Mirtazapine 30mg Film-Coated Tablets
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Patient Information Leaflet MIRTAZAPINE 30mg FILM-COATED 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 further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others.
- It may harm them, even if their symptoms are the same as yours.
In this leaflet:
1. What mirtazapine is and what it is used for?
2. Before you take mirtazapine.
3. How to take mirtazapine.
4. Possible side effects.
5. Storing mirtazapine.
6. More information.
1. WHAT MIRTAZAPINE IS AND WHAT IT IS 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 if 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; felling 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
Do not take mirtazapine:
• if you are allergic to mirtazapine or any of the other ingredients of Mirtazapine 30mg Film-Coated Tablets.
• if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is).
Take special care with mirtazapine:
If you have or have used:
- epilepsy (seizures or fits). If you develop seizures or your seizures become more frequent, stop taking mirtazapine and contact your doctor immediately
- liver disease (including jaundice) or kidney disease. If jaundice occurs, stop taking mirtazapine and contact your doctor immediately.
- heart disease or a heart condition that may change your heart rhythm, a recent heart attack, heart failure or take certain medicines that may affect the heart's rhythm
- low blood pressure
- difficulty in passing water (urinating), which may be caused by an enlarged prostate
- eye disease, such as glaucoma
- diabetes (you may need to adjust your dose of insulin or other antidiabetic medicines)
- schizophrenia. If psychotic symptoms, such as paranoid thoughts become more frequent or severe, contact your doctor straight away.
- 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 develop signs of infection such as inexplicable high fever, sore throat and mouth ulcers. 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.
Alcohol:
You may get drowsy if you drink alcohol while you are taking mirtazapine. It is therefore advisable to avoid drinking any alcohol.
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.
Use in children and adolescents under 18 years of age:
Mirtazapine Film-Coated 30mg Tablets should normally not be used for children and adolescents under 18 years. Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, defiant behaviour and anger) when they take this class of medicines. In addition, significant weight gain has been observed in this age category more often when treated with mirtazapine compared with adults. Despite this, your doctor may prescribe Mirtazapine 30mg Film-Coated Tablets for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Mirtazapine 30mg Film-Coated Tablets 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 30mg Film-Coated Tablets. The long-term safety effects concerning growth, maturation and cognitive and behavioural development of Mirtazapine Film-Coated 30mg Tablets in this age group have not yet been demonstrated.
Pregnancy and Breast-feeding
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 and you become pregnant or you plan to get pregnant, ask your doctor whether you may continue taking mirtazapine. If you use mirtazapine until, or shortly before birth, your baby should be supervised for possible adverse effects. Ask your doctor whether you can breast-feed, while taking mirtazapine.
Make sure your midwife and/or doctor know you are on mirtazapine. When taking during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (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:
Antidepressants can affect your concentration or judgement. When you first start taking mirtazapine, make sure your abilities are not affected before you drive or operate machinery.
Taking other medicines:
Other antidepressants:
You should not take Mirtazapine Film-Coated Tablets if you are taking other antidepressants known as Monoamine Oxidase Inhibitors (MAOIs), or in the two weeks after they have been stopped. If you stop taking mirtazapine, do not take MAOIs during the next two weeks either.
Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used for Parkinson's disease).
Drugs for anxiety or insomnia: Mirtazapine can increase the drowsiness caused by benzodiazepines.
Take care when taking any of the following medicines:
- 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), methylene blue (used to treat high levels of methemoglobin in the blood) 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.
- drugs for infection, such as erythromycin, medicines for fungal infections (such as ketoconazole) and medicines for HIV/AIDS (such as HIV protease inhibitors). 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.
- drugs for epilepsy such as carbamazepine and phenytoin
- drugs for indigestion or stomach ulcers
- drugs to prevent clotting e.g. 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 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 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 that may affect the heart's rhythm such as certain antibiotics and some anti-psychotics.
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Important information about some of the ingredients of mirtazapine:
Mirtazapine tablets contain lactose. If you have been told by your doctor that you have an intolerance for some sugars, contact your doctor before taking this medicinal product.
3. HOW TO TAKE MIRTAZAPINE
The usual starting dose is 15mg, taken preferably in the evening. Your doctor may advise you to increase your dose after a few days to the amount that will be best for you. Usually mirtazapine will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better. After 2 to 4 weeks, talk to your doctor about the effect the treatment has had. If you still don't feel well, your doctor may prescribe a higher dose. After another 2 to 4 weeks talk to your doctor again. If you have the impression that the effect of mirtazapine is too strong or too week, talk to your doctor or pharmacist.
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Your doctor will probably advise you to take mirtazapine as a single dose before you go to bed, as it may help you to sleep. However, your doctor may suggest you split your dose - for example one tablet in the morning, and another in the evening before you go to bed. The higher dose should be taken before you go to bed. The tablets should be swallowed whole without chewing and with plenty of fluid. Mirtazapine Film-Coated Tablets are not recommended for use in children or adolescents (under the age of 18).
Mirtazapine Film-Coated Tablets can be taken by elderly patients, any dose changes will be done under close supervision by your doctor. Patients with kidney or liver problems may be given a lower dose of Mirtazapine.
Overdose: If you take more mirtazapine than you should:
Call a doctor straight away or go immediately to the nearest casualty department, taking the remaining tablets with you. The most likely signs of overdose are drowsiness, disorientation and increased heart rate.
If you forget to take mirtazapine:
Do not take a double dose to make up for forgotten individual doses. Just skip that dose and take your next one at the normal time.
Effects when treatment with mirtazapine is stopped:
Do not suddenly stop taking mirtazapine even if your depression has lifted. If you stop suddenly, you may feel sick, anxious or agitated and have headaches. It is possible that some of your symptoms may come back. Once you are feeling better, talk to your doctor who will tell you how to reduce the dose gradually. This will usually be about 4 to 6 months after you start feeling better.
Like all medicines, mirtazapine can cause side effects, although not everybody gets these side effects. Some side effects are more likely to occur than others. The possible side effects of mirtazapine are listed below and can be divided as:
Very common: affects more than 1 user in 10
Common: affects 1 to 10 users in 100
Uncommon: affects 1 to 10 users in 1,000
Rare: affects 1 to 10 users in 10,000
Very rare: affects less than 1 user in 10,000
Not known: cannot be estimated from the available data
If you experience any of the following events you should tell your doctor immediately, as your medication may need to be discontinued.
Very common:
- increase in appetite and weight gain
- drowsiness or sleepiness
- headache
- dry mouth Common:
- lethargy
- dizziness
- shakiness or tremor
- nausea
- diarrhoea
- vomiting
- constipation
- rash or skin eruptions (exanthema)
- pain in your joints (arthralgia) or muscle (myalgia)
- back pain
- feeling dizzy or faint when you stand up suddenly (orthostatic hypotension)
- swelling (typical in ankles or feet caused by fluid retention (oedema)
- tiredness
- vivid dreams
- confusion
- feeling anxious
- sleeping problems
In children under 18 years the following adverse events were observed commonly in clinical trials: significant weight gain, hives and increased blood triglycerides.
Uncommon:
- feeling elated or emotionally 'high' (mania)
Stop taking mirtazapine and tell your doctor straight away.
- 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
- nightmares
- feeling agitated
- hallucinations
- urge to move
Rare:
- aggression
- muscle twitching or contractions (myoclonus)
- pancreatitis Not known:
- signs of infection such as sudden inexplicable high fever, sore throat and mouth ulcers (agranulocytosis)
Stop taking mirtazapine and contact your doctor straight away for a blood test.
- 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).
- 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, unconsciousness and increased salivation. In very rare cases these can be signs of serotonin syndrome.
Stop taking mirtazapine and tell your doctor straight away.
- thoughts of harming or killing yourself
Contact your doctor or go to a hospital straight away.
- abnormal sensations in the mouth (oral paraesthesia)
- swelling in the mouth (mouth oedema)
- low sodium levels (hyponatraemia)
- yellow colouring of skin or eyes (jaundice)
- 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.
- speech disorder
- severe skin reactions (dermatitis bullous, erythema multiforme)
- sleepwalking (somnambulism)
- swelling throughout the body (generalised oedema)
- localised swelling
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.
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. By reporting side effects you can help provide more information on the safety of this medicine.
KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
Do not store above 25°C.
Store in the original package.
Keep the blister in the outer carton.
If your doctor tells you to stop treatment, return any left over to the pharmacist.
Mirtazapine 30mg Film-Coated Tablets are reddish brown, biconvex capsule-shaped, film-coated tablets with a score line between 0 and 9 on one side and 'W' debossed on the other side.
Each film-coated tablet contains 30mg of the active substance mirtazapine.
The other ingredients are lactose monohydrate, hydroxypropylcellulose, maize starch, colloidal anhydrous silica, low-substituted hydroxypropyl cellulose, magnesium stearate, purified water, opadry brown (hydroxypropyl cellulose), hypromellose, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red and iron oxide black.
The tablets are supplied in blister packs of 28 film-coated tablets.
Who makes your medicine
Marketing Authorisation Holder: Wockhardt UK Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Manufactured by: CP Pharmaceuticals Limited, Ash Road North, Wrexham, LL13 9UF, UK.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge: 0800 198 5000 (UK Only)
Please be ready to give the following information:
|
Product name |
Reference number |
|
Mirtazapine 30mg Film-Coated Tablets |
29831/0142 |
This is a service provided by the Royal National Institute of Blind People. This leaflet was revised: February 2015
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