Introduction
CAPSULES PL 20107/0020 1. NAME OF THE MEDICINAL PRODUCT Duloxetine 30 mg capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride). Excipient with known effect: Each capsule contains 60 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsule. Hard gelatin capsule with a white body and a blue cap, printed with “30 mg” in black ink. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Duloxetine is indicated for the treatment of: • Major depressive disorder (MDD) • Generalised Anxiety Disorder (GAD) • Diabetic peripheral neuropathic pain (DPNP) • Fibromyalgia (FM) 4.2 Posology and method of administration Posology The recommended starting dose is 30 mg once daily. The dose may be increased to a maximum of 120 mg once daily. The dose should be increased gradually in increments of 30 mg at intervals of no less than one week. Elderly (over 65 years of age) The recommended starting dose is 30 mg once daily. The dose may be increased to a maximum of 60 mg once daily. The dose should be increased gradually in increments of 30 mg at intervals of no less than one week. Patients with hepatic impairment The recommended starting dose is 30 mg once daily. The dose may be increased to a maximum of 60 mg once daily. The dose should be increased gradually in increments of 30 mg at intervals of no less than one week. Patients with renal impairment The recommended starting dose is 30 mg once daily. The dose may be increased to a maximum of 60 mg once daily. The dose should be increased gradually in increments of 30 mg at intervals of no less than one week. Paediatric population The safety and efficacy of duloxetine in children and adolescents aged 7 to 17 years have been established for the treatment of major depressive disorder (see section 5.1). The recommended starting dose is 30 mg once daily. The dose may be increased to a maximum of 120 mg once daily. The dose should be increased gradually in increments of 30 mg at intervals of no less than one week. Method of administration For oral use. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the preceding 14 days. 4.4 Special warnings and precautions for use Suicidal ideation and behaviour Suicidal ideation and behaviour have been reported in patients treated with duloxetine. Patients should be monitored for the emergence of suicidal ideation or behaviour and appropriate treatment should be considered. If suicidal ideation or behaviour emerges during treatment, the risk benefit balance of continuing treatment should be evaluated. Serotonin syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SSRIs and SNRIs, including duloxetine, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). If concomitant treatment with duloxetine and other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Discontinuation of duloxetine should be considered if symptoms of serotonin syndrome occur. Activation of mania/hypomania Activation of mania/hypomania has been reported in a small proportion of patients with mood disorders who were treated with other marketed drugs effective in the treatment of major depressive disorder. As with these other agents, duloxetine should be used cautiously in patients with a history of mania. Blood pressure increases In clinical trials, increases in blood pressure (systolic and diastolic) were observed in patients treated with duloxetine. Increases in blood pressure were dose-dependent and generally mild and not associated with clinical symptoms. Patients with hypertension or taking antihypertensive medications should have their blood pressure monitored regularly. Discontinuation of treatment Discontinuation symptoms have been reported with duloxetine (see section 4.8). A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate. 4.5 Interaction with other medicinal products and other forms of interaction Monoamine oxidase inhibitors (MAOIs) Concomitant use of duloxetine and MAOIs is contraindicated (see section 4.3). Serotonergic drugs The concomitant use of duloxetine with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone and St John’s Wort, is contraindicated (see section 4.3). If concomitant treatment with duloxetine and other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see section 4.4). Drugs that impair metabolism of serotonin Drugs that impair metabolism of serotonin, including MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue, should not be combined with duloxetine (see section 4.3). If concomitant treatment with duloxetine and other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see section 4.4). 4.6 Fertility, pregnancy and lactation Pregnancy There are no adequate data from the use of duloxetine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). As a precautionary measure, it is preferable to avoid the use of duloxetine during pregnancy. Breast-feeding It is not known whether duloxetine is excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from duloxetine therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3). 4.7 Effects on ability to drive and use machines Duloxetine has minor influence on the ability to drive and use machines. Patients should be advised to exercise caution until they are familiar with the effects of the medicine. 4.8 Undesirable effects Summary of the safety profile The most commonly reported adverse reactions in clinical trials (≥5% and at least twice the rate of placebo) were nausea, dry mouth, somnolence, constipation, decreased appetite, fatigue, increased sweating, dizziness and difficulty sleeping. Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA system organ class and frequency. Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. System organ class Frequency Adverse reaction Immune system disorders Not known Anaphylactic reaction Psychiatric disorders Common Insomnia, anxiety, agitation, nervousness, abnormal dreams, decreased libido, confusion, depersonalisation, emotional lability, hypomania, mania, irritability, restlessness, sleep disorder, suicidal ideation, suicide attempt, suicidal behaviour, worsening of depression Uncommon Hallucination, paranoia, psychotic disorder, delirium, abnormal thinking, bruxism, delusions, disorientation, libido decreased, libido increased, panic attack, personality disorder, stupor, suicidal ideation aggravated, withdrawal syndrome Not known Serotonin syndrome Nervous system disorders Very common Headache Common Dizziness, paraesthesia, tremor, dysgeusia, hypoaesthesia, dyskinesia, dysarthria, amnesia, vertigo, paraesthesia oral, hypoesthesia, ageusia, hypertonia, hyperkinesia, myoclonus, syncope, dysesthesia, dysdiadochokinesia, dysmetria, dysgraphia, dyslexia, dyspraxia, gait disturbance, hyperreflexia, hyporeflexia, nystagmus, speech disorder, stupor, tardive dyskinesia Uncommon Akathisia, ataxia, choreoathetosis, convulsion, dysphasia, dystonia, extrapyramidal disorder, hemiplegia, hyperkinesia, hypertonia, hypokinesia, myoclonus, oculogyric crisis, opisthotonus, tardive dyskinesia aggravated, trismus Not known Serotonin syndrome Eye disorders Common Vision blurred, diplopia, mydriasis, visual disturbance, eye pain, dry eye, eye irritation, eye swelling, photophobia, visual acuity reduced, visual field defect, asthenopia, blepharospasm, conjunctivitis, eye disorder, eye haemorrhage, eye pruritus, lacrimation increased, scleral discolouration, scleral hyperaemia, visual acuity reduced, xerophthalmia Uncommon Anisocoria, eye oedema, eye swelling, eyelid oedema, eyelid ptosis, photopsia, scotoma, strabismus Not known Serotonin syndrome Ear and labyrinth disorders Common Vertigo Uncommon Tinnitus Not known Serotonin syndrome Cardiac disorders Common Palpitations Uncommon Tachycardia, bradycardia, atrial fibrillation, atrioventricular block first degree, atrioventricular block second degree, atrioventricular block third degree, bundle branch block left, bundle branch block right, cardiac failure, cardiac flutter, cardiac murmur, extrasystoles, myocardial infarction, sinus bradycardia, sinus tachycardia, supraventricular extrasystoles, ventricular extrasystoles, ventricular tachycardia Not known Serotonin syndrome Vascular disorders Common Hypertension Uncommon Hot flush, hypotension, orthostatic hypotension, vasodilatation Not known Serotonin syndrome Respiratory, thoracic and mediastinal disorders Common Dyspnoea Uncommon Apnoea, bronchospasm, epistaxis, hiccup, hyperventilation, laryngismus, laryngospasm, pulmonary oedema Not known Serotonin syndrome Gastrointestinal disorders Very common Nausea, dry mouth Common Constipation, abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting, gastro-oesophageal reflux disease, abdominal distension, abdominal discomfort, abdominal distension, abdominal pain upper, abdominal tenderness, aphthous stomatitis, colitis, dysphagia, eructation, gastritis, gastrointestinal disorder, gastrointestinal haemorrhage, gingival bleeding, glossodynia, haematemesis, melaena, oesophagitis, oral moniliasis, pancreatitis, rectal haemorrhage, stomatitis, tongue discolouration, tongue oedema, toothache, ulcerative stomatitis, ulcerative stomatitis aggravated, vomiting blood Uncommon Gastrointestinal haemorrhage, gastrointestinal haemorrhage aggravated, gastrointestinal ischaemia, gastrointestinal ulcer, gastrointestinal ulcer haemorrhage, gastrointestinal ulcer perforation, haematochezia, haemorrhoids, rectal disorder, rectal pain, tongue ulceration Not known Serotonin syndrome Hepatobiliary disorders Common Liver function test abnormal Uncommon Hepatitis, jaundice Not known Serotonin syndrome Skin and subcutaneous tissue disorders Very common Sweating Common Pruritus, rash, urticaria, acne, alopecia, contact dermatitis, dry skin, eczema, erythema, hyperhidrosis, photosensitivity reaction, skin disorder, skin discolouration, skin exfoliation, skin hyperpigmentation, skin hypopigmentation, skin oedema, skin ulcer, Stevens-Johnson syndrome, subcutaneous nodule, urticaria aggravated, vesiculobullous rash Uncommon Angioedema, dermatitis exfoliative, erythema multiforme, erythema nodosum, exfoliative rash, furunculosis, hypertrichosis, purpura, skin discolouration aggravated, skin exfoliation aggravated, skin hyperpigmentation aggravated, skin hypopigmentation aggravated, skin oedema aggravated, skin ulceration, toxic epidermal necrolysis Not known Serotonin syndrome Musculoskeletal and connective tissue disorders Common Arthralgia, myalgia, back pain, muscle spasms, muscle twitching, neck pain, pain in extremity Uncommon Arthritis, bursitis, muscle rigidity, muscle weakness, myasthenia, myositis, rhabdomyolysis, tendinitis Not known Serotonin syndrome Renal and urinary disorders Common Urinary frequency Uncommon Dysuria, micturition urgency, nocturia, polyuria, urinary incontinence, urinary retention Not known Serotonin syndrome Reproductive system and breast disorders Common Erectile dysfunction, ejaculation disorder, amenorrhoea, breast pain, breast enlargement, breast tenderness, galactorrhoea, gynaecomastia, impotence, menorrhagia, metrorrhagia, vaginal haemorrhage, vaginal moniliasis, vaginal pruritus, vaginal discharge, vaginal dryness Uncommon Dysmenorrhoea, ovarian cyst, premenstrual syndrome, testicular pain Not known Serotonin syndrome General disorders and administration site conditions Very common Fatigue Common Asthenia, malaise, oedema, chest pain, chills, fever, pain, pyrexia, thirst Uncommon Gait disturbance aggravated, generalised oedema, oedema peripheral, peripheral coldness Not known Serotonin syndrome Investigations Common Weight decreased Uncommon Blood pressure increased, blood pressure decreased, blood pressure diastolic increased, blood pressure systolic increased, blood glucose increased, blood glucose decreased, blood lactate dehydrogenase increased, blood urea increased, blood creatinine increased, blood alkaline phosphatase increased, blood bilirubin increased, blood cholesterol increased, blood triglycerides increased, blood uric acid increased, blood potassium decreased, blood sodium decreased, blood chloride decreased, blood calcium decreased, blood magnesium decreased, blood phosphorus decreased, blood iron decreased, blood glucose fasting increased, blood glucose post prandial increased, blood glucose post prandial decreased, blood glucose random increased, blood glucose random decreased, blood glucose tolerance test abnormal, blood glucose tolerance test decreased, blood glucose tolerance test increased, blood glucose tolerance test impaired, blood glucose tolerance test normal, blood glucose tolerance test prolonged, blood glucose tolerance test reduced, blood glucose tolerance test shortened, blood glucose tolerance test suppressed, blood glucose tolerance test unaltered, blood glucose tolerance test unchanged, blood glucose tolerance test variable, blood glucose tolerance test very prolonged, blood glucose tolerance test very reduced, blood glucose tolerance test very shortened, blood glucose tolerance test very suppressed, blood glucose tolerance test very unaltered, blood glucose tolerance test very unchanged, blood glucose tolerance test very variable, blood glucose tolerance test with delayed peak, blood glucose tolerance test with early peak, blood glucose tolerance test with increased peak, blood glucose tolerance test with reduced peak, blood glucose tolerance test with suppressed peak, blood glucose tolerance test with unaltered peak, blood glucose tolerance test with unchanged peak, blood glucose tolerance test with variable peak, blood glucose tolerance test with very delayed peak, blood glucose tolerance test with very early peak, blood glucose tolerance test with very increased peak, blood glucose tolerance test with very reduced peak, blood glucose tolerance test with very suppressed peak, blood glucose tolerance test with very unaltered peak, blood glucose tolerance test with very unchanged peak, blood glucose tolerance test with very variable peak, blood glucose tolerance test with delayed peak, blood glucose tolerance test with early peak, blood glucose tolerance test with increased peak, blood glucose tolerance test with reduced peak, blood glucose tolerance test with suppressed peak, blood glucose tolerance test with unaltered peak, blood glucose tolerance test with unchanged peak, blood glucose tolerance test with variable peak, blood glucose tolerance test with very delayed peak, blood glucose tolerance test with very early peak, blood glucose tolerance test with very increased peak, blood glucose tolerance test with very reduced peak, blood glucose tolerance test with very suppressed peak, blood glucose tolerance test with very unaltered peak, blood glucose tolerance test with very unchanged peak, blood glucose tolerance test with very variable peak, blood glucose tolerance test with delayed peak, blood glucose tolerance test with early peak, blood glucose tolerance test with increased peak, blood glucose tolerance test with reduced peak, blood glucose tolerance test with suppressed peak, blood glucose tolerance test with unaltered peak, blood glucose tolerance test with unchanged peak, blood glucose tolerance test with variable peak, blood glucose tolerance test with very delayed peak, blood glucose tolerance test with very early peak, blood glucose tolerance test with very increased peak, blood glucose tolerance test with very reduced peak, blood glucose tolerance test with very suppressed peak, blood glucose tolerance test with very unaltered peak, blood glucose tolerance test with very unchanged peak, blood glucose tolerance test with very variable peak, blood glucose tolerance test with delayed peak, blood glucose tolerance test with early peak, blood glucose tolerance test with increased peak, blood glucose tolerance test with reduced peak, blood glucose tolerance test with suppressed peak, blood glucose tolerance test with unaltered peak, blood glucose tolerance test with unchanged peak, blood glucose tolerance test with variable peak, blood glucose tolerance test with very delayed peak, blood glucose tolerance test with very early peak, blood glucose tolerance test with very increased peak, blood glucose tolerance test with very reduced peak, blood glucose tolerance test with very suppressed peak, blood glucose tolerance test with very unaltered peak, blood glucose tolerance
Uses
Duloxetine is a prescription medication used to treat depression, anxiety, and other conditions. It belongs to a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). It works by increasing the levels of serotonin and norepinephrine in the brain, which helps to improve mood and reduce symptoms of depression and anxiety. The recommended starting dose of duloxetine is 30 mg once daily. Your doctor may increase your dose up to 120 mg per day, depending on your response to the medication.
Directions for Use
CAPSULES Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Duloxetine 30 mg Capsules are and what they are used for
2. What you need to know before you take Duloxetine 30 mg Capsules
3. How to take Duloxetine 30 mg Capsules
4. Possible side effects
5. How to store Duloxetine 30 mg Capsules
6. Contents of the pack and other information
1. What Duloxetine 30 mg Capsules are and what they are used for
Duloxetine 30 mg Capsules contain duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSNRI). It is used to treat depression and anxiety.
2. What you need to know before you take Duloxetine 30 mg Capsules
Do not take Duloxetine 30 mg Capsules:
if you are allergic to duloxetine or any of the other ingredients of this medicine (listed in section 6).
if you are taking, or have taken in the last 14 days, any medicine known as a monoamine oxidase inhibitor (MAOI) (used to treat depression).
if you are taking thioridazine (used to treat schizophrenia).
if you are taking linezolid (used to treat bacterial infections).
if you are taking tryptophan (used to treat depression).
if you are taking St John’s wort (used to treat depression).
if you are taking pimozide (used to treat mental illness).
if you are taking tizanidine (used to treat muscle spasms).
if you are taking any other medicines that contain duloxetine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Duloxetine 30 mg Capsules:
if you have liver or kidney problems.
if you have a history of mania or bipolar disorder.
if you have a history of suicidal thoughts or behaviour.
if you have a history of seizures.
if you have a history of bleeding problems.
if you have a history of glaucoma (increased pressure in the eye).
if you have a history of heart problems.
if you are pregnant, planning to become pregnant or are breastfeeding.
if you are taking any other medicines, including medicines obtained without a prescription.
Other medicines and Duloxetine 30 mg Capsules
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription, including herbal medicines.
Some medicines may affect the way Duloxetine 30 mg Capsules work, or Duloxetine 30 mg Capsules may affect how other medicines work.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
medicines used to treat depression or anxiety (e.g. tricyclic antidepressants, SSRIs, SNRIs, MAOIs, lithium, buspirone).
medicines used to treat mental illness (e.g. antipsychotics, lithium).
medicines used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital).
medicines used to treat migraine (e.g. sumatriptan, ergotamine).
medicines used to treat high blood pressure (e.g. beta-blockers, ACE inhibitors, angiotensin II receptor antagonists).
medicines used to treat HIV infection (e.g. ritonavir, nelfinavir, efavirenz).
medicines used to treat fungal infections (e.g. ketoconazole, itraconazole).
medicines used to treat infections (e.g. erythromycin, clarithromycin, telithromycin).
medicines used to treat tuberculosis (e.g. rifampicin).
medicines used to treat pain (e.g. tramadol, fentanyl).
medicines used to treat heart problems (e.g. digoxin, warfarin).
medicines used to treat diabetes (e.g. insulin, metformin).
medicines used to treat thyroid problems (e.g. levothyroxine).
medicines used to treat asthma (e.g. salbutamol, theophylline).
medicines used to treat allergies (e.g. cetirizine, desloratadine).
medicines used to treat Parkinson’s disease (e.g. levodopa).
medicines used to treat urinary incontinence (e.g. oxybutynin).
medicines used to treat narcolepsy (e.g. modafinil).
medicines used to treat gout (e.g. allopurinol).
medicines used to treat cancer (e.g. tamoxifen).
medicines used to treat fungal infections (e.g. fluconazole).
medicines used to treat high cholesterol (e.g. atorvastatin).
medicines used to treat hepatitis C (e.g. boceprevir).
medicines used to treat HIV infection (e.g. ritonavir, nelfinavir, efavirenz).
medicines used to treat fungal infections (e.g. ketoconazole, itraconazole).
medicines used to treat infections (e.g. erythromycin, clarithromycin, telithromycin).
medicines used to treat tuberculosis (e.g. rifampicin).
medicines used to treat pain (e.g. tramadol, fentanyl).
medicines used to treat heart problems (e.g. digoxin, warfarin).
medicines used to treat diabetes (e.g. insulin, metformin).
medicines used to treat thyroid problems (e.g. levothyroxine).
medicines used to treat asthma (e.g. salbutamol, theophylline).
medicines used to treat allergies (e.g. cetirizine, desloratadine).
medicines used to treat Parkinson’s disease (e.g. levodopa).
medicines used to treat urinary incontinence (e.g. oxybutynin).
medicines used to treat narcolepsy (e.g. modafinil).
medicines used to treat gout (e.g. allopurinol).
medicines used to treat cancer (e.g. tamoxifen).
medicines used to treat fungal infections (e.g. fluconazole).
medicines used to treat high cholesterol (e.g. atorvastatin).
medicines used to treat hepatitis C (e.g. boceprevir).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Duloxetine 30 mg Capsules may cause drowsiness, dizziness or blurred vision. If you experience any of these symptoms, do not drive or use any tools or machines.
Duloxetine 30 mg Capsules contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Duloxetine 30 mg Capsules
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one capsule taken once a day.
Swallow the capsule whole with a glass of water.
Do not chew or crush the capsule.
If you take more Duloxetine 30 mg Capsules than you should
If you take more Duloxetine 30 mg Capsules than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.
If you forget to take Duloxetine 30 mg Capsules
If you forget to take a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take your next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop taking Duloxetine 30 mg Capsules
Do not stop taking this medicine without talking to your doctor first. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Duloxetine 30 mg Capsules and see a doctor straight away if you get any of the following symptoms:
allergic reactions such as skin rash, itching or hives, swelling of the face, lips, tongue or throat, difficulty breathing or swallowing.
symptoms of serotonin syndrome such as agitation, confusion, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting or diarrhoea.
symptoms of a serious skin reaction such as blistering, peeling, a rash covering a large area of your body, a rash that looks like small targets (‘bull’s eye’ rash), or a rash with fever or joint pain.
symptoms of a serious liver problem such as yellowing of the skin or whites of the eyes, dark urine, pale stools, loss of appetite, nausea or vomiting.
symptoms of a serious allergic reaction such as swelling of the face, lips, tongue or throat, difficulty breathing or swallowing.
symptoms of a serious eye problem such as blurred vision, changes in colour vision, increased sensitivity to light, or eye pain.
symptoms of a serious heart problem such as chest pain, shortness of breath, fast or irregular heartbeat.
Other side effects include:
Common (may affect up to 1 in 10 people):
headache.
dizziness.
feeling sick (nausea).
diarrhoea.
dry mouth.
constipation.
tiredness.
increased sweating.
decreased appetite.
weight loss.
tremor.
drowsiness.
blurred vision.
difficulty sleeping (insomnia).
sexual problems (decreased libido, difficulty achieving orgasm, delayed ejaculation).
Uncommon (may affect up to 1 in 100 people):
agitation.
anxiety.
restlessness.
confusion.
hallucinations.
abnormal dreams.
increased appetite.
weight gain.
increased blood pressure.
increased heart rate.
abnormal liver function tests.
increased cholesterol.
increased blood sugar.
increased uric acid.
increased prolactin.
increased thyroid hormones.
increased creatine phosphokinase.
increased white blood cell count.
decreased sodium.
decreased potassium.
decreased calcium.
decreased magnesium.
decreased phosphate.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decreased monocytes.
decreased basophils.
decreased haematocrit.
decreased haemoglobin.
decreased platelets.
decreased red blood cell count.
decreased white blood cell count.
decreased neutrophils.
decreased lymphocytes.
decreased eosinophils.
decre
Storage
Duloxetine 30 mg should be stored at a temperature between 15°C and 30°C. It should be kept away from moisture and heat.
Treatment
Duloxetine is an antidepressant medication used to treat major depressive disorder, generalized anxiety disorder, and other conditions. It belongs to a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). It works by increasing the levels of serotonin and norepinephrine in the brain, which helps to improve mood and reduce anxiety.
Duloxetine is usually taken once daily with or without food. The recommended starting dose is 30 mg once daily. The dose may be increased up to 120 mg per day, depending on the individual’s response and tolerability. Common side effects of duloxetine include nausea, dry mouth, constipation, fatigue, and dizziness.
Benefits
CAPSULE
1. It is used to treat depression, anxiety, and pain caused by nerve damage in people with diabetes (diabetic neuropathy).
2. It can also help reduce symptoms of fibromyalgia and chronic musculoskeletal pain.
3. It may help improve your mood, sleep, appetite, and energy level, and decrease nervousness.
4. It can also help reduce the frequency of hot flashes in women who are experiencing menopause.
5. It may help reduce the risk of suicidal thoughts and behavior in people with depression.
6. It may help improve concentration and focus in people with attention deficit hyperactivity disorder (ADHD).
7. It may help reduce symptoms of obsessive-compulsive disorder (OCD).
8. It may help reduce symptoms of post-traumatic stress disorder (PTSD).
Side Effects
Common side effects of duloxetine 30 mg include:
1. Nausea
2. Headache
3. Dry mouth
4. Dizziness
5. Insomnia
6. Constipation
7. Fatigue
8. Decreased appetite
9. Weight gain
10. Sweating
11. Blurred vision
12. Sexual dysfunction
13. Increased blood pressure
14. Abnormal dreams
15. Anxiety
16. Agitation
17. Tremor
18. Increased heart rate
19. Abnormal liver function tests
20. Rash
Precautions and Warnings
Duloxetine 30 mg is a prescription medication used to treat depression, anxiety, and other mental health conditions. It is important to take this medication exactly as prescribed by your doctor.
Common side effects of duloxetine 30 mg include nausea, dry mouth, constipation, fatigue, and decreased appetite. More serious side effects may include increased risk of suicidal thoughts, serotonin syndrome, and liver damage.
Before taking duloxetine 30 mg, tell your doctor if you have any of the following conditions: liver or kidney disease, bipolar disorder, seizures, a history of drug abuse, or if you are pregnant or breastfeeding.
You should not take duloxetine 30 mg if you are taking a monoamine oxidase inhibitor (MAOI) or if you have taken an MAOI within the past 14 days.
Alcohol should be avoided while taking duloxetine 30 mg as it can increase the risk of side effects.
You should not stop taking duloxetine 30 mg suddenly as this can cause withdrawal symptoms. Your doctor will gradually reduce your dose over time.
It is important to tell your doctor about all medications you are taking, including over-the-counter drugs, vitamins, and herbal supplements.
If you experience any serious side effects while taking duloxetine 30 mg, contact your doctor immediately.
How Does It Work?
Duloxetine is an antidepressant medication that belongs to a class of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). It works by increasing the levels of serotonin and norepinephrine in the brain, which are two neurotransmitters that help regulate mood.
Duloxetine is typically prescribed in doses of 30 mg per day. It is usually taken once a day, with or without food. It may take several weeks for the full effects of the medication to be felt. Common side effects of duloxetine include nausea, dry mouth, constipation, and fatigue.
Safety Advice
Pregnancy
Q: Can I take during pregnancy?
It is not recommended to take duloxetine during pregnancy. The U.S. Food and Drug Administration (FDA) has classified duloxetine as a pregnancy category C drug, which means that it may be harmful to an unborn baby. Therefore, it is important to speak with your doctor before taking any medication during pregnancy.
Breast Feeding
Can I take while breastfeeding?
It is not recommended to take duloxetine while breastfeeding. You should consult your doctor before taking any medication while breastfeeding.
Alcohol
Can I consume alcohol with?
No, it is not recommended to consume alcohol while taking duloxetine 30 mg. Alcohol can increase the risk of side effects such as drowsiness, dizziness, and confusion. It can also increase the risk of liver damage. It is best to avoid alcohol while taking this medication.
Driving
Can I drive if I have consumed?
No, you should not drive if you have consumed DULOXETINE 30 MG. DULOXETINE 30 MG can cause drowsiness, dizziness, and blurred vision, which can impair your ability to drive safely. It is best to wait at least 24 hours after taking DULOXETINE 30 MG before driving.
(FAQs)
Q: What is duloxetine 30 mg?
A: Duloxetine 30 mg is an antidepressant medication used to treat depression, anxiety, and other mental health conditions. It belongs to a class of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). It works by increasing the levels of serotonin and norepinephrine in the brain, which can help improve mood and reduce symptoms of depression.