Venlafaxine Teva, 37.5 mg, prolonged-release, hard capsules
Venlafaxine
Venlafaxine Teva contains the active substance venlafaxine.
Venlafaxine Teva is an antidepressant that belongs to a group of medicines called serotonin and norepinephrine reuptake inhibitors (SNRI). This group of medicines is used to treat depression and other conditions, such as anxiety disorders. It is believed that people with depression and/or anxiety disorders have lower levels of serotonin and norepinephrine in the brain. The mechanism of action of antidepressants is not fully understood, but they may help by increasing the concentration of serotonin and norepinephrine in the brain.
Venlafaxine Teva is used to treat depression in adults. It is also indicated for the treatment of the following anxiety disorders in adults: generalized anxiety disorder, social phobia (fear or avoidance of social situations), and panic disorder (panic attacks). For the patient to feel better, it is essential that the treatment of depression and anxiety disorders is carried out properly. If left untreated, the patient's condition may not improve, may worsen, and will be much more difficult to cure.
Side effects can be serious. Also, before starting to take any IMAO medicine, you should wait at least 7 days after stopping Venlafaxine Teva (see also "Venlafaxine Teva and other medicines" and the information in this section on serotonin syndrome).
Before taking Venlafaxine Teva, you should discuss with your doctor:
Venlafaxine Teva may cause feelings of restlessness or inability to sit or stand still in the first few weeks of treatment. If such symptoms occur, you should inform your doctor.
Do not drink alcohol while taking Venlafaxine Teva, as it may cause extreme fatigue and loss of consciousness. Taking it with alcohol and/or certain medicines may increase the symptoms of depression and other conditions, such as anxiety disorders.
Suicidal thoughts and worsening of depression or anxiety disorders
Patients with depression and/or anxiety disorders may sometimes have thoughts of self-harm or suicide. Such thoughts may increase when starting antidepressant treatment, as these medicines usually start working after about 2 weeks, sometimes later. These thoughts may also occur when reducing the dose or stopping Venlafaxine Teva treatment.
Suicidal thoughts are more likely to occur if:
If you experience suicidal thoughts or self-harm, you should immediately contact your doctor or go to the hospital.
It may be helpful to inform your family or friends about your depression or anxiety disorder and ask them to read this leaflet. You can ask your family or friends to help you and tell you if your depression or anxiety gets worse, or if you experience any worrying changes in your behavior.
Dry mouth
Dry mouth has been reported by 10% of patients treated with venlafaxine. This may increase the risk of tooth decay. Therefore, you should pay special attention to oral hygiene.
Diabetes
Blood glucose levels may change while taking Venlafaxine Teva. Therefore, it may be necessary to adjust the dosage of antidiabetic medicines.
Sexual dysfunction
Medicines like Venlafaxine Teva (SNRI) may cause sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.
Pellets in the stool
Do not worry if you see small, white balls or granules in your stool after taking this medicine. The capsules of Venlafaxine Teva contain spheroids (small white balls) that contain the active substance (venlafaxine). These balls are released from the capsule into the stomach. As they pass through the stomach and intestines, venlafaxine is slowly released. The spheroid "shell" does not dissolve and is excreted in the stool. Therefore, even if the spheroids are visible in the stool, the dose of the medicine has been absorbed.
Venlafaxine Teva should not normally be used in children and adolescents under 18 years of age.
It should be noted that in the case of taking medicines of this class, patients under 18 years of age are at increased risk of side effects, such as suicidal attempts, suicidal thoughts, and hostility (especially aggression, rebellious behavior, and expressions of anger). Nevertheless, the doctor may prescribe Venlafaxine Teva to patients under 18 years of age, considering that it is in their best interest. If the doctor prescribes Venlafaxine Teva to a patient under 18 years of age and there are any doubts, you should consult the doctor. You should inform the doctor if a patient under 18 years of age taking Venlafaxine Teva experiences or worsens any of the symptoms mentioned above. There is also a lack of available data on the long-term safety of using this medicine in this age group regarding growth, maturation, and cognitive and behavioral development.
You should tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Your doctor will decide whether to use Venlafaxine Teva with other medicines.
Do not start or stop taking other medicines, including those available without a prescription, herbal or natural remedies, without consulting your doctor or pharmacist first.
Examples of such medicines include:
The subjective and objective symptoms of serotonin syndrome may include the following symptoms: restlessness, hallucinations, loss of coordination, rapid heart rate, elevated body temperature, rapid changes in blood pressure, overreactivity, diarrhea, coma, nausea, vomiting.
The most severe form of serotonin syndrome can resemble neuroleptic malignant syndrome. Its symptoms include: fever, rapid heart rate, sweating, muscle stiffness, disorientation, increased muscle enzyme levels (detected in a blood test).
You should inform your doctor if you are taking medicines that may affect heart rhythm.
Examples of such medicines include:
The following medicines may also interact with Venlafaxine Teva and should be used with caution. It is especially important to inform your doctor if you are taking medicines containing:
Venlafaxine Teva should be taken with food (see section 3 "How to take Venlafaxine Teva").
Do not drink alcohol while taking Venlafaxine Teva. Taking it with alcohol may cause extreme fatigue and loss of consciousness, as well as increase the symptoms of depression and other conditions, such as anxiety disorders.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. Venlafaxine Teva should only be used after consulting your doctor about the potential benefits and risks to the unborn child.
You should inform your doctor and/or midwife about taking Venlafaxine Teva. Taking similar medicines (SSRIs) during pregnancy may increase the risk of serious complications in the newborn, called persistent pulmonary hypertension of the newborn (PPHN), which is characterized by rapid breathing and blue discoloration. These symptoms usually appear within the first day of life. If such symptoms occur in the newborn, you should immediately contact the midwife and/or doctor.
Taking Venlafaxine Teva at the end of pregnancy may increase the risk of severe vaginal bleeding shortly after delivery, especially if there is a history of bleeding disorders in the patient. If you are taking Venlafaxine Teva, you should inform your doctor or midwife so that they can provide you with appropriate advice.
If you are taking this medicine during pregnancy, after the baby is born, in addition to breathing difficulties, the baby may experience other symptoms, such as problems with sucking. If you are concerned about such symptoms in your newborn, you should contact your doctor and/or midwife, who will be able to provide you with proper advice.
Venlafaxine Teva passes into breast milk. There is a risk of affecting the baby. Therefore, you should discuss this with your doctor, and your doctor will decide whether to stop breastfeeding or stop treatment with this medicine.
You should not drive or operate machinery until you know how the medicine affects you.
If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine.
This medicine should always be taken exactly as your doctor has told you. If you are not sure, you should ask your doctor or pharmacist.
Usually, the recommended initial dose for the treatment of depression, generalized anxiety disorder, social phobia is 75 mg per day. This dose may be gradually increased by your doctor if necessary, up to a maximum dose of 375 mg per day in the case of depression. In the case of panic disorder, treatment should be started with a lower dose (37.5 mg) and then gradually increased. The maximum dose for the treatment of generalized anxiety disorder, social phobia, and panic disorder is 225 mg per day.
Venlafaxine Teva should be taken orally.
Venlafaxine Teva should be taken daily at approximately the same time, regardless of whether the medicine is taken in the morning or evening. To ensure that the pellets (granules inside the capsules) are swallowed completely, the capsules should be swallowed whole, with a drink of water, and not opened, crushed, chewed, or dissolved.
Venlafaxine Teva should be taken with food.
If you have liver or kidney problems, you should inform your doctor, as there may be a need to adjust the dose.
Do not stop taking this medicine without consulting your doctor (see "Stopping Venlafaxine Teva treatment").
If you have taken more than the recommended dose of the medicine, you should immediately contact your doctor or pharmacist.
Overdose can be life-threatening, especially when taken with alcohol and/or certain medicines (see "Venlafaxine Teva and other medicines").
Symptoms of possible overdose may include rapid heart rate, changes in consciousness (from drowsiness to coma), changes in vision, seizures, and vomiting.
If you forget to take a dose, you should take it as soon as possible. However, if it is almost time for your next dose, you should skip the missed dose and take only one dose at the usual time. Do not take a double dose of Venlafaxine Teva in one day, more than the daily dose of Venlafaxine Teva prescribed by your doctor.
You should not stop treatment or reduce the dose of the medicine without consulting your doctor, even if you feel better. If your doctor decides that you can stop taking Venlafaxine Teva, they will tell you how to gradually reduce the dose before completely stopping treatment. When stopping this medicine, especially if treatment is stopped abruptly or the dose is reduced too quickly, side effects may occur. Some patients may experience symptoms such as suicidal thoughts, aggressive behavior, fatigue, dizziness, headache, insomnia, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, restlessness, disorientation, ringing in the ears, tingling or numbness, weakness, sweating, seizures, or flu-like symptoms, and changes in vision 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 Teva. This may take several weeks or months. In some patients, it may be necessary to stop the medicine very gradually over a period of months or longer. If you experience any of the symptoms mentioned above or other symptoms that are troublesome to you, you should consult your doctor.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, you should stop taking Venlafaxine Teva and immediately contact your doctor or go to the emergency department of the nearest hospital:
You should tell your doctorif you experience other side effects, such as (the frequency of these side effects is listed below in the "Other side effects" section):
Venlafaxine Teva may sometimes cause side effects that you are not aware of, such as increased blood pressure or abnormal heart function; slight changes in sodium, cholesterol, or liver enzyme levels in the blood. More rarely, Venlafaxine Teva may affect platelet function, leading to an increased risk of bruising or bleeding. Therefore, your doctor may recommend a blood test from time to time, especially during long-term treatment with Venlafaxine Teva.
If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
The medicine should be stored out of sight and reach of children.
Do not use Venlafaxine Teva after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
The active substance of the medicine is venlafaxine.
Venlafaxine Teva, 37.5 mg:
Each prolonged-release capsule contains venlafaxine hydrochloride, equivalent to 37.5 mg of venlafaxine.
Venlafaxine Teva, 75 mg:
Each prolonged-release capsule contains venlafaxine hydrochloride, equivalent to 75 mg of venlafaxine.
Venlafaxine Teva, 150 mg:
Each prolonged-release capsule contains venlafaxine hydrochloride, equivalent to 150 mg of venlafaxine.
The other ingredients are:
Capsule contents: Sucrose, pellets (sucrose + cornstarch), hypromellose, type 2910, ethylcellulose, type B, talc.
Capsule shell:
Venlafaxine Teva, 37.5 mg:
Black iron oxide (E 172), titanium dioxide (E 171), gelatin, red iron oxide (E 172)
Venlafaxine Teva, 75 mg:
Red iron oxide (E 172), titanium dioxide (E 171), gelatin
Venlafaxine Teva, 150 mg:
Yellow iron oxide (E 172), titanium dioxide (E 171), gelatin, red iron oxide (E 172)
Ink: shellac, propylene glycol, concentrated ammonia solution, black iron oxide (E172), potassium hydroxide
Venlafaxine Teva 37.5 mg:
Hard capsules with a non-transparent, gray cap and a non-transparent, pink body, filled with white to beige microgranules. The capsules are marked with black ink on the cap with the inscription "VNL" and on the body with "37.5". Dimensions: approximately 16 mm x 6 mm
Venlafaxine Teva 75 mg:
Hard capsules with a non-transparent, pink cap and a non-transparent, pink body, filled with white to beige microgranules. The capsules are marked with black ink on the cap with the inscription "VNL" and on the body with "75". Dimensions: approximately 20 mm x 7 mm.
Venlafaxine Teva 150 mg:
Hard capsules with a non-transparent, brown cap and a non-transparent, brown body, filled with white to beige microgranules. The capsules are marked with black ink on the cap with the inscription "VNL" and on the body with "150". Dimensions: approximately 24 mm x 8 mm.
Blisters containing: 10, 14, 20, 28, 30, 50, 98, and 100 prolonged-release, hard capsules or single-dose blisters containing 100x1 prolonged-release, hard capsules.
Not all pack sizes may be marketed.
Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands
Teva Pharma S.L.U.
C/C, n. 4, Poligono Industrial Malpica
50016 Zaragoza,
Spain
Teva Operations Poland Sp. z o.o.
ul. Mogilska 80,
31-546 Kraków
Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warszawa, tel. (22) 345 93 00.
Austria:
Venlafaxin Actavis
Bulgaria:
Лароксин XR
Croatia: Velafax XL
Denmark:
Venlafaxin Teva
Laroxin XR
Finland:
Venlafaxin ratiopharm
France:
VENLAFAXINE TEVA LP
Netherlands:
Venlafaxine retard Teva
Iceland;
Venlafaxin Teva
Luxembourg: Venlafaxin-ratiopharm
Germany:
Venlafaxin-ratiopharm
Norway: Venlafaxin Teva
Poland:
Venlafaxine Teva
Portugal: Venlafaxina ratiopharm
Sweden:
Venlafaxin Teva
Italy:
Venlafaxina Teva
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