Modipran Capsules

MODIPRAN 20 CAPSULES contains fluoxetine, which belongs to a group of medicines called antidepressants. MODIPRAN 20 CAPSULES is used for the treatment of:

• Major depressive disorders.
• Obsessive - compulsive disorder.
• An eating disorder called bulimia nervosa.

Do not take MODIPRAN 20 CAPSULES:

• If you are hypersensitive (allergic) to fluoxetine or any of the other ingredients of MODIPRAN 20 CAPSULES (listed in section 6).
• If you suffer from severe kidney failure.
• If you are on antidepressant medicine called monoamine oxidase inhibitors (MAOIs), e.g. phenelzine, tranylcypromine and selegiline, since serious or even fatal reactions may occur. Treatment with MODIPRAN 20 CAPSULES should only be started at least 2 weeks after stopping the MAOI. Do not take any MAOIs for at least 5 weeks after you stop taking MODIPRAN 20 CAPSULES. If MODIPRAN 20 CAPSULES has been prescribed for a long period and/or at a high dose, a longer interval needs to be considered by your doctor.
• If you are taking linezolid (an antibiotic used to treat bacterial infections).
• If you are taking metoprolol (a medicine used in heart failure).
• If you are taking pimozide (a medicine used in Tourette’s syndrome).
• If you or your child is younger than 18 years of age.

Warnings and precautions:

Take special care with MODIPRAN 20 CAPSULES:

• Stop taking MODIPRAN 20 CAPSULES if you experience a combination of the following symptoms: muscle spasms, muscle stiffness, irritability, agitation, sweating, diarrhoea, confusion, disorientation, unusually increased reflexes, tremor, rigidity, incoordination and fever. These symptoms could be indicative of a potentially life - threatening condition called serotonin syndrome.
• Treatment with MODIPRAN 20 CAPSULES should be discontinued if you develop a rash or allergic reaction (characterised by itching, swollen lips or face or shortness of breath).
• If you experience worsening of your depression and/or the emergence of suicidal ideation and behaviour, immediately inform your doctor.
• 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 younger than 25 years with psychiatric conditions who were treated with an antidepressant (see “Thoughts of suicide and worsening of your depression or anxiety disorder”).
• If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away (see “Thoughts of suicide and worsening of your depression or anxiety disorder”).
• If you suffer from any heart dysfunction.
• Do not stop taking your medicine without consulting your doctor. The frequency of taking MODIPRAN 20 CAPSULES should be decreased slowly.
• Inform your doctor of any of the following:
• If you suffer from epilepsy or fits. Treatment with MODIPRAN 20 CAPSULES should be stopped if seizures occur for the first time, or if there is an increase in the seizure frequency (if you have a previous diagnosis of epilepsy). You should not take MODIPRAN 20 CAPSULES if you have unstable epilepsy. If your epilepsy is controlled, your doctor should monitor you carefully.
• If you are receiving electroconvulsive therapy (ECT).
• If you suffer from any liver or kidney disease.
• If you are underweight.
• If you suffer from high blood sugar. MODIPRAN 20 CAPSULES may alter your blood sugar levels. Your doctor may need to adjust your dose of insulin or other antidiabetic medicine.
• If you have a history of bleeding disorders or you develop unusual bruising and purple or red - brown spots (pin - point bleeds) visible through the skin or bleeding from any other part of the body, or if you are pregnant (see “Pregnancy and breastfeeding”).
• If you are taking any medicine that thins your blood (see “Other medicines and MODIPRAN 20 CAPSULES”).
• If you are starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of MODIPRAN 20 CAPSULES may make this worse.
• If you suffer from Parkinson’s disease.
• If you suffer from glaucoma (increased pressure in your eye).
• If you have a history of mental illness known as mania or hypomania. Treatment with MODIPRAN 20 CAPSULES should be stopped if you enter a manic phase (characterised by unusual and rapid changing ideas or inappropriate happiness and excessive physical activity).
• If you are taking tamoxifen (a medicine used to treat breast cancer). MODIPRAN 20 CAPSULES may cause symptoms of sexual dysfunction: See section 4. In some cases, these symptoms have continued after stopping treatment.

Do not share medicines prescribed for you with any other person. Always take MODIPRAN 20 CAPSULES exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Major depressive disorders:

Adults and elderly patients: 20 mg daily, preferably in the morning.

Obsessive - compulsive disorder:

Adults: 20 mg – 60 mg daily.

Bulimia nervosa (eating disorder):

Adults: 60 mg daily. Caution is advised in elderly: dosages above 20 mg daily are not recommended. Hepatic/concurrent diseases: A lower or less frequent dose will be given to you if you suffer from liver disease or other diseases. Your doctor will tell you how long your treatment with MODIPRAN 20 CAPSULES will last. If you have the impression that the effect of MODIPRAN 20 CAPSULES is too strong or too weak, tell your doctor or pharmacist. Your doctor will help you when you need to change your dose. The dose should be increased/decreased carefully to ensure that you receive the lowest effective dose. You may not feel better immediately when you first start taking your medicine for depression. This is usual because an improvement in depressive symptoms may not occur until after the first few weeks.

If you take more MODIPRAN 20 CAPSULES than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Symptoms of overdose include heart problems (such as an irregular heartbeat and heart attack), lung problems, drowsiness, tremor, rapid, uncontrollable movements of the eyes, nausea, vomiting, agitation, restlessness, seizures and signs of altered central nervous system status ranging from excitation to coma.

If you forget to take MODIPRAN 20 CAPSULES

Do not take a double dose to make up for the forgotten individual doses. Continue to take the next dose at the usual time. If you have trouble remembering when to take MODIPRAN 20 CAPSULES, ask your pharmacist for some hints.

DO NOT STOP TAKING MODIPRAN 20 CAPSULES WITHOUT CONSULTING YOUR DOCTOR.

If you stop taking MODIPRAN 20 CAPSULES do not stop taking MODIPRAN 20 CAPSULES without asking your doctor first, even when you start to feel better. It is important that you keep taking MODIPRAN 20 CAPSULES. Make sure you do not run out of capsules. You may notice the following effects (withdrawal symptoms) when you stop taking MODIPRAN 20 CAPSULES: Dizziness; tingling feelings like pins and needles; headache; sleep disturbances (intense dreams, inability to sleep); unusual tiredness or weakness; tremor (shakiness); feeling confused; feeling agitated; feeling anxious; nausea/vomiting (feeling sick or being sick). When stopping MODIPRAN 20 CAPSULES, your doctor will help you to reduce your dose slowly over one or two weeks – this should help reduce the chance of withdrawal effects. Most people find that any symptoms on stopping MODIPRAN 20 CAPSULES are mild and disappear within a few weeks.

MODIPRAN 20 CAPSULES can have side effects. Not all side effects reported for MODIPRAN 20 CAPSULES are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MODIPRAN 20 CAPSULES, please consult your health care provider for advice.

If any of the following happens, stop taking MODIPRAN 20 CAPSULES and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to MODIPRAN 20 CAPSULES. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Suicidal behaviour (thoughts of suicide or harming yourself) (see section 2).
• A reaction to the medicine causing increased levels of serotonin in your body known as serotonin syndrome (including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness (see section 2)).
• Unexplained bleeding or bruising more easily than normal.
• Frequent infections, such as fever, severe chills, sore throat or mouth ulcers.
• Stroke. Symptoms can include collapse, numbness or weakness of the arms or legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech.
• Inappropriate antidiuretic hormone secretion (a condition where your body retains too much water, resulting in weakness, drowsiness, nausea and vomiting, cramps or tremors, confusion or coma).
• Fits (seizures).
• Changes in the way your heart beats, for example, if you notice it beating faster than normal or skipping beats.

MODIPRAN 20 CAPSULES can have side effects. Not all side effects reported for MODIPRAN 20 CAPSULES are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking MODIPRAN 20 CAPSULES, please consult your health care provider for advice.

If any of the following happens, stop taking MODIPRAN 20 CAPSULES and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of your hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to MODIPRAN 20 CAPSULES. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Suicidal behaviour (thoughts of suicide or harming yourself) (see section 2).
• A reaction to the medicine causing increased levels of serotonin in your body known as serotonin syndrome (including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness (see section 2)).
• Unexplained bleeding or bruising more easily than normal.
• Frequent infections, such as fever, severe chills, sore throat or mouth ulcers.
• Stroke. Symptoms can include collapse, numbness or weakness of the arms or legs, headache, dizziness and confusion, visual disturbance, difficulty swallowing, slurred speech and loss of speech.
• Inappropriate antidiuretic hormone secretion (a condition where your body retains too much water, resulting in weakness, drowsiness, nausea and vomiting, cramps or tremors, confusion or coma).
• Fits (seizures).
• Changes in the way your heart beats, for example, if you notice it beating faster than normal or skipping beats.

• Store at or below 25 °C in the original container. Protect from light.

• Keep the blister strips in the carton until required for use.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

• Do not use after the expiry date stated on the container/carton.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).