Venlafaxine Retard Stadagen 75 mg hard capsules for prolonged releaseEFG
Venlafaxine Retard Stadagen 150 mg hard capsules for prolonged releaseEFG
Venlafaxine Retard Stadagen 225 mg hard capsules for prolonged releaseEFG
Venlafaxina Retard Stadagen is an antidepressant that belongs to a group of medications called serotonin and norepinephrine reuptake inhibitors (SNRIs). This group of medications is used to treat depression and other conditions such as anxiety disorders. The exact mechanism of how antidepressants work is not fully understood, but they may help increase levels of serotonin and norepinephrine in the brain.
Venlafaxina 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 properly is important to help you feel better. If left untreated, your condition may not go away or may worsen and become harder to treat.
Consult your doctor or pharmacistbeforetaking venlafaxine if you:
Venlafaxina Retard Stadagen may cause a feeling of restlessness or difficulty sitting or staying still during the first weeks of treatment. You should consult your doctor if this happens.
Do not drink alcohol during treatment with venlafaxine, as it may cause extreme fatigue and unconsciousness. Taking it with certain medicines and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.
If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when you start taking antidepressants, as all these medicines take time to work, usually two weeks, although sometimes more. These thoughts may also occur when your dose is reduced or during the interruption of treatment with venlafaxina.
This is more likely to happen:
If you have thoughts of harming yourself or committing suicide at any time, contact your doctor or go to the hospital directly.
You may find it helpful to tell a close relative or friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You can also ask them to tell you if they think your depression or anxiety is getting worse, or if they are concerned about changes in your behavior.
Dry mouth
Dry mouth has been reported in 10% of patients treated with venlafaxine. This may increase the risk of tooth decay (caries). Therefore, you should take good care of your dental hygiene.
Diabetes
Your blood glucose levels may be affected by venlafaxine. Therefore, your doses of diabetes medicines may need to be adjusted.
Sexual problems
Some medicines in the group to which venlafaxine belongs (called SSRIs) may cause sexual symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.
Venlafaxina should not be used normally in the treatment ofchildren and adolescents under 18 years. Also, you should know that in patients under 18 yearsthere is agreater risk of side effects such as suicidal thoughts,suicidal ideationand hostility (predominantly aggression, confrontational behavior and irritability) when taking this type of medicine. Despite this, your doctor may prescribe this medicine to patients under 18 years when they decide it is the best option for the patient. Ifyour doctorhas prescribed this medicine to a patient under 18 years and wants to discuss this decision,please returnto your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years taking venlafaxina.
Also, the long-term safety in relation to growth, maturation and cognitive and behavioral development has not been demonstrated.
Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.
Your doctor should decide if you can take venlafaxine with other medicines.
Do not start or stop taking any medicine, including those available over the counter, natural remedies and herbal remedies, without checking with your doctor or pharmacist.
A potentially fatal state, or reactions similar to Malignant Neuroleptic Syndrome (MNS) (see section “Possible side effects”) may occur with treatment with venlafaxine, particularly when taken with other medicines.
Examples of these medicines include:
The signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, hyperactive reflexes, diarrhea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome may resemble Malignant Neuroleptic Syndrome (MNS). The signs and symptoms of MNS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased muscle enzymes (determined by a blood test).
Inform your doctor immediately or go to the nearest hospital emergency department if you think you are experiencing serotonin syndrome.
Inform your doctor if you are taking medicines that may affect your heart rhythm.
Some examples of these medicines include:
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 that contain:
Venlafaxina should be taken with food (see section 3 “How to take Venlafaxina Retard Stadagen”).
Do not drink alcohol during treatment with venlafaxine. Taking it with alcohol may cause extreme fatigue and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.
Pregnancy
If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. You should only take venlafaxine after discussing the possible benefits and risks for the unborn baby with your doctor.
Make sure your midwife and/or doctor knows that you are taking venlafaxine. When taken during pregnancy, similar medicines (SSRIs) may increase the risk of a serious condition in the newborn, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and turn blue. These symptoms usually start within the first 24 hours after the baby's birth. If this happens to your baby, contact your midwife and/or doctor immediately.
If you take venlafaxine in the final stages of pregnancy, there may be a greater 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 feeding problems and breathing difficulties. If your baby has these symptoms when born and you are concerned, 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 the case with your doctor and they will decide if you should stop breastfeeding or stop taking this medicine.
Do not drive or operate tools or machines until you know how this medicine affects you
Venlafaxina Retard Stadagen 150 mg contains sodium and the colourants yellow iron oxide (E 172) and red iron oxide (E 172)
Venlafaxina Retard Stadagen 225 mg contains the colourant carmoisine (E 122)
Carmoisine (E 122) may cause allergic reactions.
.
Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.consulte de nuevo a su médico o farmacéutico.
Dosage
Depression
The recommended initial dose is 75 mg per day. Your doctor may gradually increase the dose and if necessary, even more 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
Speak with your doctor as your dose of this medication may need to be different.
Administration Form
Take venlafaxine approximately at the same time every day, either in the morning or at night.
The capsules must be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.
Venlafaxine should be taken with food.
Do not stop taking this medication without consulting your doctor (see section “If you stop treatment with Venlafaxina Retard Stadagen”).
Contact your doctor or pharmacist immediately if you take more medication than prescribed by your doctor. You can also contact the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.
Overdose can be life-threatening, especially with the simultaneous use of certain medications and/or alcohol (see “Taking Venlafaxina Retard Stadagen with other medications”).
The symptoms of a possible overdose may include palpitations, changes in alertness (ranging from drowsiness to coma), blurred vision, seizures or attacks, and vomiting.
If you have not taken a dose, take it as soon as you remember. However, if it is already time for your next dose, skip the missed dose and take only one dose as usual. Do not take a double dose to compensate for the missed doses. Do not take more than the daily dose of venlafaxine prescribed in a day.
Do not stop taking your treatment or reduce the dose without consulting your doctor, even if you feel better. If your doctor thinks you no longer need venlafaxine, they may ask you to gradually reduce the dose before stopping treatment completely.
It is known that adverse effects occur when people stop using this medication, especially when it is stopped suddenly or if the dose is reduced very quickly. Some patients may experience symptoms such as suicidal thoughts, aggression, fatigue, dizziness, instability, headaches, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, numbness or, in rare cases, electric shock sensations, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headaches, dizziness, tinnitus, sweating, etc.).
Your doctor will advise you on how to gradually stop treatment with venlafaxine. This may take several weeks or months. In some patients, the interruption may need to be very gradual over months or more. If you experience any of these or other symptoms that bother you, consult your doctor for advice.
If you have any other doubts about the use of this medication, ask your doctor or pharmacist.
Severe side effects
If any of the following side effects occur, do not take more venlafaxine.Inform your doctor immediately, or go to the nearest hospital emergency room:
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
In its most severe form, serotonin syndrome may resemble Malignant Neuroleptic Syndrome (MNS). The signs and symptoms of MNS may include a combination of fever, rapid heartbeat, sweating, severe muscle rigidity, confusion, increased muscle enzymes (determined by blood tests).
Unknown frequency (cannot be estimated from available data)
Other side effects that you should inform your doctor are (the frequency of these side effects are included in the list below "Other side effects that may occur"):
Other side effects that may occur
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Unknown frequency (cannot be estimated from available data)
Blood tests
Venlafaxine may sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heartbeat; slight changes in liver enzyme levels, sodium, or cholesterol. Less frequently, venlafaxine may reduce the function of platelets in the blood, leading to an increased risk of bruising or bleeding. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking venlafaxine for a long time.
Reporting side effects
Ifyou experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
Keep this medication out of the sight and reach of children.
Do not usethis medication after the expiration date that appears on the blister pack and on the packaging, after CAD. The expiration date is the last day of the month indicated.
This medication does not require special storage conditions.
Do not use this medication if the capsules appear significantly discolored or show other signs of significant deterioration.
Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.
The active ingredient is venlafaxine.
Venlafaxine Retard Stadagen 75 mg hard capsules with prolonged releaseEFG:
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).
Capsule 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),dióxido de titanio(E171), gelatina, red ink (composition: shellac, propylene glycol, strong ammonia solution and red iron oxide (E172)).
Venlafaxine Retard Stadagen 150 mg hard capsules with prolonged releaseEFG:
Each capsule contains 169.8 mg of venlafaxine hydrochloride equivalent to 150 mg ofvenlafaxine.
The other components are:
Core: microcrystalline cellulose (E460), povidone, talc (E553b), anhydrous colloidal silica (E551), magnesium stearate (E572).
Capsule coating: ethylcellulose, copovidone.
Capsule cap: brilliant blue FCF (E133), allura red AC (E129), yellow orange S (E110), titanium dioxide (E171), gelatina
Capsule body: brilliant blue FCF (E133), allura red AC (E129), yellow orange S (E110), titanium dioxide (E171), gelatina, white ink (composition: shellac, propylene glycol, sodium hydroxide, povidone, titanium dioxide (E171)).
Venlafaxine Retard Stadagen 225 mg hard capsules with prolonged releaseEFG:
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)
Capsule coating: ethylcellulose, copovidone
Capsule cap: carmoisine (E122), titanium dioxide (E171), gelatina
Capsule body: carmoisine (E122), titanium dioxide (E171), gelatina, blue ink (composition: shellac, propylene glycol, strong ammonia solution and cochineal extract (E132)).
Venlafaxine Retard Stadagen 75 mgare hard gelatin capsules, size “1”, orange opaque/orange opaque, with thick and thin circular bands of red on the body and cap. The capsule contains 6 mini tablets coated with a film, white to off-white, round and biconvex, 12.5 mg each.
It is available in packages of 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 105 and 120 capsules packaged in blisters (PVC/Aclar-Aluminum or Aluminum-PVC/PVdC white opaque). Only some package 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 on the body and cap. The capsule contains 12 mini tablets coated with a film, white to off-white, round and biconvex, 12.5 mg each.
It is available in packages of 10, 14, 20, 28, 30, 50, 56, 98, 100, 105 and 120 capsules packaged in blisters (PVC/Aclar-Aluminum or Aluminum-PVC/PVdC white opaque). Only some package 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 on the body and cap. The capsule contains 18 mini tablets coated with a film, white to off-white, round and biconvex, 12.5 mg each.
It is available in packages of 10, 14, 20, 28, 30, 50 and 100 capsules packaged in blisters
(Aluminum-OPA/aluminum/PVC or Aluminum-PVC/Aclar white opaque or Aluminum-PVC/PVdC white opaque).Only some package sizes may be marketed.
Marketing authorization holder
STADA Laboratorios, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern (Barcelona)
Spain
Responsible 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 member states of the European Economic Area with 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 hard capsules with prolonged release EFG
Venlafaxina Retard Stadagen 150 mg hard capsules with prolonged release EFG
Venlafaxina Retard Stadagen 225 mg hard capsules with prolonged release 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 ggélules 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
Last review date of this leaflet:March 2024
Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
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