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What Remeron is and what it is used for
Mirtazapine is one of a group of medicines called antidepressants. Mirtazapine is used to treat depressive illness.
How to take Remeron
Always take this medicine exactly as your doctor or pharmacist tells you to. You should check with your doctor or pharmacist if you are not sure. The recommended dose is The usual starting dose is 15 or 30mg every day. Your doctor may advise you to increase your dose after a few days to the amount that may be best for you (between 15 and 45mg per day). The dose is usually the same for all ages. However, if you are an elderly person or if you have renal or liver disease, your doctor may adapt the dose. When to take Mirtazapine Orodispersible tablets Take Mirtazapine Orodispersible tablets at the same time each day. It is best to take Mirtazapine Orodispersible tablets as a single dose before you go to bed. However your doctor may suggest to split your dose of Continued top of next column BBBA3071 Continued over page Package leaflet: Information for the patient T00073-01 Malta Zejtun 170x380 PIL * Please note that only Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date Proof Round [email protected] Technical Approval Colours Non Printing Colours Date sent: Date received: Item number: Originator: Origination Date: Revision Date: Revised By: Dimensions: Min Body Text Size: Supplier: 1. 2. 3. 4. 5. 6. 1. 2. 3. FMD info NA (not a carton) No Yes Details Mirtazapine Orodispersible 15mg, 30mg & 45mg Tablets (Blister packing) PIL
•UK Black BBBA3071 RH 28-09-18 29-10-18 RH 170 x 380 7pt Actavis Malta Zejtun 28-09-18 05 01-10-18 Version 2 01.11.2017 Continued top of next column BBBA3071 Accord Healthcare Ltd, North Harrow, HA1 4HF, UK Mirtazapine Orodispersible tablets – once in the morning and once at night-time before you go to bed. The higher dose should be taken before you go to bed. Take the orodispersible tablets as follows; Take your tablets orally. 1.Do not crush the orodispersible tablet In order to prevent crushing the orodispersible tablet, do not push against the tablet pocket (Figure 1). 2. Tear off one tablet pocket Each blister contains six pockets, which are separated by perforations. Tear off one tablet pocket along the dotted lines (Figure 2). 3. Peel off the lid Carefully peel off the lidding foil starting at the corner as indicated by the arrow (Figure 3 and 4). 4. Take out the orodispersible tablet Take the tablet out of the pocket with dry hands and place it on the tongue (Figure 5). It will rapidly disintegrate and can be swallowed without water. When can you expect to start feeling better Usually Mirtazapine Orodispersible tablets will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better. It is important that, during the first few weeks of the treatment, you talk to your doctor about the effects of Mirtazapine Orodispersible tablets: 2 to 4 weeks after you have started taking Mirtazapine Orodispersible tablets, talk to your doctor about how this medicine has affected you. If you still don’t feel better, your doctor may prescribe a higher dose. In that case, talk to your doctor again after another 2 to 4 weeks. Usually you will need to take Mirtazapine Orodispersible tablets until your symptoms of depression have disappeared for 4 to 6 months. If you take more Mirtazapine Orodispersible tablets than you should If you or someone else have taken too many Mirtazapine Orodispersible tablets, call a doctor straight away. The most likely signs of an overdose of Mirtazapine Orodispersible tablets (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate. The symptoms of a possible overdose may include changes to your heart rhythm (fast, irregular heartbeat) and/or fainting which could be symptoms of a life-threatening condition known as Torsade de Pointes. If you forget to take Mirtazapine Orodispersible tablets If you are supposed to take your dose once a day
• If you have forgotten to take your dose of Mirtazapine Orodispersible tablets, do not take a double dose to make up for a forgotten dose. Just skip it. Take your next dose at the normal time. If you are supposed to take your dose twice a day
• if you have forgotten to take your morning dose, simply take it together with your evening dose.
• if you have forgotten 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 have forgotten to take both doses, do not attempt to make up for the missed doses. Skip both doses and continue the next day with your normal morning and evening doses. If you stop taking Mirtazapine Orodispersible tablets Only stop taking Mirtazapine Orodispersible tablets in consultation with 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 Orodispersible tablets, even when your depression has lifted. If you suddenly stop taking Mirtazapine Orodispersible tablets 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 decrease the dose gradually. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop taking Mirtazapine Orodispersible tablets and tell your doctor straight away if you experience the following:
• thoughts of harming or killing yourself. Contact your doctor or go to a hospital straight away.
• severe form of skin rash with flushing, fever, blisters or ulcers (StevensJohnson Syndrome). Skin blistering or inflammation (Dermatitis bullous), widespread skin rash – circular, irregular red patches on the skin of the hands and arms (Erythema multiforme). Severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (toxic epidermal necrolysis).
• feeling elated or emotionally ‘high’ (mania)
• yellow colouring of eyes or skin; this may suggest disturbance in liver function (jaundice)
• signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcer (agranulocytosis) contact your doctor straight away for a blood test.
• in rare cases, Mirtazapine Orodispersible tablets can cause disturbances in the production of blood cells (bone marrow depression). Some people become less resistant to infection because Mirtazapine Orodispersible tablets can cause a temporary shortage of white blood cells (granulocytopenia). In rare cases Mirtazapine can also cause a shortage of red and white blood cells, as well as blood platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia).
• epileptic attack (convulsions)
• a combination of symptoms such as inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness. In very rare cases these can be signs of serotonin syndrome. Some side effects are more likely to occur than others. The possible side effects of Mirtazapine Orodispersible tablets are listed below and can be divided as:
Very common: affects more than 1 user in 10
• increase in appetite and weight gain
• drowsiness or sleepiness
• dry mouth
Common: affects 1 to 10 users in 100
• shakiness or tremor
• nausea (feeling sick)
• 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 (oedema)
• vivid dreams
• feeling anxious
• sleeping problems
Uncommon: affects 1 to 10 users in 1,000
• abnormal sensation in the skin e.g. burning, stinging, tickling or tingling (paraesthesia)
• restless legs
• fainting (syncope)
• sensations of numbness in the mouth (oral hypoaesthesia)
• low blood pressure
• feeling agitated
• urge to move
Rare: affects 1 to 10 users in 10,000
• muscle twitching or contractions (myoclonus)
• abdominal pain and nausea; this may suggest inflammation of the pancreas (pancreatitis)
Not known: cannot be estimated from the available data
• abnormal sensations in the mouth (oral paraesthesia)
• swelling in the mouth (mouth oedema)
• swelling throughout the body (generalised oedema)
• localised swelling
• speech disorder (dysarthria)
• abnormal muscle breakdown
• increased salivation
• sleep walking
• inappropriate anti-diuretic hormone secretion Other possible side effects with mirtazapine are:
• Increased creatine kinase blood levels, difficulty in passing urine and muscle pain, stiffness and/or weakness and darkening or discoloration of the urine. Children and adolescents In children under 18 years the following adverse events were observed commonly in clinical trials: significant weight gain, hives and increased blood triglycerides.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to Store Remeron
Keep out of the sight and reach of children. Do not store above 25°C. Do not use Mirtazapine Orodispersible tablets after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month. Store in the original package in order to protect from light and moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
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