POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL 18909/0141, PL 18909/0145, PL 18909/0140.
Mirtazapine 15 mg, 30mg, 45mg Tablets (Arrow)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Mirtazapine 15mg, 30mg and 45mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What Mirtazapine is and what it is used for
2. Before you take Mirtazapine Film-coated Tablets
3. How to take Mirtazapine Film-coated Tablets
4. Possible side effects
5. How to store Mirtazapine Film-coated Tablets
6. Further information
1.WHAT MIRTAZAPINE IS AND WHAT IT IS USED FOR
Mirtazapine is one of a group of medicines called antidepressants.
Mirtazapine Tablets are used to treat depressive illness.
2. BEFORE YOU TAKE MIRTAZAPINE FILM-COATED TABLETS
Do not take Mirtazapine Tablets:
Take special care with Mirtazapine Tablets:
Use in children and adolescents under 18 years of age
Mirtazapine Tablets should normally not be used for children and adolescents under 18 years because efficacy was not demonstrated. Also, you should know that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Despite this, your doctor may prescribe Mirtazapine Tablets for patients under 18 because he/she decides that this is in their best interests.
If your doctor has prescribed Mirtazapine Tablets for a patient under 18 and you want to discuss this, please go back to your doctor.
You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 are taking Mirtazapine Tablets. The long term safety effects related to growth and development in this age group have not yet been demonstrated. In addition, significant weight gain has been observed in this age category more often when treated with Mirtazapine Tablets compared with adults.
Thoughts of suicide and worsening of your depression
If you are depressed you can sometimes have thoughts of harming or killing yourself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
Also take special care with Mirtazapine Tablets
Taking other medicines
Tell your doctor or pharmacist if you are taking (or plan to take) any of the medicines in the following list.
Please also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Do not take Mirtazapine Tablets in combination with:
Take care when taking Mirtazapine Tablets in combination with:
Taking Mirtazapine Tablets with food and drink
You may get drowsy if you drink alcohol while you are taking Mirtazapine Tablets. You are advised not to drink any alcohol.
You can take Mirtazapine Tablets with or without food.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Limited experience with mirtazapine administration to pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy.
Make sure your midwife and/or doctor knows you are on Mirtazapine Tablets. When taken during pregnancy, similar drugs (SSRIs) may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your baby you should contact your midwife and/or doctor immediately.
If you are taking Mirtazapine Tablets and you become pregnant or you plan to get pregnant, ask your doctor whether you may continue taking Mirtazapine Tablets.
If you use Mirtazapine Tablets until, or shortly before birth, your baby should be supervised for possible adverse effects.
Ask your doctor whether you can breast-feed, while taking Mirtazapine Tablets.
Driving and using machines
Mirtazapine Tablets can affect your concentration or alertness.
Make sure these abilities are not affected before you drive or operate machinery.
Important information about some of the ingredients of Mirtazapine Tablets
Mirtazapine Tablets contain 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 15mg tablets also contain sunset yellow FCF (E-110) which can cause allergic reactions including asthma.
3. HOW TO TAKE MIRTAZAPINE FILM-COATED TABLETS
Always take mirtazapine exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
How much to take
The usual starting dose is 15 or 30 mg every day.
Your doctor may advise you to increase your dose after a few days to the amount that is best for you (between 15 and 45 mg per day). The dose is usually the same for all ages.
However, if you are an elderly person or if you have renal or liver disease, your doctor may prescribe a lower dose.
When to take Mirtazapine Tablets
When can you expect to start feeling better
Usually Mirtazapine Tablets will start working after 1 to 2 weeks and after 2 to 4 weeks you may start to feel better.
It is important that, during the first few weeks of the treatment, you talk with your doctor about the effects of Mirtazapine Tablets:
If you still don’t feel better, your doctor may prescribe a higher dose. In that case, talk to your doctor again after another 2 to 4 weeks.
Usually you will need to take Mirtazapine Tablets until your symptoms of depression have disappeared for 4 to 6 months.
If you take more Mirtazapine Tablets than you should
The most likely signs of an overdose of Mirtazapine Tablets (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate.
If you forget to take Mirtazapine Tablets
If you are supposed to take your dose once a day
If you are supposed to take your dose twice a day
If you stop taking Mirtazapine Tablets
If you stop too early, your depression might come back.
Once you are feeling better, talk to your doctor. Your doctor will decide when treatment can be stopped.
Do not suddenly stop taking Mirtazapine Tablets, even when your depression has lifted. If you suddenly stop taking Mirtazapine Tablets you may feel sick, dizzy, agitated or anxious, and have headaches. These symptoms can be avoided by stopping gradually. Your doctor will tell you how to decrease the dose gradually.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, mirtazapine can cause side effects, although not everybody gets them.
Some side effects are more likely to occur than others.
The possible side effects of Mirtazapine Tablets are listed below and can be divided as:
Tell your doctor and stop taking mirtazapine immediately if you notice any of the following side effects :
If you have any thoughts of suicide or harming yourself whilst taking this medicine, you should contact your doctor immediately (see also Section 2 – Before you take).
In children under 18 years the following adverse events were observed commonly in clinical trials: significant weight gain, hives and increased blood triglycerides.
If any of the side effects listed above get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MIRTAZAPINE FILM-COATED TABLETS:
Keep out of the reach and sight of children.
Do not use Mirtazapine Tablets after the expiry date which is stated on the blister and carton after EXP:. The expiry date refers to the last day of that month.
Store in the original package. Keep the blister in the outer carton.
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.
6. FURTHER INFORMATION
What Mirtazapine Tablets contain:
What Mirtazapine Tablets look like and contents of the pack:
Your medicine is in the form of film-coated tablets.
Mirtazapine Tablets are available in blisters of:
15mg: 14, 28, 30, 56, 60, 70, 90 and 100 tablets.
30mg: 14, 20, 28, 30, 50, 56, 60, 70, 90, 100, 200 and 500 tablets
45mg: 14, 20, 28, 30, 50, 56, 70, 100, 200 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
This leaflet was last approved in: 03/2012.