Sertraline 50 Mg Film-Coated Tablets
PATIENT INFORMATION LEAFLET
SERTRALINE 50mg and lOOmg Film-Coated Tablets
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Sertraline Tablets are and what they are used for
2. Before you take Sertraline Tablets
3. How to take Sertraline Tablets
4. Possible side effects
5. How to store Sertraline Tablets
6. Further information
1. What Sertraline Tablets are and what they are used for
These tablets contain the active ingredient sertraline. 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.
This medicine is used in adults to treat depression and prevent recurrence of depression, and to treat social anxiety disorder, post traumatic stress disorder (PTSD) and panic disorder. It is also used to treat obsessive compulsive disorder (OCD) in adults and children and adolescents aged 6-17 years old.
2. Before you take Sertraline Tablets Do not take these tablets if you:
• are allergic to sertraline or to any of the other ingredients in the tablets
• are taking or have taken in the last 2 weeks any medicines called monoamine oxidase inhibitors (MAOIs) such as selegiline (to treat Parkinson's disease) or moclobemide (to treat depression) or MAOI like drugs such as linezolid (an antibiotic). If you stop treatment with sertraline, you must wait until at least one week has passed before you start treatment with a MAOI. After stopping treatment with a MAOI, you must wait at least 2 weeks before you can start treatment with sertraline
• are taking another medicine called pimozide
(a medicine for mental disorders such as psychosis). Check with your doctor before taking these tablets if you:
• have epilepsy or a history of seizures. If you have a fit (seizure), contact your doctor immediately
• have suffered from mania or hypomania, or schizophrenia. If you have a manic episode, contact your doctor immediately
• have or have previously had thoughts of harming or killing yourself (see below - Thoughts of suicide and worsening of your depression or anxiety disorder)
• have low sodium levels in your blood, since this can occur as a result of treatment with sertraline.
You should also tell your doctor if you are taking diuretics (water tablets), since these medicines may also alter the sodium level in your blood
• are elderly as you may be more at risk of having low sodium levels in your blood
• have liver disease. Your doctor may decide that you should take a lower dose of sertraline
• have diabetes. The dose of your diabetes medicine may need to be adjusted
• have suffered from bleeding disorders or you are taking any medicines which thin the blood or which may increase the risk of bleeding (e.g. acetylsalicylic acid (aspirin) or warfarin)
• have or have a history of glaucoma.
• are having electro-convulsive therapy (ECT).
Tell your doctor or pharmacist if you are taking other medicines including any that you can buy without a prescription. This is particularly important if you are taking any of the medicines referenced under “Do not take” or “Check with your doctor” or any of the following:
• other medicines to treat depression or mania (e.g. tryptophan, lithium, amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)
• medicines to treat migraines (e.g. sumatriptan)
• a herbal medicine containing St. John’s Wort (Hypericum perforatum)
• medicines used to regulate the rate and rhythm of the heart (e.g. flecainide, propafenone)
• medicines to treat schizophrenia and other mental disorders (e.g. perphenazine, levomepromazine and olanzapine)
• medicines to treat severe pain (e.g. tramadol)
• medicines to treat blood clotting (e.g. warfarin, ticlopidine)
• medicines to treat pain/arthritis (Non steroidal antiinflammatory drugs (NSAIDs) such as ibuprofen or acetylsalicylic acid (aspirin))
• sedatives (e.g. diazepam)
• diuretics (also called ‘water' tablets)
• phenytoin, carbamazepine or phenobarbital (to treat epilepsy)
• medicines to treat diabetes (e.g. tolbutamide)
• cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole (to treat excessive stomach acid and ulcers)
• clarithromycin, telithromycin, erythromycin, rifompicin (to treat infections)
• fluconazole, ketoconazole, itraconazole, posaconazole, voriconazole (to treat fungal infections)
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• medicines for HIV infection or Hepatitis C
• fentanyl (an anaesthetic or to treat chronic pain)
• aprepitant (to treat nausea and vomiting)
• diltiazem and verapamil (to treat high blood pressure or angina).
Other special warnings: Restlessness/Akathisia: The use of sertraline has been linked to an unpleasant or distressing restlessness and need to move, often being unable to sit or stand still (akathisia). This is most likely to occur during the first few weeks of treatment. Increasing the dose may be harmful and make these feelings worse, so if you develop such symptoms you should tell your doctor.
Serotonin Syndrome or Neuroleptic Malignant Syndrome:
In rare cases Serotonin Syndrome or Neuroleptic Malignant Syndrome may occur. The risk of this occurring is increased if you are taking certain other medicines at the same time as sertraline.
(For symptoms, see section 4. Possible side effects). Withdrawal reactions: Withdrawal reactions are common when treatment is stopped, particularly if stopped suddenly (see section 3 - Stopping Sertraline Tablets and withdrawal effects and section 4 Possible side effects). The risk of withdrawal symptoms depends on the length of treatment, dosage, and the rate at which the dose is reduced. Generally, such symptoms are mild to moderate. However, they can be serious in some patients.
They normally occur within the first few days after stopping treatment. Symptoms usually disappear within 2 weeks but may take up to 2-3 months in some people. When stopping treatment with sertraline it is recommended the dose should be gradually reduced over several weeks or months, and you should always discuss the best way of stopping treatment with your doctor.
Thoughts of suicide and worsening of your depression or anxiety disorder:
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
• 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 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 or have an anxiety disorder, and ask them to read this leaflet.
You might ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behaviour.
Use in children and adolescents: Sertraline should not usually be used in children and adolescents less than 18 years old, except for patients with Obsessive Compulsive Disorder. Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, suicidal thoughts and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this class of medicine. Nevertheless, it is possible that your doctor decides to prescribe sertraline to a patient under 18 if it is in the patient’s interest. If your doctor has prescribed sertraline to a patient less than 18 years old and you want to discuss this, please contact him/her. Furthermore, if any of the symptoms listed above appear to worsen when a patient under 18 is taking sertraline, you should inform your doctor.
Also, the long-term safety of sertraline in regard to growth, maturation and cognitive and behavioural development in this age group has not yet been demonstrated.
Alcohol: Avoid alcohol while taking this medicine. Grapefruit juice: Do not take this medicine in combination with grapefruit juice, as this may increase the level of sertraline in your body. Pregnancy and breast-feeding: Check with your doctor before taking this medicine if you are pregnant or breast feeding. Make sure your midwife and/or doctor know you are taking sertraline. When taken during pregnancy, particularly in the last 3 months of pregnancy, this medicine 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.
There is evidence that sertraline passes into human breast milk. Sertraline should only be used in women during breast-feeding if your doctor considers that the benefit exceeds any possible risk to the baby.
If you are a woman capable of having children you should use a reliable method of contraception (such as the contraceptive pill), when taking sertraline.
Some medicines like sertraline may reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but impact on human fertility has not been observed as yet.
Driving and using machines: Sertraline may influence your ability to drive or use machines. Do not drive or operate machinery, until you know how this medication affects your ability to perform these activities.
Urine screening tests: If you are to have a urine screening test make sure the doctor performing the test knows you are taking this medicine, as it may affect the result.
3. How to take Sertraline Tablets
Swallow your tablets whole with a drink of water. The tablets may be taken with or without food. Take the tablets once daily either in the morning or evening. The recommended dose should not be exceeded.
Your doctor will decide the dose that is best for you. The pharmacist’s label will also tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.
Do not suddenly stop taking this medicine as you may experience withdrawal symptoms (see “Stopping Sertraline Tablets” at the end of this section).
The usual dose is:
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Depression and Obssessive Compulsive Disorder: The usual dose is 50 mg/day.
Panic disorder, Social anxiety disorder and Post Traumatic Stress Disorder: Treatment should be started at 25 mg/day, and increased to 50 mg/day after one week.
Your doctor may then increase your daily dose by 50 mg increments at intervals of at least one week over a period of weeks up to a maximum of 200 mg/day. Children and adolescents Sertraline must only be used to treat children and adolescents suffering from OCD aged 6-17 years old. Obsessive Compulsive Disorder Children aged 6 to 12: The recommended starting dose is 25 mg/day and increased to 50 mg/day after one week.
Adolescents aged 13 to 17: The recommended starting dose is 50 mg daily.
The daily dose may then be increased in 50 mg increments and at intervals of at least one week over a period of weeks. The maximum recommended dose is 200 mg/day.
If you have liver or kidney problems, please tell your doctor and follow the doctor's instructions.
Your doctor will advise you on how long to take this medicine for. This will depend on the nature of your illness and how well you are responding to the treatment. It may take several weeks before your symptoms begin to improve. Treatment of depression should usually continue for 6 months after improvement.
If you have taken too many Sertraline Tablets:
Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
If you forget to take Sertraline Tablets:
If you forget to take a dose of this medicine, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at the usual time. DO NOT TAKE TWO DOSES AT THE SAME TIME.
Stopping Sertraline Tablets and withdrawal effects:
This medicine should not be stopped suddenly; keep taking it until your doctor tells you how to reduce the dose slowly. If you stop taking the tablets suddenly you may experience the following withdrawal effects: dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking. If you experience any of these side effects, or any other side effects whilst stopping taking sertraline, please speak to your doctor.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.The side effects depend on the dose and often disappear or lessen with continued treatment. Nausea is the most common side effect.
If you notice any of the following effects tell your doctor straightaway:
• severe skin reactions that cause rash, peeling or blistering which may also 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
• itchy skin rash, breathing problems, wheezing, swollen eyelids, face, throat or lips. These may be signs of an allergic reaction
• agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating, rapid heartbeat, rigid muscles, tremors, delirium.
These may be symptoms of a serious condition (Serotonin Syndrome or Neuroleptic Malignant Syndrome). In rare cases the syndrome may occur when you are taking certain medicines at the same time as sertraline. Your doctor may wish to stop your treatment with sertraline
• yellowing of the skin or whites of the eyes, pale stools and dark urine, loss of appetite, stomach discomfort caused by liver or blood problems, changes in liver function (detected by blood tests)
• feeling more depressed, including thinking about harming or killing yourself
• feeling restless or are unable to sit or stand still
• sudden severe headache
• shortness of breath (this may be due to inflammation or scarring of the lungs)
• you have a fit (seizure)
• you have a manic episode.
The following other effects have been reported:
Very common (may affect more than 1 in 10 people):
• difficulty sleeping, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, problems ejaculating, tiredness.
Common (may affect less than 1 in 10 people):
• depression, feeling strange, anxious, agitated or nervous, decreased sexual interest, nightmares, teeth grinding
• sore throat, loss of appetite or increased appetite
• muscle tension or pain, numbness and tingling, shaking, abnormal taste, lack of attention
• visual disturbance, ringing in ears
• chest pain, palpitations, hot flush, yawning
• abdominal pain, vomiting, constipation, upset stomach, flatulence
• sexual or erectile dysfunction
• rash or acne, increased sweating.
Uncommon (may affect less than 1 in 100 people):
• hallucination, feeling too happy, lack of caring, abnormal thoughts
• convulsions (fits), memory loss, speech disorder, involuntary muscle contractions, abnormal coordination, decreased feeling, dizziness while standing up, migraine
• fast heartbeat, high blood pressure, flushing, nosebleed
• purple spots on skin, eye swelling, hair loss, cold sweat, dry skin, hives
• night-time urination, unable to urinate, increase in urination, increase in frequency of urination, problem urinating
• inflammation of the oesophagus, difficulty swallowing, increased saliva, tongue disorder, burping, haemorrhoids
• joint pain, swelling or stiffness, muscular weakness or twitching, back pain
• chest cold, runny nose, ear pain
• vaginal bleeding, female sexual dysfunction, breast pain, cystitis
• feeling generally unwell, chills, fever, weakness, thirst, weight decreased or increased.
Rare (may affect less than 1 in 1,000 people):
• abnormal tissue masses (growths), enlarged lymph nodes (swollen glands), low blood sugar or high cholesterol levels, intestinal problems, ear infection
• drug dependence, psychosis (loss of contact with reality), feeling paranoid, suicidal thoughts, aggression, sleep walking, premature ejaculation
• coma, abnormal movements or difficulty moving, increased sensations
• increased pressure inside the eye (glaucoma), tear problems, spots in front of eyes, double vision, light hurting the eyes, blood in the eyes, enlarged pupils
• heart problems including heart attack, slow heart beat and poor circulation
• closing up of throat, breathing problems, difficulty talking, hiccups
• bloody stools, sore or ulcerated mouth or tongue, problems with the teeth
• abnormal hair texture or skin odour, bone disorder
• decreased urination, urinary incontinence, urinary hesitation
• abnormally heavy or prolonged menstruation, dry vaginal area, red painful penis and foreskin, genital discharge or abnormal semen, prolonged erection, production of breast milk
• hernia, injection site scarring, drug tolerance decreased, difficulty walking, increase in liver enzymes, widening of blood vessels
• cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 2).
Other side effects reported are:
• changes in blood cells or platelets which may increase the risk of bleeding or bruising and make infections more likely
• underactive thyroid gland which can cause tiredness or weight gain, high levels of prolactin in the blood which may cause fertility problems, loss of interest in sex and menstruation problems, decreased secretion of the antidiuretic hormone which may make you urinate more frequently
• low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma
• terrifying abnormal dreams
• muscular movement problems (such as moving a lot, tense muscles, uncontrolled or abnormal movements), fainting
• bleeding problems (such as stomach bleeding, or blood in urine), inflammation of the pancreas which causes severe pain in the abdomen and back
• high blood sugar levels or problems controlling blood sugar levels (diabetes)
• increased sensitivity to sunlight, itching, muscle cramps, breast enlargement in males, menstruation irregularities, swelling of the ankles, feet or fingers, problems with blood clotting, unequal pupils.
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Side effects in children and adolescents:
In clinical trials with children and adolescents, the side effects were generally similar to adults (see above). The most common side effects in children and adolescents were headache, insomnia, diarrhoea and feeling sick.
Do not be concerned by this list of side effects, you may not get any of them.
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sertraline Tablets
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information
Ingredients:
Sertraline Tablets contain sertraline hydrochloride equivalent to either 50 mg or 100 mg of sertraline as the active ingredient. The other ingredients are: calcium hydrogen phosphate, microcrystalline cellulose, hydroxypropylcellulose, sodium starch glycollate and magnesium stearate. The coating contains titanium dioxide (E171), hypromellose, macrogol 400 and polysorbate 80.
What the medicine looks like:
Sertraline 50mg film-coated tablets are white, capsule shaped, film-coated tablets marked ‘A’ on one side and ‘81’with a scoreline on the other. Sertraline 100mg film-coated tablets are white, capsule shaped, film-coated tablets marked 'A' on one side and ‘82’ with a scoreline on the other. This medicine is available in pack sizes of 28 or 56 tablets. Not all pack sizes may be marketed.
Who makes this medicine and holds the Product Licence:
Crescent Pharma Ltd, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK.
Date leaflet revised: October 2015.
If you would like this leaflet in a different format please contact the licence holder at the above address.