Mirtazapine Mylan Generics: detailed information

Package Leaflet: Information for the User

Mirtazapine Mylan Generics 30 mg film-coated tablets, Generics 45 mg film-coated tablets

(mirtazapine)
Generic Medicinal Product
Please read all of this leaflet carefully before you 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to other people, even if their symptoms seem identical to yours, as it may be harmful to them.
If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effect not listed in this leaflet. See section 4.

Contents of this leaflet:

What Mirtazapine Mylan Generics is and what it is used for
What you need to know before taking Mirtazapine Mylan Generics
How to take Mirtazapine Mylan Generics
Possible side effects
How to store Mirtazapine Mylan Generics
Contents of the pack and other information

1. What Mirtazapine Mylan Generics is and what it is used for
Mirtazapine Mylan Generics belongs to a group of medicines called antidepressants. Mirtazapine Mylan Generics is used for the treatment of depressive disorders.

2. What you need to know before taking Mirtazapine Mylan Generics

Do not take Mirtazapine Mylan Generics

if you are allergic to mirtazapine or to any of the excipients of this medicine (listed in section 6).
if you are taking or have recently taken (within the last two weeks) medicines known as Monoamine Oxidase Inhibitors (MAOIs).

Warnings and precautions:
Children and adolescents under 18 years of age.
Mirtazapine Mylan Generics should normally not be used in children and adolescents under 18 years of age. You should be aware that in patients under 18 years of age, this class of medicines is associated with a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, abusive behaviour, and anger). Nevertheless, a doctor may decide to prescribe Mirtazapine Mylan Generics to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Mirtazapine Mylan Generics to a patient under 18 years of age and you wish to obtain clarification, please consult your doctor directly. Inform your doctor immediately if any of the symptoms described above appear or worsen in patients under 18 years of age receiving Mirtazapine Mylan Generics. It should also be noted that the long-term safety effects of Mirtazapine Mylan Generics in this age group in terms of growth, maturation, and cognitive and behavioural development have not yet been established. In addition, during treatment with mirtazapine, significant weight gain has been observed more frequently in this age group than in adults.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes think about harming yourself or taking your life. These thoughts may increase shortly after starting treatment with antidepressants, as these medicines require time to take effect, usually about two weeks but sometimes longer.
You are more likely to have such thoughts if:

you have previously thought about taking your life or harming yourself.
you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in adults under 25 years of age with psychiatric disorders being treated with antidepressants.

If at any time you find yourself thinking about taking your life or harming yourself, contact your doctor or go to hospital immediately.
You may find it helpful to confide in a relative or friend who suffers from depression and ask them to read this leaflet. You could ask them to inform you if they believe your depression is worsening, or if they are concerned about changes in your behaviour.
Talk to your doctor or pharmacist before taking Mirtazapine Mylan Generics if you suffer or have previously suffered from any of the following conditions.
If you have not already done so, inform your doctor about these conditions before taking Mirtazapine Mylan Generics.

seizures (epilepsy).
liver disease, including jaundice.
kidney disease.
heart disease or certain types of heart conditions that may alter heart rhythm, recent heart attack, heart failure, or if you are taking certain medicines that may affect heart rhythm.
low blood pressure.
schizophrenia.
bipolar disorder (alternating periods of mania/hyperactivity and depressed mood).
diabetes (adjustment of insulin or other antidiabetic medicine doses may be necessary).
eye diseases, such as increased eye pressure (glaucoma).
difficulty urinating, which may be caused by an enlarged prostate.

During treatment

if you develop signs of infection, such as unexplained high fever, sore throat, or mouth ulcers. In rare cases, these symptoms may indicate a disorder in blood cell production in the bone marrow. Although rare, these symptoms usually occur after 4–6 weeks of treatment.
if you are elderly. You may be more sensitive to the side effects of antidepressants.

Other medicines and Mirtazapine Mylan Generics
Do not take Mirtazapine Mylan Generics in combination with:
monoamine oxidase inhibitors (MAOIs). In addition, do not take Mirtazapine Mylan Generics within two weeks after stopping MAO inhibitors. Likewise, if you stop taking Mirtazapine Mylan Generics, do not take MAO inhibitors within two weeks of stopping. MAO inhibitors include, for example, moclobemide, tranylcypromine (both are antidepressants), and selegiline (used in Parkinson’s disease).
Inform your doctor or pharmacist if you are taking, have recently taken, or plan to take any other medicines, including those without a prescription, especially those listed below:

antidepressants such as SSRIs, e.g. citalopram, venlafaxine, and L-tryptophan, or triptans such as sumatriptan (used to treat migraine), tramadol (for pain treatment), linezolid (an antibiotic), lithium (used to treat certain psychiatric conditions), methylene blue (used to treat certain types of blood poisoning), and St. John’s wort – preparations based on Hypericum perforatum (a herbal remedy for depression). Very rarely, Mirtazapine Mylan Generics, alone or in combination with these medicines, may lead to the so-called serotonin syndrome. Some symptoms of this syndrome include unexplained fever, sweating, increased heart rate, diarrhoea, muscle contractions (involuntary), tremor, hyperactive reflexes, restlessness, mood changes, and loss of consciousness. If a combination of these symptoms occurs, speak to your doctor immediately.
the antidepressant nefazodone. This may increase the amount of Mirtazapine Mylan Generics in the blood. Inform your doctor if you are taking this medicine, as this may require a reduction in the dose of Mirtazapine Mylan Generics or, when nefazodone is discontinued, an increase in the dose of Mirtazapine Mylan Generics.
medicines for anxiety or insomnia, such as benzodiazepines, e.g. diazepam, chlordiazepoxide; medicines for schizophrenia, such as olanzapine; medicines for allergies, such as cetirizine; medicines for severe pain, such as morphine. When administered together with these medicines, Mirtazapine Mylan Generics may increase the drowsiness caused by these substances.
medicines to treat infections; medicines for bacterial infections (such as erythromycin), medicines to treat fungal infections (such as ketoconazole), and medicines to treat HIV/AIDS (such as HIV protease inhibitors, e.g. ritonavir, nelfinavir).
cimetidine, medicines for gastric ulcers. These medicines, when taken together with Mirtazapine Mylan Generics, may increase the amount of Mirtazapine Mylan Generics in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of Mirtazapine Mylan Generics or, when use of these medicines is discontinued, to increase the dose of Mirtazapine Mylan Generics again.
carbamazepine and phenytoin, medicines for epilepsy.
medicines for tuberculosis, such as rifampicin. These medicines, when taken together with Mirtazapine Mylan Generics, may decrease the amount of Mirtazapine Mylan Generics in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of Mirtazapine Mylan Generics or, when use of these medicines is discontinued, to reduce the dose of Mirtazapine Mylan Generics again.
warfarin, medicines that prevent blood clotting. Mirtazapine Mylan Generics may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If warfarin is taken concomitantly, your doctor must closely monitor your blood.
medicines that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Mirtazapine Mylan Generics and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking Mirtazapine Mylan Generics.
It is recommended not to consume alcoholic beverages.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Limited experience with mirtazapine administration in pregnant women does not indicate an increased risk. However, caution should be exercised when administering Mirtazapine Mylan Generics during pregnancy.
If you use Mirtazapine Mylan Generics up to or immediately before delivery, the newborn must be closely monitored for possible adverse effects.
Ensure that your midwife and/or doctor is aware that you are taking Mirtazapine Mylan Generics. Medicines such as Mirtazapine Mylan Generics, if taken during pregnancy, especially during the third trimester, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, you must contact your midwife and/or doctor immediately.

Breastfeeding
Mirtazapine Mylan Generics passes into breast milk in small amounts. There is a potential risk of effects on the infant. Therefore, you must discuss this issue with your doctor, who will decide whether you should discontinue breastfeeding or treatment with Mirtazapine Mylan Generics.

Driving and using machines
Mirtazapine Mylan Generics may affect concentration or alertness. Make sure your abilities are not impaired before driving or operating machinery.

Mirtazapine Mylan Generics contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, such as lactose, contact them before taking this medicine.

3. How to take Mirtazapine Mylan Generics

Always take this medicine exactly as instructed by your doctor or pharmacist. If you
have
any doubts, consult your doctor or pharmacist.
How much Mirtazapine Mylan Generics to take
Adults
The recommended starting dose is 15 mg or 30 mg daily. Your doctor may advise you to increase the dose
after a few days to reach the appropriate amount (between 15 and 45 mg daily). Normally the recommended
dose is the same for all age groups. However, your doctor may adjust the dose if you are elderly or if you have
a kidney or liver disease.
The breakline is only intended to facilitate tablet splitting if you have difficulty swallowing it whole.
When to expect to feel better
Mirtazapine Mylan Generics normally takes 1-2 weeks to start working, and after 2-4 weeks
you may notice an improvement.
It is important that, during the first weeks of treatment, you inform your doctor about the effects of Mirtazapine Mylan
Generics:
2-4 weeks after starting Mirtazapine Mylan Generics, discuss with your doctor the effects the medicine has had on you.
If you continue to notice no improvement, your doctor may prescribe a higher dose. In this case, speak to your doctor again after another 2-4 weeks. Normally, Mirtazapine
Mylan Generics should be taken for 4-6 months after the symptoms of depression have disappeared.
Use in children and adolescents under 18 years of age:
Mirtazapine Mylan Generics must not be taken by children and adolescents under 18 years of age
(see also section 2 “Children and adolescents under 18 years”).
When to take Mirtazapine Mylan Generics
Take Mirtazapine Mylan Generics every day at the same time. It is best to take Mirtazapine Mylan
Generics as a single dose before going to bed. However, your doctor may suggest dividing the dose
of Mirtazapine Mylan Generics, once in the morning and once in the evening before going to bed. The higher dose should be taken at bedtime.
Swallow the tablet without chewing, with water or fruit juice.
If you take more Mirtazapine Mylan Generics than you should
If you or someone else takes too much Mirtazapine Mylan Generics, call your doctor immediately.
The most common signs of an overdose of Mirtazapine Mylan Generics (without other medicines or alcohol) are
drowsiness, disorientation, changes in heart rhythm (fast, irregular heartbeat) and/or fainting, which
may be symptoms of a life-threatening condition called "torsade de pointes".
If you forget to take Mirtazapine Mylan Generics
If you are supposed to take the dose once daily

If you forget to take your dose of Mirtazapine Mylan Generics, do not take the missed dose. Skip the dose. Take the next dose at the usual time.

Do not take a double dose to make up for a missed one.
If you are supposed to take the dose twice daily

if you forget the morning dose, simply take this dose together with the evening dose.
if you forget the evening dose, do not take it together with the next morning dose; skip the dose and continue normally with the morning and evening doses.
if you have forgotten to take both doses, do not try to make up for the missed doses. Skip both doses and continue the next day normally with the morning and evening doses.

If you stop taking Mirtazapine Mylan Generics
You should only stop taking Mirtazapine Mylan Generics after speaking with your doctor.
If you stop treatment too early, depression may return. When you start feeling better, discuss this with your
doctor. Your doctor will decide when to stop treatment.
Do not stop taking Mirtazapine Mylan Generics suddenly, even if your depression has
disappeared. If you stop Mirtazapine Mylan Generics suddenly, you may feel unwell, experience
dizziness, agitation or anxiety, and have headaches. These symptoms can be avoided by stopping treatment
gradually. Your doctor will tell you how to reduce the dose gradually.
If you have any questions about the use of Mirtazapine Mylan Generics, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. In some cases, the side effect may not be caused by the medicine but may be a sign of your underlying illness.
If any of the following side effects occur, stop treatment with Mirtazapine Mylan Generics and speak to your doctor immediately or go to the nearest Emergency Department:

Rare (may affect up to 1 in 1,000 people):

inflammation of the pancreas. This causes moderate to severe stomach pain spreading to the back
yellowing of the eyes and skin; this may indicate liver problems (jaundice).

Frequency not known (cannot be estimated from the available data):

severe allergic reactions, such as rash, itching or hives
swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or breathing difficulties
signs of infection such as sudden high fever, sore throat and mouth ulcers (agranulocytosis). Mirtazapine Mylan Generics may cause a disturbance in blood cell production (bone marrow depression). Some people become more susceptible to infections because Mirtazapine Mylan Generics may cause a temporary shortage of white blood cells (granulocytopenia). Mirtazapine Mylan Generics may also cause a shortage of white and red blood cells and platelets (aplastic anaemia), which may cause paleness of the skin, feeling tired and shortness of breath, and dark urine; a shortage of platelets (thrombocytopenia) with signs of bleeding or bruising more easily than normal; or an increase in white blood cells (eosinophilia)
lower than normal sodium levels in the blood, which may cause weakness, confusion and muscle pain. This may be due to inappropriate ADH secretion, a hormone causing water retention and dilution of the blood, thereby reducing sodium levels
thoughts of harming yourself or of suicide (see section 2 “Suicidal thoughts and worsening of depression”)
seizures (fits)
a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, muscle contractions (involuntary), tremor, overactive reflexes, exhaustion, mood changes and loss of consciousness. These may be symptoms of serotonin syndrome
signs of a serious skin reaction or illness that may include rash, skin redness, fever, sore throat, fatigue, which may be followed by ulcers and other lesions, usually around the mouth and lips (Stevens-Johnson syndrome, toxic epidermal necrolysis, bullous dermatitis or erythema multiforme)
breakdown of muscle tissue, causing muscle pain, flaccidity, stiffness and/or weakness and darkening or discolouration of urine (rhabdomyolysis)
difficulty urinating or emptying the bladder

Other possible side effects
Very common (may affect more than 1 in 10 people):

increased appetite and body weight
tiredness or drowsiness
headache
dry mouth

Common (may affect up to 1 in 10 people):

lethargy
dizziness
tremor or shaking
nausea
diarrhoea
vomiting
constipation
rash or skin eruptions (exanthema)
joint pain (arthralgia) or muscle pain (myalgia)
back pain
dizziness or fainting when standing up suddenly (orthostatic hypotension)
swelling (usually in the ankles and feet) due to fluid retention (oedema)
fatigue
vivid dreams
confusion
anxiety
sleep problems

Uncommon (may affect up to 1 in 100 people):

euphoria or emotional excitement (mania). Stop taking Mirtazapine Mylan Generics and consult your doctor immediately.
abnormal sensations on the skin, e.g. burning, pricking, itching or tingling (paraesthesia)
restless legs syndrome
fainting (syncope)
numbness of the mouth (oral hypoesthesia)
low blood pressure
nightmares
agitation
seeing, sensing or hearing things that are not there (hallucinations)
urge to move

Rare (may affect up to 1 in 1,000 people):

muscle spasms or contractions (myoclonus)
aggressive behaviour
increased enzyme levels, observed through a blood test

Frequency not known (cannot be estimated from the available data):

abnormal sensation in the mouth (oral paraesthesia)
swelling of the mouth (mouth oedema)
low sodium levels in the blood (hyponatraemia), observed through a blood test
increased levels of creatine kinase in the blood, observed through blood tests
difficulty speaking
increased salivation
sleepwalking

Additional side effects in children and adolescents under 18 years of age
In children and adolescents under 18 years of age, the following adverse events have been commonly observed in clinical studies: marked weight gain, urticaria and increased blood triglyceride levels.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Mirtazapine Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging or container after
EXP. The expiry date refers to the last day of the month.
Store in the original packaging.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Mirtazapine Mylan Generics contains
The active substance is mirtazapine.
Each tablet contains 30 mg of mirtazapine.
Each tablet contains 45 mg of mirtazapine.
The other excipients are: anhydrous lactose (see section 2 “Mirtazapine contains lactose”), maize starch,
anhydrous colloidal silica, low-substituted hydroxypropylcellulose, and magnesium stearate.
The coating contains: titanium dioxide (E171), macrogol 4000, monohydrate lactose (see section 2
“Mirtazapine contains lactose”), iron oxide red (E172) (only in 30 mg tablets), iron oxide yellow (E172) (only in 30 mg tablets), iron oxide black (E172) (only in 30 mg tablets), and hypromellose.

Description of the appearance of Mirtazapine Mylan Generics and package contents
Your medicine is available as film-coated, round tablets.
The 30 mg tablets are dark yellow, with “MR/30” printed on one side and “G” on the other.
The 45 mg tablets are white, with “MR45” printed on one side and “G” on the other.
Mirtazapine Mylan Generics is available in blister packs or plastic containers containing
10, 14, 20, 28, 30, 50, 100, 250, and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano, Italy

Manufacturer responsible for batch release:
McDermott Laboratories t/a Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13 - Ireland
Generics [UK] Ltd.
Station Close, Potters Bar, Hertfordshire, EN6 1TL – United Kingdom
Mylan Hungary Kft
H-2900 Komarom, Mylan utca 1 - Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Finland - Trimazimyl
Belgium – Mirtazapine Mylan 15mg, 30mg and 45mg filmomhulde tabletten
Denmark – Trimazimyl
Germany - Mirtazapin dura 15mg, 30mg and 45mg Filmtabletten
Greece - MIRTAZAPINE/GENERICS F.C. TAB 30 mg/TAB and 45mg/TAB
Ireland - Zismirt 30mg Film Coated Tablets
Italy - Mirtazapina Mylan Generics 30mg and 45mg
Netherlands - Mirtazapine Mylan 15mg, 30mg and 45mg filmomhulde tabletten
Portugal - Mirtazapina Mylan 30mg Comprimidos Revestidos
Spain - Mirtazapina Mylan Pharmaceuticals 30 mg comprimidos recubiertos con película EFG
United Kingdom - Mirtazapine 30mg Tablets

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