Sertraline 100mg 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Out of date information, search anotherRead all of this leaflet carefully before you start taking this medicine.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 any further questions, 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.
PACKAGE LEAFLET: INFORMATION FOR THE USER
SERTRALINE 50 mg & 100 mg TABLETS
THIS LEAFLET CONTAINS
1. What Sertraline is for
2. Before you take Sertraline
3. How to take Sertraline
4. Possible side effects
5. How to store Sertraline
6. Further information
1. WHAT SERTRALINE IS FOR
Sertraline belongs to a group of medicines called selective serotonin re-uptake inhibitors, (SSRIs).
This medicine is used to treat:
• depression
• obsessive-compulsive disorder, (OCD)
• post-traumatic stress disorder, (PTSD)
• panic / social anxiety disorder
If you are not sure why you have been prescribed these tablets then please ask your doctor.
2. BEFORE YOU TAKE SERTRALINE
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.
• are taking other medicines to treat depression known as monoamine oxidase inhibitors (MAOIs) or if you have taken MAOIs within the last 14 days. Treatment with Sertraline should only be started 2 weeks after discontinuation of an irreversible MAOI, (e.g. Tranylcypromine), and you should not start taking any MAOIs for at least 2 weeks after finishing Sertraline treatment.
• have severe liver problems
Take special care with Sertraline tablets
Tell your doctor before you take this medicine if you:
• have epilepsy or have ever had a fit (seizure)
• have a history of feeling elated or over-excited, which causes unusual behaviour (mania)
• have liver, kidney or heart problems
• have diabetes, as Sertraline can alter your blood sugar levels
• have a history of bleeding disorders or are taking medicines which may increase the risk of bleeding, (see 'Taking other medicines', section 2)
• are having electro-convulsive therapy (ECT).
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. Sertraline tablets should not normally be used for depression in children and adolescents under the age of 18 years.
Clinical trials have shown that patients under 18 have an increased risk of side-effects such as suicide attempt, suicidal thoughts and hostility (predominantly aggression, oppositional behaviour and anger) when they take this class of medicines. Also, the long-term safety effects concerning growth, maturation and cognitive and behavioural development are not yet known.
Despite this, your doctor may prescribe Sertraline for patients under 18 because they decide that this is in their best interests. If you want to discuss this, please go back to your doctor. You should inform your doctor if any of the symptoms listed above develop or become worse.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even medicines bought without a prescription.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines, as they may affect how Sertraline tablets work:
• medicines to treat depression known as monoamine oxidase inhibitors (MAOIs) such as Moclobemide or Tranylcypromine
• other medicines to treat depression such as Duloxetine, Mirtazapine, Tryptophan or the herbal remedy St John's Wort
• medicines to treat mental health problems such as Aripiprazole, Clozapine, Pimozide or Lithium
• medicines to stop blood clots from forming such as coumarins, for example Warfarin
• medicines called triptans used to treat migraine such as Sumatriptan or Frovatriptan
• medicines called non-steroidal anti-inflammatory drugs (NSAIDs) for pain and inflammation such as Aspirin, Ibuprofen or Indometacin
• medicines to treat Parkinson's disease such as Rasagiline or Selegiline (MAOI-type B)
• medicines to treat epilepsy such as Barbiturates, Carbamazepine, Lamotragine or Phenytoin
• medicines used to suppress appetite such as Fenfluramine or Sibutramine
• medicines to treat anxiety such as Diazepam
• medicines to treat diabetes such as Glibenclamide or Tolbutamide
• medicines used to treat viral infections such as Ritonavir or Darunavir
• strong painkillers such as Methadone, Pethidine or Tramadol
• antibiotics such as Erythromycin or Linezolid
• Cimetidine to treat heartburn and gastric ulcers AVOID ALCOHOL whilst taking Sertraline.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Do not take Sertraline if you are pregnant or planning to become pregnant, unless your doctor has told you to. 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.
Do not take Sertraline while breast-feeding, unless your doctor has told you to. Sertraline passes into breast milk in small amounts and there is a risk that it could affect your baby.
Driving and using machines
Antidepressants, such as Sertraline, may affect your judgement and co-ordination. Do not drive or operate machinery unless you are sure you are not affected.
Important information about some of the ingredients of Sertraline
Sertraline tablets contain lactose. If you know you have an intolerance to lactose or other sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE SERTRALINE
Always take Sertraline tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The tablets should only be taken by mouth. Swallow the tablets whole with a glass of water. The tablets may be taken with or without food.
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.
Dosage
• Your doctor will decide your dose and length of treatment, as it depends on your condition.
• It may take two to four weeks of treatment before you notice an improvement in your symptoms.
• Even when you start to feel better it is important for you to keep taking them for as long as your doctor tells you to.
Adults:
Depression and obsessive compulsive disorder
The usual starting dose is 50 mg daily. Your doctor will review and adjust your dosage if necessary. If required, the dose may be increased gradually up to a maximum of 200 mg daily.
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. Your doctor will review and adjust your dosage if necessary. If required, the dose may be increased 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
Children and adolescents (under the age of 18):
Obsessive compulsive disorder
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.
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.
Sertraline is not recommended for use in children under 6 years of age.
If you take more Sertraline tablets than you should
If you take too many tablets consult your doctor 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
Don't worry. Take it as soon as you remember. However, if it is nearly time for the next dose, miss the forgotten dose altogether and take your next scheduled dose at the correct time. Do not take a double dose to make up for the one you have missed.
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 one to two weeks at the end of treatment, though this is often not necessary.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Sertraline can cause side effects, although not
everybody gets them.
STOP TAKING Sertraline and see a doctor straight away if you:
• have an allergic reaction which may cause skin rash, itching, red and raised lumps (hives), sensitivity to sunlight or swelling of your face or tongue leading to difficulty in breathing or swallowing.
Serious side effects - Tell a doctor straight away if you:
• feel more depressed or have thoughts of harming or killing yourself
• develop fits or epilepsy, or experience an increase in seizure frequency
• start to experience fever, probably with rapid heartbeat, sweating, muscle stiffness, diarrhoea, confusion, restlessness and extreme agitation (although rare, you may have 'serotonin syndrome' or 'neuroleptic malignant syndrome')
• develop serious skin reactions with blistering of the skin ('Stevens-Johnson syndrome' or 'Lyell syndrome')
• feel elated or over-excited which causes unusual behaviour (mania)
• feel tired, confused, have muscles that twitch, have fits or a coma. This may be due to a low level of sodium in your blood and it is more likely to happen if you are elderly or taking water tablets (diuretics).
Other effects:
Very common (affects more than 1 in 10 people)
• Difficulty sleeping (insomnia)
• Dizziness, sleepiness, headache
• Diarrhoea, feeling sick (nausea), dry mouth
• Failure to ejaculate
• Fatigue
Common (affects more than 1 in 100 people)
• Sore throat
• Loss of or increased appetite
• 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, gas
• Rash, increased sweating
• Muscle pain
• Sexual dysfunction, erectile dysfunction
• Chest pain
Uncommon (affects more than 1 in 1,000 people)
• Chest infection, runny nose
• Hallucination, feeling too happy, lack of interest, abnormal thinking
• Uncontrolled shaking (convulsions), involuntary muscle contractions, abnormal coordination, hyperactivity, memory loss, decreased sensitivity, speech disorder, dizziness on standing up, migraine
• Ear pain
• Rapid heartbeat
• High blood pressure, flushing
• Breathing difficulties, 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, hair loss, cold sweat, dry skin, hives
• Osteoarthritis, muscular weakness, back pain, muscle twitching
• Passing urine at night, inability to urinate, passing large volumes of urine, frequent urination, problems urinating
• Vaginal bleeding, female sexual dysfunction
• Feeling uncomfortable, chills, fever, weakness, thirst
• Weight increase or decrease
Rare (affects more than 1 in 10,000 people)
• Digestive disease, infection of the stomach and bowels, ear infection
• Cancer
• Swollen glands
• High cholesterol, low blood sugar
• Convulsion disorder, drug dependence, psychotic disorder, aggression, paranoia, sleep walking, premature ejaculation
• Coma, involuntary movements, difficulty moving, increased sensation, sensory disturbance
• Eye conditions that affect vision (glaucoma), tear problems, blind spots, double vision, sensitivity to light, blood in the eye, dilated pupils
• 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
• Blood in faeces, inflammation of the mouth or tongue, tooth disorder, tongue inflammation, ulceration of the mouth or tongue
• Abnormal liver function
• Hair rash, abnormal hair texture, abnormal skin odour
• Bone disorder
• Decreased urination, urinary incontinence, urinary hesitation
• Abnormal vaginal bleeding, vaginal dryness, inflammation of the penis and foreskin, genital discharge, prolonged erection, secretion of breast milk
• Hernia, scarring of injection site, decreased drug tolerance, difficulty walking
Frequency unknown
• Reduction in the number of white blood cells which makes infections more likely, reduction in blood platelets which increases risk of bleeding or bruising
• High levels of prolactin hormone, low level of thyroid hormone, inappropriate antidiuretic hormone secretion
• Passing out
• bleeding problems (such as stomach bleeding or blood in urine)
• Inflammation of the pancreas, which causes severe pain in the abdomen and back
• Serious liver problems (such as inflammation of the liver, yellowing of the skin or whites of the eyes caused by liver or blood problems, or liver failure)
• Joint pain, muscle cramps
• Breast enlargement, menstrual irregularities
• Swelling of lower limbs
• Abnormal clinical laboratory results, problems with clotting
• Increased risk of bone fractures
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.
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.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE SERTRALINE
Keep out of the reach and sight of children.
There are no special storage instructions for this medicine.
Do not use these tablets after the expiry date, which is stated on the package. The expiry date refers to the last day of that month.
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
What Sertraline tablets contain
The active ingredient in Sertraline tablets 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, biconvex, film-coated tablets with a break-line.
Sertraline 100 mg tablets are white to off white, biconvex, film-coated tablets with a break-line.
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
Chatfield Pharmaceuticals Ltd., Kramer Mews, London SW5 9JL
Manufacturer
DDSA Pharmaceuticals Ltd., 310 Old Brompton Road, London SW5 9JQ For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 07/2012
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