Mirtazapine Tarbis 15 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mirtazapine Tarbis 15 mg orodispersible tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as 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 and must not be given to other people, even if they have the same symptoms as you, because it could be harmful to them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Mirtazapina Tarbis is and what it is used for

Mirtazapina Tarbis belongs to a group of medicines called antidepressants.

Mirtazapine is used to treat depression.

2. What you need to know before taking Mirtazapine Tarbis

Do not take Mirtazapine Tarbis

• if you are allergic to mirtazapine or to any of the other ingredients of this medicine (listed in section 6). In this case, consult your doctor as soon as possible before taking Mirtazapine Tarbis.
• if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAOIs).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Mirtazapine Tarbis.

Use in children and adolescents under 18 years of age

Mirtazapine Tarbis should not normally be used to treat children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontation behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Mirtazapine Tarbis to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed Mirtazapine Tarbis to a patient under 18 years of age and you wish to discuss this decision, please contact your doctor again. You must inform your doctor if any of the symptoms listed above appear or worsen in patients under 18 years of age who are taking Mirtazapine Tarbis. In addition, the long-term effects on growth, maturation, and cognitive and behavioural development with mirtazapine in this age group are not yet fully known.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts of self-harm or suicide. These may increase when starting antidepressants, as these medicines take time to begin working—usually about two weeks, although in some cases it may take longer.

You are more likely to have such thoughts:

• if you have previously had thoughts of self-harm or suicide.
• if you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders who were treated with an antidepressant.

? If at any time you have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

It may help you to tell a family member or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You may ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behaviour.

Also, take special care with Mirtazapine Tarbis:

• if you have or have ever had any of the following conditions

? Inform your doctor about these conditions before taking Mirtazapine Tarbis, if you have not already done so:

• seizures (epilepsy). If seizures occur or your seizures become more frequent, stop taking mirtazapine and contact your doctor immediately;

• liver disease, including jaundice. If jaundice occurs, stop taking mirtazapine 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;

• bipolar depression (periods of elevated mood/hyperactivity alternate with periods of depression). If you start feeling elated or overexcited, stop taking mirtazapine and contact your doctor immediately;

• diabetes (you may need to adjust your insulin dose or other antidiabetic medicines);

• eye disorders, such as increased pressure in the eye (glaucoma);

• difficulty urinating, which may be due to an enlarged prostate;

• if you develop signs of infection such as unexplained high fever, sore throat, or mouth ulcers

? Stop taking Mirtazapine Tarbis and contact your doctor immediately for a blood test. Rarely, these symptoms may indicate disturbances in blood cell production in the bone marrow. Although rare, these symptoms typically appear 4–6 weeks after starting treatment.

• if you are elderly, you may be more sensitive to the adverse effects of antidepressant medicines.

Taking Mirtazapine Tarbis with other medicines

Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines listed below.

Also inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Do not take Mirtazapine Tarbis together with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine during the two weeks following discontinuation of MAOIs. If you stop taking mirtazapine, do not take MAOIs for the following two weeks.

Examples of MAOIs include moclobemide, tranylcypromine (both are antidepressants), and selegiline (used for Parkinson’s disease).

Be cautious if you take Mirtazapine Tarbis together with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, and L-tryptophan or triptans (used for migraine), tramadol (for pain), linezolid (an antibiotic), lithium (used to treat certain psychiatric disorders), and St. John’s wort – Hypericum perforatum (a herbal remedy for depression). In very rare cases, mirtazapine alone or in combination with these medicines may lead to a condition called serotonin syndrome. Some symptoms of this syndrome include unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, contact your doctor immediately.
• the antidepressant nefazodone. This may increase the amount of mirtazapine in the blood. Inform your doctor if you are taking this medicine. It may be necessary to reduce the dose of mirtazapine, or increase it again when stopping nefazodone.
• 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 together with these medicines, mirtazapine may increase the drowsiness caused by them.

• medicines for infections: antibiotics (such as erythromycin), antifungal medicines (such as ketoconazole), and medicines for HIV/AIDS (HIV protease inhibitors).

When taken together with mirtazapine, these medicines 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, or increase it again when stopping these medicines.

• medicines for epilepsy such as carbamazepine and phenytoin; medicines for tuberculosis such as rifampicin.

When taken together with mirtazapine, these medicines 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, or reduce it again when stopping these medicines.

• medicines to prevent blood clotting such as warfarin.

Mirtazapine may enhance the effects of warfarin in the blood. Inform your doctor if you are taking this medicine. If taken together, your doctor may recommend regular blood monitoring.

Taking Mirtazapine Tarbis with food, drinks, and alcohol

You may feel drowsy if you drink alcohol while taking mirtazapine.

It is recommended not to drink any alcohol.

You may take mirtazapine with or without food.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medicine.

Limited experience with mirtazapine use in pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. If you take mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects.

If you are taking mirtazapine during pregnancy, inform your midwife and/or doctor. When similar medicines (known as serotonin reuptake inhibitor antidepressants: SSRIs) are taken during pregnancy, there may be an increased risk of a serious condition in the newborn 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 birth. If this occurs in your case, contact your doctor and/or midwife immediately.

Consult your doctor if you can breastfeed while taking Mirtazapine Tarbis.

Driving and using machines

Mirtazapine Tarbis may affect your concentration or level of alertness.

During treatment with Mirtazapine Tarbis, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this treatment affects you.

Mirtazapine Tarbis contains aspartame

This medicine may be harmful to people with phenylketonuria, as it contains aspartame, which is a source of phenylalanine.

3. How to take Mirtazapine Tarbis

Follow exactly the instructions given by your doctor or pharmacist for using this medicine. If in doubt, consult your doctor or pharmacist again.

How much to take

The usual starting dose is 15 or 30 mg per day. Your doctor may recommend increasing the dose after a few days to the amount that is best for you (between 15 and 45 mg per day). The dose is usually the same for all age groups. However, if you are elderly or have kidney or liver disease, your doctor may adjust the dose.

When to take it

? Take Mirtazapine Tarbis at the same time each day.

It is best to take the mirtazapine dose as a single dose before bedtime. However, your doctor may recommend that you split your mirtazapine dose, taking part in the morning and part in the evening before bedtime. The higher dose should be taken before bedtime.

How to take the orodispersible tablet

The tablets are taken by mouth.

1. Do not press the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press on the blister (Fig. A).

Fig. A.

2. Separate one blister

Each blister pack contains six blisters, separated by perforations. Separate one blister along the perforated lines (Fig. 1).

Fig. 1.

3. Open the blister

Carefully peel back the foil, starting at the corner indicated by the arrow (Figs. 2 and 3).

Fig. 2.

Fig. 3.

4. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on your tongue (Fig. 4).

Fig. 4.

It will dissolve rapidly and can be swallowed without water.

When you can expect to feel better

Mirtazapine Tarbis usually starts to take effect after 1 or 2 weeks, and you may start to feel better after 2 to 4 weeks. It is important that during the first few weeks of treatment you talk to your doctor about how mirtazapine is affecting you:

? 2 to 4 weeks after starting mirtazapine, discuss with your doctor how this medicine has affected you.

If you still do not feel better, your doctor may prescribe a higher dose. In that case, talk to your doctor again after another 2–4 weeks.

You will usually need to continue taking mirtazapine until depressive symptoms have been absent for 4–6 months.

If you take more Mirtazapine Tarbis than you should

? If you or someone else takes too much Mirtazapine Tarbis, consult a doctor immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20.

The most likely symptoms of an overdose of mirtazapine (without other medicines or alcohol) are drowsiness, confusion, and palpitations.

If you forget to take Mirtazapine Tarbis

If you are supposed to take your dose once daily

• if you forget to take your dose of mirtazapine, do not take the missed dose. Skip it and take your usual dose the next day.

If you are supposed to take your dose twice daily

• if you forget the morning dose, simply take it together with the evening dose
• if you forget the evening dose, do not take it the next morning; skip it and continue with your normal morning and evening doses.
• if you forget both doses, do not try to make them up. Skip both doses and the next day continue with your normal morning and evening doses.

If you stop taking Mirtazapine Tarbis

? Only stop taking mirtazapine after consulting your doctor.

If you stop too early, depression may return. When you start to feel better, talk to your doctor. Your doctor will decide when you can stop treatment.

Do not stop taking mirtazapine abruptly, even if depression has resolved. If you stop taking mirtazapine suddenly, you may feel unwell, dizzy, agitated or anxious, and may have headaches. These symptoms can be avoided by stopping treatment gradually. Your doctor will advise you on how to reduce the dose step by step.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Mirtazapine Tarbis may cause adverse effects, although not everyone experiences them.

Some adverse effects are more likely than others. The possible adverse effects of mirtazapine are listed below and can be divided into:

• Very common: affects more than 1 in 10 patients
• Common: affects 1 to 10 in every 100 patients
• Uncommon: affects 1 to 10 in every 1,000 patients
• Rare: affects 1 to 10 in every 10,000 patients
• Very rare: affects fewer than 1 in every 10,000 patients
• Not known: cannot be estimated from available information

Very common:

• increased appetite and weight gain
• drowsiness
• headache
• dry mouth

Common:

• lethargy
• dizziness
• tremor
• nausea
• diarrhoea
• vomiting
• constipation
• hives or skin rash (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• dizziness or fainting when standing up quickly (orthostatic hypotension)
• swelling (usually in ankles or feet) due to fluid retention (oedema)
• fatigue
• vivid dreams
• confusion
• anxiety
• difficulty sleeping
• memory problems, which in most cases resolved when treatment was discontinued

Uncommon:

• feeling of exaggerated euphoria (mania)

? Stop taking mirtazapine and contact your doctor immediately.

• unusual skin sensations such as burning, prickling, tingling or pins and needles (paraesthesia)
• involuntary restless leg movements during sleep
• fainting (syncope)
• numbness sensation in the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• restlessness
• hallucinations
• inability to remain still

Rare:

• yellowing of the eyes or skin; may suggest liver dysfunction (jaundice).

? Stop taking mirtazapine and contact your doctor immediately.

• muscle tics or contractions (myoclonus)
• pancreatitis

Frequency not known:

• signs of infection such as sudden unexplained fever, sore throat and mouth ulcers (agranulocytosis).

? Stop taking mirtazapine and contact your doctor immediately for a blood test.

In rare cases, mirtazapine may cause disturbances in blood cell production (bone marrow depression). Some people become less resistant to infections because mirtazapine may cause a temporary decrease in white blood cells (granulocytopenia). In rare cases, mirtazapine may also cause a decrease in red and white blood cells and platelets (aplastic anaemia), a decrease in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).

• epileptic seizure (convulsions).

? Stop taking mirtazapine and contact your doctor immediately.

• combination of symptoms such as unexplained fever, sweating, palpitations, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, restlessness, mood changes and loss of consciousness. In very rare cases, these symptoms may indicate a disorder called "serotonin syndrome."

? Stop taking mirtazapine and contact your doctor immediately.

• thoughts of harming yourself or suicide

? Stop taking mirtazapine and contact your doctor immediately.

• abnormal sensations in the mouth (oral paraesthesia)
• swelling in the mouth (oral oedema)
• hyponatraemia
• inappropriate secretion of antidiuretic hormone
• increased levels of creatine kinase in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness and/or weakness, darkening or discoloration of urine (rhabdomyolysis)
• red patches on the trunk, appearing as well-defined or circular macules, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) ? Stop taking mirtazapine and contact your doctor immediately.
• widespread erythema, elevated body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) ? Stop taking mirtazapine and contact your doctor immediately.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Tarbis

• The active substance is mirtazapine.

Mirtazapine Tarbis 15 mg orodispersible tablets contains 15 mg of mirtazapine per tablet.

• The other components are: mannitol, microcrystalline cellulose, magnesium carbonate, low-substituted hydroxypropylcellulose, colloidal anhydrous silica, L-methionine, crospovidone, microcrystalline cellulose and guar gum (Avicel CE-15), aspartame (E951), Silesia orange flavour, and magnesium stearate.

Appearance of the product and contents of the pack

Mirtazapine Tarbis 15 mg orodispersible tablets are white, round, biconvex tablets, marked with "M1" on one side.

The orodispersible tablets are packed in child-resistant blisters, perforated for single doses.

The following pack sizes are available: 30 orodispersible tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028-Barcelona (Spain)

Manufacturer

Actavis HF

Reyjavikuvegur 78

220 Hafnarfjordur

Iceland

Or

Actavis Limited

BLB 016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

Date of the most recent revision of this summary: October 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/