Mirtazapine 30mg tablets
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
- 1 What Mirtazapine tablets are and what they are used for
- 2 Before you take Mirtazapine tablets
- 3 How to take Mirtazapine tablets
- 4 Possible side effects
- 5 How to store Mirtazapine tablets
- 6 Further information
What Mirtazapine tablets are and what they are used for
Mirtazapine belongs to a group of medicines called antidepressants and is used to treat major depression.
It may take 2 to 4 weeks before you start to feel or sleep better. It is important to take Mirtazapine every day and not to stop taking it unless your doctor tells you to. If you do, your symptoms may come back.
Before you take Mirtazapine tablets
Do not take Mirtazapine
If you are allergic (hypersensitive) to mirtazapine or any of the other ingredients of Mirtazapine tablets (see section 6).
Take special care with Mirtazapine if you have or have had:
- epilepsy (seizures or fits)
- kidney or liver disease (including jaundice)
- heart disease, angina or a recent heart attack
- low blood pressure
- difficulty in passing water (urinating), which may be caused by an enlarged prostate
- eye disease, such as glaucoma
- diabetes
- psychiatric disorders such as schizophrenia or manic depression
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders 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:
- If you have previously had thoughts about killing or harming yourself.
- If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) with psychiatric conditions who were treated with an antidepressant.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Children and adolescents under 18 years of age
Mirtazapine should not be used for children and adolescents under 18 years except for patients with depression. Patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (mainly aggression, oppositional behaviour and anger) when they take this type of medicine.
Despite this, your doctor may prescribe Mirtazapine for patients under 18 because they have decided 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 of Mirtazapine concerning growth, development and cognitive and behavioural development in this age group have not yet been demonstrated.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
- Other antidepressants:
You should not take Mirtazapine tablets if you are taking other antidepressants known as Monoamine Oxidase Inhibitors (MAOIs), or in the two weeks after they have been stopped. The use of other antidepressants or medicines containing the product serotonin can lead to the development of serotonin syndrome and should be used with caution.
- Drugs for anxiety or insomnia:
Mirtazapine can increase the drowsiness caused by benzodiazepines.
- Take care when taking any of the following medicines:
- drugs used in the treatment of HIV
- antibiotics such as erythromycin or rifampicin
- antifungal agents such as ketoconazole
- nefazodone, an antidepressant
- drugs for epilepsy e.g. phenytoin or carbamazapine
- cimetidine a drug used to treat for indigestion or stomach ulcers
- drugs to prevent blood clotting e.g. warfarin
Taking Mirtazapine with food and drink
You may get drowsy if you drink alcohol while you are taking Mirtazapine. It is therefore advisable to avoid drinking any alcohol.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking this medicine, as mirtazapine should not be taken if you are pregnant, trying to become pregnant or are breastfeeding.
Driving and using machines
Mirtazapine can affect your concentration or make you less alert. When you first start taking Mirtazapine, make
sure your abilities are not affected before you drive or operate machinery.
Sugar intolerance
If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.
How to take Mirtazapine tablets
Important: only take Mirtazapine as your doctor or pharmacist tells you to. Don’t stop taking it unless your doctor tells you to.
Swallow the tablets whole without chewing, with water.
Dosage
Adults and elderly patients:
The usual starting dose is 15mg or 30mg, taken preferably in the evening. Maintenance dose is usually between 15mg and 45mg each day.
Children under 18 years old: not recommended
Patients with kidney or liver problems may be given a lower dose of Mirtazapine.
Duration of treatment
After 2 to 4 weeks, talk to your doctor about the effect the treatment has had. If you still don’t feel well, your doctor may prescribe a higher dose. After another 2 to 4 weeks talk to your doctor again.
Method and Route of Administration
Your doctor will probably advise you to take Mirtazapine as a single dose before you go to bed, as it may help you to sleep. However, your doctor may suggest you split your dose – for example one tablet in the morning, and another in the evening before you go to bed.
If you take more Mirtazapine than you should
Call a doctor straight away or go immediately to the nearest casualty department, taking the remaining tablets with you. The most likely signs of overdose are drowsiness, fast heart rate, disorientation and high or low blood pressure.
If you forget to take Mirtazapine
Do not take a double dose to make up for forgotten individual doses. Just skip that dose and take your next
one at the normal time.
Effects when treatment with Mirtazapine is stopped
Do not suddenly stop taking Mirtazapine even if your depression has lifted. If you stop suddenly, you may
feel sick, anxious or agitated. It is possible that some of your symptoms may come back.
Once you are feeling better, talk to your doctor who will tell you how to reduce the dose gradually. This will
usually be about 4 to 6 months after you start feeling better.
Possible side effects
Like all medicines, Mirtazapine can have side effects.
Please remember that it can sometimes be hard to tell the difference between some of the milder side effects and the symptoms of your depression.
Serious side effects:
If you experience any of the following events you should tell your doctor immediately:
- Signs of infection such as fever, sore throat, mouth ulcer or stomach upset. In very rare cases, people
become less resistant to infection in the first few weeks of taking Mirtazapine, as it can cause a temporary shortage of white blood cells. If you have these symptoms, your doctor will arrange a blood test to check.
Other side effects:
The following events are less serious but you may wish to discuss them with your doctor or pharmacist if they
become troublesome or last a long time:
Common (occurs in 1 to 10 in 100 users)
- Dizziness
- Headaches
- Increase in appetite and weight gain
- Drowsiness during the first few weeks of treatment
- Swollen ankles caused by fluid retention (oedema)
Uncommon (occurs in 1 to 10 in 1,000 users)
- Feeling sick
Rare (occurs in 1 to 10 in 10,000 users)
- Mania (feeling elated or emotionally ‘high’), feeling agitated or confused
- Difficulty sleeping, tiredness, nightmares, wild dreams or hallucinations
- Dry mouth, diarrhoea
- A rash or skin eruptions
- Shakiness, tremor or ‘restless legs’, muscle spasm, pains in your joints or muscles
- ‘Pins and needles’ (paraesthesia)
- Feeling dizzy or faint especially when you stand up quickly
- Increased liver enzyme levels (seen in blood tests)
- Fits (seizures or convulsions)
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Storing Mirtazapine tablets
Keep out of the reach and sight of children
Store in the original package.
Do not use after the expiry date stated on the carton or foil.
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.
Further information
What Mirtazapine tablets contain
- The active substance is mirtazapine. Each tablet contains 30mg of the active ingredient
- The other ingredients are lactose monohydrate, pregelatinised maize starch, silica (colloidal anhydrous), croscarmellose sodium and magnesium stearate.
- The film-coating contains hypromellose, macrogol 8000, titanium dioxide (E171), red iron oxide (E172) and yellow iron oxide (E172).
What Mirtazapine tablets look like and contents of the pack
Each Mirtazapine tablet is an oval, biconvex, brownish film-coated tablet.
Pack sizes are 28 tablets
Marketing Authorisation holder and manufacturer
Date of last revision: March 2008
ACTPL054
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