15 mg, 30 mg, 45 mg film-coated tablets
mirtazapine
What Mirtazapine Orion is and what it is used for
Mirtazapine Orion belongs to a group of medicines called antidepressants.
Mirtazapine Orion is used to treating depression in adults.
It takes 1 to 2 weeks for Mirtazapine Orion to start working. After 2 to 4 weeks, you can start to feel better. You must talk to a doctor if you do not feel better or worse after 2 to 4 weeks. For more information, see section 3, entitled “When can you expect to start feeling better?”
Mirtazapine contained in Mirtazapine Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Mirtazapine Orion
Do not take Mirtazapine Orion
- 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 ( MAOIs ).
Warnings and cautions
Talk to your doctor or pharmacist before taking Mirtazapine Orion.
Tell your doctor before taking Mirtazapine Orion
- if you have ever had a severe rash or flaky skin, blisters and / or sores in your mouth after taking Mirtazapine Orion.
Children and young people
Mirtazapine Orion should not normally be used in the treatment of children and adolescents under 18 years of age, as no effect has been established. 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 this type of drug. Nevertheless, your doctor may prescribe Mirtazapine Orion to patients under 18 years of age, if he/she deems it appropriate for that patient. If your doctor has prescribed Mirtazapine Orion to a patient under the age of 18 and you want to discuss this, see your doctor again. You should also inform your doctor if any of the above symptoms occur or worsen when patients under the age of 18 use Mirtazapine Orion. The long-term effects of Mirtazapine Orion on growth, maturation, and cognitive and behavioral development have not yet been established for children and adolescents under 18 years of age. In addition, significant weight gain has been observed more frequently in this age group when receiving mirtazapine compared to adults.
Suicidal thoughts and if your depression worsens
If you are depressed, you may 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 a young adult. Studies have shown an increased risk of suicidal behavior in adults younger than 25 years with mental illness treated with antidepressants.
If you have thoughts of injuring yourself or committing suicide, consult a doctor or see your nearest hospital immediately.
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 your depression is getting worse or if they are worried that your behavior is changing.
Also, take special care with Mirtazapine Orion
- if you have or have had any of the following conditions. If you have not done this before, tell your doctor before you start taking Mirtazapine Orion.
- cramps ( epilepsy ). If you get cramps or if your cramps come more often, stop using Mirtazapine Orion and contact your doctor immediately;
- liver disease , including jaundice. If you get jaundice, stop using Mirtazapine Orion and contact your doctor immediately;
- kidney disease ;
- heart disease , or low blood pressure ;
- schizophrenia . If psychotic symptoms such as paranoid thoughts occur more frequently or become more severe, consult a physician immediately;
- bipolar disorder (alternating periods of feeling elated / overactive and depressed). If you start to feel elated or overexcited, stop using Mirtazapine Orion and contact your doctor immediately;
- diabetes (you may need to adjust the dose one on insulin or other diabetes medicines);
- eye disease , such as increased pressure in the eye ( glaucoma );
- difficulty urinating (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 using Mirtazapine Orion and contact your doctor immediately for a blood test. In rare cases, these symptoms may be a sign of a disturbance in the production of blood cells in the bone marrow . It is rare, but if they do occur, it is usually after 4-6 weeks of treatment.
- If you are an elderly person, you may be more sensitive to the side effects of antidepressant drugs.
- 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 Mirtazapine Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Mirtazapine Orion in combination with:
- monoamine oxidase inhibitors ( MAOIs ). Also, do not take Mirtazapine Orion two weeks after you stop taking MAOIs . If you stop taking Mirtazapine Orion, do not take MAO inhibitors for the next two weeks. Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used in Parkinson’s disease ).
Be careful with Mirtazapine Orion in combination with:
- antidepressants such as SSRIs , venlafaxine and L-tryptophan or triptans (used to treat migraines ), tramadol (painkillers), buprenorphine, linezolid (an antibiotic ), lithium (used to treat certain mental conditions), methylene blue (used to treat high levels of methemoglobin in the blood) and preparations containing St. John’s wort – Hypericum perforatum(an herbal remedy for depression). In very rare cases, Mirtazapine Orion or Mirtazapine Orion in combination with these medicines may lead to a so-called serotonergic 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 a doctor immediately.
- the antidepressant drug nefazodone. It can increase the amount of Mirtazapine Orion in the blood. Tell your doctor if you are taking this medicine. It may be necessary to reduce the dose of Mirtazapine Orion, or to increase it again after stopping the use of nefazodone.
- • anti-anxiety or sleeping pills like benzodiazepines;
- schizophrenia drugs such as olanzapine;
- anti- allergy medicines like cetirizine ;
- drugs for severe pain such as morphine.
In combination with these medicines, Mirtazapine Orion may increase the drowsiness that these medicines may cause. - medicines for infection ; drugs against bacterial infection (such as erythromycin); medicines for fungal infections (like ketoconazole ) and medicines for HIV / AIDS (like HIV protease inhibitors ) and medicines for stomach ulcers (like cimetidine).
In combination with Mirtazapine Orion, these medicines may increase the amount of Mirtazapine Orion in the blood. Tell your doctor if you are taking these medicines. It may be necessary to reduce the dose of Mirtazapine Orion 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 Mirtazapine Orion, these medicines may reduce the amount of Mirtazapine Orion in the blood. Tell your doctor if you are taking these medicines. You may need to increase the dose of one of Mirtazapine Orion, and decrease it again when you stop using these medicines. - drugs used to prevent blood clots such as warfarin .
Mirtazapine Orion may increase the effect of warfarin in the blood. Tell your doctor that you are using this medicine. If these drugs are combined, it is advisable that doctors carefully monitor your blood levels. - drugs that can affect the heart rhythm such as certain antibiotics and certain antipsychotic drugs.
Mirtazapine Orion with food and alcohol
You may become drowsy if you drink alcohol while taking Mirtazapine Orion.
Do not drink alcohol while using Mirtazapine Orion.
You can take Mirtazapine Orion with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, 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 Mirtazapine Orion in pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy. If you are taking Mirtazapine Orion 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’s born. If this affects your baby, contact a midwife or doctor immediately.
Driving and using machines
Mirtazapine Orion may affect your concentration or reactivity. Make sure your ability has not been affected before driving or using machines. If your doctor has prescribed Mirtazapine Orion to a patient under 18 years of age, make sure that concentration or attention is not affected before the person goes out into the traffic (eg by bicycle).
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. 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.
Mirtazapine Orion contains lactose
Mirtazapine Orion tablets contain lactose monohydrate 102 mg (15 mg tablet), 204 mg (30 mg tablet), and 306 mg (45 mg tablet). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Mirtazapine Orion
Always take 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 or 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 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 Mirtazapine Orion
Take Mirtazapine Orion at the same time each day.
It is best to take Mirtazapine Orion as a single dose before going to bed. However, your doctor may suggest that you split a dose of Mirtazapine Orion – once in the morning and once before going to bed. The higher dose one should take before going to bed. Take the tablets by mouth. Swallow your prescribed dose of Mirtazapine Orion without chewing on the tablet, with water or juice.
When can you expect to start feeling better?
It usually takes 1-2 weeks before Mirtazapine Orion starts working and after 2-4 weeks you may start to feel better.
It is important during the first weeks of treatment that you talk to your doctor about the effects of Mirtazapine Orion:
- talk to your doctor 2 to 4 weeks after you start taking Mirtazapine Orion 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 should usually take Mirtazapine Orion until your depressive symptoms have been gone for 4-6 months.
If you take more Mirtazapine Orion than you should
The most likely signs of an overdose of Mirtazapine Orion (without other medicines or alcohol) are drowsiness, 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 torsades de pointes.
If you forget to take Mirtazapine Orion
If you are going to take your dose once a day
- Do not take a double dose to make up for a forgotten dose . 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, take it with your evening dose.
- if you forget to take your evening dose, do not take it with your morning dose the next day, 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 doses and continue the next day with your usual morning and evening doses.
If you stop taking Mirtazapine Orion
Only stop taking Mirtazapine Orion if you have agreed with your doctor.
If you quit too soon, your depression may return. When you start to feel better, talk to a doctor. Your doctor will decide when you can stop treatment.
Do not suddenly stop taking Mirtazapine Orion, even if your depression has subsided. If you stop taking Mirtazapine Orion 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 experience any of the following serious side effects, stop taking mirtazapine and contact your doctor immediately.
Uncommon ( may affect up to 1 in 100 people ):
- feeling elated 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 liver dysfunction (jaundice).
Has been reported ( occurs in an unknown number of users ):
- signs of infection such as sudden unexplained high fever, sore throat and sore mouth. ( 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 temporary 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 such as unexplained fever, sweating, increased heart rate, diarrhea, (uncontrollable) muscle contractions, chills, overactive reflexes, restlessness, mood swings and unconsciousness and increased salivation. In very rare cases, this may be a sign of serotonergic 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 of mirtazapine are:
Very common ( may affect more than 1 user in 10 ):
- increased appetite and weight gain
- drowsiness or drowsiness
- headache
- dry mouth .
Common ( may affect up to 1 in 10 people ):
- decreased alertness
- dizziness
- shaking or trembling
- nausea
- diarrhea
- vomiting
- constipation
- 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 )
- fatigue
- vivid dreams
- confusion
- 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 )
- ant crawls in the legs (restless legs)
- fainting ( syncope )
- feeling of numbness in the mouth ( oral hypesthesia )
- low blood pressure
- nightmares
- feeling of upset
- hallucinations
- strong need to move.
Rare ( may affect up to 1 in 1,000 people ):
- muscle twitching or contractions ( myoclonus )
- aggression
- 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 in the body (general edema )
- local swelling (local edema )
- hyponatremia (low level of sodium in the blood)
- improper secretion of antidiuretic hormone
- severe skin reactions (bullous dermatitis , erythema multiforme)
- go to sleep (somnambulism)
- speech difficulties
- increased levels of creatine kinase in the blood
- difficulty urinating ( urinary retention )
- muscle pain, stiffness and / or weakness
- dark 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 in children and adolescents
In children under 18 years of age, the following side effects were common in clinical trials: significant weight gain, hives, and increased triglycerides (a type of blood fat) in the blood.
How to store Mirtazapine Orion
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. 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
Content declaration
- The active substance is mirtazapine. Each tablet contains 15 mg, 30 mg or 45 mg of mirtazapine.
- The other ingredients are:
Tablet core : lactose monohydrate , corn starch, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, magnesium stearate and anhydrous colloidal silica.
Tablet coating : hypromellose, hydroxypropylcellulose and titanium dioxide (E171).
Coating of Mirtazapine Orion 15 mg film-coated tablets also contain yellow iron oxide (E172), 30 mg tablet coating contains yellow, red, and black iron oxide (E172).
What the medicine looks like and contents of the pack
15 mg film-coated tablet: Yellow, biconvex capsule-shaped, film-coated tablet with a scoreline between an embossed 1 and 5 on one side and ‘MI’ embossed on the other side. The tablet is 9.1 mm x 4.6 mm.
30 mg film-coated tablet: Reddish-brown, biconvex, capsule-shaped, film-coated tablet with a scoreline between an embossed 3 and 0 on one side and ‘MI’ embossed on the other side. The tablet is 14.1 mm x 6.1 mm.
45 mg film-coated tablet: A white, biconvex, capsule-shaped, film-coated tablet with ’45’ embossed on one side and ‘MI’ embossed on the other side. The tablet is 14.1 mm x 7.1 mm.
15 mg and 30 mg tablets can be divided into two equal doses.
The tablets are available in blister packs of 28, 30, 98, or 100 tablets and HDPE cans of 100 and 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com