Informations for option: Sertraline 100mg Film-Coated Tablets, show other option

Select option:

1. Sertraline 100mg Film-Coated Tablets
2. Sertraline 100mg Film Coated Tablets

Document: leaflet MAH GENERIC_PL 44041-0032 change

• leaflet MAH BRAND_PL 08553-0244
• leaflet MAH BRAND_PLPI 18799-2179
• leaflet MAH BRAND_PLPI 19488-1035
• leaflet MAH GENERIC_PL 00057-1205
• leaflet MAH GENERIC_PL 08553-0244
• leaflet MAH GENERIC_PL 11311-0492
• leaflet MAH GENERIC_PL 20075-0068
• leaflet MAH GENERIC_PL 29831-0183
• leaflet MAH GENERIC_PL 44041-0032

---

•    have or previously had thoughts of suicide or wanting to harm yourself (See below: Thoughts of suicide, suicidal attempts and worsening of your depression or anxiety disorder)

•    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)

• If you have eye problems, such as certain kinds of glaucoma (increased pressure in the eye)

Restlessness/Akathisia: the use of sertraline has been linked to akathisia (a distressing restlessness and need to move, often unable to sit or stand still). This is most likely to occur during the first few weeks of treatment. Increasing the dose may be harmful to patients who develop such symptoms.

Withdrawal Reactions: withdrawal reactions when treatment is stopped are common, particularly if the treatment is stopped suddenly (see 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). When stopping treatment with sertraline it is recommended to reduce the dose gradually over a period of several weeks or months, depending on the patient's needs.

Thoughts of suicide, suicidal attempts 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 anti-depressants, 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 anti-depressant

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 aged 6-17 years old. Patients under 18 have an increased risk of undesirable effects, such as suicide attempt, 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 to a patient under 18 if it is in the patient's interest. If your doctor has prescribed sertraline to a patient 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 when a patient under 18 is taking sertraline, you should inform your doctor. Also, the long-term safety of Sertraline in regard to growth, maturation and cognitive and behavioural development in this age group has not yet been demonstrated.

Other medicines and setraline tablets:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicine including medicines obtained without a prescription. Some medicines can affect the way sertraline works, or sertraline can reduce the effectiveness of other medicines taken at the same time.

Taking sertraline together with the following medicines may cause serious side effects:

•    Medicines called monoamine oxidase inhibitors (MAOIs), like moclobemid to treat depression) and selegiline (to treat Parkinson's disease) and the antibiotic linezolid. Do not use setraline together with these medicines

•    Medicines to treat mental disorders such as psychosis (pimozide). Do not use sertraline together with pimozide

Tell your doctor BEFORE starting your medicine if you are taking any of the following:

•    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 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)

Sertraline Tablets with food, drink and alcohol

It is not recommended to take Sertraline tablets with alcohol. Sertraline can be taken with or without food.

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. The safety of sertraline has not fully been established in pregnant women. Sertraline will only be given to pregnant women if the doctor considers that the benefit for the mother exceeds any possible risk to the foetus. Women of childbearing potential should employ an adequate method of contraception if taking sertraline.

There is evidence that sertraline is excreted in human breast milk. Sertraline should only be used in women during lactation, if the doctor considers that the benefit for the mother exceeds any possible risk to the 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 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 bluish skin or being to 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. Some medicines like sertraline may reduce the quality of sperm in animal studies. Theoretically, this could affect fertility, but the 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.

3. How to take Sertraline Tablets

Always take this medicine exactly as your doctor has told you. Sertraline tablets may be taken with or without food. Sertraline tablets are for oral administration only. Take your medication once daily either in the morning or evening. You should check with your doctor or pharmacist if you are not sure.

The usual dose is:

Adults: Depression and Obssessive Compulsive Disorder

For depression and OCD, the usual effective dose is 50mg/day. The daily dose may be

increased in 50mg increments and at intervals of at least one week over a period of weeks. The maximum recommended dose is 200mg/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 25mg/day and increased to 50mg/day after a week.

The daily dose then may be increased in 50mg increments over a period of weeks. The maximum recommended dose is 200mg/day

Children and adolescents:

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

Obsessive Compulsive Disorder:

Children aged 6-12: the recommended starting dose is 25mg daily. After one week, your doctor may increase this to 50mg daily. The maximum dose is 200mg daily.

Adolescents aged 13 to 17:

the recommended starting dose is 50mg daily. The maximum dose is 200mg daily.

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

The 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.

If you take more Sertraline Tablets than you should

If you take too many tablets or someone else takes your tablets, consult your nearest casualty department or doctor for advice. 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 worry. If you forget to take a tablet, do not take that tablet. Just take the next tablet at the right time. It is possible to suffer withdrawal effects if you miss a dose but this is very rare. If this happens to you, please contact your doctor.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Sertraline Tablets

Do not stop taking sertraline unless your doctor tells you to. Your doctor will want to gradually reduce your dose of sertraline 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, 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 Sertraline Tablets can cause side effects, although not everybody gets them. Nausea is the most common side effect. The side effects depend on the dose and are often transient with continued treatment.

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. 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 “Warnings and precautions”)

The following side effects were seen in clinical trials in adults.

Very common side effects (may affect more than 1 in 10 people):

Insomnia, dizziness, sleepiness, headache, diarrhoea, feeling sick, dry mouth, ejaculation failure, fatigue.

Common side effects (may affect up to 1 in 10 people):

Sore throat, anorexia, increased appetite, decreased 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, joint pain, malaise.

Uncommon side effects (may affect up to 1 in 100 people):

Chest cold, runny nose, hypersensitivity, hallucination, low thyroid hormones, hallucination, feeling too happy, lack of caring, thinking abnormal, aggression, convulsion, involuntary muscle contractions, abnormal coordination, moving a lot, amnesia, decreased feeling, speech disorder, dizziness while standing up, migraine, fainting, enlarged pupils, ear pain, fast heartbeat, high blood pressure, flushing, breathing difficulty, possible wheezing, shortness of breath, nose bleed, oesophageal problem, difficulty swallowing, haemorrhoids, increased saliva, tongue disorder, burping, eye swelling, purple spots on skin, face oedema, hair loss, cold sweat, dry skin, hives, itching, osteoarthritis, muscular weakness, back pain, muscle twitching, nighttime urination, unable to urinate, increase in urination, increase in frequency of urination, problem urinating, urinary incontinence, vaginal haemorrhage, female sexual dysfunction, menstrual irregularities, chills, fever, weakness, thirst, increase in liver enzyme levels, weight decreased, weight increased.

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

Intestine problem, ear infection, cancer, swollen glands, high cholesterol, low blood sugar, physical symptoms due to stress or emotions, drug dependence, psychotic disorder, paranoia, suicidal thoughts, sleep walking, premature ejaculation, serious allergic reaction which causes difficulty in breathing or dizziness, 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, problems controlling blood sugar levels (diabetes), 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 hesitation, excessive vaginal bleeding, dry vaginal area, red painful penis and foreskin, genital discharge, prolonged erection, breast discharge, hernia, injection site scarring, drug tolerance decreased, difficulty walking, semen abnormal, increase in blood cholesterol levels, injury, relaxation of blood vessels procedure, Cases of suicidal ideation and suicidal behaviours have been reported during sertraline therapy or early after treatment discontinuation

Not known: frequency cannot be estimated from the available data After marketing sertraline, the following side effects have been reported:

Decrease in white blood cells, decrease in clotting cells, endocrine problem, low blood salt, increase in blood sugar levels, terrifying abnormal dreams, suicidal behaviour, muscular movement problems (such as moving a lot, tense muscles and difficulty walking and stiffness, spasms and involuntary movements of the muscles), sudden severe headache (which may be a sign of a serious condition known as Reversible Cerebral Vasoconstriction Syndrome (RCVS)), vision abnormal, 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 jaundice, skin oedema, skin reaction to sun, muscle cramps, breast enlargement, unable to control urination, abnormal laboratory tests, problems with clotting, and severe allergic reaction.

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

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”).

Undesirable effects which occurred most commonly in children were:

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.

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: http://www.mhra.gov.uk/yellowcard.

By reporting side affects you can help provide more information on the safety of this medicine.

How quickly will the treatment start to work?

You may need to take Sertraline Tablets for up to 2-4 weeks before you notice them starting to work and some people feel worse before they feel better. Your doctor will want to monitor your progress closely during this period. You must keep taking Sertraline Tablets to help you get better.

•    See your doctor before your tablets run out.

•    Even if you begin to feel better, keep taking your tablets. You may need to keep taking them to stay well and it could be harmful if you stop taking your tablets suddenly

What if you do not feel better?

Tell your doctor if:

•    You have taken a course of tablets and you still feel unwell.

•    You feel worse.

•    You have suicidal thoughts or want to harm yourself. Sertraline may increase the risk of these thoughts especially when you first start taking it. Please let your family and/or friends know about this risk. You must seek help and advice if you start to feel worse or want to self harm.

5.    How to store Sertraline Tablets

•    Keep this medicine out of the sight and reach of children.

•    Do not use after the expiry date which is stated on the box. The expiry date refers to the last day of that month.

•    Do not throw away medicines via wastewater or household waste. Ask you pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information What Sertraline Tablets contain:

The active substance is sertraline hydrochloride

The other ingredients are: calcium hydrogen phosphate, hydroxypropylcellulose, Hypromellose, magnesium stearate, microcrystalline cellulose, Macrogol, polysorbate-80, sodium starch glycollate and titanium dioxide (E171).

What Sertraline Tablets look like and contents of the pack

Sertraline 50mg Tablets are white, oblong, biconvex, film-coated tablets with score line on one face.

Sertraline 100mg Tablets are white, oblong, biconvex, film-coated tablets. The tablets come in blisters of 28 tablets in a cardboard carton.

NOUMED LIFE SCIENCES

5 Cattle Market, Hexham, Northumberland NE46 1NJ, United Kingdom

Manufacturer:

MEDREICH PLC

Warwick House, Plane Tree Crescent,

Feltham TW13 7HF, UK E-mail : info@medreich.co.uk

Sertraline 50 mg Film-coated Tablets - PL 44041/0031 Sertraline 100 mg Film-coated Tablets - PL 44041/0032

This leaflet was last updated in April 2016

I POM

I21XXXX-V1

©