Venlafaxine prolonged-release Stadagen 225 mg prolonged-release hard capsules EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Venlafaxine Retard Stadagen 75 mg prolonged-release hard capsules EFG

Venlafaxine Retard Stadagen 150 mg prolonged-release hard capsules EFG

Venlafaxine Retard Stadagen 225 mg prolonged-release hard capsules EFG

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

1. What Venlafaxine Retard Stadagen is and what it is 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. The exact way antidepressants work is not fully understood, but they may help increase 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). Properly treating depressive and anxiety disorders 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.

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

Do not take Venlafaxine Retard Stadagen

• If you are allergic to venlafaxine or to 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 medicine known as an irreversible monoamine oxidase inhibitor (MAOI), used to treat depression or Parkinson's disease. Taking an irreversible MAOI together with venlafaxine may result in serious, and even potentially life-threatening, adverse effects. In addition, you must wait at least 7 days after stopping venlafaxine before taking any MAOI (see also section “Other medicines and Venlafaxine Retard Stadagen” and the information in that section regarding “Serotonin syndrome”).

Warnings and precautions

Consult your doctor or pharmacist before taking venlafaxine if you:

• are using other medicines that, when taken together with venlafaxine, could 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 that your heart rhythm is abnormal
• have a history of seizures (fits)
• have a history of low levels of sodium in the blood (hyponatremia)
• have a history of bleeding disorders (tendency to develop bruises or tendency to bleed easily) or if you are taking other medicines that may increase the risk of bleeding, e.g., warfarin (used to prevent blood clots), or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”)
• have a history of, or if a family member has had, mania or bipolar disorder (feeling over-excited or euphoric)
• have a history of aggressive behavior

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

Do not drink alcohol during treatment with venlafaxine, as it may cause extreme drowsiness and unconsciousness. Taking it together 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 anxiety disorders, you may sometimes experience thoughts of harming yourself or committing suicide. These thoughts may increase when you first start taking antidepressants, as all of these medicines take time to work—usually about two weeks, although sometimes longer. These thoughts may also occur when your dose is reduced or during discontinuation of venlafaxine treatment.

This is more likely to happen:

• if you have previously had thoughts of suicide or of harming yourself.
• if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with antidepressants.

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

It may be helpful to inform a close family member or friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may 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 behaviour.

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 take care with your dental hygiene.

Diabetes

Venlafaxine may alter your blood glucose levels. Therefore, the doses of your diabetes medications may need to be adjusted.

Sexual problems

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

Children and adolescents

Venlafaxine should normally not be used in the treatment of children and adolescents under 18 years of age. In addition, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontation behavior, and irritability) when taking this type of medication. Nevertheless, your doctor may prescribe this medicine to patients under 18 years of age if they decide it is in the patient's best interest. If your doctor has prescribed this medicine to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms listed above develop or worsen while these patients under 18 years of age are taking venlafaxine.

Furthermore, the long-term safety with regard to growth, maturation, and cognitive and behavioral development has not been established.

Other medicines and Venlafaxine Retard Stadagen

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

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

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

• Monoamine oxidase inhibitors (MAOIs) 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 within the last 14 days. (MAOIs: see section “What you need to know before taking Venlafaxine Retard Stadagen”)

• Serotonin syndrome:

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

Examples of these medicines include:

• triptans (used for migraine)
• other medicines used to treat 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 opioids (e.g., buprenorphine, tramadol, fentanyl, tapentadol, meperidine, or pentazocine) used to treat severe pain
• medicines containing dextromethorphan (used to treat cough)
• medicines containing methadone (used to treat opioid addiction or for the treatment of severe pain)
• medicines containing methylene blue (used to treat elevated levels of methemoglobin in blood)
• products containing St. John’s wort (also called “Hypericum perforatum”, a natural or herbal remedy used to treat mild depression)
• products containing tryptophan (used for conditions such as sleep problems and depression)
• antipsychotics (used to treat conditions with symptoms such as hearing, seeing, or feeling things that are not there, false beliefs, unusual suspiciousness, unclear thinking, and tendency to withdraw)

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 may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, and increased muscle enzymes (detected by a blood test).

Contact 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 irregular heart rhythm)
• antipsychotics such as thioridazine (see also “Serotonin syndrome” above)
• antibiotics such as erythromycin or moxifloxacin (used to treat bacterial infections)
• antihistamines (used to treat allergies)

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

• ketoconazole (an antifungal medicine)
• haloperidol or risperidone (used to treat psychiatric conditions)
• metoprolol (a beta-blocker used to treat 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 together with alcohol may cause extreme drowsiness and unconsciousness, and may 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 become pregnant, consult your doctor or pharmacist before using this medicine. You should only take venlafaxine after discussing with your doctor the potential benefits and possible risks to the unborn child.

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

If you take venlafaxine in the later 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 be aware that you are taking venlafaxine so they can advise you appropriately.

If you take this medicine during pregnancy, other symptoms your baby may have at birth include feeding difficulties and breathing problems. If your baby has these symptoms at birth and you are concerned, contact your doctor and/or midwife, who can provide advice.

Breastfeeding

Venlafaxine passes into breast milk. There is a risk of effects on the baby. Therefore, you must discuss this with your doctor, who will decide whether you should discontinue breastfeeding or discontinue treatment with this medicine.

Driving and operating machinery

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

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

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

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

Venlafaxine Retard Stadagen 225 mg contains the colouring agent carmoisine (E122).

Carmoisine (E122) may cause allergic reactions.

3. How to take Venlafaxine Retard Stadagen

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

Depression

The recommended starting dose is 75 mg per day. Your doctor may gradually increase the dose and, if necessary, further 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 starting dose is 75 mg per day. The maximum dose is 225 mg/day.

Liver or kidney problems

Talk to your doctor, as your dose of this medicine may need to be different.

Method of administration

Take venlafaxine at approximately the same time each day, either in the morning or at night.

The capsules must be swallowed whole with liquid and must 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 prescribed by your doctor. You may also contact the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

Overdose may be life-threatening, especially when taken simultaneously with certain medicines and/or alcohol (see "Taking Venlafaxine Retard Stadagen with other medicines").

Symptoms of a possible overdose may include palpitations, changes in 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 have missed 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 your next single dose as usual. Do not take a double dose to make up for missed doses. Do not take more than the daily amount of venlafaxine prescribed for you in one day.

If you interrupt treatment with Venlafaxine Retard Stadagen

Do not stop taking this medication or reduce the dose without consulting your doctor, even if you feel better. If your doctor considers that you no longer need venlafaxine, they may instruct you to gradually reduce the dose before stopping treatment completely.

Adverse effects are known to occur when people stop taking this medicine, especially if it is stopped suddenly or 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, tinnitus (ringing in the ears), tingling sensations, or, in rare cases, electric shock-like sensations, weakness, sweating, seizures, flu-like symptoms, vision problems, and increased blood pressure (which may cause headache, dizziness, tinnitus, sweating, etc.).

Your doctor will advise you on how to gradually discontinue treatment with venlafaxine. This process may take several weeks or months. In some patients, discontinuation may need to be very gradual over several months or longer. If you experience any of these or other bothersome symptoms, consult your doctor for advice.

If you have any further questions about 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 everyone will experience them.

Serious adverse effects

If you experience any of the following effects, stop taking venlafaxine immediately and contact your doctor right away or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

• swelling of the face, mouth, tongue, throat, hands or feet and/or swollen, itchy rash, difficulty swallowing or breathing.

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

• chest tightness, noisy breathing, difficulty swallowing or breathing.
• severe skin rash, itching or hives (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, vomiting.

In its most severe form, serotonin syndrome may resemble Neuroleptic Malignant Syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, and increased muscle enzymes (detected 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 may progress to the formation of severe blisters and peeling of the skin.
• unexplained muscle pain, tenderness, 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,” which may include chest pain, difficulty breathing, dizziness, fainting, or irregular heartbeats.

Other adverse effects you should report to your doctor (the frequency of these adverse effects is included in the list below “Other adverse effects that may occur”) include:

• cough, noisy breathing, and difficulty breathing, which may be accompanied by increased temperature.
• tarry stools or blood in the stool.
• itching, yellowing of the eyes or skin, 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.
• nerve problems, such as dizziness, tingling, movement disorders (muscle spasms and stiffness), seizures or fits.
• psychiatric problems, such as hyperactivity (unusual feeling of being overexcited).
• withdrawal effects (see section “How to take Venlafaxina Retard STADAGEN, if you stop taking Venlafaxina Retard STADAGEN”).
• prolonged bleeding—if you are cut or injured, it may take longer than normal 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, inability to achieve orgasm, decreased libido, agitation, nervousness, abnormal dreams
• tremor; a feeling of restlessness or inability to sit still or remain motionless, tingling, altered taste perception, increased muscle tone
• visual disturbances including blurred vision, dilated pupils, inability of the eye to automatically adjust focus from distant to near objects
• ringing in the ears (tinnitus)
• rapid heartbeat, palpitations
• increased blood pressure, hot flushes
• difficulty breathing, yawning
• vomiting, diarrhea
• mild skin rash, itching
• increased frequency of urination, inability to urinate, difficulties urinating
• menstrual irregularities, such as increased bleeding or increased irregular bleeding, abnormal ejaculation/orgasm (in men), erectile dysfunction (impotence)
• weakness (asthenia), fatigue, chills
• weight gain or weight loss
• increased cholesterol

Uncommon (may affect up to 1 in 100 people)

• hyperactivity, racing thoughts, and reduced need for sleep (mania)
• hallucinations, feeling detached from reality, abnormal orgasm, lack of feelings or emotions, feeling overexcited, teeth grinding
• fainting, involuntary muscle movements, disturbance in coordination and balance
• feeling dizzy (especially when standing up too quickly), decreased blood pressure
• vomiting blood, tarry stools (bowel movements), or blood in the stool, which may be a sign of internal bleeding
• sensitivity to sunlight, bruising, abnormal hair loss
• inability to control urination
• muscle stiffness, spasms, and involuntary muscle movements
• slight changes in blood levels of liver enzymes

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

• seizures or fits
• cough, noisy breathing, and shortness of breath, which may be accompanied by high temperature
• disorientation and confusion, often accompanied by hallucinations (delirium)
• excessive water intake (known as SIADH)
• decreased levels of sodium in the blood
• severe eye pain and reduced or blurred vision
• abnormal, 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, yellowing of the eyes or skin, dark urine, flu-like symptoms, which are signs of liver inflammation (hepatitis)

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

• prolonged bleeding, which may be a sign of a low platelet count in the blood, leading to an increased risk of bruising or bleeding
• abnormal production of breast milk
• unexpected bleeding, for example, bleeding from the 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 suicidal behaviour—cases of suicidal thoughts and behaviour have been reported during treatment with venlafaxine or shortly after stopping treatment (see section 2 “What you need to know before taking Venlafaxina Retard Stadagen”).
• aggression
• vertigo
• heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage)—see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

Blood tests

Venlafaxine may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or an abnormal heartbeat; slight 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 wish to carry out occasional blood tests, especially if you have been taking venlafaxine for a long time.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide 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 expiry date stated on the blister pack and container, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be returned to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Venlafaxine Retard Stadagen

The active substance is venlafaxine.

Venlafaxine Retard Stadagen 75 mg prolonged-release hard capsules EFG:

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

The other components are:

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

Coating: ethylcellulose, copovidone.

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

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

Venlafaxine Retard Stadagen 150 mg prolonged-release hard capsules EFG:

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

The other components are:

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

Coating: ethylcellulose, copovidone.

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

Capsule body: brilliant blue FCF (E133), allura red AC (E129), sunset yellow FCF (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 capsules EFG:

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

The other components are:

Core: microcrystalline cellulose (E460), povidone, talc (E553b), anhydrous colloidal 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 Contents of the Pack

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

It is available in packs of 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 105 and 120 capsules packed in blisters (PVC/Aclar-Aluminium or Aluminium-PVC/PVdC white opaque). Only certain pack sizes may be marketed.

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

It is available in packs of 10, 14, 20, 28, 30, 50, 56, 98, 100, 105 and 120 capsules packed in blisters (PVC/Aclar-Aluminium or Aluminium-PVC/PVdC white opaque). Only certain pack sizes may be marketed.

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

It is available in packs of 10, 14, 20, 28, 30, 50 and 100 capsules packed in blisters (Aluminium-OPA/Aluminium/PVC or Aluminium-PVC/Aclar white opaque or Aluminium-PVC/PVdC white opaque). Only certain 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 medicinal product is authorized in the European Economic Area member states under the following names:

Germany: Venlafaxin AL 37.5 mg Hard Capsules, Prolonged Release
Venlafaxin AL 75 mg Hard Capsules, Prolonged Release
Venlafaxin AL 150 mg Hard Capsules, Prolonged Release
Venlafaxin AL 225 mg Hard Capsules, Prolonged Release

Belgium: Venlafaxine EG 37.5 mg Hard Capsules with Prolonged Release
Venlafaxine EG 75 mg Hard Capsules with Prolonged Release
Venlafaxine EG 150 mg Hard Capsules with Prolonged Release

Denmark: Efastad, Hard Depot Capsules

Spain: Venlafaxina Retard Stadagen 75 mg Prolonged-Release Hard Capsules, EFG
Venlafaxina Retard Stadagen 150 mg Prolonged-Release Hard Capsules, EFG
Venlafaxina Retard Stadagen 225 mg Prolonged-Release Hard Capsules, EFG

France: VENLAFAXINE EG LABO LP 37.5 mg, Prolonged-Release Capsule
VENLAFAXINE EG LABO LP 75 mg, Prolonged-Release Capsule

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 Prolonged-Release Capsules
Venlafaxine EG 75 mg Prolonged-Release Capsules
Venlafaxine EG 150 mg Prolonged-Release Capsules

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 Prolonged-Release Capsule
Venlafaxina Ciclum 75 mg Prolonged-Release Capsule
Venlafaxina Ciclum 150 mg Prolonged-Release Capsule
Venlafaxina Ciclum 225 mg Prolonged-Release Capsule

Sweden: Efastad 75 mg Depot Capsules, Hard
Efastad 150 mg Depot Capsules, Hard

Date of latest revision of this leaflet: March 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/