Mirtazapine bluefish 15mg, Mirtazapine bluefish 30mg, 45 mg mirtazapine orodispersible tablets
What Mirtazapine Bluefish Is And What It Is Used For
Mirtazapine Bluefish belongs to a group of medicines called antidepressants. Mirtazapine Bluefish is used to treat depression.
Mirtazapine contained in Mirtazapine Bluefish may also be approved for treating other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before You Take Mirtazapine Bluefish
Do Not Take Mirtazapine Bluefish
- 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, monoamine oxidase inhibitors ( MAOIs ).
DO NOT TAKE – OR – TELL YOUR DOCTOR BEFORE TAKING Mirtazapine Bluefish:
If you have ever had a severe rash or flaky skin, blisters, and sores in your mouth after taking mirtazapine or other medicines.
Warnings And Cautions
Talk to your doctor, pharmacist, or nurse before taking Mirtazapine Bluefish.
Children and young people
Mirtazapine Bluefish should not be used to treat children and adolescents under 18 years of age. 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 Bluefish can be prescribed to patients under 18 years of age if the doctor deems it appropriate. If your doctor has prescribed Mirtazapine Bluefish to someone under 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 worsen when patients under 18 years of age use Mirtazapine Bluefish. The long-term effects of Mirtazapine Bluefish on growth, maturation, cognition, and behavioral development have not yet been established for children and adolescents under 18 years of age.
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 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 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 your behavior is changing.
Also, take special care with Mirtazapine Bluefish.
- If you have or have had any of the following conditions.→ Tell your doctor about these conditions before taking Mirtazapine Bluefish if you have not done so before.
- Cramps ( epilepsy ). If you get cramps or if your cramps come more often, stop taking Mirtazapine Bluefish and contact your doctor immediately;
- Liver disease, including jaundice. If you get jaundice, stop taking Mirtazapine Bluefish 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 Bluefish 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;
- We see 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 Bluefish 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.
- 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 symptoms described in section 4 concerning these severe skin reactions. If you have ever had a severe skin reaction, you should never be treated with this medicine again.
- If you are an older person. You may be more sensitive to the side effects of antidepressants.
Other Medicines And Mirtazapine Bluefish
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take Mirtazapine Bluefish in combination with:
- Monoamine oxidase inhibitors ( MAOIs ). Also, do not take Mirtazapine Bluefish for two weeks after stopping MAOIs . If you stop taking this medicine, do not take MAO inhibitors 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 Bluefish in combination with:
- Antidepressants such as SSRIs , venlafaxine, 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 Bluefish or Mirtazapine Bluefish, 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 Bluefish in your blood. Tell your doctor if you are using this medicine. You may need to reduce the dose of one of Mirtazapine Bluefish 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 Bluefish 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 ).In combination with this medicine, these medicines may increase the amount of Mirtazapine Bluefish in your blood. Tell your doctor if you are taking these medicines. You may need to reduce the dose of one of Mirtazapine Bluefish and increase it again when you stop taking these medicines.
- Medicines for stomach ulcers, such as cimetidine. In combination with Mirtazapine Bluefish, these may increase the amount of Mirtazapine Bluefish in your blood.
- Antiepileptic drugs such as carbamazepine and phenytoin; drugs against tuberculosis such as rifampicin. In combination with Mirtazapine Bluefish, these medicines may reduce the amount of Mirtazapine Bluefish in your blood. Tell your doctor if you are taking these medicines. You may need to increase the dose of one of Mirtazapine Bluefish and decrease it again when you stop taking these medicines.
- Drugs used to prevent blood clots, such as warfarin. This medicine 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 include certain antibiotics and antipsychotic drugs.
Mirtazapine Bluefish With Food, Drink, And Alcohol
You may become drowsy if you drink alcohol while using Mirtazapine Bluefish. It would help if you did not drink any alcohol. You can take this medicine with or without food.
Pregnancy, Breastfeeding, And Fertility
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 this medicine in pregnant women shows no increased risk. However, caution should be exercised when used during pregnancy. Tell your midwife or doctor that you are taking Mirtazapine Bluefish. 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.
If you are taking Mirtazapine Bluefish and are planning to become pregnant, ask your doctor if you should continue taking Mirtazapine Bluefish. If you are using this medicine until or just before delivery, your baby should be checked for any side effects.
Ask your doctor if you can breastfeed while using Mirtazapine Bluefish.
Driving And Using Machines
This medicine may affect your ability to concentrate or react. Make sure your ability has not been affected before driving or using machines.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects 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 Bluefish Contains Aspartame (E951)
This medicine contains 3 mg, 6 mg, and 9 mg aspartame per 15, 30, and 45 mg orodispersible tablets, respectively. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that accumulates high levels of phenylalanine in your body.
How To Take Mirtazapine Orodispersible
- Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended starting dose is 15 to 30 mg per day. Your doctor may increase the dose after a few days to the amount best for you (between 15 and 45 mg daily). 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 Bluefish
- Take this medicine at the same time each day.
- It is best to take Mirtazapine Bluefish as a single dose before bed. However, your doctor may suggest that you split the dose of Mirtazapine Bluefish – once in the morning and once before going to bed.
- Take the orodispersible tablets as follows:
- It would help if you took the tablets by mouth.
1. Do not crush the orodispersible tablet
To prevent crushing the orodispersible tablet, do not press against the tablet pocket (Figure A).
Fig. A.
2. Tear off a tablet pocket
Each blister contains six tablets separated by a perforation. Tear off a tablet pocket along the dotted line (Figure 1).
Fig. 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).
Fig. 4.
It will dissolve quickly, and you can swallow it without water.
When can you expect to start feeling better?
It usually takes 1-2 weeks before Mirtazapine Bluefish starts working, and after 2-4 weeks, you can start to feel better. It is important during the first weeks of treatment that you and your doctor talk about the effects of Mirtazapine Bluefish:
→ talk to your doctor 2 to 4 weeks after starting Mirtazapine Bluefish 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. It would help if you usually took Mirtazapine Bluefish until your depressive symptoms have been gone for 4-6 months.
If You Take More Mirtazapine Bluefish Than You Should
The most likely signs of an overdose of this medicine (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 heart rhythm) or fainting, which can be symptoms of a life-threatening condition called Torsade de Pointes.
If You Forget To Take Mirtazapine Bluefish
If you are going to take your dose once a day :
- If you forget to take this medicine, do not take the missed dose but skip it. 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 next morning dose. 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 with your usual morning and evening doses the next day.
If You Stop Taking Mirtazapine Bluefish
Only stop taking Mirtazapine Bluefish 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 Bluefish, even if your depression has subsided. If you stop taking Mirtazapine Bluefish 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 about the use of this product, ask your doctor or pharmacist.
Mirtazapine Bluefish Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them.
Stop taking this medicine and contact your doctor immediately or seek medical advice if you get any of the following serious side effects:
Uncommon: may affect less than 1 user in 100
- Feeling elated or feeling ‘high’ (mania)
Rare: may affect less than 1 in 1,000 users
- Yellowing of the whites of the eyes or the skin; 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 include unexplained high fever, sore throat, and mouth ulcer ( agranulocytosis ). In rare cases, Mirtazapine Bluefish may interfere with the production of blood cells (bone marrow depression). Some people become more susceptible to infection because Mirtazapine Bluefish can cause a temporary lack of white blood cells ( granulocytopenia ). In rare cases, Mirtazapine Bluefish 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 (eosinophils ).
- 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
- 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 rash, high body temperature, and enlarged lymph nodes (DRES’s syndrome or drug hypersensitivity syndrome).
Other possible side effects with Mirtazapine Bluefish 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 less than 1 user in 10
- Fatigue
- Dizziness
- Shaking or trembling
- Nausea
- Diarrhea
- Constipation
- Vomiting
- 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
- Lively dreams
- Confusion
- Feelings of anxiety
- Sleeping problems
- Memory problems, which in most cases went back to when the treatment was stopped
Uncommon: may affect less than 1 user in 100
- Abnormal sensation in the skin, e.g.,
- Burning
- Stinging
- Tickling or irritating ( paresthesia )
- Ant crawls
- Fainting ( syncope )
- A 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 less than 1 in 1,000 users
- Muscle twitching or contractions ( myoclonus )
- Aggression
- Stomach pain and nausea, which may indicate inflammation of the pancreas ( pancreatitis )
Has been reported: occurs in an unknown number of users
- Somnambulism
- Abnormal sensation in the mouth ( oral paresthesia )
- Swelling of the mouth ( edema of the mouth)
- Swelling of the whole body (general edema )
- Local swelling
- Severe skin reactions
- Bullous dermatitis
- Erythema multiforme
- Speech disorder
- Hyponatremia
- Improper secretion of antidiuretic hormone
- Elevated blood levels of creatine kinase
- Difficulty emptying the bladder ( urinary retention )
- Muscle pain, stiffness, weakness, darker or discolored urine ( rhabdomyolysis ).
How To Store Mirtazapine Bluefish
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton and blister after “EXP.” The expiration date is the last day of the specified month.
- This product has no special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are 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 orodispersible tablet contains 15 mg, 30 mg or 45 mg of mirtazapine.
- The other ingredients are crospovidone (type B), mannitol (E421), microcrystalline cellulose, aspartame (E951), colloidal anhydrous silica, magnesium stearate, strawberry/guarana flavor [maltodextrin, propylene glycol, artificial flavors, acetic acid, [acetic acid] ].
What The Medicine Looks Like And Contents Of The Pack
- Mouth-disintegrating tablet.
- Mirtazapine Bluefish 15 mg orodispersible tablets:
- White, round, orodispersible tablets imprinted with “36” on one side and “A” on the other side with a raised, round edge.
- Mirtazapine Bluefish 30 mg orodispersible tablets:
- White, round, orodispersible tablets imprinted with “37” on one side and “A” on the other side with a raised, round edge.
- Mirtazapine Bluefish 45 mg orodispersible tablets:
- White, round, orodispersible tablets imprinted with “38” on one side and “A” on the other side with a raised, round edge.
- 15mg & 30mg:
- Mirtazapine Bluefish orodispersible tablets are marketed in perforated unit dose blister packs of polyamide/aluminum / PVC / paper/polyester/aluminum with 6, 18, 30, 48, 60, 90, and 96 tablets.
- 45mg:
- Mirtazapine Bluefish orodispersible tablets are marketed in perforated unit dose blister packs of polyamide/aluminum / PVC / paper/polyester/aluminum with 6, 18, 30, 48, 90, and 96 tablets
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
This medicinal product is authorized under the European Economic Area under the names:
| Austria: | Mirtazapine Bluefish 15 mg / 30 mg / 45 mg orodispersible tablets |
| Denmark | Mirtazapine Bluefish 15 mg / 30 mg / 45 mg orodispersible tablets |
| France: | MIRTAZAPINE BLUEFISH 15 mg / 30 mg / 45 mg, orodispersible compresses |
| Ireland: | Mirtazapine Bluefish 15 mg / 30 mg / 45 mg orodispersible tablets |
| Iceland: | Mirtazapine Bluefish 15 mg / 30 mg / 45 mg orodispersible tablets |
| Italy: | BLUMIRTAX 15 mg / 30 mg / 45 mg compresses orodispersible |
| Norway: | Mirtazapine Bluefish 15 mg / 30 mg / 45 mg orodispersible tablets |
| Portugal: | Mirtazapine Bluefish |
| Spain: | Mirtazapine Bluefish 15 mg / 30 mg / 45 mg compresses bucodispersables |
| Sweden: | Mirtazapine Bluefish 15 mg / 30 mg / 45 mg orodispersible tablets |
| UK: | Mirtazapine 15 mg / 30 mg / 45 mg orodispersible tablets |