Cymbalta Capsules

The active substance is duloxetine hydrochloride. CYMBALTA is a serotonin and norepinephrine reuptake inhibitor and increases the levels of serotonin and noradrenaline in the nervous system. CYMBALTA is used in adults to treat

• depression
• diabetic peripheral neuropathic pain.

CYMBALTA may take 2 to 4 weeks to start working in most people with depression. Talk to your doctor if you do not start to feel better after this time. In people with diabetic neuropathic pain, it can take some weeks before you feel better. Talk to your doctor if you do not feel better after 2 months.

Do not take CYMBALTA:

• If you are hypersensitive (allergic) to duloxetine or any of the other ingredients of CYMBALTA (listed in section 6).
• If you are taking or have recently taken within the last 14 days, another antidepressant medicine known as monoamine oxidase inhibitor (MAOI) or linezolid. Taking CYMBALTA with a MAOI or linezolid could cause serious side effects or be life-threatening.
• If you have liver disease.
• If you have severe kidney disease.
• If you are pregnant or breastfeeding your baby.
• If you are under 18 years of age.

Warnings and precautions

Take special care with CYMBALTA:

• If you have thoughts of suicide and worsening of your depression: If you are depressed, 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. 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 antidepressants.
• If you have had previous episodes of mania.
• If you have had previous episodes of seizures/fits.
• If you suffer from bipolar disorder.
• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• If you have or had kidney problems. You may need a lower dose.
• If you have or had liver problems. You may need a lower dose.
• If you have high blood pressure.
• If you are currently being treated with another medicine which may cause liver damage.
• If you have a history of bleeding disorders (tendency to develop bruises), especially if you are pregnant (see ‘Pregnancy and breast-feeding‘).
• If you are at risk of having low sodium levels (for example if you are taking diuretics, especially if you are elderly).
• If you are taking St. John’s Wort ( Hypericum perforatum), a herbal treatment.
• CYMBALTA may cause a sensation of restlessness or an inability to sit or stand still. You should tell your doctor if this happens to you.
• If you are taking other medicines containing duloxetine (see ‘Other medicines and CYMBALTA’).
• CYMBALTA may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

• Do not share medicines prescribed for you with any other person.

• Always take CYMBALTA exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

For depression and diabetic peripheral neuropathic pain:

• The usual dose of CYMBALTA is 60 mg capsule once a day, but your doctor will prescribe the dose that is right for you.
• You can take CYMBALTA with or without food. You should swallow the capsule whole with water.
• Your doctor will tell you how long your treatment with CYMBALTA will last.

If you have the impression that the effect of CYMBALTA is too strong or too weak, talk to your doctor or pharmacist.

If you take more CYMBALTA 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. Symptoms of overdose include sleepiness, coma, serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles), fits, vomiting and fast heart rate.

If you forget to take CYMBALTA

If you miss a dose, take it as soon as you remember. However if it is time for your next dose, skip the missed dose and take only a single dose as usual. Do not take more than your total daily dose in any 24-hour period. Do not take a double dose to make up for forgotten individual doses.

If you stop taking CYMBALTA

Do not stop taking your capsules without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need CYMBALTA, he will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether. Some patients who stop taking CYMBALTA suddenly have had symptoms such as dizziness, fatigue, tingling feelings like pins and needles, sleep disturbances (nightmares, inability to sleep, vivid dreams) feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, feeling irritable, diarrhoea, excessive sweating or vertigo. These symptoms are usually not serious and disappear within a few days, but if you have symptoms that are troublesome you should ask your doctor for advice.

CYMBALTA can have side effects. Not all side effects reported for CYMBALTA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking CYMBALTA, please consult your doctor, pharmacist or other healthcare professional for advice.

If any of the following happens, stop taking CYMBALTA 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,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to CYMBALTA. You may need urgent medical attention or hospitalisation.

Tell your doctor if you notice any of the following:

Frequent side effects:

• Headache
• Feeling sleepy
• Dry mouth
• Feeling sick (nausea)
• Lack of appetite
• Trouble sleeping, anxiety, feeling agitated, less sex drive, difficulty or failure to experience orgasm, unusual dreams
• Dizziness, feeling sluggish, tremor, numbness, prickling or tingling of the skin
• Blurred eyesight
• Tinnitus (hearing sound in the ear when there is no external sound)
• Feeling the heart pumping in the chest
• Increased blood pressure, flushing
• Increased yawning
• Constipation, diarrhoea, being sick (vomiting), heartburn or indigestion, stomach pain, breaking wind
• Increased sweating, feeling itchy
• Muscle pain, muscle spasm
• Frequent urination, painful urination
• Problems getting an erection, changes in ejaculation
• Falls (mostly in elderly people), feeling tired
• Weight loss

Less frequent side effects:

• Throat inflammation that causes a hoarse voice
• Suicidal thoughts
• Difficulty sleeping, grinding or clenching the teeth, feeling disorientated, lack of motivation
• Difficulty concentrating, changes in sense of taste, sudden involuntary jerks or twitches of the muscles, poor sleep quality, restless leg syndrome
• Large pupils (dark centre of the eye), problems with eyesight, dry eye
• Feeling of dizziness or “spinning” (vertigo), ear pain
• Fast and/or irregular heartbeat
• Fainting, dizziness, light-headedness or fainting on standing up, cold fingers and/or toes, nose bleeds
• Burping, inflammation of the stomach and/or intestines, bleeding of the stomach and/or intestines, difficulty swallowing
• Night sweats, sensitivity to sunlight, cold sweat, inflammation of the skin when in contact with a substance, contact dermatitis, increased tendency to bruise
• Muscle tightness, muscle twitching
• Difficulty or inability to pass urine, difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow
• Changes in ejaculation, abnormal sexual function,
• Feeling abnormal, feeling cold, feeling hot, thirst, chills, abnormal gait
• Increased liver enzymes, increased weight
• Decreased thyroid gland activity which can cause tiredness or weight gain
• Dehydration
• Irregular involuntary contraction of muscles
• Throat tightness
• Inflammation of the mucous membranes of the mouth, bad breath
• Abnormal urine odour
• Pain in the testicles, abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods, menopausal symptoms
• Increased blood cholesterol
• Sudden onset of chest pain, difficulty breathing, palpitations, nausea and/or vomiting, in response to stress.

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 or pharmacist. You can also report side effects to SAHPRA via the “ 6.04 Adverse Drug Reaction Form ”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 . Alternatively, report suspected adverse events to the company at [email protected]. By reporting side effects, you can help provide more information on the safety of CYMBALTA.

Store all medicines out of reach of children. Store at or below 30 °C in original blister packs. Do not use after expiry date stated on the carton. Store in the original carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).