Active ingredient
- mirtazapine
Legal Category
POM: Prescription only medicine
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 leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL00427/0241.
Mirtazapine 15mg/ml Oral Solution
Package leaflet: Information for the user
Mirtazapine 15mg/ml Oral Solution
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet:
1. What Mirtazapine Oral Solution is and what it is used for
2. What you need to know before you take Mirtazapine Oral Solution
3. How to take Mirtazapine Oral Solution
4. Possible side effects
5. How to store Mirtazapine Oral Solution
6. Contents of the pack and other information
1. What Mirtazapine Oral Solution is and what it is used for
The full name of your medicine is Mirtazapine 15mg/ml Oral Solution. In this leaflet the shorter name Mirtazapine is used.
Mirtazapine is one of a group of medicines called antidepressants.
Mirtazapine is used to treat depressive illness in adults.
Mirtazapine will take 1 to 2 weeks before it starts working. After 2 to 4 weeks you may start feeling better. You must talk to your doctor if you do not feel better or if you feel worse after 2 to 4 weeks. More information is in section 3 heading "When can you expect to start feeling better".
2. What you need to know before you take Mirtazapine Oral Solution
Do not take Mirtazapine:
Warnings and precautions
Talk to your doctor or pharmacist before taking Mirtazapine.
Children and adolescents
Mirtazapine 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 for patients under 18 because he/she decides that this is in their best interests. If your doctor has prescribed Mirtazapine 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. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Mirtazapine 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 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:
You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
The use of Buprenorphine together with Mirtazapine can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Mirtazapine”).
Also take special care with Mirtazapine
Other medicines and Mirtazapine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Mirtazapine in combination with:
Take care when taking Mirtazapine in combination with:
Mirtazapine with food and alcohol
You may get drowsy if you drink alcohol while you are taking Mirtazapine.
You are advised not to drink any alcohol.
You can take Mirtazapine with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, 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 Mirtazapine administration to pregnant women does not indicate an increased risk. However, caution should be exercised when used during pregnancy.
If you use Mirtazapine until, or shortly before birth, your baby should be supervised for possible adverse effects.
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.
Driving and using machines
Mirtazapine can affect your concentration or alertness. Make sure these abilities are not affected before you drive or operate machinery. If your doctor has prescribed Mirtazapine for a patient under 18 years make sure the concentration and alertness is not affected before participation in traffic (e.g. on bicycle).
Mirtazapine Oral Solution contains:
3. How to take Mirtazapine Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
How much to take
The recommended 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 adapt the dose.
When to take Mirtazapine
It is best to take Mirtazapine as a single dose before you go to bed. However your doctor may suggest to split your dose of Mirtazapine
Take the Oral Solution as follows
Take the oral solution orally. Drink your prescribed dose of Mirtazapine oral solution in a glass or cup mixed with some water. Mirtazapine oral solution comes with a measuring syringe to help you measure your dose.
Measuring your dose
1. Open the bottle: press the cap and turn it anticlockwise (Figure 1).
2. Insert the syringe adaptor into the bottle neck (Figure 2).
3. Take the syringe and put it in the adaptor opening (Figure 3).
4. Turn the bottle upside down (Figure 4).
5. Fill the syringe with a small amount of solution by pulling the piston down (Figure 4A). Then push the piston upward in order to remove any possible bubbles (Figure 4B). Finally, pull the piston down to the graduation mark corresponding to the quantity in millilitres (ml) prescribed by your doctor. The top flat edge of the piston should be in line with the graduation mark you are measuring to (Figure 4C).
6. Turn the bottle the right way up (Figure 5A).
7. Remove the syringe from the adaptor (Figure 5B).
8. Put the end of the syringe into your mouth and push the piston slowly back in to take the medicine. Alternatively, dispense the solution onto a spoon or into a small glass of water and take your medicine straight away.
9. Wash the syringe with water and let it dry before you use it again (Figure 6).
10. Close the bottle with the plastic screw cap - leave the syringe adaptor in the bottle.
When can you expect to start feeling better
Usually Mirtazapine 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:
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 until your symptoms of depression have disappeared for 4 to 6 months.
If you take more Mirtazapine than you should
The most likely signs of an overdose of Mirtazapine (without other medicines or alcohol) are drowsiness, disorientation and increased heart rate. The symptoms of a possible overdose may include changes to your heart rhythm (fast, irregular heartbeat) and/or fainting which could be symptoms of a life-threatening condition known as Torsade de Pointes.
If you forget to take Mirtazapine
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
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, even when your depression has lifted. If you suddenly stop taking Mirtazapine 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, 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 tell your doctor immediately.
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data):
Other possible side effects with mirtazapine are:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Not known (frequency cannot be estimated from the available data):
Additional side effects in children and adolescents
In children under 18 years the following adverse events were observed commonly in clinical trials: significant weight gain, hives and increased blood triglycerides.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Mirtazapine Oral Solution
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 the bottle. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not use the bottle more than 6 weeks after opening. Make a note of the date of opening of the bottle.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Mirtazapine Oral Solution contains
What Mirtazapine Oral Solution looks like and contents of the pack
This medicine is a clear, colourless to pale yellow solution
It comes in a brown glass bottle holding 66ml of solution with a 3ml purple syringe and adaptor.
Marketing Authorisation Holder and Manufacturer
This leaflet was last revised in 12/2020.
Rosemont House, Yorkdale Industrial Park, Braithwaite Street, Leeds, Yorkshire, LS11 9XE
+44 (0)113 244 1400
+44 (0)800 919 312
+44 (0)113 245 3567
+44 (0)7836 557 879