Cymgen Side Effects

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

What is Cymgen?

Cymgen contains the active ingredient Duloxetine hydrochloride.

• Active ingredient — Duloxetine hydrochloride
• Registration number — 41/1.2/1029; 41/1.2/1030
• Registration holder — PHARMACARE LIMITED

It is approved for:

• depression
• diabetic peripheral neuropathic pain (often described as burning, stabbing, stinging, shooting, aching or like an electric shock. There may be loss of feeling in the affected area, or sensations such as touch, heat, cold or pressure that may cause pain)

Common side effects of Cymgen

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

• Lack of appetite including anorexia which is an eating disorder causing people to obsess about weight and what they eat
• trouble sleeping (insomnia)
• less sex drive, abnormal orgasm
• problems getting an erection, and with ejaculation
• anxiety, feeling agitated, also includes feeling jittery, nervousness, restlessness, tension
• sleep disorder, unusual dreams, nightmares
• headache, dizziness, feeling sluggish (lethargy, asthenia, fatigue), drowsiness, increased yawning, tremor
• impaired sense of taste, numbness, tingling, pins and needles
• blurred eyesight
• ringing in the ears (tinnitus)
• increased blood pressure (hypertension), flushing (also includes hot flush)
• constipation, dry mouth, feeling sick (nausea), diarrhoea, being sick (vomiting), heartburn or indigestion, stomach pain, breaking wind
• increased sweating
• muscle pain, muscle spasm
• falls
• feeling tired
• frequent urination
• difficulty or inability to pass urine
• weight loss

Less frequent side effects

• Throat inflammation that causes a hoarse voice
• high blood sugar
• dehydration, low levels of sodium in the blood mostly in elderly people; the symptoms may include feeling dizzy, weak, confused, sleepy or very tired, or feeling or being sick, more serious symptoms are fainting, fits or falls, syndrome of inappropriate secretion of antidiuretic hormone (SIADH), a condition that causes the body to retain water instead of excreting it normally in urine
• excessive grinding of the teeth or clenching of the jaw (bruxism), confusional state (disorientation), feeling indifferent or lacking emotion (apathy)
• over activity, racing thoughts, extremely elevated and excitable mood (mania), aggression and anger
• difficulty concentrating, sudden involuntary jerks or twitches of the muscles, uncontrolled urge to move the legs (restless legs syndrome), poor quality sleep
• large pupils, wide eyes, problems with eyesight, or increased pressure in the eye (glaucoma)
• ear pain, spinning feeling (vertigo)
• Takotsubo cardiomyopathy (a condition affecting heart muscle)
• feeling cold
• low blood pressure
• throat tightness, nose bleeds
• painful swelling and sores inside the mouth, inflammation of the stomach and/or intestine, a stomach infection marked by diarrhoea, cramps, nausea, vomiting and fever leading to bad breath, burping
• night sweats, sensitivity to sunlight, cold sweat, a skin rash caused by contact with a certain substance, hives, increased tendency to bruise
• muscle tightness, muscle twitching, restriction of the range of motion of the jaws
• difficulty to start urinating, needing to pass urine during the night, needing to pass more urine than normal, having a decreased urine flow, abnormal urine odour
• menopausal symptoms, abnormal production of breast milk in men or women
• pain in the testicles
• abnormal vaginal bleeding, abnormal periods, including heavy, painful, irregular or prolonged periods, unusually light or missed periods
• sexual dysfunction
• feeling abnormal, feeling hot, malaise, thirst, gait disturbance
• elevated liver enzymes seen on blood tests with symptoms of stomach pain, dark urine, feeling tired, itching, loss of appetite, nausea and vomiting
• too much fatty substance in your blood (increased blood cholesterol) shown on blood tests
• high potassium levels in your blood with symptoms of tiredness and muscle weakness
• decreased thyroid gland activity which can cause tiredness or weight gain

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 duloxetine or any of the other ingredients of CYMGEN (listed in section 6)
• if you have liver disease
• if you have severe kidney disease
• if you are taking another antidepressant medicine known as monoamine oxidase inhibitor (MAOI) or linezolid. Taking CYMGEN with a MAOI or linezolid could cause serious side effects or be life-threatening
• if you are under 18 years of age
• if you are pregnant or breastfeeding your baby

Use with care, and tell your doctor, if

• If you have thoughts of suicide and worsening of your depression: 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. You may be more likely to think like this if you:
• have previously had thoughts about killing or harming yourself
• are a young adult. Reports have 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 straight away. You may find it helpful to tell a relative or close friend that you are depressed and ask them to read this leaflet. You might ask them to tell you if they think your depressed, or if they are worried about changes in your behaviour
• if you have had previous episodes of seizures (fits)
• if you have had previous episodes of mania (feeling elated or over-excited which causes unusual behaviour)
• if you suffer from bipolar disorder
• if you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) and mydriasis (enlarged pupils)
• if you have kidney problems, you may need a lower dose
• if you are taking any opioid medicines, such as buprenorphine containing medicines, tramadol and pethidine, MAOIs, other antidepressants and antipsychotics. The use of these medicines together with CYMGEN can lead to serotonin syndrome, a potentially life- threating condition with symptoms that may include mental status changes (e.g. agitation, perceiving things that are not there, coma), feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles, fits, vomiting and fast heart rate
• if you are taking St. John’s Wort, a herbal treatment (Hypericum perforatum)
• if you have high blood pressure or heart disease, talk to your doctor. Your doctor will tell you if you should be taking CYMGEN. If you experience increase in blood pressure while taking CYMGEN, your doctor will tell you to reduce the dose or gradually stop taking CYMGEN
• if you experience sexual dysfunction. CYMGEN may cause symptoms of sexual dysfunction. In some cases, these symptoms have continued after stopping treatment
• if you have a 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), or if you are pregnant
• if you are at risk of low sodium levels (for example if you are taking diuretics, especially if you are elderly, dehydrated, or have liver impairment). Signs and symptoms may include dizziness, weakness, feeling sick, vomiting, confusion, drowsiness, and tiredness. Signs and symptoms associated with more severe cases have included fainting and fits
• if you have liver problems or are currently being treated with another medicine which may cause liver damage. You may have liver problems such as jaundice, increased liver enzymes and liver disease if you are taking CYMGEN. Most of these liver problems develop during the first months of treatment and may be linked to high alcohol intake, pre-existing liver disease, or treatment with other medicines which may cause liver damage
• if you are feeling a sensation of restlessness or an inability to sit or stand still after taking CYMGEN. You should tell your doctor if this happens to you
• if you are feeling sudden, severe chest pain (angina), shortness of breath, or irregular heartbeats (arrhythmias), as these may be symptoms of Takotsubo cardiomyopathy. Takotsubo cardiomyopathy (also known as stress cardiomyopathy) is a condition where your heart muscle becomes suddenly weakened, due to your body releasing stress hormones in your blood. This condition is reversible upon stopping CYMGEN and receiving appropriate treatment. It is important for you that your doctor knows about all your medical conditions
• if you are elderly. Exercise caution when taking CYMGEN at high doses (120 mg) to treat depression. Children and adolescents CYMGEN should not be used for children and adolescents under 18 years. Also, you should know that patients under 18 years and young adults (< 25 years of age) 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. If your doctor has prescribed CYMGEN for a patient under 18 years and you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or worsen when patients under 18 years are taking CYMGEN. Also, the long-term safety effects concerning growth, maturation, and mental and behavioural development of duloxetine, as in CYMGEN, in this age group have not yet been established

Pregnancy and breastfeeding

• You should not take CYMGEN if you are pregnant or breastfeeding your baby
• • CYMGEN may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), making the baby breathe faster and appear bluish
• These symptoms usually begin during the first 24 hours after the baby is born
• If this happens to your baby, you should contact your midwife and/or doctor immediately
• • If you take CYMGEN near the end of your pregnancy, your baby might have some symptoms when it is born
• These usually begin at birth or within a few days of your baby being born

Interactions and medicines to check

The approved leaflet names these interactions.

• Monoamine oxidase inhibitors (MAOIs): You should not take CYMGEN if you are taking or have recently taken (within the last 14 days) another antidepressant medicine called a monoamine oxidase inhibitor (MAOI). Examples of MAOIs include moclobemide (an antidepressant) and linezolid (an antibiotic). Taking a MAOI together with CYMGEN can cause serotonin syndrome, a potentially life-threating condition. You must wait at least 14 days after you have stopped taking an MAOI before you can take CYMGEN. Also, you need to wait at least 5 days after you stop taking CYMGEN before you take a MAOI
• Medicines that increase the level of serotonin: triptans, tryptophan, SSRIs (such as paroxetine and fluoxetine), SNRIs (such as venlafaxine), tricyclic antidepressants (such as clomipramine, amitriptyline), St. John’s Wort, MAOIs (such as moclobemide and linezolid) and opioid medicines such as buprenorphine containing medicines, tramadol and pethidine. These medicines increase the risk of side effects such as serotonin syndrome; if you get any unusual symptoms taking any of these medicine together with CYMGEN, you should see your doctor
• Medicines that cause sleepiness: These include medicines prescribed by your doctor including benzodiazepines, strong painkillers, antipsychotics, phenobarbitone and antihistamines
• Oral anticoagulants or antiplatelet medicines: Medicines which thin the blood or prevent the blood from clotting (e.g. warfarin). These medicines might increase the risk of bleeding
• Fluvoxamine used for treatment of obsessive-compulsive disorder
• Quinolone antibiotics used to treat bacterial infections
• Risperidone used to treat schizophrenia and bipolar disorder
• Flecainide, propafenone, and metoprolol used to prevent and treat abnormally fast heart rates
• Oral contraceptives used for birth control
• Highly protein-bound medicines such as phenobarbitone, diazepam, and cefazolin. CYMGEN is highly protein-bound, therefore if you are taking CYMGEN with other highly protein-bound medicines, the medicines may negatively affect one another. CYMGEN with food, drink and alcohol CYMGEN may be taken with or without food. Care should be taken if you drink alcohol while you are being treated with CYMGEN

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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