Mirtazapine 30mg Film-Coated Tablets
Other possible side effects with Mirtazapine are:
Very common (may affect more than 1 in 10 people):
• increase in appetite and weight gain
• drowsiness or sleepiness
• headache
• dry mouth
Common (may affect up to 1 in 10 people):
• 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
• constipation
• 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)
In children under 18 years the following side effects have been commonly observed:
• significant weight gain
• hives
• increased blood triglycerides Uncommon (may affect up to 1 in 100 people):
• 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 (may affect up to 1 in 1,000 people):
• muscle twitching or contractions (myoclonus)
• feeling aggressive
Not known (frequency cannot be estimated from the available data):
• abnormal sensations in the mouth (oral paraesthesia)
• swelling in the mouth (mouth oedema)
• hyponatraemia
• inappropriate anti-diuretic hormone secretion
• increased salivation
• slurred speech (dysarthria)
• sleepwalking
• difficulty in passing urine
• increased creatine kinase blood levels.
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.
Continued top of next column 50869193 AAAI2408
_5| How to store Mirtazapine tablets
Keep this medicine out of the sight and reach of children.
Store in the original package. Keep the blister in the outer carton.
Do not use this medicine after the expiry date stated on the carton or foil after EXP. The expiry date refers to the last day of that month.
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.
"6 Contents of the pack and other information
What Mirtazapine tablets contain
• The active substance is mirtazapine. Each tablet contains 30mg of the active ingredient
• The other ingredients are lactose monohydrate, pregelatinised maize starch, silica colloidal anhydrous, croscarmellose sodium and magnesium stearate.
• The film coating contains hypromellose, macrogol 8000, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E 172) and talc.
What Mirtazapine tablets look like and contents of the pack
Mirtazapine 30mg tablets are film-coated tablets. Brownish, scored on both sides, oval, biconvex, film-coated tablets. Marked with "I" on one side. The tablets can be divided into equal halves.
Pack size is 28 tablets.
Marketing Authorisation Holder Actavis Group PTC ehf.
Reykjavikurvegi 76-78, 220 Hafnarfjor5ur, Iceland Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in September 2015
Read all of this leaflet carefully before you l start taking this medicine because it contains ! important information for you.
! • Keep this leaflet. You may need to read it again. ; • If you have any further questions, ask your
■ doctor, pharmacist or nurse.
l • This medicine has been prescribed for you
■ only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
H What Mirtazapine tablets are and what they are used for
|2 What you need to know before you take Mirtazapine tablets J) How to take Mirtazapine tablets 4| Possible side effects T| How to store Mirtazapine tablets 6 Contents of the pack and other information
H What Mirtazapine tablets are and what they are used for
Mirtazapine is one of a group of medicines called antidepressants. Mirtazapine tablets are used to treat depressive illness.
|2 What you need to know before you take Mirtazapine tablets Do not take Mirtazapine tablets 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 tablets.
• taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).
Mirtazapine 30mg Film-coated Tablets
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Mirtazapine tablets Children and adolescents
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
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.
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, 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.
Also take special care with Mirtazapine tablets if you
• have, or have ever had one of the following conditions. 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 straight away
- manic depression (alternating periods of feeling elated/overactivity and depressed mood). If you start feeling elated or overexcited, 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.
• 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.
• are an elderly person. You could be more sensitive to the side-effects of a ntidepressa nts.
Other medicines and Mirtazapine tablets
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 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 ascetirizine; 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), medicines for HIV/AIDS (such as HIV protease 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.
Mirtazapine tablets with food, drink 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 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.
Driving and using machines
Mirtazapine can affect your concentration or alertness. Make sure these abilities are not affected before you drive or operate machinery.
Mirtazapine tablets contain lactose
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.
0 How to take Mirtazapine tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
The recommended 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 is 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 tablets
Take Mirtazapine at the same time each day. It
is best to take Mirtazapine tablets as a single dose before you go to bed. However your doctor may suggest you to split your dose of Mirtazapine - once in the morning and once at night-time before you go to bed. The higher dose should be taken before you goto bed.Take your tablets orally. Swallow your prescribed dose of Mirtazapine without chewing, with some water.
When can you expect to start feeling better
Usually Mirtazapine will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better.
It is i mportant that, du ri ng the fi rst few weeks of the treatment, you talk with your doctor about the effects of Mirtazapine: 2 to 4 weeks after you have started taking Mirtazapine 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 until your symptoms of depression have disappeared for 4 to 6 months.
If you take more Mirtazapine tablets than you should
If you or someone else have taken too many Mirtazapine tablets, call a doctor straight away.
The most likely signs of an overdose of Mirtazapine (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate.
If you forget to take Mirtazapine tablets
If you are supposed to take your dose once a day.
• If you have forgotten to take your dose of Mirtazapine, do not take the missed 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 tablets
Only stop taking Mirtazapine 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, even when your depression has lifted. If you suddenly stop taking Mirtazpine 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, pharmacist or nurse.
□ Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects are more likely to occur than others.
Stop taking Mirtazapine tablets and tell your doctor immediately if you experience any of the following side effects:
Uncommon (may affect up to 1 in 100 people):
• Feeling elated or emotionally'high'(mania).
Rare (may affect up to 1 in 1,000 people):
• Yellow colouring of eyes or skin; this may suggest disturbance in liver function (jaundice).
• Severe upper abdominal pain often with nausea and vomiting (pancreatitis).
Not known (frequency cannot be estimated from the available data):
• Signs of infection such as sudden unexplainable high fever, sore throat and mouth ulcers (agranulocytosis).
• Fatigue, bleeding from the skin and mucous membranes as well as infections and fever due to changes in the blood (bone marrow depression).
• Fatigue and paleness, tendency to laryngitis and bleeding in the skin due to severe anemia and possible other changes in the blood (Aplastic anemia).
• Bleeding from the skin and mucous membranes and bruises due to changes in the blood (too few platelets).
• An increase in the number of white blood cells (eosinophilia).
• Some people become less resistant to infection because Mirtazapine can cause a temporary shortage of white blood cells (granulocytopenia).
• 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.
• Thoughts of harming or killing yourself-contact your doctor or go to a hospital straight away.
• A skin reaction known as'erythema multiforme'(itchy reddish purple patches on the skin, especially on the palms of the hands or soles of the feet, 'hive-like' raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and genitals, which may be accompanied by fever and tiredness.)
• Severe rash, blistering (bullous dermatitis), peeling or other effects on the skin, eyes, mouth or genitals, itching or high temperature (symptoms of severe skin reactions called Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Muscle pain, stiffness and/or weakness and darkening or discolouration of the urine (rhabdomyolysis).
Continued top of next column Continued over page