5 mg, 10 mg, 15 mg and 20 mg film-coated tablets
escitalopram, respectively
What Escitalopram Teva is and what it is used for
Escitalopram Teva contains the active substance escitalopram. Escitalopram Teva 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.
Escitalopram Teva is used to treat depression and anxiety disorders (such as panic disorder with or without market fear, social phobia, generalized anxiety disorder, and obsessive-compulsive disorder).
It may take a few weeks before you start to feel better. Continue to take Escitalopram Teva 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.
Escitalopram contained in Escitalopram Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Escitalopram Teva
Do not take Escitalopram Teva
- 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 Escitalopram Teva”).
Warnings and cautions
Talk to your doctor or pharmacist before taking Escitalopram Teva.
Tell your doctor if you have other illnesses, as your doctor may need to consider this. This is especially true if you:
- have epilepsy. Treatment with Escitalopram Teva 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 Escitalopram Teva.
- have diabetes. Treatment with Escitalopram Teva 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.
- tend to easily get bleeding or bruising.
- receive electrical treatment.
- have coronary heart disease.
- 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 ).
- experiencing a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up, which may indicate abnormal heart rhythm function.
- if you have increased pressure in the eye (known as glaucoma or glaucoma ).
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 Escitalopram Teva (so-called SSRIs / SNRIs) may 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 using antidepressants, as it takes time for this type of medicine 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 a young adult. 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
Escitalopram Teva 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. Nevertheless, Escitalopram Teva 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 Escitalopram Teva
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tell your doctor if you are taking any of the following medicines:
- “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 Escitalopram Teva. After stopping treatment with Escitalopram Teva, 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, omeprazole, and esomeprazole (used to treat stomach ulcers ), fluconazole (used to treat fungal infections), 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 Escitalopram Teva, your doctor will probably check your blood clotting time to make sure your dose of anticoagulants 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.
- Flecainide, propafenone and metoprolol (used in various cardiovascular diseases), desipramine, clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose one of Escitalopram Teva 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 Escitalopram Teva if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, such as Class IA – and III antiarrhythmics(medicines to treat irregular heart activity), antipsychotics (eg phenothiazines, pimozide, haloperidol ), tricyclic antidepressants (drugs for depression), certain antimicrobial drugs (eg sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, treatment for malaria, especially halofantrine), certain antihistamines (astemizole, mizolastine). If you have any further questions on the use of this product, ask your doctor.
Escitalopram Teva with food, drink, and alcohol
Escitalopram Teva can be taken with or without food (see section 3 “How to take Escitalopram Teva”).
As with many other medicines, the use of alcohol during treatment with Escitalopram Teva is not recommended, although Escitalopram Teva 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 Escitalopram Teva if you are pregnant or breast-feeding without first discussing the risks and benefits of treatment with your doctor.
If Escitalopram Teva is used during the last three months of pregnancy, you should be aware that the following symptoms may be seen in the newborn: difficulty breathing, dark blue or violet skin discoloration, cramps, difficulty regulating body temperature, difficulty breastfeeding, vomiting, low blood sugar, tension or slack muscles, lively reflexes, tremors, jerkiness, irritability, lethargy, persistent crying, drowsiness and difficulty sleeping. If your child gets any of these symptoms, contact your doctor as soon as possible.
Tell your midwife or doctor that you are taking Escitalopram Teva. When drugs such as Escitalopram Teva 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 Escitalopram Teva is used during pregnancy, abrupt discontinuation of treatment should be avoided.
Escitalopram Teva 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
You should not drive or use machines until you know how the Escitalopram Teva tablets affect you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Escitalopram Teva contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie it is essentially ‘sodium-free’.
How to take Escitalopram Teva
Always use 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 (over 65 years)
The recommended starting dose for Escitalopram Teva is 5 mg once daily. Your doctor may increase the dose one to 10 mg per day.
Use for children and adolescents
Escitalopram Teva should not be given to children and adolescents under 18 years of age. For further information see section 2 “What you need to know before taking Escitalopram Teva”.
Escitalopram Teva can be taken with or without food. Swallow the tablet with water. Do not chew the tablet due to its bitter taste.
Escitalopram Teva 10 mg film-coated tablets and Escitalopram Teva 20 mg film-coated tablets:
If necessary, the tablets can be divided (see section 6). 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 Escitalopram Teva even if it takes time before you experience any improvement in your condition.
Do not change the dosage without first talking to your doctor.
Keep taking Escitalopram Teva 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.
If you take more Escitalopram Teva then you should
If you have ingested too much medicine or if e.g. a child has ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Do this even if you / the child does not notice any symptoms.
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 Escitalopram Teva pack with you when contacting your doctor or hospital.
If you forget to take Escitalopram Teva
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 taking Escitalopram Teva
Do not stop taking Escitalopram Teva until your doctor tells you to. Usually, your doctor will advise you to slowly reduce your dose for a few weeks.
When you stop taking Escitalopram Teva, and especially if it happens quickly, you may experience so-called withdrawal symptoms. These are common when treatment with Escitalopram Teva is stopped. The risk is higher if Escitalopram Teva 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 balance), 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 and/or vomiting, sweating (including night sweats) feeling of restlessness or agitation, tremor (tremors), feeling of being 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 a doctor or hospital immediately if you experience any of the following side effects:
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 ).
- 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 an 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 can be symptoms of a life-threatening condition known as Torsade de Pointes.
- Thoughts of self-harm or suicide, (see also section 2 “Warnings and Precautions”).
- Sudden swelling of the skin or mucous membranes ( angioedema ).
Also, 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 in 100 people):
- Hives ( urticaria ), rash, itching
- Tooth grinding, anxiety, nervousness, panic attacks, states of confusion
- Sleep disturbance, taste change, fainting ( syncope )
- Enlarged pupils ( mydriasis ), visual disturbances, earrings ( 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 an 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 ( Eskimos er)
- 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 (“prolongation of QT interval”, observed with ECG(a measurement of the electrical activity of the heart)
- In addition to the above, several 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
5. How to store Escitalopram Teva
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 blister/jar and outer carton after EXP or EXP. The expiration date is the last day of the specified month.
Blister + jar:
Do not store above 25 ° C. Store in the original package. Sensitive to light. Moisture sensitive.
Jar: Use within 100 days after first opening.
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 Escitalopram Teva film-coated tablet contains 5 mg, 10 mg, 15 mg or 20 mg escitalopram (as oxalate).
Other ingredients are:
Tablet core: Microcrystalline cellulose, colloidal anhydrous silica, croscarmellose sodium, stearic acid, magnesium stearate
Tablet coating: Hypromellose (E464), macrogol 400, and titanium dioxide (E171).
What the medicine looks like and the contents of the pack
Escitalopram Teva 5 mg is a white, round, biconvex film-coated tablet, debossed with “5” on one side of the tablet and smooth on the other side of the tablet.
Escitalopram Teva 10 mg is a white, round, biconvex film-coated tablet, debossed with “10” on one side of the tablet and with a scoreline on the other side of the tablet. The tablet can be divided into two equal doses.
Escitalopram Teva 15 mg is a white, round, biconvex film-coated tablet, with a scoreline on one side and imprinted with “S” and “C” on each side of the score. The other side of the tablet is marked with “15”. The breaker is not for dividing the tablet into equal doses but only for easier swallowing.
Escitalopram Teva 20 mg is a white, round, biconvex film-coated tablet, with a scoreline on one side and imprinted with “9” and “3” on each side of the score. The other side of the tablet is marked with “7463”. The tablet can be divided into two equal doses.
Escitalopram Teva is available in blister packs of: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 90, 98, 100, 120, 200 and 500 film-coated tablets and perforated single-dose blister packs of 49×1 , 50×1, 100×1, and 500×1 film-coated tablets.
PVC / PVdC-Aluminum blisters are available in cartons.
Escitalopram Teva is available in a plastic jar of 100 tablets.
Not all pack sizes may be marketed.
Manufacturer:
TEVA Pharmaceutical Works Private Limited Company, Debrecen, Hungary
TEVA UK Ltd, Eastbourne, United Kingdom
Pharmachemie BV, Haarlem, The Netherlands
Teva Operations Poland Sp. zoo, Krakow, Poland
Merckle GmbH, Blaubeuren, Germany