Mianserin 10mg 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
1. What Mianserin is and what it is used for
2. Before you take Mianserin
3. How to take Mianserin
4. Possible side effects
5. How to store Mianserin
6. Further information
OWHAT MIANSERIN IS AND WHAT IT IS USED FOR
• Mianserin belongs to a group of drugs known as antidepressants • Mianserin is used to treat depression.
BEFOREYOUTAKE MIANSERIN
Do NOT take Mianserin if you:
• are allergic (hypersensitive) to mianserin hydrochloride or any of the other ingredients of this medicine
• are taking monoamine oxidase inhibitors (MAOIs), or have stopped taking them during the past 14 days
• have severe liver problems • suffer from mania (a mood disorder characterised by high levels of excitement and activity)
• are under the age of 18 years • have a hereditary problem of galactose intolerance, Lapp lactose deficiency or glucose malabsorption.
Take special care with Mianserin 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 adults aged less than 25 years 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.
Tell your doctor before you start to take this medicine if you:
• have recently had a heart attack or have any other heart problems • have diabetes • have glaucoma (loss of vision due to abnormally high pressure in the eye)
• have problems with your
kidneys, liver or prostate gland • are elderly you may experience agitation, confusion, and a fall in blood pressure on standing up which causes dizziness,
light-headedness or fainting have suicidal thoughts suffer from epilepsy or have brain damage
have a tumour of the adrenal gland (phaeochromocytoma) have a withdrawal from alcohol or any anticonvulsive drugs. Other important information you should remember while taking this medicine:
You may not notice an improvement in your depression immediately. It may take 2-4 weeks for Mianserin to have an effect
Tell your doctor or dentist you are taking Mianserin if you are to have surgery which requires an anaesthetic. If you are given an anaesthetic while you are taking Mianserin, the two drugs may make your blood pressure drop or alter your heart rate You may have to have regular blood tests during the first few months of your treatment to monitor your liver and blood If you see another doctor or visit a hospital, remember to tell them what medicines you are already taking.
Taking other medicines DO NOT take Mianserin Tablets in combination with or if you have taken within the last 14 days:
• antidepressants known as MAOI's e.g. moclobemide or phenelzine.
Tell your doctor if you are due to start taking moclobemide as it should not be started until at least 1 week after stopping Mianserin.
Talk to your doctor if you are taking any of the following:
• antiepileptics e.g. phenytoin, carbamazepine or barbiturates e.g. phenobarbital, primidone
• drugs to stop your blood clotting e.g. warfarin
• drugs to lower your blood pressure e.g. bethanidine, clonidine, diazoxide, hydralazine, guanethidine, nitroprusside or propranolol (your doctor may want to check your blood pressure more often if you are taking these medicines)
• antihistamines (for allergies and hayfever)
• sublingual nitrates (tablets placed under the tongue to treat chest pain)
• apraclonidine or brimonidine (for glaucoma)
• sibutramine (for weight reduction)
• artemether with lumefantrine (for malaria)
• antimuscarinic drugs
• anxiolytic or sedative drugs e.g. diazepam
• hypnotic drugs (e.g. zopiclone)
• antipsychotics (drugs used for mental illness).
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Important information about some of the ingredients of Mianserin
• Patients who are intolerant to lactose should note that MianserinTablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Taking Mianserin with food and drink
• DO NOT drink alcohol while you are taking these tablets as it may increase the sedative effects of these tablets.
Pregnancy and breast-feeding
• Mianserin is not recommended if you are pregnant, planning to become pregnant or are breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
• Mianserin may cause drowsiness during the day. If affected, DO NOT drive or operate machinery.
Always take Mianserin exactly as your doctor has told you.You should check with your doctor or pharmacist if you are not sure.The tablets should be swallowed whole preferably with a glass of water. The usual dose is:
• Adults:
Initially 30 - 40 mg a day either in divided doses or as a single dose at bedtime.Your doctor may increase this gradually if necessary.The maintenance dose range is usually 30 mg to 90 mg a day.
• Elderly:
If you are elderly, your doctor may give you a lower dose than those mentioned above.
• Children and Adolescents (below 18 years old): Mianserin should not be used for children and adolescents under 18 years.
If you take more Mianserin than you should
If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.
caused by a fall in blood pressure when you stand up from a sitting or lying position
• oedema (water retention)
• joint problems such as polyarthropathy, arthralgia (joint pain), arthritis
• skin rash
• sweating
• shaking
• psychiatric disorders such as paranoid delusions
• sexual problems
• withdrawal symptoms in adults and babies whose mothers received similar drugs during pregnancy.
An overdose may cause nausea (feeling sick), vomiting (being sick), dry mouth, abnormally large or small pupils, involuntary eye movements, dizziness, lack of coordination, difficulty moving, drowsiness, convulsions (fits) or coma.You may also experience abnormally fast or slow heartbeats and an increase or decrease in blood pressure. Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
The following side effects have also been reported and occur more in elderly patients:
• bone marrow depression (an impairment in blood cell production which can result in anaemia and reduced ability to fight infection and bruising or bleeding)
• hyponatraemia (low blood levels of sodium), which can cause tiredness and confusion, muscle twitching, fits or coma
• blood disorders including leucopenia, agranulocytosis and aplastic anaemia - reduction in the number of red or white blood cells, which causes weakness, bruising or makes infections more likely.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
If you forget to take Mianserin
If you forget to take a dose at the right time, take it as soon as you remember. If it is almost time to take the next dose, wait until then and then carry on as before. DO NOT take a double dose to make up for a forgotten dose.
If you stop taking Mianserin
DO NOT stop taking Mianserin without talking to your doctor first, even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
POSSIBLE SIDE EFFECTS
Like all medicines, Mianserin can cause side effects, although not everybody gets them.
If the following happens, stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital:
• an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).
This is a very serious but rare side effect.You may need urgent medical attention or hospitalisation.
Mianserin can occasionally cause serious side effects.These include:
• fits
• jaundice (your skin and whites of you r eyes may become yellow)
• feeling elated or over-excited
• fever and a sore throat and mouth.
If you have any of these symptoms tell your doctor immediately.
The following side effects are brief, mild and go away over time or if the dose is reduced.These include:
• blurred vision
• dry mouth
• constipation.
The following side effects have also been reported:
• breast changes (breast enlargement in men, tender nipples, milk production)
• liver problems
• dizziness and feeling faint,
Keep out of the reach and sight of children.
You should keep MianserinTablets in a cool, dry place, away from light. Keep them in the pack they came in. Do not put them into another container.
Do not use Mianserin after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month.
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.
What MianserinTablets contain:
• The active ingredient is mianserin hydrochloride
• The other ingredients are lactose, maize starch, povidone, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, isopropyl alcohol, opadry whiteY-1-7000B, titanium dioxide (El71), indigo carmine (E132), purified water.
What MianserinTablets look like
and contents of the pack:
• Mianserin 10 mg Tablets are white, biconvex, film-coated tablets.They are marked 'MSN 10' on one side and twin triangle logo on reverse
• Mianserin 30 mg Tablets are white, biconvex, film-coated tablets.They are marked 'MSN 30' on one side and twin triangle logo on reverse.
• MianserinTablets are available in pack sizes of 28, 50, 100, 250 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder: Teva UK Limited, Eastbourne, BN22 9AG.
Company responsible for manufacture:
TEVA Pharmaceutical Works Private Limited Company, 4042 Debrecen, Pallagi ut 13, Hungary. This leaflet was last revised: January 2012
TEVA UK LIMITED
39956-A