15 mg, 30 mg and 45 mg orodispersible tablets
mirtazapine<\/p>\n\n\n\n
Remeron-S belongs to a group of medicines called\u00a0antidepressants<\/strong>.<\/p>\n\n\n\n Remeron-S is used to treat depression in adults.<\/p>\n\n\n\n It will take 1-2 weeks before Remeron-S starts working. After 2-4 weeks, you can start to feel better. Contact your doctor if you do not feel better or if you feel worse after 2-4 weeks. For more information, see section 3 under the heading “When you can expect to start feeling better”.<\/p>\n\n\n\n The mirtazapine contained in Remeron-S may also be approved for the treatment of other conditions not mentioned in this leaflet.\u00a0Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.<\/p>\n\n\n\n Talk to your doctor or pharmacist before taking Remeron-S.<\/p>\n\n\n\n Talk to your doctor before taking Remeron-S:<\/strong><\/p>\n\n\n\n If you have ever had a severe skin rash or flaking skin, blisters, and\/or sores in your mouth after taking Remeron \u2011 S.<\/p>\n\n\n\n Children and adolescents<\/strong> These thoughts may be common:<\/p>\n\n\n\n \u2192 Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.<\/p>\n\n\n\n It can be helpful to tell a relative or close friend that you are depressed. <\/strong>Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.<\/p>\n\n\n\n Also, take special care with Remeron-S<\/p>\n\n\n\n Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Do not take Remeron-S<\/strong> in combination with:<\/p>\n\n\n\n Be careful<\/strong> with Remeron-S in combination with:<\/p>\n\n\n\n You may become drowsy if you drink alcohol while using Remeron-S.<\/p>\n\n\n\n You should not drink any alcohol.<\/p>\n\n\n\n You can take Remeron-S with or without food.<\/p>\n\n\n\n If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.<\/p>\n\n\n\n Limited experience with Remeron-S in pregnant women shows no increased risk.\u00a0However, caution should be exercised when used during pregnancy.<\/p>\n\n\n\n If you are using Remeron-S until or just before delivery, your baby should be checked for any\u00a0side effects.<\/p>\n\n\n\n When similar drugs (\u00a0SSRIs\u00a0) are used during pregnancy, the risk of a serious condition called\u00a0persistent\u00a0pulmonary\u00a0hypertension\u00a0in the newborn (PPHN) may increase.\u00a0This condition causes the baby to breathe faster and look blue.\u00a0The symptoms usually appear within 24 hours of the baby being born.\u00a0If this affects your baby, contact your midwife and\/or doctor immediately.<\/p>\n\n\n\n Remeron-S may affect your concentration or reactivity. Make sure your ability has not been affected before driving or using tools or machines. If your doctor has prescribed Remeron-S to a patient under the age of 18, make sure that their ability to concentrate and react is not affected before the person enters traffic (eg by bicycle).<\/p>\n\n\n\n You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.\u00a0One of the factors that can affect your ability in these respects is the use of drugs due to their effects and\/or\u00a0side effects.\u00a0Descriptions of these effects and\u00a0side effects\u00a0can be found in other sections.\u00a0Read all the information in this leaflet for guidance.\u00a0If you are not sure, talk to your doctor or pharmacist.<\/p>\n\n\n\n Remeron-S orodispersible tablets contain sugar spheres with sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.<\/p>\n\n\n\n Remeron-S orodispersible tablets contain aspartame, a source of phenylalanine<\/strong><\/p>\n\n\n\n This medicine contains aspartame, a source of phenylalanine. Each 15 mg orodispersible tablet contains 4.65 mg aspartame. Each 30 mg orodispersible tablet contains 9.3 mg of aspartame. Each 45 mg orodispersible tablet contains 13.95 mg of aspartame.<\/p>\n\n\n\n It can be harmful to people with phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in the body.<\/p>\n\n\n\n Remeron orodispersible tablets contain sodium<\/strong><\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per orodispersible tablet, ie is essential ‘sodium-free’.<\/p>\n\n\n\n Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.<\/p>\n\n\n\n How much to take<\/strong><\/p>\n\n\n\n The recommended starting dose is 15 or 30 mg per day.\u00a0<\/strong>Your doctor may increase the\u00a0dose\u00a0one after a few days to the amount that is best for you (between 15 and 45 mg per day).\u00a0Dose\u00a0one is usually the same for all age groups.\u00a0If you are elderly or have kidney or liver disease, your doctor may need to adjust your\u00a0dose.<\/p>\n\n\n\n When to take Remeron-S<\/strong><\/p>\n\n\n\n \u2192 Take Remeron-S at the same time each day. It is best to take Remeron-S as a single dose before going to bed. However, your doctor may suggest that you split the dose of a Remeron-S – once in the morning and once at night before going to bed. The higher dose one should take before going to bed.<\/p>\n\n\n\n Take the\u00a0orodispersible\u00a0tablets as follows<\/strong><\/p>\n\n\n\nWhat you need to know before you take Remeron-S<\/h2>\n\n\n\n
Do not take Remeron-S<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Remeron-S should not normally be used in the treatment of children and adolescents under 18 years of age as no effect has been demonstrated.\u00a0The risk of\u00a0side effects\u00a0such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when taking drugs of this type.\u00a0Despite this, Remeron\u00acS can be prescribed to patients under 18 years of age, if the doctor deems it appropriate.\u00a0If your doctor has prescribed Remeron-S for someone under the age of 18 and you want to discuss this, you should consult your doctor again.\u00a0You should also tell your doctor if you notice any of the above symptoms or if they get worse when patients under 18 use Remeron-S.\u00a0The long-term effects of Remeron-S on growth, maturation, cognitin, and behavioral development have not yet been established for children and adolescents under 18 years of age.\u00a0In addition, significant weight gain has been observed more frequently in this age group when receiving Remeron-S compared to adults.<\/p>\n\n\n\n
If you start to feel worse and have thoughts of harming yourself<\/strong>
You who are depressed can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking antidepressants, as it takes time for a drug of this type to take effect, usually about 2 weeks, sometimes longer.<\/p>\n\n\n\n
\u2192 Tell your doctor about these conditions before you start taking Remeron-S if you have not done so before
–\u00a0seizures<\/strong>\u00a0(\u00a0epilepsy\u00a0).\u00a0If you get cramps or if your cramps come more often, stop taking Remeron-S and contact your doctor immediately;
–\u00a0liver disease<\/strong>, including jaundice.\u00a0If you get jaundice, stop taking Remeron-S and contact your doctor immediately;
–\u00a0kidney disease\u00a0;
–\u00a0heart disease, or\u00a0low blood pressure\u00a0;
–\u00a0schizophrenia.\u00a0If psychotic symptoms such as paranoid thoughts occur more often or become more severe, contact your doctor immediately;
–\u00a0manic depression\u00a0(alternating periods of feeling elated\/overactive and depressed).\u00a0If you start to feel excited or overexcited, stop taking Remeron-S and contact your doctor immediately;
–\u00a0diabetes\u00a0(you may need to adjust\u00a0the dose\u00a0one on\u00a0insulin\u00a0or other antidiabetic drugs);
–\u00a0eye disease, such as increased pressure in the eye (\u00a0glaucoma);
–\u00a0difficulty\u00a0urinating (urinating), which may be due to enlarged prostate;
–\u00a0certain types of heart problems\u00a0that can change your heart rhythm, a recent heart attack,\u00a0heart failure, or taking certain medications that can affect your heart rhythm.<\/li>
\u2192 Stop taking Remeron-S and contact your doctor immediately for a blood test.
In rare cases, these symptoms may be a sign of a disturbance in the production of\u00a0blood cells\u00a0in the\u00a0bone marrow.\u00a0It is rare, but if they do occur, it is generally after 4-6 weeks of treatment.<\/li>Other medicines and Remeron-S<\/h2>\n\n\n\n
Examples of\u00a0MAO inhibitors\u00a0are moclobemide, tranylcypromine<\/a> (both are antidepressants), and\u00a0selegiline\u00a0(used in\u00a0Parkinson’s disease\u00a0).<\/li><\/ul>\n\n\n\n
schizophrenia drugs\u00a0such as olanzapine;\u00a0anti-allergy
medicines like\u00a0cetirizine\u00a0;
medicines for severe pain\u00a0such as morphine.
Combining these medicines with Remeron-S may increase the drowsiness of these medicines.<\/li>
In combination with Remeron-S, these medicines may increase the amount of Remeron-S in your blood.\u00a0Tell your doctor if you are taking these medicines.\u00a0You may need to reduce the\u00a0dose\u00a0of one Remeron-S and increase it again when you stop taking these medicines.<\/li>
drugs against\u00a0tuberculosis\u00a0such as rifampicin.
In combination with Remeron-S, these medicines can reduce the amount of Remeron-S in your blood.\u00a0Tell your doctor if you are taking these medicines.\u00a0You may need to increase the\u00a0dose\u00a0of one of Remeron-S, and decrease it again when you stop taking these medicines.<\/li>
Remeron-S may increase the effect of\u00a0warfarin\u00a0on the blood.\u00a0Tell your doctor that you are using this medicine.\u00a0If they are combined, it is advisable that your doctor carefully examines your blood.<\/li>Remeron-S with food and alcohol<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Remeron-S orodispersible tablets contain sugar spheres with sucrose<\/h2>\n\n\n\n
How to take Remeron-S<\/h2>\n\n\n\n