Sertraline 100mg film-coated Tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Sertraline film-coated Tablets are and what they are used for
2. What you need to know before you take Sertraline film-coated Tablets
3. How to take Sertraline film-coated Tablets
4. Possible side effects
5. How to store your Sertraline film-coated Tablets
6. Contents of the pack and other information

• if you are allergic to sertraline or any of the other ingredients of this medicine (listed in Section 6)
• if you are taking or have taken medicines called monoamine oxidase inhibitors (MAOIs such as selegiline, moclobemide) or MAOI like drugs (such as linezolid). If you stop treatment with sertraline, you must wait until at least one week before you start treatment with a MAOI. After stopping treatment with a MAOI, you must wait at least 2 weeks before you can start treatment with sertraline
• if you are taking another medicine called pimozide (a medicine for mental disorders such as psychosis).

Talk to your doctor or pharmacist before taking Sertraline.

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

• if you have epilepsy (fit) or a history of seizures. If you have a fit (seizure), contact your doctor immediately
• 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 level in your blood, since this can occur as a result of treatment with Sertraline film-coated Tablets. You should also tell your doctor if you are taking certain medicines for hypertension, since these medicines may also alter the sodium level in your blood
• if you are elderly as you may be more at risk of having low sodium level in your blood (see above)
• if you have liver disease; your doctor may decide that you should have a lower dose of Sertraline film-coated Tablets
• if you have diabetes; your blood glucose levels may be altered due to Sertraline film-coated Tablets and your diabetes medicines may need to be adjusted
• if you have suffered from bleeding disorders or have been taking medicines which thin the blood (e.g. acetylsalicylic acid (aspirin), or warfarin) or may increase the risk of bleeding, or if you are pregnant (see “Pregnancy, breast-feeding and fertility”)
• if you are a child or adolescent under 18 years old. Sertraline film-coated Tablets should only be used to treat children and adolescents aged 6-17 years old, suffering from obsessive compulsive disorder (OCD). If you are being treated for this disorder, your doctor will want to monitor you closely (see below- Children and adolescents)
• if you are having electro-convulsive therapy (ECT)
• if you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)
• if you have been told that you have an abnormality of your heart tracing after an electrocardiogram (ECG) known as prolonged QT interval
• 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
• The use of Buprenorphine together with Sertraline can lead to serotonin syndrome, a potentially life-threatening condition (see “Other medicines and Sertraline”).

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

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.

Side effects relating to stopping treatment (withdrawal reactions) are common, particularly if the treatment is stopped suddenly (see section 3 If you stop taking Sertraline film-coated Tablets and section 4 Possible side effects). The risk of withdrawal symptoms depends on the length of treatment, dosage and the rate at which the dose is reduced. Generally, such symptoms are mild to moderate. However, they can be serious in some patients. They normally occur within the first few days after stopping treatment. In general, such symptoms disappear on their own and wear off within 2 weeks. In some patients they may last longer (2-3 months or more). When stopping treatment with sertraline it is recommended to reduce the dose gradually over a period of several weeks or months, and you should always discuss the best way of stopping treatment with your doctor.

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.

• 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.

Sertraline should not usually be used in children and adolescents less than 18 years old, except for patients with Obsessive Compulsive Disorder (OCD). Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, thoughts of harming or killing themselves (suicidal thoughts) and hostility (mainly aggressiveness, oppositional behaviour and anger) when they are treated with this class of medicines. Nevertheless, it is possible that your doctor decides to prescribe Sertraline film-coated Tablets to a patient under 18 if it is in the patient’s interest. If your doctor has prescribed Sertraline film-coated Tablets to you and you are less than 18 years old and you want to discuss this, please contact him/her. Furthermore, if any of the symptoms listed above appear or worsen while you are taking Sertraline film-coated Tablets, you should inform your doctor. The long-term safety of Sertraline film-coated Tablets in regard to growth, maturation and learning (cognitive) and behavioural development was evaluated in a long term study in more than 900 children aged 6 to 16 years of age who were monitored over a 3 year period. Overall the results of the study showed that children treated with sertraline developed normally other than mild weight gain in those treated with a higher dose.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicines can affect the way Sertraline film-coated Tablets work, or Sertraline film-coated Tablets themselves can reduce the effectiveness of other medicines taken at the same time.

• medicines called monoamine oxidase inhibitors (MAOIs) like moclobemide(to treat depression) and selegiline (to treat Parkinson’s disease), the antibiotic linezolid and methylene blue (to treat high levels of methaemoglobin in the blood). Do not use Sertraline film-coated Tablets together with these medicines
• medicines to treat mental disorders such as psychosis (pimozide). Do not use Sertraline film-coated Tablets together with pimozide
• buprenorphine/opioids. These medicines may interact with Sertraline and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms.

• medicines containing amphetamines (used to treat attention deficit hyperactivity disorder (ADHD), narcolepsy and obesity)
• herbal medicines containing St. John’s Wort (Hypericum perforatum). The effects of St. John’s Wort may last for 1-2 weeks
• products containing the amino acid tryptophan
• medicines used to treat severe pain (e.g. tramadol)
• medicines used in anaesthesia or to treat chronic pain (fentanyl, mivacurium and suxamethonium)
• medicines used to treat migraines (e.g. sumatriptan)
• blood thinning medicine (warfarin)
• medicines used to treat pain/arthritis (Non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen, 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)
• metamizole, a medicine used to treat pain and fever.

Sertraline film-coated Tablets can be taken with or without food.

Alcohol should be avoided while taking Sertraline film-coated Tablets.

Sertraline should not be taken in combination with grapefruit juice, as this may increase the level of sertraline in your body.

Pregnancy

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

The safety of sertraline has not been fully 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. 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 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 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 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.

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.

This medicine contains less than 1 mmol sodium (23 mg) per 50 mg and 100 mg tablet, that is to say essentially ‘sodium free’.

Adults:

• Depression and Obsessive 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.
• PTSD, Panic Disorder, Social Anxiety Disorder and Post Traumatic Stress Disorder: The recommended dose is 25 mg daily increasing to 50 mg a 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.

Sertraline film-coated Tablets must only be used to treat children and adolescents suffering from OCD aged 6-17 years old.

Children aged 6 to 12 years: 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.

Sertraline tablets may be taken with or without food. The tablets should not be chewed or crushed; they should always be swallowed whole, with a drink of water. Take your medicine 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 accidentally take too many tablets, contact your doctor at once or go to your nearest hospital emergency department (or casualty). 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.

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. Taking your medicine at the same time each day may help you to remember to take it regularly.

Do not stop taking Sertraline film-coated Tablets unless your doctor tells you to. Your doctor will want to gradually reduce your dose of Sertraline film-coated 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 film-coated Tablets, please speak to your doctor.

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.

If you suddenly stop taking this medicine you may experience side effects such as dizziness, numbness, sleep disturbances, agitation or anxiety, headaches, feeling sick, being sick and shaking (see section 3 “If you stop taking Sertraline film-coated Tablets”).

An increased risk of bone fractures has been observed in patients taking this type of medicine.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow 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.

• The active substance is sertraline hydrochloride
• The other ingredients are cellulose microcrystalline, calcium hydrogen phosphate dihydrate, colloidal silica, sodium starch glycolate, hydroxypropyl cellulose, magnesium stearate, polysorbate 80, hypromellose, titanium dioxide (E171), polyethylene glycol.

Sertraline 50mg and 100mg film-coated Tablets are white tablets, and marked with either “50” or “100” on one side, and ‘S’ and ‘ET’ on the other side.

Your Sertraline film-coated Tablets are presented in blister packs. They are supplied in boxes containing 28, 30 or 100 tablets. Not all pack sizes may be marketed.