Package Insert: Information for the User
ZARELIS Retard 225 mg prolonged-release tablets
venlafaxine
6. Contents of the pack and additional information
Zarelis Retard contains the active substance venlafaxine.
Zarelis Retard 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 action of antidepressants is not fully understood, but they may help increase levels of serotonin and norepinephrine in the brain.
Zarelis Retard is a treatment for adults with depression.Zarelis Retard is also a treatment for adults with the following anxiety disorders:generalized anxiety disorder,social anxiety disorder (fear or avoidance of social situations) andpanic 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 more difficult to treat.
Speak with your doctor or pharmacist before starting to take Zarelis Retard
Zarelis Retard 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 occurs.
Do not drink alcohol during treatment with Zarelis Retard, as it may cause extreme fatigue and unconsciousness. Taking it with certain medications and/or alcohol may worsen the symptoms of depression and other conditions, such as anxiety disorders.
If you are depressed and/or have an anxiety disorder, you may sometimes have thoughts of harming yourself or committing suicide. These thoughts may increase when you start taking antidepressants, as all these medications take time to work, usually two weeks but sometimes longer. These thoughts may also occur when you reduce your dose or during the end of treatment with Zarelis Retard.
It 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 family member 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 dental decay (caries). Therefore, you should take care with your dental hygiene.
Your blood glucose levels may be affected by Zarelis Retard. Therefore, you may need to adjust the dose of your diabetes medication.
Sexual problems
Some medications in the group to which Zarelis Retard belongs (called IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.
Zarelis Retard should not be used normally in the treatment of children and adolescents under 18 years old. Additionally, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal thoughts, ideas of suicide, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes it may prescribe it to patients under 18 years old when they decide it is the best option for the patient. If the doctor who prescribes it has prescribed it to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen in these patients under 18 years old who are taking Zarelis Retard. Additionally, the long-term effects of this medication on growth, maturation, and cognitive and behavioral development have not yet been demonstrated.
Inform your doctor or pharmacist if you are using, have used recently, or may use any other medication.
Your doctor should decide if you can take Zarelis Retard with other medications.
Do not start or stop taking any medication, including those sold without a prescription, natural remedies, and herbal products, before checking with your doctor or pharmacist.
Serotonin syndrome, a potentially life-threatening state, or Malignant Neuroleptic Syndrome (MNS) (see section “Possible side effects”), may occur with treatment with venlafaxine, particularly when taken with other medications.
Examples of these medications 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, and vomiting.
Serotonin syndrome, in its most severe form, may resemble Malignant Neuroleptic Syndrome (MNS). The symptoms and signs of MNS may include a combination of fever, rapid heart rate, sweating, severe muscle rigidity, confusion, and increased levels of muscle enzymes (determined in blood).
Inform your doctor immediately or go to the nearest hospital if you think you are experiencing Serotonin syndrome.
You should inform your doctor if you are taking medications that affect heart rate.
Examples of these medications include:
The following medications may also interact with Zarelis Retard and should be used with caution. It is especially important to mention to your doctor or pharmacist if you are taking medications that contain:
Zarelis Retard should be taken with food (see section 3 “How to take Zarelis Retard”).
Do not drink alcohol during treatment with Zarelis Retard. Taking it with alcohol may cause extreme fatigue and unconsciousness, and worsen the symptoms of depression and other conditions, such as anxiety disorders.
If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist before taking this medication. You should only take Zarelis Retard after discussing with your doctor the possible benefits and risks for the unborn baby.
Make sure your midwife and/or doctor know that you are using Zarelis Retard. When taking similar medications (called serotonin reuptake inhibitors: SSRIs) during pregnancy, there may be an increased risk of a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually start within the first 24 hours after birth. If this happens to you, you should contact a doctor and/or midwife immediately.
If you take Zarelis Retard 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 Zarelis Retard to be able to advise you.
If you are taking this medication during pregnancy, other symptoms that 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.
Zarelis Retard passes into breast milk. There is a risk of an effect on the baby, so you should discuss the case with your doctor, and they will decide whether you should stop breastfeeding or stop taking this medication.
Driving and operating machinery
Do not drive or operate tools or machines until you know how Zarelis Retard affects you.
Zarelis Retard contains lactose
This medication contains lactose. If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medication.
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.consulte de nuevo a su médico o farmacéutico.
The usual initial dose recommended for the treatment of depression, generalized anxiety disorder, and social anxiety disorder is 75 mg per day. Your doctor may increase the dose gradually and, if necessary, raise it 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 increase it gradually. The maximum dose for generalized anxiety disorder, social anxiety disorder, and panic disorder is 225 mg/day.
Take Zarelis Retard approximately at the same time every day, either in the morning or at night. The tablets should be swallowed whole with liquids and should not be opened, crushed, chewed, or dissolved.
Zarelis Retard should be taken with food.
If you have liver or kidney problems, talk to your doctor as your dose of this medication may be different.
Do not stop taking Zarelis Retard without consulting your doctor (see section “If you interrupt treatment with Zarelis Retard”).
Immediately contact your doctor or pharmacist if you take more medication than prescribed by your doctor. You can also contact the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken.
A overdose can put your life in danger, especially with the simultaneous taking of certain medications and/or alcohol (see Taking Zarelis Retard 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 a missed dose. Do not take more than the daily dose of Zarelis Retard 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 Zarelis Retard, they may ask you to reduce the dose gradually 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, ringing in the ears, tingling, or, in rare cases, electrical discharge sensations, weakness, sweating, seizures, or symptoms similar to the flu, vision problems, and increased blood pressure (which can cause headaches, dizziness, ringing in the ears, sweating, etc.).
Your doctor will advise you on how to gradually stop treatment with Zarelis Retard. This may take several weeks or months. In some patients, the interruption may need to be very gradual over periods of several months or more. If you experience any of these or other symptoms that bother you, consult your doctor for further advice.
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following effects occur, do not take more Zarelis Retard. Inform your doctor immediately, or go to the nearest hospital emergency room:
Rare (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Serotonin syndrome, in its most severe form, may resemble Malignant Neuroleptic Syndrome (MNS). The symptoms and signs of MNS may include a combination of fever, rapid heart rate, sweating, severe muscle rigidity, confusion, and increased levels of muscle enzymes (determined by blood tests).
Unknown frequency (cannot be estimated from available data)
Other side effects that you should inform your doctor include(the frequency of these side effects are included in the lower list “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)
Rare (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)
Zarelis Retardmay sometimes cause unwanted effects that you may not be aware of, such as increased blood pressure or abnormal heart rhythm; mild changes in liver enzyme levels, sodium, or cholesterol. Less frequently, Zarelis Retardmay reduce the function of platelets in the blood, which increases the risk of petechiae or bleeding. Therefore, your doctor may wish to perform occasional blood tests, particularly if you have been taking Zarelis Retard for a long time.
If you experience any of the side effects, inform your doctor or pharmacist. This includes any side effects not listed in this leaflet.
Reporting of side effects
If you 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 theSpanish System for the 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 medicine.
Keep this medication out of the sight and reach of children.
Do not usethis medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.
This medication does not require any special storage temperature. Store in the original packaging to protect it from moisture.
Do not dispose of any medication through the drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.
The active ingredient is venlafaxine.
Each tablet contains 225 mg of venlafaxine (as hydrochloride).
The other components are:
Core:mannitol (E421), povidone K-90, macrogol 400, microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate.
Covering:cellulose acetate, macrogol 400, Opadry Y 30 18037 (a mixture of hypromellose, lactose monohydrate, titanium dioxide (E171), and triacetin).
Prolonged-release tablets 11 mm in diameter, round, biconvex, white.
Zarelis Retard 225 mg is available in blisters of10, 14, 20, 28, 30, 50, 56, 60, 70, 98, 100, and 500 tablets, and in plastic bottles of 10, 14, 20, 28, 30, 50, 56, 60, 100, and 500 tablets.
Only some package sizes may be marketed.
Marketing Authorization Holder:
ITALFARMACO, S.A.
San Rafael, 3 – 28108 Alcobendas (Madrid), SPAIN
Tel.: 916572323
Responsible for manufacturing:
Laboratorios LICONSA, S.A.
Avda.Miralcampo, Nº 7, Industrial Estate Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN
or
Sandoz A/S
Edvard Thomsens Vej 14
2300 København S,
Denmark
or
Genericon Pharma
Gesellschaft m.b.H.,
Hafnerstrasse 211, 8054 Graz,
Austria
This medicine is authorized in the member states of the European Economic Area with the following names:
Austria: Venlafaxin Genericon 225 mg, Retardtabletten
Sweden: Venlafaxine AGP 225 mg depottabletter
Spain: Zarelis Retard 225 mg prolonged-release tablets
Germany:Venlafaxin AAA-Pharma 225 mg Retardtabletten
Finland: Subelan 225 mg depottabletti
Belgium:Sybexlan 225 mg tablets with prolonged release / comprimés à libération prolongée/ Retardtabletten
Luxembourg: Sybexlan 225 mg tablets with prolonged release / comprimés à libération prolongée/ Retardtabletten
Last review date of this leaflet:June 2023
Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es
Маєте питання щодо цього лікування або ваших симптомів? Зв'яжіться з ліцензованим лікарем для отримання допомоги та персонального догляду.