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Indications:

Major Depressive Episodes

Contraindications:

Not to be used in: Children under 18 years of age Severe liver disease Breastfeeding Mania People who have taken a monoamine oxidase inhibitor antidepressant (MAOI) in the last two weeks.

Adverse reactions:

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect. Drowsiness Dizziness A drop in blood pressure that occurs when going from lying down to sitting or standing, which results in dizziness and lightheadedness (postural hypotension) Joint pain (arthralgia) Excessive fluid retention in the body tissues, resulting in swelling (oedema) Skin rash Sweating Tremor Disturbances of liver function Yellowing of the skin and whites of the eyes (jaundice) Disturbances in the normal numbers of blood cells in the blood Seizures (convulsions) Breast enlargement and tenderness Production of breast milk Sexual problems The side effects listed above may not include all of the side effects reported by the drug’s manufacturer.For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

Interactions:

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe. Mianserin should not be taken in combination with a monoamine oxidase inhibitor antidepressant (MAOI), eg phenelzine, tranylcypromine, isocarboxazid, or moclobemide. Treatment with mianserin should not be started until at least two weeks after stopping an MAOI. Conversely, an MAOI should not be started until two weeks after stopping mianserin. Moclobemide should not be started until at least a week after stopping mianserin. There may be an increased risk of drowsiness if other medicines that can cause drowsiness, such as the following, are taken in combination with mianserin: sedating antihistamines, eg chlorphenamine, promethazine benzodiazepines, eg diazepam, temazepam sleeping tablets, eg zopiclone strong opioid painkillers, such as morphine, codeine. Mianserin may alter the anti-blood-clotting effect of anticoagulant medicines such as warfarin. Your blood clotting time (INR) should be carefully monitored if you are taking these two medicines together. The level of mianserin in the blood may be decreased by the antiepileptic medicines phenytoin, phenobarbital and carbamazepine. This may make it less effective, so your doctor may need to prescribe a larger dose of mianserin if you are taking one of these medicines. Sibutramine is not recommended for use in combination with this medicine.

Warnings:

Depression is associated with an increased risk of suicidal thoughts, self-harm, and suicide. You should be aware that this medicine may not start to make you feel better for at least two to four weeks. However, it is important that you keep taking it in order for it to work properly and for you to feel better. If you feel your depression has got worse, or if you have any distressing thoughts or feelings, particularly about suicide or harming yourself in these first few weeks, or indeed at any point during treatment or after stopping treatment, then it is very important to talk to your doctor. This medicine may cause drowsiness and could reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won’t affect your performance. It is recommended that you avoid drinking alcohol while taking this medicine because it may enhance drowsiness. This medicine can occasionally cause your blood pressure to drop when you move from a lying down or sitting position to sitting or standing, especially when you first start taking the medicine. This may make you feel dizzy or unsteady. To avoid this try getting up slowly. If you do feel dizzy, sit or lie down until the symptoms pass. Antidepressants may cause the amount of sodium in the blood to drop - a condition called hyponatraemia. This can cause symptoms such as drowsiness, confusion, muscle twitching or convulsions. Elderly people may be particularly susceptible to this effect. You should consult your doctor if you develop any of these symptoms while taking this medicine so that your blood sodium level can be checked if necessary. You should not suddenly stop taking this medicine, as this can cause withdrawal symptoms such as nausea, vomiting, loss of appetite, headache, giddiness, chills, insomnia, restlessness or anxiety. Withdrawal symptoms are temporary and are not due to addiction or dependence on the medicine. They can usually be avoided by stopping the medicine gradually, usually over a period of weeks or months, depending on your individual situation. Follow the instructions given by your doctor when it is time to stop treatment with this medicine. During long-term treatment with this medicine your doctor may want to monitor your heart and liver function and take blood tests to monitor the levels of blood cells in your blood. (Blood tests are recommended every four weeks during the first three months of treatment.) You should let your doctor know if you get a fever, sore throat, mouth ulcers or other signs of infection while taking this medicine, as these may indicate a problem with your blood cells. You also let your doctor know if you experience symptoms such as persistent nausea and vomiting, abdominal pain, or the development of jaundice (a yellow colouring to the skin and the whites of the eyes), as these may indicate a problem with your liver. Use with caution in Elderly people Decreased liver function Decreased kidney function Heart disease People who have recently had a heart attack Defect of the heart’s electrical message pathways resulting in decreased function of the heart (heart block) Irregular heart beats (arrhythmias) Enlarged prostate gland (prostatic hypertrophy) Closed angle glaucoma History of epilepsy People at risk of seizures (fits), eg due to alcohol/drug withdrawal, brain damage, other medicines Diabetes Psychotic illness, eg schizophrenia Bipolar affective disorder (manic depression) People receiving electroconvulsive therapy (ECT) Hereditary blood disorders called porphyrias. This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately. Pregnancy and breastfeeding Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine. The safety of this medicine for use during pregnancy has not been established. It is not recommended for pregnant women, particularly in the first and third trimesters, unless considered essential by your doctor and the benefits to the mother outweigh the potential risks to the unborn baby. Seek medical advice from your doctor. This medicine may pass into breast milk. It should not be used by mothers who are breastfeeding. It is recommended that mothers who need to take this medicine should bottlefeed their babies. Seek medical advice from your doctor. Label warnings This medication is to be swallowed whole, not chewed. This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

Form:

SOLUTION FOR INJECTION

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