Felitor 10 mg Film-Coated Tablets

FELITOR (escitalopram) is a selective serotonin reuptake inhibitor (SSRIs) that belongs to a group of medicines known as antidepressants. These medicines help to normalise serotonin levels in the brain. Disruptions to the serotonin system in the brain are believed to be an important factor in the development of depression and related illnesses. FELITOR is used to treat depression (major depressive episodes).

Do not take FELITOR

• if you are hypersensitive (allergic) to escitalopram or any of the other ingredients of FELITOR (listed in section 6).
• if you are a child or adolescent under the age of 18 years
• if you are pregnant or breastfeeding your baby (FELITOR can lead to severe vaginal bleeding after childbirth)
• if you are already taking medicines which belongs to a group called MAO inhibitors (a type of antidepressant medicine). Ask your doctor or pharmacist if you are uncertain
• if you are taking medicines such as pimozide (taken to reduce uncontrolled movements or outbursts of words /sounds caused by Tourette syndrome) that are known to prolong the QT interval (medicines that lengthen the time it takes for the heart muscle to recharge between beats)
• if you have the following condition: QT interval prolongation or congenital long QT syndrome (when the heart muscle takes longer to recharge between beats).
• if you are taking linezolid (antibiotic belonging to the oxazolidinone class taken to treat certain bacterial infections)

Warnings and precautions

Take special care with FELITOR:

• if you have epilepsy. Treatment with FELITOR should be stopped if seizures occur or if there is an increase in the seizure frequency
• if you suffer from impaired liver function or diabetes (your doctor may need to adjust the dose of medicine you take for these diseases or the dose of FELITOR)
• symptoms like fever, unintentional jerky muscle movements and agitation may develop during treatment. Tell your doctor immediately if you experience these symptoms
• symptoms such as restlessness or difficulty in sitting or standing still can occur during the first weeks of the treatment. Tell your doctor immediately if you experience these symptoms
• if you are taking medicine that lowers you blood sodium, magnesium or potassium (salt) levels
• if you have a tendency to easily develop bleedings or bruises or if you are taking medicine that affect your body’s ability to prevent bleeding
• if you are receiving electroconvulsive treatment
• if you have coronary heart disease or have had a heart attack
• if you are taking any herbal medicine containing St. John’s wort (a herb used to treat depression)
• if you suffer from glaucoma (a condition of increased pressure within the eyeball, causing gradual loss of sight).
• if you suffer from mood disturbances characterised by rapidly changing moods ranging from mood elevations to depressed states.
• if you experience any sexual dysfunctions, as it may be due to FELITOR.

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. 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

If you are under 18 years of age. FELITOR should normally not be used for children and adolescents under 18 years (see 3. What you need to know before you take FELITOR - Do not take FELITOR). Patients under 18 years of age have an increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (predominately aggression, oppositional behaviour and anger), especially when starting treatment with antidepressants.

Other medicines and FELITOR:

Always tell your healthcare professional if you are taking any other medicine. (This includes complementary or traditional medicines). Tell your doctor or pharmacist if you are taking any of the following medicines:

• warfarin, dipyridamole, and phenprocoumon (medicines used to thin the blood, so called anticoagulants). Your doctor will probably check the coagulation time of your blood when starting and discontinuing FELITOR in order to verify that your dose of anticoagulant is still adequate
• moclobemide (used to treat depression)
• pimozide (taken to reduce uncontrolled movements or outbursts of words/sounds caused by Tourette syndrome)
• ritonavir (an antiviral medicine taken to treat HIV)

Do not share medicines prescribed for you with any other person. Always take FELITOR exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is a single tablet taken once daily.

Your doctor will tell you how long your treatment with FELITOR will last. Do not stop treatment early. It may take a couple of weeks before you start to feel better. Continue to take FELITOR even if it takes some time before you feel any improvement in your condition.

If you have the impression that the effect of FELITOR is too strong or too weak, talk to your doctor or pharmacist.

Adults

The normal recommended dose of FELITOR is 10 mg taken as one daily dose. The dose may be increased by your doctor to a maximum of 20 mg per day.

Children and adolescents (below 18 years of age)

FELITOR should not be given to children and younger people under the age of 18 (see 3. What you need to know before you take FELITOR - Do not take FELITOR).

If you take more FELITOR than you should

In the event of over dosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.

If you forget to take FELITOR

If you forget a dose, but remember a little later on that you should have taken it, take that day’s dose as usual. However, if a long delay has occurred and the next dose is near, skip the forgotten dose and take the next normal dose at the scheduled time. Do not take a double dose.

If you stop taking FELITOR

Do not stop your treatment because you are feeling better without consulting with your doctor. When you do so after consulting your doctor you should go off your treatment gradually as you may suffer severe symptoms of withdrawal. The risk is higher, when FELITOR has been used for a long time or in high doses or when the dose is reduced too quickly. Most people find that the symptoms are mild and go away on their own within two weeks. However, in some patients they may be severe in intensity or they may be prolonged (2 - 3 months or more). If you get severe discontinuation symptoms when you stop taking FELITOR, please contact your doctor. Discontinuation symptoms may include, but are not restricted to:

• feeling dizzy (unsteady or off-balance)
• feelings like pins and needles, burning sensations and (less commonly) electric shock sensations, including in the head
• sleep disturbances (vivid dreams, nightmares, inability to sleep)
• feeling anxious, headaches
• feeling sick (nausea), sweating (including night sweats), feeling restless or agitated, tremor (shakiness), feeling confused or disorientated, feeling tired, sleepy and yawning more often than usual
• diarrhoea (loose stools), constipation
• fever
• sinusitis
• lower sex drive
• loss of appetite

FELITOR can have side effects. If the side effects are troublesome or last for more than 1 - 2 weeks, you should contact your doctor again. Not all side effects reported for FELITOR are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking FELITOR, please consult your health care provider for advice.

If any of the following happen, stop taking FELITOR and tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of the hands, feet, ankles, face, lips, mouth, or throat which may cause difficulty in swallowing or breathing
• rash or itching
• fainting

These are all very serious side effects. If you have them, you may have had an allergic reaction to FELITOR. You may need urgent medical attention or hospitalisation. All of these serious side effects are less frequent.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Less frequent
• yellowing of the skin and eyes, also called jaundice
• Feeling hostile, suicidal, want to harm yourself
• Panic attack
• Loss of consciousness
• changes in the way your heart beats, for example, if you notice it beating faster/slower
• bleeding in the intestines

Frequency unknown

• Blood disorders
• less urine than is normal for you.
• excessive weight loss due to not wanting to eat
• abnormal liver function tests

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

• Frequent
• Changes in appetite for food
• Weight gain
• Feeling anxious, restless, have abnormal dreams, loss in sex drive, sexual dysfunction
• Headaches, dizziness, fever
• Experiencing ‘pins and needles’; quivering
• Sleep disturbances (insomnia)
• Sinusitis (inflammation of sinuses in the nose)
• Yawning more than is normal for you; tiredness
• Nausea (feeling sick); lose stools (diarrhoea), constipation, vomiting
• Dry mouth
• Increased sweating
• Joint and muscle pain

Less frequent

• Weight loss
• Grinding of teeth
• Agitation, nervousness, confusion, aggressiveness.

Frequency unknown

• Movement disorders
• Discolouration of the skin; swelling under the skin
• Excessive or inappropriate production of milk
• Heavy vaginal bleeding shortly after birth (postpartum haemorrhage), see ‘Do not take FELITOR’ in section 2 for more information.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of FELITOR.

Store all medicines out of the reach and sight of children. Store at or below 30 °C. Keep the container in the outer carton. Do not use after the expiry date stated on the carton. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).