15 mg, 30 mg, 45 mg orodispersible tablets
What Mirtin is and what it is used for
Mirtin belongs to a group of medicines called antidepressants .
Mirtin is used to treat depression in adults.
It will take 1-2 weeks before Mirtin starts working. After 2-4 weeks, you can start to feel better. Contact your doctor if you do not feel better or if you feel worse after 2-4 weeks. For more information, see section 3 under the heading “When you can expect to start feeling better”.
Mirtazapine contained in Mirtin may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
What you need to know before you use Mirtin
Do not use Mirtin
- if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, talk to your doctor as soon as possible before taking Mirtin.
- if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors ( MAOIs ).
Warnings and cautions
Talk to your doctor or pharmacist before taking Mirtin:
- if you have ever had a severe rash or flaky skin, blisters and / or sores in your mouth after taking mirtazapine or other medicines.
Children and young people
Mirtin should not normally be used in the treatment of children and adolescents under 18 years of age as an effect has not been demonstrated. The risk of side effects such as suicide attempts, suicidal thoughts and hostility (mainly aggression, defiance and anger) is greater in patients under 18 years of age, when taking drugs of this type. Despite this, Mirtin can be prescribed by a doctor to patients under the age of 18, if the doctor deems it appropriate.
If your doctor has prescribed Mirtin to someone under the age of 18 and you want to discuss this, you should see your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse when patients under 18 years of age use Mirtin. The long-term effects of Mirtin on growth, maturation and cognitive and behavioral development have not yet been established in children and adolescents below 18 years of age. In addition, significant weight gain has been observed more frequently in this age group when receiving mirtazapine compared to adults.
If you start to feel worse and have thoughts of harming yourself
You who are depressed can sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking antidepressants, as it takes time for a drug of this type to take effect, usually about 2 weeks, sometimes longer.
These thoughts may be common:
- if you have previously had thoughts of harming yourself or committing suicide,
- if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.
→ Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide. It can be helpful to tell a relative or close friend that you are depressed. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.
Also, be especially careful with Mirtin
• if you have or have had any of the following conditions.
→ Tell your doctor about these conditions before starting Mirtin if you have not done so before.
- cramps ( epilepsy ). If you get cramps or if your cramps come more often, stop taking Mirtin and contact your doctor immediately
- liver disease , including jaundice. If you get jaundice, stop taking Mirtin and contact your doctor immediately
- kidney disease .
- heart diseaseor low blood pressure
- schizophrenia . If psychotic symptoms such as paranoid thoughts occur more often or become more severe, contact your doctor immediately
- manic depression(alternating periods of feeling elated / overactive and depressed). If you start to feel excited or overexcited, stop taking Mirtin and contact your doctor immediately.
- diabetes(you may need to adjust your dose of insulin or other diabetes medicines)
- eye disease , such as increased pressure in the eye ( glaucoma )
- difficultyurinating (urinating), which may be due to an enlarged prostate
- certain types of heart problems that can change your heart rhythm, a recent heart attack, heart failure , or taking certain medications that can affect your heart rhythm.
• if you get signs of infection such as unexplained high fever, sore throat and sore mouth.
→ Stop taking Mirtin and contact your doctor immediately for a blood test. In rare cases, this may be a sign of a disorder in the production of blood cells in the bone marrow . It is rare, but if they do occur, it is generally after 4-6 weeks of treatment
• if you are an elderly person. You may be more sensitive to the side effects of antidepressants.
• severe 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. Stop using the medicine and seek medical attention immediately if you get any of the symptoms described in section 4 in connection with these severe skin reactions.
• if you have ever had a severe skin reaction, you should never be treated with mirtazapine again.
Other medicines and Mirtin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Mirtin in combination with:
- monoamine oxidase inhibitors( MAOIs ). Also, do not take Mirtin for two weeks after stopping MAOIs . If you stop taking Mirtin, do not take MAO inhibitors during the first two weeks. Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used in Parkinson’s disease )
Be careful with Mirtin in combination with:
- antidepressants such as SSRIs , venlafaxine and L-tryptophan or triptans ( used to treat migraines ), buprenorphine (used to treat pain or opioid abuse), tramadol (a painkiller), linezolid (an antibiotic ), lithium (used to treat certain mental conditions), methylene blue (used to treat high levels of methemoglobin in the blood) and preparations with St. John’s wort – Hypericum perforatum)(an herbal remedy for depression). In very rare cases, Mirtin or Mirtin in combination with these medicines can lead to so-called serotonin syndrome. Some of the symptoms of this syndrome are: unexplained fever, sweating, increased heart rate, diarrhea, (uncontrollable) muscle contractions, chills, overactive reflexes, restlessness, mood swings and unconsciousness. If you get a combination of these symptoms, contact your doctor immediately
- the antidepressant drug nefazodone . It can increase the amount of Mirtin in your blood. Tell your doctor if you are using this medicine. You may need to reduce the dose of Mirtin one and increase it again when you stop taking nefazodone.
- medicines for anxiety or sleep disorderssuch as benzodiazepines;
- schizophrenia drugs such as olanzapine;
- Allergy medicines such as cetirizine ;
- medicines for severe pain such as morphine If you combine these medicines with Mirtin, the drowsiness you get from these medicines may increase.
- medicines for infections , medicines for bacterial infections (like erythromycin), medicines for fungal infections (like ketoconazole ), medicines for HIV / AIDS (like HIV protease inhibitors ) and medicines for stomach ulcers (like cimetidine). In combination with Mirtin, these medicines can increase the amount of Mirtin in your blood. Tell your doctor if you are taking these medicines. You may need to reduce the dose of one of Mirtin and increase it again when you stop taking these medicines.
- antiepileptic drugs such as carbamazepine and phenytoin;
- drugs against tuberculosis such as rifampicin. In combination with Mirtin, these medicines can reduce the amount of Mirtin in your blood. Tell your doctor if you are taking these medicines. You may need to increase the dose of one of Mirtin, and decrease it again when you stop taking these medicines.
- drugs used to prevent blood clots such as warfarin . Mirtin may increase the effect of warfarin on the blood. Tell your doctor that you are using this medicine. If they are combined, it is advisable that your doctor carefully examines your blood.
- drugs that can affect the heart rhythm such as certain antibiotics and certain antipsychotic drugs.
Mirtin with food, drink and alcohol
You may become drowsy if you drink alcohol while using Mirtin.
You should not drink any alcohol.
You can take Mirtin with or without food.
Pregnancy, breastfeeding 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 Mirtin in pregnant women shows no increased risk. However, caution should be exercised when using during pregnancy.
If you are using Mirtin until or just before delivery, your baby should be checked for any side effects .
When similar drugs ( SSRIs ) are used during pregnancy, the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN) may increase. This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.
Driving and using machines
Mirtin may affect your concentration or reactivity. Make sure your ability has not been affected before driving or using tools or machines. If your doctor has prescribed Mirtin to a patient under the age of 18, make sure that their ability to concentrate and react is not affected before the person enters traffic (eg by bicycle).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Mirtin contains excipients
Mirtin contains lactose , sorbitol and aspartame . This medicine contains lactose . If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains sorbitol.
Mirtin 15 mg orodispersible tablet contains 4.9-13.8 mg sorbitol per tablet.
Mirtin 30 mg orodispersible tablet contains 9.9-27.7 mg sorbitol per tablet.
Mirtin 45 mg orodispersible tablet contains 14.8-41.5 mg sorbitol per tablet.
This medicine contains aspartame.
Mirtin 15 mg orodispersible tablet contains 1.6 mg aspartame per tablet.
Mirtin 30 mg orodispersible tablet contains 3.2 mg aspartame per tablet.
Mirtin 45 mg orodispersible tablet contains 4.8 mg aspartame per tablet.
Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body.
How to use Mirtin
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
How much to take
The recommended starting dose is 15 mg to 30 mg per day. Your doctor may increase the dose one after a few days to the amount that is best for you (between 15 mg and 45 mg per day). Dose one is usually the same for all age groups. If you are elderly or have a kidney or liver disease, your doctor may need to adjust your dose .
When to take Mirtin
→ Take Mirtin at the same time each day. It is best to take Mirtin as a single dose before going to bed. However, your doctor may suggest that you split the dose of Mirtin – once in the morning and once before going to bed. The highest dose should be taken before going to bed.
Take the orodispersible tablets as follows:
You should take the tablets by mouth.
Mirtin is fragile. They must not be pushed out through the foil on the blister strip as this may damage the tablet. Remove the tablet from the package as follows:
1. Hold the edges of the blister strip and detach a blister cell from the rest of the strip by gently tearing it off along the perforation.
2. Lift the edge of the foil and pull off the foil completely.
3. Tip out the tablet in your hand.
4. Place the tablet on your tongue immediately after removing it from the package.
When placed on the tongue, it dissolves quickly. The reconstituted tablet can be swallowed with or without water. Your mouth should be empty when you place the tablet on your tongue.
When can you expect to start feeling better?
It usually takes 1-2 weeks before Mirtin starts working and after 2-4 weeks you can start to feel better. It is important that during the first weeks of treatment you and your doctor talk about the effects of Mirtin:
→ talk to your doctor 2 to 4 weeks after starting Mirtin about the effect of the treatment. If you still do not feel better, your doctor may give you a higher dose . In that case, talk to your doctor again after another 2 to 4 weeks. You usually need to use Mirtin until your depressive symptoms have been gone for 4-6 months.
If you use more Mirtin than you should
→ The most likely signs of an overdose of Mirtin (without other medicines or alcohol) are fatigue, confusion and an increased heart rate. The symptoms of a possible overdose can be changes in heart rhythm (fast, irregular heartbeat) and / or fainting, which can be symptoms of a life-threatening condition called Torsade de pointes .
If you forget to use Mirtin
Do not take a double dose to make up for a forgotten dose .
If you are going to take your dose once a day:
- If you forget to take your dose of Mirtin, do not take the missed dose but skip it. Take your next dose at the usual time.
If you are going to take your dose twice a day:
- If you forget to take your morning dose, simply take it with your evening dose.
- If you forget to take your evening dose, do not take it with your next morning dose, just skip it and continue with your usual morning and evening doses.
- if you have missed both doses , do not try to compensate for the missed doses . Skip both and continue the next day with your usual morning and evening doses.
If you stop using Mirtin
→ Only stop taking Mirtin if you have agreed with your doctor.
If you quit too soon, your depression may return. When you start to feel better, talk to your doctor. Your doctor will decide when you can stop treatment.
Do not suddenly stop taking Mirtin, even if your depression has subsided. If you stop taking Mirtin suddenly, you may feel nauseous, dizzy, upset, anxious or have a headache. These symptoms can be avoided if you step down gradually. Your doctor will tell you how to reduce the dose gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
If you get any of the following serious side effects , stop taking mirtazapine and contact your doctor immediately.
Uncommon (may affect up to 1 in 100 people):
- a feeling of elation or feeling ‘high’ (mania).
Rare (may affect up to 1 in 1,000 people):
- yellowing of the whites of the eyes or the skin; it may be a sign of a disorder of liver function (jaundice).
Has been reported (occurs in an unknown number of users):
- signs of infection such as unexplained, high fever, sore throat and mouth ulcer ( agranulocytosis ). In rare cases, mirtazapine may interfere with the production of blood cells (bone marrow depression). Some people become more susceptible to infection because mirtazapine can cause a lack of white blood cells ( granulocytopenia ). In rare cases, mirtazapine may also cause a lack of red and white blood cells as well as platelets ( aplastic anemia ), a lack of platelets ( thrombocytopenia ) or an increase in white blood cells ( eosinophilia ).
- epileptic seizures (seizures).
- a combination of symptoms unexplained fever, sweating, increased heart rate, diarrhea (uncontrollable) muscle contractions, chills, overactive reflexes, restlessness, mood swings, unconsciousness and increased amount of saliva. In very rare cases, it may be a sign of serotonin syndrome.
- thoughts of wanting to hurt yourself or commit suicide.
- severe skin reactions:
- reddish spots on the torso that resemble targets or are round, often with blisters in the middle; flaking skin; sores in the oral cavity, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms ( Stevens-Johnson syndrome , toxic epidermal necrolysis ).
- widespread skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
Other possible side effects are with mirtazapine:
Very common (may affect more than 1 user in 10):
- increased appetite and increased weight
- drowsiness or drowsiness
- dry mouth
Common (may affect up to 1 in 10 people):
- shaking or trembling
- skin rash or eczema (exanthema)
- joint pain ( arthralgia ) or muscle ( myalgia )
- back pain
- feeling dizzy or fainting when you get up suddenly ( orthostatic hypotension )
- swelling (especially ankles and feet) due to fluid retention ( edema )
- vivid dreams
- feelings of anxiety
- sleeping problems
- memory problems, which in most cases went back when treatment was stopped
Uncommon (may affect up to 1 in 100 people):
- abnormal sensation in the skin, e.g. burning, stinging, tickling or irritating ( paresthesia )
- fainting ( syncope )
- feeling of numbness in the mouth ( oral hypoesthesia )
- low blood pressure
- feeling of upset
- strong need to want to move
Rare (may affect up to 1 in 1,000 people):
- muscle twitching or contractions ( myoclonus )
- aggressive behavior
- abdominal pain and nausea; this may indicate inflammation of the pancreas ( pancreatitis )
Has been reported (occurs in an unknown number of users):
- abnormal sensation in the mouth ( oral paresthesia )
- swelling of the mouth ( edema of the mouth)
- swelling all over the body (general edema )
- local swelling
- decreased sodium content in the blood ( hyponatremia )
- improper secretion of antidiuretic hormone
- severe skin reaction (bullous dermatitis and erythema multiforme)
- speech disorder
- elevated blood levels of creatine kinase
- difficulty emptying the bladder ( urinary retention )
- muscle pain, stiffness and / or weakness, darker or discolored urine ( rhabdomyolysis )
- elevated levels of the hormone et prolactin in the blood ( hyperprolactinemia , including symptoms of enlarged breasts and / or milk flow from the breasts)
- prolonged painful erection of the penis
Additional side effects are in children and adolescents
The following common side effects in children under 18 years of age were observed in clinical trials:
Significant weight gain, hives and elevated blood fat levels.
How to store Mirtin
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 expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
– The active substance is mirtazapine. Each orodispersible tablet contains 15 mg, 30 mg, or 45 mg of mirtazapine.
The other ingredients are lactose monohydrate , ethylcellulose, mannitol (E 421), sorbitol (E 420), crospovidone, colloidal hydrated silica, orange flavoring (contains maltodextrin, modified corn starch), aspartame (E 951), magnesium stearate. See section 2 “Mirtin contains lactose , sorbitol and aspartame”.
What the medicine looks like and contents of the pack
The orodispersible tablets are white, round and biconvex.
This medicine is available in pack sizes of 6, 10, 12, 14, 18, 20, 28, 30, 48, 50, 56, 60, 70, 90, 96, 100, 100×1, or 180 tablets in perforated unit dose blisters.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
KRKA Sverige AB, Göta Ark 175, 118 72 Stockholm
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Str. 5, D-27472 Cuxhaven, Germany