Modipran Dispersible Tablets

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

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

Do not take MODIPRAN TABLETS:

• If you are hypersensitive (allergic) to fluoxetine or any of the other ingredients of MODIPRAN TABLETS (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 TABLETS. If MODIPRAN TABLETS 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 TABLETS:

• Stop taking MODIPRAN TABLETS 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 TABLETS 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 TABLETS should be decreased slowly.

Inform your doctor of any of the following:

• If you suffer from epilepsy or fits. Treatment with MODIPRAN TABLETS 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 TABLETS 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 TABLETS 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 TABLETS”).
• If you are starting to feel restless and cannot sit or stand still (akathisia). Increasing your dose of MODIPRAN TABLETS 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 TABLETS 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 TABLETS may cause symptoms of sexual dysfunction: See section 4. In some cases, these symptoms have continued after stopping treatment.

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 you first start taking antidepressants. These medicines usually take about two weeks or sometimes longer to work. In that time, you may be more likely to think like this. 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.

Children and adolescents

MODIPRAN TABLETS is not intended for use in children under the age of 18 years.

Other medicines and MODIPRAN TABLETS

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines).

Do not take MODIPRAN TABLETS with:

• MAOIs e.g. phenelzine, tranylcypromine and selegiline (used to treat depression). MODIPRAN TABLETS should only be started at least 2 weeks after stopping an irreversible, non-selective MAOI. Do not take any irreversible non-selective MAOIs for at least 5 weeks after you stopped taking MODIPRAN TABLETS.
• Metoprolol (a medicine used to treat high blood pressure, heart failure and angina).

Tell your doctor if you are taking:

• Tamoxifen (used to treat breast cancer).
• Mequitazine, cyproheptadine (antihistamines used for allergies).
• Medicines with serotonergic activity (e.g. SNRIs and other SSRIs, such as lithium (used for mental illness), tramadol (used for pain relief), triptans (used for migraine or cluster headaches), tryptophan (an amino acid), selegiline (used for Parkinson’s disease) or the St John’s wort (Hypericum perforatum) (a complementary medicines used to treat depression).
• Antiepileptic medicine (phenytoin, carbamazepine, oxcarbazepine), medicine used to treat anxiety disorders (diazepam, alprazolam), medicine used to treat psychiatric disorders (haloperidol, clozapine) and antidepressants (imipramine and desipramine).
• Buprenorphine and opioids (used for pain management).
• Medicines that may affect the rhythm of your heart, e.g. class IA and III antiarrhythmic medicines, antipsychotic medicines (e.g. phenothiazine derivatives, pimozide), tricyclic antidepressants (TCAs), certain antimicrobial medicines (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine used to treat bacterial infections), antimalaria treatment (particularly halofantrine, used to treat malaria) or certain antihistamines (astemizole, mizolastine, used to treat allergies).
• Digoxin (heart medicine used to treat heart failure).
• Medicines that have a blood thinning effect e.g. warfarin, nonsteroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen) or aspirin.
• Diuretics (used to treat high blood pressure and reduce water retention in your body).
• Desmopressin (used to reduce the amount of urine produced by your kidneys).
• Mefloquine, chloroquine (used to prevent or treat malaria).
• Bupropion (used to assist smoking cessation).
• A group of medicines known as butyrophenones, e.g. benperidol (used to treat psychiatric disorders).
• Propafenone or flecainide (used to treat heart problems).
• Nebivolol (used to treat high blood pressure).
• Atomoxetine (used to treat attention deficit hyperactivity disorder (ADHD)).
• Risperidone (used to treat mental disorders).

Do not share medicines prescribed for you with any other person. Always take MODIPRAN TABLETS exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure. MODIPRAN TABLETS may be taken dissolved in a small quantity of water or may be swallowed whole with water.

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. Your doctor will tell you how long your treatment with MODIPRAN TABLETS will last. If you have the impression that the effect of MODIPRAN TABLETS 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 TABLETS 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, nausea, vomiting, agitation, restlessness, seizures and signs of altered central nervous system status ranging from excitation to coma.

If you forget to take MODIPRAN TABLETS 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 TABLETS, ask your pharmacist for some hints.

DO NOT STOP TAKING MODIPRAN TABLETS WITHOUT CONSULTING YOUR DOCTOR. If you stop taking MODIPRAN TABLETS Do not stop taking MODIPRAN TABLETS without asking your doctor first, even when you start to feel better. It is important that you keep taking MODIPRAN TABLETS. Make sure you do not run out of tablets. You may notice the following effects (withdrawal symptoms) when you stop taking MODIPRAN TABLETS: 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 TABLETS, 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 TABLETS are mild and disappear within a few weeks. If you experience any symptoms when you stop your treatment, contact your doctor immediately.

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

If any of the following happens, stop taking MODIPRAN TABLETS 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 TABLETS. 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.
• Lung problems, including inflammation of your lungs and fibrosis (scarring or thickening of lung tissue) characterised by troubled breathing, shortness of breath, a dry cough, fatigue, unexplained weight loss, aching muscles and joints.
• Bleeding inside of your stomach or intestines (including bleeding gums, vomiting blood, blood in your stool or the passage of black, tarry stools).
• Hepatitis (inflammation of your liver characterised by yellowing of your skin or whites of the eyes, tiredness and pain in your stomach area).
• Irregular or prolonged vaginal bleeding.
• Heavy vaginal bleeding shortly after giving birth (postpartum haemorrhage) (see section 2, “Pregnancy, breastfeeding and fertility”).
• Persistent, painful erection.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

• Frequent side effects
• Not feeling hungry, weight loss.
• Trouble sleeping, abnormal dreams (including nightmares), having difficulty falling asleep.
• Feeling nervous, anxious or tense.
• Decreased or loss of sex drive (libido).
• Headache.
• Poor concentration.
• Dizziness.
• Change in taste.
• Feeling tired or sleepy.
• Shaking or tremors.
• Blurred vision.
• Flushing (blushing/redness of your skin).
• Increased yawning.
• Diarrhoea, nausea (feeling sick), vomiting (being sick), indigestion, dry mouth.
• Excessive sweating.
• Joint pain.
• Frequent, abnormal urination.
• Sexual problems (including difficulty in maintaining an erection for sexual activity), orgasm problems.
• Feeling shaky or having chills.

Less frequent side effects

• Low sodium levels in your blood, characterised by muscle weakness, spasms or cramps.
• Feeling detached from yourself, abnormal thinking, elevated mood, hallucinations (seeing, feeling or hearing things that are not real), feeling agitated, panic attacks, feeling confused, stuttering, feeling aggressive.
• Grinding or clenching your teeth.
• Feeling restless or having difficulty sitting still, uncontrollable twitching, jerking or writhing movements, problems with balance or coordination.
• Memory loss or memory problems.
• Enlarged (dilated) pupils.
• Buzzing, hissing, whistling, ringing or other persistent noise in the ears.
• Low blood pressure.
• Inflammation of your blood vessels (characterised by redness, swelling of the affected area, general aches and pains).
• Widening of your blood vessels usually near the surface of your skin, leading to increased blood flow with flushing or warmth.
• Nosebleeds.
• Sore throat (pharyngitis).
• Difficulty swallowing, pain in the tube connecting your mouth and your stomach (oesophageal pain).
• Unusual hair loss or thinning.
• Cold sweat, feeling hot or cold.
• Sensitivity to sunlight.
• Muscle pain, muscle tenderness or weakness, not caused by exercise.
• Inability to urinate, passing urine more frequently, painful urination.
• High prolactin levels in your blood and unusual secretion of breast milk.
• Feeling abnormal, generally unwell or overall weak.
• Abnormal liver function test results.

Side effects with unknown frequency

• An underactive thyroid gland, causing a decrease in metabolism. Symptoms include feeling tired and lethargic, muscle weakness, cramps, feeling cold, a slow heart rate, dry and flaky skin, hair loss, a deep and husky voice and weight gain.
• Visual disturbances.
• Bone fractures.
• Abdominal pain.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get side effects, talk to doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of MODIPRAN TABLETS.

• Store at or below 25 °C. Protect from light. Do not remove the blister from the outer carton until required for use.

• STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

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

• Return all unused medicine to your pharmacist.

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