30 mg, 45 mg film-coated tablets
mirtazapine
What Mirtazapine Hexal is and what it is used for
Mirtazapine Hexal belongs to a group of medicines called antidepressants.
Mirtazapine Hexal is used to treat depression in adults.
It will take 1-2 weeks before Mirtazapine Hexal 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 Mirtazapine Hexal may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you take Mirtazapine Hexal
Do not take or tell your doctor before taking Mirtazapine Hexal
- if you are allergic to mirtazapine or any of the other ingredients of this medicine (listed in section 6). If you are allergic, you must talk to your doctor as soon as possible before taking Mirtazapine Hexal.
- if you are taking or have recently taken (within the last two weeks) medicines called monoamine oxidase inhibitors ( MAOIs )
- if you have ever had a severe rash or flaky skin, blisters and / or sores in your mouth after taking Mirtazapine Hexal or other medicines.
Warnings and cautions
Talk to your doctor or pharmacist before taking Mirtazapine Hexal.
Children and young people
Mirtazapine Hexal should not normally be used in the treatment of children and adolescents under 18 years of age as an effect has not been established. The risk of certain 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 Hexal can be prescribed to patients under the age of 18, if the doctor deems it appropriate. If your doctor has prescribed Mirtazapine Hexal 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 the age of 18 use Mirtazapine Hexal. The long-term effects of Mirtazapine Hexal on growth, maturation, and cognition 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 during treatment with Mirtazapine Hexal 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 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 Hexal
- if you have or have had any of the following conditions.→ Tell your doctor about these conditions before you start taking Mirtazapine Hexal if you have not done so before.
- cramps ( epilepsy ). If you get cramps or if your cramps come more often, stop taking Mirtazapine Hexal and contact your doctor immediately;
- liver disease, including jaundice. If you get jaundice, stop taking Mirtazapine Hexal 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 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 Hexal 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 Hexal 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 Hexal. 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 Hexal again.
Other medicines and Mirtazapine Hexal
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Mirtazapine Hexal in combination with:
- monoamine oxidase inhibitors ( MAOIs ). Also, do not take Mirtazapine Hexal for two weeks after stopping MAOIs . If you stop taking Mirtazapine Hexal, do not take MAOIs 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 Hexal 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 Hexal or Mirtazapine Hexal 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 Hexal in your blood. Tell your doctor if you are using this medicine. You may need to reduce the dose of one of Mirtazapine Hexal, 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 Hexal 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 Hexal, these medicines may increase the amount of Mirtazapine Hexal in your blood. Tell your doctor if you are taking these medicines. You may need to reduce the dose of one of Mirtazapine Hexal, 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 Hexal, these medicines may reduce the amount of Mirtazapine Hexal in your blood. Tell your doctor if you are taking these medicines. You may need to increase the dose of one of Mirtazapine Hexal, and decrease it again when you stop taking these medicines.
- drugs used to prevent blood clots such as warfarin .Mirtazapine Hexal 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 Hexal with food and alcohol
You may become drowsy if you drink alcohol while taking Mirtazapine Hexal.
You should not drink any alcohol.
You can take Mirtazapine Hexal 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 Hexal in pregnant women shows no increased risk. However, caution should be exercised when used during pregnancy.
If you are taking Mirtazapine Hexal 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 Hexal 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 Hexal 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 Hexal 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 take Mirtazapine Hexal
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 kidney or liver disease, your doctor may need to adjust your dose.
When to take Mirtazapine Hexal
→ Take Mirtazapine Hexal at the same time each day. It is best to take Mirtazapine Hexal as a single dose before going to bed. However, your doctor may suggest that you split the dose of Mirtazapine Hexal – once in the morning and once at night before going to bed. The higher dose one should take before going to bed.
The tablets should be swallowed. Swallow the prescribed dose of Mirtazapine Hexal without chewing the tablet with water or juice.
30 mg film-coated tablets:
The tablet can be divided into two equal doses.
When can you expect to start feeling better?
It usually takes 1-2 weeks before Mirtazapine Hexal 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 Hexal:
→ talk to your doctor 2 to 4 weeks after starting Mirtazapine Hexal 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 Mirtazapine Hexal until your depressive symptoms have been gone for 4-6 months.
If you take more Mirtazapine Hexal than you should
The most likely signs of an overdose of Mirtazapine Hexal (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 Hexal
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 Hexal
→ Only stop taking Mirtazapine Hexal 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 Hexal, even if your depression has subsided. If you stop taking Mirtazapine Hexal 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 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 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 saliva production. 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
- headache
- dry mouth
Common (may affect up to 1 in 10 people):
- fatigue
- 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 )
- bogs
- fainting ( syncope )
- feeling of numbness in the mouth ( oral hypoesthesia )
- low blood pressure
- nightmares
- feeling of upset
- hallucinations
- strong need to want to move
Rare (may affect up to 1 in 1,000 people):
- muscle twitching or contractions ( myoclonus )
- aggressiveness
- abdominal pain and nausea, which may indicate inflammation of the pancreas ( pancreatitis ) that causes pain in the abdomen and back
Has been reported (occurs in the 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
- hyponatremia
- improper secretion of antidiuretic hormone
- severe skin reactions (bullous dermatitis , erythema multiforme)
- somnambulism
- speech disorder
- increased creatine kinase in the blood
- difficulty emptying the bladder ( urinary retention )
- muscle aches, stiffness and / or weakness and dark or discolored urine ( rhabdomyolysis )
- elevated levels of the hormone et prolactin in the blood ( hyperprolactinemia , including the symptoms of milk flow from the breasts and enlarged breasts in men).
Additional side effects are in children and adolescents
The following common side effects were observed in clinical trials in children under 18 years of age: significant weight gain, hives, and high blood fats.
How to store Mirtazapine Hexal
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.
The medicine 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 film-coated tablet contains 30 mg mirtazapine.Each film-coated tablet contains 45 mg mirtazapine.
- Other ingredients are:
30 mg, 45 mg film-coated tablets:Tablet core:Lactose monohydrateCorn starchHydroxypropylcelluloseColloidal anhydrous silicaMagnesium stearate
30 mg film-coated tablets:Outer casing:HypromellosMacrogol 8000Titanium dioxide (E171)Yellow iron oxide (E172)Red iron oxide (E172)Black iron oxide (E172)
45 mg film-coated tablets:Outer casing:HypromellosMacrogol 8000Titanium dioxide (E171)
What the medicine looks like and contents of the pack
30 mg film-coated tablets :
Beige, film-coated, round, biconvex tablet with a notch on one side.
45 mg film-coated tablets :
White, film-coated, round, biconvex tablet.
The film-coated tablets are packaged in opaque/white PVC / PVDC / aluminum blisters and inserted in a carton.
Pack sizes:
6, 10, 14, 18, 20, 28, 30, 48, 50, 56, 60, 70, 90, 96, 100, 30×1, 50×1, 100×1 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
HEXAL A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, D-39179 Barleben, Germany