Mirtazapine Tevagen 15 mg orodispersible tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Mirtazapine Tevagen 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 you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

Mirtazapine Tevagen belongs to a group of medicines called antidepressants.

Mirtazapine Tevagen is used to treat depression in adults.

It takes 1 to 2 weeks before mirtazapine starts to take effect. After 2 to 4 weeks, you may begin to feel better. You should consult your doctor if your condition worsens or if you do not improve after 2 to 4 weeks.

For more information, see section 3, “When can you expect to start feeling better?”

2. What you need to know before taking Mirtazapine Tevagen

Do not take Mirtazapine Tevagen:

• 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 Tevagen.
• 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 mirtazapine.

Tell your doctor before taking Mirtazapine Tevagen:

If you have ever experienced a severe skin rash, skin peeling, blisters, or mouth sores after taking mirtazapine.

Children and adolescents

Mirtazapine Tevagen is not normally used to treat children and adolescents under 18 years of age because its efficacy has not been demonstrated. Also, you should know that in patients under 18 years of age there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Mirtazapine Tevagen 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 Tevagen to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. 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 Tevagen. In addition, the long-term safety effects of mirtazapine on growth, maturation, and cognitive and behavioural development in this age group are still unknown. A considerable weight gain has also been observed more frequently in this age group when treated with mirtazapine, compared to adults.

Suicidal thoughts and worsening depression

If you are depressed, you may sometimes have thoughts of harming yourself or of suicide. This may worsen when you first start taking antidepressants, as these medicines usually take time to work—typically two weeks or sometimes longer.

You may be more likely to have such thoughts if:

• you have previously had suicidal thoughts or thoughts of self-harm.

• you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

• If at any time you have thoughts of harming yourself or of suicide, consult your doctor or go to a hospital immediately.

It may be helpful to tell a close family member or friend that you are depressed and ask them to read this leaflet. You may ask them to inform you if they think your depression is getting worse or if they are concerned about changes in your behaviour.

Also, take special care with Mirtazapine Tevagen:

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

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

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

• liver disease, including jaundice. If jaundice develops, 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 (alternating periods of elevated mood/hyperactivity and 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 eye pressure (glaucoma);

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

• certain types of heart disease that may alter your heart rhythm, a recent heart attack, heart failure, or if you are taking certain medicines that may affect heart rhythm.

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

• Stop taking Mirtazapine Tevagen 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.

• Serious skin reactions, such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with mirtazapine use. Stop taking the medicine and seek immediate medical attention if you notice any of the symptoms described in section 4 related to these serious skin reactions.

If you have ever experienced serious skin reactions, re-initiation of mirtazapine treatment is not recommended.

Other medicines and Mirtazapine Tevagen

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Mirtazapine Tevagen together with:

• monoamine oxidase inhibitors (MAOIs). Also, do not take mirtazapine within two weeks after stopping MAOIs. If you stop taking mirtazapine, do not take MAOIs for the following two weeks. Examples of MAOIs include moclobemide, tranylcypromine (both antidepressants), and selegiline (used for Parkinson’s disease).

Be cautious if you take Mirtazapine Tevagen 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, rapid heartbeat, diarrhoea, uncontrollable muscle contractions, chills, exaggerated reflexes, agitation, mood changes, and loss of consciousness. If you experience a combination of these symptoms, consult 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), HIV/AIDS medicines (HIV protease inhibitors), and medicines for stomach ulcers (such as cimetidine).

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 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 both are taken together, your doctor may recommend regular blood monitoring.

• medicines that may affect heart rhythm, such as certain antibiotics and some antipsychotics.

Taking Mirtazapine Tevagen 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

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.

Limited experience with the administration of Mirtazapine Tevagen to pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

Limited experience with the administration of mirtazapine to pregnant women does not indicate an increased risk. However, caution should be exercised if used during pregnancy.

If you take mirtazapine up to or shortly before delivery, your baby will be monitored for possible adverse effects. Antidepressants similar to mirtazapine (SSRIs) taken during pregnancy may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, you should contact your midwife and/or doctor immediately.

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

Driving and using machines

Mirtazapine Tevagen may affect your concentration or level of alertness. Make sure your abilities are not impaired before driving or operating machinery. If your doctor has prescribed mirtazapine to a patient under 18 years of age, ensure that concentration and alertness are not affected before engaging in activities such as cycling.

Mirtazapine Tevagen contains aspartame

This medicine contains 6 mg of aspartame in each orodispersible tablet.

Aspartame contains a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

Mirtazapine Tevagen contains sulfites, bisulfites, and metabisulfites

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains traces of sulfur dioxide (E-220) and potassium acid sulfite (E-228).

3. How to take Mirtazapine Tevagen

Follow exactly the instructions for administration of this medicine as given by your doctor. 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). Normally the dose is the same for all ages. However, if you are elderly or if you have kidney or liver disease, your doctor may adjust the dose.

When to take it

• Take Mirtazapine Tevagen at the same time each day.

It is best to take the mirtazapine dose as a single dose before going to bed. However, your doctor may recommend that you split your mirtazapine dose, taking part in the morning and part at night before going to bed. 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 (Figure A).

Fig. A.

1. Separate one blister

Each blister contains six blisters separated by perforations. Separate one blister by following the perforated lines (Figure 1).

Fig. 1.

1. Open the blister

Carefully remove the foil, starting at the corner indicated by the arrow (Figures 2 and 3).

Fig. 2.

Fig. 3.

1. Remove the orodispersible tablet

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

Fig. 4.

It will dissolve rapidly and can be swallowed without water.

When to expect to feel better

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

• 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.

Usually, you will need to take mirtazapine until depressive symptoms have disappeared for 4–6 months.

If you take more Mirtazapine Tevagen than you should

If you or someone else takes too much mirtazapine, consult a doctor immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

The most likely symptoms of an overdose of mirtazapine (without other medicines or alcohol) are drowsiness, confusion, and palpitations. Symptoms of a possible overdose may include changes in your heart rhythm (fast, irregular heartbeat) and/or fainting, which could be signs of a potentially life-threatening condition known as Torsades de pointes.

If you forget to take Mirtazapine Tevagen

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 your evening dose
• if you forget the evening dose, do not take it the next morning; skip it and continue with your usual 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 usual morning and evening doses.

If you stop taking Mirtazapine Tevagen

• Only stop taking mirtazapine after consulting your doctor.

If you stop too early, depression may return. When you 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 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 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, this medicine can cause adverse effects, although not everyone will experience 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: may affect more than 1 in 10 patients.

Common: may affect up to 1 in 10 patients.

Uncommon: may affect up to 1 in 100 patients.

Rare: may affect up to 1 in 1,000 patients.

Very rare: may affect up to 1 in 10,000 patients.

Not known: cannot be estimated from the 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 consult your doctor immediately.

• unusual sensations in the skin such as burning, prickling, tingling or pins and needles (paraesthesia)

• involuntary restless leg movements during sleep

• fainting (syncope)

• numbness or reduced sensation in 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 tics or jerks (myoclonus)

• aggression

• abdominal pain, nausea; this may indicate inflammation of the pancreas (pancreatitis)

Frequency not known:

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

• Stop taking mirtazapine and consult your doctor immediately to have 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 consult 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 be signs of a disorder 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.

• serious skin reactions:

  • red patches on the trunk, as circumscribed or circular macules, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • generalized erythema, elevated body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

?Stop taking mirtazapine and consult your doctor immediately

• abnormal sensations in the mouth (oral paraesthesia)
• swelling of the mouth (oral oedema)
• swelling throughout the body (generalized oedema)
• localized swelling
• hyponatraemia
• inappropriate secretion of antidiuretic hormone
• serious skin reactions (bullous dermatitis, erythema multiforme)
• sleepwalking
• speech disorder
• increased levels of creatine kinase in the blood
• difficulty urinating (urinary retention)
• muscle pain, stiffness and/or weakness, darkening or discoloration of the urine (rhabdomyolysis)
• increased levels of prolactin hormone in the blood (hyperprolactinaemia, including symptoms such as breast enlargement and/or milky nipple discharge)
• painful and prolonged penile erection

Other adverse effects in children and adolescents

In patients under 18 years of age, the following adverse effects were commonly observed in clinical trials: considerable weight gain, urticaria and increased blood triglyceride levels.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Tevagen

Keep out of sight and reach of children.

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

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

Store at a temperature below 25°C.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mirtazapine Tevagen

• The active substance is mirtazapine. Mirtazapine Tevagen 15 mg orodispersible tablets contain 15 mg of mirtazapine per tablet.
• The other components (excipients) are: mannitol (E-421), microcrystalline cellulose, heavy magnesium carbonate, low-substituted hydroxypropylcellulose, crospovidone, anhydrous colloidal silica, L-methionine, purified water, avicel, aspartame (E-951), Silesia orange flavour (potato maltodextrin, gum arabic E414, triacetin E1518, flavouring preparations, flavouring ingredients identical to natural flavours, and natural flavouring ingredients, contains traces of sulfur dioxide (E-220) and potassium metabisulfite (E-228)) and magnesium stearate.

Nature of the product and pack contents

Mirtazapine Tevagen are orodispersible tablets. The tablets are white, biconvex, and marked with 'M1' on one side.

The following pack size is available: 30 orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/Anabel Segura, 11

Edificio Albatros B, 1st floor

28108 Alcobendas, Madrid, Spain

Manufacturer

Actavis, Ltd

BLB016 Bulebel Industrial Estate (Zejtun)

ZTN3000 Malta

Date of the most recent revision of this leaflet: August 2024

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (https://www.aemps.gob.es/)