15 mg film-coated tablets
mirtazapine
What Mirtazapine Alternova is and what it is used for
Mirtazapine Alternova belongs to a group of medicines called antidepressants.
Mirtazapine Alternova is used to treat depression in adults.
It will take 1 to 2 weeks for Mirtazapine Alternova to start 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 Mirtazapine Alternova 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 use Mirtazapine Alternova
Do not use Mirtazapine Alternova
- 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 ).
DO NOT TAKE – OR – TELL YOUR DOCTOR BEFORE TAKING Mirtazapine Alternova:
If you have ever had a severe rash or flaky skin, blisters, and/or sores in your mouth after taking Mirtazapine Alternova or other medicines.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Mirtazapine Alternova.
Children and young people
Mirtazapine Alternova should not normally be used in the treatment of children and adolescents under 18 years of age as no effect has 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, Mirtazapine Alternova can be prescribed to patients under 18 years of age, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you received this medicine, consult your doctor again.
You should also tell your doctor if you notice any of the above symptoms or if they get worse. The long-term effects on growth, maturity, 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 Alternova 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, take special care with Mirtazapine Alternova
- if you have or have had:
- cramps ( epilepsy ). If you get cramps or if your cramps come more often, stop taking Mirtazapine Alternova and contact your doctor immediately.
- liver disease, including jaundice. If you get jaundice, stop taking Mirtazapine Alternova and contact your doctor immediately.
- kidney disease
- heart disease (eg conduction disorders, angina, heart attack). Especially if you are taking certain medicines that may affect your heart rhythm with Mirtazapine Alternova.
- low blood pressure
- difficulty urinating (eg due to enlarged prostate )
- eye disease, such as increased pressure in the eye ( glaucoma )
- diabetes (you may need to adjust dose one on insulin or other antidiabetic drugs)
- schizophrenia. If psychotic symptoms such as paranoid thoughts occur more often or become more severe, contact your doctor immediately.
- manic depression (alternating periods of elation and depression). If you start to feel elated or overexcited, stop taking Mirtazapine Alternova and contact your doctor immediately.
- akathisia / psychomotor restlessness (inability to sit still)
- If you get signs of infection such as unexplained high fever, sore throat and sore mouth, stop taking Mirtazapine Alternova 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 generally after 4-6 weeks of treatment. - if you are an older person. You may be more sensitive to the side effects of antidepressants.
A syndrome called serotonergic syndrome can occur in rare cases if mirtazapine is used in combination with other drugs that increase the release of serotonin. The main symptoms of a serotonergic syndrome are fever (above 38 ° C) and muscle twitching but can also include confusion, irritability, and extreme agitation that turns into delirium (a mental disorder with symptoms such as attention deficit, motor problems, and delusions) and coma. Contact your doctor if such symptoms occur. You may need to stop taking the medicine and receive treatment.
Although mirtazapine is not considered addictive, abrupt discontinuation of treatment may lead to withdrawal symptoms such as nausea, headache, dizziness, agitation, anxiety, and malaise. Contact your doctor for advice on how to reduce the treatment gradually.
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 Alternova again.
Other medicines and Mirtazapine Alternova
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Mirtazapine Alternova in combination with:
- monoamine oxidase inhibitors ( MAOIs ). Also, do not take Mirtazapine Alternova for two weeks after stopping MAOIs . If you stop taking Mirtazapine Alternova, do not take MAO inhibitors for the first two weeks.
Examples of MAO inhibitors are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used in Parkinson’s disease ).
Be careful with Mirtazapine Alternova in combination with:
- antidepressants such as SSRIs , venlafaxine and L-tryptophan or triptans (used to treat migraines ), 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 wortHypericum perforatum (a natural remedy for depression). In very rare cases, Mirtazapine Alternova or Mirtazapine Alternova in combination with these medicines may 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 Mirtazapine Alternova in your blood. Tell your doctor if you are using this medicine. You may need to reduce the dose of one of Mirtazapine Alternova and increase it again when you stop taking nefazodone.
- medicines for anxiety or sleep disorders such as benzodiazepines; schizophrenia drugs such as olanzapine; anti- allergy medicines like cetirizine; medicines for severe pain such as morphine. Combining these medicines with Mirtazapine Alternova may increase the drowsiness of these medicines.
- medicines for infections , medicines for bacterial infections (like 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 Alternova, these medicines may increase the amount of Mirtazapine Alternova in your blood. Tell your doctor if you are taking these medicines. You may need to reduce the dose of one of Mirtazapine Alternova, 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 Alternova, these medicines may reduce the amount of Mirtazapine Alternova in your blood. Tell your doctor if you are taking these medicines. You may need to increase the dose of one of Mirtazapine Alternova, and decrease it again when you stop taking these medicines.
- drugs used to prevent blood clots such as warfarin . Mirtazapine Alternova 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.
Mirtazapine Alternova with food, drink and alcohol
Mirtazapine Alternova can potentiate the depressant effect of alcohol, you can e.g. get drowsy. You should therefore avoid alcohol during the time you are being treated with Mirtazapine Alternova.
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 Alternova in pregnant women shows no increased risk. However, caution should be exercised when used during pregnancy.
If you are taking Mirtazapine Alternova until or just before delivery, your baby should be checked for any side effects.
Tell your midwife or doctor that you are taking Mirtazapine Alternova. 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 Alternova may impair the ability to concentrate and react, especially at the beginning of treatment. This you should keep in mind e.g. when driving and using mechanical equipment.
If your doctor has prescribed Mirtazapine Alternova 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 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 Alternova 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.
How to use Mirtazapine Alternova
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The usual starting dose is 15-30 mg per day. Dose one may be increased to 45 mg daily. If you are elderly or have kidney or liver disease, your doctor may need to adjust your dose.
Mirtazapine Alternova should not be used in adolescents under 18 years of age (see also section 2 Children and adolescents ).
The tablets should be swallowed with a glass of liquid. The full daily dose can be taken at bedtime, but dose one can also be divided into two intakes per day (one dose in the morning and one dose in the evening at bedtime). The higher dose one should take before going to bed. The tablet can be divided into two equal doses.
When you can expect to start feeling better
It usually takes 1-2 weeks before Mirtazapine Alternova starts to work and after 2-4 weeks you can start to feel better.
You must talk to your doctor during the first few weeks of treatment about the effects of Mirtazapine Alternova:
- talk to your doctor 2 to 4 weeks after starting Mirtazapine Alternova 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 use Mirtazapine Alternova until your depressive symptoms have been gone for 4-6 months.
If you take more Mirtazapine Alternova than you should
The most likely signs of an overdose of Mirtazapine Alternova (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 take Mirtazapine Alternova
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, 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 taking Mirtazapine Alternova
Only stop taking Mirtazapine Alternova 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 Mirtazapine Alternova, even if your depression has subsided. If you stop taking Mirtazapine Alternova 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, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Stop taking Mirtazapine Alternova and contact your doctor immediately if the following serious side effects occur:
Uncommon (may affect less than 1 user in 100):
- feeling elated or feeling ‘high’ (mania)
Rare side effects (may affect less than 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)
No known frequency (can not be calculated from the available data) :
- 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 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, unconsciousness and increased salivation. In very rare cases, it may be a sign of serotonin syndrome.
- thoughts of wanting to hurt yourself or commit suicide
- 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 side effects that may occur:
Very common side effects ( may affect more than 1 user in 10):
- increased appetite and weight gain
- drowsiness (especially during the first weeks of treatment)
- dry mouth
- headache
Common side effects ( may affect up to 1 in 10 people):
- vivid dreams, confusion, anxiety, insomnia, lethargy (drowsiness), dizziness
- shaking
- orthostatic hypotension (drop in blood pressure, especially when getting up from a supine position)
- nausea, diarrhea, vomiting, constipation
- skin rash or eczema (exanthema)
- joint pain, muscle aches, back pain, swelling of the feet, ankles and hands
- fatigue..
- memory problems, which in most cases went back when treatment was stopped.
Uncommon side effects ( may affect up to 1 in 100 people) :
- nightmares
- indignation
- hallucinations
- psychomotor restlessness (including inability to sit or stand still and involuntary movements)
- bogs
- tingling or numbness in the skin
- restless legs
- fainting
- low blood pressure
- decreased oral sensitivity
Rare side effects (may affect up to 1 in 1,000 people):
- aggression,
- sudden muscle contractions
- abdominal pain and nausea, which may indicate inflammation of the pancreas ( pancreatitis )
Has been reported (occurs in an unknown number of users):
- hyponatremia (decreased sodium in the blood),
- tingling or numbness in the mouth, difficulty speaking, or swelling in the mouth, increased salivation
- severe skin reactions (dermatitis bullous, erythema multiforme)
- somnambulism
- muscle pain, stiffness and / or muscle weakness, darker or discolored urine ( rhabdomyolysis )
- elevated blood levels of creatine kinase
- difficulty emptying the bladder
- local swelling or swelling throughout the body
Additional side effects are in children and adolescents
Significant weight gain, hives, and increased blood fat ( triglycerides ) were common side effects in clinical trials in children.
How to store Mirtazapine Alternova
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.
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 of mirtazapine.
- The other ingredients are lactose monohydrate , maize starch, hydroxypropylcellulose, colloidal anhydrous silica, magnesium stearate, hypromellose and macrogol 8000. Dyes included are titanium dioxide (E171), yellow iron oxide (E172), quinoline yellow (E104) and paraang.
What the medicine looks like and contents of the pack
Appearance
Yellow, oblong, and biconvex tablets with a scoreline.
Pack sizes
Blisters: 14, 28, 30, 56, 60, 70, 90 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Alternova A / S, Lodshusvej 11, 4230 Skælskør, Denmark
Manufacturer
Combino Pharm SL, Fructuós Gelabert 6-8, E-08970 Sant Joan Despi, Barcelona, Spain
or
Combino Pharm Malta Ltd, HF 60 Hal Far Industrial Estate, Hal Far BBG 07, Malta
or
Orifarm Generics A / S, Energivej 15, 5260 Odense, Denmark
This medicinal product is authorized in the European Economic Area under the names:>
Denmark, Sweden: Mirtazapine Alternova