5 mg, 10 mg, 15 mg and 20 mg film-coated tablets
escitalopram
What Escitalopram Sandoz is and what it is used for
Escitalopram Sandoz contains the active substance escitalopram. Escitalopram Sandoz belongs to a group of antidepressant drugs called selective serotonin reuptake inhibitors ( SSRIs ). These drugs affect the serotonin system in the brain by raising serotonin levels. Disorders of the serotonin system are considered to be an important factor in the development of depression and related diseases.
Escitalopram Sandoz is used to treating depression (actual depressive episodes) and anxiety disorders such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder, and obsessive-compulsive disorder.
It may take a couple of weeks before you start to feel better. Continue to take Escitalopram Sandoz 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 Sandoz 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 use Escitalopram Sandoz
Do not use Escitalopram Sandoz
- 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 of medicines called MAO inhibitors and which include i.a. 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 Sandoz”).
Warnings and cautions
Talk to your doctor or pharmacist before taking Escitalopram Sandoz.
Tell your doctor if you have any other condition or disease, as your doctor may need to consider this. Tell your doctor in particular:
- if you have epilepsy. Treatment with Escitalopram Sandoz must be stopped if you have a seizure for the first time or if the seizures become more frequent (see also section 4 “Possible side effects”).
- if you have impaired liver or kidney function. Your doctor may need to adjust the dosage one.
- if you have diabetes. Treatment with Escitalopram Sandoz can affect your blood sugar levels. The insulin dose and/or dose of one of the antidiabetic medicines that you take by mouth may need to be adjusted.
- if you have low sodium in your blood
- if you tend to easily get bleeding or bruising
- if you are receiving electroconvulsive therapy (ECT)
- if you have coronary heart disease
- if you have or have had heart problems or have recently had a heart attack
- if you have a low resting heart rate and/or know that you may have a salt deficiency due to prolonged severe diarrhea and vomiting or use diuretics ( diuretics )
- if you experience a fast or irregular heartbeat, fainting, collapse, or dizziness when you get up, which may indicate abnormal heart rhythm function
- if you have or have previously had eye problems, such as a certain type of glaucoma (increased pressure in the eye).
NOTE!
Some patients with bipolar disorder may go into a manic phase. This is characterized by unusual and rapidly changing ideas, unmotivated joy, and excessive physical activity. If you experience this, consult your doctor.
During the first weeks of treatment, symptoms of restlessness or difficulty sitting or standing still may also occur. Tell your doctor immediately if you get such symptoms.
Drugs such as Escitalopram Sandoz ( SSRIs / SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuation of treatment.
Suicidal ideation and aggravated depression or anxiety disorder
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 more 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 antidepressants have an increased risk of suicidal behavior.
Contact a doctor as soon as possible or see a 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 your depression or anxiety has worsened or if they think your behavior is changing.
Children and young people
Escitalopram Sandoz 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 Sandoz can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If your doctor has prescribed Escitalopram Sandoz to a patient under 18 years of age and you want to discuss this, you should contact your doctor again. You should also inform your doctor if you notice any of the above symptoms or if they worsen in patients under 18 years of age. The long-term effects on growth, maturity, and cognitive and behavioral development are not yet established in this age group.
Other medicines and Escitalopram Sandoz
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 MAOIs containing phenelzine, iproniazide, isocarboxazid, nialamide, or tranylcypromine as active substances. If you have used any of these medicines, you must wait 14 days before you can start using Escitalopram Sandoz. After stopping treatment with Escitalopram Sandoz, you must wait 7 days before you can start taking the above medicines.
- Reversible, selective MAO-A inhibitors containing moclobemide (used to treat depression).
- Irreversible MAO-B inhibitors containing selegiline (used to treat Parkinson’s disease ). These increase the risk of side effects.
- Linezolid , an antibiotic
- Lithium (used to treat bipolar disorder ) and tryptophan.
- Imipramine and desipramine (used to treat depression).
- Sumatriptan and similar medicines (used to treat migraines ) and tramadol(used to treat severe pain). These increase the risk of side effects.
- Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers ), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke ). These may increase the level of escitalopram in the blood.
- St. John’s wort ( Hypericum perforatum ) – a natural remedy used to treat depression.
- Acetylsalicylic acid and non-steroidal anti-inflammatory drugs (so-called NSAIDs ) (medicines used to relieve pain or for blood thinning, so-called anticoagulants ). These may increase the risk of bleeding.
- Warfarin, dipyridamole, and phenprocoumon (blood-thinning drugs, so-called anticoagulants ). Your doctor will probably check how fast your blood coagulates when treatment with Escitalopram Sandoz starts and ends to check that the dose of one of the anticoagulants is still the right one.
- Mefloquine (for the treatment of malaria ), bupropion (for the treatment of depression), and tramadol (for the treatment of severe pain), as the threshold for seizures, may fall.
- Neuroleptics (medicines for the treatment of schizophrenia, psychosis ) and antidepressants ( tricyclic antidepressants and SSRIs ) due to a possible risk of lowering the threshold for seizures.
- Flecainide, propafenone and metoprolol (for the treatment of cardiovascular disease), clomipramine and nortriptyline (antidepressants), and risperidone, thioridazine, and haloperidol (antipsychotics). Dose an Escitalopram Sandoz may need to be adjusted.
- Drugs that lower the potassium or magnesium levels in the blood, as these conditions increase the risk of life-threatening heart rhythm disorders.
Do not take Escitalopram Sandoz if you are taking medicines for heart rhythm problems or medicines that can affect your heart rhythm, such as Class IA and III antiarrhythmics (medicines for irregular heart activity), antipsychotics (eg phenothiazine derivatives, pimozide, haloperidol ), tricyclic antidepressants ( 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 Sandoz with food, drink, and alcohol
Escitalopram Sandoz can be taken with or without food (see section 3 “How to use Escitalopram Sandoz”).
As with many other medicines, Escitalopram Sandoz should not be combined with alcohol even if it 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 use Escitalopram Sandoz if you are pregnant or breast-feeding unless you have discussed any possible risks and benefits with your doctor.
If you are taking Escitalopram Sandoz during the last 3 months of pregnancy, you should be aware that your newborn may experience the following symptoms: difficulty breathing, bluish skin color, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, tense or weak muscles, lively reflexes tremors, nervousness, tendency to become irritable, lethargy, incessant crying, drowsiness and difficulty sleeping. If your newborn child has any of these symptoms, contact your doctor immediately.
Tell your midwife and/or doctor that you are taking Escitalopram Sandoz. When drugs such as Escitalopram Sandoz 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 your midwife and/or doctor immediately.
If Escitalopram Sandoz is used during pregnancy, its use should never be stopped abruptly.
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
You are not advised to drive or use machines until you have an idea of how Escitalopram Sandoz affects you.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 Sandoz contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
How to use Escitalopram Sandoz
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 of Escitalopram Sandoz is 10 mg as a single daily dose. Your doctor may increase the dosage one to a maximum of 20 mg per day.
Panic Syndrome:
The starting dose is 5 mg as a single daily dose for the first week, then 10 mg per day. Your doctor may increase the dose further to a maximum of 20 mg per day.
Social anxiety disorder:
The usual recommended dose of Escitalopram Sandoz is 10 mg as a single daily dose. Your doctor may either reduce the dose of the medicine to 5 mg per day or increase it to a maximum of 20 mg per day, depending on how you respond to the medicine.
Generalized Anxiety Disorder:
The usual recommended dose of Escitalopram Sandoz is 10 mg as a single daily dose. Your doctor may increase the dosage one to a maximum of 20 mg per day.
Obsessive-compulsive disorder:
The usual recommended dose of Escitalopram Sandoz is 10 mg as a single daily dose. Your doctor may increase the dosage one to a maximum of 20 mg per day.
Elderly (over 65 years)
The recommended starting dose for Escitalopram Sandoz is 5 mg once daily. Your doctor may increase the dose one to 10 mg per day.
Use for children and adolescents (under 18 years)
Escitalopram Sandoz should not normally be given to children and adolescents (see section 2 “Warnings and Precautions”).
How to take the tablets
You can take Escitalopram Sandoz with or without food. The tablet is swallowed whole with water.
Escitalopram Sandoz 10 mg only: If needed, you can split the tablet into two equal parts.
Escitalopram Sandoz 15 mg only: If needed, you can split the tablet into three equal parts.
Escitalopram Sandoz 20 mg only: If needed, you can divide the tablet into two or four equal parts.
Escitalopram Sandoz 15 mg film-coated tablets:
The tablet can be divided into three doses. If you have the impression that you are unable to divide the tablet properly, consult your doctor. Your doctor may prescribe a tablet with a lower dose.
How long the treatment should last
- It may take a few weeks before you feel better. Keep taking Escitalopram Sandoz even though it may take some time before your condition improves.
- Do not change the dosage without first talking about it with your doctor.
- Continue to use Escitalopram Sandoz for as long as your doctor recommends. If you stop treatment too soon, your symptoms may return. Continued treatment is recommended for at least 6 months after you feel well again.
If you take more Escitalopram Sandoz then you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Do this even if there is no discomfort. Symptoms of overdose may include dizziness, tremors, agitation, seizures, unconsciousness, nausea, vomiting, altered heart rate, low blood pressure, and altered fluid and salt balance in the body. Take the Escitalopram Sandoz pack/jar to your doctor or hospital.
If you forget to take Escitalopram Sandoz
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose but remember to go to bed at night, take the tablet immediately. Continue as usual the following day. If you remember a missed dose at night or the following day, do not take it but continue as usual.
If you stop taking Escitalopram Sandoz
You should not stop using Escitalopram Sandoz until your doctor tells you to. After discontinuation of treatment, it is generally recommended that dose one of Escitalopram Sandoz be gradually reduced over several weeks.
When you stop using Escitalopram Sandoz you may experience withdrawal symptoms, especially if the interruption is sudden. These symptoms are common when treatment with Escitalopram Sandoz is stopped. The risk is higher if you have used Escitalopram Sandoz for a long time or in a high dose or if the dose is reduced too quickly. In most people, the symptoms are mild and go away on their own within 2 weeks. However, in some patients, these symptoms may be severe or prolonged (2-3 months or longer). If you experience severe withdrawal symptoms when stopping treatment with Escitalopram Sandoz, consult your doctor. Your doctor may ask you to start taking the tablets again and then reduce the use more slowly.
The symptoms of withdrawal include dizziness (insecure gait or balance disturbance), tingling and crawling, burning sensation and (less often) feeling of electric shock also in the head, sleep disturbances (vivid dreams, nightmares or difficulty sleeping), anxiety, headache, nausea, sweating (even at night) sweating), restlessness or agitation, tremors, confusion or disorientation, emotional or irritability, diarrhea, visual disturbances, rapid heartbeat or palpitations (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 the treatment is continued for a few weeks. Note that many of the side effects can also be due to your illness and that they, therefore, pass when you start to feel better.
If you experience the following symptoms, contact your doctor immediately or see a hospital:
Uncommon (may affect up to 1 in 100 people)
- unusual bleeding, including bleeding in the gastrointestinal tract.
Rare (may affect up to 1 in 1,000 people)
- swelling of the skin, tongue, lips, throat or face, hives or difficulty breathing or swallowing (severe allergic reaction )
- high fever, agitation, confusion, muscle tremors, and sudden muscle cramps; These may be signs of a rare condition called serotonergic syndrome.
Has been reported (occurs in an unknown number of users)
- urination difficulties
- seizures, see also section “Warnings and Precautions”
- yellowing of the skin and whites of the eyes indicates disturbed liver function/hepatitis
- rapid, irregular heartbeat, fainting, which may be symptoms of a life-threatening condition known as Torsade de Pointes
- suicidal ideation or suicidal ideation, see also section “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)
- stuffy or runny nose (sinusitis)
- decreased or increased appetite
- anxiety, restlessness, abnormal dreams, difficulty falling asleep, drowsiness, dizziness, yawning, shaking, crawling in the skin
- diarrhea, constipation, vomiting, dry mouth
- increased sweating
- muscle and joint pain
- sexual disorders (late ejaculation, erection difficulties, decreased sex drive and in women, difficulties in achieving orgasm may occur)
- fatigue, fever
- weight gain.
Uncommon (may affect up to 1 in 100 people)
- hives, rash, itching
- gnashing of teeth, agitation, nervousness, panic attacks, confusion
- changes in taste, sleep disorders, fainting
- enlarged pupil s, abnormal vision, tinnitus ( tinnitus )
- hair loss
- abundant menstrual bleeding
- irregular menstruation
- weight loss
- fast pulse
- swelling in the arms or legs
- nosebleeds.
Rare (may affect up to 1 in 1,000 people)
- aggression, depersonalization, hallucination
- slow pulse.
Has been reported (occurs in an unknown number of users)
- decreased sodium content in the blood (symptoms consist of nausea and malaise with muscle weakness or confusion)
- dizziness when rising due to low blood pressure ( orthostatic hypotension )
- abnormal results in liver function tests (elevated levels of liver enzymes in the blood)
- movement disorders (involuntary muscle movements)
- a painful erection (priapism)
- bleeding disorders including skin and mucous membrane bleeding ( ecchymosis )
- increased secretion of hormone et ADH, which causes fluid to accumulate in the body, and the blood-thinning and sodium content drops (abnormal ADHsecretion).
- milk secretion in non-lactating women and men
- mania
- changes in heart rhythm (prolonged QT interval, visible on heart film recorded with ECG ).
Also, several side effects are known to occur with the use of medicines that work in the same way as escitalopram (which is the active substance in Escitalopram Sandoz). These side effects are:
- motor restlessness ( akathisia )
- loss of appetite
- increased risk of bone fractures
5. How to store Escitalopram Sandoz
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 or EXP. The expiration date is the last day of the specified month.
No special storage instructions.
HDPE Jar
After first opening the jar, the tablets can be stored in the opened HDPE jar for a maximum of 6 months. The opened jar must be stored at a maximum of 25 ° C.
When this six-month period has expired, any unused tablets in the HPDE jar should not be used but should be discarded.
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. One film-coated tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of the active substance escitalopram (as oxalate).
- Other ingredients are: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, magnesium stearate, colloidal anhydrous silica coating: hypromellose, macrogol 6000, titanium dioxide (E171), talc
What the medicine looks like and the contents of the pack
Escitalopram Sandoz 5 mg:
The tablets are white, round, and film-coated, diameter 5.7–6.3 mm.
Escitalopram Sandoz 10 mg:
The tablets are white, oval, and film-coated and have a break notch on one side, length 7.7–8.3 mm, and width 5.2–5.8 mm.
Escitalopram Sandoz 15 mg:
The tablets are white, oval, and film-coated and have two break grooves on each side, length 12.7–13.3 mm and width 4.7–5.3 mm.
Escitalopram Sandoz 20 mg:
The tablets are white, round, and film-coated and have a cross-shaped break notch on each side, diameter 9.2–9.8 mm.
Escitalopram Sandoz is available in the following pack sizes:
OPA-Al-PVC / Al-blister pack in cardboard
7, 10, 14, 20, 28, 30, 50, 56, 56×1, 60, 60×1, 90, 98, 98×1, 100, 100×1, 200 and 500 film-coated tablets
HDPE cans with PP screw cap and drying capsule
28, 30, 56, 60, 98, 100 and 250 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
LEK SA, Ul. Domaniewska 50C, 02-672, Warsaw, Poland
or
Lek Pharmaceuticals dd, Verovskóva 57, 1526 Ljubljana, Slovenia
or
Lek SA, Ul. Podlipie 16, 95-010 Stryków, Poland