Dyna Sertraline Film-Coated Tablets

Sertraline is one of a group of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders. DYNA SERTRALINE is indicated for the treatment of:

• depression and panic disorder in adults
• Obsessive Compulsive Disorder (OCD) in adults and children (aged 13 - 17 years), a condition identified by unwanted, but stubbornly persistent thoughts, and/or unreasonable rituals you feel compelled to repeat.

Do not take DYNA SERTRALINE:

• if you are hypersensitive (allergic) to sertraline, or to any of the ingredients of DYNA SERTRALINE (see section 6)
• if you are taking other medicines for depression called monoamine oxidase inhibitors (MAOIs, e.g., selegiline, moclobemide and linezolid), or have taken them at any time within the last two weeks. Your doctor will advise you on how you should begin taking DYNA SERTRALINE once you have stopped taking the MAOI. You should also not start taking MAO inhibitors for at least 7 days after DYNA SERTRALINE treatment is terminated
• if you are pregnant or breastfeeding your baby (see Pregnancy, breastfeeding and fertility)
• if you are taking a medicine called pimozide (to treat a mental disorder), as DYNA SERTRALINE may cause a serious irregular heartbeat when taken in combination with these medicines, which can be fatal
• if you have a severe liver or kidney disorder or disease
• if you have a condition called porphyria (an enzyme disorder with symptoms such as severe abdominal pain, pain in your chest, back or legs, vomiting or a rapid heartbeat)
• DYNA SERTRALINE should not be used for children and adolescents under the age of 18 years except for children between 13 - 17 years who are being treated for Obsessive Compulsive Disorder (OCD) (see Take special care with DYNA SERTRALINE).

Warnings and precautions

Take special care with DYNA SERTRALINE:

• if you take other medicines to treat mood disorders, as you may be at risk of serotonergic syndrome (a condition with symptoms such as agitation or restlessness, dilated pupils and heavy sweating)
• if you are taking other similar medicines for a mental condition, as this may lead to Neuroleptic Malignant Syndrome, a life-threatening condition with symptoms such as rigid muscles and fever
• if you are taking, or have taken in the last two weeks, any medicines called monoamine oxidase inhibitors (MAOIs), like selegiline (to treat Parkinson’s disease), moclobemide (to treat depression), linezolid (an antibiotic) and methylene blue
• if you are switching from another antidepressant medicine
• if you are taking other medicines containing tryptophan (a herbal supplement for depression), fenfluramine (used in the management of obesity), other 5-HT agonists (used for depression) or St John’s Wort (a herbal supplement for depression)
• if you have been told that you have an abnormality of your heart rhythm known as prolonged QT interval (after an electrocardiogram (ECG))
• if you have episodes of hypomania or mania (overactive behaviour or thoughts)
• if you have suffered from manic depressive illness (bipolar disorder) or schizophrenia
• if you suffer from epilepsy or seizures (fits)
• 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, such as DYNA SERTRALINE, since these medicines take time to work (usually about two weeks but sometimes longer)
• if you have previously had thoughts about killing or harming yourself
• if you have any thoughts of harming or killing yourself at any time, contact your doctor immediately or go to a hospital straight away. Your doctor will monitor your treatment and your progress carefully for the first few weeks
• if you are taking medicine to prevent the clotting of blood, or are prone to bleeding easily, as DYNA SERTRALINE may increase the risk of bleeding
• if you are pregnant and your doctor has prescribed DYNA SERTRALINE for you in the month before your baby is due, there is a risk of excessive bleeding after childbirth
• if you are taking a water tablet (as in some medicines used for hypertension), tell your doctor, since these medicines may alter the sodium level in your blood
• if you stop taking your DYNA SERTRALINE tablets suddenly, you may experience withdrawal effects (see POSSIBLE SIDE EFFECTS). Do not stop taking DYNA SERTRALINE without talking to your doctor
• if you experience a feeling of restlessness, usually within the first few weeks of treatment (see POSSIBLE SIDE EFFECTS)
• if you have kidney or liver problems.
• if you are an elderly patient DYNA SERTRALINE may alter the sodium level in your blood
• if you have diabetes, as the dosage of your medicine may have to be adjusted
• if you are having electro-convulsive therapy (brain stimulation with electric currents to treat depression)
• if you drink grapefruit juice, it may affect the way DYNA SERTRALINE works
• if you need to undergo urine or blood tests, as DYNA SERTRALINE may affect the results (false positive banned substance results in urine tests)
• if you suffer from glaucoma (an eye condition that can result in the damage of the optic nerve)
• if you have a problem with low body weight
• if you have a recent history of heart disease or had a heart attack.

Do not share medicines prescribed for you with any other person. Always take DYNA SERTRALINE exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

The dose of DYNA SERTRALINE will be different for each patient and depends on what the medicine is being used for, and if other medicines are also being used at the same time. Your doctor will decide the appropriate dose for your condition. The tablets should be swallowed whole with a glass of water and should be taken at the same time each day.

Children

The use of DYNA SERTRALINE in children is not recommended, other than in children between 13 - 17 years with OCD. Your doctor will tell you how long your treatment with DYNA SERTRALINE will last. Do not stop treatment early because may experience withdrawal symptoms (see If you stop taking DYNA SERTRALINE).

If you have the impression that the effect of DYNA SERTRALINE is too strong or too weak, tell your doctor or pharmacist.

If you take more DYNA SERTRALINE 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. Take this leaflet and the rest of the remaining tablets with you so the doctor will know what you have taken. Symptoms of overdose may include:

• drowsiness, nausea and vomiting, rapid heart rate, shaking, agitation, dizziness and in rare cases unconsciousness.

If you forget to take DYNA SERTRALINE

If you miss a dose, take it as soon as you remember. Do not take DYNA SERTRALINE if it has been more than 12 hours since you missed your last dose. Wait and take the next dose at your regular time. Do not take a double dose to make up for forgotten individual doses.

If you stop taking DYNA SERTRALINE

Do not stop taking DYNA SERTRALINE unless your doctor tells you to. Your doctor will want to gradually reduce your dose of DYNA SERTRALINE over several weeks, before you finally stop taking this medicine. If you suddenly stop taking DYNA SERTRALINE you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick (nausea), being sick (vomiting) and shaking.

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

If any of the following happens, stop using DYNA SERTRALINE 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.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to DYNA SERTRALINE. 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:

• yellowing of the skin and eyes, also called jaundice
• fast irregular or slow heartbeat, chest pain
• high blood pressure or low blood pressure (feeling dizzy when standing up)
• increased infections
• lack of ability to urinate, loss of bladder control, passing more or less urine than is normal for you
• abnormal bleeding of skin, eye or stomach
• feeling anxious (especially children)
• panic attacks
• thinking of killing yourself (suicidal ideation) and suicidal behaviour
• blurred or abnormal vision, dilated pupils or glaucoma (high eye pressure)
• feeling confused
• having hallucinations (strange visions or sounds)
• seizures, shivering, excessive sweating
• liver damage or failure, inflammation of the liver (hepatitis), with symptoms such as fatigue, loss of appetite and muscle or joint ache
• severe skin rash that causes blistering (erythema multiforme), (this can affect the mouth and tongue). These may be signs of a condition known as Stevens-Johnson Syndrome, or Toxic Epidermal Necrolysis (TEN). Your doctor will stop your treatment in these cases
• memory loss, impaired concentration, coma.

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:

• sore throat
• increased or decreased appetite, weight loss
• nervousness, depression, depersonalisation (a feeling where your thoughts and feelings seem unreal or not to belong to yourself), inability to sit still, decreased sex drive
• headache, feeling dizzy or shaky (tremors), not sleeping well (insomnia) or feeling sleepy, tingling or pricking sensation (pins and needles), stiff muscles, metallic taste
• ringing or buzzing in the ears
• hot flush
• yawning
• feeling sick, diarrhoea, constipation, abdominal pain, excessive gas (wind), dry mouth, indigestion, anorexia (eating disorder, characterised by low weight, fear of gaining weight and strong desire to be thin), being sick
• rash, increased sweating
• muscle and joint pain
• ejaculation delay or failure to ejaculate
• fever, generally feeling tired or unwell.

Less frequent side effects:

• runny or blocked nose, throat and sinus infection, diverticulitis (an infected pouch in the colon), middle ear infection
• neoplasm (abnormal growth of tissue)
• abnormal blood, heart and urine test results
• underactive thyroid (you may feel depressed, tired or experience memory loss)
• increased or decreased blood sugar levels, increased cholesterol, milky nipple discharge, milk production when not pregnant or breastfeeding
• aggression, intense excitement or happiness, lack of interest, thinking abnormally, paranoia, medicine dependence, sleep walking
• increase or decrease in sense of touch, twitching, speech disorder, loss of coordination, migraine (very severe headache), abnormal coordination, moving a lot, amnesia, dizziness while standing up, abnormal movements, difficulty moving, increased sensation, sensory disturbance
• inability to produce tears, discomfort, or pain of the eyes due to light exposure, partial loss of vision or seeing black dots, double vision, blood in the eye
• ear pain
• sinusitis, bronchitis, coughing, nose bleeds, difficulty speaking due to a disorder of the mouth, tongue, throat or vocal cords, hiccups
• difficulty swallowing, haemorrhoids, excessive saliva, bloody or black, tarry stools, inflamed tongue, tongue and mouth ulcer, tooth disorders
• hair loss or abnormal texture of hair, skin odour, cold sweats, dry skin, swelling of the face, purple spots on the skin, rash, itching, blisters
• muscle weakness, back pain, muscle twitching, bone disorders
• urinating more at night or after waking, burning sensation when urinating
• sexual dysfunction or spontaneous flow of milk from the breasts, inflamed vagina or inflamed penis in uncircumcised males, painful erection, painful or abnormal menstruation, abnormal discharge, premature ejaculation, dry vaginal area
• thirst, chills, hernia (a condition by which part of an organ is displayed and protrudes on the outside of the body, usually the intestine), decrease of tolerance to medicine, swelling of the legs, fever
• injury
• relaxation of blood vessels procedure.

The following side effects have been reported but the frequency for them to occur is not known:

• increased secretion of a hormone which causes imbalance of salt and fluid levels (antidiuretic hormone), elevated prolactin levels in the blood
• delusions, confused and disturbed thoughts
• heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy in section 2 for more information
• morbid dreams and nightmares, teeth grinding, Serotonin Syndrome (with symptoms including agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and rapid heartbeat), sudden severe headache (which may be a sign of a serious condition known as reversible cerebral vasoconstriction syndrome)
• absence of, or decrease in, body movements
• unequal pupils, optic neuritis (eye pain or problems seeing colours), cataract (clouding of the eyes which affects vision)
• pancreatitis (inflammation of the pancreas characterised by abdominal pain that feels worse after eating, tenderness when touching the abdomen, nausea and vomiting), black or tarry stool, bright red blood in vomit, cramps in the abdomen, dark or bright red blood mixed with stool
• sensitivity of the skin to sunlight
• muscle cramps, bone fractures, lockjaw, muscle injury where the muscles break down (rhabdomyolysis)
• breast enlargement in men, heavy bleeding after childbirth
• abnormal laboratory readings, abnormal platelet function test
• bone fracture.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Store all medicines out of reach of children. Store at or below 25 °C. Store in a cool dry place. Do not remove the blisters from the carton until required for use. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).