Mirtazapine Almus

PATIENT LEAFLET: INFORMATION FOR THE USER

Mirtazapine Almus 15 mg orodispersible tablets, 30 mg orodispersible tablets

Generic medicine
Please read this leaflet carefully before 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, pharmacist, or nurse.
• 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, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

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

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

2. What you should know before taking Mirtazapine Almus

Do not take Mirtazapine Almus

• 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 Almus.
• 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, pharmacist, or nurse before taking Mirtazapine Almus.
Inform your doctor before taking Mirtazapine Almus:

• if you have previously experienced a severe skin rash or skin peeling, blisters and/or mouth ulcers after taking Mirtazapine Almus or other medicines.

Children and adolescents
Mirtazapine Almus is generally not recommended for use in children and adolescents under 18 years of age. It should be noted that in patients under 18 years of age, this class of medicines has been associated with a higher risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, hostile behaviour, and anger). Nevertheless, a doctor may decide to prescribe Mirtazapine Almus to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Mirtazapine Almus to a patient under 18 years of age and you would like further 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 receiving Mirtazapine Almus.
It should also be noted that the long-term safety effects of Mirtazapine Almus 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 more frequently in this age group when treated with mirtazapine compared to 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, because these medicines take time to work—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 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. It may be helpful to tell a relative or friend about your depression and ask them to read this leaflet. You may wish to ask them to inform you if they think your depression is worsening or if they are concerned about changes in your behaviour.

Talk to your doctor, pharmacist, or nurse before taking Mirtazapine Almus and pay particular attention 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 Almus.

• seizures (epilepsy). If you begin to have seizures or if your seizures become more frequent, stop taking Mirtazapine Almus and contact your doctor immediately.
• liver disease, including jaundice. If you develop jaundice, stop taking Mirtazapine Almus 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 Almus and contact your doctor immediately.
• diabetes (it may be necessary 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, which may affect heart rhythm, a recent heart attack, heart failure, or if you are 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 Mirtazapine Almus and contact your doctor immediately for a blood test. In rare cases, these symptoms may indicate 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 side effects of antidepressants.
• Serious skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of Mirtazapine Almus. Discontinue use 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 experienced serious skin reactions, treatment with Mirtazapine Almus should not be restarted.

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

• monoamine oxidase inhibitors (MAO inhibitors). In addition, do not take Mirtazapine Almus within two weeks after stopping MAO inhibitors. Likewise, if you stop taking Mirtazapine Almus, 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 careful when taking Mirtazapine Almus 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, Mirtazapine Almus alone or in combination with these medicines may lead to a condition known as serotonin syndrome. Some symptoms of this syndrome include unexplained fever, sweating, increased heart rate, diarrhoea, uncontrollable muscle contractions, tremor, overactive 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 Almus in your blood. Inform your doctor if you are taking this medicine, as this may require a reduction in the dose of Mirtazapine Almus or, when nefazodone is discontinued, an increase in the dose of Mirtazapine Almus.

• 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 taken together with these medicines, Mirtazapine Almus may increase the drowsiness caused by these substances.

• medicines to treat infections, including antibacterial agents (such as erythromycin), antifungal agents (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 Mirtazapine Almus, may increase the amount of Mirtazapine Almus in your blood. Inform your doctor if you are taking any of these medicines. It may be necessary to reduce the dose of Mirtazapine Almus or, when these medicines are discontinued, to increase the dose of Mirtazapine Almus again.

• antiepileptic medicines, such as carbamazepine and phenytoin; medicines for tuberculosis, such as rifampicin. These medicines, when taken together with Mirtazapine Almus, may decrease the amount of Mirtazapine Almus in your blood. Inform your doctor if you are taking any of these medicines. It may be necessary to increase the dose of Mirtazapine Almus or, when these medicines are discontinued, to reduce the dose of Mirtazapine Almus again.

• medicines that prevent blood clotting, such as warfarin. Mirtazapine Almus 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 Almus with food, drinks, and alcohol
You may experience drowsiness if you consume alcoholic beverages while taking Mirtazapine Almus.
It is best not to consume alcoholic beverages.
Mirtazapine Almus 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.
Limited experience with the administration of Mirtazapine Almus in pregnant women does not indicate an increased risk. However, caution is advised when administering Mirtazapine Almus during pregnancy.
If you take Mirtazapine Almus up to or immediately before delivery, the newborn must be carefully monitored for possible adverse effects.
Ensure that your midwife and/or doctor knows that you are taking Mirtazapine Almus.
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 begin within the first 24 hours after the baby’s birth. If this occurs in your baby, contact your midwife and/or doctor immediately.

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

Mirtazapine Almus contains aspartame
This medicine contains 6 mg of aspartame per 15 mg orodispersible tablet and 12 mg of aspartame per 30 mg orodispersible tablet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot properly break it down.

3. How to take Mirtazapine Almus

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

How much Mirtazapine Almus to take
The recommended starting dose is 15 or 30 mg per day. Your doctor may advise increasing the dose after a few days to reach the appropriate amount (between 15 and 45 mg per day).
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 Almus
→ Take Mirtazapine Almus at the same time every day.
It is best to take Mirtazapine Almus as a single dose before going to bed. However, your doctor may suggest splitting the dose of Mirtazapine Almus into one dose in the morning and one dose 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 by mouth.

1. Do not press on the tablet imprint on the blister (Figure 1).

Figure 1

2. Separate each cell from the strip (Figure 2).

Figure 2

3. Carefully lift the foil lid, starting from the corner indicated by the arrow (Figures 3 and 4).

Figure 3

Figure 4

4. Remove the tablet from its pocket with dry hands and place it on the tongue (Figure 5). It will disintegrate rapidly and can be swallowed without water.

Figure 5

When to expect to feel better
Mirtazapine Almus usually takes 1–2 weeks to start working, and you may notice improvement after 2–4 weeks.
It is important that during the first weeks of treatment you inform your doctor about the effects of Mirtazapine Almus:
2–4 weeks after starting Mirtazapine Almus, 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 Almus should be taken for 4–6 months after the symptoms of depression have disappeared.

If you take more Mirtazapine Almus than you should
If you or someone else takes too much Mirtazapine Almus, contact your doctor immediately.
The most common signs of an overdose of Mirtazapine Almus (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 Torsade de Pointes.

If you forget to take Mirtazapine Almus
If you are supposed to take the dose once daily:

• Do not take a double dose to make up for a missed dose. Take the next dose at your 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 your 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 your morning and evening doses.

If you stop taking Mirtazapine Almus
You should only stop taking Mirtazapine Almus after consulting your doctor.
If you stop taking it 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 Almus suddenly, even if your depression has disappeared. If you stop Mirtazapine Almus suddenly, you may feel unwell, dizzy, 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 Mirtazapine Almus, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Mirtazapine Almus and contact your doctor immediately if you experience any of the following serious side effects:

Very common (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 problems (jaundice).

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

• Signs of infection such as sudden unexplained high fever, sore throat, and mouth ulcers (agranulocytosis). In rare cases, mirtazapine may cause disorders in blood cell production (bone marrow depression). Some people may become less resistant to infections because mirtazapine may cause a temporary shortage of white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a shortage of red and white blood cells and platelets (aplastic anaemia), a shortage of 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, fatigue, mood changes, and loss of consciousness. Very rarely, these may be symptoms of serotonin syndrome.
• Thoughts of harming yourself or taking your life – contact your doctor immediately or go to hospital straight away.
• Red spots on the trunk, or target-shaped or circular rashes, often with central blisters, skin peeling, mouth, throat, nose, genital, or eye ulcers. These serious skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

The following side effects have also been reported:

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
• 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)
• Tiredness
• Vivid dreams
• Confusion
• Anxiety
• Sleep problems
• Memory problems, which in most cases resolved after stopping treatment

In children under 18 years, the following adverse events are commonly observed in clinical studies:

• Weight gain
• Urticaria
• Increased blood triglycerides

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

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

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

• Muscle twitch (myoclonus)
• Feeling of aggressiveness
• Abdominal pain and nausea, which may indicate inflammation of the pancreas (pancreatitis)

Not known (frequency cannot be estimated from 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
• Serious skin reactions (bullous dermatitis, erythema multiforme)
• Increased salivation
• Difficulty speaking (dysarthria)
• Sleepwalking
• Difficulty urinating
• Muscle pain, stiffness and/or weakness, dark or unusual-coloured urine (rhabdomyolysis)
• Changes in liver enzymes in the blood (detected in blood tests)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mirtazapine Almus

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, on the tablet container, and on the blister after EXP. The expiry date refers to the last day of the month.
Storage conditions (blister): store in the original packaging to protect the medicine from moisture and light.
Storage conditions (tablet container): store in the original tablet container and keep it tightly closed to protect the medicine from moisture and light.
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. Contents of the pack and other information

What Mirtazapina Almus contains

• The active substance is mirtazapine. Each orodispersible tablet of Mirtazapina Almus contains 15 mg or 30 mg of mirtazapine.
• The other excipients are: mannitol, microcrystalline cellulose, heavy magnesium carbonate, hydroxypropylcellulose, crospovidone, anhydrous colloidal silica, L-methionine, microcrystalline cellulose and guarana gum, aspartame (E951), orange flavour.

Description of the appearance of Mirtazapina Almus tablets and pack contents
Orodispersible tablets.
15 mg tablets: white to off-white, round, 8 mm in diameter, biconvex, uncoated tablets marked with “M1”.
30 mg tablets: white to off-white, round, 10 mm in diameter, biconvex, uncoated tablets marked with “M2”.

15 mg:
Blister packs containing 6, 18, 30, 48, 90, 96 and 180 tablets (hospital packs 18 x 10 tablets)
Blister packs with easy opening, divisible into single doses, containing 6, 18, 30, 48, 90, 96 and 180 tablets (hospital packs 18 x 10 tablets).
Bottle: 50, 100 tablets (desiccant included).

30 mg:
Blister packs containing 6, 18, 30, 48, 90, 96 and 180 tablets (hospital packs 18 x 10 tablets)
Blister packs with easy opening, divisible into single doses, containing 6, 18, 30, 48, 90, 96 and 180 tablets (hospital packs 18 x 10 tablets).
Bottle: 50, 100 tablets (desiccant included).

Not all pack sizes may be marketed.

Marketing Authorization Holder
Almus S.r.l.
Via Cesarea, 11/10 – 16121 Genoa, Italy

Manufacturing and batch release
Actavis hf.
Reykjavíkurvergur 76-78
220 Hafnarfjordur
Iceland

Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta

This medicinal product has been authorised in the Member States of the European Economic Area under the following names:
Italy: Mirtazapina Almus 15 mg orodispersible tablets
Mirtazapina Almus 30 mg orodispersible tablets