Mirtazapine 30mg Tablets
797*4835
Please read this leaflet carefully before you start to take this medicine.
Please keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally and you should not pass it on to others.
It may harm them, even if their symptoms are the same as yours.
In this leaflet
1. What is in your medicine and what is it used for?
2. Before you take your medicine
3. How to take your medicine
4. Possible side effects
5. Looking after your medicine
1. What is in your medicine and what is it used for?
The name of your medicine is Mirtazapine 30 mg Tablets.
Each film-coated tablet contains 30 mg mirtazapine as the active ingredient.
The inactive ingredients are: lactose monohydrate, pregelatinised maize starch, anhydrous colloidal silica, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).
Mirtazapine 30 mg Tablets are oval, brownish, film-coated tablets with a score line on both sides and marked I on one side. They are available in blister packs of 28,30, 60, 90, and 100 tablets, and containers of 28, 30,60,90,100 and 250 tablets.
The Marketing Authorisation Holder is: Waymade Pic t/a Sovereign Medical, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR. Manufacturer Responsible for Release: Delta Limited, Reykjavikurvegi 78, IS-222 Hafnarfjordur, Iceland.
Mirtazapine is one of a group of medicines called antidepressants, which are used to treat depression. It works by helping to relieve the shortage of messenger chemicals in the brain (such as serotonin and noradrenaline) which is linked to depression. Common signs of depression include feelings of worthlessness or deep sadness; difficulty with everyday tasks; sleeping too much or not being able to sleep; feeling anxious; and changes in appetite.
Ask your doctor for information if you have any questions or if your medicine seems to have no effect.
2. Before you take your medicine
You should not take this medicine, but tell your doctor first if:
• you are hypersensitive (allergic) to mirtazapine or to any of the other ingredients listed above.
Make sure your doctor knows if you suffer from:
• epilepsy (seizures or fits)
• liver disease, including jaundice, or kidney disease
• heart problems such as angina, a recent heart attack or irregularities with your heart beat
• low blood pressure
• difficulty in passing water (urine), possibly caused by an enlarged prostate gland
• eye conditions such as glaucoma
• diabetes
• psychiatric disorders such as schizophrenia or manic depression.
Taking other medicines
Tell your doctor if you are taking any other medicines, including:
• antidepressants known as monoamine oxidase inhibitors (MAOIs), whether you are taking them now or have taken any within the past two weeks
• other antidepressants, especially those known as the selective serotonin reuptake inhibitors (SSRIs), or nefazodone
• benzodiazepines, used to treat anxiety or to help you sleep, as you may feel more drowsy if both are being taken.
• HIV protease inhibitors, used in the treatment of HIV
• antifungal medicines such as fluconazole or ketoconazole, used to treat fungal infections
• carbamazepine or phenytoin, which are used to treat epilepsy
• erythromycin or rifampicin, which are used to treat infections
• cimetidine, used to treat stomach ulcers
• warfarin, an anticoagulant medicine used to thin the blood or any medicines that you can buy without a prescription.
You should avoid drinking alcohol while you are taking these tablets, as it may make you drowsy.
If you become pregnant or you are breast-feeding
Tell your doctor as soon as possible if you are being treated with Mirtazapine 30 mg Tablets and you are pregnant, you become pregnant, or if you are breast-feeding.
Driving and operating machinery
Your medicine may affect your concentration or alertness. If this happens to you, you should consider whether it is safe for you to drive or operate machinery.
Important information about one of the ingredients in your medicine
Mirtazapine 30 mg Tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking these tablets.
3. How to take your medicine
Your doctor will tell you how and when to take your medicine. Follow the instructions on the pharmacy label which should tell you how many to take in a day. If it does not or you are unsure, consult your doctor or pharmacist.
The tablets should be swallowed whole with a glass of water. Do not chew them.
Adults:
The initial dose is 15 or 30 mg, taken preferably in the evening. The maintenance dose is usually between 15 mg and 45 mg per day.
Elderly patients:
As in adults. Changes, especially increments of dosage must be made cautiously and under close supervision.
Children and adolescents (under 18 years of age):
Since the safety and efficacy of mirtazapine have not been investigated in these patients, the use is not recommended.
It is best to take your tablets just before going to bed. However, your doctor may want you to take your tablets in two doses, one in the morning and one in the evening. If the doses are not equal the larger dose should be taken in the evening.
If you have liver or kidney disease you may be prescribed a lower dose.
DATE REQUIRED: _ASAP_ DIE TYPE & NO.: 150MM X 28QMM COLOUR PAN:
Do not exceed the prescribed dose.
Mirtazapine 30 mg Tablets should start to work 1 - 2 weeks after you start taking them. If you do not feel any better your doctor may increase your dose. If there has not been any improvement after taking the maximum dose for 2 - 4 weeks your doctor may want you to stop taking the tablets.
When you are feeling better
Do not suddenly stop taking Mirtazapine 30 mg Tablets even if your depression has lifted. If you stop suddenly, you may feel sick, anxious or agitated and have headaches. It is even 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.
If you take more tablets than you should
If you take too many tablets tell your doctor at once or go to your nearest hospital casualty department. Remember to take this leaflet and the package with you to show the doctor what you have taken, whether or not there are any left.
If you forget to take your medicine
If you miss a dose do not take the missed dose. Take your next dose at the usual time. Never double-up on a dose to make up for one you have missed.
4. Possible side effects
As with all medicines Mirtazapine 30 mg Tablets can cause unwanted side effects in some patients.
If you experience any of the following side effects stop taking your tablets and tell your doctor immediately:
• sore throat
• fever
• mouth ulcers
• tiredness
• breathlessness
• bruising easily and prolonged bleeding
• fits
These are serious but rare side effects, some of which may be a sign of changes in your blood.
The following side effects are less serious, but tell your doctor if any of them becomes troublesome or lasts a long time:
• mania (feeling very happy and overactive), confusion or anxiety
• difficulty sleeping, nightmares, vivid dreams or hallucinations
• tremor (shaking), sudden muscle twitches, tingling or 'pins and needles', restless legs
• joint or muscle pain
• feeling dizzy when you stand up
• fainting
• rash
• diarrhoea
These side effects are also rare.
The following side effects are usually mild, but you should tell your doctor if they become a nuisance to you:
Common:
• increased appetite and weight gain
• sleepiness, usually occurring during the first few weeks of treatment
• dizziness
• headaches
• swollen ankles or general weight gain, caused by fluid retention Uncommon:
• nausea Rare:
• dry mouth
• weariness
Tell your doctor or pharmacist if you notice any side effects not mentioned in this leaflet, or if any side effects are bad or last a long time.
5. Looking after your medicine
Blister packs: Store in the original package. Keep the blister in the outer carton.
Container: Store in the original package. Keep the container tightly closed.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
Do not use your tablets after the expiry date shown on the label. If your tablets go out of date, or if your doctor tells you to stop taking them, please return them to the pharmacist for safe disposal. Only keep the tablets if your doctor tells you to.
Remember: These tablets have been prescribed for you by your doctor. You should not pass them on to others as they may harm them, even if their symptoms are the same as yours.
This leaflet does not contain all the available information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
The information in this leaflet applies only to Mirtazapine 30 mg Tablets.
PL 06464/2055
SOVEREIGN
mmm m f d i c a l
Date of preparation: September 2004