Sertraline 100 Mg Tablets
Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine.
• Keep this leaflet you may need to read it again.
• If you have further questions, please 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 any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Important things that you need to know about Sertraline Tablets:
• Sertraline Tablets treats depression and anxiety disorders in adults (over 18 years). Like all medicines it can have unwanted effects. It is important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment.
• Tell a close friend or relative that you are taking Sertraline Tablets and ask them to read this leaflet. Ask them to tell you if they are worried that you are behaving differently whilst you are taking Sertraline Tablets. It is important that you receive the right treatment and you should see your doctor again if you feel any worse.
• Sertraline Tablets will not work straight away. You may feel worse at first and it could be at least two weeks before you start to feel any better. You should be seeing your doctor regularly and it may take several weeks to find the best dose for you.
• Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse or have thoughts of harming or killing yourself at any time, see your doctor or go to a hospital straight away (see Section 2).
• You should not change your dose or stop taking Sertraline Tablets unless your doctor tells you to. If you stop taking Sertraline Tablets suddenly or miss a dose, you may get withdrawal effects (see Section 3).
• If you are pregnant or planning to get pregnant, talk to your doctor. See section 2: Pregnancy, Breast-feeding and Fertility, inside this leaflet.
• Seek medical help at once if you have difficulty in breathing, swelling of the face, lips, tongue or throat (that causes difficulty in swallowing or breathing), severe itching of the skin (with raised lumps) or fast, irregular heart beat and fainting which could be symptoms of a life-threatening heart condition (see section 4).
• If you feel restless and feel like you cannot sit or stand still, tell your doctor. Increasing the dose of Sertraline Tablets may make these feelings worse (see section 4).
Now read the rest of this leaflet. If you have more questions, ask your doctor or pharmacist (chemist).
You may also find it helpful to contact a self-help group, or patient organisation, to find out more about
your condition. Your doctor will be able to give you details.
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
Sertraline is one of a group of medicines called selective serotonin reuptake inhibitors (SSRIs). These work by bringing the level of serotonin in the brain, back up to normal. Low levels of serotonin are thought to be a cause of depression and related disorders.
Sertraline is used to treat symptoms of :-
Depression (feelings of sadness, tearfulness, inability to sleep or enjoy life as you once used to) including the accompanying symptoms of anxiety;
Obsessive-compulsive disorder (OCD) an illness linked to anxiety in which you can become constantly troubled by persistent ideas (obsessions), that make you carry out repetitive rituals (compulsions);
Post traumatic stress disorder (PTSD) which can occur after a very emotionally traumatic experience. Some of the symptoms of PTSD may be similar to those of depression and anxiety.
2. BEFORE YOU TAKE SERTRALINE TABLETS
Do not take Sertraline Tablets if:
• you are allergic (hypersensitive) to sertraline or any of the other ingredients in the tablets (these are listed in Section 6, Further Information).
• you are taking a monoamine oxidase inhibitor drug (MAOI) for depression or have stopped taking one within the last two weeks.
Examples of MAOIs include selegiline and moclobemide
• you are taking a medicine called pimozide (for the treatment of schizophrenia or psychosis)
• you have a liver disorder
• you are a child or adolescent under 18 years suffering from depression Take special care with Sertraline Tablets
Before you take Sertraline Tablets you should tell your doctor:
• If you have suffered from manic depressive illness (bipolar disorder) or schizophrenia. If you have a manic episode, contact your doctor immediately.
• If you have or have previously had thoughts of harming or killing yourself (see below-Important information about Sertraline Tablets and thoughts of suicide and worsening of your depression or anxiety disorder).
• 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).
• If you have low sodium level in your blood, since this can occur as a result of treatment with Sertraline Tablets. 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.
• Take special care if you are elderly as you may be more at risk of having low sodium level in your blood
• If you are a child or adolescent under 18 years old. Sertraline 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.
• if you have epilepsy or are receiving ECT (electroconvulsive therapy)
• if you suffer from diabetes, as your insulin/medication may need adjusting
• if you have kidney problems
• if you have suffered from bleeding disorders or have been taking medicines to thin the blood (e.g. acetylsalicyclic acid (aspirin), or warfarin) or may increase the risk of bleeding
• if you are pregnant, planning to become pregnant or you suspect you are pregnant
• if you are breast-feeding
• if you have angle-closure glaucoma or history of glaucoma
Sertraline can affect the results of some blood, urine or other tests. It may not affect all tests. If you have a blood or urine test done, tell the doctor or medical staff that you are taking Sertraline Tablets.
Important information about Sertraline Tablets and 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.
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 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.
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 are treated with this class of medicines. Nevertheless, it is possible that your doctor decides to prescribe Lustral to a patient under 18 if it is in the patient's interest. If your doctor has prescribed Sertraline 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 tablets, you should inform your doctor. Also, the long-term safety of Sertraline tablets in regard to growth, maturation and learning (cognitive) and behavioural development in this age group has not yet been demonstrated.
Taking other medicines
You should tell your doctor if you are taking or have recently taken any of the following medicines, including medicines obtained without a prescription, as they may increase or decrease the effect of your Sertraline Tablets.
Taking Sertraline Tablets together 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 Tablets together with these medicines.
• Medicines to treat mental disorders such as psychosis (pimozide). Do not use Sertraline Tablets together with pimozide.
Talk to your doctor if you are taking the following medicines:
• Herbal medicine 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 to treat severe pain (e.g. tramadol).
• Medicines used in anaesthesia or to treat chronic pain (fentanyl).
• Medicines to treat migraines (e.g. sumatriptan).
• Blood thinning medicine (warfarin).
• Medicines to treat pain/arthritis (Non steroidal anti-inflammatory drug (NSAID) such as ibuprofen, 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, lanzoprazole, pantoprazole, rabeprazole).
• Medicines to treat mania and depression (lithium).
• Other medicines to treat depression (such as 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).
Taking your medicine with food and alcohol
Sertraline Tablets can be taken with or without food. Drinking alcohol while being treated with sertraline is not recommended. Sertraline should not be taken in combination with grapefruit juice, as this may increase the level of sertraline in your body.
Pregnancy and breast-feeding
If you are pregnant, likely to become pregnant or are breast-feeding, you must tell your doctor before taking this medicine and your doctor will decide if this medicine is right for you.
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 Tablets. When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Sertraline Tablets 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.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
These tablets may make you feel drowsy or affect your concentration. You should not drive or operate machinery if affected.
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SERTRALINE 50 & 100 mg TABLETS
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3. HOW TO TAKE SERTRALINE TABLETS
Method of Administration: Sertraline Tablets should be swallowed whole with a drink of water, preferably at the same time each day.
Dosage: Your doctor will decide on the right starting dose for you and on any increase in the dose depending on your condition and whether you are taking any other medicines. Always take Sertraline Tablets exactly as your doctor has told you to do so. You should check with your doctor or pharmacist if you are not sure. The label on the carton will tell you how many tablets you should take and when.
The usual doses for Sertraline Tablets are as follows:
Adults:
Depression (including accompanying symptoms of anxiety) and Obsessive Compulsive Disorder The usual starting and maintenance dose for treatment in adults is 50 mg once a day. Some patients may need a higher dose up to a maximum of 200 mg a day. Your doctor should not increase the dose by more than 50 mg per week.
Post-Traumatic Stress Disorder
The usual starting dose for treatment in adults is 25 mg once a day. After one week, this should be increased to 50 mg once a day. Response to treatment should be reviewed at intervals by your doctor and if there seems to be no evidence of benefit, the treatment should be withdrawn.
Children and Adolescents:
Obsessive Compulsive Disorder
Children aged 13 -17 should be started at a dose of 50 mg daily.
Children aged 6 - 12 should be started at a dose of 25 mg once a day increasing to 50 mg daily after one week. If there is lack of response, the dose can be increased at not less than weekly intervals but your doctor will take into account the lower body weight of the child to avoid excessive doses.
Not recommended for use in children under 6 years of age.
Depression
Not recommended for use in children and adolescents under 18 years of age.
Treatment duration
You may not start to feel better when you first start taking this medicine. It may take up to 2-4 weeks for your symptoms to improve, so keep taking the tablets. Tell your doctor if you feel worse after starting the medication.
Even when you start to feel better you should continue to take this medicine. If you suffer from depression this may be for 4-6 months or longer. You may need to continue taking the medicine for longer if you suffer from OCD. Tell your doctor if you have taken all your tablets and you still feel unwell.
If you take more Sertraline Tablets than you should:
If you have accidentally taken more than your prescribed dose, contact your nearest casualty department or tell your doctor or pharmacist immediately. Remember to take the pack and any remaining tablets with you. The most common signs and symptoms of overdose are nausea and vomiting, a forceful and rapid heartbeat, tremor, agitation and dizziness.
If you forget to take Sertraline Tablets
It is important that you take your medicine every day. If you forget to take your medicine, just take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Sertraline Tablets
If you stop taking Sertraline Tablets suddenly, you may experience withdrawal/discontinuation symptoms. These can include headaches, feeling dizzy, shaky, sick, anxious, agitated or confused.
Some people experience tingling sensations, pins and needles, burning sensations, electric-shock like sensations or they find that they sweat more. Difficulty in sleeping and strange dreams can also occur.
If you are troubled by any of these withdrawal symptoms, your doctor may advise you to reduce the amount of medicine gradually by taking smaller amounts or taking the medicine less frequently for some time before stopping the tablets completely. Do not stop taking your medicine abruptly and do not stop taking your medicine without talking to your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
- heart attack, slow heart beat, 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 problem with blisters, hair rash, hair texture abnormal, skin odour abnormal, bone disorder,
- decreased urination, urinary incontinence, urinary hesitation,
- excessive vaginal bleeding, dry vaginal area, red painful penis and foreskin, genital discharge, prolonged erection, breast discharge,
- hernia, drug tolerance decreased, difficulty walking, abnormal laboratory tests, semen abnormal, 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, low thyroid hormones, endocrine problem, low blood salt, problems controlling blood sugar levels (diabetes), 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), passing out, 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 nose bleed, stomach bleeding, or blood in urine), progressive scarring of lung tissue (Interstitial Lung Disease), pancreatitis, serious liver function problems, yellow skin and eyes (jaundice),
- skin oedema, skin reaction to sun, itching, joint pain, muscle cramps, breast enlargement, menstrual irregularities, swelling in legs, problems with clotting, bedwetting and severe allergic reaction.
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 Tablets”).
The concentration of sodium in your blood may become lower (hyponatraemia) and may be associated with other drugs such as diuretics, or occur more commonly in the elderly or patients with liver disease. Symptoms include, nausea (feeling sick), vomiting (being sick), headaches, tiredness and confusion, muscle twitching, fits and coma.
An increased risk of bone fractures has been observed in patients taking this type of medicine.
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.
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
Do not take this medicine after the expiry date shown on the carton. The expiry date is the last day of that month.
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
Like all medicines, Sertraline Tablets can cause side effects although not everybody gets them.
Tell your doctor immediately:
If you experience any of the following symptoms after taking this medicine, these symptoms can be serious.
- 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.
- Allergic reaction or allergy, which may include symptoms such as an itchy skin rash, breathing problems, wheezing, swollen eyelids, face or lips.
- If you experience agitation, confusion, diarrhoea, high temperature and blood pressure, excessive sweating and rapid heartbeat. 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 develop yellow skin and eyes which may mean liver damage.
- If you experience depressive symptoms with ideas of harming or killing yourself (suicidal thoughts).
- If you start to get feelings of restlessness and are not able to sit or stand still after you start to take Sertraline Tabletsl. 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 “Take special care with Sertraline Tablets”).
If you develop any of the following side effects tell your doctor:
Very common side effects (occurs in more than 1 out of 10 patients):
Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation failure, fatigue.
Common side effects (occurs in between 1 and 10 out of 100 patients):
- Sore throat, anorexia, increased appetite,
- depression, feeling strange, nightmare, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding,
- numbness and tingling, shaking, muscle tense, 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, sexual dysfunction, erectile dysfunction, chest pain.
Uncommon side effects (occurs in between 1 and 10 out of 1.000 patients):
- Chest cold, runny nose,
- hallucination, feeling too happy, lack of caring, thinking abnormal,
- convulsion, involuntary muscle contractions, abnormal coordination, moving a lot, amnesia, decreased feeling, speech disorder, dizziness while standing up, migraine,
- 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, purple spots on skin, hair loss, cold sweat, dry skin, hives,
- osteoarthritis, muscular weakness, back pain, muscle twitching,
- nighttime urination, unable to urinate, increase in urination, increase in frequency of urination, problem urinating,
- vaginal haemorrhage, female sexual dysfunction, malaise, chills, fever, weakness, thirst, weight decreased, weight increased.
Rare side effects (occurs in between 1 and 10 out of 10.000 patients):
- Intestine problem, ear infection, cancer, swollen glands, high cholesterol, low blood sugar,
- physical symptoms due to stress or emotions, drug dependence, psychotic disorder, aggression, paranoia, sleep walking, premature ejaculation,
- coma, abnormal movements, difficulty moving, increased sensation, sensory disturbance,
- glaucoma, tear problem, spots in front of eyes, double vision, light hurts eye, blood in the eye, enlarged pupils,
What Sertraline Tablets contain:
The active substance is sertraline (as hydrochloride). Each tablet contains 50 or 100 mg of sertraline (as hydrochloride).
The other ingredients are microcrystalline cellulose, maize starch, sodium starch glycolate (Type A), magnesium stearate, titanium dioxide (E171), hypromellose and macrogol 6000.
What Sertraline Tablets look like and the contents of the pack:
Sertraline 50 mg Tablets are white, capsular shaped, film-coated tablets, with a break line, and ‘SRN 50' embossed on one side and ‘NEO' on the other side.
Sertraline 100 mg Tablets are white, capsular shaped, film-coated tablets, with ‘SRN 100' embossed on one side and ‘NEO' on the other side.
Sertraline Tablets available in blister packs of 28 tablets.
Marketing Authorisation Holder
Cipla (EU) Limited, Hillbrow House, Hillbrow Road, Esher, Surrey, KT10 9NW, United Kingdom. Manufacturer
Cipla (EU) Limited, 4th Floor, 1 Kingdom Street, London, W2 6BY, United Kingdom This leaflet was last revised in 12/2014.
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