Mirtazapine Alter

Italy
Brand name Mirtazapine Alter
Form tablets, film-coated
Active substance / Dosage
MIRTAZAPINE
Prescription type Prescription only
ATC code
N06AX11
Registration number 036854
Manufacturer LABORATORI ALTER S.R.L.

Table of Contents

Package leaflet: Information for the patient

MIRTAZAPINE ALTER 30 mg film-coated tablets

Mirtazapine
Equivalent medicine
Please read all of this leaflet carefully before 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 other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

MIRTAZAPINE ALTER belongs to a group of medicines called antidepressants.
MIRTAZAPINE ALTER is used to treat depressive disorders in adults.
It will take MIRTAZAPINE ALTER 1 to 2 weeks before it starts to work. After a period of 2 to 4 weeks, you may begin to feel better. You should contact your doctor if you do not feel better or if you feel worse after 2 to 4 weeks. More information is provided in section 3, under the heading “When can you expect to start feeling better”.

2. What you need to know before taking MIRTAZAPINA ALTER

Do not take MIRTAZAPINA ALTER

  • if you are allergic to mirtazapine or to any of the other ingredients of this medicine (listed in section 6). In this case, you should speak to your doctor as soon as possible before taking MIRTAZAPINA ALTER.
  • if you are currently taking or have recently taken (within the last 2 weeks) medicines called monoamine oxidase inhibitors (MAO-I).

Warnings and precautions
Talk to your doctor or pharmacist before taking MIRTAZAPINA ALTER.
Take special care with MIRTAZAPINA ALTER
Children and adolescents under 18 years of age.
MIRTAZAPINA ALTER should generally not be given to children and adolescents under 18 years of age because its effectiveness 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 ideation, and hostility (particularly aggression, hostile behavior, and anger).
Nevertheless, a doctor may decide to prescribe MIRTAZAPINA ALTER to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed MIRTAZAPINA ALTER to a patient under 18 years of age and you wish to obtain clarification, please consult them directly. Inform your doctor immediately if any of the symptoms listed above appear or worsen in patients under 18 years of age receiving MIRTAZAPINA ALTER. It should also be noted that the long-term safety effects of MIRTAZAPINA ALTER in this age group in terms of growth, maturation, and cognitive and behavioral development have not yet been established.
In addition, a significant weight gain has been observed more frequently in this age group compared to adults when treated with mirtazapine.

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 ending your life or harming yourself.
  • you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in adults under 25 years of age with psychiatric disorders treated with antidepressants. → If at any time you find yourself thinking about ending your life or harming yourself, 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 behavior.

Take special care with MIRTAZAPINA ALTER 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 MIRTAZAPINA ALTER:
  • seizures (epilepsy). If you begin to have seizures or if seizures become more frequent, stop taking MIRTAZAPINA ALTER and contact your doctor immediately.
  • liver disease, including jaundice. If you develop jaundice, stop taking MIRTAZAPINA ALTER 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 MIRTAZAPINA ALTER and contact your doctor immediately.
  • diabetes (you may need to adjust the dose of insulin or other anti-diabetic 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, 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, and mouth ulcers. → Stop taking MIRTAZAPINA ALTER 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 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 MIRTAZAPINA ALTER
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take MIRTAZAPINA ALTER in combination with:

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

Be cautious when taking MIRTAZAPINA ALTER 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-Hypericum perforatum preparations (a herbal remedy for depression). Very rarely, MIRTAZAPINA ALTER 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, diarrhea, uncontrollable muscle contractions, tremor, 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 MIRTAZAPINA ALTER in the blood. Inform your doctor if you are taking this medicine, as this may require a reduction in the dose of MIRTAZAPINA ALTER or, when nefazodone is discontinued, an increase in the dose of MIRTAZAPINA ALTER.
  • 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. In combination with these medicines, MIRTAZAPINA ALTER 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), medicines for treating HIV/AIDS (such as HIV protease inhibitors), and medicines for gastric ulcer (such as cimetidine).

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

  • medicines for epilepsy, such as carbamazepine and phenytoin.
  • medicines for tuberculosis, such as rifampicin. These medicines, when taken together with MIRTAZAPINA ALTER, may decrease the amount of MIRTAZAPINA ALTER in the blood. Inform your doctor if you are taking these medicines. It may be necessary to increase the dose of MIRTAZAPINA ALTER or, when the use of these medicines is stopped, to increase the dose of MIRTAZAPINA ALTER again.
  • medicines that prevent blood clotting, such as warfarin. MIRTAZAPINA ALTER may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If used in combination, your doctor must monitor your blood closely.
  • medicines that may affect heart rhythm, such as certain antibiotics and certain antipsychotics.

MIRTAZAPINA ALTER with food and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking MIRTAZAPINA ALTER.
It is recommended not to consume alcoholic beverages.
MIRTAZAPINA ALTER 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, ask your doctor or pharmacist for advice before taking this medicine.
Limited experience with the administration of MIRTAZAPINA ALTER to pregnant women does not indicate an increased risk. However, caution is advised when administering MIRTAZAPINA ALTER during pregnancy.
If you take MIRTAZAPINA ALTER 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), causing the baby to breathe faster and appear bluish. These symptoms usually occur within the first 24 hours after birth.
If this happens to your baby, contact your midwife and/or doctor immediately.

Driving and using machines
MIRTAZAPINA ALTER may affect concentration or alertness. Make sure your abilities are not impaired before driving or operating machinery. If MIRTAZAPINA ALTER has been prescribed to a patient under 18 years of age, ensure that concentration and alertness are not impaired before engaging in activities such as cycling.

MIRTAZAPINA ALTER contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take MIRTAZAPINE ALTER

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
The recommended starting dose is 15 or 30 mg per day. Your doctor may advise you to increase the
dose after a few days to reach the appropriate amount (between 15 and 45 mg per day). Usually,
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 ALTER
→ Take MIRTAZAPINE ALTER at the same time every day. It is best to take
MIRTAZAPINE ALTER 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 higher dose should be taken at bedtime.
Take the tablets by mouth. Swallow the prescribed dose of MIRTAZAPINE ALTER without
chewing it, with a little water or juice.
When to expect to feel better
MIRTAZAPINE ALTER usually 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 ALTER:
→ 2–4 weeks after starting MIRTAZAPINE ALTER, 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 ALTER for 4–6 months after
depression symptoms have disappeared.
If you take more MIRTAZAPINE ALTER than you should
If you or someone else takes too much MIRTAZAPINE ALTER, contact your doctor immediately.
The most likely signs of an overdose of MIRTAZAPINE ALTER (without other medicines or
alcohol) are drowsiness, confusion, and increased heart rate.
If you forget to take MIRTAZAPINE ALTER
If you are supposed to take the dose once a day:

  • Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
    If you are supposed to take the dose twice a day:

  • 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 normally with the morning and evening doses.
If you stop taking MIRTAZAPINE ALTER
→ You should only stop taking MIRTAZAPINE ALTER 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 MIRTAZAPINE ALTER suddenly, even if your depression has resolved. If you stop
MIRTAZAPINE ALTER suddenly, you may feel unwell, have dizziness, feel agitated or anxious, and experience 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 experience any of the following serious side effects, stop taking mirtazapine 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; this may indicate liver function disorders (jaundice)

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

  • Signs of infection such as sudden unexplained high 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 more susceptible to infections because mirtazapine can cause a temporary deficiency in white blood cells (granulocytopenia). In very rare cases, mirtazapine may also cause a deficiency in both white and red blood cells and platelets (aplastic anaemia), a deficiency in platelets (thrombocytopenia), or an increase in the number of white blood cells (eosinophilia).
  • Seizures (convulsions).
  • A combination of symptoms such as unexplained fever, sweating, increased heart rate, diarrhoea, uncontrollable muscle contractions, tremor, hyperactive reflexes, agitation, 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 of 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
  • Tremors
  • 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):

  • Abnormal sensations on the skin, e.g. burning, itching, pruritus, or tingling (paraesthesia)
  • Restless legs
  • 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 secretion of antidiuretic hormone
  • Severe skin reactions (bullous dermatitis, erythema multiforme)
  • Night walking (sleepwalking)
  • Speech disorder
  • Increased levels of creatine kinase in the blood
  • Difficulty in urination (urinary retention)
  • Muscle pain, stiffness and/or weakness, dark or discoloured urine (rhabdomyolysis)

Additional side effects in children and adolescents
In children under 18 years of age, the following side effects have been commonly observed in clinical studies: significant 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. You can also report side effects directly via the national reporting system at the following website:
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 ALTER

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. The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, unopened packaging, correctly stored.
Store in the original packaging to protect it from light and moisture.
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 ALTER contains
Each tablet contains:
Active substance: mirtazapine 30 mg.
Other components:
core
pregelatinized starch
hypromellose
magnesium stearate
anhydrous colloidal silica
lactose monohydrate
hypromellose
titanium dioxide (E 171)
glycerol triacetate

Description of the appearance of MIRTAZAPINE ALTER and contents of the pack
Film-coated tablets, 30 tablets

MARKETING AUTHORISATION HOLDER
Laboratori Alter S.r.l.
Via Egadi, 7 - 20144 Milan, Italy

MANUFACTURER
Laboratorios Alter SA, C/Mateo Inurria, 30 - 28036 MADRID, Spain