Mirtazapine Doc Generici: detailed information

Package leaflet: Information for the user

MIRTAZAPINE DOC 30 mg film-coated tablets

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. Never give it to other people, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. What MIRTAZAPINE DOC is and what it is used for

MIRTAZAPINE DOC belongs to a group of medicines called antidepressants.
MIRTAZAPINE DOC is used to treat depressive disorders in adults.
It will take 1 or 2 weeks before MIRTAZAPINE DOC starts to take effect. You will start to feel better after 2–4 weeks. You should speak to 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 to feel better”.

2. What you need to know before taking MIRTAZAPINE DOC

Do not take MIRTAZAPINE DOC

if you are allergic to mirtazapine or to any of the excipients of this medicine (listed in section 6). In this case, you should discuss it with your doctor as soon as possible before taking MIRTAZAPINE DOC.
if you are currently taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAO-Is).

Warnings and precautions
Talk to your doctor or pharmacist before taking MIRTAZAPINE DOC.
Take particular care with MIRTAZAPINE DOC
Children and adolescents
Mirtazapine should generally not be used in children and adolescents under 18 years of age, as its efficacy has not been demonstrated. It is important to know 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, hostile behaviour, and anger). Nevertheless, your doctor may prescribe MIRTAZAPINE DOC to patients under 18 years of age if they decide it is in their best interest. If your doctor has prescribed MIRTAZAPINE DOC to a patient under 18 years of age and you would like clarification, please consult them directly. Inform your doctor immediately if any of the symptoms described above appear or worsen in patients under 18 years of age being treated with MIRTAZAPINE DOC. It should also be noted that the long-term safety effects of mirtazapine in this age group in terms of growth, maturation, and cognitive and behavioural development have not yet been established.
In addition, a significant weight gain has been observed in this age group when treated with mirtazapine, more frequently than in adults.

Suicidal thoughts and worsening of depression
If you are depressed, you may sometimes think about harming yourself or taking your own 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 own life or harming yourself.
you are a young adult. Clinical studies 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 own life or harming yourself, contact your doctor or go to hospital immediately. It may be helpful to confide in a family member or friend who suffers from depression and ask them to read this leaflet. You may ask them to inform you if they believe your depression is worsening, or if they are concerned about changes in your behaviour.

Take particular care with MIRTAZAPINE DOC also

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 DOC.
seizures (epilepsy). If you begin to have seizures or if seizures become more frequent, stop taking MIRTAZAPINE DOC and contact your doctor immediately.
liver disease, including jaundice. If you develop jaundice, stop taking MIRTAZAPINE DOC 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 DOC and contact your doctor immediately.
diabetes (it may be necessary to adjust the dose of insulin or other antidiabetic medicines).
eye conditions, 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 taking certain medicines that may affect heart rhythm.
if you develop signs of infection, such as unexplained high fever, sore throat, or mouth ulcers. → Stop taking MIRTAZAPINE DOC and contact your doctor immediately for a blood test.

In rare cases, these symptoms may be signs of a disorder affecting blood cell production in the bone marrow. Although rare, these symptoms usually occur more commonly after 4–6 weeks of treatment.

if you are elderly. You may be more sensitive to the adverse effects of antidepressants.

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

monoamine oxidase inhibitors (MAO inhibitors). In addition, do not take MIRTAZAPINE DOC within two weeks after stopping MAO inhibitors. Likewise, if you stop taking MIRTAZAPINE DOC, do not take MAO inhibitors within two weeks afterwards. MAO inhibitors include, for example, moclobemide, tranylcypromine (both are antidepressants), and selegiline (used in Parkinson's disease).

Be cautious when taking MIRTAZAPINE DOC in combination with:

antidepressants such as SSRIs, venlafaxine, and L-tryptophan or triptans (used to treat migraine), tramadol (for pain treatment), 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 preparations (a herbal remedy for depression). Very rarely, mirtazapine, 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, uncontrollable muscle contractions, chills, hyperactive reflexes, restlessness, mood changes, and loss of consciousness. If a combination of these symptoms occurs, speak to your doctor immediately.
the antidepressant called nefazodone, which may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medicine, as this may require a reduction in the dose of MIRTAZAPINE DOC or, when nefazodone is discontinued, an increase in the dose of MIRTAZAPINE DOC.
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. When administered together with these medicines, mirtazapine may increase the drowsiness caused by these substances.
medicines to treat infections; medicines for bacterial infections (such as erythromycin), medicines for fungal infections (such as ketoconazole), medicines for treating HIV/AIDS (such as HIV protease inhibitors), and medicines for treating gastric ulcers (such as cimetidine). These medicines, when combined with mirtazapine, 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 DOC or, when use of these medicines is discontinued, to increase the dose of MIRTAZAPINE DOC again.
antiepileptic medicines, such as carbamazepine and phenytoin;
medicines for tuberculosis, such as rifampicin. These medicines, when combined with MIRTAZAPINE DOC, may decrease the amount of MIRTAZAPINE DOC in the blood. Inform your doctor if you are taking these medicines.

It may be necessary to increase the dose of MIRTAZAPINE DOC or, when use of these medicines is discontinued, to reduce the dose of MIRTAZAPINE DOC again.

medicines that prevent blood clotting, such as warfarin. MIRTAZAPINE DOC 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 certain antipsychotics.

MIRTAZAPINE DOC with food and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking MIRTAZAPINE DOC.
It is recommended not to consume alcoholic beverages.
MIRTAZAPINE DOC may be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Limited experience with the administration of mirtazapine to pregnant women does not indicate an increased risk. However, caution is advised when administering mirtazapine during pregnancy.
If you use MIRTAZAPINE DOC up to or immediately before delivery, the newborn must be carefully monitored for possible adverse effects.
Ensure that your midwife and/or doctor are informed that you are being treated with MIRTAZAPINE DOC.
Medicines similar to this one (SSRIs), when taken during pregnancy, may increase the risk of a serious condition in the baby called persistent pulmonary hypertension of the newborn (PPHN), which causes rapid breathing and a bluish skin colour in the newborn. These symptoms usually appear within the first 24 hours after birth. Inform your midwife and/or doctor immediately if your baby shows these symptoms.

Driving and using machines
MIRTAZAPINE DOC may affect concentration or alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed MIRTAZAPINE DOC to a patient under 18 years of age, ensure that concentration and alertness are not impaired before engaging in traffic (e.g., cycling).

MIRTAZAPINE DOC tablets contain lactose.
This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take MIRTAZAPINE DOC

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

How much MIRTAZAPINE DOC to take
The recommended starting dose is 15 or 30 mg daily. Your doctor may advise you to increase the dose after a few days until reaching the appropriate amount (between 15 and 45 mg daily).
The dose is usually the same for all age groups. However, your doctor may adjust the dose if you are elderly or if you have had kidney or liver disease.

When to take MIRTAZAPINE DOC
→ Take MIRTAZAPINE DOC every day at the same time. It is best to take MIRTAZAPINE DOC as a single dose before going to bed. However, your doctor may suggest splitting the dose, taking one in the morning and one in the evening before going to bed. The larger dose should be taken at bedtime.
Take the tablets orally. Swallow the prescribed dose of MIRTAZAPINE DOC without chewing, with some water or juice.

When to expect to feel better
Normally, MIRTAZAPINE DOC 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 DOC:
→ 2–4 weeks after starting MIRTAZAPINE DOC, 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 with your doctor again after another 2–4 weeks.
Usually, it is necessary to continue taking MIRTAZAPINE DOC for 4–6 months after the symptoms of depression have disappeared.

If you take more MIRTAZAPINE DOC than you should
→ If you or someone else takes too much MIRTAZAPINE DOC, call your doctor immediately.
The most common signs of an overdose of MIRTAZAPINE DOC (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 signs of a life-threatening condition known as Torsades de Pointes.

If you forget to take MIRTAZAPINE DOC
If you are supposed to take the dose once daily:

Do not take a double dose to make up for a forgotten dose. Skip the missed dose and 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 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 normally the next day with the morning and evening doses.

If you stop taking MIRTAZAPINE DOC
→ You should only stop taking MIRTAZAPINE DOC after consulting 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 it is appropriate to stop treatment.
Do not stop taking MIRTAZAPINE DOC suddenly, even if your depression has resolved. If you stop MIRTAZAPINE DOC abruptly, you may feel unwell, experience dizziness, agitation or anxiety, and have headaches. These symptoms can be avoided by gradually reducing the dose. Your doctor will tell you how to taper 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, MIRTAZAPINE DOC may cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking MIRTAZAPINE DOC and inform 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, which may indicate liver problems (jaundice).

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 DOC may cause disturbances in blood cell production (bone marrow depression). Some people may become more susceptible to infections because MIRTAZAPINE DOC may cause a temporary deficiency of white blood cells (granulocytopenia). In rare cases, MIRTAZAPINE DOC may also cause a deficiency of red 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).
Seizure (convulsion)
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.
Suicidal or self-harming thoughts
Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other possible side effects that may occur with MIRTAZAPINE DOC include:
Very common (may affect more than 1 in 10 people):

Increased appetite and body weight
Drowsiness
Headache
Dry mouth

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

Constipation
Lethargy
Dizziness
Tremor
Nausea
Diarrhoea
Vomiting
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 ankles and feet) due to fluid retention (oedema)
Fatigue
Vivid dreams
Confusion
Anxiety
Sleep problems

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

Abnormal skin sensations, e.g. burning, itching, pruritus, or tingling (paraesthesia)
Restless legs syndrome
Fainting (syncope)
Numbness of the mouth (oral hypoesthesia)
Low blood pressure
Nightmares
Agitation
Hallucinations
Urge to move

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

Muscle twitch (myoclonus)
Aggressiveness
Abdominal pain and nausea; this may indicate inflammation of the pancreas (pancreatitis)

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)
Localised swelling
Hyponatraemia
Inappropriate antidiuretic hormone secretion
Sleepwalking (somnambulism)
Severe skin reactions (bullous dermatitis, erythema multiforme)
Speech disorders

Other possible side effects with mirtazapine are:
Increased levels of creatine kinase in the blood, difficulty urinating, muscle pain, stiffness and/or weakness, and dark or discoloured urine.

Additional side effects in children and adolescents
The following side effects have been frequently observed in clinical studies in children under 18 years of age: marked weight gain, urticaria, and increased levels of triglycerides in the blood.

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

5. How to store MIRTAZAPINE DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "Exp.". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
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 MIRTAZAPINA DOC contains

The active substance is mirtazapine. Each film-coated tablet contains 30 mg of mirtazapine.
The other components (excipients) are:

Core
monohydrate lactose
maize starch
hydroxypropylcellulose
anhydrous colloidal silica
low-substituted hydroxypropylcellulose
magnesium stearate

Coating:
hydroxypropylcellulose
hypromellose
titanium dioxide (E171)
yellow iron oxide (E172)
red iron oxide (E172)
black iron oxide (E172)

Description of the appearance of MIRTAZAPINA DOC and the contents of the pack
Film-coated tablets, biconvex, reddish-brown in colour, oval-shaped (14.0 x 6.0 mm), with a score line and engraved with "0" and "9" on one side and an "A" on the other side. The tablets can be divided into two equal parts.
MIRTAZAPINA DOC 30 mg film-coated tablets are available in packs containing 14, 20, 30, 50 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milan
Italy

Manufacturers
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Milpharm Limited
Ares, Odyssey Business Park,
West End Road,
South Ruislip HA4 6QD
United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
Germany: MirtazapinAurobindo 30 mg Filmtabletten
Italy: MIRTAZAPINA DOC 30 mg film-coated tablets