Patient Leaflet Updated 26-May-2021 | Zentiva
Sertraline 25 mg Film-coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Sertraline 25 mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is in this leaflet
1. What Sertraline is and what it is used for
2. What you need to know before you take Sertraline
3. How to take Sertraline
4. Possible side effects
5. How to store Sertraline
6. Contents of the pack and other information
1. WHAT SERTRALINE IS AND WHAT IT IS USED FOR
What it is used for
Sertraline 25 mg Film-coated Tablets (Sertraline) is one of a group of medicines called Selective Serotonin Re-uptake Inhibitors (SSRIs); these medicines are used to treat depression and/or anxiety disorders.
Sertraline can be used to treat:
Depression is a clinical illness with symptoms like feeling sad, unable to sleep properly or to enjoy life as you used to.
OCD and Panic disorders are illnesses linked to anxiety with symptoms like being constantly troubled by persistent ideas (obsessions) that make you carry out repetitive rituals (compulsions).
PTSD is a condition that can occur after a very emotionally traumatic experience and has some symptoms that are similar to depression and anxiety.
Social anxiety disorder (social phobia) is an illness linked to anxiety. It is characterised by feelings of intense anxiety or distress in social situations (for example: talking to strangers, speaking in front of groups of people, eating or drinking in front of others or worrying that you might behave in an embarrassing manner).
Your doctor has decided that this medicine is suitable for treating your illness.
You should ask your doctor if you are unsure why you have been given sertraline.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SERTRALINE
Do not take sertraline if you are:
Do not take if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before you take sertraline.
Warnings and precautions
Medicines are not always suitable for everyone. Talk to your doctor or pharmacist before taking sertraline if you suffer from or have suffered in the past from any of the following conditions:
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 and section 4). 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 2 weeks but sometimes longer.
You may be more likely to think like this:
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.
Medicines like sertraline (SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after stopping treatment.
Children and adolescents
Sertraline should not usually be used in children and adolescents less than 18 years old, except for patients with 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 to a patient under 18 if it is in the patient’s interest. If your doctor has prescribed sertraline 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, you should inform your doctor. Also, the long-term safety of sertraline in regard to growth, maturation and learning (cognitive) and behavioural development in this age group has not yet been demonstrated.
Other medicines and sertraline
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 works, or sertraline itself can reduce the effectiveness of other medicines taken at the same time.
Taking sertraline together with the following medicines may cause serious side effects:
Talk to your doctor if you are taking the following medicines:
Sertraline with food, drink and alcohol
Sertraline tablets can be taken with or without food.
Alcohol should be avoided whilst taking sertraline.
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 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:
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.
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.
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.
Important information about some of the ingredients of Sertraline
Sertraline contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free’.
3. HOW TO TAKE SERTRALINE
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:
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 1 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 1 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.
Children and adolescents
Sertraline must only be used to treat children and adolescents suffering from OCD aged 6 - 17 years old.
Children aged 6 - 12: the recommended starting dose is 25 mg daily.
After 1 week, your doctor may increase this to 50 mg daily. The maximum dose is 200 mg daily.
Adolescents aged 13 - 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 than you should
If you accidentally take too much sertraline contact your doctor at once or go to the nearest hospital casualty department. 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
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
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 product, 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 after taking this medicine, these symptoms can be serious:
The following side effects were seen in clinical trials in adults and after marketing.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
+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 1 in 1,000 people):
Not known: frequency cannot be estimated from the available data:
*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”).
An increased risk of bone fractures has been observed in patients taking this type of medicines.
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 Yellow Card Scheme Website: 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.
5. HOW TO STORE SERTRALINE
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
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.
Do not use this medicine if you notice any visible signs of deterioration.
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 INFORMATION
What Sertraline 25mg film-coated tablets contain
What Sertraline 25mg film-coated tablets look like and contents of the pack
Sertraline 25mg film-coated tablets are white to off-white, round, biconvex, film coated tablets with a diameter of 6.0 ± 0.5mm.
The tablets are packed into PVC/PVDC/Alu blisters and cartons and are available in packs of 28.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
For information in large print, Braille or on CD, telephone +44 (0)800 090 2408
This leaflet was last revised in March 2021