SERTRALINE 50 MG TABLETS - patient leaflet, side effects, dosage

2. what you need to know before you take sertraline tablets

Do not take Sertraline Tablets if you:

• are allergic to sertraline or any of the other ingredients of this medicine (listed in section 6).
• 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 MAOI. After stopping treatment with MAOI, you must wait at least two weeks before you can start treatment with sertraline.
• are taking another medicine called pimozide (a medicine for mental disorders such as psychosis).

Warnings and precautions

Talk to your doctor or pharmacist before taking Sertraline Tablets.

Medicines are not always suitable for everyone. Tell your doctor before you take Sertraline Tablets, if you suffer from or have suffered in the past from any of the following conditions:

• 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- Thoughts of suicide and 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 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 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 (see below-Children and adolescents).
• If you have epilepsy (fits) or a history of seizures. If you have a fits (seizure), contact your doctor immediately.
• If you are having electro-convulsive therapy (ECT).
• If you have diabetes; your blood glucose levels may be altered due to Sertraline Tablets and your diabetes medicines may need to be adjusted.
• If you have liver disease; your doctor may decide that you should have a lower dose of Sertraline Tablets.
• If you have suffered from bleeding disorders or have been taking medicines which thin the blood (e.g.

acetylsalicyclic acid (aspirin), or warfarin) or may increase the risk of bleeding or if you are pregnant (see Pregnancy).

• 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.
• If you have heart disease, low potassium levels or low magnesium levels, family history of QT prolongation, low heart rate and concomitant use of medications which prolong QT interval.

Medicines like Sertraline Tablets (so called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.

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.

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.

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 years 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 Tablets to a patient under 18 years 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.

Other medicines and Sertraline Tablets

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 Tablets work or Sertraline Tablets themselves can reduce the effectiveness of other medicines taken at the same time.

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.
• medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity).
• herbal medicine containing St. John’s Wort (Hypericum perforatum). The effects of St. John’s Wort may last for I –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, mivacurium and suxamethonium).
• 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, lansoprazole, 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).
• medicines known to increase the risk of changes in the electrical activity of the heart (e.g. some antipsychotics and antibiotics).

Sertraline Tablets with food, drink 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, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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.

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 newborn (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.

If you take Sertraline Tablets near the end of your pregnancy there may be an increased risk of heavy vaginal bleeding shortly after birth, especially if you have a history of bleeding disorders, your doctor or midwife should be aware that you are taking Sertraline Tablets so they can advise you.

Breast-feeding

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.

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

Psychotropic drugs such as sertraline may influence your ability to drive or use machines. You should therefore not drive or operate machinery, until you know how this medication affects your ability to perform these activities.

Information on Sodium content

This medicine contains less than I mmol sodium (23 mg) per I tablet, that is to say essentially ‚sodium-free‘.

3. how to take sertraline tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is:

Adults

Depression and Obssessive compulsive disorder

For depression and OCD, the recommended 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.

Use in children and adolescents

Sertraline Tablets must only be used to treat children and adolescents suffering from 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.

If you have liver or kidney problems, please tell your doctor and follow the doctor’s instruc­tions.

Method of administration

Sertraline Tablets may be taken with or without food.

Take your medication once daily either in the morning or evening.

Your doctor will advise you on how long to take this medication for. This will depend on the nature of your illness and how well you are responding to the treatment. It may take several weeks before your symptoms begin to improve. Treatment of depression should usually continue for 6 months after improvement.

If you take more Sertraline Tablets than you should

If you have accidentally taken more than your prescribed dose, contact your nearest hospital casualty department or contact your doctor or pharmacist immediately. Always take the labelled medicine package with you, whether there is any medication left or not.

Symptoms of overdose may include drowsiness, nausea and vomiting, rapid heart rate, shaking, agitation, dizziness and in rare cases unconsciousness.

If you forget to take Sertraline Tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, do not take the missed dose. Just take the next dose at the right time.

If you stop taking Sertraline Tablets

Do not stop taking Sertraline Tablets unless your doctor tells you to. Your doctor will want to gradually reduce your dose of Sertraline Tablets over several weeks, before you finally stop taking this medicine. 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.

If you experience any of these side effects or any other side effects whilst stopping taking Sertraline Tablets, please speak to your doctor.

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.

Nausea is the most common side effect. The side effects depend on the dose and often disappear or lessen with continued treatment.

Tell your doctor immediately

If you experience any of the following symptoms after taking this medicine, these symptoms can be serious.

Common: (may affect up to I in 10 people)

• If you have a manic episode (see section 2 “Warnings and precautions”).
• Allergic reaction or allergy, which may include symptoms such as an itchy skin rash, breathing problems, wheezing, swollen eyelids, face or lips.
• If you start to get feelings of restlessness and are not able to sit or stand still after you start to take Sertraline Tablets. You should tell your doctor.
• If you have fits (seizures).
• If you experience depressive symptoms with ideas of harming or killing yourself (suicidal thoughts).
• If you develop a severe skin rash that causes blistering (erythema multiforme), (this can affect the mouth and tongue). These may be signs of a condition known as Stevens Johnson Syndrome or Toxic Epidermal Necrolysis (TEN). Your doctor will stop your treatment in these cases.
• If you 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.
• Very common: (may affect more than I in 10 people) insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation failure, fatigue.
• chest cold, sore throat, runny nose, decreased appetite, increased appetite, depression, feeling strange, nightmare, anxiety, agitation, nervousness, decreased sexual interest, teeth grinding,
• shaking, muscular movement problems (such as moving a lot, tense muscles, difficulty walking and stiffness, spasms and involuntary movements of muscles), numbness and tingling, 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, joint pain, back pain, muscle pain,
• a vague feeling of bodily discomfort, feeling badly (malaise), chest pain, fever, weight increased, injury,
• menstrual irregularities, erectile dysfunction.
• hypersensitivity, seasonal allergy,
• gastroenteritis, ear infection,
• tumour,
• low thyroid hormones,
• hallucination, feeling too happy, lack of caring, thinking abnormal, aggression, suicidal thougths, suicidal behaviour psychotic disorder, paranoia,
• convulsion, involuntary muscle contractions, abnormal coordination, moving a lot, amnesia, decreased feeling, speech disorder, dizziness while standing up, passing out, migraine,
• enlarged pupils, ear pain,
• fast heartbeat, heart problem,
• bleeding problems (such as stomach bleeding), high blood pressure, flushing, blood in urine,
• breathing difficulty, possible wheezing, shortness of breath, nose bleed,
• tarry stools, tooth disorder, tongue problem, inflammation of the oesophagus, difficulty swallowing, haemorrhoids, increased saliva, tongue disorder, burping,
• eye swelling, purple spots on skin, face swelling (oedema), skin problem with blisters, hair loss, cold sweat, dry skin, hives, itching,
• osteoarthritis, muscular weakness, muscle cramps, muscle twitching,
• nighttime urination, unable to urinate, increase in urination, increase in frequency of urination, problem urinating, urinary incontinence,
• vaginal haemorrhage, sexual dysfunction, female sexual dysfunction, excessive vaginal bleeding,
• swelling in legs, chills, difficulty walking, thirst,
• increase in liver enzyme levels, weight decreased,
• cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation (see section 2).

Rare: (may affect up to I in 1,000 people)

• diverticulitis, swollen lymph glands, decrease in clotting cells*, decrease in white blood cells*
• endocrine problems*
• problems controlling blood sugar levels (diabetes), increase in blood sugar levels* low blood salt*, high cholesterol, low blood sugar,
• physical symptoms due to stress or emotions, drug dependence, terrifying abnormal dreams* sleep walking, premature ejaculation,
• severe allergic reaction,
• coma, abnormal movements, difficulty in moving, increased sensation, sudden severe headache (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS))* sensory disturbance,
• glaucoma, tear problem, spots in front of eyes, double vision, light hurts eye, blood in the eye, unequal sized pupils*, vision abnormal*
• heart attack, slow heart beat, light-headedness, fainting, or chest discomfort which could be signs of changes in the electrical activity (seen on electrocardiogram) or abnormal rhythm of the heart*, poor circulation of arms and legs,
• closing up of throat, breathing fast, breathing slow, difficulty talking, hiccups, progressive scarring of lung tissue (Interstitial Lung Disease),
• blood in stool, sore mouth, tongue ulceration, pancreatitis, mouth ulceration,
• problems with liver function, serious liver function problem* yellow skin and eyes (jaundice),
• skin reaction to sun*, skin oedema*, hair rash, hair texture abnormal, skin odour abnormal,
• breakdown of muscle tissue* bone disorder,
• decreased urination, urinary hesitation,
• breast enlargement*, dry vaginal area, red painful penis and foreskin, genital discharge, prolonged erection, breast discharge,
• hernia, drug tolerance decreased,
• abnormal laboratory tests*, problems with clotting*, semen abnormal, increase in blood cholesterol levels,
• relaxation of blood vessels procedure.

Not known: frequency cannot be estimated from the available data

• lockjaw*,
• bedwetting*,
• partial loss of vision,
• Inflammation of the colon (causing diarrhoea),
• heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see Pregnancy in section 2 for more information.

• * side effects reported after marketing.

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 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the ^fellow Card Scheme at: or search for MHRA>fellow Card in the Google Play or Apple App store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store sertraline tabletskeep 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 after exp the expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

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 protect the environment.

6. contents of the pack and other informationwhat sertraline tablets containthe active substance is sertraline.

• Each 50 mg film-coated tablet contains 50 mg of sertraline (as hydrochloride).
• Each 100 mg film-coated tablet contains 100 mg of sertraline (as hydrochloride).
• The other ingredients are microcrystalline cellulose, maize starch, sodium starch glycolate (Type A), magnesium stearate, titanium dioxide (El71), hypromellose and macrogol 6000.

What Sertraline Tablets look like and the contents of the pack

Sertraline 50 mg film-coated tablets are white, capsule shaped, biconvex, film-coated tablet debossed with SRN and 50 on either side of break line and plain on other.

Sertraline 100 mg film-coated tablets are white, capsule shaped, biconvex, film-coated tablet with ’SRN 100’ debossed on one side and plain on other.

Sertraline Tablets are available in calendar packs of 28 tablets.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, WAS ORR UK.

Product Licence Number

PL 20395/0276 – Sertraline 50 mg film-coated tablets and

PL 20395/0277 – Sertraline 100 mg film-coated tablets

| POM |

This leaflet was last revised in August 2021.

297 mm