Document: Mirtazapin Bluefish orodispersible tablet ENG PL change

• Mirtazapin Bluefish orodispersible tablet PL
• Mirtazapin Bluefish orodispersible tablet ENG PL

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Package leaflet: Information for the user

Mirtazapin Bluefish 15 mg orodispersible tablets

Mirtazapin Bluefish 30 mg orodispersible tablets

Mirtazapin Bluefish 45 mg orodispersible tablets

Mirtazapine

Read all of this leaflet carefully before you start taking this medicinebecause it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist or nurse.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4

What is in this leaflet:

1. What Mirtazapin Bluefish is and what it is used for

Mirtazapin Bluefish is one of a group of medicines called antidepressants.Mirtazapin Bluefish is used to treat depressive illness.

2. What you need to know before you takeMirtazapin Bluefish

Do not take Mirtazapin Bluefish:

- if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6).

- if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors (MAO-Is).

Warnings and precautions

Talk to your doctor or pharmacist or nurse before taking Mirtazapin Bluefish.

Children and adolescents

Mirtazapin Bluefish should normally not be used for children and adolescents under 18 years. Also, you shouldknow that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Mirtazapin Bluefish for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Mirtazapin Bluefish for a patient under 18 and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Mirtazapin Bluefish. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Mirtazapin Bluefish in this age group have not yet been demonstrated.

Thoughts of suicide and worsening of your depression:

If you are depressed, you can sometimes have thoughts of harming or killing yourself. These may be increased when you first start taking antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

Youmay be more likely to think like this:

• If you have previously had thoughts about killing or harming yourself.

• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.

You may find it helpful to tell a relativeor close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.

Also take special care with Mirtazapin Bluefish

 Tell your doctor about these conditions before taking Mirtazapin Bluefish, if not done previously.

-seizures (epilepsy). If you develop seizures or your seizures become more frequent, stop taking Mirtazapin Bluefish and contact your doctor immediately;

-liver disease, including jaundice. If jaundice occurs, stop taking Mirtazapin Bluefish 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 straight away;

-manic depression (alternating periods of feeling elated/overactivity and depressed mood). If you start feeling elated or over-excited, stop taking Mirtazapin Bluefish and contact your doctor immediately;

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

-eye disease, such as increased pressure in the eye (glaucoma);

-difficulty in passing water (urinating), which might be caused by an enlarged prostate.

Stop taking Mirtazapin Bluefish and consult your doctor immediately for a blood test.

In rare cases these symptoms can be signs of disturbances in blood cell production in the bone marrow. While rare, these symptoms most commonly appear after 4-6 weeks of treatment.

Other medicines and Mirtazapin Bluefish

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

Do not take Mirtazapin Bluefish in combination with:

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

Take care when taking Mirtazapin Bluefish in combination with:

• antidepressants such as SSRIs, venlafaxine and L-tryptophan, or triptans (used to treat migraine), tramadol (a pain-killer), linezolid (an antibiotic), lithium (used to treat some psychiatric conditions) and St. John’s Wort – Hypericum perforatum preparations (a herbal remedy for depression). In very rare cases Mirtazapin Bluefish alone or the combination of Mirtazapin Bluefish with these medicines, can lead to a so-called serotonin syndrome. Some of the symptoms of this syndrome are: inexplicable fever, sweating, increased heart rate, diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes, and unconsciousness. If you get a combination of these symptoms, talk to your doctor immediately.

• the antidepressant nefazodone. It can increase the amount of Mirtazapin Bluefish in your blood. Inform your doctor if you are using this medicine. It might be needed to lower the dose of Mirtazapin Bluefish, or when use of nefazodone is stopped, to increase the dose of Mirtazapin Bluefish again.

• 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.

In combination with these medicines Mirtazapin Bluefish can increase the drowsiness caused by these medicines.

In combination with Mirtazapin Bluefish these medicines can increase the amount of Mirtazapin Bluefish in your blood. Inform your doctor if you are using these medicines. It might be needed to lower the dose of Mirtazapin Bluefish, or when these medicines are stopped, to increase the dose of Mirtazapin Bluefish again.

In combination with Mirtazapin Bluefish this medicine may increase the amount of mirtazapinein your blood.

medicines for tuberculosis such as rifampicin.

In combination with Mirtazapin Bluefish these medicines can reduce the amount of Mirtazapin Bluefish in your blood. Inform your doctor if you are using these medicines. It might be needed to increase the dose of Mirtazapin Bluefish, or when these medicines are stopped to lower the dose of Mirtazapin Bluefish again.

MirtazapinBluefish can increase the effects of warfarin on the blood. Inform your doctor if you are using this medicine. In case of combination it is advised that a doctor monitors your blood carefully.

Mirtazapin Bluefish with food, drink and alcohol

You may get drowsy if you drink alcohol while you are taking Mirtazapin Bluefish.

You should therefore avoid alcohol when using Mirtazapin Bluefish.

You can take Mirtazapin Bluefish with or without food.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Limited experience with Mirtazapin Bluefish administration to pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy.

Make sure your midwife and/or doctor knows you are on Mirtazapin Bluefish. When taking during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.

If you are taking Mirtazapin Bluefish and you become pregnant or you plan to get pregnant, ask your doctor whether you may continue taking Mirtazapin Bluefish. If you use Mirtazapin Bluefishuntil, or shortly before birth, your baby should be supervised for possible adverse effects.

Ask your doctor whether you can breast-feed, while taking Mirtazapin Bluefish.

Driving and using machines

Mirtazapin Bluefish can affect your concentration or alertness. Make sure your abilities are not affected before driving or operating machinery.

Important information about some of the ingredients of Mirtazapin Bluefish

Mirtazapin Bluefish contains aspartame, a source of phenylalanine. This may be harmful for people with phenylketonuria.

3. How totakeMirtazapin Bluefish

Always take this medicineexactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is

The usual starting dose is 15 or 30 mg every day. Your doctor may advise you to increaseyour 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 ages. However, if you are an elderly person or if you have renal or liver disease, your doctor may adapt the dose.

When to take Mirtazapin Bluefish

 Take Mirtazapin Bluefish at the same time each day.

It is best to take Mirtazapin Bluefish as a single dose before you go to bed. However your doctor may suggest to split your dose of Mirtazapin Bluefish– once in the morning and once at night-time before you go to bed. The higher dose should be taken before you go to bed.

Take the orodispersible tablet as follows

Take your tablets orally.

1. Do not crush the orodispersible tablet

In order to prevent crushing the orodispersible tablet, do not push against the tablet pocket

(Figure A).

Fig. A.

2. Tear off one tablet pocket

Each blister contains six tablet pockets, which are separated by perforations. Tear off one tablet pocket along the dotted lines (Figure 1).

Fig. 1.

3. Peel off the lid

Carefully peel off the lidding foil, starting in the corner indicated by the arrow (Figures 2 and

3).

Fig. 2.

Fig. 3.

4. Take out the orodispersible tablet

Take out the orodispersible tablet with dry hands and place it on the tongue.

(Figure 4).

Fig. 4.

It will rapidly disintegrate and can be swallowed without water.

When can you expect to start feeling better

Usually Mirtazapin Bluefish will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better.

It is important that, during the first few weeks of the treatment, you talk with your doctor about the effects of Mirtazapin Bluefish:

2 to 4 weeks after you have started taking Mirtazapin Bluefish, talk to your doctor about how this medicine has affected you.

If you still don’t feel better, your doctor may prescribe a higher dose. In that case, talk to your doctor again after another 2 to 4 weeks. Usually you will need to take Mirtazapin Bluefish until your symptoms of depression have disappeared for 4 to 6 months.

If you take more Mirtazapin Bluefish than you should

If you or someone else have taken too much Mirtazapin Bluefish, call a doctor straight away.

The most likely signs of an overdose of Mirtazapin Bluefish (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate.

If you forget to take Mirtazapin Bluefish

If you are supposed to take your dose once a day

Take your next dose at the normal time.

If you are supposed to take your dose twice a day

• if you have forgotten to take your morning dose, simply take it together with your evening dose.

• if you have forgotten to take your evening dose, do not take it with the next morning dose; just skip it and continue with your normal morning and evening doses.

• if you have forgotten to take both doses, do not attempt to make up for the missed doses. Skip both doses and continue the next day with your normal morning and evening doses.

If you stop taking Mirtazapin Bluefish

 Only stop taking Mirtazapin Bluefish in consultation with your doctor.

If you stop too early, your depression might come back. Once you are feeling better, talk to your doctor. Your doctor will decide when treatment can be stopped.

Do not suddenly stop taking Mirtazapin Bluefish, even when your depression has lifted. If you suddenly stop taking Mirtazapin Bluefish you may feel sick, dizzy, agitated or anxious, and have headaches. These symptoms can be avoided by stopping gradually. Your doctor will tell you how to decrease the dose gradually.

If you have any further questions on the use of this product, straight away ask your doctor or pharmacist.

4. Possible side effects

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

Some side effects are more likely to occur than others. The possible side effects of Mirtazapin Bluefish are listed below and can be defined as:

• Very common: may affect more than 1 in 10 people

• Common: may affect up to 1 in 10 people

• Uncommon: may affect up to 1 in 100 people

• Rare: may affect up to 1 in 10,00 people

• Very rare : may affect up to 1 in 10,000 people

• Not known: frequency cannot be estimated from the available data

Very common:

• increase in appetite and weight gain

• drowsiness or sleepiness

• headache

• dry mouth

Common:

• lethargy

• dizziness

• shakiness or tremor

• nausea

• diarrhoea

• constipation

• vomiting

• rash or skin eruptions (exanthema)

• pain in your joints (arthralgia) or muscles (myalgia)

• back pain

• feeling dizzy or faint when you stand up suddenly (orthostatic hypotension)

• swelling (typically in ankles or feet) caused by fluid retention (oedema)

• tiredness

• vivid dreams

• confusion

• feeling anxious

• sleeping problems

Uncommon:

 Stop taking Mirtazapin Bluefish and tell your doctor straight away.

• abnormal sensation in the skin e.g. burning, stinging, tickling or tingling (paraesthesia)

• restless legs

• fainting (syncope)

• sensations of numbness in the mouth (oral hypoaesthesia)

• low blood pressure

• nightmares

• feeling agitated

• hallucinations

• urge to move

Rare:

 Stop taking Mirtazapin Bluefish and tell your doctor straight away.

• muscle twitching or contractions (myoclonus)

• Aggression

• Inflammation of the pancreas

Frequency not known:

(agranulocytosis)

 Stop taking Mirtazapin Bluefish and contact your doctor straight away for a blood test.

In rare cases Mirtazapin Bluefish can cause disturbances in the production of blood cells (bone marrow depression). Some people become less resistant to infection because Mirtazapin Bluefishcan cause a temporary shortage of white blood cells (granulocytopenia). In rare cases Mirtazapin Bluefish can also cause a shortage of red and white blood cells, as well as blood platelets (aplastic anemia), a shortage of blood platelets (thrombocytopenia) or an increase in the number of white blood cells (eosinophilia).

 Stop taking Mirtazapin Bluefish and tell your doctor straight away.

diarrhoea, (uncontrollable) muscle contractions, shivering, overactive reflexes, restlessness, mood changes and unconsciousness. In very rare cases these can be signs of serotonin syndrome.

 Stop taking Mirtazapin Bluefish and tell your doctor straight away.

• thoughts of harming or killing yourself

• Walking during sleep (Somnambulism)

 Contact your doctor or go to a hospital straight away.

• abnormal sensations in the mouth (oral paraesthesia)

• Hoarseness of the voice (Dysarthria)

• swelling in the mouth (mouth oedema)

• Increased salivation

• Severe allergic reaction, that may include raised lumps(weals), swelling of the skin and around the mouth (Stevens-Johnson Syndrome)

• Blistering or peeling of the skin (Dermatitis bullous)

• allergic reaction of the skin consisting of reddening, itching, fever with rash and eruption of the skin (Erythema multiforme)

• Severe blistering rash of the skin and mouth with fever and weakness (Toxic epidermal necrolysis)

• hyponatraemia

• inappropriate anti-diuretic hormone secretion

• increased creatine kinase blood levels

• difficulty in passing urine

• muscle pain, stiffness and/or weakness and darkening or discoloration of the urine.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist immediately.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to storeMirtazapin Bluefish

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 carton and blister after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask yor pharmacists how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Mirtazapin Bluefish contains

- The active substance is mirtazapine. Each orodispersible tablet contains 15 mg, 30 mg or 45 mg mirtazapine.

- The other ingredients are crospovidone (type B), mannitol (E421), Cellulose, microcrystalline, aspartame (E951), silica colloidal anhydrous, magnesium stearate, strawberry guarana flavor [maltodextrin, propylene glycol, artificial flavours, acetic acid] and peppermint flavor [artificial flavours, corn starch].

What Mirtazapin Bluefish looks like and contents of the pack

Orodispersible tablet.

Mirtazapin Bluefish 15 mg orodispersible tablets:

White, round orodispersible tablets debossed with “36”on one side and ‘A’ on the other sidewith an embossed circular edge.

Mirtazapin Bluefish 30 mg orodispersible tablets:

White, round orodispersible tablets debossed with “37” on one side and ‘A’ on the other side with an embossed circular edge.

Mirtazapin Bluefish 45 mg orodispersible tablets:

White, round orodispersible tablets debossed with “38” on one side and ‘A’ on the other side with an embossed circular edge.

15mg & 30mg:

Mirtazapin Bluefish orodispersible tablets are available in Polyamide/ Aluminium/ PVC/ Paper/ Polyster/ Aluminium perforated unit dose blister packs of 6, 18, 30, 48, 60, 90 and 96 tablets.

45mg:

Mirtazapin Bluefish orodispersible tablets are available in Polyamide/ Aluminium/ PVC/

Paper/ Polyster/ Aluminium perforated unit dose blister packs of 6, 18, 30, 48, 90 and 96

tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Bluefish Pharmaceuticals AB

P.O. Box 49013

100 28 Stockholm

Sweden

Manufacturer

Bluefish Pharmaceticals AB

Torsgatan 11

111 23 Stockholm

Sverige

This medicinal product is authorized in the Member States of the EEA under the following names:

This leaflet was last revised in 21 July 2016