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What you need to know before you take Mirtazapine Oral Solution

Do not take Mirtazapine: ■ if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, you must talk to your doctor as soon as you can before taking Mirtazapine. ■ if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is) ■ if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking mirtazapine or other medicinal products. Warnings and precautions Talk to your doctor or pharmacist before taking Mirtazapine. Children and adolescents Mirtazapine should normally not be used for children and adolescents under 18 years because efficacy was not demonstrated. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Mirtazapine for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Mirtazapine for a patient under 18 and you want to discuss this, please go back to your doctor.You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Mirtazapine. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Mirtazapine in this age group have not yet been demonstrated. In addition, significant weight gain has been observed in this age category more often when treated with Mirtazapine compared with adults. Thoughts of suicide and worsening of your depression If you are depressed you can sometimes have thoughts of harming or killing yourself.These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer. You may be more likely to think like this: ■ if you have previously had thoughts about killing or harming yourself. ■ if you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant. Ú If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straightaway. 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 behaviour. The use of Buprenorphine together with Mirtazapine can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Mirtazapine”). Also take special care with Mirtazapine ■ serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of mirtazapine. Stop using and seek medical attention immediately if you notice any of the symptoms described in section 4 in relation to these serious skin reactions. If you have ever developed any severe skin reactions, treatment with mirtazapine should not be restarted. ■ if you have, or have ever had one of the following conditions. Ú Tell your doctor about these conditions before taking Mirtazapine, if not done previously – seizures (epilepsy). If you develop seizures or your seizures become more frequent, stop taking Mirtazapine and contact your doctor immediately – liver disease, including jaundice. If jaundice occurs, stop taking Mirtazapine and contact your doctor immediately – kidney disease – heart disease, or low blood pressure – schizophrenia. If psychotic symptoms, such as paranoid thoughts become more frequent or severe, contact your doctor straightaway – manic depression (alternating periods of feeling elated/overactivity and depressed mood). If you start feeling elated or over-excited, stop taking Mirtazapine and contact your doctor immediately – diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines) – eye disease, such as increased pressure in the eye (glaucoma) – difficulty in passing water (urinating), which might be caused by an enlarged prostate – certain kinds of heart conditions that may change your heart rhythm, a recent heart attack, heart failure, or take certain medicines that may affect the heart’s rhythm. ■ if you develop signs of infection such as inexplicable high fever, sore throat and mouth ulcers. Ú Stop taking Mirtazapine and consult your doctor immediately for a blood test. In rare cases these symptoms can be signs of disturbances in blood cell production in the bone marrow. While rare, these symptoms most commonly appear after 4-6 weeks of treatment. ■ if you are an elderly person.You could be more sensitive to the side-effects of antidepressants. Other medicines and Mirtazapine Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Do not take Mirtazapine in combination with: ■ monoamine oxidase inhibitors (MAO inhibitors). Also, do not take Mirtazapine during the two weeks after you have stopped taking MAO inhibitors. If you stop taking Mirtazapine, do not take MAO inhibitors during the next two weeks either. Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used for Parkinson’s disease). Take care when taking Mirtazapine in combination with: ■ antidepressants such as SSRIs, venlafaxine and L-tryptophan or triptans (used to treat migraine), tramadol (a painkiller), linezolid (an antibiotic), lithium (used to treat some psychiatric conditions), methylene blue (used to treat high levels of methemoglobin in the blood) and St. John’s Wort – Hypericum perforatum preparations (a herbal remedy for depression). In very rare cases Mirtazapine alone or the combination of Mirtazapine with these medicines, can lead to a so-called serotonin syndrome. Some of the symptoms of this syndrome are: inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness. If you get a combination of these symptoms, talk to your doctor immediately. ■ the antidepressant nefazodone. It can increase the amount of Mirtazapine in your blood. Inform your doctor if you are using this medicine. It might be needed to lower the dose of Mirtazapine, or when use of nefazodone is stopped, to increase the dose of Mirtazapine again. ■ medicines for anxiety or insomnia such as benzodiazepines, medicines for schizophrenia such as olanzapine, medicines for allergies such as cetirizine, medicines for severe pain such as morphine. In combination with these medicines Mirtazapine can increase the drowsiness caused by these medicines. buprenorphine/ opioids (morphine or naloxone) – These medicines may interact with Mirtazapine and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension and body temperature above 38°C. Contact your doctor when experiencing such symptoms. ■ medicines for infections: medicines for bacterial infections (such as erythromycin, medicines for fungal infections (such as ketoconazole) and medicines for HIV/AIDS (such as HIV-protease inhibitors) and drugs for stomach ulcers (such as cimetidine). In combination with Mirtazapine these medicines can increase the amount of Mirtazapine in your blood. Inform your doctor if you are using these medicines. It might be needed to lower the dose of Mirtazapine, or when these medicines are stopped, to increase the dose of Mirtazapine again. ■ medicines for epilepsy such as carbamazepine and phenytoin, medicines for tuberculosis such as rifampicin. In combination with Mirtazapine these medicines can reduce the amount of Mirtazapine in your blood. Inform your doctor if you are using these medicines. It might be needed to increase the dose of Mirtazapine, or when these medicines are stopped to lower the dose of Mirtazapine again. ■ medicines to prevent blood clotting such as warfarin. Mirtazapine can increase the effects of warfarin on the blood. Inform your doctor if you are using this medicine. In case of combination it is advised that a doctor monitors your blood carefully. ■ medicines that may affect the heart’s rhythm such as certain antibiotics and some antipsychotics. Mirtazapine with food and alcohol You may get drowsy if you drink alcohol while you are taking Mirtazapine. You are advised not to drink any alcohol. You can take Mirtazapine with or without food. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Limited experience with Mirtazapine administration to pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy. If you use Mirtazapine until, or shortly before birth, your baby should be supervised for possible adverse effects. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish.These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately. Driving and using machines Mirtazapine can affect your concentration or alertness. Make sure these abilities are not affected before you drive or operate machinery. If your doctor has prescribed Mirtazapine for a patient under 18 years make sure the concentration and alertness is not affected before participation in traffic (e.g. on bicycle). Mirtazapine Oral Solution contains: ■ Liquid maltitol (E965) (a type of sugar). If you have been told by your doctor that you have intolerance for some sugars, contact your doctor before taking this medicinal product. ■ Sodium benzoate (E211) 1.2mg in each ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). ■ This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.