, breathing noise, and shortness of breath that may be accompanied by a high temperature
• disorientation and confusion often accompanied by hallucinations (delirium)
• excessive water intake (known as SIADH)
• decreased sodium levels in the blood
• severe eye pain and reduced or blurred vision
• abnormal heartbeat, rapid or irregular, which can 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 people)

• prolonged bleeding, which may be a sign of a reduced number of platelets in the blood, leading to an increased risk of bruising or bleeding
• abnormal milk production
• unexpected bleeding, for example, bleeding gums, blood in urine or vomit, or the sudden appearance of bruises or broken blood vessels (broken veins).

Frequency Not Known (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 stopping treatment (see section 2 "What you need to know before taking Venlafaxine Retard Stadagen").
• aggression
• vertigo
• excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information.

Blood Tests

Venlafaxine 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 Adverse Effects

If 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 leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Venlafaxine Retard Stadagen

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

Do not use this medicine after the expiration date that appears on the blister pack and carton, after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Do not use this medicine if the capsules appear to be significantly discolored or show other signs of significant deterioration.

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

6. Package Contents and Additional Information

Composition of Venlafaxine Retard Stadagen

The active ingredient is venlafaxine.

Venlafaxine Retard Stadagen 75 mg prolonged-release hard capsulesEFG:

Each capsule contains 84.9 mg of venlafaxine hydrochloride equivalent to 75 mg of venlafaxine.

The other ingredients are:

Core: microcrystalline cellulose (E460), povidone, talc (E553b), colloidal anhydrous silica (E551), magnesium stearate (E572).

Coating: ethylcellulose, copovidone.

Capsule cap: iron oxide black (E172), iron oxide red (E172), titanium dioxide (E171), gelatin.

Capsule body: iron oxide black (E172), iron oxide red (E172), titanium dioxide (E171), gelatin, red ink (composition: shellac, propylene glycol, strong ammonia solution, and iron oxide red (E172)).

Venlafaxine Retard Stadagen 150 mg prolonged-release hard capsulesEFG:

Each capsule contains 169.8 mg of venlafaxine hydrochloride equivalent to 150 mg of venlafaxine.

The other ingredients are:

Core: microcrystalline cellulose (E460), povidone, talc (E553b), colloidal anhydrous silica (E551), magnesium stearate (E572).

Coating: ethylcellulose, copovidone.

Capsule cap: brilliant blue FCF (E133), allura red AC (E129), orange yellow S (E110), titanium dioxide (E171), gelatin.

Capsule body: brilliant blue FCF (E133), allura red AC (E129), orange yellow S (E110), titanium dioxide (E171), gelatin, white ink (composition: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171)).

Venlafaxine Retard Stadagen 225 mg prolonged-release hard capsulesEFG:

Each capsule contains 254.7 mg of venlafaxine hydrochloride equivalent to 225 mg of venlafaxine.

The other ingredients are:

Core: microcrystalline cellulose (E460), povidone, talc (E553b), colloidal anhydrous silica (E551), magnesium stearate (E572).

Coating: ethylcellulose, copovidone.

Capsule cap: carmoisine (E122), titanium dioxide (E171), gelatin.

Capsule body: carmoisine (E122), titanium dioxide (E171), gelatin, blue ink (composition: shellac, propylene glycol, strong ammonia solution, and indigo carmine (E132)).

Appearance of the Product and Package Contents

Venlafaxine Retard Stadagen 75 mgare hard gelatin capsules, size "1", peach opaque/peach opaque, with thick and thin circular bands of red color on the body and cap. The capsule contains 6 film-coated mini-tablets, white to off-white, round, and biconvex, 12.5 mg each.

It is available in packs of 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 105, and 120 capsules in blisters (PVC/Aclar-Aluminum or Aluminum-PVC/PVdC white opaque). Not all pack sizes may be marketed.

Venlafaxine Retard Stadagen 150 mgare hard gelatin capsules, size "0", dark orange/dark orange opaque, with thick and thin circular bands of white color on the body and cap. The capsule contains 12 film-coated mini-tablets, white to off-white, round, and biconvex, 12.5 mg each.

It is available in packs of 10, 14, 20, 28, 30, 50, 56, 98, 100, 105, and 120 capsules in blisters (PVC/Aclar-Aluminum or Aluminum-PVC/PVdC white opaque). Not all pack sizes may be marketed.

Venlafaxine Retard Stadagen 225 mgare hard gelatin capsules, size "00", pink opaque/pink opaque, with thick and thin circular bands of blue color on the body and cap. The capsule contains 18 film-coated mini-tablets, white to off-white, round, and biconvex, 12.5 mg each.

It is available in packs of 10, 14, 20, 28, 30, 50, and 100 capsules in blisters (Aluminum-OPA/aluminum/PVC or Aluminum-PVC/Aclar white opaque or Aluminum-PVC/PVdC white opaque). Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorio STADA, S.L.

C/Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

Sanico N.V.

Veedijk 59,

B-2300, Turnhout,

Belgium

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

Germany: Venlafaxin AL 37.5 mg Hartkapsel, retardiert

Venlafaxin AL 75 mg Hartkapsel, retardiert

Venlafaxin AL 150 mg Hartkapsel, retardiert

Venlafaxin AL 225 mg Hartkapsel, retardiert

Belgium: Venlafaxine EG 37.5 mg harde capsules met verlengde afgifte

Venlafaxine EG 75 mg harde capsules met verlengde afgifte

Venlafaxine EG 150 mg harde capsules met verlengde afgifte

Denmark: Efastad, hårde depotkapsler

Spain: Venlafaxina Retard Stadagen 75 mg cápsulas duras de liberación prolongada EFG

Venlafaxina Retard Stadagen 150 mg cápsulas duras de liberación prolongada EFG

Venlafaxina Retard Stadagen 225 mg cápsulas duras de liberación prolongada EFG

France: VENLAFAXINE EG LABO LP 37,5 mg, gélule à libération prolongée

VENLAFAXINE EG LABO LP 75 mg, gélule à libération prolongée

Ireland: Venex XL 37.5 mg prolonged release capsules, hard

Venex XL 75 mg prolonged release capsules, hard

Venex XL 150 mg prolonged release capsules, hard

Luxembourg: Venlafaxine EG 37.5 mg gélules à libération prolongée

Venlafaxine EG 75 mg gélules à libération prolongée

Venlafaxine EG 150 mg gélules à libération prolongée

Malta: Venex XL 37.5 mg Prolonged-release Capsules, hard

Venex XL 75 mg Prolonged-release Capsules, hard

Venex XL 150 mg Prolonged-release Capsules, hard

Portugal: Venlafaxina Ciclum 37.5 mg Cápsula de libertação prolongada

Venlafaxina Ciclum 75 mg Cápsula de libertação prolongada

Venlafaxina Ciclum 150 mg Cápsula de libertação prolongada

Venlafaxina Ciclum 225 mg Cápsula de libertação prolongada

Sweden: Efastad 75 mg depotkapslar, hårda

Efastad 150 mg depotkapslar, hårda

Date of the last revision of this leaflet:March 2024

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/