15 mg orodispersible tablets
What Mirtazapine Sandoz is and what it is used for
Mirtazapine Sandoz belongs to a group of medicines called antidepressants.
Mirtazapine Sandoz is used to treating depression in adults. It will take 1 to 2 weeks for Mirtazapine Sandoz 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 Sandoz 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 Sandoz
Do not take Mirtazapine Sandoz:
- if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If so, you should talk to your doctor as soon as possible before taking Mirtazapine Sandoz.
- if you are taking or have recently taken (within the last two weeks) medicines calledmonoamine oxidase inhibitors ( MAOIs ).
Warnings and cautions
Talk to your doctor or pharmacist before taking Mirtazapine Sandoz:
- if you have ever had a severe rash or flaky skin, blisters and / or sores in your mouth after taking Mirtazapine Sandoz or other medicines.
Children and young people
Mirtazapine Sandoz should not normally be used in children and adolescents under 18 years of age as the effect has not 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 drugs of this type. Despite this, Mirtazapine Sandoz can be prescribed to patients under 18 years of age, if the doctor deems it appropriate. If your doctor has prescribed Mirtazapine Sandoz to someone under the age of 18 and you want to discuss this, you should consult 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 use Mirtazapine Sandoz. The long-term effects of Mirtazapine Sandoz on growth, maturation, cognition 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 than in adults, following treatment with mirtazapine.
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 see 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 Sandoz
- if you have or have had any of the following conditions.→ Tell your doctor about these conditions before you start taking Mirtazapine Sandoz if you have not done so before.
- cramps ( epilepsy ). If you get cramps or if your cramps come more often, stopMirtazapine Sandoz and contact your doctor immediately;
- liver disease , including jaundice. If you get jaundice, stop taking Mirtazapine Sandoz and contact your doctor immediately;
- kidney disease ;
- heart disease , or 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 elated or overexcited, stop taking Mirtazapine Sandoz and contact your doctor immediately;
- diabetes (you may need to adjust dose one on insulin or other antidiabetic drugs);
- 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 taking Mirtazapine Sandoz 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.
- 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 the use of Mirtazapine Sandoz. 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 Sandoz again.
Other medicines and Mirtazapine Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Mirtazapine Sandoz in combination with:
- monoamine oxidase inhibitors ( MAOIs ). Also, do not take Mirtazapine Sandoz for two weeks after stopping MAOIs . If you stop taking Mirtazapine Sandoz, do not take MAOIs 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 Mirtazapine Sandoz 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 wort – Hypericum perforatum(an herbal remedy for depression). In very rare cases, Mirtazapine Sandoz or Mirtazapine Sandoz 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 may increase the amount of Mirtazapine Sandoz in your blood.Tell your doctor if you are using this medicine. You may need to reducedose one of Mirtazapine Sandoz, 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 Sandoz 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 Sandoz, these medicines may increase the amount of Mirtazapine Sandoz in your blood. Tell your doctor if you are taking these medicines. You may need to reduce the dose of one of Mirtazapine Sandoz, 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 Sandoz, these medicines may reduce the amount of Mirtazapine Sandoz in your blood. Tell your doctor if you are taking these medicines. You may need to increase the dose of one of Mirtazapine Sandoz, and decrease it again when you stop taking these medicines.
- drugs used to prevent blood clots such as warfarin .Mirtazapine Sandoz 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 Sandoz with food and alcohol
You may become drowsy if you drink alcohol while using Mirtazapine Sandoz.
You should not drink any alcohol.
You can take Mirtazapine Sandoz 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 Sandoz in pregnant women shows no increased risk. However, caution should be exercised when used during pregnancy.
If you are using Mirtazapine Sandoz 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 Sandoz may affect your concentration or ability to react. Make sure your ability has not been affected before driving or using tools or machines. If your doctor has prescribed Mirtazapine Sandoz 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 Sandoz contains aspartame, benzyl alcohol, sulfites and sodium
This medicine contains 3 mg of aspartame per orodispersible 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.
This medicine contains 0.047 mg of benzyl alcohol per orodispersible tablet. Benzyl alcohol can cause allergic reactions. If you are pregnant or breastfeeding or have impaired liver function or kidney function, consult your doctor or pharmacist before using this medicine. Large amounts of benzyl alcohol can be stored in the body and cause side effects (metabolic acidosis ).
This medicine contains a very small amount of sulfites. In rare cases, this can cause severe hypersensitivity reactions and convulsions in the trachea.
This medicine contains less than 1 mmol (23 mg) sodium per orodispersible tablet, ie is essential ‘sodium-free’.
How to take Mirtazapine Sandoz
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 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 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 Sandoz
Take Mirtazapine Sandoz at the same time each day. It is best to take Mirtazapine Sandoz as a single dose before going to bed. However, your doctor may suggest that you split the dose of a Mirtazapine Sandoz – once in the morning and once before going to bed. The higher dose one should take before going to bed.
Take the orodispersible tablets as follows:
You should take the tablets by mouth.
1. Do not crush the orodispersible tablet
To prevent crushing of the orodispersible tablet, do not press against the tablet pocket (Figure A).
2. Tear off a tablet pocket
Each blister contains a tablet pocket that is separated by a perforation. Tear off a tablet pocket along the dotted line (Figure 1).
3. Pull off the closure
Carefully pull off the foil and start in the corner marked with an arrow (Figures 2 and 3).
4. Take a mouth-watering tablet
With dry hands, take out an orodispersible tablet and place it on the tongue (Figure 4).
It will dissolve quickly and you can swallow it without water.
When you can, you can expect to feel better
It usually takes 1-2 weeks before Mirtazapine Sandoz starts working and after 2-4 weeks you can start to feel better. During the first weeks of treatment you and your doctor must talk about the effects of Mirtazapine Sandoz:
→ talk to your doctor 2-4 weeks after starting Mirtazapine Sandoz 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 2-4 weeks. You should usually use Mirtazapine Sandoz until your depressive symptoms have been gone for 4-6 months.
If you take more Mirtazapine Sandoz than you should
The most likely signs of an overdose of Mirtazapine Sandoz (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 points.
If you forget to take Mirtazapine Sandoz
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 Sandoz
Only stop taking Mirtazapine Sandoz 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 Sandoz, even if your depression has subsided. If you stop taking Mirtazapine Sandoz 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 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 the unknown number of users):
- signs of infection such as sudden and 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 the symptoms of 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 possible side effects with mirtazapine are:
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 hypesthesia )
- 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 )
- abdominal pain and nausea, which 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 of the whole body (general edema )
- local swelling
- improper secretion of antidiuretic hormone
- severe skin reactions (bullous dermatitis , erythema multiforme)
- speech disorder
- increased creatine kinase in the blood
- difficulty emptying the bladder ( urinary retention )
- muscle aches, stiffness and / or weakness, dark or discolored urine ( rhabdomyolysis )
- elevated levels of the hormone et prol actin in the blood ( hyperprolactinemia , including symptoms of milk flow from the breasts and enlarged breasts in men).
Other side effects that can occur with mirtazapine are:
Elevated creatine kinase in the blood, difficulty emptying the bladder and muscle aches, stiffness and/or weakness, and dark or discolored urine.
Additional side effects are in children and adolescents
The following common side effects have been observed in clinical trials in children under 18 years of age: significant weight gain, hives, and high blood fats.
How to store Mirtazapine Sandoz
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.
Do not store above 30 ° C. Store in the original package. Moisture sensitive.
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. An orodispersible tablet contains 15 mg mirtazapine.
- The other ingredients are mannitol (E421), povidone K30, crospovidone, colloidal anhydrous silica, aspartame (E951), calcium stearate, orange flavor ( maltodextrin , natural and artificial flavors, di ‑ alpha ‑ tocopherol, sodium amine alcohol, benzyl alcohol, , dextrin, sulfites).
What the medicine looks like and contents of the pack
Mouth-disintegrating tablet: White to off-white, round, flat tablet with beveled edges and smooth on both sides.
Aluminum / Aluminum blister pack containing 6, 10, 14, 18, 20, 28, 30, 30 (single dose), 48, 50, 56, 60, 84, 90, 96, 100 or 100 (single dose) orodispersible tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
LEK dd Pharmaceuticals, Verovškova 57, 1526 Ljubljana, Slovenia