Sertraline 50 Mg Film-Coated Tablets
If you stop taking Sertraline
Do not stop taking Sertraline until your doctor tells you to. It is important to keep taking your medicine, even if you feel better.
If you stop taking it abruptly, you may experience withdrawal symptoms such as dizziness, numbness and tingling, sleep disturbances, weakness, agitation or anxiousness, feeling or being sick, shaking and headache. These symptoms are usually mild and short-lived.
Your doctor may gradually reduce your dose over several weeks at the end of treatment.
Like all medicines, Sertraline can cause side effects, although not everybody gets them.
Nausea is the most common side effect. The side effects depend on the dose and often disappear or lessen
with continued treatment.
Tell your doctor immediately:
• if you develop a 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.
• if you have allergic reaction which may cause skin rash, itching, red and raised lumps (hives), wheezing, swelling of your face or tongue leading to difficulty in breathing or swallowing.
• if you develop yellow skin and eyes which may mean liver damage.
• if you start to get feelings of restlessness and are not able to sit or stand still after you start to take sertraline. You should tell your doctor if you start to feel restless.
• if you feel more depressed or have thoughts of harming or killing yourself (suicidal thoughts).
• if you develop fits or epilepsy, or experience an increase in seizure frequency.
• if you experience fever, probably with rapid heartbeat, blood pressure, sweating, muscle stiffness, diarrhoea, confusion, restlessness and agitation These are symptoms of serotonin syndrome. In rare cases this syndrome may occur when you are taking certain medicines at the same time as sertraline. Your doctor may wish to stop your treatment.
• if you feel elated or over-excited which causes unusual behavior, mania (see section 2, "Warnings and Precautions”).
The following side effects were seen in clinical trials in adults.
Very common (may affect more than 1 in 10 people)
• difficulty sleeping (insomnia)
• dizziness, sleepiness, headache
• diarrhoea, feeling sick (nausea), dry mouth
• failure to ejaculate
• fatigue
Common (may affect up to 1 in 10 people)
• sore throat
• loss of or increased appetite, malaise
• depression, feeling detached, nightmare, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding
• tingling or numbness, shaking, increased muscle tension, taste disturbance, lack of attention
• visual disturbance, ringing in ears
• awareness of heartbeats (palpitations), hot flush, yawning
• abdominal pain, being sick (vomiting), constipation, indigestion, wind
• rash, increased sweating, muscle pain, joint pain
• erectile dysfunction
• chest pain
Uncommon (may affect up to 1 in 100 people)
• chest infection, runny nose
• hallucination, feeling too happy, lack of interest, abnormal thinking, aggression
• uncontrolled shaking (convulsions), involuntary muscle contractions, abnormal coordination, hyperactivity, memory loss, decreased sensitivity, speech disorder, dizziness on standing up, passing out, migraine
• enlarged pupils
• ear pain, rapid heartbeat, high blood pressure, flushing
• breathing difficulties, possible wheezing, shortness of breath, nose bleed
• inflammation of the food pipe, difficulty swallowing, piles, increased saliva, tongue disorder, burping
• swelling around the eyes, purple spots on skin, face oedema, hair loss, cold sweat, dry skin, hives, itching
• osteoarthritis, muscular weakness, back pain, muscle twitching
• passing urine at night, unable to urinate, passing large volumes of urine, frequent urination, problems urinating, urinary incontinence
• vaginal bleeding, female sexual dysfunction, sexual dysfunction, menstrual irregularities, swelling in legs, increase in liver enzyme levels
• chills, fever, weakness, thirst
• low thyroid hormones
• weight increase or decrease
Rare (may affect up to 1 in 1,000 people)
• intestine problem, ear infection, cancer, swollen glands, high cholesterol, low blood sugar or problems controlling blood sugar levels (diabetes)
• physical symptoms due to stress or emotions, drug dependence, psychotic disorder, aggression, paranoia, suicidal thoughts, sleep walking, premature ejaculation
• Coma, abnormal movements, difficulty moving, increased sensation, sensory disturbance
• eye conditions that affect vision (glaucoma), tear problems, blind spots in front of eyes, double vision, sensitivity to light, blood in the eye
• heart attack, slower heart beat, heart problem, poor circulation in arms and legs, closing up of the throat, breathing fast, breathing slow, noisy breathing, voice disorder, hiccups
• black tarry stools or blood in stools, inflammation of the mouth or tongue, tooth disorder, tongue disorder, ulceration of the mouth or tongue, abnormal liver function
• severe allergic reactions, skin inflammation, skin problem with blisters, hair rash, abnormal hair texture, abnormal skin odour, bone disorder
• decreased urination, urinary hesitation, blood in urine
• excessive vaginal bleeding, vaginal dryness, inflammation of the penis and foreskin, genital discharge, prolonged erection, secretion of breast milk
• hernia, decreased drug tolerance, difficulty walking, semen abnormal, increase in blood cholesterol levels, injury, relaxation of blood vessels procedure
• cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 2)
Not Known (frequency cannot be estimated from the available data)
• reduction in the number of white blood cells, reduction in clotting cells, endocrine problem, low blood salt, increase in blood sugar levels
• high levels of prolactin hormone, inappropriate antidiuretic hormone secretion
• muscular movement problems (such as moving a lot, tense muscles, difficulty walking and stiffness, spasms and involuntary movements of the muscles), sudden severe headache (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS))
• vision abnormal, unequal sized pupils
• bleeding problems (such as stomach bleeding or blood in urine), progressive scarring of lung tissue (Interstitial lung disease), inflammation of the pancreas, serious liver problems (such as inflammation of the liver, yellowing of the skin or whites of the eyes caused by liver)
• skin oedema, sensitivity to sun, muscle cramps, enlargement of male breast tissue, bedwetting
• abnormal clinical laboratory results, problems with clotting
• light headedness, fainting, or chest discomfort which could be signs of changes in the electrical activity (electrocardiogram) or abnormal rhythm of the heart
• Increased risk of bone fractures
Additional 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.
Withdrawal symptoms:
When you stop taking this medication you may experience withdrawal symptoms. This is most likely if you stop taking your medicine suddenly. Withdrawal symptoms include dizziness, numbness and tingling, sleep disturbances, agitation, headache, shaking, feeling or being sick and anxiety (see section 3 "If you stop taking sertraline”).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow card Scheme website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP), which is stated on the label or carton. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Sertraline tablets contain
The active substance is Sertraline hydrochloride. The other ingredients are anhydrous colloidal silica, microcrystalline cellulose, croscarmellose sodium, co-povidone, lactose, magnesium stearate, hypromellose, hydroxypropyl cellulose, titanium dioxide (E171) and macrogol 400.
What Sertraline tablets look like and contents of the pack
Sertraline 50 mg tablets are white to off-white capsule shaped biconvex film-coated tablets, scored on one side and marked '50' on the other side. The tablet can be divided into equal doses.
Sertraline 100 mg tablets are white to off-white capsule shaped biconvex film-coated tablets, scored on one side and marked '100' on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
The tablets come in blister packs of 28, 30, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder: Chelonia Healthcare Ltd., 11 Boumpoulinas, Nicosia, P.C. 1060, Cyprus Manufacturer: DDSA Pharmaceuticals Ltd., 310 Old Brompton Road, London, SW5 9JQ, United Kingdom
For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 03/2016.
CL0148-0149/O/PIL/CL4
PACKAGE LEAFLET: INFORMATION FOR THE USER
SERTRALINE 50 mg & 100 mg FILM-COATED TABLETS
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.
WHAT IS IN THIS LEAFLET
1. What Sertraline is and what it is used for
2. What you need to know before you take Sertraline
3. How to take Sertraline
4. Possible side effects
5. How to store Sertraline
6. Contents of the pack and other information
Sertraline Tablets contain the active substance sertraline hydrochloride. Sertraline belongs to a group of medicines called selective serotonin re-uptake inhibitors, (SSRIs); these medicines are used to treat depression and/or anxiety disorders.
Sertraline is used to treat:
• depression and prevention of recurrence of depression (in adults)
• obsessive-compulsive disorder, (OCD) (in adults and children and adolescents aged 6-17 years)
• post-traumatic stress disorder, (PTSD) (in adults)
• panic / social anxiety disorder (in adults)
Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic experience, and has some symptoms that are similar to depression and anxiety. Social anxiety disorder (social phobia) is an illness linked to anxiety. It is characterised by feelings of intense anxiety or distress in social situations (for example: talking to strangers, speaking in front of groups of people, eating or drinking in front of others or worrying that you might behave in an embarrassing manner).
Your doctor has decided that this medicine is suitable for treating your illness.
If you are not sure why you have been prescribed these tablets then please ask your doctor.
Do not take Sertraline and tell your doctor if you:
• are allergic (hypersensitive) to Sertraline or any of the other ingredients (listed in section 6 of this leaflet). The signs of an allergic reaction can include rash, itching, swollen lips or face, or shortness of breath
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• are taking other medicines to treat depression known as monoamine oxidase inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs (such as linezolid). If you stop treatment with sertraline, you must wait until at least one week 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)
Warnings and Precautions
Talk to your doctor or pharmacist before you take Sertraline if you:
• have epilepsy (fit) or have ever had a fit (seizure).
• have suffered from manic depressive illness (bipolar disorder) 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 Serotonin Syndrome. In rare cases this syndrome may occur when you are taking certain medicines at the same time as sertraline. (For symptoms, see section 4). Your doctor will have told you whether you have suffered from this in the past.
• have low sodium level in your blood, since this can occur as a result of treatment with sertraline. You should also tell your doctor if you are taking certain medicines for hypertension, 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 level in your blood (see above).
• have liver disease; your doctor may decide that you should have a lower dose of sertraline.
• have diabetes, as sertraline can alter your blood glucose levels and your diabetes medicines may need to be adjusted.
• have a history of bleeding disorders or are taking medicines which thin the blood (e.g. aspirin or warfarin) or may increase the risk of bleeding (see 'Taking other medicines').
• are a child or adolescent under 18 years old. Sertraline should only be used to treat children and adolescents aged 1-17 years old, suffering from obsessive compulsive disorder (OCD). If you are being treated for this disorder, your doctor will want to monitor you closely (see below children and adolescents).
• are having electro-convulsive therapy (ECT).
• have eye problems, such as certain kinds of glaucoma (increased pressure in the eye).
• have been told that you have an abnormality of your heart tracing after an electrocardiogram (ECG) known as prolonged QT interval.
Restlessness/Akathisia:
The use of sertraline has been linked to a 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 so if you develop such symptoms you should talk to your doctor.
Withdrawal reactions:
Side effects relating to stopping treatment (withdrawal reactions) are common, particularly if the treatment is stopped suddenly (see section 3 and section 4). 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. In general, such symptoms disappear on their own and wear off within 2 weeks. In some patients they may last longer (2-3 months or more). When stopping treatment with sertraline it is recommended to reduce the dose gradually over a period of 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
• 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 (OCD). Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, thoughts of harming or killing themselves (suicidal thoughts) and hostility (mainly aggressiveness, oppositional behaviour and anger) when they take this class of medicines. 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 you and you are less than 18 years old and you want to discuss this, please contact him/her. Furthermore, if any of the symptoms listed above appear or worsen while you are taking sertraline, you should inform your doctor. Also, the long-term safety of sertraline in regard to growth, maturation and learning (cognitive) and behavioural development in this age group has not yet been demonstrated
Other medicines and Sertraline Tablets
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how sertraline tablets work:
Taking sertraline together with the following medicines may cause serious side effects:
• medicines to treat depression known as monoamine oxidase inhibitors (MAOIs) such as Moclobemide (to treat depression) or selegiline (to treat Parkinson's disease), the antibiotic linezolid and methylene blue (to treat high levels of methaemoglobin in the blood). Do not use sertraline together with these medicines
• medicines to treat mental disorders such as psychosis (pimozide). Do not use sertraline together with pimozide
Talk to your doctor if you are taking the following medicines:
• medicines containing amino acid such as tryptophan
• herbal medicine containing St. John's Wort (Hypericum perforatum). The effects of St. John's Wort may last for 1-2 weeks
• medicines to treat mania and depression (lithium)
• other medicines to treat depression (amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)
• medicines to stop blood clots from forming (warfarin)
• medicines to treat migraine (sumatriptan or frovatriptan)
• medicines to treat pain/arthritis (Non-steroidal anti-inflammatory drugs (NSAIDs), Aspirin, Ibuprofen or Indometacin)
• medicines to treat Parkinson's disease such as rasagiline or selegiline (MAOI-type B)
• medicines to treat epilepsy (carbamazepine, lamotrigine or phenytoin)
• medicines used to suppress appetite (fenfluramine or sibutramine)
• medicines to treat anxiety (diazepam)
• medicines to treat diabetes (glibenclamide, tolbutamide)
• medicines to treat bacterial infections such as antibiotics (rifampicin, clarithromycin, telithromycin, erythromycin)
• medicines to treat fungal infections (ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole)
• medicines used to treat viral infections (HIV/AIDS, Hepatitis C) such as ritonavir or darunavir
• medicines to treat severe pain (tramadol)
• medicines to treat heartburn and gastric ulcers (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole)
• medicines to prevent nausea and vomiting after an operation or chemotherapy
• medicines used in anaesthesia or to treat chronic pain (fentanyl)
• medicines for excretion of excess water and electrolytes (Diuretics, also called 'water' tablets)
• medines to treat high blood pressure, chest pain or regulate the rate and rhythm of the heart (such as verapamil, diltiazem, flecainide, propafenone)
• medicines to treat schizophrenia and other mental disorders (perphenazine, levomepromazine and olanzapine)
• medicines known to increase the risk of changes in the electrical activity of the heart (antipsychotics and antibiotics)
Sertraline with food, drink and alcohol
Sertraline tablets can be taken with or without food.
AVOID ALCOHOL whilst taking sertraline.
Sertraline should not be taken in combination with grapefruit juice, as this may increase the level of sertraline in your body.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
The safety of sertraline has not fully been established in pregnant women. Sertraline will only be given to you when pregnant if your doctor considers that the benefit for you is greater than any possible risk to the developing 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.
Make sure your midwife and/or doctor know you are on sertraline. When taken during pregnancy, particularly in the last 3 months, medicines like Sertraline may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the new born (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.
Your newborn baby might also have other conditions, which usually begin during the first 24 hours after birth. Symptoms include:
• trouble with breathing,
• a blueish skin or being too hot or cold,
• blue lips,
• vomiting or not feeding properly,
• being very tired, not able to sleep or crying a lot,
• stiff or floppy muscles,
• tremors, jitters or fits,
• increased reflex reactions, irritability,
• low blood sugar
If your baby has any of these symptoms when it is born, or you are concerned about your baby's health, contact your doctor or midwife who will be able to advise you.
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.
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
Antidepressants, such as Sertraline, may influence your ability to drive or use machines. Do not drive or operate machinery unless you know how this medication affects your ability to perform these activities.
Sertraline tablets contain lactose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take Sertraline tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
• your doctor will decide your dose and length of treatment, as it depends on your condition
• it may take several weeks of treatment before you notice an improvement in your symptoms
• treatment of depression should usually continue for 6 months after improvement
The recommended dose is:
Adults:
Depression and obsessive compulsive disorder
The usual starting dose is 50 mg daily. If required, the daily dose may be increased in 50mg increments and at intervals of at least one week over a period of weeks gradually up to a maximum of 200 mg daily.
Panic disorder, social anxiety disorder and post-traumatic stress disorder:
For panic disorder, social anxiety disorder and post-traumatic stress disorder, the usual starting dose is 25 mg daily, increased after one week to 50 mg daily. If required, the daily dose may be increased in 50 mg increments over a period of weeks gradually up to a maximum of 200 mg daily.
Elderly patients:
The usual adult doses may be used. However, your doctor will increase your dose with more caution. Patients with liver problems:
Your doctor may prescribe a lower or less frequent dose
Use in children and adolescents (under the age of 18):
Sertraline must only be used to treat children and adolescents suffering from OCD aged 6-17 years old. Obsessive compulsive disorder
Children aged 6 - 12 years: the usual starting dose is 25 mg daily increasing to 50 mg daily after 1 week. If required, your doctor may increase the dose gradually up to a maximum of 200 mg daily. Adolescents aged 13 - 17 years: the usual starting dose is 50 mg daily. If required, your doctor may increase the dose gradually up to a maximum of 200 mg daily.
Sertraline is not recommended for use in children under 6 years of age.
Method of administration:
The tablets should only be taken by mouth. Swallow the tablets whole with a glass of water. The tablets should be taken once daily either in the morning or evening. It is best to take them at the same time every day.
If you take more Sertraline than you should
If you take too many tablets consult your doctor at once or the nearest hospital casualty department immediately. Take this leaflet and the container with you so they know what has been taken.
Symptoms of an overdose include: drowsiness, feeling sick, being sick, rapid heartbeat, shaking, agitation, dizziness and less frequently coma.
If you forget to take Sertraline
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, do not take the missed dose. Just take the next dose at the right time.