LORIEN: Uses, Dose Side Effects, Precautions

It is a prescription antidepressant used in South Africa for specific mental-health conditions. Lorien contains fluoxetine (as fluoxetine hydrochloride), a selective serotonin reuptake inhibitor (SSRI). It is a Schedule 5 (S5) medicine and is available as 20 mg capsules and 20 mg tablets.

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What it is and what it is used for

LORIEN contains fluoxetine, an SSRI antidepressant. SSRIs help improve mood and reduce anxiety symptoms by increasing levels of serotonin, a natural chemical messenger in the brain.

Indications

• Major depressive episodes.
• Obsessive-compulsive disorder (OCD) – a condition with intrusive, repetitive thoughts that can lead to compulsive behaviours and mental acts.
• Bulimia nervosa – used to reduce binge-eating and purging.

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How it works

Nerve cells in the brain communicate using chemicals like serotonin. After serotonin delivers a message, it is normally reabsorbed into the nerve cell. Fluoxetine blocks this “reuptake” step, so more serotonin stays available in the spaces between nerve cells. Over time, this can lift mood, reduce anxiety, and lessen compulsive behaviours. The effect is not immediate—it usually takes about 2 weeks, and sometimes longer, to notice benefit.

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Who should NOT use this medicine

Do not take LORIEN if:

• You are allergic to fluoxetine or any ingredient in LORIEN (see What the medicine contains).
• You have severe kidney failure.
• You are taking monoamine oxidase inhibitors (MAOIs) used for depression (irreversible, non-selective MAOIs or reversible MAOIs type A like moclobemide) or have recently taken them. Serious, sometimes fatal reactions (serotonin syndrome) can occur.
  • Start LORIEN only 2 weeks after stopping an irreversible MAOI (e.g., tranylcypromine).
  • LORIEN may be started the day after stopping certain reversible MAOIs (e.g., moclobemide, linezolid, methylene blue)—but you must be carefully monitored.
  • Do not take any irreversible, non-selective MAOI for at least 5 weeks after stopping LORIEN. If you’ve taken LORIEN for a long time or at high doses, your doctor may advise an even longer gap.
• You are taking thioridazine now or have taken it in the last 5 weeks (risk of serious heart rhythm problems).
• You are under 18 years of age (safety and efficacy not established; higher risk of certain psychiatric side effects in this age group).
• You are taking metoprolol for heart failure (risk of your heartbeat becoming too slow).

Stop LORIEN and seek medical advice immediately if you develop a rash, itching, swollen lips/face, or shortness of breath—these can indicate an allergic reaction.

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Warnings and precautions (Read before use)

Tell your doctor before starting LORIEN if any of the following apply to you, or if they occur while taking it:

• Seizures/epilepsy: If seizures start or become more frequent, contact your doctor—LORIEN may need to be stopped.
• History of mania: If you develop an episode of abnormally elevated mood or over-activity (mania), contact your doctor—treatment may need to be stopped.
• Diabetes: Dose adjustments to insulin or other antidiabetic medicines may be required.
• Liver problems: Your doctor may adjust the dose.
• Heart problems or low resting heart rate; salt depletion from prolonged vomiting/diarrhoea or diuretics—this can increase risks, including low sodium.
• Glaucoma (raised eye pressure).
• Electro-convulsive therapy (ECT)—you will need careful monitoring.
• Bleeding disorders (e.g., von Willebrand disease, haemophilia A/B) or if you bruise easily or develop unusual bleeding.
• Pregnancy or plans to become pregnant (see Pregnancy, planning pregnancy, and breastfeeding).
• Tamoxifen use (for breast cancer)—fluoxetine may reduce its effect; your doctor may consider alternative antidepressants.
• Restlessness/akathisia: If you feel unable to sit or stand still, tell your doctor; increasing the dose may worsen it.
• Serotonin syndrome / Neuroleptic malignant syndrome: Rare but serious. Seek urgent help if you develop fever, muscle stiffness or tremor, sweating, fast heartbeat, confusion, irritability, or severe agitation.
• Sexual dysfunction: Issues such as reduced sex drive or difficulties with sexual function can occur and have sometimes persisted after stopping treatment.
• Buprenorphine (or other opioids): Using these with LORIEN can trigger serotonin syndrome—monitor for symptoms listed above.
• Thoughts of self-harm: Depression and anxiety can be associated with suicidal thoughts, especially early in treatment and in adults under 25. If you have thoughts about harming yourself, contact a doctor or go to a hospital immediately. Consider asking a relative or friend to help monitor your mood and behaviour.

Children and adolescents (<18 years): Safety and efficacy have not been established. This age group is at increased risk of suicidal thoughts, suicide attempts and hostility (aggression, oppositional behaviour, anger). Only limited data exist on long-term effects on growth and development.

Driving and using machines: Headaches, visual disturbances, and fits have been reported. Do not drive or use machinery until you know how LORIEN affects you.

Alcohol: Do not drink alcohol while taking LORIEN.

Food: You may take LORIEN with or without food.

Lactose warning (capsules): LORIEN capsules contain lactose. If you have been told you are intolerant to some sugars, speak to your doctor before using the capsules. (The tablets are sugar-free.)

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Pregnancy, planning pregnancy, and breastfeeding

• Pregnancy: Safety in pregnancy has not been demonstrated. Speak to your doctor before use.
• Breastfeeding: Fluoxetine passes into breast milk and can cause side effects in babies—do not breastfeed while using LORIEN.
• Fertility: No impact has been observed as yet in humans.

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Interactions

Always tell your healthcare provider about all medicines you use, including complementary or traditional remedies. Important interactions include:

Do not use with (or within the specified time frames)

• Irreversible, non-selective MAOIs (e.g., tranylcypromine, phenelzine, isocarboxazid, iproniazid, nialamide, toloxatone): Risk of serotonin syndrome.
  • Wait 2 weeks after stopping an irreversible MAOI before starting LORIEN.
  • Wait at least 5 weeks after stopping LORIEN before starting an irreversible MAOI (longer if on high dose or long-term).
• Reversible MAOI-A (e.g., moclobemide, linezolid, methylene blue)—may be started the day after stopping these in some cases, with careful monitoring; your doctor will advise.
• Thioridazine: Do not use within 5 weeks of LORIEN (risk of serious heart rhythm problems).
• Metoprolol for heart failure: Increased risk of a dangerously slow heartbeat—contraindicated.

Medicines that may increase the risk of serotonin syndrome or other serious effects

• Lithium or tryptophan—higher risk of serotonin syndrome; requires closer monitoring.
• Buprenorphine/opioids—risk of serotonin syndrome (see Warnings).
• Tramadol (strong painkiller) or triptans (for migraine).
• Clozapine (certain mental-health conditions) and other antipsychotics (e.g., phenothiazines, butyrophenones).
• Other antidepressants (including tricyclics such as imipramine, desipramine, amitriptyline; other SSRIs; bupropion).
• Mefloquine/chloroquine (antimalarials).

Medicines that may affect the heart’s rhythm (QT prolongation/arrhythmias)

• Class IA/III antidysrhythmics; certain antipsychotics; tricyclic antidepressants; some antibiotics (e.g., sparfloxacin, moxifloxacin, intravenous erythromycin); pentamidine; halofantrine (antimalarial); certain antihistamines (e.g., astemizole, mizolastine); mequitazine. Using these with LORIEN may increase the risk of changes in heart rhythm.

Medicines that may need dose adjustments or extra monitoring

• Phenytoin (for epilepsy)—blood levels can be affected; careful dose introduction and monitoring advised.
• Carbamazepine (for epilepsy) and tricyclic antidepressants—may require dose reductions when used with LORIEN.
• Warfarin and other anticoagulants, NSAIDs (e.g., ibuprofen, diclofenac), and aspirin—LORIEN can alter bleeding risk; your doctor may order blood tests if warfarin is started or stopped with LORIEN.
• Medicines that lower sodium (e.g., diuretics, desmopressin, carbamazepine, oxcarbazepine)—greater risk of hyponatraemia (low blood sodium).
• Tamoxifen—LORIEN may reduce its effect; your doctor may consider other options.
• Cyproheptadine (for allergies)—may reduce LORIEN’s effect.

Herbal medicines and other products

• St John’s Wort (Hypericum perforatum): Do not use with LORIEN—can increase side effects.

Practical tips:

• If you start or stop warfarin while on LORIEN, you will likely need additional blood tests.
• Avoid alcohol while taking LORIEN.
• Seek medical advice before adding any new medicine (including over-the-counter and herbal products).

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How to take (Step-by-step)

Always use LORIEN exactly as your doctor or pharmacist has told you.

Step 1 — Check the form you have

• Capsules (20 mg): Swallow whole with water. Do not chew the capsules.
• Tablets (20 mg): Swallow whole, or disperse in about 100 ml of water and take immediately.

Step 2 — Food and timing

• You can take LORIEN with or without food. Take it consistently at the time of day your doctor recommends.

Step 3 — Dose

• Your doctor determines the dose based on your condition. Do not change your dose on your own.

Step 4 — If you miss a dose

• Take the missed dose as soon as you remember.
• If it is almost time for your next dose, skip the missed dose and take your next dose at the usual time.
• Do not take a double dose to make up for the one you missed.
• If you have missed several doses, contact your doctor.

Step 5 — If you take too much (overdose)

• Contact your doctor or pharmacist immediately. If they are unavailable, go to the nearest hospital or poison information centre.

Step 6 — Do not stop suddenly

• Keep taking LORIEN even if you start to feel better, unless your doctor tells you to stop.
• Stopping suddenly can lead to withdrawal symptoms, such as dizziness, pins-and-needles, sleep problems (vivid dreams, nightmares, difficulty sleeping), restlessness, anxiety, unusual tiredness, nausea/vomiting, tremor, or headaches.
• When stopping, your doctor will help you taper the dose slowly over 1–2 weeks to reduce withdrawal effects.
• If withdrawal symptoms occur, contact your doctor.

Note: LORIEN is not recommended for children—safety and efficacy have not been established.

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Possible side effects

Not everyone gets side effects. If your general health worsens while using LORIEN, speak to your healthcare provider. Stop LORIEN and seek urgent medical help if you develop signs of a severe allergic reaction (swelling of the face/lips/tongue/throat, difficulty breathing), severe skin reactions (blistering, peeling) or serotonin syndrome (see below).

Serious—seek urgent help and stop the medicine

• Allergic reactions/angioedema: swelling of hands/feet/face/lips/mouth or throat, rash, itching, fainting, difficulty breathing.
• Severe skin reactions: Stevens-Johnson syndrome (SJS)/Toxic epidermal necrolysis (TEN)—blistering of skin, mouth, eyes, or genitals.
• Lung problems: Eosinophilic pneumonia (shortness of breath).
• Serotonin syndrome: Unexplained fever, fast breathing/heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation, or sleepiness.
• Heart rhythm problems: Fast/irregular heartbeat, fainting, collapse, or dizziness on standing.
• Seizures (fits).
• Inability to urinate.
• Unusual bleeding, including gastrointestinal bleeding.
• Thoughts of suicide or harming yourself, especially early in treatment—seek help immediately.

Common (frequent) side effects

• Sleep problems, unusual dreams.
• Headache, dizziness, yawning.
• Nausea, diarrhoea, indigestion, vomiting, dry mouth, change in taste.
• Tiredness, feeling shaky/chills.
• Appetite changes (loss or increase); weight loss or weight gain.
• Nervousness, anxiety, restlessness, poor concentration, tension.
• Decreased sex drive, sexual problems (including erectile difficulties).
• Blurred vision.
• Tremor or uncontrollable shaking.
• Muscle or joint pain (myalgia/arthralgia), flushing.
• Urticaria (hives), excessive sweating.
• Passing urine more often.
• Unexplained vaginal bleeding.

Less common side effects

• Feeling detached or experiencing strange thinking.
• Abnormally high mood.
• Weakness, drowsiness, or confusion (more often in elderly or in people on diuretics).
• Irritability, extreme agitation, panic attacks, aggression, depersonalisation.
• Teeth grinding.
• Muscle twitching, involuntary movements, or coordination/balance problems.
• Memory problems.
• Dilated pupils, ringing in the ears.
• Low blood pressure, nosebleeds, difficulty swallowing.
• Hair loss.
• Easy bruising, unexplained bruising or bleeding, cold sweat.
• Difficulty passing urine, feeling hot or cold.
• Abnormal liver function tests, hepatitis.
• Vasculitis (blood vessel inflammation).
• Photosensitivity (sensitivity to sunlight).
• Oesophageal pain.
• Untypical wild behaviour, hallucinations, stuttering.

Also reported (frequency not known)

• Blood problems: Pancytopenia, aplastic anaemia, immune-related haemolytic anaemia.
• Low platelets (thrombocytopenic purpura)—increased bleeding/bruising.
• Galactorrhoea (unexpected production of breast milk).
• Low sodium (hyponatraemia) and inappropriate ADH secretion (SIADH)—risk increased with diuretics and in the elderly.
• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage).
• Bone fractures—an increased risk has been observed with this type of medicine.

What to do:

• For mild effects, discuss with your doctor or pharmacist—dose adjustments or supportive measures may help.
• For serious symptoms listed above, stop LORIEN and seek urgent medical help.

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Storage and disposal

• Keep out of the 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 and in the original packaging until use.
• Do not store in bathrooms.
• Do not use after the expiry date on the label.
• Return unused or expired medicine to your pharmacist.
• Do not dispose of medicines in drains or toilets.

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What the medicine contains

Active ingredient

• Fluoxetine 20 mg (as fluoxetine hydrochloride) in both the capsules and tablets.

Excipients and sugar information

Product	Sugar status	Key excipients (not exhaustive)	Lactose content
LORIEN 20 mg capsules	Contains sugar (lactose)	Colloidal anhydrous silica, gelatine, lactose monohydrate, magnesium stearate, maize starch, patent blue, povidone, titanium dioxide, yellow iron oxide	Lactose monohydrate 130.70 mg per capsule
LORIEN 20 mg tablets	Sugar-free	Colloidal silicon dioxide, magnesium stearate, maize starch, microcrystalline cellulose	No lactose stated

Note: If you are lactose-intolerant, discuss the capsule formulation with your doctor. The tablet is sugar-free.

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Pack information and appearance

• Capsules: White powder inside a size “3” hard gelatine capsule with an opaque green body and cap.
  • Packs of 28 and 112 capsules (blister strips inside cartons), or plastic containers with a tamper-evident cap and silica gel.
• Tablets:Round, white, bevelled-edge tablet, scored (bisected) on one side.
  • Packs of 28 or 30 tablets (blister or container).
• Not all packs and pack sizes are necessarily marketed.
• Holder of Certificate of Registration: PHARMACARE LIMITED.

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FAQs

How long does LORIEN take to start working?
It usually takes about two weeks, and sometimes longer, before you start feeling the benefit.

Can I drink alcohol while taking LORIEN?
No. You are advised not to drink alcohol with LORIEN.

Can I drive or operate machinery?
Avoid driving, using machines, or doing tasks that require concentration until you know how LORIEN affects you. Headaches, visual disturbances, or fits have been reported.

What should I do if I forget a dose?
Take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose—do not double up. If you have missed several doses, contact your doctor.

Can I stop LORIEN when I feel better?
Do not stop abruptly. Your doctor will help you taper over 1–2 weeks to reduce withdrawal effects like dizziness, sleep problems, anxiety, nausea, tremor, or headaches.

Is LORIEN safe in pregnancy or while breastfeeding?
Pregnancy: Safety has not been demonstrated—speak to your doctor. Breastfeeding: Fluoxetine passes into breast milk and may cause side effects in babies—do not breastfeed while taking LORIEN.

Is LORIEN suitable for children or teens?
No. Safety and efficacy have not been established in those under 18, and there is an increased risk of suicidal thoughts and hostility in this age group.

Can I take LORIEN with other medicines?
Tell your healthcare provider about all medicines. Do not use with MAOIs, thioridazine, or metoprolol for heart failure. Some medicines (e.g., lithium, tramadol, triptans, certain antibiotics/antipsychotics, warfarin/NSAIDs, diuretics) can interact—your doctor will advise and may order monitoring.

Does LORIEN contain sugar or lactose?
Capsules contain lactose (about 130.70 mg per capsule). Tablets are sugar-free.

Can I take LORIEN with or without food?
Yes. You may take it with or without food.

Can the tablets be dispersed in water?
Yes. Tablets may be dispersed in about 100 ml of water. Capsules should be swallowed whole and not chewed.