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What Venlacon PR is and what it is used for
Venlacon PR is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. People who are depressed and / or anxious are thought to have lower levels of serotonin and norepinephrine in the brain. It is not completely clear how antidepressants work, but they can help by increasing the levels of serotonin and norepinephrine in the brain.
Venlocone PR is intended for the treatment of adults with depression. Venlacon PR is also intended for the treatment of adults with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations) and panic disorder (panic attacks). Proper treatment of depression or anxiety disorders is important to make you feel better. If left untreated, your condition may not go away and may become more serious and difficult to treat.
2. What you need to know before taking Venlacon PR
Do not take Venlacon PR:
If you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6);
If you also take or have ever taken in the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOI along with other medicines, including Venlacon PR, can cause serious or even life-threatening side effects. You should also wait at least 7 days after you stop taking Venlacon PR before taking any MAOIs (see also section "Other medicines and Venlacon PR" and information in this section on "Serotonin syndrome").
Warnings and precautions
Talk to your doctor before taking Venlacon PR if any of the following apply to you:
If you use other medicines that are taken at the same time as Venlacon PR may increase your risk of developing serotonin syndrome (see section "Other medicines and Venlacon PR");
If you have eye problems like certain types of glaucoma (high pressure in the eye);
If you have a history of high blood pressure;
If you have a history of heart problems;
If you have been told that you have an irregular heartbeat;
If you have a history of seizures (seizures);
If you have a history of low blood sodium levels (hyponatremia);
If you have a tendency to develop bruising or a tendency to bleed easily (a history of clotting disorders) or if you are taking other medicines that may increase your risk of bleeding, such as warfarin (used to prevent blood clots);
If you have a history or if someone in your family has had a mania or bipolar disorder (feel over-excited or euphoric);
If you have a history of aggressive behavior.
Venlacon PR can cause anxiety or inability to sit still or upright for the first few weeks of treatment. You should tell your doctor if this happens to you.
Thoughts of suicide and aggravation of your depressive or anxiety disorder
If you are depressed and / or have anxiety disorders, you may sometimes have thoughts of harming yourself or killing yourself. These may be intensified when you first start taking antidepressants, since all these medications take time to take, usually about two weeks, but sometimes longer. You are more likely to think:
If you had previously thought about killing yourself or hurting yourself;
If you are a young man. Information from clinical studies indicates an increased risk of behavior in adolescents (under 25 years of age) with psychiatric conditions who have been treated with antidepressants.
If you ever have thoughts of harming or killing yourself, contact your doctor or go to a hospital immediately.
It may be 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 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.
Oral dry mouth has been reported in 10% of patients treated with venlafaxine. This can increase the risk of caries. Therefore, you should pay special attention to the hygiene of your teeth.
Blood sugar levels may change due to taking Venlacon PR. Therefore, the dosage of your antidiabetic medicines should be adjusted.
Children and adolescents
Use in children and adolescents under 18 years of age
Venlocone PR should not normally be used in children and adolescents under 18 years of age. You should also be aware that patients under 18 are at increased risk of side effects, such as suicidal experience, suicidal thoughts
Other Medicines and Venlacon PR
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Your doctor should decide if you can take Venlacon PR with other medicines. Do not start or stop taking any medicines, including medicines obtained without a prescription, natural or herbal medicines, before consulting your doctor or pharmacist.
Monoamine oxidase inhibitors used to treat depression or Parkinson's disease should not be co-administered with Venlacon PR. Tell your doctor if you have taken such medicines in the last 14 days (MAOI: see "Before taking Venlacon PR").
A potential life-threatening condition or neuroleptic malignant syndrome (NMS) (see "Possible side effects") may occur with venlafaxine, especially when taken with other medicines. Examples of such drugs include:
Tryptanes (used for migraines);
Other medicines for treating depression, such as SNRIs, SSRIs, tricyclic antidepressants, or lithium-containing drugs;
Medicines containing sibutramine (used for weight loss);
Medicines containing linezolid, which is an antibiotic (used to treat infections);
Medicines containing moclobemide, which is a MAOI (used to treat depression);
Medicines containing tramadol, fentanyl, tapentadol, pethidine or pentazocine (used to treat severe pain);
Medicines containing methylene blue (used to treat high levels of methaemoglobin in the blood);
Products containing St. John's wort (also called Hypericum perforatum, which is a natural or herbal medicine used to treat mild depression);
Tryptophan-containing products (used for problems such as sleep and depression);
Antipsychotic medicines (used to treat illnesses with symptoms such as hearing, seeing or sensing non-existent things, misconceptions, unusual suspicion, vague reasoning, or lack of sociability).
The signs and symptoms of serotonin syndrome may include a combination of the following: restlessness, hallucinations, loss of coordination, increased heart rate, fever, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting.
In its most severe form, serotonin syndrome resembles neuroleptic malignant syndrome (NMS). The signs and symptoms of NMS may include a combination of fever, palpitations, sweating, severe muscle stiffness, confusion, increased levels of muscle enzymes (determined by blood tests).
Tell your doctor or seek immediate medical attention at your nearest hospital if you think you are receiving serotonin syndrome.
Please tell your doctor if you are taking any medicines that may affect your heart rate. Examples of such drugs include:
Antiarrhythmics such as quinidine, amiodarone or dofetilide (used to treat arrhythmia);
Antipsychotics such as thioridazine (see serotonin syndrome);
Antibiotics such as erythromycin or moxifloxacin (used for bacterial infections);
Antihistamines (used to treat allergies).
The following medicines may also interact with Venlacon PR and should be used with caution. It is especially important to mention your doctor or pharmacist if you are taking medicines containing:
Ketoconazole (an antifungal medicine);
Haloperidol or risperidone (for the treatment of psychiatric conditions);
Metoprolol (beta-blocker for the treatment of high blood pressure and heart problems).
Venlacon PR with food, drink and alcohol
Venlacon PR should be taken with food (see section 3 "How to take Venlacon PR"). You should avoid alcohol while taking Venlacon PR.
Pregnancy, breastfeeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, ask your doctor for advice before using this medicine. You should only use Venlacon PR after discussing the potential benefits and potential risks to your unborn child with your doctor.
You should make sure your midwife (s) or doctor knows that you are taking Venlacon PR. When taken during pregnancy, such medicines (SSRIs-selective serotonin reuptake inhibitors) may increase the risk of serious newborn infants, called persistent neonatal hypertension (PBC), which causes the baby to breathe fast. until the appearance of bruises. These symptoms usually begin within the first 24 hours after birth. If this happens to your child, you should contact your midwife and / or doctor immediately.
If you are taking this medicine during pregnancy, other symptoms that may appear in your baby after birth are: poor nutrition and difficulty breathing. If your baby has these symptoms when you are born and you are worried, contact your doctor and / or midwife who
If you take more Venlanac PR than you should
Call your doctor or pharmacist immediately if you have taken more Venlacon PR than your doctor prescribed.
Symptoms of possible overdose may include heart palpitations, changes in wakefulness (ranging from drowsiness to coma), blurred vision, seizures or seizures, and vomiting.
If you forget to take Venlacon PR
If you miss a dose, take it as soon as you remember. However, if it is time for the next dose, skip the missed dose and take only a single dose as usual. Do not take a double dose to make up for a forgotten dose. Do not take more than the daily amount of Venlacon PR you have been prescribed for a day.
If you stop taking Venlacon PR
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 Venlacon PR, he / she may ask you to slowly lower your dose before stopping treatment altogether. Adverse reactions are known to occur when people stop using this medicine, especially when the medicine is stopped suddenly or the dose is reduced too quickly. Some patients may experience symptoms such as fatigue, dizziness, dizziness, headache, drowsiness, nightmares, dry mouth, loss of appetite, nausea, diarrhea, nervousness, agitation, confusion, tinnitus, tingling or, rarely, sensation electric shock, weakness, sweating, convulsions or flu-like symptoms.
Your doctor will advise you on how you should gradually stop treatment with Venlacon PR. If you experience any of these or other symptoms of concern, consult your doctor for further advice.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following, do not take Venlacon PR. Tell your doctor immediately or go to the emergency room 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 relief, itchy rash (hives), difficulty swallowing or breathing
With unknown frequency (cannot be estimated from available data):
Chest tightness, wheezing, difficulty swallowing or breathing;
Severe rash, itching or hives (raised plaques of red or pale skin that often itch);
Signs and symptoms of serotonin syndrome, which may include anxiety, hallucinations, loss of coordination, increased heart rate, fever, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting. In its most severe form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). The signs and symptoms of NMS include a combination of fever, palpitations, sweating, severe muscle stiffness, confusion, increased levels of muscle enzymes (found in blood tests).
Signs of infection such as fever, shivering, shaking, headache, sweating, flu-like symptoms. This may be due to blood disorders, leading to an increased risk of infection;
Severe rash that can lead to severe flushing and peeling of the skin;
Inexplicable muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.
Other side effects you should tell your doctor about (the frequency of these side effects is included in the list of "Other side effects" below:
Cough, wheezing, shortness of breath and fever;
Black (gummy) stools or blood in the stools;
Yellowing of the skin and sclera of the eyes, itching or darkening of the urine, which may be a sign of liver inflammation (hepatitis);
Heart problems such as rapid or irregular heart rhythm, high blood pressure;
Eye problems such as blurred vision, dilated pupils;
Nervous problems such as dizziness, needles, movement disorders, seizures or seizures;
Psychiatric problems such as hyperactivity and euphoria (feeling of unusual excitement);
Withdrawal syndrome (see "How to take Venlacon PR", "If you stop taking Venlacon PR");
Prolonged bleeding time - If you cut or injure yourself, stopping bleeding may take longer.
Don't worry if you notice small white pellets or pellets in your stool after taking this medicine. The inside of the Venlacon PR capsules is filled with spheres (small balls) that contain the active substance (venlafaxine). These spheres are released from the capsule in your stomach. As they move from the stomach to the intestine, venlafaxine is slowly released. The shell of the spheres does not open and dissolve
How to store Venlacon PR
Keep out of the reach and sight of children.
Do not use Venlacon PR after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not dispose of medicines into sewage or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Venlakon PR contains
The active substance is venlafaxine.
Venlacon PR 75 mg prolonged-release hard capsules: Each capsule contains 75 mg of venlafaxine, such as venlafaxine hydrochloride.
Venlacon PR 150 mg prolonged-release hard capsules: Each capsule contains 150 mg venlafaxine, such as venlafaxine hydrochloride.
Capsule content: 3 sugar spheres, hypromellose, talc, ethylcellulose.
Capsule shell: Gelatin, titanium dioxide (E 171), red iron oxide (E 172), sodium lauryl sulfate.
Ink: shellac, black iron oxide (E172).
What VENLAKON PR looks like and contents of the pack
Extended release hard capsule.
VENLAKON PR 75 mg prolonged-release hard capsules
Solid size 1 gelatin capsules with opaque, peach-colored lid and opaque, peach-colored body, black lettering "E" on the cap and "74" on the body, filled with white to off-white, spherical to elliptical pellets.
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