15 mg, 30 mg, and 45 mg film-coated tablets
mirtazapine
What Mirtazapine Actavis is and what it is used for
Mirtazapine Actavis belongs to a group of medicines called antidepressants.
Mirtazapine Actavis is used to treat depression in adults.
It takes 1 to 2 weeks for Mirtazapine Actavis 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 Actavis 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 Actavis
Do not take Mirtazapine Actavis
- 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 Mirtazapine Actavis.
- 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, pharmacist, or nurse before taking Mirtazapine Actavis.
DO NOT TAKE – OR – TELL YOUR DOCTOR BEFORE TAKING MIRTAZAPINE ACTAVIS:
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
Mirtazapine Actavis should not normally be used in the treatment of children and adolescents under 18 years of age, as efficacy 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 Actavis can be prescribed to patients under 18 years of age if the doctor deems it appropriate. If your doctor has prescribed Mirtazapine Actavis 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 Actavis. The long-term effects of Mirtazapine Actavis 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.
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 Actavis
if you have or have had any of the following conditions.
- → Tell your doctor about these conditions before you start taking Mirtazapine Actavis if you have not done so before.
- cramps ( epilepsy ). If you get cramps or if your cramps come more often, stop taking Mirtazapine Actavis and contact your doctor immediately;
- liver disease , including jaundice. If you get jaundice, stop taking Mirtazapine Actavis 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 Actavis and contact your doctor immediately;
- diabetes (you may need to adjust the dose of one of your 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 taking Mirtazapine Actavis 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 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 Actavis
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Mirtazapine Actavis in combination with:
- monoamine oxidase inhibitors ( MAOIs ). Also, do not take Mirtazapine Actavis for two weeks after stopping MAOIs . If you stop taking Mirtazapine Actavis, do not take MAOIs for the first two weeks. Examples of MAOIs are moclobemide, tranylcypromine (both are antidepressants) and selegiline (used in Parkinson’s disease).
Be careful with Mirtazapine Actavis in combination with:
- antidepressant drugs 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 (a natural remedy for depression). In very rare cases, Mirtazapine Actavis or Mirtazapine Actavis in combination with these medicines can lead to a so-called serotonergic syndrome. 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 Actavis in your blood. Tell your doctor if you are using this medicine. You may need to reduce the dose of one of Mirtazapine Actavis, 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 Actavis may increase the drowsiness of these medicines.
- 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 Mirtazapine Actavis, these medicines may increase the amount of Mirtazapine Actavis in your blood. Tell your doctor if you are taking these medicines. You may need to reduce the dose of one of Mirtazapine Actavis, and increase it again when you stop taking these medicines.
- antiepileptic drugs such as carbamazepine and phenytoin; medicines for tuberculosis such as rifampicin. In combination with Mirtazapine Actavis, these medicines may reduce the amount of Mirtazapine Actavis in your blood. Tell your doctor if you are taking these medicines. You may need to increase the dose of one of Mirtazapine Actavis, and decrease it again when you stop taking these medicines.
- drugs used to prevent blood clots such as warfarin . Mirtazapine Actavis 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 Actavis with food and alcohol
You may become drowsy if you drink alcohol while taking Mirtazapine Actavis.
You should not drink any alcohol.
You can take Mirtazapine Actavis 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.
Pregnancy:
Limited experience with Mirtazapine Actavis in pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy.
If you are taking Mirtazapine Actavis before or just before delivery, your baby should be checked for any side effects.
Ask your doctor if you can breastfeed while taking Mirtazapine Actavis.
Tell your midwife or doctor that you are taking Mirtazapine Actavis. 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.
Breast-feeding:
Ask your doctor if you can breastfeed while taking Mirtazapine Actavis.
Driving and using machines
Mirtazapine Actavis 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 Actavis 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 Actavis contains lactose and sodium
Mirtazapine Actavis 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.
Mirtazapine Actavis contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
How to use Mirtazapine Actavis
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 kidney or liver disease, your doctor may need to adjust your dose.
When to take Mirtazapine Actavis
→ Take Mirtazapine Actavis at the same time each day. It is best to take Mirtazapine Actavis as a single dose before going to bed. However, your doctor may suggest that you split the dose of a Mirtazapine Actavis – 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 Actavis with water or juice without chewing.
When can you expect to start feeling better?
It usually takes 1-2 weeks before Mirtazapine Actavis 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 Actavis:
→ Talk to your doctor 2 to 4 weeks after starting Mirtazapine Actavis 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 Actavis until your depressive symptoms have been gone for 4-6 months.
If you take more Mirtazapine Actavis than you should
The most likely signs of an overdose of Mirtazapine Actavis (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 Torsades de pointes.
If you forget to use Mirtazapine Actavis
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 Actavis
→ Only stop taking Mirtazapine Actavis 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 Actavis, even if your depression has subsided. If you stop taking Mirtazapine Actavis 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.
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)
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 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 serotonergic 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 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 hypesthesia )
- 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 )
- aggression
- 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
- hyponatremia
- improper secretion of antidiuretic hormone
- severe skin reactions (bullous dermatitis , erythema multiforme)
- somnambulism
- 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 were observed in clinical trials in children under 18 years of age: significant weight gain, hives, and high blood fats.
How to store Mirtazapine Actavis
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 or can after EXP. The expiration date is the last day of the specified month.
This medicine has 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.Mirtazapine Actavis 15 mg film-coated tablets contain 15 mg mirtazapine per film-coated tablet.Mirtazapine Actavis 30 mg film-coated tablets contain 30 mg mirtazapine per film-coated tablet.Mirtazapine Actavis 45 mg film-coated tablets contain 45 mg mirtazapine per film-coated tablet.
- Other ingredients are:Tablet core: lactose monohydrate , pregelatinized maize starch, anhydrous croscarmellose sodium, magnesium stearate.Tablet coating: hypromellose, macrogol 8000, titanium dioxide (E171), talc.Mirtazapine Actavis 15 mg film-coated tablets (tablet coating) also contain yellow iron oxide (E172) and red iron oxide (E172).Mirtazapine Actavis 30 mg film-coated tablets (tablet coating) also contain yellow iron oxide (E172) and red iron oxide (E172).
What the medicine looks like and contents of the pack
Mirtazapine Actavis film-coated tablets are:
15 mg tablets: yellow, scored on both sides, oval, biconvex, film-coated tablets. Marked with “I” on one side.
30 mg tablets: brown, scored on both sides, oval, biconvex, film-coated tablets. Marked with “I” on one side. The tablet can be divided into two equal parts.
45 mg tablets: white, oval, biconvex, film-coated tablets. Marked with “I” on one side.
Pack sizes
Blisters: 10, 14, 20, 28, 30, 50, 56 and 100 tablets.
Jar: 30, 100 and 500 tablets.
The pack size of 500 tablets is intended for hospital use.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Actavis Group PTC EHF.
Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland
Actavis Ltd.
BLB 015-016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta
Balkanpharma-Dupnitsa AD
3 Samakovsko Shosse Str., Dupnitsa, 2600, Bulgaria