MIRZATEN 45 mg. 30 tablets
Mirzaten belongs to a group of medicines called antidepressants. Mirzaten be used for the treatment of depressive disorders.
2. BEFORE YOU TAKE MIRZATEN
Do not use Mirzaten:
- If you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Mirzaten. If so, you should talk to your doctor as soon as you can before use Mirzaten.
- If you are taking or have recently (in the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
Take special care with Mirzaten
Use in children and adolescents under 18 years of age
Mirzaten should generally not be used in children and adolescents under 18 years of age as efficacy is not established. Also you should know that patients under 18 years - age there is an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behavior and anger) when they take this class of medicines. However, your doctor may prescribe Mirzaten patients under the age of 18, if it decides that it is in their interest.
If your doctor has prescribed Mirzaten a patient under the age of 18 and you want to discuss this, please contact your doctor. You should tell your doctor if any of the symptoms listed above appear or worsen when patients under 18 years of age receiving Mirzaten. Furthermore, long-term safety effects of Mirzaten concerning growth, maturation and cognitive and behavioral development in this age group have not yet been established. In addition, compared to adults, a significant weight gain in this age group, more often in the treatment of mirtazapine
Thoughts of suicide and worsening of your depression
If you are depressed you can sometimes have thoughts of harming or killing themselves. These may be increased when first starting antidepressants, since traveling a while these drugs its effects - usually about two weeks but sometimes longer.
More likely to have such thoughts:
• if you have previously had thoughts of suicide or harming yourself.
• If you are a young person. Information or clinical trials showed an increased risk of suicidal behavior in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
♦ If you have thoughts of harming or killing yourself at any time, immediately contact your doctor or go to hospital.
You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behavior. Also take special care with Mirzaten
• if you have or ever had any of the following:
- Tell your doctor about these conditions before taking Mirzaten if you have not already done so.
- Seizures (epilepsy). If you develop seizures or your seizures become more frequent, stop taking Mirzaten and immediately contact your doctor;
- Liver disease including jaundice. If jaundice occurs, stop taking Mirzaten and immediately contact your doctor;
- Kidney disease;
- Heart disease or low blood pressure;
- Schizophrenia. If psychotic symptoms, such as paranoid thoughts occur more often or become severe, immediately contact your doctor;
- Manic depression (alternating periods of feeling elated / overactivity and depressed mood). If you start feeling elated or over-excited, stop taking Mirzaten and immediately contact your doctor;
- Diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines);
- An eye disease such as elevated intraocular pressure (glaucoma);
- Difficulty in the separation of liquids (urination), which may be caused by an enlarged prostate.
• if you develop signs of infection such as inexplicable high fever, sore throat and mouth ulcers.
Stop taking Mirzaten and immediately consult your doctor for a blood test.
In rare cases these symptoms can be signs of disturbances in blood cell production in the bone marrow. Although rare, these symptoms most commonly appear after 4-6 weeks of treatment.
• if you are elderly. You may be more sensitive to the side effects of antidepressants.
Taking other medicines
Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines listed below.
Please also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not take Mirzaten in combination with:
• monoaminookendazata inhibitors (MAOIs).
Do not take Mirzaten also in the two weeks after discontinuation of MAO inhibitors. If you stop taking Mirzaten not take MAO inhibitors during the next two weeks. Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used in the treatment of Parkinson's disease).
Be careful when taking Mirzaten in combination with:
• antidepressants such nnhnbigori reuptake serotonnn (SSKI), venlafakeni and L-tryptophan or triptans (used to treat migraine), tramadol (analgesic), lithium (used to treat some psychiatric conditions) and St. John's Wort Hypericum perforatum (a herbal remedy for depression). In very rare cases Mirzaten alone or the combination of Mirzaten with these drugs can lead to so-called serogoninov syndrome. Some of the symptoms of this syndrome are:
• unexplained fever, sweating, increased heart rate, diarrhea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness. If you get a combination of these symptoms, contact your doctor immediately.
• the antidepressant nefazodone. It can increase the amount of Mirzaten in your blood. Tell your doctor if you are using this medicine. It may be necessary to reduce the dose Mirzaten or when use of nefazodone is stopped, to increase the dose Mirzaten.
• medicines for anxiety or insomnia such as benzodiazepines;
• medicines for the treatment of schizophrenia such as olanzapine;
• drugs for the treatment of allergies such as cetirizine;
• drugs for the treatment of acute pain such as morphine. In combination with these medicines Mirzaten may increase drowsiness caused by these drugs.
• drugs for the treatment of infections, drugs used to treat bacterial infections (such as erythromycin), medicines for the treatment of fungal infections (such as ketoconazole) and medicines for the treatment of HIV / AIDS (e.g. 11IV protease inhibitors).
• medicines to treat stomach ulcers (cimetidine) in combination with Mirzaten these medicines may increase the amount of Mirzaten in your blood. Tell your doctor if you are using these medicines. It may be necessary to reduce the dose Mirzaten or when these medicines are stopped, to increase the dose Mirzaten.
• medicines for the treatment of epilepsy,
• medicines for tuberculosis such as rifampicin. In combination with Mirzaten these medicines can reduce the amount of Mirzaten in your blood. Tell your doctor if you are using these medicines. It may be necessary to increase the dose Mirzaten or when these medicines are stopped, to reduce the dose Mirzaten. • medicines to prevent blood clots, such as warfarin.
Mirzaten can increase the effects of warfarin on the blood. Tell your doctor if you are using this medicine. In case of combination it is advised that a doctor monitors your blood carefully.
Taking Mirzaten is food and drink
You may get drowsy if you drink alcohol while taking Mirzaten. It is recommended not to drink any alcohol. You can take Mirzaten with or without food.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. Limited experience with Mirzaten in pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy. If you take Mirzaten and pregnant or plan to become pregnant, ask your doctor whether you may continue taking Mirzaten. If you use Mirzaten to birth or shortly before birth. Your baby should be supervised for possible adverse reactions.
Tell your doctor / midwife acceptance Mirzaten. When taken during pregnancy, similar drugs (inhibitors plow uptake of serotonin, SSRIs) may increase the risk of developing a serious complication of the baby, called persistent pulmonary hypertension of the newborn (PPHN), associated with the onset of rapid breathing and bruising of the newborn baby. Described symptoms usually appear during the first 24 hours after birth. If these symptoms occur in your baby, you should immediately contact your doctor and / or midwife. Ask your doctor whether you can breast-feed while taking Mirzaten.
Driving and using machines
Mirzaten can affect your concentration or alertness. Make sure these abilities are not affected before you drive or operate machinery.
Important information about some of the ingredients of Mirzaten
Mirzaten film-coated tablets contain lactose.
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this medicine.
3. HOW TO TAKE MIRZATEN
Always take Mirzaten just as you have been told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
How much to take?
The usual starting dose is 15 or 30 mg every day. Your doctor may advise you to increase your dose after a few days to the amount that is best for you (between 15 and 45 mg daily). The dose is usually the same for all ages. However, if you are elderly or have kidney or liver disease. Your doctor may change the dose.
When to take Mirzaten?
Take Mirzaten at the same time each day.
- It is best to take Mirzaten as a single dose at bedtime. However, your doctor may suggest to split your dose Mirzaten - once in the morning and once at night before bedtime. The higher dose should be taken at bedtime.
When can you expect to feel better?
Mirzaten usually starts working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better.
It is important during the first few weeks, talk to your doctor about the effects of Mirzaten:
- 2 to 4 weeks after you start taking Mirzaten should discuss with your doctor how this medication affects you.
If you still do not feel better, your doctor may prescribe a higher dose. In this case, talk to your doctor again after another 2 to 4 weeks.
Usually you will need to take Mirzaten until a period of 4-6 months you do not have symptoms of depression.
If you take more dose Mirzaten
If you or someone else have taken too much Mirzaten, call a physician immediately. The most likely signs of an overdose Mirzaten (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate.
If you forget to take Mirzaten
If you are supposed to take your dose once a day
• If you forget to take your dose Mirzaten not take the missed dose. Just skip it. Take your next dose at the usual time.
If you are supposed to take your dose twice daily
• If you forget to take your morning dose, simply take it together with your evening dose.
• If you forget to take your evening dose, do not take it with the next morning dose; just skip it and continue with your normal morning and evening doses.
• If you forget to take both doses, do not attempt to make up for missed doses. Skip both doses and continue the next day with your normal morning and evening doses.
If you stop taking Mirzaten
Stop taking Mirzaten only after consulting your doctor. If you stop too early, your depression might come back. Once you are feeling better, talk to your doctor. Your doctor will decide when treatment can be stopped. Do not suddenly stop taking Mirzaten, even when your depression has lifted. If you suddenly stop taking Mirzaten, you may feel sick, dizzy, agitated or anxious, and have headaches. These symptoms can be avoided by stopping gradually. Your doctor will tell you how to gradually reduce the dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Mirzaten can cause side effects, although not everybody gets them.
Some side effects are likely to occur is greater than the other. Possible side effects of Mirzaten are described below and can be divided into:
• increased appetite and weight gain
• dry mouth
• shaking or tremors
• rash or skin eruptions (exanthema)
• pain in your joints (arthralgia) or muscles (myalgia)
• back pain
• feeling dizzy or faint when you stand up suddenly (orthostatic hypotension)
• swelling (typically in ankles or feet) caused by fluid retention (edema)
• vivid dreams
• feeling of anxiety
• trouble sleeping
Children under 18 have reported the following side effects, especially in clinical trials: significant weight gain, hives and increased triglycerides in the blood.
• feeling elated or emotionally elation (mania).
• Stop taking Mirzaten and tell your doctor immediately.
• abnormal sensation in the skin eg burning, stinging, tickling or tingling (paraesthesia)
• restless legs
• fainting (syncope)
• reduced sensitivity in the mouth (oral hypoaesthesia)
• low blood pressure
• feeling agitated
• urge to move
• yellow eyes or skin; this may suggest disturbance in liver function (jaundice)
• Stop taking Mirzaten and tell your doctor immediately.
• muscle twitching or contractions (myoclonus)
• aggressive behavior
• signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers (agranulocytosis).
• Stop taking Mirzaten and immediately contact your doctor for a blood test.
In rare cases Mirzaten can cause disturbances in the production of blood cells (suppression of bone marrow function). Some people become less resistant to infection because Mirzaten can cause a temporary shortage of white blood cells (granulocytopenia). In rare cases Mirzaten may also cause a shortage of red and white blood cells, and platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia).
• epileptic attack (convulsions).
STOP Taking Mirzaten and contact your doctor immediately.
• a combination of symptoms such as inexplicable fever, sweating, increased heart rate, diarrhea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness. In very rare cases these symptoms can be signs of serotonin syndrome.
STOP Taking Mirzaten and contact your doctor immediately.
• thoughts of harming or killing
Contact your doctor or go to hospital.
• abnormal sensations in the mouth (oral paraesthesia)
• slurred speech
• swelling in the mouth (mouth edema)
• inadequate secretion of antidiuretic hormone
• severe skin reactions (syndrome Stevens-Johnson, bullous dermatitis, erythema multiforme, toxic epidermal necrolysis).
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MIRZATEN?
Keep out of reach of children.
Mirzaten not use after the expiry date stated on the carton and blister. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
The active substance is mirtazapine (mirtazapine). One tablet contains 30 mg or 45 mg of mirtazapine (as hemihydrate).
The other ingredients of Mirzaten 30 mg film-coated tablets are lactose monohydrate, powdered cellulose, sodium starch glycolate, pregelatinized starch, silicon dioxide, colloidal anhydrous and magnesium stearate in the tablet core and hypromellose, titanium dioxide (E 171), talc, Macrogol 6000,