Cymgen 30 mg Capsules

CYMGEN belongs to a group of medicines called antidepressants. CYMGEN is a serotonin and norepinephrine reuptake inhibitor (SNRI) and increases the levels of serotonin and noradrenaline in the nervous system. CYMGEN is used in adults to treat:

• 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).

Do not take CYMGEN:

• 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 (see ‘Other medicines and CYMGEN’).
• if you are under 18 years of age.
• if you are pregnant or breastfeeding your baby.

Warnings and precautions

Take special care with CYMGEN:

• 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 (see ‘Do not take CYMGEN’). The use of these medicines together with CYMGEN can lead to serotonin syndrome, a potentially life-threatening 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 (see ‘Other medicines and CYMGEN’),
• 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 (see section 4). 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 (see ‘Pregnancy and breastfeeding’),
• 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 (see ‘Do not take CYMGEN’). 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.

Do not share medicines prescribed for you with any other person. Always take CYMGEN exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

CYMGEN is for oral use.

For depression and diabetic peripheral neuropathic pain: The usual dose of CYMGEN is 60 mg once a day. Your doctor will prescribe the dose that is right for you. If you suffer from depression, CYMGEN may take 2 to 4 weeks to start working. Talk to your doctor if you do not start to feel better after this time. If you have diabetic peripheral neuropathic pain, it can take some weeks before you feel better. Talk to your doctor if you do not feel better after 2 months. Your doctor will tell you how long your treatment with CYMGEN will last. Do not stop treatment early. If you have the impression that the effect of CYMGEN is too strong or too weak, tell your doctor or pharmacist.

If you stop treatment early, you may have withdrawal symptoms, especially if you stop suddenly. Common withdrawal symptoms include dizziness, sensory disturbances (including pins and needles or electric shock-like sensations, especially in the head), sleep disturbances (including lack of sleep and intense dreams, nightmares), tiredness, drowsiness, agitation or anxiety, feeling sick and/or vomiting, tremor, headache, muscle aches and pain, irritability, diarrhoea, excessive sweating, and spinning sensation.

If you take more CYMGEN 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 rare 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 CYMGEN Do not take a double dose to make up for forgotten individual doses. If you stop taking CYMGEN Do not stop taking CYMGEN without the advice of your doctor even if you feel better. If your doctor thinks that you no longer need CYMGEN, your doctor will ask you to reduce your dose over at least 2 weeks before stopping treatment altogether. Some patients who stop taking CYMGEN suddenly have had symptoms such as: dizziness, tingling feelings like pins and needles or electric shock-like feelings (particularly in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), fatigue, sleepiness, feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), shaking (tremor), headaches, muscle pain, feeling irritable, diarrhoea, excessive sweating or vertigo. These symptoms are usually not serious and occur within the first few days of stopping treatment. But they may be severe in some patients. These symptoms have also been reported in patients who have missed a dose. If you have symptoms that are troublesome you should ask your doctor for advice.

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

If any of the following happens, stop taking CYMGEN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting,
• blistering of the skin, mouth, eyes and genitals as these may be due to a serious allergic reaction known as Stevens-Johnson Syndrome (SJS).

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

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Thoughts of harming or killing yourself (suicidal behaviour), perceiving things that are not there (hallucinations),
• fit, seizure (convulsions),
• a rare reaction which may cause feelings of great happiness, drowsiness, clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles (serotonin syndrome),
• fast/slow or irregular heartbeat,
• increase in blood pressure that can lead to a stroke (hypertensive crisis),
• chest pain, dry cough, shortness of breath, especially with activity,
• bleeding in the stomach, passing of fresh blood in the stools, inflammation of the large intestine that causes persistent watery diarrhoea,
• liver disease with symptoms of stomach pain and swelling, and yellowing of the skin or whites of the eyes (jaundice),
• lesions and/or ulcers in the skin,
• excessive vaginal bleeding shortly after birth (postpartum haemorrhage).

These are all serious side effects. You may need urgent medical attention.

Tell your doctor if you notice any of the following:

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.

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, pharmacist or nurse. You can also report side effects to SAHPRA: via the “6.04 Adverse Drug Reactions Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8 Aspen Pharmacare: E-mail: [email protected] Tel: 0800 118 088/+27 (0)11 239 - 6200 By reporting side effects, you can help provide more information on the safety of CYMGEN.

Store all medicines out of reach of children. Store at or below 30 °C in blister packs. Do not store in a bathroom. Do not use after the expiry date stated on the label.

Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).