Sertraline 100mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Sertraline 50mg & 100mg film-coated Tablets Sertraline hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you:
- Keep this leaflet as you may wish 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 signs of illness are the same as yours.
- If you get any side effects talk to your doctor or pharmacist. This includes possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Sertraline film-coated Tablets are and what they are used for
2. What you need to know before you take Sertraline film-coated Tablets
3. How to take Sertraline film-coated Tablets
4. Possible side effects
5. How to store your Sertraline film-coated Tablets
6. Contents of the pack and other information
1. What Sertraline film-coated Tablets are and what they are used for_
Sertraline is one of a group of medicines called selective serotonin re-uptake inhibitors (SSRI) antidepressants. Sertraline is used to treat:
• depression and prevention of recurrence of depression (in adults)
• social anxiety disorder (in adults)
• post traumatic stress disorder (in adults)
• panic disorder (in adults)
• obsessive compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years old).
2. What you need to know before you take Sertraline film-coated Tablets
Do not take Sertraline:
• if you are allergic (hypersensitive) to Sertraline or any of the other ingredients in Sertraline film-coated Tablets (listed in Section 6). An allergy may include rash, itching, swollen face or lips or shortness of breath
• if you are taking or have taken medicines called 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
• if you are taking pimozide (a medicine for mental disorders such as psychosis).
Warnings and precautions
Talk to your doctor or pharmacist before taking Sertraline
• if you have epilepsy or have had a fit in the past; if you have a fit (seizure) or experience an increase in seizure frequency, contact your doctor immediately, the use of Sertraline might need to be discontinued
• if you have suffered from manic depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor immediately, the use of sertraline might need to be discontinued
• if you have or have previously had thoughts of harming or killing yourself (see below - Thoughts of suicide or worsening of your depression or anxiety disorder)
• if you 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. Possible side effects). Your doctor will have told you whether you have suffered from this in the past
• if you have low sodium levels in your blood, since this can occur as a result of treatment with Sertraline film-coated Tablets. You should also tell your doctor if you are taking certain medicines for hypertension, since these medicines may also alter the sodium levels in your blood
• if you are elderly as you may be more at risk of having low sodium levels in your blood (see above)
• if you have liver disease; your doctor may decide that you should have a lower dose of Sertraline film-coated Tablets
• if you have diabetes; your blood glucose levels may be altered due to Sertraline film-coated Tablets and your diabetes medicines may need to be adjusted
• if you have suffered from bleeding disorders or have been taking medicines which thin the blood (e.g. acetylsalicylic acid (aspirin) or warfarin) or may increase the risk of bleeding
• if you are a child or adolescent under 18 years old. Sertraline film-coated Tablets should only be used to treat children and adolescents aged 6-17 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)
• if you are having Electroconvulsive therapy (ECT)
• if you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)
• If you 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 If you stop taking Sertraline film-coated Tablets 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. 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
• 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.
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 are treated with this class of medicines. Nevertheless, it is possible that your doctor decides to prescribe Sertraline film-coated Tablets to a patient under 18 if it is in the patient’s interest.
If your doctor has prescribed Sertraline film-coated Tablets 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 film-coated Tablets, you should inform your doctor. Also, the long-term safety of Sertraline film-coated Tablets in regard to growth, maturation and learning (cognitive) and behavioural development in this age group has not yet been demonstrated.
Other medicines and Sertraline
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines can affect the way Sertraline film-coated Tablets work, or Sertraline film-coated Tablets themselves can reduce the effectiveness of other medicines taken at the same time.
Taking Sertraline film-coated Tablets with the following medicines may cause serious side effects:
• medicines called monoamine oxidase inhibitors (MAOIs) like moclobemide(to treat depression) and 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 film-coated Tablets together with these medicines
• medicines to treat mental disorders such as psychosis (pimozide). Do not use Sertraline film-coated Tablets together with pimozide.
Talk to your doctor if you are taking the following medicines:
• herbal medicines containing St. John’s Wort (Hypericum perforatum). The effects of St. John’s Wort may last for 1-2 weeks
• products containing the amino acid tryptophan
• medicines used to treat severe pain (e.g. tramadol)
• medicines used in anaesthesia or to treat chronic pain (fentanyl)
• medicines used to treat migraines (e.g. sumatriptan)
• blood thinning medicine (warfarin)
• medicines used to treat pain/arthritis (Non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen, naproxen, diclofenac, acetylsalicylic acid (aspirin))
• sedatives (diazepam)
• diuretics (also called ‘water’ tablets)
• medicines to treat epilepsy (phenytoin, phenobarbital, carbamazepine)
• medicines to treat diabetes (tolbutamide)
• medicines to treat excessive stomach acid, ulcers and heartburn (cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole)
• medicines to treat mania and depression (lithium)
• other medicines to treat depression (such as imipramine, desipramine, amitriptyline, nortriptyline, nefazodone, fluoxetine, fluvoxamine)
• medicines to treat schizophrenia and other mental disorders (such as perphenazine, levomepromazine and olanzapine)
• medicines used to treat high blood pressure, chest pain or regulate the rate and rhythm of the heart (such as verapamil, diltiazem, flecainide, propafenone)
• medicines used to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin, erythromycin)
• medicines used to treat fungal infections (such as ketoconazole, itraconazole, posaconazole, voriconazole, fluconazole)
• medicines used to treat HIV/AIDS and Hepatitis C (protease inhibitors such as ritonavir, telaprevir)
• medicines used to prevent nausea and vomiting after an operation or chemotherapy (aprepitant)
• medicines known to increase the risk of changes in the electrical activity of the heart (e.g. some antipsychotics and antibiotics).
Sertraline with food, drink and alcohol
You should avoid alcohol while you are taking this medicine. You can take your tablets with or without food. Sertraline should not be taken in combination with grapefruit juice, as this may increase the level of sertraline in your body.
Pregnancy, breastfeeding and fertility Pregnancy
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.
If you are a woman of childbearing age, you are advised to use contraception whilst taking Sertraline tablets. Make sure your midwife and/or doctor know you are on Sertraline. When taken during pregnancy, particularly in the last 3 months of pregnancy, 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.
Breast-feeding
Sertraline is excreted in breast milk and can cause side effects in babies. You should only breast-feed if it is clearly necessary. If breastfeeding is continued, your doctor may prescribe a lower dose of Sertraline.
Fertility
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
Some medicines may affect your judgement or coordination. Do not drive or use machinery unless you are sure that you are not affected.
3. How to take Sertraline film-coated Tablets
Sertraline may be prescribed for depressive illness (adults only), obsessive compulsive disorder (OCD) and post traumatic stress disorder (adults only).
Your doctor will tell you how many tablets to take, and when to take them. The tablets should not be chewed or crushed; they should always be swallowed whole, with a drink of water.
Dosage information
Your doctor may start you on lower strength of Sertraline (e.g. 25 mg), but check with your doctor or pharmacist if you are not sure of the correct dose.
• Depression: The recommended dose is 50 mg daily. Your doctor will review and adjust your dosage if necessary. The dose should be increased carefully to ensure that you receive the lowest effective dose. You may not feel better immediately when you first start taking your medicine for depression. This is usual because an improvement in depressive symptoms may not occur until after the first few weeks. Patients with depression should be treated for a period of at least 6 months.
• OCD: The recommended adult and adolescent (13-17yr old) dose is 50 mg daily; children aged 6-12yr old should only initially be given 25 mg daily. Your doctor/specialist will review and adjust your dosage if necessary. When appropriate the dosage can be gradually increased up to a maximum of 200 mg.
• PTSD, Panic Disorder and Social Anxiety Disorder: The recommended dose is 25 mg daily increasing to 50 mg a day after a week. Your treatment will be reviewed if there is no improvement after a few weeks.
Sertraline should NOT be used in children under the age of 6
If you take more Sertraline film-coated Tablets than you should
If you take too many tablets, go to your nearest hospital emergency department (or casualty) or tell your doctor straight away. Always take the labelled medicine package with you, whether there is any medication left or not. Symptoms of overdose include: nausea, vomiting, seizures, heart problems (like irregular heart beat and cardiac arrest), lung problems and change in mental condition ranging from agitation to coma.
If you forget to take Sertraline film-coated Tablets
If you forget to take your dose, do not worry. Take your next dose the next day at the usual time. Do not take a double dose to make up for a forgotten individual dose. Taking your medicine at the same time each day may help you to remember to take it regularly.
If you stop taking Sertraline film-coated Tablets
Always follow your doctor’s instructions on how many Sertraline film-coated Tablets to take and for how long to take them. Keep taking your medicine until your doctor asks you to stop. Do not stop taking your medicine without asking your doctor first, even when you start to feel better. Make sure you do not run out of tablets.
When your doctor does instruct you to stop taking Sertraline he/she will help you to reduce your dose slowly over one to two weeks - this should help reduce the chance of withdrawal effects.
You may notice the following effects when you stop taking Sertraline: dizziness; tingling feelings like pins and needles; sleep disturbances (vivid dreams, nightmares, inability to sleep); feeling restless or agitated; unusual tiredness or weakness; feeling anxious; nausea/vomiting (feeling sick/being sick); tremor (shakiness); headaches.
Most people find that any symptoms on stopping Sertraline (under guidance from your doctor) are mild and go away on their own within a few weeks. If you experience symptoms when you stop treatment, contact your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Sertraline may sometimes cause side effects, as well as the effects that are needed.
Tell your doctor immediately if:
• you have distressing thoughts, thoughts of harming yourself or committing suicide
• you get a rash or an allergic reaction such as itching, swollen lips, tongue or face, wheezing or shortness of breath. If this happens, stop taking the tablets straight away and 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 treatment in these cases
• a combination of symptoms (known as Serotonin Syndrome), including unexplained fever with faster breathing or heart rate, sweating, muscle stiffness or tremor, confusion, extreme agitation or sleepiness (only rarely)
• 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 film-coated Tablets. You should tell your doctor if you start to feel restless
• if you have a fit (seizure)
• if you have a manic episode (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): Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation failure, fatigue.
Common (may affect up to 1 in 10 people):
• sore throat, poor appetite, increased appetite
• depression, feeling strange, nightmare, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding
• numbness and tingling, shaking, joint pain, abnormal taste, lack of attention
• visual disturbance, ringing in ears
• palpitations, hot flush, yawning
• abdominal pain, vomiting, constipation, upset stomach, gas
• rash, increased sweating, muscle pain, muscle tension, erectile dysfunction, chest pain, malaise
Uncommon (may affect up to 1 in 100 people):
• chest cold, runny nose
• hypersensitivity
• low thyroid hormones
• hallucinations, abnormally high mood, lack of caring, thinking abnormal, aggression
• convulsion, involuntary muscle contractions, abnormal coordination, moving a lot, amnesia, decreased feeling, speech disorder, feeling dizzy when you stand up, fainting, migraine
• enlarged pupils, ear pain, fast heartbeat, high blood pressure, flushing
• breathing difficulty, possible wheezing, shortness of breath, nose bleed
• inflammation of the oesophagus, difficulty swallowing, haemorrhoids, increased saliva, tongue disorder, burping
• eye swelling, bruising, face oedema, hair loss, cold sweats, dry skin, hives, itching
• osteoarthritis, muscular weakness, back pain, muscle twitching
• night time urination, unable to urinate, increase in urination, increase in frequency of urination, problem urinating, urinary incontinence
• vaginal haemorrhage, sexual dysfunction, female sexual dysfunction, menstrual irregularities, swelling in legs, chills, fever, weakness, thirst, increase in liver enzyme levels, weight decreased, weight increased.
Rare (may affect up to 1 in 1,000 people):
• intestine problem, ear infection, cancer, swollen glands, high cholesterol, low blood sugar
• physical symptoms due to stress or emotions, drug dependence, psychotic disorder, paranoia, suicidal thoughts, sleep walking, premature ejaculation
• severe allergic reaction
• coma, abnormal movements, difficulty moving, increased sensation, sensory disturbance
• glaucoma, tear problems, spots in front of the eyes, double vision, light hurts eye, blood in the eye, problems controlling blood sugar levels (diabetes)
• heart attack, slow heartbeat, heart problem, poor circulation of arms and legs, closing up of throat, breathing fast, breathing slow, difficulty talking, hiccups
• blood in stool, sore mouth, tongue ulceration, tooth disorder, tongue problem, mouth ulceration, problems with liver function
• skin problems with blisters, hair rash, hair texture abnormal, skin odour abnormal, bone disorder
• decreased urination, urinary hesitation, blood in urine
• excessive vaginal bleeding, dry vaginal area, red painful penis and foreskin, genital discharge, prolonged erection, breast discharge
• hernia, drug tolerance decreased, 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).
After marketing sertraline, the following side effects have been reported:
• decrease in white blood cells, decrease in clotting cells, endocrine problems, low blood salt, increase in blood sugar levels
• terrifying abnormal dreams, suicidal behaviour
• 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), progressive scarring of lung tissue (Interstital Lung Disease), pancreatitis, serious liver function problems, yellow skin and eyes (jaundice)
• skin oedema, skin reaction to sun, muscle cramps, breast enlargement, problems with clotting, abnormal laboratory tests, bedwetting, light-headedness, fainting, or chest discomfort which could be a sign of changes in the electrical activity (seen on electrocardiogram) or abnormal rhythm of the heart.
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.
Symptoms that can occur when treatment is discontinued
If you suddenly stop taking this medicine you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking (see section 3 “If you stop taking Sertraline film-coated Tablets”).
An increased risk of bone fractures has been observed in patients taking this type of medicine.
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 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 film-coated Tablets
This medicinal product does not require any special storage conditions. Do not use Sertraline film-coated Tablets after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Keep your Sertraline film-coated Tablets in a safe place out of the sight and reach of children. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Sertraline film-coated Tablets contain
• The active substance is sertraline hydrochloride
• The other ingredients are cellulose microcrystalline, calcium hydrogen phosphate dihydrate, colloidal silica, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, polysorbate 80, hypromellose, titanium dioxide (E171), propylene glycol.
What Sertraline film-coated Tablets look like and contents of the pack
Sertraline 50mg and 100mg film-coated Tablets are white tablets, and marked with either “50” or “100” on one side, and ‘S’ and ‘ET’ on the other side.
Your Sertraline film-coated Tablets are presented in blister packs. They are supplied in boxes containing 28, 30 or 100 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Dr. Reddy’s Laboratories (UK) Ltd, 6 Riverview Road, Beverley, HU17 0LD, UK
This leaflet was last updated in 01/2015 Dr Reddy’s Laboratories (UK) Ltd