Mirtazapine Doc Generici
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Table of Contents
PATIENT LEAFLET: INFORMATION FOR THE USER
MIRTAZAPINE DOC Generici 15 mg orodispersible tablets, 30 mg orodispersible tablets, 45 mg orodispersible tablets
Equivalent medicine
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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.
Contents of this leaflet:
- What MIRTAZAPINE DOC Generici is and what it is used for
- What you need to know before taking MIRTAZAPINE DOC Generici
- How to take MIRTAZAPINE DOC Generici
- Possible side effects
- How to store MIRTAZAPINE DOC Generici
- Contents of the pack and other information
1. WHAT MIRTAZAPINE DOC Generici IS AND WHAT IT IS USED FOR
MIRTAZAPINE DOC Generici belongs to a group of medicines called antidepressants.
MIRTAZAPINE DOC Generici is used to treat depressive disorders in adults.
It will take MIRTAZAPINE DOC Generici 1 to 2 weeks before it starts to work. After 2-4 weeks, you may begin to feel better. 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 to start feeling better”.
2. WHAT YOU SHOULD KNOW BEFORE TAKING MIRTAZAPINE DOC Generici
Do not take MIRTAZAPINE DOC Generici
if you are allergic to mirtazapine or to any of the other ingredients of this medicine
(listed in section 6). In this case, you must speak to your doctor as soon as possible before
taking MIRTAZAPINE DOC Generici.
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 this medicine.
Exercise special caution with MIRTAZAPINE DOC Generici
Children and adolescents under 18 years of age
MIRTAZAPINE DOC Generici should generally not be used in children and adolescents under
18 years of age, as its efficacy has not been demonstrated. It is also important to know that patients
under 18 years of age who take this class of medicines have a higher risk of experiencing adverse
effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, hostile
behaviour, and anger). Nevertheless, your doctor may prescribe MIRTAZAPINE DOC Generici to
patients under 18 years of age if they consider it to be in their best interest. If your doctor has
prescribed MIRTAZAPINE DOC Generici to a patient under 18 years of age and you wish to discuss
this, consult your doctor. You must inform your doctor if any of the symptoms listed above appear or
worsen when patients under 18 years of age are taking MIRTAZAPINE DOC Generici.
Furthermore, the long-term safety effects of MIRTAZAPINE DOC Generici 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 ending your life. These
thoughts may increase shortly after starting treatment with antidepressants, as these medicines need
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 suicide or self-harm.
you are a young adult. Data from clinical trials have shown an increased risk of suicidal
behaviour in psychiatric patients under 25 years of age treated with antidepressants.
If at any time you find yourself thinking about suicide or self-harm, contact your doctor or go to
hospital immediately.
It may be helpful to confide in a relative 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.
Exercise special caution with MIRTAZAPINE DOC Generici 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 Generici.
- Seizures (epilepsy). If you begin to have seizures or if seizures become more frequent, stop taking MIRTAZAPINE DOC Generici and contact your doctor immediately.
- Liver diseases, including jaundice. If you develop jaundice, stop taking MIRTAZAPINE DOC Generici and contact your doctor immediately.
- Kidney diseases;
- 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 begin to feel euphoric or overexcited, stop taking MIRTAZAPINE DOC Generici and contact your doctor immediately.
- diabetes (it may be necessary to adjust the dose of insulin or other antidiabetic medicines).
- eye diseases, such as increased eye pressure (glaucoma).
- difficulty urinating, which may be caused by an enlarged prostate.
If you experience signs of infection, such as unexplained high fever, sore throat, or mouth ulcers.
Stop taking MIRTAZAPINE DOC Generici and contact your doctor immediately for a blood test. In rare cases, these symptoms may indicate a disorder in blood cell production 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 adverse effects of antidepressants.
Other medicines and MIRTAZAPINE DOC Generici
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take MIRTAZAPINE DOC Generici in combination with:
- monoamine oxidase inhibitors (MAO inhibitors). In addition, do not take MIRTAZAPINE DOC Generici within two weeks after stopping MAO inhibitors. Likewise, if you stop taking MIRTAZAPINE DOC Generici, do not take MAO inhibitors within two weeks thereafter. MAO inhibitors include, for example, moclobemide, tranylcypromine (both are antidepressants), and selegiline (used in Parkinson’s disease).
Be cautious when taking MIRTAZAPINE DOC Generici in combination with:
antidepressants such as SSRIs, venlafaxine, and L-tryptophan or triptans (used to treat
migraine), tramadol (a painkiller), linezolid (an antibiotic), lithium (used to treat certain
psychiatric conditions), and St. John’s wort preparations, Hypericum perforatum (a herbal
medicinal product for depression). Very rarely, MIRTAZAPINE DOC Generici, alone or in
combination with these medicines, may cause the so-called serotonin syndrome. Some of the
symptoms of this syndrome include unexplained fever, sweating, increased heart rate, diarrhoea,
involuntary muscle contractions, tremor, hyperactive reflexes, restlessness, mood changes, and loss
of consciousness. If you experience a combination of these symptoms, speak to your doctor
immediately.
the antidepressant called nefazodone, which may increase the amount of MIRTAZAPINE DOC
Generici in the blood. Inform your doctor if you are taking this medicine, as this may require a
reduction in the dose of MIRTAZAPINE DOC Generici or, when nefazodone is discontinued, an
increase in the dose of MIRTAZAPINE DOC Generici.
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 taken in combination with these medicines, MIRTAZAPINE DOC Generici 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), medicines to treat HIV/AIDS (such as
HIV protease inhibitors), and medicines for stomach ulcers (such as cimetidine).
These medicines, when taken with MIRTAZAPINE DOC Generici, may increase the amount of
MIRTAZAPINE DOC Generici in the blood. Inform your doctor if you are taking these medicines. It
may be necessary to reduce the dose of MIRTAZAPINE DOC Generici or, when these medicines are
discontinued, to increase the dose of MIRTAZAPINE DOC Generici again.
medicines for epilepsy, such as carbamazepine and phenytoin;
medicines for tuberculosis, such as rifampicin.
These medicines, when taken with MIRTAZAPINE DOC Generici, may decrease the amount of
MIRTAZAPINE DOC Generici in the blood. Inform your doctor if you are taking these medicines. It
may be necessary to increase the dose of MIRTAZAPINE DOC Generici or, when these medicines
are discontinued, to reduce the dose of MIRTAZAPINE DOC Generici again.
medicines that prevent blood clotting, such as warfarin.
MIRTAZAPINE DOC Generici 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.
MIRTAZAPINE DOC Generici with food, drinks and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking MIRTAZAPINE
DOC Generici.
It is best not to consume alcoholic beverages.
MIRTAZAPINE DOC Generici may be taken with or without food.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Limited experience with the administration of MIRTAZAPINE DOC Generici in pregnant women does
not indicate an increased risk. However, caution is advised when administering MIRTAZAPINE DOC
Generici during pregnancy.
If you take MIRTAZAPINE DOC Generici up to delivery or immediately before delivery, the newborn
must be closely monitored for possible adverse effects.
Ensure that your midwife and/or doctor are informed that you are being treated with MIRTAZAPINE
DOC Generici.
Similar medicines to this one (SSRIs), when taken during pregnancy, may increase the risk of a
serious condition in newborns 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 this occurs in your baby.
Driving and using machines
MIRTAZAPINE DOC Generici may affect your concentration or alertness. Make sure your abilities are
not impaired before driving or operating machinery. If your doctor has prescribed MIRTAZAPINE DOC
Generici to a patient under 18 years of age, ensure that concentration and alertness are not impaired
before allowing participation in traffic (e.g., cycling).
MIRTAZAPINE DOC Generici orodispersible tablets contain aspartame, a source of phenylalanine. It may be harmful for individuals with phenylketonuria.
3. HOW TO TAKE MIRTAZAPINE DOC Generici
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 Generici 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, up to 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 had kidney or liver disease.
When to take MIRTAZAPINE DOC Generici
Take MIRTAZAPINE DOC Generici every day at the same time.
It is best to take MIRTAZAPINE DOC Generici as a single dose before going to bed. However, your doctor may suggest dividing the dose, taking one in the morning and one in the evening before going to bed. The higher dose should be taken at bedtime.
How to take the orodispersible tablet as described below:
Take the tablets orally.
1. Do not break the orodispersible tablet
To prevent breaking the orodispersible tablet, do not press on the tablet imprint on the blister (Figure A).
Fig. A.
2. Detach a tablet imprint
Each blister contains 6 tablets (imprints), separated by perforated lines. Detach one portion by tearing along the perforated lines (Figure 1).
Fig. 1.
3. Lift the cover sheet
Carefully lift the cover sheet, starting from the corner indicated by the arrow
(Figures 2 and 3).
Fig. 2. Fig. 3
.
4. Remove the orodispersible tablet
The orodispersible tablet must be removed from its blister pack with dry hands and placed on the tongue. (Figure 4).
Fig. 4.
It will disintegrate rapidly and can be swallowed without water.
When can you expect to feel better?
MIRTAZAPINA DOC Generici 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 MIRTAZAPINA DOC Generici:
2–4 weeks after starting MIRTAZAPINA DOC Generici, 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. Normally, MIRTAZAPINA DOC Generici should be taken for 4–6 months after the symptoms of depression have disappeared.
If you take more MIRTAZAPINA DOC Generici than you should
If you or someone else takes too much MIRTAZAPINA DOC Generici, contact your doctor immediately.
The most common signs of an overdose of MIRTAZAPINA DOC Generici (without other medicines or alcohol) are drowsiness, confusion, and increased heart rate.
If you forget to take MIRTAZAPINA DOC Generici
If your dose is to be taken once daily
- Do not take a double dose to make up for the missed dose. Skip the missed dose and take the next dose at the usual time.
If your dose is to be taken 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 the next day with your normal morning and evening doses.
If you stop taking MIRTAZAPINA DOC Generici
You may only stop taking MIRTAZAPINA DOC Generici 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 to stop treatment.
Do not stop taking MIRTAZAPINA DOC Generici suddenly, even if your depression has resolved. If you stop MIRTAZAPINA DOC Generici abruptly, you may feel unwell, experience dizziness, agitation or anxiety, and have headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to reduce the dose gradually.
If you have any questions about the use of MIRTAZAPINA DOC Generici, consult your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following serious side effects, stop taking
MIRTAZAPINE DOC Generici 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 eyes and skin; this may indicate liver function disorders (jaundice).
Not known (frequency cannot be estimated from the available data):
- Signs of infection such as sudden and unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, MIRTAZAPINE DOC Generici may cause a disorder in blood cell production (bone marrow depression). Some people become less resistant to infections because MIRTAZAPINE DOC Generici may cause a temporary deficiency of white blood cells (granulocytopenia). In rare cases, MIRTAZAPINE DOC Generici may also cause a deficiency of white and red blood cells and platelets (aplastic anaemia), a deficiency of platelets (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia).
- Seizure (convulsions)
- A combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, uncontrollable muscle contractions, tremor, hyperactive reflexes, fatigue, mood changes, loss of consciousness, and increased salivation. Very rarely, these may be symptoms of serotonin syndrome.
- Thoughts of harming yourself or of suicide
- Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
Other possible side effects with mirtazapine are:
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):
- 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)
- Tiredness
- Vivid dreams
- Confusion
- Anxiety
- Sleep problems
Uncommon (may affect up to 1 in 100 people):
- 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
- Hallucinations
- Need to move around
Rare (may affect up to 1 in 1,000 people):
- Muscle twitch (myoclonus)
- Aggression
- 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 of the entire body (generalised oedema)
- Localised swelling
- Hyponatraemia
- Inappropriate secretion of antidiuretic hormone
- Sleepwalking (somnambulism)
- Severe skin reactions (bullous dermatitis, erythema multiforme)
- Speech disorders
Additional side effects in children and adolescents
The following adverse events have commonly been observed in children under 18 years of age in clinical studies: marked increase in body weight, urticaria, and increased blood triglycerides.
Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at:
http://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 GENERICS
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 on the blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
6. PACK CONTENTS AND OTHER INFORMATION
What MIRTAZAPINA DOC Generici contains
- The active substance is mirtazapine. MIRTAZAPINA DOC Generici 15 mg orodispersible tablets contain 15 mg of mirtazapine per orodispersible tablet. MIRTAZAPINA DOC Generici 30 mg orodispersible tablets contain 30 mg of mirtazapine per orodispersible tablet. MIRTAZAPINA DOC Generici 45 mg orodispersible tablets contain 45 mg of mirtazapine per orodispersible tablet.
- The other components are crospovidone (type B), mannitol (E421), microcrystalline cellulose, aspartame (E951), anhydrous colloidal silica, magnesium stearate, strawberry guarana flavour [maltodextrin, propylene glycol, artificial flavours, acetic acid] and peppermint flavour [artificial flavours, maize starch].
Description of the appearance of MIRTAZAPINA DOC Generici and pack contents
MIRTAZAPINA DOC Generici are orodispersible tablets.
MIRTAZAPINA DOC Generici 15 mg orodispersible tablets:
White, round orodispersible tablets (diameter 6.5 mm), with a raised circular edge, and engraved with the number “36” on one side and the letter ‘A’ on the opposite side.
MIRTAZAPINA DOC Generici 30 mg orodispersible tablets:
White, round orodispersible tablets (diameter 8.0 mm), with a raised circular edge, and engraved with the number “37” on one side and the letter ‘A’ on the opposite side.
MIRTAZAPINA DOC Generici 45 mg orodispersible tablets:
White, round orodispersible tablets (diameter 9.5 mm), with a raised circular edge, and engraved with the number “38” on one side and the letter ‘A’ on the opposite side.
MIRTAZAPINA DOC Generici orodispersible tablets are available in perforated blisters made of polyamide/aluminum/PVC/paper/polyester/aluminum Unit Dose containing 6, 18, 30, 48, 90 and 96 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
DOC Generici Srl
Via Turati 40
20121 Milano – Italy
Manufacturer
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
or
Pfizer Services Company BVBA
Hoge Wei 10
B-1930 Zaventem
Belgium
or
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
or
LABORATORIOS CINFA, S.A.
Ctra. Olaz-Chipi 10, Pol. Ind. Areta
31620 Huarte-Pamplona (Navarra)
Spain
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Belgium: Mirtazapine Apotex 15 mg/ 30 mg/ 45 mg orodispergeerbare tabletten
Mirtazapine Apotex 15 mg/ 30 mg/ 45 mg comprimés orodispersible
Mirtazapine Apotex 15 mg/ 30 mg/ 45 mg Schmelztabletten
Bulgaria: Mirtazapine Aurobindo 15 mg/ 30 mg/ 45 mg таблетки, диспергираща се в устата
Cyprus: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg δισκία διασπειρόμενο στο στόμα
Denmark: Mirtazapin “Aurobindo”
Estonia: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg suus dispergeeruvad tabletid
Finland: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg tabletti, suussa hajoava
Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg munsönderfallande tabletter
France: MIRTAZAPINE AUROBINDO 15 mg/ 30 mg/ 45 mg, comprimés orodispersible
Germany: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg Schmelztabletten
Greece: mirtazaFer Aurobindo 15 mg/ 30 mg/ 45 mg δισκία διασπειρόμενο στο στόμα
Hungary: Mirtazapine Aurobindo 15 mg/ 30 mg/ 45 mg szájban diszpergálódó tabletta
Ireland: Mirtazapine Aurobindo 15 mg/ 30 mg/ 45 mg orodispersible tablets
Italy: MIRTAZAPINA DOC Generici 15 mg/ 30 mg/ 45 mg compresse orodispersibili
Latvia: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg mutē disperģējamās tabletes
Lithuania: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg burnoje disperguojamosios tabletės
Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg orodispersible tablets
Netherlands: Mirtazapine Aurobindo 15mg/30mg/45mg orodispergeerbare tabletten
Poland: Mirtazapine Aurobindo
Portugal: Mirtazapina Aurobindo
Romania: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg comprimate orodispersabile
Spain: MIRTAZAPINA FLAS CINFA 15 mg/ 30 mg/ 45 mg comprimidos bucodispersables
Sweden: Mirtazapin Aurobindo 15 mg/ 30 mg/ 45 mg munsönderfallande tabletter
United Kingdom: Mirtazapine 15 mg/ 30 mg/ 45 mg orodispersible tablets
This leaflet was last updated on