Mirtazapine 30 mg. 30 tablets
Mirtazapine belongs to the group of medicines called antidepressants. Mirtazapine is used for the treatment of depressive disorders.
2. BEFORE YOU TAKE mirtazapine
Do not use Mirtazapine:
if you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Mirtazapine. If so, you should talk to your doctor as soon as you can before you use Mirtazapine;
if you are taking or have recently (in the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
Take special care with Mirtazapine
Use in children and adolescents under 18 years of age:
Mirtazapine should not normally be used in children and adolescents below 18 years as efficacy is not established. Also you should know that patients under 18 years of age have 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. Furthermore, long-term safety effects of Mirtazapine concerning growth, maturation and cognitive and behavioral development in this age group have not yet been established. Furthermore, significant weight gain was observed in this age category more frequently during treatment with mirtazapine compared to adults.
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 self-harm;
if you are a young person. Information from clinical trials has shown 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 Mirtazapine:
if you have or ever had any of the following - Tell your doctor about these conditions before taking Mirtazapine, if you have not already done so:
seizures (epilepsy). If you develop seizures or your seizures become more frequent, stop taking Mirtazapine and immediately contact your doctor;
liver disease including jaundice. If jaundice occurs, stop taking Mirtazapine and immediately contact your doctor;
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 Mirtazapine and immediately contact your doctor;
diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines);
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 Mirtazapine 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 Mirtazapine in combination with:
monoamine oxidase inhibitors (MAOIs). Do not take Mirtazapine also in the two weeks after discontinuation of MAO inhibitors. If you stop taking Mirtazapine, do 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).
Take care when taking Mirtazapine in combination with:
antidepressants as inhibitors of serotonin reuptake (SSRI), venlafaxine and L-tryptophan, or triptans (used for the treatment of migraine), tramadol (analgesic), linezolid (an antibiotic), lithium (used for the treatment of certain psychiatric conditions) and St. John's Wort - Hypericum perforatum (a herbal remedy for depression). In very rare cases Mirtazapine alone or the combination of Mirtazapine with these drugs can lead to so-called serotonin syndrome. Some of the symptoms of this syndrome are: inexplicable 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 mirtazapine in your blood. Tell your doctor if you are using this medicine. It may be necessary to reduce the dose Mirtazapine, or when use of nefazodone is stopped, to increase the dose of Mirtazapine;
drugs for the treatment of anxiety or insomnia such as benzodiazepines;
drugs for 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 Mirtazapine can increase the drowsiness caused by these medicines;
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 (for example HIV protease inhibitors). In combination with Mirtazapine these medicines can increase the amount of Mirtazapine in your blood. Tell your doctor if you are using these medicines. It may be necessary to reduce the dose Mirtazapine, or when these medicines are stopped, to increase the dose of Mirtazapine;
drugs for treatment of epilepsy such as carbamazepine and phenytoin;
drugs for treatment of tuberculosis, such as rifampicin. In combination with Mirtazapine these medicines can reduce the amount of Mirtazapine in your blood. Tell your doctor if you are using these medicines. It may be necessary to increase the dose Mirtazapine, or when these medicines are stopped, to reduce the mirtazapine dose;
medicines to prevent blood clotting such as warfarin. Mirtazapine 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 Mirtazapine with food and drink
You may get drowsy if you drink alcohol while taking Mirtazapine. It is recommended not to drink any alcohol.
You can take Mirtazapine with or without food.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine. Limited experience with the use of mirtazapine in pregnant women do not indicate an increased risk. However, caution should be exercised when used during pregnancy. If you are taking Mirtazapine and you become pregnant or plan to become pregnant, ask your doctor whether you may continue taking Mirtazapine. If you use Mirtazapine until birth or shortly before birth, your baby should be supervised for possible adverse reactions.
Make sure your midwife and / or doctor knows you are on Mirtazapine Aurobindo. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called resistant pulmonary hypertension of the newborn (PPHN), in which the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after birth. If this happens to your baby you should contact your midwife and / or doctor.
Ask your doctor whether you can breast-feed while taking Mirtazapine.
Driving and using machines
Mirtazapine 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 Mirtazapine
Mirtazapine tablets, orodispersible contain aspartame, a source of phenylalanine. May be harmful for people with phenylketonuria.
3. HOW TO TAKE mirtazapine
Always take Mirtazapine exactly as you 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 Mirtazapine
Take Mirtazapine at the same time each day.
It is best to take Mirtazapine as a single dose at bedtime. However, your doctor may suggest to split your dose of Mirtazapine - once in the morning and once at night before bedtime.
The higher dose should be taken at bedtime.
Take the tablet, orodispersible as follows:
Take your tablets orally.
1. Do not crush the tablet, orodispersible.
To avoid breaking the tablet, orodispersible, do not push against the tablet pocket.
2. Tear off one tablet pocket.
Each blister contains six tablet pockets, which are separated by perforations. Tear off one tablet pocket along the dotted lines.
3. Peel off the lid.
Carefully peel off the foil, starting in the corner indicated by the arrow.
4. Remove the tablet, orodispersible.
Remove the tablet, orodispersible, with dry hands and place it on the tongue.
It will rapidly disintegrate and can be swallowed without water.
When can you expect to feel better
Usually Mirtazapine will start 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 Mirtazapine:
2 to 4 weeks after you have started taking Mirtazapine 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 Mirtazapine until a period of 4-6 months you do not have symptoms of depression.
If you take more than the amount of Mirtazapine
If you or someone else have taken too much Mirtazapine, call a physician immediately. The most likely signs of an overdose of Mirtazapine (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate.
If you forget to take Mirtazapine
If you are supposed to take your dose once a day:
If you forget to take your dose of Mirtazapine, do 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 Mirtazapine
Stop taking Mirtazapine 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 Mirtazapine, even when your depression has lifted. If you suddenly stop taking Mirtazapine, 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, Mirtazapine 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 mirtazapine are described below and can be divided into:
Very common: affects more than 1 user in 10;
Common: affects 1 to 10 users in 100;
Uncommon: affects 1 to 10 users in 1000;
Rare: affects 1 to 10 users in 10,000;
Very rare: affects less than 1 user in 10,000;
Not known: from the available data can not be estimated.
increased appetite and weight gain;
shivering or tremors;
rash or skin eruptions (exanthema);
pain in your joints (arthralgia) or muscles (myalgia);
feeling dizzy or faint when you stand up suddenly (orthostatic hypotension);
swelling (typically in ankles or feet) caused by fluid retention (edema);
For children under 18, the following adverse reactions are frequently observed in clinical trials, significant weight gain, hives (urticaria) and increased triglycerides in the blood.
feeling elated or emotionally elation (mania) - Stop taking Mirtazapine and contact your doctor immediately;
abnormal sensation in the skin eg burning, stinging, tickling or tingling (paraesthesia);
sensations of numbness in the mouth (oral hypoaesthesia);
a strong desire to move.
yellowing of eyes or skin; this may suggest disturbance in liver function (jaundice) - Stop taking Mirtazapine and contact your doctor immediately;
muscle spasms or contractions (myoclonus);
signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers (agranulocytosis) - Stop taking Mirtazapine and immediately contact your doctor for a blood test. In rare cases Mirtazapine may cause disturbances in the production of blood cells (inhibition of the function of the bone marrow). Some people become less resistant to infection because Mirtazapine can cause a temporary shortage of white blood cells (granulocytopenia). In rare cases Mirtazapine 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 seizure (convulsions), speech disorder - Stop taking Mirtazapine 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 Mirtazapine and contact your doctor immediately;
thoughts of harming or killing - Immediately contact your doctor or go to hospital;
abnormal sensations in the mouth (oral paraesthesia);
swelling in the mouth (mouth edema), increased salivation;
inappropriate antidiuretic hormone;
skin problem with blisters (Bullous dermatitis);
skin rash which may be blistered, and looks like small targets (dark spots in the middle, surrounded by a bright circles, dark circles around the edge - erythema multiforme);
large rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (syndrome of Stevens-Johnson);
Large, skin rashes causing skin peeling extensive areas of the body (toxic epidermal necrolysis).