Lorien Side Effects

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Answer the side-effect intent for lorien without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Lorien?

Lorien contains the active ingredient Fluoxetine.

• Active ingredient — Fluoxetine
• Registration number — 30/1.2/0024; 34/1.2/0381
• Registration holder — PHARMACARE LIMITED

It is approved for:

• 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

Common side effects of Lorien

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

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

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• 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). Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking LORIEN. If LORIEN 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 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

Use with care, and tell your doctor, if

• 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
• 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
• if you are taking ongoing treatment with tamoxifen (used to treat breast cancer)
• 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. 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

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking this medicine
• Pregnancy Safety in pregnancy has not been demonstrated
• Breastfeeding LORIEN is excreted in breast milk and can cause side effects in babies
• You should not breastfeed your baby if you are in treatment with LORIEN
• Fertility Impact on human fertility has not been observed as yet

Interactions and medicines to check

The approved leaflet names these interactions.

• Buprenorphine/opioids. These medicines may interact with LORIEN and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38ºC
• certain irreversible, non-selective monoamine oxidase inhibitors (MAO-inhibitors, used to treat depression). Irreversible, Non-selective MAO-inhibitors and MAO-inhibitors type A (moclobemide) must not be used with LORIEN as serious or even fatal reactions (serotonin syndrome) can occur. Treatment with LORIEN should only be started at least 2 weeks after discontinuation of an irreversible MAOI (for instance tranylcypromine). Do not take any irreversible, non-selective MAOIs for at least 5 weeks after you stop taking LORIEN. If LORIEN has been prescribed for a long period and/or at a high dose, a longer interval than 5 weeks may need to be considered by your doctor
• metoprolol (used for heart failure) may increase the risk of your heartbeat becoming too slow
• lithium, tryptophan (used to treat mental illness); there is an increased risk of serotonin syndrome when these medicines are taken with LORIEN. Your doctor will carry out more frequent check-ups
• monoamine oxidase inhibitors A (MAOI-A) including moclobemide, linezolid (an antibiotic) and methylthioninium chloride also called methylene blue (used to treat high levels of methaemoglobin in the blood): due to the risk of serious or even fatal reactions (called serotonin syndrome). Treatment with LORIEN can be started the day after stopping treatment with reversible MAOIs but the doctor may wish to monitor you carefully and use a lower dose of the MAOI-A medicine. However, treatment with LORIEN can be started the following day after discontinuation of certain reversible MAOIs (for instance moclobemide, linezolid, methylthioninium chloride (methylene blue)). Some MAO-inhibitors type B (selegiline) can be used with LORIEN provided that your doctor monitors you closely
• phenytoin (for epilepsy) because LORIEN may influence the blood levels of this medicine, your doctor may need to introduce phenytoin more carefully and carry out check-ups when given with LORIEN
• clozapine (used to treat certain mental disorders), tramadol (a painkiller) or triptans (for migraine); there is an increased risk of hypertension (raised blood pressure)
• carbamazepine (for epilepsy), tricyclic antidepressants (for example imipramine, desipramine and amitriptyline); because LORIEN may possibly change the blood levels of these medicines, your doctor may need to lower their dose when administered with LORIEN
• anticoagulants such as warfarin, NSAID (such as ibuprofen, diclofenac) or aspirin and other medicines used to thin the blood; LORIEN may alter the effect of these medicines on the blood. If LORIEN treatment is started or stopped when you are taking warfarin, your doctor will need to perform certain blood tests
• you should not use the herbal remedy St John’s Wort (Hypericum perforatum) while you are being treated with LORIEN since this may result in an increase in side effects. If you are already taking St John’s Wort when you start on LORIEN, stop taking St John’s Wort and tell your doctor at your next visit
• Mequitazine (for allergies) because taking this medicine with LORIEN may increase the risk of changes in the electrical activity of the heart
• medicines that may affect the heart’s rhythm, e.g. Class IA and III antidysrhythmic, antipsychotics (e.g. fentiazine derivatives, phenothiazine derivatives pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial medicines (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine), anti-malaria treatment particularly halofantrine, certain antihistamines (astemizole, mizolastine). Taking one or more of these medicines with LORIEN may increase the risk of changes in the electrical activity of the heart
• Tamoxifen (used to treat breast cancer), because LORIEN may change the blood levels of this medicine and a reduction of the effect of tamoxifen cannot be excluded, your doctor may need to consider different antidepressant treatments
• Cyproheptadine (for allergies) because it may reduce the effect of LORIEN
• medicines that lower sodium levels in the blood (including, medicines that causes increase in urination, desmopressin, carbamazepine and oxcarbazepine); because these medicines may increase the risk of sodium levels in the blood becoming too low when taken with LORIEN
• anti-depressants such as tricyclic anti-depressants, other selective serotonin reuptake inhibitors (SSRIs) or bupropion, mefloquine or chloroquine (used to treat malaria), tramadol (used to treat severe pain) or anti-psychotics such as phenothiazines or butyrophenones because LORIEN may increase the risk of seizures when taken with these medicines. LORIEN with food, drink and alcohol You can take LORIEN with or without food. You are advised NOT to drink alcohol with LORIEN

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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