Mirtazapine Tarbis 30 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Mirtazapine Tarbis 30 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, consult 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 harm 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 Mirtazapine Tarbis is and what it is used for

Mirtazapine 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 in the treatment of 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, confrontational behavior, 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 consult your doctor again. You must inform your doctor if any of the symptoms described 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 behavioral development with mirtazapine in this age group are not yet 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 thoughts may increase when first 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 these types of 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 behavior 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 behavior.

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 dose of insulin or other antidiabetic medicines);

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

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

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

? Stop taking Mirtazapine Tarbis and contact your doctor immediately for a blood test. In rare cases, 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 that you are using, have recently used, or might need to use any other medicine.

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 are taking Mirtazapine Tarbis together with:

• antidepressants such as selective serotonin reuptake inhibitors (SSRIs), venlafaxine, 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 known as serotonin syndrome. Some symptoms of this syndrome include unexplained fever, sweating, rapid heartbeat, diarrhea, 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).

If 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.

If 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 decrease 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 tests.

Taking Mirtazapine Tarbis with food, drinks, and alcohol

You may feel drowsy if you drink alcohol while being treated with 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 plan 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 the baby developing a serious condition 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, contact your doctor and/or midwife immediately.

Consult your doctor about whether 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 medicine 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 Miratzapina Tarbis

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. 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 your dose after a few days to the amount that is best for you (between 15 and 45 mg per day). Normally the dose is 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 Mirtazapina 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 at night 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 strip contains six blisters, separated by perforations. Separate one blister along the perforated lines (Fig. 1).

Fig. 1.

3. Open the blister

Carefully remove 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

Mirtazapina 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 weeks of treatment you discuss the effects of mirtazapine with your doctor:

? 2 to 4 weeks after starting mirtazapine, talk to your doctor about 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 your depressive symptoms have disappeared for 4–6 months.

If you take more Mirtazapina Tarbis than you should

? If you or someone else takes too much Mirtazapina 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 Mirtazapina Tarbis

If you are supposed to take your dose once daily

• if you forget to take your mirtazapine dose, 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 your 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 Mirtazapina Tarbis

? Stop taking mirtazapine only after consulting your doctor.

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

Do not stop taking mirtazapine abruptly, even if your depression has resolved. If you stop mirtazapine suddenly, you may feel unwell, dizzy, restless, 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 gradually.

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 categorized as follows:

• Very common: affects more than 1 in 10 patients
• Common: affects between 1 and 10 in 100 patients
• Uncommon: affects between 1 and 10 in 1,000 patients
• Rare: affects between 1 and 10 in 10,000 patients
• Very rare: affects fewer than 1 in 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
• diarrhea
• vomiting
• constipation
• hives or skin rash (exanthema)
• joint pain (arthralgia) or muscle pain (myalgia)
• back pain
• dizziness or fainting upon standing up quickly (orthostatic hypotension)
• swelling (typically in ankles or feet) due to fluid retention (edema)
• 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 consult your doctor immediately.

• unusual skin sensations such as burning, prickling, tingling, or numbness (paresthesia)
• involuntary leg movements during sleep
• fainting (syncope)
• numbness of the mouth (oral hypoesthesia)
• low blood pressure
• nightmares
• restlessness
• hallucinations
• inability to remain still

Rare:

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

? Stop taking mirtazapine and consult your doctor immediately.

• muscle twitches or contractions (myoclonus)
• pancreatitis

Frequency not known:

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

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

In rare cases, mirtazapine may cause disturbances in blood cell production (bone marrow depression). Some people become more susceptible 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 blood cells, white blood cells, and platelets (aplastic anemia), a reduction in platelets (thrombocytopenia), or an increase in the number of white blood cells in the blood (eosinophilia).

• epileptic seizure (convulsions).

? Stop taking mirtazapine and consult your doctor immediately.

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

? Stop taking mirtazapine and consult your doctor immediately.

• thoughts of harming yourself or of suicide

? Stop taking mirtazapine and consult your doctor immediately.

• abnormal sensations in the mouth (oral paresthesia)
• swelling in the mouth (oral edema)
• hyponatremia
• 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, as circumscribed or circular macules, often with blisters in the center, skin peeling, 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 consult your doctor immediately.
• generalized erythema, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome) ? Stop taking mirtazapine and consult your doctor immediately.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mirtazapine Tarbis

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and 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. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. 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 30 mg orodispersible tablets contain 30 mg of mirtazapine per tablet.

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

Appearance of the medicinal product and contents of the pack

Mirtazapine Tarbis 30 mg orodispersible tablets are white, round, biconvex tablets, marked with "M2" on one side.

The orodispersible tablets are packaged in child-resistant blisters, perforated for unit dosing.

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 leaflet: 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/