Scheduling Status
S5
Proprietary Name, Strength and Pharmaceutical Form
Cipralex 5, 10, 15 and 20 mg film-coated tablets
Active Ingredient
Escitalopram as oxalate
Read Before Taking Cipralex
Read this information carefully before starting Cipralex.
Keep this information because it may be needed again. If further questions arise, ask a doctor or pharmacist.
Cipralex has been prescribed personally and should not be passed on to others. It may harm them, even if their symptoms are the same.
If any side effects become serious, or if side effects not listed here are noticed, tell a doctor or pharmacist.
What Cipralex Contains
The active substance is escitalopram as oxalate.
Each Cipralex tablet contains one of the following strengths:
| Tablet strength | Active substance |
|---|---|
| Cipralex 5 mg | Escitalopram as oxalate |
| Cipralex 10 mg | Escitalopram as oxalate |
| Cipralex 15 mg | Escitalopram as oxalate |
| Cipralex 20 mg | Escitalopram as oxalate |
The other ingredients are:
| Other ingredients |
|---|
| Colloidal anhydrous silica |
| Croscarmellose sodium |
| Hypromellose |
| Macrogol 400 |
| Magnesium stearate |
| Microcrystalline cellulose |
| Talc |
| Titanium dioxide, also known as E-171 |
What Cipralex Is Used For
Cipralex contains escitalopram.
Cipralex is used to treat:
| Condition |
|---|
| Depression, also known as major depressive episodes |
| Panic disorder with or without agoraphobia |
| Social anxiety disorder |
| Generalised anxiety disorder |
| Obsessive-compulsive disorder |
Before You Take Cipralex
Do Not Take Cipralex
Do not take Cipralex if any of the following apply:
| Do not take Cipralex if | Details |
|---|---|
| You are allergic to escitalopram | This includes allergy to the active substance |
| You are allergic to any other ingredient in Cipralex | Check the ingredients section |
| You are under 18 years of age | Cipralex should not be used in children and adolescents under 18 years |
| You are taking monoamine oxidase inhibitors | These include selegiline and tranylcypromine |
| You have taken a monoamine oxidase inhibitor recently | Wait 14 days before starting Cipralex |
| You have stopped Cipralex and need to take a monoamine oxidase inhibitor | Allow 7 days after stopping Cipralex before taking these medicines |
| You are taking linezolid | This medicine must not be taken at the same time as Cipralex |
| You are taking pimozide | This medicine must not be taken at the same time as Cipralex |
Take Special Care With Cipralex
Tell your doctor or pharmacist if any of the following apply before taking Cipralex:
| Condition or situation |
|---|
| Epilepsy |
| Unstable epilepsy |
| First-time seizures or increased seizure frequency |
| Impaired liver function |
| Impaired kidney function |
| Diabetes |
| Decreased sodium level in the blood |
| Tendency to bleed or bruise easily |
| Electroconvulsive treatment |
| Coronary heart disease |
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.
Treatment with Cipralex may alter glycaemic control in diabetes. Insulin or oral hypoglycaemic medicine may need dose adjustment.
Please Note
Improvement is not immediate. It may take several weeks after starting Cipralex before improvement is experienced.
In panic disorder, improvement usually takes 2 to 4 weeks.
At the beginning of treatment, some patients may experience anxiety. This usually disappears with continued treatment.
It is important to follow the doctor’s instructions exactly and not stop treatment or change the dose without consulting the doctor.
Thoughts of Suicide or Self-Harm
Symptoms of depression or panic disorder may include thoughts of suicide or self-harm.
These symptoms may continue, worsen, or the risk of suicide may increase until the full antidepressant effect becomes apparent.
The risk is greater in people younger than 25 years.
Tell a doctor immediately or contact the nearest hospital if distressing thoughts or experiences occur during treatment.
Mania and Behaviour Changes
Some patients with manic-depressive illness may enter a manic phase.
Possible signs include:
| Possible signs |
|---|
| Unusual and rapidly changing ideas |
| Inappropriate happiness |
| Excessive physical activity |
Contact a doctor if these symptoms occur.
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.
It may be helpful to ask a friend or relative to help watch for changes in behaviour.
Use in Children and Adolescents Under 18 Years of Age
Cipralex should not be used in children and adolescents under 18 years.
Patients under 18 years have an increased risk of side effects such as:
| Possible increased risks |
|---|
| Suicide attempts |
| Suicidal thoughts |
| Hostility |
| Aggression |
| Oppositional behaviour |
| Anger |
Taking Cipralex With Food and Drink
Cipralex can be taken with or without food.
Cipralex has been shown not to increase the effects of alcohol. However, it is recommended not to drink alcohol during treatment with Cipralex.
Pregnancy and Breast-Feeding
If you become pregnant or have been breastfeeding your baby, consult a doctor, pharmacist or other healthcare professional before taking Cipralex.
Do not take Cipralex if you are pregnant.
Tell your doctor if you are pregnant or planning to become pregnant.
If Cipralex is taken during the last 3 months of pregnancy, the newborn baby may experience:
| Possible effects in newborn baby |
|---|
| Trouble breathing |
| Bluish skin |
| Fits |
| Body temperature changes |
| Feeding difficulties |
| Vomiting |
| Low blood sugar |
| Stiff or floppy muscles |
| Vivid reflexes |
| Tremor |
| Jitteriness |
| Irritability |
| Lethargy |
| Constant crying |
| Sleepiness |
| Sleeping difficulties |
These effects usually start immediately or within 24 hours after delivery.
There may also be a higher risk of persistent pulmonary hypertension in the newborn.
Do not take Cipralex if you are breastfeeding.
Driving and Using Machines
Cipralex does not usually cause drowsiness.
However, as with any new medicine, take care while driving or using machinery until you know how Cipralex affects you.
Taking Other Medicines With Cipralex
Always tell your healthcare professional if you are taking any other medicines, including complementary or traditional medicines.
Tell your doctor or pharmacist especially if you are taking any of the following:
| Medicine or medicine group | Use or concern |
|---|---|
| Monoamine oxidase inhibitors | Includes selegiline, tranylcypromine, phenelzine, isocarboxazid, nialamide, moclobemide and linezolid |
| Lithium | Used in manic-depressive disorder |
| Selegiline | Used in Parkinson’s disease |
| Imipramine and desipramine | Used to treat depression |
| Metoprolol | Used in cardiovascular diseases |
| Sumatriptan and similar medicines | Used to treat migraine |
| Tramadol and pethidine | Used for severe pain |
| Cimetidine and omeprazole | Used to treat stomach ulcers |
| St John’s Wort | Herbal remedy used for low mood |
| Aspirin and non-steroidal anti-inflammatory medicines | May increase bleeding risk |
| Oral anticoagulants such as warfarin | May alter blood-clotting control |
| Medicines that lower the seizure threshold | Includes neuroleptics, some antidepressants, mefloquine, bupropion and tramadol |
| Flecainide and propafenone | Used in cardiovascular diseases |
| Desipramine, clomipramine and nortriptyline | Antidepressants |
| Risperidone, thioridazine and haloperidol | Antipsychotic medicines |
If high fever, abrupt muscle contractions, agitation or confusion occurs when using certain combinations, see a doctor immediately.
Your doctor may need to adjust the dose of Cipralex or other medicines.
How to Take Cipralex
How Much to Take
Always take Cipralex exactly as the doctor has instructed.
Check with a doctor or pharmacist if unsure or if further information is needed.
How and When to Take Cipralex
Cipralex is taken every day as a single daily dose.
It can be taken with or without food.
Swallow the tablets with water.
Do not chew the tablets because the taste is bitter.
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.
Duration of Treatment
It may take a couple of weeks before you start to feel better.
Continue taking Cipralex even if it takes some time before improvement is felt.
Do not change the dose without speaking to your doctor first.
Continue taking Cipralex for as long as the doctor recommends.
If treatment is stopped too soon, symptoms may return.
It is recommended that treatment should continue for at least 6 months after feeling well again.
If You Take More Cipralex Than You Should
If more than the prescribed dose is taken, contact a doctor, pharmacist, nearest hospital emergency department or poison control centre immediately.
Do this even if there are no signs of discomfort.
Possible signs of overdose include:
| Possible overdose signs |
|---|
| Dizziness |
| Tremor |
| Agitation |
| Convulsion |
| Coma |
| Nausea |
| Vomiting |
| Change in heart rhythm |
| Decreased blood pressure |
| Change in body fluid or salt balance |
If You Forget to Take Cipralex
Do not take a double dose to make up for a forgotten dose.
If a dose is forgotten and remembered before going to bed, take it straight away and continue as usual the next day.
If the missed dose is only remembered during the night or the next day, leave out the missed dose and continue as usual.
If You Stop Taking Cipralex
Do not stop taking Cipralex until your doctor tells you to do so.
When treatment is completed, the dose is generally reduced gradually over several weeks.
Stopping Cipralex suddenly may cause discontinuation symptoms.
The risk is higher when Cipralex has been used for a long time, at high doses, or when the dose is reduced too quickly.
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.
If severe discontinuation symptoms occur, contact a doctor. The doctor may ask that the tablets be restarted and then reduced more slowly.
Discontinuation Symptoms
| Possible discontinuation symptoms |
|---|
| Feeling dizzy, unsteady or off-balance |
| Pins and needles |
| Burning sensations |
| Electric shock sensations, including in the head |
| Sleep disturbances |
| Vivid dreams |
| Nightmares |
| Inability to sleep |
| Anxiety |
| Headaches |
| Nausea |
| Sweating, including night sweats |
| Restlessness or agitation |
| Tremor |
| Confusion or disorientation |
| Emotional changes or irritability |
| Diarrhoea |
| Visual disturbances |
| Fluttering or pounding heartbeat, also known as palpitations |
Possible Side Effects
Cipralex can cause side effects.
If any side effect becomes serious, or if side effects not listed here are noticed, tell a doctor or pharmacist.
Side Effects Table
| Side-effect category | Side effects / symptoms | Recommended action |
|---|---|---|
| Serious side effects requiring immediate medical attention | Difficulties urinating | Tell a doctor immediately or go to hospital straight away |
| Serious side effects requiring immediate medical attention | Seizures or fits | Tell a doctor immediately or go to hospital straight away |
| Serious side effects requiring immediate medical attention | Yellowing of the skin and the whites of the eyes, which may indicate liver function impairment or hepatitis | Tell a doctor immediately or go to hospital straight away |
| Serious side effects | Unusual bleeding, including gastrointestinal bleeding | Tell a doctor |
| Allergic reaction | Swelling of the skin, tongue, lips or face; difficulty breathing or swallowing | Contact a doctor or go to hospital straight away |
| Serotonin syndrome warning signs | High fever, agitation, confusion, trembling and abrupt contractions of muscles | Contact a doctor immediately |
| Mental health warning signs | Suicidal thoughts or self-harm while taking Cipralex or after stopping Cipralex | Seek urgent medical advice |
| Common or bothersome effects | Feeling sick, also known as nausea | Tell a doctor if continuing or bothersome |
| Common or bothersome effects | Blocked or runny nose, also known as sinusitis | Tell a doctor if continuing or bothersome |
| Common or bothersome effects | Decreased or increased appetite | Tell a doctor if continuing or bothersome |
| Common or bothersome effects | Anxiety, restlessness, abnormal dreams, difficulty falling asleep, sleepiness, dizziness, yawning, tremors, prickling of the skin | Tell a doctor if continuing or bothersome |
| Common or bothersome effects | Diarrhoea, constipation, vomiting, dry mouth | Tell a doctor if continuing or bothersome |
| Common or bothersome effects | Increased sweating | Tell a doctor if continuing or bothersome |
| Common or bothersome effects | Pain in muscles and joints, also known as arthralgia and myalgia | Tell a doctor if continuing or bothersome |
| Common or bothersome effects | Sexual disturbances, including delayed ejaculation, erection problems, decreased sexual drive and difficulty achieving orgasm in women | Tell a doctor if continuing or bothersome |
| Common or bothersome effects | Fatigue and fever | Tell a doctor if continuing or bothersome |
| Weight-related effects | Increased weight or decreased weight | Tell a doctor |
| Skin effects | Nettle rash, rash, itching, loss of hair | Tell a doctor |
| Mental and nervous system effects | Grinding teeth, agitation, nervousness, panic attack, confusion, disturbed sleep, taste disturbance, fainting | Tell a doctor |
| Eye and ear effects | Enlarged pupils, visual disturbance, ringing in the ears | Tell a doctor |
| Reproductive effects | Vaginal bleeding, persistent painful erections, milk flow in women who are not nursing | Tell a doctor immediately, especially for persistent painful erections |
| Heart and circulation effects | Fast heartbeat, slow heartbeat, swelling of the arms or legs, dizziness when standing due to low blood pressure | Tell a doctor |
| Bleeding-related effects | Nosebleeds, skin and mucous bleeding, low blood platelets | Tell a doctor |
| Psychiatric effects | Aggression, depersonalisation, hallucination, mania, suicide-related events | Tell a doctor immediately |
| Blood chemistry effects | Decreased sodium levels in the blood, with symptoms such as feeling sick and unwell, weak muscles or confusion | Tell a doctor |
| Liver test changes | Abnormal liver function test with increased liver enzymes in the blood | Tell a doctor |
| Movement-related effects | Movement disorders, including involuntary muscle movements | Tell a doctor |
| Swelling-related effects | Sudden swelling of skin or mucosa, also known as angioedema | Seek urgent medical attention |
| Hormonal effects | Increase in the amount of urine excreted due to inappropriate ADH secretion | Tell a doctor |
| Similar-medicine effects | Motor restlessness, also known as akathisia | Tell a doctor |
| Similar-medicine effects | Anorexia | Tell a doctor |
| Side effects not listed | Any side effect not mentioned or any worsening of general health | Consult a doctor, pharmacist or other healthcare professional |
How to Store Cipralex
Store all medicine out of the reach of children.
Do not store above 30 °C.
Do not use Cipralex after the expiry date stated on the label or carton.
Medicines should not be disposed of via wastewater or household waste.
Ask a pharmacist how to dispose of medicines no longer required.
Further Information
Presentation of Cipralex
Cipralex is available in the following pack size:
| Strengths | Pack size |
|---|---|
| 5 mg, 10 mg, 15 mg and 20 mg tablets | 28 tablets in transparent blisters in a cardboard box |
Identification of Cipralex
| Strength | Tablet description |
|---|---|
| Cipralex 5 mg | Round, white, biconvex film-coated tablets marked with “EK” on one side |
| Cipralex 10 mg | Oval, white, film-coated tablets, scored and marked with “E” and “L” on each side of the score on one side |
| Cipralex 15 mg | Oval, white, film-coated tablets, scored and marked with “E” and “M” on each side of the score on one side |
| Cipralex 20 mg | Oval, white, film-coated tablets, scored and marked with “E” and “N” on each side of the score on one side |
Registration Number
| Strength | Registration number |
|---|---|
| Cipralex 5 mg | 36/1.2/0318 |
| Cipralex 10 mg | 36/1.2/0319 |
| Cipralex 15 mg | 36/1.2/0320 |
| Cipralex 20 mg | 36/1.2/0321 |
Name and Address of Registration Holder
H. Lundbeck (Pty) Ltd
252 Montrose Avenue
North Riding
2194
Date of Publication
To be inserted.
Medical Disclaimer
This article is intended as patient information based on the approved leaflet structure. It does not replace advice from a doctor, pharmacist or other healthcare professional. For regulated medical product use, follow the approved patient information leaflet and healthcare professional guidance.
