Mirtazapine Grindeks

Patient Information Leaflet

Mirtazapine Grindeks 15 mg orodispersible tablets, 30 mg orodispersible tablets, 45 mg orodispersible tablets

Mirtazapine
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Mirtazapine Grindeks is and what it is used for
2. What you need to know before taking Mirtazapine Grindeks
3. How to take Mirtazapine Grindeks
4. Possible side effects
5. How to store Mirtazapine Grindeks
6. Contents of the pack and other information

1. What Mirtazapine Grindeks is and what it is used for

Mirtazapine Grindeks contains the active substance mirtazapine, which belongs to a group of medicines
called antidepressants.
Mirtazapine Grindeks is used to treat depressive disorders in adults.
It will take 1 or 2 weeks before Mirtazapine Grindeks starts to work. You may begin to feel better after 2–4 weeks.
Contact your doctor if you do not feel better or if you feel worse after 2–4 weeks. More information is provided in section 3, “When to expect feeling better”.

2. What you should know before taking Mirtazapine Grindeks

Do not take Mirtazapine Grindeks

• if you are allergic to mirtazapine or to any of the ingredients of this medicine (listed in section 6). Mirtazapine Grindeks
• if you are currently taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions
Talk to your doctor or pharmacist before taking Mirtazapine Grindeks.
Talk to your doctor before taking Mirtazapine Grindeks
if you have ever developed a severe skin rash or skin peeling, blisters and/or mouth ulcers
after taking mirtazapine.
Children and adolescents
Mirtazapine Grindeks is normally not recommended for use in children and adolescents under
18 years of age, as its efficacy has not been demonstrated. In addition, it should be noted 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, oppositional behaviour and anger).
Nevertheless, your doctor may prescribe Mirtazapine Grindeks to patients under 18 years of age if
he or she considers it to be in their best interest. If your doctor has prescribed Mirtazapine Grindeks to a
patient under 18 years of age and you would like more information, please consult your doctor directly.
You must inform your doctor if any of the symptoms listed above appear or worsen during
treatment with Mirtazapine Grindeks in a patient under 18 years of age. In addition, the long-term
safety effects of mirtazapine on growth, maturation and cognitive and behavioural development have not yet been established in this age group. Furthermore, during treatment with mirtazapine, a significant weight gain has been observed more frequently in this age group compared to adults.
Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may increase
at the beginning of treatment with antidepressants, as these medicines usually take about two
weeks or more to show their effect.
You are more likely to have these thoughts:

• if you have previously had thoughts of suicide or self-harm;
• if you are a young adult (under 25 years of age). Data from clinical trials have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age who were treated with an antidepressant. If at any time you have thoughts of harming yourself or of suicide, contact your doctor or go to hospital immediately.

It may be helpful to inform a relative or close friend who suffers from depression and ask them to
read this leaflet. You may ask them to tell you if they think your depression is
worsening or if they are concerned about any changes in your behaviour.
Be especially careful with Mirtazapine Grindeks

• if you currently 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 Grindeks:
  • seizures (epilepsy). If you begin to have seizures or if seizures become more frequent, stop taking Mirtazapine Grindeks and contact your doctor immediately;
  • liver disease, including jaundice. If you develop jaundice, stop taking Mirtazapine Grindeks 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 immediately;
  • manic depression (alternating periods of euphoria/hyperactivity and depressed mood). If you start feeling euphoric or overexcited, stop taking Mirtazapine Grindeks and contact your doctor immediately;
  • diabetes (you may need to adjust the dose of insulin or other antidiabetic medicines);
  • eye disorders, such as increased eye pressure (glaucoma);
  • difficulty urinating, which may be caused by an enlarged prostate;
  • certain types of heart conditions that may alter heart rhythm, a recent heart attack, heart failure or use of certain medicines that may affect heart rhythm.
• if you develop signs of infection, such as unexplained high fever, sore throat and mouth ulcers.

Stop taking Mirtazapine Grindeks and contact your doctor immediately for a blood
test. In rare cases, these symptoms may indicate a disorder in the production of
blood cells in the bone marrow. Although rare, these symptoms most commonly occur after 4–
6 weeks of treatment;

• if you are elderly. You may be more sensitive to the side effects of antidepressants;
• serious skin reactions have been reported with the use of Mirtazapine Grindeks, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug reaction with eosinophilia and systemic symptoms (DRESS). Stop using the medicine and contact your doctor immediately if you notice any of the symptoms described in section 4 related to these serious skin reactions;
• if you have previously had serious skin reactions, treatment with mirtazapine should not be restarted.

Other medicines and Mirtazapine Grindeks
Inform your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
Do not take Mirtazapine Grindeks in combination with:

• monoamine oxidase inhibitors (MAOIs). Do not take Mirtazapine Grindeks even within two weeks after stopping MAOIs. Likewise, if you stop taking Mirtazapine Grindeks, do not take MAOIs within the following two weeks. Examples of MAOIs include moclobemide, tranylcypromine (both antidepressants) and selegiline (used in Parkinson’s disease).

Be careful when taking Mirtazapine Grindeks in combination with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine and L-tryptophan or triptans (used to treat migraine), tramadol (for pain therapy), linezolid (an antibiotic), lithium (used to treat certain psychiatric conditions), methylene blue (used to treat high levels of methaemoglobin in the blood) and St. John’s wort (a herbal remedy for depression). Very rarely, Mirtazapine Grindeks alone, or in combination with these medicines, may lead to a condition known as serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, increased heart rate, diarrhoea, uncontrolled muscle contractions, chills, hyperactive reflexes, restlessness, mood changes and loss of consciousness. If you experience a combination of these symptoms, speak to your doctor immediately;
• the antidepressant nefazodone. This may increase the amount of Mirtazapine Grindeks in your blood. Inform your doctor if you are taking this medicine, as this may require a reduction in the dose of Mirtazapine Grindeks or, when nefazodone is discontinued, an increase in the dose of Mirtazapine Grindeks.
• medicines for anxiety or insomnia, such as benzodiazepines;
• medicines for schizophrenia, such as olanzapine;
• medicines for allergies, such as cetirizine;
• strong painkillers, such as morphine. When administered in combination with these medicines, Mirtazapine Grindeks may increase the drowsiness caused by them.
• medicines to treat infections; medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole) and medicines for treating HIV/AIDS (such as HIV protease inhibitors) and medicines for treating gastric ulcers (such as cimetidine). These medicines, when taken with Mirtazapine Grindeks, may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be necessary to reduce the dose of Mirtazapine Grindeks or, when use of these medicines is stopped, to increase the dose of Mirtazapine Grindeks again;
• medicines for epilepsy, such as carbamazepine and phenytoin;
• medicines for tuberculosis, such as rifampicin.

These medicines, when taken with Mirtazapine Grindeks, may reduce the amount of
mirtazapine in the blood. Inform your doctor if you are taking these medicines. It may be
necessary to increase the dose of Mirtazapine Grindeks or, when use of these medicines is
stopped, to reduce the dose of Mirtazapine Grindeks again;

• medicines that prevent blood clotting, such as warfarin. Mirtazapine Grindeks may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken concomitantly, your doctor must monitor your blood closely;
• medicines that may affect heart rhythm, such as certain antibiotics and certain antipsychotics.

Mirtazapine Grindeks with food and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking Mirtazapine Grindeks.
It is recommended not to consume alcoholic beverages.
Mirtazapine Grindeks may be taken with or without food.
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 in pregnant women does not indicate an increased risk.
However, caution is advised when administering mirtazapine during pregnancy.
If you take Mirtazapine Grindeks up to or immediately before delivery, the newborn must be carefully
monitored for possible adverse effects.
When taken during pregnancy, similar medicines (SSRIs) 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 appear within the first
24 hours after the baby’s birth. If this occurs in your baby, you must contact your
midwife and/or doctor immediately.
Breastfeeding
Mirtazapine is excreted in breast milk in very small amounts. The decision to continue or discontinue
breastfeeding or to continue or discontinue mirtazapine therapy should be based on an assessment of the benefit of breastfeeding for the infant and the benefit of mirtazapine therapy for the mother.
Driving and using machines
Mirtazapine Grindeks may affect concentration or alertness. Make sure these abilities are not impaired
before driving or operating machinery. If your doctor has prescribed Mirtazapine Grindeks to a
patient under 18 years of age, ensure that concentration and alertness are not impaired
before engaging in traffic (e.g. cycling).
Mirtazapine Grindeks orodispersible tablets contain aspartame
Each 15 mg orodispersible tablet contains 1.5 mg of aspartame.
Each 30 mg orodispersible tablet contains 3 mg of aspartame.
Each 45 mg orodispersible tablet contains 4.5 mg of aspartame.
Aspartame is a source of phenylalanine. It may be harmful in phenylketonuria (PKU), a rare
genetic disorder causing accumulation of phenylalanine because the body cannot properly eliminate it.

3. How to take Mirtazapine Grindeks

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Recommended dose
The recommended starting dose is 15 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 dose is the same for
all age groups. However, your doctor may adjust the dose if you are elderly or if you have kidney or liver
disease.
When to take Mirtazapine Grindeks
Take Mirtazapine Grindeks every day at the same time.
It is best to take Mirtazapine Grindeks as a single dose before bedtime. However, your doctor may
suggest dividing the dose of Mirtazapine Grindeks, taking one dose in the morning and one in the evening
before bedtime. The larger dose should be taken before bedtime.
How to take the orodispersible tablet
Take the tablets by mouth.
Do not crush the orodispersible tablet. Remove the orodispersible tablet from the blister with dry hands and
place it on the tongue. It will disintegrate rapidly and can be swallowed without water.
When to expect to feel better
Mirtazapine Grindeks 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
Grindeks:

• 2–4 weeks after starting Mirtazapine Grindeks, inform your doctor about the effects the medicine has had on you. If you continue not to feel better, your doctor may prescribe a higher dose. In this case, speak to your doctor again after another 2–4 weeks. Normally, Mirtazapine Grindeks should be taken for 4–6 months until the symptoms of depression have disappeared.

If you take more Mirtazapine Grindeks than you should
If you have taken too much medicine or, for example, a child has accidentally ingested the medicine, seek
immediate medical advice from a doctor or the nearest hospital for risk assessment and recommendations.
The most common signs of an overdose of Mirtazapine Grindeks (without other medicines or alcohol) are
drowsiness, confusion, and increased heart rate. Symptoms of a possible overdose may include changes in
heart rhythm (fast or irregular heartbeat) and/or fainting, which could be symptoms of a potentially life-
threatening condition known as torsade de pointes.
If you forget to take Mirtazapine Grindeks
If you are supposed to take the dose once daily:

• do not take a double dose to make up for the missed dose. Take the next dose at the usual time.

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 missed dose and continue with your normal morning and evening doses.
• if you forget both doses, do not try to make up for the missed doses.

Skip both doses and continue normally the next day with the morning and
evening doses.
If you stop taking Mirtazapine Grindeks
Stop taking Mirtazapine Grindeks only after consulting your doctor.
If you stop taking the medicine too early, depression may return. When you start feeling better, discuss this
with your doctor. Your doctor will decide when you can stop treatment.
Do not stop taking Mirtazapine Grindeks suddenly, even if your depression has
disappeared. If you stop taking Mirtazapine Grindeks suddenly, you may feel unwell, experience dizziness, feel agitated or anxious, 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 this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you notice any of the following serious side effects, stop taking
mirtazapine and contact your doctor immediately.
Uncommon (may affect up to 1 in 100 people):

• euphoria or emotional excitement (mania)

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

• yellowing of the skin or eyes; this may indicate changes in liver function (jaundice)

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

• signs of infection such as sudden unexplained fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disturbances in blood cell production (bone marrow depression). Some people may become less resistant to infections because mirtazapine may cause a temporary deficiency of white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a deficiency of red blood cells and white blood cells as well as platelets (aplastic anaemia), a deficiency of platelets (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia)
• epileptic seizure (convulsions)
• a combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, uncontrollable muscle contractions, chills, overactive reflexes, agitation, mood changes, loss of consciousness, and increased salivation. In very rare cases, these may be signs of serotonin syndrome
• thoughts of harming yourself or taking your own life
• severe skin reactions:
• red, target-shaped or circular rashes on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• widespread redness, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)

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

• increased appetite and body weight
• lethargy or drowsiness
• headache
• dry mouth

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

• lethargy (an abnormal state of drowsiness)
• dizziness
• tremor
• nausea
• diarrhoea
• vomiting
• constipation
• skin rash or eczema (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• feeling dizzy or faint 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
• memory problems, which in most cases resolved when treatment was stopped

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

• abnormal sensations on the skin, e.g. burning, stinging, itching, or tingling (paraesthesia)
• restless legs syndrome
• fainting (syncope)
• numbness of the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• feeling of restlessness
• hallucinations
• urge to move

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

• muscle contractions (myoclonus)
• aggression
• abdominal pain and nausea; this may indicate inflammation of the pancreas (pancreatitis)

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

• abnormal sensation in the mouth (oral paraesthesia)
• swelling of the mouth (mouth oedema)
• swelling throughout the body (generalised oedema)
• localized swelling
• hyponatraemia
• inadequate secretion of antidiuretic hormone
• severe skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking (somnambulism)
• speech disorders
• increased blood levels of creatine kinase
• difficulty urinating (urinary retention)
• muscle pain, stiffness and/or weakness, darkening or discolouration of urine (rhabdomyolysis)
• increased blood levels of the hormone prolactin (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky discharge from the nipple)
• prolonged and painful erection of the penis

Additional side effects observed in children and adolescents:
The following side effects have been commonly observed in clinical studies in children under 18 years of age: significant weight gain, urticaria, and increased blood levels of triglycerides.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the adverse-reaction reporting system.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mirtazapine Grindeks

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature. Store in the original packaging to protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Mirtazapine Grindeks contains
The active substance is mirtazapine.
Each orodispersible tablet of Mirtazapine Grindeks contains 15 mg, 30 mg or 45 mg of mirtazapine.

• Other components are: mannitol (E421); microcrystalline cellulose; crospovidone; anhydrous colloidal silica; low-substituted hydroxypropyl cellulose; aspartame (E951); orange flavour; magnesium stearate.

Description of the appearance of Mirtazapine Grindeks and contents of the pack
Mirtazapine Grindeks 15 mg is a white to off-white, round orodispersible tablet with bevelled edges, marked '15' on one side. The tablet has a diameter of 7.5 mm.
Mirtazapine Grindeks 30 mg is a white to off-white, round orodispersible tablet with bevelled edges, marked '30' on one side. The tablet has a diameter of 9 mm.
Mirtazapine Grindeks 45 mg is a white to off-white, round orodispersible tablet with bevelled edges, marked '45' on one side. The tablet has a diameter of 11 mm.
Mirtazapine Grindeks 15 mg and 30 mg are available in blisters containing 28, 30, 50, 56, 60 or 100 orodispersible tablets.
Mirtazapine Grindeks 45 mg is available in blisters containing 30 or 100 orodispersible tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia

Manufacturers
AS GRINDEKS
Krustpils iela 53,
Rīga, LV-1057,
Latvia
PharmaEstica Manufacturing OÜ
Vanapere Tee 3, Pringi Kula Viimsi Vald,
Harju Maakond, 74011,
Estonia

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Mirtazapin Grindeks 15 mg, 30 mg, 45 mg Schmelztabletten
Belgium Mirtazapine Grindeks 15 mg, 30 mg, 45 mg comprimés orodispersibles
Bulgaria Миртазапин Гриндекс 15 mg, 30 mg, 45 mg таблетки, диспергиращи се в устата
Mirtazapine Grindeks 15 mg, 30 mg, 45 mg orodispersible tablets
Croatia Mirtazapin Grindeks 15 mg raspadljive tablete za usta
Mirtazapin Grindeks 30 mg raspadljive tablete za usta
Mirtazapin Grindeks 45 mg raspadljive tablete za usta
Czech Republic Mirtazapine Grindeks
Denmark Mirtazapin Grindeks
Estonia Mirtazapine Grindeks
Finland Mirtazapine Grindeks 15 mg, 30 mg, 45 mg suussa hajoavat tabletit
France MIRTAZAPINE GRINDEKS 15 mg, comprimé orodispersible
MIRTAZAPINE GRINDEKS 30 mg, comprimé orodispersible
MIRTAZAPINE GRINDEKS 45 mg, comprimé orodispersible
Germany Mirtazapin Grindeks 15 mg, 30 mg, 45 mg Schmelztabletten
Greece Mirtazapine/Grindeks
Hungary Mirtazapine Grindeks 15 mg, 30 mg, 45 mg szájban diszpergálódó tabletta
Ireland Mirtazapine Grindeks 15 mg, 30 mg, 45 mg orodispersible tablets
Italy Mirtazapina Grindeks
Latvia Mirtazapine Grindeks 15 mg, 30 mg, 45 mg mutē disperģējamās tabletes
Lithuania Mirtazapine Grindeks 15 mg burnoje disperguojamosios tabletės
Mirtazapine Grindeks 30 mg burnoje disperguojamosios tabletės
Mirtazapine Grindeks 45 mg burnoje disperguojamosios tabletės
Norway Mirtazapine Grindeks
Poland Mirtazapine Grindeks
Portugal Mirtazapina Grindeks 15 mg, 30 mg, 45 mg comprimidos orodispersíveis
Slovenia Mirtazapin Grindeks 15 mg, 30 mg, 45 mg orodisperzibilne tablete
Spain Mirtazapina Grindeks 15 mg, 30 mg, 45 mg comprimidos bucodispersables
Sweden Mirtazapine Grindeks 15 mg, 30 mg, 45 mg munsönderfallande tabletter