5 mg, 10 mg, 15 mg, 20 mg film-coated tablets
Escitalopram
1. What Cipralex is and what it is used or
Cipralex contains the active substance escitalopram. Cipralex belongs to a group of antidepressant medicines called selective serotonin reuptake inhibitors ( SSRIs ). These drugs act on the serotonin system in the brain by increasing serotonin levels. Disorders of the serotonin system are considered an important factor in the development of depression and related diseases.
Cipralex is used to treat depression and anxiety disorders (such as panic disorder with or without market anxiety, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take a few weeks before you start to feel better. Continue to take Cipralex even if it takes time before you experience any improvement in your condition.
You need to talk to a doctor if you do not feel better or if you feel worse.
2. What you need to know before using Cipralex
Do not use Cipralex
- if you are allergic to escitalopram or any of the other ingredients of this medicine (listed in section 6).
- if you are taking other medicines that belong to a group called MAO inhibitors, including selegiline (used to treat Parkinson’s disease ), moclobemide (used to treat depression), and linezolid (an antibiotic ).
- if you have been born with or have had a period of abnormal heart rhythm (as observed with ECG, a method that examines how the heart works).
- if you are taking medicines for heart rhythm problems or that may affect your heart rhythm (see section 2 “Other medicines and Cipralex”).
Warnings and cautions
Tell your doctor or pharmacist before taking Cipralex. Tell your doctor if you have other diseases. This is especially true if you:
- have epilepsy. Treatment with Cipralex should be discontinued if you experience seizures for the first time or if the seizures occur at more frequent intervals (see section 4 “Possible side effects”).
- have impaired liver or kidney function (your doctor may need to adjust the dose of Cipralex).
- have diabetes. Treatment with Cipralex may affect your blood sugar level. The dose of one of the insulin and/or blood sugar-lowering tablets may need to be changed.
- have decreased levels of sodium in the blood.
- have a tendency to easily get bleeding or bruising.
- have coronary heart disease.
- receive treatment with electric shocks.
- suffers from or has suffered from heart problems or recently had a heart attack.
- have a low resting heart rate and/or know that you have a salt deficiency due to prolonged severe diarrhea and vomiting or use diuretics ( diuretics ).
- experience a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up, which may indicate the abnormal function of the heartbeat.
- have or have previously had problems with their eyes, such as certain types of glaucoma (increased pressure in the eye).
Note!
Some patients with manic-depressive illness may go into a manic phase. This is characterized by unusual and rapidly changing thoughts, unmotivated joy, and excessive physical activity. Contact your doctor if you experience these symptoms.
Symptoms such as restlessness and difficulty sitting or standing still can also occur during the first weeks of treatment. Contact your doctor immediately if you experience these symptoms.
Drugs such as Cipralex (so-called SSRIs / SNRIs) can cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.
If you start to feel worse and have thoughts of harming yourself
You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start taking antidepressants, as it takes time for drugs of this type to take effect, usually about 2 weeks, sometimes longer.
These thoughts may be common:
- If you have previously had thoughts of harming yourself or committing suicide.
- If you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.
Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.
It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.
Children and young people
Cipralex should not normally be used in the treatment of children and adolescents under 18 years of age. The risk of side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, defiance, and anger) is greater in patients under 18 years of age when taking drugs of this type. Despite this, Cipralex can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you were given this medicine, consult your doctor again. You should also tell your doctor if you notice any of the above symptoms or if they get worse. The long-term effects on growth, maturity, and cognitive and behavioral development have not yet been established for children and adolescents under 18 years of age.
Other medicines and Cipralex
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be especially careful to tell your doctor about the following medications:
- “Non-selective monoamine oxidase inhibitors” (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substance. If you have taken any of these medicines, you must wait 14 days before starting Cipralex. After stopping treatment with Cipralex, you must wait 7 days before taking any of these medicines.
- “Reversible, selective MAO-A inhibitors” containing moclobemide (antidepressant).
- “Irreversible MAO-B inhibitors” containing selegiline (medicines for Parkinson’s disease ). These increase the risk of side effects.
- Linezolid, an antibiotic .
- Lithium (medicine for manic depressive illness) and tryptophan.
- Imipramine and desipramine (antidepressants).
- Sumatriptan and similar medicines (medicines for migraines ) and tramadol (medicines for severe pain). These increase the risk of side effects.
- Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers ), fluconazole (used to treat fungal infections), and fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of blood clots). These can cause increased levels of escitalopram in the blood.
- St. John’s wort (Hypericum perforatum – an herbal remedy for depression).
- Acetylsalicylic acid and NSAIDs (analgesics or blood thinners, so-called anticoagulants ). They may increase the tendency to bleed.
- Warfarin, dipyridamole, and phenprocoumon (blood thinners, called anticoagulants). When starting and stopping treatment with Cipralex, your doctor will probably check your blood clotting time to make sure your dose of anticoagulants is appropriate.
- Mefloquine (anti- malarial drug ), bupropion (anti-depressant drug), and tramadol (anti-severe pain medication) due to a possible risk of lowering the seizure threshold.
- Neuroleptics (medicines for schizophrenia, psychosis ) and antidepressants ( tricyclic antidepressants and SSRIs) due to a possible risk of lowering the seizure threshold.
- Metoprolol, flecainide, and propafenone (used in various cardiovascular diseases) clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose one of Cipralex may need to be adjusted.
- Drugs that lower blood levels of potassium or magnesium , as these conditions increase the risk of life-threatening heart rhythm disorders.
Do not take Cipralex if you are taking medicines for heart rhythm problems or medicines that can affect your heart rhythm, such as Class 1A and III antiarrhythmics, antipsychotics (eg phenothiazines, pimozide, haloperidol ), tricyclic antidepressants, certain antimicrobial medicines (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, treatment for malaria, especially halofantrine), certain antihistamines(astemizole, hydroxyzine mizolastine). If you have any further questions on the use of this product, ask your doctor.
Cipralex with food, drink, and alcohol
Cipralex can be taken with or without food (see section 3 “How to use Cipralex”).
As with many other medicines, the use of alcohol during treatment with Cipralex is not recommended, although Cipralex is not expected to interact with alcohol.
Pregnancy, breastfeeding, 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. Do not take Cipralex if you are pregnant or breast-feeding without first discussing the risks and benefits of treatment with your doctor.
If you are taking Cipralex during the last three months before delivery, you should be aware that the following symptoms may be seen in your newborn: difficulty breathing, bluish skin, cramps, difficulty regulating body temperature, difficulty breastfeeding, vomiting, low blood sugar, tense or slack muscles, overactive reflexes, tremors, jerkiness, irritability, listlessness, persistent crying, increased sleepiness and difficulty sleeping. If your child gets any of these symptoms, contact your doctor or midwife as soon as possible.
Tell your midwife or doctor that you are taking Cipralex. When drugs such as Cipralex are used during pregnancy, especially during the last three months, they may increase the risk of a serious condition called persistent pulmonary hypertension in the newborn (PPHN). This condition causes the baby to breathe faster and look blue. The symptoms usually appear within 24 hours of the baby being born. If this affects your baby, contact a midwife or doctor immediately.
If Cipralex is used during pregnancy, abrupt discontinuation of treatment should be avoided.
Escitalopram is expected to be excreted in human milk.
In animal studies, citalopram , a drug similar to escitalopram, has been shown to reduce sperm quality. In theory, this could affect fertility, but no such degrading effect of citalopram on fertility has yet been demonstrated in humans.
Driving and using machines
Cipralex may impair the ability to react in some people, which should be considered at times when increased attention is required, e.g. while driving and precision work.
You are responsible for assessing whether you are fit to drive motor vehicles or perform risky work. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Cipralex contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
3. How to use Cipralex
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Adults
Depression
The usual recommended dose is 10 mg once daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.
Panic syndrome
The starting dose is 5 mg once daily for the first week, then 10 mg daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.
Social Phobia
The usual recommended dose is 10 mg once daily. Your doctor may either reduce the dose one to 5 mg per day or increase the dose one to a maximum of 20 mg per day, depending on how you respond to treatment.
Anxiety
The usual recommended dose is 10 mg once daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.
Obsessive-compulsive disorder
The usual recommended dose is 10 mg once daily. Dose one can be increased by your doctor to a maximum of 20 mg per day.
Elderly patients (over 65 years)
The recommended starting dose is 5 mg once daily. Your doctor may increase the dose one to 10 mg per day.
Children and young people
Cipralex should not be given to children and adolescents under 18 years of age. For further information, see section 2 “Warnings and precautions”.
How to take the tablets
Cipralex can be taken with or without food. Swallow the tablet with water. Do not chew the tablet due to its bitter taste.
If needed, the tablets can be divided. Place the tablet on a flat surface with the notch facing up. Press each end of the tablet with your index fingers, as shown in the sketch.
Duration of treatment
It may take a few weeks before you start to feel better. Continue to take Cipralex even if it takes time before you experience any improvement in your condition.
Do not change the dosage one without first talking to your doctor.
Continue to take Cipralex for as long as your doctor recommends it. If you stop treatment too soon, the symptoms may return. It is recommended that you continue treatment for at least 6 months after feeling well again.
Signs of overdose can include dizziness, tremors, anxiety, seizures, unconsciousness, nausea, vomiting, disturbed heart rhythm, decreased blood pressure, and effects on the body’s salt and fluid balance. Take the Cipralex pack with you when contacting your doctor or hospital.
If you forget to use Cipralex
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose and you remember this before going to bed, take one dose at a time. Continue as usual the next day. If you forget during the night or the next day that you have missed a dose, do not miss the dose and continue as usual.
If you stop using Cipralex
Do not stop taking Cipralex until your doctor tells you to. Usually, your doctor will advise you to slowly reduce your dose for a few weeks.
When you end treatment with Cipralex, and especially if this happens quickly, you may experience so-called withdrawal symptoms. These are common when treatment with Cipralex is stopped. The risk is higher if Cipralex has been used for a long time or in higher doses, or if dose one is reduced too quickly. In most cases, these symptoms are mild and usually resolve within two weeks, although in some individuals they may persist for a longer period (2-3 months or more). Contact your doctor if you experience severe withdrawal symptoms after stopping treatment. He or she may ask you to start taking the tablets again, and then put them out more slowly.
Withdrawal symptoms: dizziness (feeling unsteady or unbalanced), sensory disturbances such as ant crawling, burning sensation and, less commonly, feeling of electric shock (including such feelings in the head), sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache, nausea, sweating (including night sweats), feeling restless or upset, tremor (tremors), feeling confused or disoriented, emotional instability or irritability, diarrhea, visual disturbances, palpitations.
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.
The side effects usually disappear after a few weeks of treatment. Be aware that several of the effects described below can be symptoms of your illness and will therefore subside as you begin to feel better.
Contact your doctor or see a hospital immediately if you experience any of the following side effects during treatment:
Uncommon (may affect up to 1 in 100 people):
- Uncommon bleeding, including gastrointestinal bleeding.
Rare (may affect up to 1 in 1,000 people):
- Swelling of the skin, tongue, lips, throat, or face, rash or difficulty breathing or swallowing (severe allergic reaction ), contact your doctor or go to the hospital immediately.
- High fever, anxiety, feeling confused, trembling, and having sudden muscle contractions, can be signs of a rare condition called serotonergic syndrome.
Has been reported (occurs in the unknown number of users):
- Difficulty urinating
- Seizures, see also section “Warnings and precautions”
- Yellowish skin and yellowish whites of the eyes (signs of hepatic impairment/hepatitis).
- Rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as Torsade de Pointes
- Thoughts of self-harm or suicide, (see section 2 “Warnings and Precautions”).
- Sudden swelling of the skin or mucous membranes ( angioedema ).
In addition, the following side effects have been reported:
Very common (may affect more than 1 user in 10):
- Nausea
- Headache
Common (may affect up to 1 in 10 people):
- Clogged or runny nose ( sinusitis )
- Decreased or increased appetite
- Anxiety, restlessness, unusual dreams, difficulty falling asleep, drowsiness, dizziness, yawning, tremors, tingling sensation in the skin
- Diarrhea, constipation, vomiting, dry mouth
- Increased sweating
- Pain in muscles and joints ( arthralgia and myalgia )
- Sexual disorders (men may experience delayed ejaculation or erection problems while women may experience decreased sexual desire and difficulty reaching orgasm)
- Fatigue, fever
- Weight gain
Uncommon (may affect up to 1 to 100 users):
- Hives ( urticaria ), rash, itching
- Tooth grinding, anxiety, nervousness, panic attacks, states of confusion
- Sleep disturbance, taste change, fainting ( syncope )
- Enlarged pupils ( mydriasis ), visual disturbances, ear rings ( tinnitus )
- Hair loss
- Abundant menstrual bleeding
- Irregular menstruation
- Weight loss
- Palpitation
- Swollen arms and legs
- Nasal blood
Rare (may affect up to 1 in 1,000 people):
- Aggression, personality changes, hallucinations
- Slow heartbeat
Has been reported (occurs in the unknown number of users):
- Decreased sodium levels in the blood (symptoms are nausea and malaise with muscle weakness or confusion)
- Dizziness in a standing position due to low blood pressure ( orthostatic hypotension )
- Abnormal liver function values (elevated levels of liver enzymes in the blood)
- Movement disorders (involuntary muscle movements)
- A painful erection (priapism)
- Signs of abnormal bleeding e.g. from the skin and mucous membranes ( ecchymosis )
- Increased secretion of a hormone called ADH, which causes the body to collect water and dilute the blood, which leads to a reduced amount of sodium(Inadequate ADH – secretion )
- The flow of breast milk in men and women who are not breastfeeding
- Mania
- An increased risk of bone fractures has been seen in patients taking this type of drug
- Changes in heart rate (” QT prolongation”, observed with ECG (a measurement of the electrical activity of the heart))
In addition to the above, a number of side effects have been observed with the use of drugs that act in a similar way to Cipralex. These are:
- Motor restlessness ( akathisia )
- Loss of appetite
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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cipralex
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiration date is the last day of the specified month.
This medicine does not require any special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is escitalopram. Each Cipralex tablet contains 5 mg, 10 mg, 15 mg, or 20 mg escitalopram (as oxalate).
The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, talc, croscarmellose sodium, magnesium stearate, hypromellose, macrogol 400, and titanium dioxide (E 171).
What the medicine looks like and the contents of the pack
Cipralex is available as 5 mg, 10 mg, 15 mg, and 20 mg film-coated tablets. The tablets have the following appearance:
5 mg Round, white, biconvex, film-coated tablets, 6 mm, marked with “EK” on one side.
10 mg Oval, white, scored film-coated tablets, 8×5.5 mm, marked with “E” and “L” on each side of the notch on one side of the tablet.
15 mg Oval, white, scored film-coated tablets, 9.8×6.3 mm, marked with “E” and “M” on each side of the notch on one side of the tablet.
20 mg Oval, white, scoed film-coated tablets, r, 11.5×7 mm marked with “E” and “N” on each side of the notch on one side of the tablet.
Printing package (transparent) with outer carton:
5, 10, 15 and 20 mg: 14, 28, 56 and 98 tablets.
Printing package (white) with outer carton:
5, 10, 15 and 20 mg: 14, 20, 28, 50, 100, 200 tablets.
Polyethylene jar
15 and 20 mg: 100 tablets
5 and 10 mg: 100 and 200 tablets
A dose:
5, 10, 15 and 20 mg: 49×1, 56×1, 98×1, 100×1 and 500×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
H. Lundbeck A / S
Ottiliavej 9
2500 Valby
Denmark
Contact the representative of the marketing authorization holder to find out more about this medicine:
Agent
H. Lundbeck AB
Slagthuset
211 20 Malmö
Tel: 040-699 82 00
This medicinal product is authorized under the European Economic Area under the names:
Belgium: Sipralexa
Bulgaria: Cipralex
Cyprus: Cipralex
Denmark: Cipralex
Estonia: Cipralex
Finland: Cipralex
France: Seroplex
Greece: Cipralex
Holland: Lexapro
Ireland: Lexapro
Iceland: Cipralex
Italy: Cipralex
Latvia: Cipralex 10 mg film-coated tablets: Cipralex 20 mg film-coated tablets
Lithuania: Cipralex
Luxembourg: Sipralexa
Malta: Cipralex
Netherlands: Lexapro
Norway: Cipralex
Poland: Cipralex
Portugal: Cipralex
Romania: Cipralex
Slovakia: Cipralex
Slovenia: Cipralex
Spain: Cipralex
United Kingdom: Cipralex
Czech Republic: Cipralex
Germany: Cipralex
Hungary: Cipralex
Austria: Cipralex