REMIRTA 45 mg. 30 tablets

ACTAVIS
REMIRTA 45 mg. 30 tablets
€ 39.00
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What Remirta and what it is used
Remirta belongs to a group of medicines called antidepressants.
Remirta be used for the treatment of depressive disorders.

2. What you need to know before taking Remirta
Do not take Remirta:
If you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6);
If you receive or have received in the last two weeks of medicines called monoamine oxidase inhibitors (MAOIs).
Ask your doctor if you are unsure of described above.
Warnings and Precautions
Talk to your doctor or pharmacist before taking Remirta.
Use in children and adolescents below 18 years
Mirtazapine should not normally be used in the treatment of children and adolescents under 18 years of age. 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. However, your doctor may prescribe Remirta for patients under the age of 18, if it decides that this is in their interest. If your doctor has prescribed Remirta 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 Remirta. However, long-term safety effects of Remirta in terms of growth, maturation and cognitive and behavioral development in this age group have not yet been established.

Thoughts of suicide and worsening of your depression
If you are depressed it is possible sometimes to think about harming or killing yourself. These may be increased when first starting antidepressants for the first time, as it takes some time (about two weeks or longer), while these drugs begin to work.

More likely to have such thoughts:
If you have previously had thoughts of harming or killing;
If you are a young person. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years) with mental disorders who were treated with antidepressants.
If you have thoughts of harming or killing yourself at any time, immediately contact your doctor or go to hospital.
For it will be helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to share with you whether your depression is getting worse, or if they are worried by the changes in your behavior.

Also take special care with Remirta:
If you have or ever had any of the following conditions inform your doctor about these conditions before taking Remirta if you have not already done so:
Seizures (epilepsy). If you develop seizures or your seizures begin to occur more often, stop taking Remirta and immediately contact your doctor;
Liver disease, including jaundice. If jaundice occurs, stop taking Remirta 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 serious, it is necessary to immediately call your doctor;
Manic depression (alternating periods of feeling elated / overactivity and depressed mood). If feel elated or over-excited, stop taking Remirta and immediately contact your doctor;
Diabetes (you may need to change the dose of insulin or other antidiabetic agents);
Eye diseases, such as increased intraocular pressure (glaucoma);
Micturition disorders that may be caused by prostate enlargement (prostatic hypertrophy);
If you develop signs of infection such as fever, sore throat and mouth ulcers, stop taking the medication and consult your doctor to perform blood tests. In rare cases, these symptoms could be the result of abnormalities in the formation of blood cells in the bone marrow. Such symptoms most commonly appear after 4-6 weeks of treatment;
If you are elderly, you might be more sensitive to the side effects of antidepressants.
Other medicines and Remirta
Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines.

Your doctor or pharmacist should be informed if you are taking (or plan to take) any of the following medications:
Do not take Remirta in combination with:
Monoamine oxidase inhibitors (MAOIs). Do not take Remirta during the two weeks after discontinuation of MAO inhibitors. If you stop treatment with Remirta, 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).
Be careful when taking Remirta in combination with:
Antidepressants as inhibitors of serotonin reuptake inhibitors (SSRIs), venlafaxine and L-tryptophan or triptans (used for the treatment of migraine), tramadol (analgesic); Linezolid (an antibiotic); lithium (used to treat some psychiatric conditions) and herbal products for the treatment of depression, St. John's wort. In very rare cases Remirta alone or the combination of Remirta with these medicines may lead to the development of so-called serotonin syndrome. Some of the symptoms of this syndrome are: fever, sweating, increased heart rate, diarrhea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness. If a combination of these symptoms, contact your doctor immediately;
Antidepressant nefazodone. It can increase the amount of blood Remirta. Tell your doctor if you are using this medicine. Its use requires a lower dose Remirta, and when stop taking nefazodone, dose Remirta again can be increased;
Medicines to treat anxiety or insomnia such as benzodiazepines;
Medicines to treat schizophrenia such as olanzapine;
Medicines to treat allergies such as cetirizine;
Medicines to treat acute pain such as morphine.
In combination with these medicines Remirta can increase the drowsiness caused by these medicines:
Drugs for treatment of infections, bacterial infections (e.g. erythromycin), fungal infections (such as ketoconazole) and drugs used to treat HIV / AIDS (for example HIV protease inhibitors). When combining Remirta these products it is possible to increase the concentration of Remirta blood. Tell your doctor if you are taking these drugs. It may be necessary to reduce the dose of Remirta or when discontinued these drugs to increase again dose Remirta;
Medicines to treat epilepsy, such as carbamazepine and phenytoin; Drugs for treatment of tuberculosis such as rifampicin.
In combination with Remirta these drugs can reduce the content of Remirta in your blood. Inform your doctor if you use these drugs. It may be necessary to reduce the dose of Remirta, or when you stop taking those drugs again to increase the dose of Remirta:
Drugs that affect clotting here of the blood, such as warfarin.
Remirta can enhance the effects of warfarin on the blood. Inform your doctor if you are using this medicine. In case it needs their combined application is advised that a doctor can closely monitor your blood counts.
Remirta with food, drink and alcohol
You may feel drowsy if you drink alcohol while being treated with Remirta.
It is advisable not to drink any alcohol.
You can take Remirta with or without food.
Pregnancy, lactation and fertility
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 take Remirta and pregnant or planning to become pregnant Ask your doctor whether you can continue taking Remirta. If you use Remirta to or shortly before birth, your baby should be supervised for possible adverse effects.
If you take Remirta should tell the midwife and / or doctor about it. If taken during pregnancy, drugs like Remirta may increase the risk of serious complication in newborns, called persistent pulmonary hypertension in the newborn, leading to shortness of breath and blueness of the baby. These symptoms usually begin within the first 24 hours after the baby is born. Should this occur in your baby, immediately contact your midwife and / or doctor).
Ask your doctor whether you can breast-feed while taking Remirta.

Driving and using machines
Remirta can affect your concentration or alertness. Make sure these abilities are not affected before you drive or operate machinery.

Remirta contains lactose monohydrate
If your doctor has told you that you have an intolerance to some sugars, contact him before taking this product.

3. How to take Remirta
Always take this medicine exactly as prescribed by your doctor. If you're 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 intake of a few days to a dose that is best for you (between 15 mg and 45 mg daily). The dose is usually the same for all ages. However, if you are elderly or have kidney or liver problems, your doctor may change the dose.

When taking Remirta
Take Remirta at the same time each day.
It is best to take Remirta as a single dose at bedtime. Your doctor can offer to split the intake of Remirta - once in the morning and once at night before bedtime. The higher dose should be taken at bedtime.
Take the tablets by mouth. Tablets should be swallowed without chewing, with some water.

When can you expect a result
Remirta usually starts working after 1 to 2 weeks and after 2 to 4 weeks you may feel better.
It is important during the first few weeks of treatment, talk to your doctor about the effects of Remirta.
2 to 4 weeks after you start treatment with Remirta you should discuss with your doctor how you affect this medicine.
If you still do not feel better, your doctor may prescribe a higher dose. In this case, discuss the results with him again after 2-4 weeks.
It is usually necessary to take Remirta until a period of 4-6 months you do not have symptoms of depression.

If you take more dose
If you or someone you take more than the prescribed dose immediately call a doctor. The most likely symptoms of overdose with Remirta (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate.

If you forget to take Remirta
If you are supposed to take your dose once a day:
If you forget to take your dose, do not take the missed dose. Take your next dose at the usual time.
If you are supposed to take your dose twice daily:
If you missed your morning dose, take it together with your evening;
If you forget your evening dose, do not add to the morning; just skip it and then continue with the usual morning and evening reception;
If you have forgotten both doses, do not attempt to make up for missed doses. Skip both doses and then continue with the normal intake in the morning and evening.
If you stop taking Remirta
Stop taking Remirta only after consulting your doctor.
If you stop treatment too soon, your depression will resume. Once you feel better, talk to your doctor. He will decide when treatment can be stopped.
Do not suddenly stop taking Remirta even when your depression has lifted. If you stop abruptly Remirta, it may feel sick, dizzy, nervous, tense, anxious, and have headaches. These symptoms can be avoided by gradually stop taking the drug. Your doctor will tell you how to reduce your dose gradually.

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.

Some side effects are more common than others. Possible side effects are listed below, and may be divided into ::
Very common - affecting more than 1 user in 10;
Common - affecting 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 - affecting less than 1 user in 10 000;
Not known - from the available data can not be estimated.
Very common:
Increased appetite and weight gain;
Drowsiness;
Comfort;
Headache;
Dry mouth.
Common:
Lethargy;
Dizziness;
Shaking or tremors;
Nausea;
Diarrhea;
Vomiting;
Rash or skin eruptions (exanthema);
Joint pain (arthralgia) or muscles (myalgia);
Back pains;
Dizziness or fainting when standing up (postural hypotension);
Edema (swelling in the ankle and foot) caused by fluid retention;
Fatigue;
Vivid dreams;
Confusion;
Anxiety;
Sleep problems.
Uncommon:
Feeling elated or emotionally elation (mania). Stop taking Remirta and immediately tell your doctor;
Abnormal skin sensitivity, burning, stinging, tickling or tingling (paraesthesia);
Restless legs;
Fainting (syncope);
Feeling of numbness of the mouth;
Low blood pressure;
Nightmares;
Tension;
Hallucinations;
Need to move.
Rare:
aggression;
yellowing of the skin and eyes, in what could be suspected hepatic dysfunction (jaundice). Stop taking Remirta and tell your doctor immediately;
muscle spasms or contractions (myoclonus);
pancreatitis (inflammation of the pancreas).
Not known:
Signs of infection, such as an abrupt, unexplained fever, sore throat, ulcers in the mouth (agranulocytosis). Stop taking the drug immediately and consult a doctor to perform the blood tests;
In rare cases Remirta disrupt the production of blood cells (suppression of bone marrow function). Some people become less resistant to infection because Remirta can cause a temporary shortage of white blood cells (granulocytopenia). In rare cases Remirta can also cause a shortage of red and white blood cells, and platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or enhance some of the white blood cells (eosinophilia);
Seizures (convulsions). Stop treatment 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, unconsciousness. In very rare cases this may be signs of serotonin syndrome. Stop taking the drug and contact your doctor immediately;
Thoughts of harming or killing themselves. Immediately consult your doctor or go to hospital;
Abnormal sensations in the mouth (oral paraesthesia); speech disorders;
Swelling in the mouth (edema); increased salivation;
Hyponatremia (reduced sodium);
Inappropriate antidiuretic hormone;
Somnanbulizam (you are walking during sleep);
Severe skin reactions (toxic epidermal necrolysis, Stevens-Johnson, bullous dermatitis, erythema multiforme).
Additional side effects in children and adolescents
The following adverse reactions have been observed in children, mainly in clinical trials: weight gain, hives and increased triglycerides in the blood.

5. How to store Remirta

Keep out of reach of children.
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