Mirtazapine 30mg Tablets
RelonGhem
PACKAGE LEAFLET: INFORMATION FOR THE USER
Mirtazapine 30mg Tablets
Read all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Mirtazapine Tablets are and what they are used for
2. Before you take Mirtazapine Tablets
3. How to take Mirtazapine Tablets
4. Possible side effects
5. How to store Mirtazapine Tablets
6. Further Information
1. What Mirtazapine Tablets are and what they are used for
Mirtazapine is one of a group of medicines called antidepressants. Depression is linked to a shortage of substances which carry messages in the brain (including serotonin and noradrenaline). Mirtazapine helps to relieve the shortage of these 'brain messages'. Common signs of depression include feelings of worthlessness or deep sadness, difficulty with everyday tasks, sleeping too much or not being able to sleep, feeling anxious and changes in appetite.
It may take 2 to 4 weeks before you start to feel better and sleep better. It is important to take Mirtazapine every day and not to stop taking it unless your doctor tells you to. If you do, your symptoms may come back.
2. Before you take Mirtazapine Tablets
Do not take Mirtazapine Tablets:
• If you are allergic (hypersensitive) to mirtazapine or any other ingredients in these tablets. An allergic reaction may include a rash, itching or shortness of breath.
• taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
Take special care with Mirtazapine Tablets:
Use in children and adolescents under 18 yearsof age
Mirtazapine should normally not be used for children and adolescents under 18 years because efficacy has not been 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 or anxiety disorder
If you are depressed and/or have anxiety disorders 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.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Tell your doctor before you start taking these tablets:
• If you develop seizures or your seizures become more frequent, stop taking Mirtazapine and contact your doctor immediately.
• If you have heart disease, angina or a heart-attack.
• If you have difficulty passing water (urinating) as this may be caused by an enlarged prostate.
• If you have eye disease or glaucoma.
• If you have schizophrenia. If psychotic symptoms, such as paranoid thoughts become more frequent or severe, contact your doctor straight away.
• If you have 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.
• If you have liver disease (If you get jaundiced, stop taking Mirtazapine and contact your doctor immediately.) or kidney disease.
• If you have low blood pressure.
• If you have diabetes.
• If you are develop signs of infection such as inexplicable high fever, sore throat and mouth ulcers. Stop taking Mirtazapine tablets 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 elderly you may be more sensitive to the side effects of Mirtazapine Tablets.
Taking other medicines:
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines in the following list.
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 pain-killer), linezolid (an antibiotic), lithium (used to treat some psychiatric conditions) and St. Johns 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.
• medicines for infections; medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole) and medicines for HIV/AIDS (such as HIVprotease inhibitors) and cimetidine (used for stomach ulcers and heartburn). 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.
Taking Mirtazapine Tablets with food and drink:
Swallow the tablets whole with a glass of water. You may take your medicine with or without a meal. It is advisable to avoid drinking any alcohol whilst taking Mirtazapine as this can increase drowsiness.
POM
Pregnancy and Breastfeeding:
Ask your doctor or pharmacist for advice before taking any 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 are taking Mirtazapine tablets and you become pregnant or you plan to get pregnant, ask your doctor whether you may continue taking Mirtazapine tablets. If you use Mirtazapine tablets until, or shortly before birth, your baby should be supervised for possible adverse effects. Make sure your midwife and/or doctor knows you are on Mirtazapine. 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.
Ask your doctor whether you can breast-feed, while taking Mirtazapine tablets.
Driving and using machines:
Antidepressants can affect your judgment or coordination. Make sure you are not affected before you drive or operate machinery.
Important information about some of the ingredients of Mirtazapine Tablets:
Mirtazapine Tablets contain lactose monohydrate. If you have been told by your doctor that you have intolerance to some sugars contact your doctor before taking these tablets.
3. How to take Mirtazapine Tablets
Always take Mirtazapine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Swallow the tablets with a glass of water.
Usual dose:
Adults
15mg or 30mg taken orally preferably in the evening. Your doctor may advise you to increase your dose after a few days to the amount that may be best for you.
Elderly: Dose is the same as for adults. As in adults any dose changes should under strict supervision of your doctor.
Patients with liver or kidney problems may be
given a lower dose.
Antidepressants may not make you feel better for the first two weeks or more. This medicine should be taken for as long as your doctor tells you to. It may be dangerous to stop taking it without your doctor's advice.
If you have the impression that the effect of Mirtazapine is too strong or too weak, talk to your doctor or pharmacist.
If you take more Mirtazapine Tablets than you should:
Symptoms of an overdose include disorientation, fast heart beat and prolonged drowsiness. If you swallow too many tablets or someone else accidentally takes your medicine, contact your doctor pharmacist or nearest hospital straight away
Ifyou forget to take Mirtazapine Tablets:
Try to take your Mirtazapine Tablets daily as prescribed. If you forget to take a dose take the next dose at the usual time. Do not take two doses together.
Ifyou stop taking Mirtazapine Tablets:
Do not stop taking Mirtazapine Tablets without first discussing it with your doctor, even if you feel your depression has lifted. If you stop taking Mirtazapine Tablets suddenly, you may feel sick, anxious or agitated and have headaches. It is possible that your symptoms may come back. Once you are feeling better, talk to your doctor who may suggest reducing your dose gradually. This will usually be about 4 to 6 months after you start feeling better.
If you have any further questions on the use of Mirtazapine Tablets ask your doctor or pharmacist.
4. Possible side effects:
Like all medicines, Mirtazapine tablets can cause side
effects, although not everybody gets these side effects.
Some side effects are more likely to occur than others.
Serious side effects
• thoughts of harming or killing yourself.
Contact your doctor or go to a hospital straight away.
• feeling elated or emotionally 'high' (mania). Stop taking Mirtazapine and tell your doctor straight away.
• signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers (agranulocytosis). Stop taking Mirtazapine and contact your doctor straight away for a blood test.
• epileptic attack (convulsions). Stop taking Mirtazapine and tell your doctor straight away.
• 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. Stop taking Mirtazapine and tell your doctor straight away.
• yellow colouring of eyes or skin; this may suggest disturbance in liver function (jaundice). Stop taking Mirtazapine and tell your doctor straight away.
Rare (affects 1 to 10 users in 10,000):
• Inflammation of pancreas (Pancreatitis)
Other side effects
Other possible side effects of Mirtazapine 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
• headache
• dry mouth
Common (affects 1 to 10 users in 100):
• lethargy, tiredness, vivid dreams, sleeping problems
• dizziness, feeling dizzy or faint when you stand up suddenly (orthostatic hypotension), confusion, feeling anxious
• shakiness or tremor
• nausea, diarrhoea, vomiting
• rash or skin eruptions (exanthema)
• pain in your joints (arthralgia) or muscles (myalgia), back pain
• swelling (typically in ankles or feet) caused by fluid retention (oedema)
Uncommon (affects 1 to 10 users in 1,000):
• abnormal sensation in the skin e.g. burning, stinging, tickling or tingling (paraesthesia)
• restless legs, urge to move fainting (syncope)
• sensations of numbness in the mouth (oral hypoaesthesia)
• low blood pressure
• nightmares, feeling agitated, hallucinations
Rare (affects 1 to 10 users in 10,000):
• muscle twitching or contractions (myoclonus)
Frequency not known:
• in rare cases Mirtazapine can cause disturbances in the production of blood cells (bone marrow depression). Some people become less resistant to infection because Mirtazapine 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).
• abnormal sensations in the mouth (oral paraesthesia)
• swelling in the mouth (mouth oedema)
• hyponatraemia
• inappropriate anti-diuretic hormone secretion
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store Mirtazapine Tablets:
Keep out of the reach and sight of children.
Keep the blister in the original packaging.
Do not use after the expiry date shown on the carton. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Further information
What Mirtazapine Tablets contain:
The active substance in this medicine is called mirtazapine.
The 30mg tablets contain 30mg of the active ingredient mirtazapine.
The other ingredients are lactose monohydrate, pregelatinised maize starch, anhydrous colloidal silica, croscarmellose sodium, magnesium stearate, Hypromellose, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E173).
What Mirtazapine Tablets look like and contents of the pack:
Mirtazapine Tablets are brownish, oval, biconvex, film-coated tablets, scored on both sides and marked with 'I' on one side which are supplied in blister packs of 28 tablets.
Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder and manufacturer is:
Relonchem Limited
Cheshire House, Gorsey Lane, Widnes, Cheshire, WA8 0RP, UK.
PL 20395/0044
Date Leaflet revised: September 2013.
