10 mg, 30 mg, 60 mg tablets
mianserin hydrochloride
What Mianserin Mylan is and what it is used for
Mianserin Mylan contains the active substance mianserin hydrochloride. Mianserin hydrochloride belongs to a group of medicines called antidepressants which are used to treat various forms of depression.
Mianserin helps to amplify the signals in the brain of certain neurotransmitters and thus affects depression.
Mianserin hydrochloride contained in Mianserin Mylan 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 using Mianserin Mylan
Do not use Mianserin Mylan:
- if you are allergic to mianserin hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- if you have mania (overactive state)
- if you are also being treated with MAOIs (eg moclobemide, linezolid), see section 2 “Other medicines and Mianserin Mylan”.
Warnings and cautions
Talk to your doctor or pharmacist before using Mianserin Mylan if you:
- have impaired liver or kidney function
- is older than 60 years
- have epilepsy
If you get an infection with symptoms such as fever with severe general condition or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.
You who are depressed and/or suffer from worry/anxiety 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 and/or suffering from anxiety. 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.
Children and young people
Mianserin Mylan should not be used in the treatment of 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, Mianserin Mylan can be prescribed by a doctor to patients under the age of 18, if the doctor deems it necessary. 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.
Other medicines and Mianserin Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Mianserin Mylan can affect or be affected if taken at the same time as certain medicines. These are:
- MAO inhibitors (eg moclobemide and linezolid). Treatment with MAOIs should be avoided due to the risk of serotenergic syndrome. If you have been treated with irreversible MAOIs , at least 14 days should pass before you are treated with Mianserin Mylan. Similarly, two weeks should elapse before patients treated with Mianserin Mylan are treated with irreversible MAOIs . If you have been treated with reversible MAOIs with a short half-life (eg moclobemide), you can use Mianserin Mylan after 24 hours.
- drug for disorders of the heart rhythm ( quinidine ), this combination should be avoided.
- blood-thinning drugs ( warfarin ), may require a dose adjustment.
- epilepsy drugs ( phenytoin , phenobarbital and carbamazepine), concomitant treatment results in lower plasma levels of mianserin.
- combination with neuroleptics should be avoided.
- other antidepressant drugs, may inhibit each other ‘s metabolism .
Mianserin Mylan with alcohol
Alcohol should be avoided during treatment with Mianserin Mylan.
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.
There is a risk that the fetus is affected. Therefore, always consult a doctor before using Mianserin Mylan during pregnancy.
It is not known if Mianserin Mylan passes into breast milk. Therefore, consult a doctor, who will assess whether it may be appropriate to refrain from breastfeeding.
Driving and using machines
During treatment with Mianserin Mylan, some people may be less able to react. This should be taken into account when sharper attention is required, eg when driving a car.
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.
How to use Mianserin Mylan
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is determined by the doctor, who adjusts it individually for you.
The recommended dose for adults is 1-3 tablets of 30 mg per day. For the elderly, treatment is usually started with a maximum of 1 tablet of 30 mg per day.
After starting treatment, it can take up to a couple of weeks before you feel better. Some may even feel worse in the beginning. It is therefore very important that you follow the doctor’s prescription and do not interrupt the treatment or change the dose other than on the doctor’s advice. Once the full effect is achieved, treatment generally needs to be continued for at least 3 months or longer, usually 6 months.
The tablets should be swallowed whole, as the contents taste bad. The 60 mg tablet has a scoreline. The notch is not intended for splitting the tablet.
If you use more Mianserin Mylan than you should
Symptoms of overdose include effects on the brain, possible unconsciousness, seizures, rapid or slow heartbeat, blocking of the heartbeat, irregular heartbeat, drop in blood pressure, or increase in blood pressure.
If you forget to use Mianserin Mylan
Do not take a double dose to make up for a forgotten tablet.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you stop taking Mianserin Mylan
Depression can return if you stop taking Mianserin Mylan too suddenly. The risk of this decreases if dose one is instead lowered slowly. However, never change the dose other than on the advice of a doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Decreased number of white blood cells that may be due to disturbed production in the bone marrow is a serious but rare side effect. Symptoms may occur approximately 4-6 weeks after starting treatment with Mianserin Mylan. If you get a fever, sore throat, or other signs of infection, you should contact your healthcare provider so that blood samples can be taken.
Thoughts of harming oneself or committing suicide have been reported, although this is unusual. If you feel worse mentally, you should contact healthcare immediately.
Hepatic dysfunction is another rare side effect of Mianserin Mylan treatment. One symptom is so-called jaundice (you turn yellow in the eyes). If you get such symptoms, treatment should be stopped after contact with healthcare.
If you get cramps (a rare side effect) from the medication, the treatment should be stopped.
Other side effects:
Common (may affect up to 1 in 10 people): Drowsiness, which usually disappears within a week.
Uncommon (may affect up to 1 in 100 people): Weight gain.
Rare (may affect up to 1 in 1,000 people): Low blood pressure, dizziness, fainting, hyperactive state (mania), skin rash, joint problems, fluid retention ( edema ), breast enlargement in men, and crawling.
Abnormal sensations have been reported during treatment with mianserin.
How to store Mianserin Mylan
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 after EXP. 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 package and other information
Content declaration
- The active substance is mianserin hydrochloride 10 mg, 30 mg and 60 mg respectively.
- The other ingredients are microcrystalline cellulose, anhydrous calcium hydrogen phosphate, maize starch, magnesium stearate, anhydrous colloidal silica, hypromellose, macrogol 400, titanium dioxide (dye E 171), talc.
What the medicine looks like and contents of the pack
Appearance:
10 mg: white, film-coated, arched, diameter 6 mm, marked “MI 10” and “G”.
30 mg: white, film-coated, curved, diameter 8 mm, marked “MI 30” and “G”.
60 mg: white, film-coated, oval with a notch, 8×16 mm, marked “MI / 60” and “G”.
Pack sizes:
10 mg: 90 pcs and 90×1 pcs in a pressure pack, 250 pcs in a plastic jar.
30 mg: 30 pcs, 100 pcs, 30×1 pcs and 100×1 pcs in a pressure pack, 250 pcs in a plastic jar.
60 mg: 30 pcs and 30×1 pcs in a pressure pack.
Marketing Authorisation Holder
Mylan AB
Box 23033
104 35 Stockholm