Sertraline 100mg Film-Coated Tablets
PATIENT INFORMATION LEAFLET
Sertraline 50 mg film-coated tablet Sertraline 100 mg film-coated tablet
(Sertraline hydrochloride)
Eight important things you need to know about Sertraline
■ Sertraline treats depression. Like all medicines it can have unwanted effects. It is therefore important that you and your doctor weigh up the benefits of treatment against the possible unwanted effects, before starting treatment.
■ Sertraline should not be used to treat depression in children and adolescents under 18.
See section 2, Use in Children and adolescents under 18.
■ Sertraline won't work straight away. Some people taking antidepressants feel worse before feeling better. Your doctor should see you regularly during your course of treatment. Tell your doctor if you haven't started feeling better.
■ Some people who are depressed or anxious think of harming or killing themselves. If you start to feel worse, or think of harming or killing yourself, see your doctor or go to a hospital straight away.
■ Don't stop taking Sertraline without talking to your doctor. If you stop taking Sertraline suddenly or miss a dose, you may get withdrawal effects. See section 3, How to take Sertraline.
■ If you feel restless and feel like you can't sit or stand still, tell your doctor. Increasing the dose of Sertraline may make these feelings worse.
■ Taking some other medicines with Sertraline can cause problems. You may need to talk to your doctor. See section 2, Other medicines and Sertaline.
■ If you are pregnant or planning to get pregnant, talk to your doctor. See section 2, Pregnancy and breastfeeding..
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
■ Keep this leaflet. You may need to read it again.
■ If you have any further questions, ask your doctor or your 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 of the 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:
j What Sertraline is and what it is used for 0 Possible side effects
2 What you need to know before you take Sertraline m How to store Sertraline
3 How to take Sertraline □ Contents of the pack and other Information
^ What Sertraline is and what it is used for
Sertraline belongs to a group of medicines known as Selective
Serotonin Re-uptake Inhibitor (SSRIs). It is used to treat
depression and/or anxiety disorders.
Sertraline is used to treat:
■ Depression and prevention of recurrence of depression (in adults).
■ Panic disorder (in adults).
■ Obsessive compulsive disorder (OCD) (in adults and children and adolescents aged 6-17 years
old). Obsessive compulsive disorder (OCD) is an anxiety disorder with symptoms like unwanted, unpleasant thought, image or being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions).
■ Social anxiety disorder (in adults).
■ Post traumatic stress disorder (PTSD) (in adults).
What you need to know before you take Sertraline
Do not take Sertraline:
■ if you are allergic (hypersensitive) to sertraline or to any of the other ingredients of this medicine (see Section 6 “Contents of the pack and other information”)
■ you are taking medicines called monoamine oxidase inhibitors (MAOIs - for depression or Parkinson's disease) or have taken them at any time within the last 14 days. If you stop treatment with Sertraline, you must wait at least 7 days before starting treatment with a MAOI (see Section 2 “Other medicines and Sertraline”)
■ if you are being treated with linezolid, methylene blue (for specific bacterial infections) and there is no possibility for close observation and blood pressure monitoring by your doctor
■ if you are taking pimozide (for psychiatric disorders)
Warnings and precautions
Talk to your doctor before taking Sertraline:
■ if you are a child or adolescent under 18 years old. Sertraline 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-
Use in children and adolescents under 18 years of age).
■ if you have or have previously had thoughts of harming or killing yourself (see below- Thoughts of suicide/suicide attempts and worsening of your depression).
■ if you are taking other medicines for depression e.g. fluoxetine, St. John's Wort (herbal medicine for depression), tryptophan (for insomnia), fenfluramine (an appetite suppressant), dextromethorphan (for cough), pethidine or tramadol (for severe pain) (see Section 2 “Other medicines and Sertraline”)
■ if you have a history of mania (feeling elated or overexcited, which causes unusual behaviour). If you feel you are developing the symptoms of mania, treatment should be stopped. Contact your doctor
■ if you have epilepsy. In the event of seizures the treatment should be stopped. Contact your doctor immediately.
■ if you are having electric shock treatment (ECT)
■ if you have diabetes, as Sertraline can affect the control of your blood sugar levels with insulin and/or tablets. The dose of these medications may have to be adjusted.
■ if you have low sodium levels in your blood (hyponatraemia), or you are at risk of developing it e.g. due to treatment with diuretic medicines, you are elderly or have liver problems (For symptoms, see Section 4 “Possible Side Effects”)
■ if you have suffered from bleeding disorders or have been taking medicines that cause an increased risk of bleeding, e.g. medicines to thin the blood (anticoagulants), some medicines used to treat mental disorders (atypical antipsychotics and phenothiazines, most tricyclic antidepressants), medicines for pain and inflammation (NSAIDs) or aspirin (see Section 2 “Other medicines and Sertraline”)
■ if you have recently had a heart attack or have an unstable heart disorder
■ if you are elderly, as you may be more likely to have side effects
■ if you have schizophrenia
■ if you have severely impaired liver or kidney function
■ if you have a history of bleeding disturbances, e.g. bleeding in the stomach or intestine
■ If you have angle-closure glaucoma or history of glaucoma (increased fluid pressure in the eye) (sertraline may have an effect on pupil size resulting in dilation)
Thoughts of suicide/suicide attempts and worsening of your depression
If you are depressed 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 increase 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, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Restlessness/inability to sit or stand still
Sertraline can cause restlessness, the need to move often and the inability to sit or stand still.
This is most likely to occur in the first few weeks of treatment. If you think you have these symptoms you should talk to your doctor as soon as possible.
Serotonergic Syndrome or Neuroleptic Malignant Syndrome Contact your doctor if you develop symptoms such as high fever, muscle twitching, confusion and anxiety. These may be signs of a condition known as 'Serotonergic Syndrome' or 'Neuroleptic Malignant Syndrome'.
This is more likely to occur if you are also taking
SSRIs, including triptans, MAOIs e.g. moclobemide, linezolid
and methylene blue, or antipsychotic and opiate medicines.
(see Section 2 'Other medicines and Sertraline').
Treatment with Sertraline might need to be stopped.
Withdrawal symptoms when stopping treatment with Sertraline
When you stop taking Sertraline, it is common to experience withdrawal symptoms, especially if treatment is stopped suddenly. When stopping treatment, the dose should be reduced gradually (see section 3 'If you stop taking Sertraline' and section 4 'Possible withdrawal effects when stopping treatment with Sertraline').
Use in children and adolescents under 18 years of age
Sertraline should not normally be used for children and adolescents under 18 years, except for patients with obsessive compulsive disorder aged 6-17 years old. Clinical trials have shown that patients under 18, treated with Sertraline, have an increased risk of side-effects such as suicide attempts, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger). Also the long-term safety effects concerning growth, maturation and cognitive and behavioural development of Sertraline in this age group are not yet known. However, your doctor may prescribe Sertraline for patients under 18 if it is thought to be in their best interests. If you want to discuss this, please go back to your doctor. You should also inform your doctor if any of the side effects listed above develop or become worse.
Other medicines and Sertraline
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines. Medicines which may affect or be affected by Sertraline.
Taking Sertraline together with the following medicines may cause serious side effects:
■ MAOIs, e.g. 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). (see Sections "Do not take Sertraline"
■ Pimozide (to treat psychoses)
Talk to your doctor if you are taking the following medicines:
■ Interference with urine screening tests False-positive urine immunoassay screening tests for benzodiazepines have been reported in patients taking sertraline.False-positive test results may be expected for several days following discontinuation of sertraline therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish sertraline from benzodiazepines.
■ Serotonergic medicines such as tryptophan (to aid sleep), fenfluramin (an appetite suppressant), dextromethorphan (to treat cough), pethidine and tramadol (to treat severe pain) (see Section "Warnings and precautions" )
■ Fentanyl (used in anaesthesia or for chronic pain)
■ Lithium (to treat mental disorders)
■ Sumatriptan and other triptans (to treat migraine)
■ Herbal medicines (to treat depression) containing St. John's wort (Hypericum perforatum)
■ Diuretic medicines (to treat high blood pressure)
■ Medicines for diabetes (insulin and/or tablets, e.g. tolbutamide)
■ Phenytoin, phenobarbital, carbamazepine, haloperidol (to treat epilepsy)
■ Cimetidine, omeprazole, lansoprazole, pantoprazole, rabeprazole (to treat stomach ulcers indigestion and heartburn)
■ Diazepam (to treat anxiety and agitation)
■ Phenazone (for pain)
■ Medicines for irregular heart rhythm e.g. propafenone and flecainide
■ Rifampicin (for tuberculosis)
■ Ketoconazole, itraconazole, posaconazole, voriconazole,fluconazol (to treat fungal infections)
■ Clarithromycin, telithromycin, erythromycin (to treat bacterial infections)
■ Nefazodone, fluoxetine, fluvoxamine (to treat depression)
■ Protease inhibitors such as ritonavir,telaprevir (to treat HIV/AIDS and Hepatitis)
aprepitant used to prevent nausea and vomiting that can be caused by chemotherapy treatment for cancer
■ Verapamil and diltiazem use to treat heart conditions (antiarrhythmics)
The following medicines increase the risk of haemorrhages:
■ Blood-thinning medicines e.g. warfarin and ticlopidine
■ Aspirin and other pain-relieving medicines of the NSAID type (non-steroidal anti- inflammatory drugs) e.g. ibuprofen
■ Phenothiazines e.g. perphenazine and thioridazine and other medicines for psychoses
■ Tricyclic antidepressants (to treat depression) e.g. clomipramine and imipramine
Your doctor may need to monitor you more carefully and adjust the dose of the above mentioned medicines as appropriate.
Sertraline with food and drink and alcohol
■ These tablets can be taken with or without food and with sufficient amount of fluid..
■ Drinking alcohol should be avoided if you are being treated with Sertraline.
■ Sertraline must not be taken 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 for advice before taking this medicine.
Pregnancy
Do not take Sertraline if you are pregnant or planning to become pregnant. The safety of sertraline has not fully been established in pregnant women. Sertraline should only be given to pregnant women if the doctor considers that the benefit for the mother exceeds any possible risk to the foetus.
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. In addition, so called serotonergic effects or withdrawal symptoms may occur in babies whose mothers had been on sertraline during pregnancy, particularly in the last 3 months of pregnancy. The following symptoms may occur in the newborn: difficulty in breathing, temporary interruption in breathing, bluish skin, convulsions, being too hot or too cold, difficulty in feeding, vomiting, low level of sugar in the blood, high or low blood pressure, abnormally increased reflexes, tremor, extreme nervousness or nervous shaking, irritability, lethargy, constant crying, abnormal drowsiness, difficulty in sleeping. 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.
Breast-feeding: Sertraline passes into breast milk in small amounts and may affect breast-feeding infants. Do not take Sertraline while breast-feeding unless your doctor has told you to.
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
In some people Sertraline can cause side effects such as drowsiness, dizziness, blurred vision or fainting. If you have these side effects do not drive or use machinery. You should be careful, until you know how you react to Sertraline treatment.
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How to take Sertraline
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
■ These tablets are to be taken orally as a single dose in the morning or evening.
■ The tablet can be divided into equal doses.
The recommended dose is:
Adults
Depression and Obssessive Compulsive Disorder
For depression and OCD, the usual effective dose is 50 mg/day. The daily dose may 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.
Panic disorder, Social anxiety disorder and Post Traumatic Stress Disorder:
For 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.
The daily dose then may be increased in 50 mg increments over a period of weeks. The maximum recommended dose is 200 mg/day.
Older people
As for adults, but the dose should be as low as possible. Elderly should be dosed carefully, as elderly may be more at risk for having low sodium levels in their blood (hyponatraemia) (Please see section2 “Warnings and precautions ”and section 4 “Possible side effects”).
Use in children and adolescents
Sertraline must only be used to treat children and adolescents suffering from Obsessive Compulsive Disorder (OCD) aged 6-17 years old.
Obsessive Compulsive Disorder:
Children aged 6 to 12: the recommended starting dose is 25 mg daily.
After one week, your doctor may increase this to 50 mg daily. The maximum dose is 200 mg daily.
Adolescents aged 13 to 17: the recommended starting dose is 50 mg daily.
The maximum dose is 200 mg daily.
Patients with impaired kidney function
As for adults
Patients with liver disease/impaired liver function
Sertraline tablets should be used with caution. It is recommended that the dose is reduced or the interval between the dosage prolonged. Sertraline should not be used in case of severe liver impairment as no clinical data are available.
Duration of treatment
Although your symptoms of depression may improve within 7 days, the maximum effect is generally reached after 2-4 weeks. Your treatment with Sertraline should continue until you have been symptom-free for at least 6 months.
If you take more Sertraline than you should
If you accidentally take too many tablets,contact the doctor, or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you. Symptoms of overdose are: drowsiness, nausea, vomiting, rapid pulse, tremor, agitation, dizziness and deep unconsciousness.
If you forget to take Sertraline
Take it as soon as you remember, unless it is time for your next dose. If you miss a dose do not take a double dose to make up for a forgotten dose.
If you stop taking Sertraline
You should only stop treatment with Sertraline when your doctor tells you. Your doctor will usually advise you to reduce the dose gradually over a period of at least one to two weeks. Do not stop taking your tablets suddenly as there is a risk you may have withdrawal effects (see section 4 'Possible withdrawal effects when stopping treatment with Sertraline')
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
|4| Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects:
Seek medical advice immediately if you develop the
following symptoms:
■ Inflammation of the pancreas, which causes severe pain in the abdomen and back
■ Feeling tired or sick, loss of appetite stomach pain or high temperature,yellowing of the skin or whites of the eyes (symptoms of other Liver Problems)
■ Feeling agitated, confused, sweating, diarrhoea, fever, high blood pressure, rapid heart beat, muscle stiffness (symptoms of Serotonin Syndrome)
■ Allergic reaction such as skin rash, itching, shortness of breath or serious allergic reaction which causes difficulty in breathing or dizziness (Anaphylaxis/Anaphylactoid Reaction)
■ Unconsciousness
■ Swelling of the face or throat
■ Severe skin reactions, e.g. blistering of the skin, mouth, eyes and genitals (Stevens Johnson Syndrome) or peeling of the upper layer of skin (Toxic Epidermal Necrolysis)
■ Sudden severe headache (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS), stroke (Cerebrovascular Spasm)
Other side effects:
Very common side effects (may affect more than 1 in 10 people)
■ Loss of appetite
■ Sleeplessness
■ Dizziness, sleepiness, headache
■ Feeling sick, dry mouth
■ Diarrhoea/loose bowel movements
■ Problems with ejaculation
■ Fatigue
Common side effects (may affect up to 1 in 10 people)
■ Increased appetite, decreased appetite, abnormal taste
■ Depression
■ Feeling disconnected or detached (depersonalisation)
■ Nightmare
■ Agitation, anxiety, nervousness, decreased sexual interest
■ Excessive grinding of the teeth and/or clenching of the jaw
■ Movement disorders e.g. uncontrollable problems with walking
■ Tingling or numbness in the hands or feet
■ Increased muscle tension
■ Lack of attention
■ Shaking
■ Blurred vision, visual disturbance
■ Ringing in the ears
■ Feeling your heartbeat
■ Hot flushing
■ Yawning
■ Indigestion
■ Pain in the stomach/abdomen
■ Being sick
■ Constipation
■ Wind (flatulence)
■ Rash
■ Increased tendency to sweat
■ Muscle pain, pain or swelling in the joints
■ Erectile dysfunction
■ Chest pain
■ Excessive sweating, generally feeling unwell
■ Weight loss
■ Sore throat
Uncommon side effects (may affect up to 1 in 100 people):
■ Abnormal bleeding or bleeding for a long time
■ Hypersensitivity
■ Underactive thyroid gland which can cause tiredness or weight gain
■ Feeling elated or over-excited, which causes unusual behaviour
■ Seeing or hearing things that are not real
■ Lack of caring, abnormal thoughts, aggression,
■ Migraine, convulsion
■ Involuntary muscle contractions, increased muscle
movement, muscle weakness, muscle twitching
■ Abnormal co-ordination, loss of memory, speech disorder
■ Dizziness when standing up, fainting
■ Reduced sense of touch
■ Passing out
■ Enlarged pupils
■ Ear pain
■ Faster heart beat
■ High blood pressure
■ Flushing
■ Difficulty in breathing or wheezing, breathlessness
■ Nosebleed, runny nose
■ Inflammation of the oesophagus
■ Mouth problems- difficulty swallowing, increased saliva, tongue disorder, burping
■ Haemorrhoids
■ Eye swelling
■ Skin rash resulting from bleeding into the skin from small
blood vessels
■ Hair loss
■ Dry skin, itching or itchy rash, red patches on the skin
■ Back pain, osteoarthritis
■ Need to pass urine during the night
■ Increase in urine and need to urinate, unable to urinate, problem urinating, leaking or passing of urine when you do not mean to
■ Vaginal haemorrhage
■ Sexual dysfunction, female sexual dysfunction
■ Irregular periods
■ Fever, feeling unwell, chills, cold sweat
■ Feeling thirsty
■ Swelling of the ankles, feet, fingers or around the eyes
■ Feeling of weakness
■ Weight gain
■ Abnormal laboratory test results
■ Upper respiratory tract infection
Rare side effects (may affect up to 1 in 1000 people)
■ Reduction in white blood cells, which may make infections more likely
■ Reduction in blood platelets, which increases the risk of bleeding or bruising
■ Swollen or enlarged lymph nodes
■ Low blood levels of sodium which can cause tiredness and confusion, muscle twitching, fits and coma (mainly occurs in elderly patients and in patients using diuretics (water tablets) and other medicines
■ High cholesterol level
■ Low blood sugar level
■ Diabetes
■ Numbness, blindness, paralysis, or fits (conversion disorder)
■ Drug dependence, decreased drug tolerance
■ Confusion, psychotic disorder
■ Paranoia
■ Suicidal thoughts
■ Sleep walking
■ Premature ejaculation
■ Restlessness/inability to sit or stand still
■ Coma
■ Involuntary movements
■ Difficulty moving
■ Increased sensitivity of the senses, sensory disturbance
■ Eye problems- glaucoma, dry eyes, reduced vision, abnormal intolerance of the eyes to light, blood in the eye
■ Heart attack, slow heart beat, heart problems
■ Poor circulation of the arms and legs
■ Blood in urine
■ Closing up of the throat, breathing fast or slow, high-pitched breathing sound
■ Voice problems, hiccups
■ Black tarry stools
■ Bright red blood with bowel movements
■ Inflammation of the mucus lining of the mouth
■ Tongue or mouth ulcers or inflammation
■ Tooth disorder
■ Abnormal liver function
■ Skin problems e.g. blisters, hair rash, abnormal hair texture, skin odour, abnormal sensitivity of the skin to sunlight
■ Bone disorder
■ Muscle cramps
■ Low output of urine, urine hesitation
■ Persistent erection, abnormal semen, red painful penis and foreskin, premature ejaculation
■ Abnormally heavy and prolonged menstrual period
■ Inflammation of the vagina
■ Genital discharge
■ Discharge of milk from the nipples
■ Swelling of the face
■ Hernia
■ Injection site scarring
■ Difficulty walking
■ Injury
■ Bulge at side of colon
■ infection of the stomach and bowel which can cause diarrhoea and being sick
■ Inflammation of the middle ear
■ Tumour
■ Relaxation of blood vessels during surgical procedures
Not known (frequency cannot be estimated from the available data)
■ Abnormally high level of the hormone prolactin in the blood which can cause irregular periods and production of milk from breasts
■ Water retention and production of highly concentrated urine
■ High blood sugar level
■ Nightmares/excess dreaming
■ Abnormal vision, unequal pupils
■ Abnormal bleeding (nose bleeding, vomiting of blood, bloody bowel movements)
■ Inflammation of the lungs
■ Liver failure
■ Enlargement of breasts in men
■ Altered platelet function
■ Increased cholesterol
If you have thoughts of harming or killing yourself during Sertraline therapy or soon after stopping therapy contact your doctor or go to a hospital straight away.
An increased risk of bone fractures has been observed in patients taking this type of medicines.
Possible withdrawal effects when stopping treatment with Sertraline: Dizziness, prickling or tingling sensation in the skin, sleep disturbances (including not being able to sleep and intense dreams), agitation or anxiety, feeling sick and/or being sick, shaking and headache are the most commonly reported reactions. The risk is higher when Sertraline has been used for a long time, in high doses or when the dose is reduced too quickly.
Generally these symptoms are mild to moderate and stop within two weeks. However, in some patients they may be severe and/or continue for longer (2-3 months or more).
If Sertraline treatment is no longer required, your doctor will usually advise you to reduce the dose gradually over several weeks (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 the internet at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
How to store Sertraline
■ Keep this medicine out of the sight and reach of children.
■ Do not use this medicine after the expiry date which is stated on the carton/blister after EXP. The expiry date refers to the last day of that month.
■ 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.
Contents of the pack and other information
What Sertraline film-coated tablets contain
Each 50 mg film-coated tablet contains 50 mg sertraline as sertraline hydrochloride.
Each 100 mg film-coated tablet contains 100 mg sertraline as Sertraline hydrochloride.
The other ingredients are: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, hyprolose, sodium starch glycolate (type A), magnesium stearate, hypromellose, talc, titanium dioxide (E 171).
What Sertraline looks like and contents of the pack
Sertraline 50 mg is a white, capsule shaped, scored film-coated tablet, coded SE|50 on one side, approximate size 10.4mm x 4.2mm.
Sertraline 100 mg is a white, capsule shaped, scored film-coated tablet, coded SE|100 on one side, approximate size 13.1mm x 5.3mm.
Sertraline is available in:
Sertraline film-coated tablets are available in packs of:
Blister: 10, 14, 15, 20, 28, 30, 50, 50x1, 60, 98 and 100 film-coated tablets.
Container: 30, 50, 100, 250, 300 and 500 film-coated tablets. Not all pack sizes or pack types may be marketed.
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd,
3 Howard Road, Eaton Socon, St. Neots,
Cambridgeshire, PE19 8ET UK.
Product Licence Numbers
Sertraline 50mg film-coated Tablets: PL 11311/0491 Sertraline 100mg film-coated Tablets: PL 11311/0492
Date of revision: May 2015
Hard to Read? Phone 0800 970 6115 for help
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