Lorien 20 mg Capsules

LORIEN contains fluoxetine which belongs to a group of medicines called selective serotonin reuptake inhibitor (SSRI) antidepressants. LORIEN is used to treat the following conditions:

• Major depressive episodes.
• Obsessive - compulsive disorder: (is a mental disorder most commonly characterized by intrusive, repetitive thoughts resulting in compulsive behaviours and mental acts that the person feels driven to perform).
• Bulimia nervosa: LORIEN is used for the reduction of binge - eating and purging.

Do not take LORIEN:

• if you are hypersensitive (allergic) to fluoxetine or any of the other ingredients of LORIEN (listed in section 6).
• if you have severe kidney failure.
• if you develop a rash or other allergic reactions (like itching, swollen lips or face or shortness of breath), stop taking the capsules straight away and contact your doctor immediately.
• if you are taking other medicines used to treat depression, known as non - selective monoamine oxidase inhibitors or reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can occur. Examples of MAOIs include medicines used to treat depression such as selegiline, moclobemide, phenelzine nialamide, iproniazid, moclobemide, phenelzine, tranylcypromine, isocarboxazid, toloxatone and also linezolid (an antibiotic) and methylthioninium chloride also called methylene blue (used to treat high levels of methaemoglobin in the blood).or even fatal reactions can occur. Treatment with LORIEN should only be started 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine). However, treatment with LORIEN can be started the following day after discontinuation of certain reversible non - selective MAOIs (for instance moclobemide).
• if you are taking thioridazine or have taken it in the past 5 weeks. Do not take thioridazine for at least 5 weeks after you stop taking LORIEN.
• if you are under the age of 18 years.
• if you are taking metoprolol (to treat heart failure) since there is an increased risk of your heartbeat becoming too slow.

Warnings and precautions

Take special care with LORIEN

• if you have epilepsy or seizures or experience an increase in seizure frequency, contact your doctor immediately; LORIEN might need to be discontinued.
• if you have an episode of excessively intense enthusiasm, interest, or desire (mania) now or in the past; if you have a manic episode, contact your doctor immediately because LORIEN might need to be discontinued.
• if you have diabetes (your doctor may need to adjust your dose of insulin or another antidiabetic treatment).
• if you have liver problems (your doctor may need to adjust your dosage).
• if you have heart problems.
• if you have a low resting heart rate and/or if you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets).
• if you have glaucoma (increased pressure in the eye);
• if you are taking diuretics (water tablets), especially if you are elderly.
• if you are having ECT (electro - convulsive therapy) treatment.
• if you have a history of bleeding disorders or you develop bruises or unusual bleeding, or if you are pregnant (see ‘Pregnancy’).
• if you have history of bleeding disorders (e.g. von Willebrand disease, haemophilia A, deficiency in F VIII, and haemophilia B); and comorbid bleeding disorders (e.g. multiple pregnancy, gestational hypertension or preeclampsia.
• if you are taking medicines that thin the blood (see ‘Taking other medicines with LORIEN’).
• if you are taking ongoing treatment with tamoxifen (used to treat breast cancer) (see ‘Taking other medicines with LORIEN’).
• if you start to feel restless and cannot sit or stand still (akathisia). Increasing your dose of LORIEN may make this worse.
• If you start to experience fever, muscle stiffness or tremor, changes in your mental state like confusion, irritability and extreme agitation; you may suffer from the so - called “serotonin syndrome” or “neuroleptic malignant syndrome”. Although this syndrome occurs rarely it may result in potentially life threatening conditions; contact your doctor immediately as LORIEN might need to be discontinued.
• If you have thoughts of suicide and worsening of your depression or anxiety disorder.
• if you are taking other medicines used to treat depression, known as irreversible, non - selective monoamine oxidase inhibitors (MAOIs) or reversible monoamine oxidase inhibitors type A (MAOIs), since serious or even fatal reactions can occur. Examples of MAOIs include medicines used to treat depression such as nialamide, iproniazid, moclobemide, phenelzine, tranylcypromine, isocarboxazid, toloxatone and also linezolid (an antibiotic) and methylthioninium chloride also called methylene blue (used to treat high levels of methaemoglobin in the blood). LORIEN should only be started 2 weeks after discontinuation of an irreversible non selective MAOI. Do not take any irreversible, non - selective MAOIs for at least 5 weeks after you stop taking LORIEN.
• if you experience symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
• The use of buprenorphine together with LORIEN can lead to serotonin syndrome, a potentially life - threatening condition. If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These thoughts may be increased when you first start taking LORIEN, since LORIEN takes 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 immediately. 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

• Safety and efficacy in children has not been established.
• Children under 18 have an increased risk of side effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines.
• Additionally, only limited information concerning the long - term safety of LORIEN on growth, puberty, mental, emotional and behavioural development in this age group is available.

Always take LORIEN exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are unsure. Do not share medicines prescribed for you with any other person. Your doctor will determine the dosage for you, depending on your disease. Do not stop treatment early as the dose should be gradually reduced over a period of at least one to two weeks. Swallow the capsules with a drink of water. Do not chew the capsules. The tablets may be swallowed whole or be dispersed in approximately 100 ml of water. Your doctor will tell you how long your treatment with LORIEN will last. If you have the impression that the effect of LORIEN is too strong or too weak, tell your doctor or pharmacist.

Children:

The safety and efficacy of LORIEN in children have not been established.

If you take more LORIEN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take a dose of LORIEN

Do not take a double dose to make up for forgotten individual doses. If you have missed a dose of LORIEN take the dose that you have missed as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. If you have forgotten to take several doses, contact your doctor without delay.

If you stop taking LORIEN

Do not stop taking LORIEN without asking your doctor first, even when you start to feel better. It is important that you keep taking LORIEN. You may notice the following effects when you suddenly stop taking LORIEN: dizziness; tingling feelings like pins and needles; sleep disturbances (vivid dreams, nightmares, inability to sleep); feeling restless or agitated; unusual tiredness or weakness; feeling anxious; nausea/vomiting (feeling sick or being sick); tremor (shakiness); headaches. If you experience symptoms when you suddenly stop treatment, contact your doctor. When stopping LORIEN, your doctor will help you to reduce your dose slowly over one or two weeks - this should help reduce the chance of withdrawal effects. If you have any further questions on the use of LORIEN, ask your doctor or pharmacist.

LORIEN can have side effects. Not all side effects reported for LORIEN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LORIEN, please consult your healthcare provider for advice. If any of the following happens, stop taking LORIEN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing, or sudden swelling of skin or mucosa (angioedemas),
• if you get a rash or allergic reaction such as itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens - Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN),

These are all very serious side effects. If you have them, you may have had a serious reaction to LORIEN. 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:

• shortness of breath,
• lung problems (eosinophilic pneumonia)
• some patients may have a combination of symptoms (known as “serotonin syndrome”) including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness,
• thoughts of suicide or harming yourself. 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. If you have side effects such as suicide attempts, suicidal thoughts and hostility (predominately aggression, oppositional behaviour and anger),
• if you feel restless and cannot sit or stand still, you may have akathisia; increasing your dose of LORIEN may make you feel worse. If you feel like this, contact your doctor,
• heart problems, such as fast or irregular heart rate, fainting, collapsing or dizziness upon standing which may indicate abnormal functioning of the heart,
• rapid and irregular heartbeat sensation,
• seizures or fits (convulsions),
• inability to urinate,
• unusual bleeds, including gastrointestinal bleeds,
• high fever, agitation, confusion, trembling and abrupt contractions of muscles these may be signs of a rare condition called serotonin syndrome,

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:

• sleep problems,
• headache,
• feeling sick (nausea),
• diarrhoea,
• tiredness,
• not feeling hungry, weight loss,
• nervousness, anxiety,
• restlessness, poor concentration,
• feeling tense,
• decreased sex drive or sexual problems (including difficulty maintaining an erection for sexual activity),
• increased appetite, increase in weight,
• unusual dreams,
• dizziness,
• change in taste,
• uncontrollable shaking movements,
• blurred vision,
• pain in muscle and joints (arthralgia and myalgia),
• flushing,
• yawning,
• indigestion, vomiting,
• dry mouth,
• urticaria,
• excessive sweating
• passing urine more frequently,
• unexplained vaginal bleeding,
• feeling shaky or chills,

Less frequent side effects:

• feeling detached from yourself,
• strange thinking,
• abnormally high mood,
• feelings of weakness, drowsiness or confusion mostly in elderly people and in people taking diuretics (water tablets),
• irritability and extreme agitation,
• orgasm problems,
• prolonged and painful erection,
• agitation, nervousness, panic attack, confusion, aggression, depersonalization (a state in which one’s thoughts and feelings seem unreal or not to belong to oneself),
• teeth grinding,
• muscle twitching, involuntary movements or problems with balance or co - ordination,
• memory impairment,
• enlarged (dilated) pupils,
• ringing in the ears,
• low blood pressure,
• nose bleeds,
• difficulty swallowing,
• hair loss,
• increased tendency to bruising,
• unexplained bruising or bleeding,
• cold sweat,
• difficulty passing urine,
• feeling hot or cold,
• abnormal liver function test results,
• untypical wild behaviour,
• hallucinations,
• panic attacks,
• confusion,
• stuttering,
• vasculitis (inflammation of a blood vessel),
• rapid swelling of the tissues around the neck, face, mouth and/or throat,
• pain in the tube that takes food or water to your stomach,
• hepatitis,
• sensitivity to sunlight,
• muscle pain,
• problems urinating,

Side effects with an unknown frequency:

• low blood cells (pancytopenia and aplastic anaemia),
• low red blood cells (immune related haemolytic anaemia),
• reduction in blood platelets (thrombocytopenic purpura), which increases risk of bleeding or bruising,
• producing breast milk,
• low level of sodium in the blood (hyponatraemia),
• increased secretion of a hormone called ADH, causing the body to retain water and dilute the blood, reducing the amount of sodium (inappropriate ADH secretion),
• heavy vaginal bleeding shortly after birth (postpartum haemorrhage),
• bone fractures - an increased risk of bone fractures has been observed in patients taking this type of medicines.

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 your doctor, pharmacist or nurse. You can also report side effects to: SAHPRA: https://www.sahpra.org.za/health - products - vigilance/ Aspen Pharmacare: E - mail: [email protected] Tel: 0800 118 088 By reporting side effects, you can help provide more information on the safety of LORIEN.

Store all medicines out of reach of children. Store in a cool, dry place, at or below 25 °C. Protect from light and moisture. Keep the plastic container tightly closed. Keep in original packaging until required for use. Do not store in bathrooms. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).