Remeron 30 Mg 14 Tablets ingredient mirtazapine

• Excipients: Corn starch, hydroxypropyl cellulose, magnesium stearate, colloidal silicon dioxide, lactose, hypromellose, polyethylene glycol 8000, titanium dioxide (E171), yellow iron oxide (E 172) and red iron oxide ( E 172).

Please read this INSTRUCTIONS carefully before using this medicine, as it contains important information for you.

• Keep these instructions for use. You can need to read again.

• If you have other questions, please talk your doctor or pharmacist.

• This medicine has been prescribed for you personally, please do not give it to others.

• When using this medicine, tell your doctor that you are taking this medicine when you go to a doctor or hospital.

• Follow the instructions in this manual. Do not use high or low doses other than the recommended dose for the drug.

In these Instructions for Use:

1. What is REMERON and what is it used for? 2. Cautions before using REMERON 3. How to use REMERON 4. What are the possible side effects? 5. REMERON's Storage

Headers are included.

1. What is REMERON and what is it used for?

REMERON is a member of a group of drugs known as antidepressants. REMERON is used to treat major depressive disorder (severe mental depression).

2. Cautions before using

REMERON DO NOT use REMERON in the following situations

• If you are hypersensitive to mirtazapine or any of the substances in REMERON. You should talk to your doctor immediately before taking REMERON.

• If you are using drugs that are known as monoamine oxidase inhibitors (MAOIs) and are used in the treatment of depression (mental breakdown) or have recently (in the last two weeks) used.

USE REMERON CAREFULLY The use of

antidepressant medicines for children and young people up to 24 years of age is likely to increase suicidal ideation or behavior. Therefore, especially in the beginning and in the first months of treatment, the patient should be closely monitored by both his / her family and the therapists for reasons such as unexpected behavioral changes such as unease, excessive behavior, or suicidal behavior.

REMERON is used for the treatment of major depressive disorder (severe mental depression).

For children and adolescents under 18 years of age, REMERON should not be used normally in children and adolescents under 18 years of age. At the same time, it is known that when these class drugs are used, the risk of side effects such as suicide attempts, suicidal thoughts and hostile behaviors (mostly aggression, hanging and anger) in patients under 18 years of age has increased. In spite of this, your doctor may prescribe REMERON if he or she decides that it is best for them under 18 years of age. If your doctor has written REMERON to a patient under 18, and you would like to discuss this, please contact your doctor. If REMERON is taken in patients under 18 years of age, if any of the symptoms listed above develop or deteriorate, you should consult your doctor. Also in this age group, the long-term safety effects of REMERON on growth, maturation, cognitive and behavior development have not been determined yet.

Suicidal thoughts and deterioration of your depression If you are in depression, sometimes you may have thoughts of suicide or self-harm. Since antidepressant drugs usually have to be used for two weeks or sometimes longer to show their effects, they may be even more likely when antidepressant treatment is started.

The following conditions may increase the likelihood of these thoughts occurring:

• If you have previously lost your thoughts of killing yourself or harming yourself.

• If you are a young adult. Information on clinical trials has shown that the risk of suicidal behavior increases in adults under 25 years of age who are treated with antidepressants and who have psychiatric disorders. → If you ever think of killing yourself or harming yourself, contact your doctor immediately or go to a hospital immediately.

It may be beneficial for you to find a relative or friend who can tell you that you are depressed and to suggest that they read these instructions. You can ask them to let you know if you think that depression is exacerbated or if you feel sad about the changes in your behavior.

Also, be careful when using REMERON in the following cases.

• If you have any of the following or have already: → Tell your doctor the following conditions before using REMERON if you have not already mentioned it. - seizures (sara). If you have seizures or seizures, stopREMERON

takingand contact your doctor immediately;

- liver disease, jaundice. If jaundice occurs, stop taking REMERON and

contact your doctor immediately; - kidney disease; - heart disease or blood pressure (blood pressure) drop; - schizophrenia. If psychotic symptoms, such as paranoid thoughts (in the middle, with a complete and valid evidence, the person is extremely suspicious of everything), become more frequent or intense, contact your doctor immediately; - manic depression (consecutive feelings of enthusiasm / overwork and periods of depression). If you feel enthusiasm or excessive excitement, stop taking REMERON and contact your doctor immediately; -of diabetes or other antidiabetic

you may need to adjust the dosedrugs; - eye disease, increased eye pressure (glaucoma, eye pressure); - the difficulty of urination occurs due to the growth of the prostate gland.

• If you have signs of infection such as high fever, sore throat and mouth sores (ulcers), the reason for which you do not understand. → Stop receiving REMERON and see your doctor immediately for a blood test. In rare patients, these symptoms may indicate disorders in blood cell production in the bone marrow. Although rare, these symptoms are more common after 4 çok6 weeks of treatment.

• If your age is ahead. You may be more sensitive to the side effects of antidepressants.

Please consult your doctor if these warnings are valid for you, even at any time in the past.

Using REMERON with foodusing

If you drink alcohol whileREMERON, you may feel numbness. Alcohol intake is not recommended unless you use this medicine. You can take REMERON with food or on an empty stomach.

Pregnancy

Consult your doctor or pharmacist before using the medicine. The limited experience of pregnant women in the treatment of REMERON does not indicate a risk increase. However, caution should be exercised when used in pregnancy.

If you are using REMERON and are pregnant or are planning to become pregnant, ask your doctor whether you will continue to use REMERON. If you have used REMERON until delivery or shortly before birth, your baby should be checked for possible adverse effects.

If you notice that you are pregnant during your treatment, consult your doctor or pharmacist immediately.

Breastfeeding

Consult your doctor or pharmacist before using the medicine.

When using REMERON, ask your doctor if you cannot breastfeed.

Using the machine and the machine

REMERON can affect your concentration or your attention. You should make sure that these skills are not affected before using the tool or machine.

Important information about some of the excipients contained in

REMERON REMERON film-coated tablets contain lactose. If you have been told by your doctor that you have been susceptible to certain sugars, contact your doctor before taking this medicinal product.

Use with other medications

If you are taking (or are planning to take) any of the drugs listed in the list below, tell your doctor or pharmacist.

Please inform your doctor or pharmacist if you are taking any prescription medications or have recently taken over.

Do not use REMERON with the following drugs:

• Monoamine oxidase inhibitors (MAO inhibitors). Also, do not use REMERON after two weeks have elapsed since the use of MAO inhibitors has ended. If you stop using REMERON, do not use MAO inhibitors for the next two weeks. Examples of MAO inhibitors include moclobemide, tranylcypromine (both antidepressant) and selegiline (used in Parkinson's disease).

Use REMERON with the following drugs:

• serotonin reuptake inhibitors (SSRIs), venlafaxine and L-tryptophan or triptans (used in the treatment of migraine), tramadol (an analgesic), linezolid (an antibiotic), lithium (some psychiatric diseases). used in the treatment of John's Wort - Antidepressants such as St. John's wort medications (a herbal remedy for depression). In very rare cases, REMERON alone or as a combination of these drugs and REMERON may cause serotonin syndrome. Some symptoms of this syndrome include: fever, sweating, increased heart rate, diarrhea, (uncontrolled) muscle contractions, tremors, overactive reflexes, mobility, mood changes and unconsciousness. If you have a few of these symptoms, tell your doctor immediately.

• antidepressant nefazodone. This may increase the amount of REMERON in your blood. Tell your doctor if you are taking this medicine. Reduce the dose of REMERON or when the use of nefadozon is stopped. You may need to increase the REMERON dose again.

• anxiety or insomnia drugs such as benzodiazepines; schizophrenia drugs such as olanzapine (a mental illness in which reality and reality cannot be distinguished); allergy medications such as cetirizine; severe pain medications such as morphine. If REMERON is used in combination with these drugs, it may increase sedation (drowsiness).

• infection drugs; bacterial infection drugs (such as erythromycin), yeast infection drugs (such as ketoconazole) and HIV / AIDS drugs (such as HIV-protease inhibitors) and stomach ulcer drugs (such as cimetidine). When used with REMERON, these drugs can increase the amount of REMERON in the blood. If you are taking these medications, inform your doctor. It may be necessary to increase the REMERON dose when the dose of REMERON used in combination with these drugs or when the use of these drugs is stopped.

• epilepsy (sara) drugs such as carbamazepine and phenytoin; tuberculosis drugs such as rifampicin. When used with REMERON, these drugs may reduce the amount of REMERON in the blood. If you are taking these medications, inform your doctor. When the dose of REMERON used with these drugs is increased or the combined use of the drugs is stopped, the dose of REMERON may need to be reduced.

• drugs that prevent blood clotting, such as warfarin. REMERON can increase the effects of warfarin in the blood. If you are taking this medicine, inform your doctor. In patients with warfarin and REMERON combined, it is recommended that your doctor carefully monitor your blood's blood clotting status.

Please inform your doctor or pharmacist if you are currently using any prescription or non-prescription medication or if you have recently used it.

3. How to use REMERON?

Instructions for proper use and dose / frequency of administration:instructed by

Always take REMERON exactly asyour doctor or pharmacist. If you are not sure, you should check with your doctor or pharmacist.

Generally, the starting dose of treatment is 15 or 30 mg daily. Your doctor may recommend that you increase your medication dose within a few days to reach the best dose for you (15–45 mg daily). Usually the dosage is the same for all ages. However, if you are an elderly person or you have kidney or liver failure, your doctor may adapt the dose to you.

Usually the REMERON effect will begin after 1 to 2 weeks and after 2 to 4 weeks, you can start to feel better.

Talking to your doctor about the effects of REMERON is important during the first few weeks of treatment:

→ Talk to your doctor about how the medication affects you 2 to 4 weeks after you start using REMERON.

If you still feel unwell, your doctor may prescribe a higher dose. In the case of this new dose, talk to your doctor again after 2 to 4 weeks.

Generally, you will need to use REMERON until your symptoms disappear from 4 to 6 months.

Application path and method:

→ Take REMERON at the same time every day. It is best to take REMERON as a single dose before going to bed. However, your doctor may recommend that you divide your dose of REMERON - one half in the morning and the other half before bedtime. High doses should be taken before bedtime.

Take your tablets orally. Swallow the prescribed dose of REMERON with some water or fruit juice without chewing.

If you have an impression that REMERON's effect is too strong or too weak, talk to your doctor or pharmacist.

Use in different age groups: Use in

children: REMERON should not be used normally in children and adolescents under 18 years of age. You should also be aware that the risk of suicidal thoughts, suicide attempts and hostile behavior (primarily destructive behavior, inverse behaviors and anger) is increased in young people under 18 years of age. However, if your doctor believes that this is the best treatment you can do despite all these, you can also give REMERON to patients under 18 years old. If your doctor has given REMERON to a patient under 18, and you would like to discuss it, please contact your doctor. You may need to tell your doctor that any of the above symptoms have occurred or worsened in patients under 18 years of age using REMERON. Moreover, the long-term effects of REMERON on growth, maturation, cognitive and behavioral development in this age group have not been established yet.

Use in the elderly: The recommended dose is the same as for adults. In elderly patients, dose increase should be performed under close observation to obtain a satisfactory and reliable response.

Specific Use Cases: The

clearance of mirtazapine may be reduced in patients with renal or hepatic impairment. This should be considered when prescribing REMERON in this patient group.

used more REMERON than you should use

If you→ If you or someone else has received a large amount of REMERON, call your doctor immediately.

The most common symptoms of overdose of REMERON (other than other drugs or alcohol) are dizziness, disorientation (loss of time - place consciousness) and increased number of heartbeats.

Talk to a doctor or pharmacist if you have used more than you should use from REMERON.

If you forget to use REMERON

Do not take double doses to compensate for the missed doses.

If you assume that you take your dose once a day

• If you forgot to take your REMERON dose, do not take the missed dose. Take your next dose in normal time.

If you assume that you take your dose twice a day

• If you forget to take the morning dose, take it with the evening dose.

• If you forget to take the evening dose; Do not take the dose you forget with the next morning dose; skip this and continue taking your normal morning and evening doses to your treatment.

• If you forget to take both doses, do not try to balance the forgotten tablets. Skip these doses and continue your treatment the next morning with your normal morning and evening doses.

Possible effects when treatment with REMERON is discontinued

→ Only use REMERON after consulting your doctor.

If you stop using it too early, your depression may recur. If you feel very well, talk to your doctor first. Your doctor will decide when to discontinue your treatment.

Do not stop taking REMERON suddenly even if your depression has improved. If you suddenly stop using REMERON, you may feel sick, dizzy, anxious or anxious and may have headache. These symptoms may disappear after the withdrawal is gradually. Your doctor will tell you how to reduce your dose slowly.

If you have any further questions regarding the use of this product, ask your doctor or pharmacist.

4. What are the possible side effects?

Like all medicines, REMERON can cause side effects, but these side effects are not visible to everyone.

Some side effects occur more than others. The possible side effects of REMERON are listed below and can be classified as follows;

• Very common: affects more than 1 person in 10 people

• Common: affects 1 in 10 users in 100 people

• Uncommon: 1 in 10 people in 1 person affects

• Rare: 1 in 10 people affects 1

• Very rare It affects less than 1 user in 10,000 people

• Unknown: unpredictable based on available data

Very common:

• increased appetite and body weight

• drowsiness or drowsiness

• headache

• dry mouth

Common:

• weakness

• dizziness, dizziness

• shudder or promptness shivering (tremor)

• nausea

• diarrhea

• vomiting

• hives or skin rash (exanthema)

• pain in your joints (arthralgia) or in your muscles (myalgia)

• back pain

• suddenly feeling dizzy or fainting (orthostatic hypotension) when you stand up

• due to fluid retention swelling (typically in the feet or ankles)

• fatigue

• live dreams

• confusion

• feeling uneasy

• sleep problems

Uncommon:

• exuberant or excited 'high' feeling (mania) → stop using REMERON and tell your doctor immediately.

• sensory sensation of the skin such as burning, pinching, tingling or tingling (paresthesia)

• restless legs

• faint (syncope)

• feeling of numbness in the mouth (oral hypoesthesia)

• low blood pressure

• nightmares

• feeling uneasy

• hallucinations (seeing things that are not real)Hearing

•

:

• Eyes or skin yellowing; this may suggest impaired liver function (jaundice) → stop using REMERON and tell your doctor immediately.

• muscle twitching or contraction (myoclonus)

Unknown:

• symptoms of infection such as high fever, sore throat and mouth ulcers that are not known for sudden cause (agranulocytosis) → stop using REMERON and contact your doctor for a blood test immediately. In rare cases, REMERON can cause defects in blood cell production (bone marrow suppression). Because REMERON can temporarily reduce the number of white blood cells (granulocytopenia), some people have less resistance to infection. REMERON may rarely cause red blood cells (red blood cells) and red blood cells (aplastic anemia), as well as a decrease