Scheduling Status<\/p>\n\n\n\n
S5<\/strong><\/p>\n\n\n\n Cipralex 5, 10, 15 and 20 mg film-coated tablets<\/strong><\/p>\n\n\n\n Escitalopram as oxalate<\/strong><\/p>\n\n\n\n Read this information carefully before starting Cipralex.<\/p>\n\n\n\n Keep this information because it may be needed again. If further questions arise, ask a doctor or pharmacist.<\/p>\n\n\n\n Cipralex has been prescribed personally and should not be passed on to others. It may harm them, even if their symptoms are the same.<\/p>\n\n\n\n If any side effects become serious, or if side effects not listed here are noticed, tell a doctor or pharmacist.<\/p>\n\n\n\n The active substance is escitalopram as oxalate<\/strong>.<\/p>\n\n\n\n Each Cipralex tablet contains one of the following strengths:<\/p>\n\n\n\n The other ingredients are:<\/p>\n\n\n\n Cipralex contains escitalopram<\/strong>.<\/p>\n\n\n\n Cipralex is used to treat:<\/p>\n\n\n\n Do not take Cipralex if any of the following apply:<\/p>\n\n\n\n Tell your doctor or pharmacist if any of the following apply before taking Cipralex:<\/p>\n\n\n\n Treatment with Cipralex should be stopped if seizures develop for the first time or if seizure frequency increases. If epilepsy is controlled, medical supervision is required.<\/p>\n\n\n\n Treatment with Cipralex may alter glycaemic control in diabetes. Insulin or oral hypoglycaemic medicine may need dose adjustment.<\/p>\n\n\n\n Improvement is not immediate. It may take several weeks after starting Cipralex before improvement is experienced.<\/p>\n\n\n\n In panic disorder, improvement usually takes 2 to 4 weeks<\/strong>.<\/p>\n\n\n\n At the beginning of treatment, some patients may experience anxiety. This usually disappears with continued treatment.<\/p>\n\n\n\n It is important to follow the doctor\u2019s instructions exactly and not stop treatment or change the dose without consulting the doctor.<\/p>\n\n\n\n Symptoms of depression or panic disorder may include thoughts of suicide or self-harm.<\/p>\n\n\n\n These symptoms may continue, worsen, or the risk of suicide may increase until the full antidepressant effect becomes apparent.<\/p>\n\n\n\n The risk is greater in people younger than 25 years<\/strong>.<\/p>\n\n\n\n Tell a doctor immediately or contact the nearest hospital if distressing thoughts or experiences occur during treatment.<\/p>\n\n\n\n Some patients with manic-depressive illness may enter a manic phase.<\/p>\n\n\n\n Possible signs include:<\/p>\n\n\n\n Contact a doctor if these symptoms occur.<\/p>\n\n\n\n Symptoms such as restlessness or difficulty sitting or standing still may occur during the first weeks of treatment. Tell a doctor immediately if these symptoms occur.<\/p>\n\n\n\n It may be helpful to ask a friend or relative to help watch for changes in behaviour.<\/p>\n\n\n\n Cipralex should not be used in children and adolescents under 18 years<\/strong>.<\/p>\n\n\n\n Patients under 18 years have an increased risk of side effects such as:<\/p>\n\n\n\n Cipralex can be taken with or without food.<\/p>\n\n\n\n Cipralex has been shown not to increase the effects of alcohol. However, it is recommended not to drink alcohol during treatment with Cipralex.<\/p>\n\n\n\n If you become pregnant or have been breastfeeding your baby, consult a doctor, pharmacist or other healthcare professional before taking Cipralex.<\/p>\n\n\n\n Do not take Cipralex if you are pregnant.<\/p>\n\n\n\n Tell your doctor if you are pregnant or planning to become pregnant.<\/p>\n\n\n\n If Cipralex is taken during the last 3 months of pregnancy, the newborn baby may experience:<\/p>\n\n\n\n These effects usually start immediately or within 24 hours<\/strong> after delivery.<\/p>\n\n\n\n There may also be a higher risk of persistent pulmonary hypertension in the newborn<\/strong>.<\/p>\n\n\n\n Do not take Cipralex if you are breastfeeding.<\/p>\n\n\n\n Cipralex does not usually cause drowsiness.<\/p>\n\n\n\n However, as with any new medicine, take care while driving or using machinery until you know how Cipralex affects you.<\/p>\n\n\n\n Always tell your healthcare professional if you are taking any other medicines, including complementary or traditional medicines.<\/p>\n\n\n\n Tell your doctor or pharmacist especially if you are taking any of the following:<\/p>\n\n\n\n If high fever, abrupt muscle contractions, agitation or confusion occurs when using certain combinations, see a doctor immediately.<\/p>\n\n\n\n Your doctor may need to adjust the dose of Cipralex or other medicines.<\/p>\n\n\n\n Always take Cipralex exactly as the doctor has instructed.<\/p>\n\n\n\n Check with a doctor or pharmacist if unsure or if further information is needed.<\/p>\n\n\n\n Cipralex is taken every day as a single daily dose.<\/p>\n\n\n\n It can be taken with or without food.<\/p>\n\n\n\n Swallow the tablets with water.<\/p>\n\n\n\n Do not chew the tablets because the taste is bitter.<\/p>\n\n\n\n If necessary, the tablets may be broken by placing the tablet on a flat surface with the score facing upwards and pressing down on each end of the tablet with both forefingers.<\/p>\n\n\n\n It may take a couple of weeks before you start to feel better.<\/p>\n\n\n\n Continue taking Cipralex even if it takes some time before improvement is felt.<\/p>\n\n\n\n Do not change the dose without speaking to your doctor first.<\/p>\n\n\n\n Continue taking Cipralex for as long as the doctor recommends.<\/p>\n\n\n\n If treatment is stopped too soon, symptoms may return.<\/p>\n\n\n\n It is recommended that treatment should continue for at least 6 months<\/strong> after feeling well again.<\/p>\n\n\n\n If more than the prescribed dose is taken, contact a doctor, pharmacist, nearest hospital emergency department or poison control centre immediately.<\/p>\n\n\n\n Do this even if there are no signs of discomfort.<\/p>\n\n\n\n Possible signs of overdose include:<\/p>\n\n\n\n Do not take a double dose to make up for a forgotten dose.<\/p>\n\n\n\n If a dose is forgotten and remembered before going to bed, take it straight away and continue as usual the next day.<\/p>\n\n\n\n If the missed dose is only remembered during the night or the next day, leave out the missed dose and continue as usual.<\/p>\n\n\n\n Do not stop taking Cipralex until your doctor tells you to do so.<\/p>\n\n\n\n When treatment is completed, the dose is generally reduced gradually over several weeks.<\/p>\n\n\n\n Stopping Cipralex suddenly may cause discontinuation symptoms.<\/p>\n\n\n\n The risk is higher when Cipralex has been used for a long time, at high doses, or when the dose is reduced too quickly.<\/p>\n\n\n\n Most symptoms are mild and go away within two weeks, but in some patients symptoms may be severe or prolonged for 2 to 3 months or more<\/strong>.<\/p>\n\n\n\n If severe discontinuation symptoms occur, contact a doctor. The doctor may ask that the tablets be restarted and then reduced more slowly.<\/p>\n\n\n\n Cipralex can cause side effects.<\/p>\n\n\n\n If any side effect becomes serious, or if side effects not listed here are noticed, tell a doctor or pharmacist.<\/p>\n\n\n\n Store all medicine out of the reach of children.<\/p>\n\n\n\n Do not store above 30 \u00b0C<\/strong>.<\/p>\n\n\n\n Do not use Cipralex after the expiry date stated on the label or carton.<\/p>\n\n\n\n Medicines should not be disposed of via wastewater or household waste.<\/p>\n\n\n\n Ask a pharmacist how to dispose of medicines no longer required.<\/p>\n\n\n\n Cipralex is available in the following pack size:<\/p>\n\n\n\nProprietary Name, Strength and Pharmaceutical Form<\/h2>\n\n\n\n
Active Ingredient<\/h2>\n\n\n\n
\n\n\n\nRead Before Taking Cipralex<\/h1>\n\n\n\n
\n\n\n\nWhat Cipralex Contains<\/h1>\n\n\n\n
Tablet strength<\/th> Active substance<\/th><\/tr><\/thead> Cipralex 5 mg<\/td> Escitalopram as oxalate<\/td><\/tr> Cipralex 10 mg<\/td> Escitalopram as oxalate<\/td><\/tr> Cipralex 15 mg<\/td> Escitalopram as oxalate<\/td><\/tr> Cipralex 20 mg<\/td> Escitalopram as oxalate<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Other ingredients<\/th><\/tr><\/thead> Colloidal anhydrous silica<\/td><\/tr> Croscarmellose sodium<\/td><\/tr> Hypromellose<\/td><\/tr> Macrogol 400<\/td><\/tr> Magnesium stearate<\/td><\/tr> Microcrystalline cellulose<\/td><\/tr> Talc<\/td><\/tr> Titanium dioxide, also known as E-171<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nWhat Cipralex Is Used For<\/h1>\n\n\n\n
Condition<\/th><\/tr><\/thead> Depression, also known as major depressive episodes<\/td><\/tr> Panic disorder with or without agoraphobia<\/td><\/tr> Social anxiety disorder<\/td><\/tr> Generalised anxiety disorder<\/td><\/tr> Obsessive-compulsive disorder<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nBefore You Take Cipralex<\/h1>\n\n\n\n
Do Not Take Cipralex<\/h2>\n\n\n\n
Do not take Cipralex if<\/th> Details<\/th><\/tr><\/thead> You are allergic to escitalopram<\/td> This includes allergy to the active substance<\/td><\/tr> You are allergic to any other ingredient in Cipralex<\/td> Check the ingredients section<\/td><\/tr> You are under 18 years of age<\/td> Cipralex should not be used in children and adolescents under 18 years<\/td><\/tr> You are taking monoamine oxidase inhibitors<\/td> These include selegiline and tranylcypromine<\/td><\/tr> You have taken a monoamine oxidase inhibitor recently<\/td> Wait 14 days before starting Cipralex<\/td><\/tr> You have stopped Cipralex and need to take a monoamine oxidase inhibitor<\/td> Allow 7 days after stopping Cipralex before taking these medicines<\/td><\/tr> You are taking linezolid<\/td> This medicine must not be taken at the same time as Cipralex<\/td><\/tr> You are taking pimozide<\/td> This medicine must not be taken at the same time as Cipralex<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nTake Special Care With Cipralex<\/h2>\n\n\n\n
Condition or situation<\/th><\/tr><\/thead> Epilepsy<\/td><\/tr> Unstable epilepsy<\/td><\/tr> First-time seizures or increased seizure frequency<\/td><\/tr> Impaired liver function<\/td><\/tr> Impaired kidney function<\/td><\/tr> Diabetes<\/td><\/tr> Decreased sodium level in the blood<\/td><\/tr> Tendency to bleed or bruise easily<\/td><\/tr> Electroconvulsive treatment<\/td><\/tr> Coronary heart disease<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nPlease Note<\/h1>\n\n\n\n
\n\n\n\nThoughts of Suicide or Self-Harm<\/h2>\n\n\n\n
\n\n\n\nMania and Behaviour Changes<\/h2>\n\n\n\n
Possible signs<\/th><\/tr><\/thead> Unusual and rapidly changing ideas<\/td><\/tr> Inappropriate happiness<\/td><\/tr> Excessive physical activity<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nUse in Children and Adolescents Under 18 Years of Age<\/h1>\n\n\n\n
Possible increased risks<\/th><\/tr><\/thead> Suicide attempts<\/td><\/tr> Suicidal thoughts<\/td><\/tr> Hostility<\/td><\/tr> Aggression<\/td><\/tr> Oppositional behaviour<\/td><\/tr> Anger<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nTaking Cipralex With Food and Drink<\/h1>\n\n\n\n
\n\n\n\nPregnancy and Breast-Feeding<\/h1>\n\n\n\n
Possible effects in newborn baby<\/th><\/tr><\/thead> Trouble breathing<\/td><\/tr> Bluish skin<\/td><\/tr> Fits<\/td><\/tr> Body temperature changes<\/td><\/tr> Feeding difficulties<\/td><\/tr> Vomiting<\/td><\/tr> Low blood sugar<\/td><\/tr> Stiff or floppy muscles<\/td><\/tr> Vivid reflexes<\/td><\/tr> Tremor<\/td><\/tr> Jitteriness<\/td><\/tr> Irritability<\/td><\/tr> Lethargy<\/td><\/tr> Constant crying<\/td><\/tr> Sleepiness<\/td><\/tr> Sleeping difficulties<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nDriving and Using Machines<\/h1>\n\n\n\n
\n\n\n\nTaking Other Medicines With Cipralex<\/h1>\n\n\n\n
Medicine or medicine group<\/th> Use or concern<\/th><\/tr><\/thead> Monoamine oxidase inhibitors<\/td> Includes selegiline, tranylcypromine, phenelzine, isocarboxazid, nialamide, moclobemide and linezolid<\/td><\/tr> Lithium<\/td> Used in manic-depressive disorder<\/td><\/tr> Selegiline<\/td> Used in Parkinson\u2019s disease<\/td><\/tr> Imipramine and desipramine<\/td> Used to treat depression<\/td><\/tr> Metoprolol<\/td> Used in cardiovascular diseases<\/td><\/tr> Sumatriptan and similar medicines<\/td> Used to treat migraine<\/td><\/tr> Tramadol and pethidine<\/td> Used for severe pain<\/td><\/tr> Cimetidine and omeprazole<\/td> Used to treat stomach ulcers<\/td><\/tr> St John\u2019s Wort<\/td> Herbal remedy used for low mood<\/td><\/tr> Aspirin and non-steroidal anti-inflammatory medicines<\/td> May increase bleeding risk<\/td><\/tr> Oral anticoagulants such as warfarin<\/td> May alter blood-clotting control<\/td><\/tr> Medicines that lower the seizure threshold<\/td> Includes neuroleptics, some antidepressants, mefloquine, bupropion and tramadol<\/td><\/tr> Flecainide and propafenone<\/td> Used in cardiovascular diseases<\/td><\/tr> Desipramine, clomipramine and nortriptyline<\/td> Antidepressants<\/td><\/tr> Risperidone, thioridazine and haloperidol<\/td> Antipsychotic medicines<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nHow to Take Cipralex<\/h1>\n\n\n\n
How Much to Take<\/h2>\n\n\n\n
\n\n\n\nHow and When to Take Cipralex<\/h2>\n\n\n\n
\n\n\n\nDuration of Treatment<\/h2>\n\n\n\n
\n\n\n\nIf You Take More Cipralex Than You Should<\/h2>\n\n\n\n
Possible overdose signs<\/th><\/tr><\/thead> Dizziness<\/td><\/tr> Tremor<\/td><\/tr> Agitation<\/td><\/tr> Convulsion<\/td><\/tr> Coma<\/td><\/tr> Nausea<\/td><\/tr> Vomiting<\/td><\/tr> Change in heart rhythm<\/td><\/tr> Decreased blood pressure<\/td><\/tr> Change in body fluid or salt balance<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nIf You Forget to Take Cipralex<\/h2>\n\n\n\n
\n\n\n\nIf You Stop Taking Cipralex<\/h2>\n\n\n\n
Discontinuation Symptoms<\/h2>\n\n\n\n
Possible discontinuation symptoms<\/th><\/tr><\/thead> Feeling dizzy, unsteady or off-balance<\/td><\/tr> Pins and needles<\/td><\/tr> Burning sensations<\/td><\/tr> Electric shock sensations, including in the head<\/td><\/tr> Sleep disturbances<\/td><\/tr> Vivid dreams<\/td><\/tr> Nightmares<\/td><\/tr> Inability to sleep<\/td><\/tr> Anxiety<\/td><\/tr> Headaches<\/td><\/tr> Nausea<\/td><\/tr> Sweating, including night sweats<\/td><\/tr> Restlessness or agitation<\/td><\/tr> Tremor<\/td><\/tr> Confusion or disorientation<\/td><\/tr> Emotional changes or irritability<\/td><\/tr> Diarrhoea<\/td><\/tr> Visual disturbances<\/td><\/tr> Fluttering or pounding heartbeat, also known as palpitations<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nPossible Side Effects<\/h1>\n\n\n\n
Side Effects Table<\/h2>\n\n\n\n
Side-effect category<\/th> Side effects \/ symptoms<\/th> Recommended action<\/th><\/tr><\/thead> Serious side effects requiring immediate medical attention<\/td> Difficulties urinating<\/td> Tell a doctor immediately or go to hospital straight away<\/td><\/tr> Serious side effects requiring immediate medical attention<\/td> Seizures or fits<\/td> Tell a doctor immediately or go to hospital straight away<\/td><\/tr> Serious side effects requiring immediate medical attention<\/td> Yellowing of the skin and the whites of the eyes, which may indicate liver function impairment or hepatitis<\/td> Tell a doctor immediately or go to hospital straight away<\/td><\/tr> Serious side effects<\/td> Unusual bleeding, including gastrointestinal bleeding<\/td> Tell a doctor<\/td><\/tr> Allergic reaction<\/td> Swelling of the skin, tongue, lips or face; difficulty breathing or swallowing<\/td> Contact a doctor or go to hospital straight away<\/td><\/tr> Serotonin syndrome warning signs<\/td> High fever, agitation, confusion, trembling and abrupt contractions of muscles<\/td> Contact a doctor immediately<\/td><\/tr> Mental health warning signs<\/td> Suicidal thoughts or self-harm while taking Cipralex or after stopping Cipralex<\/td> Seek urgent medical advice<\/td><\/tr> Common or bothersome effects<\/td> Feeling sick, also known as nausea<\/td> Tell a doctor if continuing or bothersome<\/td><\/tr> Common or bothersome effects<\/td> Blocked or runny nose, also known as sinusitis<\/td> Tell a doctor if continuing or bothersome<\/td><\/tr> Common or bothersome effects<\/td> Decreased or increased appetite<\/td> Tell a doctor if continuing or bothersome<\/td><\/tr> Common or bothersome effects<\/td> Anxiety, restlessness, abnormal dreams, difficulty falling asleep, sleepiness, dizziness, yawning, tremors, prickling of the skin<\/td> Tell a doctor if continuing or bothersome<\/td><\/tr> Common or bothersome effects<\/td> Diarrhoea, constipation, vomiting, dry mouth<\/td> Tell a doctor if continuing or bothersome<\/td><\/tr> Common or bothersome effects<\/td> Increased sweating<\/td> Tell a doctor if continuing or bothersome<\/td><\/tr> Common or bothersome effects<\/td> Pain in muscles and joints, also known as arthralgia and myalgia<\/td> Tell a doctor if continuing or bothersome<\/td><\/tr> Common or bothersome effects<\/td> Sexual disturbances, including delayed ejaculation, erection problems, decreased sexual drive and difficulty achieving orgasm in women<\/td> Tell a doctor if continuing or bothersome<\/td><\/tr> Common or bothersome effects<\/td> Fatigue and fever<\/td> Tell a doctor if continuing or bothersome<\/td><\/tr> Weight-related effects<\/td> Increased weight or decreased weight<\/td> Tell a doctor<\/td><\/tr> Skin effects<\/td> Nettle rash, rash, itching, loss of hair<\/td> Tell a doctor<\/td><\/tr> Mental and nervous system effects<\/td> Grinding teeth, agitation, nervousness, panic attack, confusion, disturbed sleep, taste disturbance, fainting<\/td> Tell a doctor<\/td><\/tr> Eye and ear effects<\/td> Enlarged pupils, visual disturbance, ringing in the ears<\/td> Tell a doctor<\/td><\/tr> Reproductive effects<\/td> Vaginal bleeding, persistent painful erections, milk flow in women who are not nursing<\/td> Tell a doctor immediately, especially for persistent painful erections<\/td><\/tr> Heart and circulation effects<\/td> Fast heartbeat, slow heartbeat, swelling of the arms or legs, dizziness when standing due to low blood pressure<\/td> Tell a doctor<\/td><\/tr> Bleeding-related effects<\/td> Nosebleeds, skin and mucous bleeding, low blood platelets<\/td> Tell a doctor<\/td><\/tr> Psychiatric effects<\/td> Aggression, depersonalisation, hallucination, mania, suicide-related events<\/td> Tell a doctor immediately<\/td><\/tr> Blood chemistry effects<\/td> Decreased sodium levels in the blood, with symptoms such as feeling sick and unwell, weak muscles or confusion<\/td> Tell a doctor<\/td><\/tr> Liver test changes<\/td> Abnormal liver function test with increased liver enzymes in the blood<\/td> Tell a doctor<\/td><\/tr> Movement-related effects<\/td> Movement disorders, including involuntary muscle movements<\/td> Tell a doctor<\/td><\/tr> Swelling-related effects<\/td> Sudden swelling of skin or mucosa, also known as angioedema<\/td> Seek urgent medical attention<\/td><\/tr> Hormonal effects<\/td> Increase in the amount of urine excreted due to inappropriate ADH secretion<\/td> Tell a doctor<\/td><\/tr> Similar-medicine effects<\/td> Motor restlessness, also known as akathisia<\/td> Tell a doctor<\/td><\/tr> Similar-medicine effects<\/td> Anorexia<\/td> Tell a doctor<\/td><\/tr> Side effects not listed<\/td> Any side effect not mentioned or any worsening of general health<\/td> Consult a doctor, pharmacist or other healthcare professional<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nHow to Store Cipralex<\/h1>\n\n\n\n
\n\n\n\nFurther Information<\/h1>\n\n\n\n
Presentation of Cipralex<\/h2>\n\n\n\n
Strengths<\/th> Pack size<\/th><\/tr><\/thead> 5 mg, 10 mg, 15 mg and 20 mg tablets<\/td> 28 tablets in transparent blisters in a cardboard box<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nIdentification of Cipralex<\/h2>\n\n\n\n
Strength<\/th> Tablet description<\/th><\/tr><\/thead> Cipralex 5 mg<\/td> Round, white, biconvex film-coated tablets marked with \u201cEK\u201d on one side<\/td><\/tr> Cipralex 10 mg<\/td> Oval, white, film-coated tablets, scored and marked with \u201cE\u201d and \u201cL\u201d on each side of the score on one side<\/td><\/tr> Cipralex 15 mg<\/td> Oval, white, film-coated tablets, scored and marked with \u201cE\u201d and \u201cM\u201d on each side of the score on one side<\/td><\/tr> Cipralex 20 mg<\/td> Oval, white, film-coated tablets, scored and marked with \u201cE\u201d and \u201cN\u201d on each side of the score on one side<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nRegistration Number<\/h2>\n\n\n\n