Beron 15 mg/30 mg Film-Coated Tablets

BERON is used in the treatment of major depressive illness.

Do not take BERON:

• If you are hypersensitive (allergic) to Mirtazapine or any of the other ingredients of BERON.
• If you are pregnant or breastfeeding.
• Do not use in children as safety and efficacy have not been established.

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 further questions, please ask your doctor or your pharmacist.
• This medicine has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

Take special care with BERON:

• Careful dosing as well as regular and close monitoring is necessary in patients with:
• epilepsy
• liver, kidney or heart problems/diseases
• low blood pressure
• diabetes
• psychoses or bipolar disorder
• treatment should be stopped if jaundice occurs
• micturition disturbances like prostate hypertrophy
• closed-angle glaucoma and raised intra-ocular pressure

Pregnancy and Breast-feeding

Safety in pregnancy and breast-feeding has not been established.

Driving and using machinery:

BERON may decrease alertness, judgement, thinking and concentration. Therefore operating machinery or driving a vehicle should be avoided during treatment.

Taking other medicines with BERON:

BERON should not be used concomitantly with or within two weeks of discontinuing a MAOI. BERON interacts with alcohol; avoid alcohol during treatment with BERON. Caution should be taken when anxiolytics and hypnotics are prescribed together with BERON. If you are pregnant or breast feeding your baby while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of BERON with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional, for advice.

Tablets should be taken orally. BERON should be given in an initial dose of 15 mg, which may be increased gradually according to clinical response. The usual effective dose lies within the range of 15 to 45 mg. Daily doses may be given as a single dose, preferably at bedtime, or in 2 equally divided doses. Changes in dose should be made at intervals of at least 1 to 2 weeks because of the long half-life. For treatment of acute depressive episodes, treatment should be continued for at least 6 months. BERON should be withdrawn gradually to reduce the risk of withdrawal symptoms. The clearance of mirtazapine may be decreased in elderly patients and in patients with renal or hepatic impairment. This should be taken into account when prescribing BERON to this category of patients.

If you take more BERON than you should:

There is no specific antidote for BERON. Treatment is symptomatic and supportive.

If you forget to take BERON:

Do not take a double dose to make up for forgotten individual doses.

BERON can have side effects. Always take BERON exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of BERON is too strong or too weak, talk to your doctor or pharmacist. In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.

Store at or below 25 °C. Protect from light and moisture. Store blisters in the original carton until required for use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets). Not all side effects reported for this medicine are included in this leaflet. Should your general health worsen while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice. KEEP OUT OF REACH OF CHILDREN.