Cipralex: the package leaflet

Cipralex is an antidepressant medicine which helps to increase the level of seratonin in the brain and is indicated in the treatment of depression and anxiety. Let’s see when and how to take it and what are the side effects.

Cipralex contains the active substance escitalopram. Cipralex belongs to a group of antidepressant medicines called Selective Serotonin Reuptake Inhibitors (SSRIs). These medicines help increase serotonin levels in the brain. Alterations in the brain’s serotonin system are considered important factors in the development of depression and related disorders.

Cipralex

What Cipralex is and what it is used for

What you need to know before you take Cipralex

How to take Cipralex

Possible side effects

How to store Cipralex

Contents of the pack and other information

What Cipralex is and what it is used for

Cipralex is used to treat depression (major depressive episodes) and anxiety (such as panic disorder with or without agoraphobia, social anxiety disorder, generalized anxiety disorder).

It may take a couple of weeks for you to start feeling better. Continue to take Cipralex even if it takes some time before you feel an improvement in your condition.

Talk to your doctor if you do not feel better or if you feel worse.

What you need to know before you take Cipralex

Do not take 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 known as MAO inhibitors, including selegiline (used in the treatment of Parkinson’s disease), moclobemide (used in the treatment of depression) and linezolid (an antibiotic);
  • if you present from birth or if you have had an episode of abnormal heart rhythm (identified with an ECG, a test conducted to evaluate how the heart works);
  • if you take medicines for heart rhythm problems or which can affect the heart’s rhythm (see section 2 “Other medicines and Cipralex”).

Warnings and Precautions

Talk to your doctor or pharmacist before taking Cipralex.

Tell your doctor if you have any other conditions or illnesses, as your doctor may need to take them into consideration.

In particular, tell your doctor:

  • if you suffer from epilepsy. Treatment with Cipralex should be stopped if seizures occur for the first time or if there is an increase in the frequency of attacks (see also section 4 “Possible side effects”);
  • if you suffer from impaired liver or kidney function. Your doctor may need to adjust your dosage;
  • if you have diabetes. Treatment with Cipralex can alter glycemic control. The dose of insulin and / or oral hypoglycaemic may need to be adjusted;
  • if you have low blood sodium levels;
  • if you have a tendency to develop bleeding and bruising;
  • if you are receiving electroconvulsive treatment;
  • if you suffer from coronary heart disease (coronary heart disease);
  • if you have or have suffered from heart problems or have recently had a heart attack;
  • if you have a low resting heart rate and / or if you know you have saline deficiencies as a result of prolonged severe diarrhea and vomiting (having felt sick) or use diuretics (medicines to urinate);
  • if you experience a rapid or irregular heart rhythm on standing up, fainting, collapse or feel dizzy, which may indicate an abnormal heart rhythm;
  • if you have or have ever had any eye problems, for example certain types of glaucoma (increased pressure in the eye).

Keep in mind

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual ideas that change rapidly, inappropriate happiness and excessive physical activity. If you experience these sensations, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing still may occur during the first few weeks of treatment. If these symptoms occur, tell your doctor immediately.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you have depression and / or anxiety disorders you can sometimes have thoughts of harming or killing yourself. These thoughts may be more frequent at the start of treatment with antidepressants, as these medicines generally take about two weeks or more to show their effect.

You are more likely to think like this:

  • if you have previously had thoughts about killing or harming yourself;
  • if you are a young adult. Data from clinical trials have shown an increased risk of suicide-related behavior in adults under the age of 25 with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts of harming or killing yourself, contact your doctor or go to a hospital immediately.

It may be helpful to tell a relative or close friend that you have depression or an anxiety disorder, and ask them to read this leaflet. You can ask them to tell you if they think your depression or anxiety is getting worse or if they are worried about some change in your behavior.

Children and adolescents

Cipralex should normally not be taken by children and adolescents under 18 years of age. In addition, you should be aware that patients under 18 years of age are at increased risk of side effects such as suicide attempts, suicidal thoughts and hostility (essentially aggression, oppositional behavior and anger) when taking this class of medicines. ). Notwithstanding the above, your doctor may prescribe Cipralex for patients under the age of 18 if they think this is the best solution for them. If your doctor has prescribed Cipralex for a patient under the age of 18 and you would like more information, please contact your doctor again. You should inform your doctor if any of the above symptoms appear or worsen while a patient under the age of 18 takes Cipralex. Furthermore, the long-term safety effects of Cipralex related to growth, maturation and cognitive and behavioral development have not yet been demonstrated in this age group.

Other medicines and Cipralex

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 the active ingredient. If you have taken any of these medicines you must wait 14 days before starting treatment with Cipralex. After stopping treatment with Cipralex, 7 days should elapse before taking any of these medicines;
  • “Selective reversible MAO-A inhibitors” containing moclobemide (used in the treatment of depression);
  • “Irreversible MAO-B inhibitors”, containing selegiline (used in the treatment of Parkinson’s disease). These increase the risk of side effects;
  • linezolid antibiotic;
  • lithium (used in the treatment of manic-depressive disorder) and tryptophan;
  • imipramine and desipramine (both used to treat depression);
  • sumatriptan and similar medicines (used to treat migraine) and tramadol (used to relieve severe pain). These increase the risk of side effects;
  • Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcer), fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk of stroke). These can cause increased levels of escitalopram in the blood;
  • hypericum (hypericum perforatum, St. John’s wort) a herbal remedy used
    against depression;
  • acetylsalicylic acid and non-steroidal anti-inflammatory drugs (medicines used for pain relief or to reduce blood density, also called anti-aggregates). These can increase the tendency to bleed;
  • warfarin, dipyridamole and phenprocoumon (medicines used to reduce blood density, also called anti-coagulants). Your doctor will likely check the clotting time at the start and end of Cipralex treatment to see if your anticoagulant dose is still appropriate;
  • mefloquine (used to treat malaria), bupropion (used to treat depression) and tramadol (used to treat severe pain) due to the possible risk of a reduced seizure threshold;
  • neuroleptics (medicines used to treat schizophrenia, psychosis) and antidepressants (tricyclic antidepressants and SSRIs) due to the possible risk of lowering the seizure threshold;
  • flecainide, propafenone and metoprolol (used in cardiovascular diseases), clomipramine and nortriptyline (antidepressants) and risperidone, thioridazine and haloperidol (antipsychotics). The dosage of Cipralex may need to be adjusted;
  • medicines that lower the levels of potassium or magnesium in the blood, as these conditions increase the risk of life-threatening heart rhythm disturbances.

Do not take Cipralex if you are taking medicines for heart rhythm problems or which can affect the rhythm of the heart, such as class IA and III antiarrhythmics, antipsychotics (such as phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, some antimicrobial agents (such as sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial treatments, in particular halofantrine), some antihistamines (astemizole, mizolastine).
If you have any further questions, please contact your doctor.

Cipralex with food, drink and alcohol

Cipralex can be taken on an empty or full stomach (see section 3 “How to take Cipralex”). Cipralex is not expected to interact with alcohol. However, as with many medicines, the combination of Cipralex and alcohol is not recommended.

Pregnancy, breastfeeding and fertility

If you are pregnant, think you may be pregnant or are planning to have a baby, or if you are breast-feeding, ask your doctor or pharmacist for advice before using this medicine. Do not take Cipralex if you are pregnant or breastfeeding unless your doctor has discussed the risks and benefits of treatment with you.

If you take Cipralex in the third trimester of pregnancy, you should be aware that the following effects may be observed in the newborn: difficulty breathing, blue skin, seizures, body temperature instability, difficulty feeding, vomiting, hypoglycaemia (low glucose levels) in the blood), hypertonia or hypotonia, hyperflexia, tremor, nervousness, irritability, lethargy, continuous crying, drowsiness and difficulty sleeping. If your baby has any of these symptoms, contact your doctor immediately.

Make sure your midwife and / or doctor know you are taking Cipralex.
When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Cipralex may increase the risk of a serious condition in babies, called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and appear to be bluish. These symptoms usually occur during the first 24 hours after the baby is born. If this happens to your baby, you should contact your midwife and / or doctor immediately.

Sudden interruption of Cipralex treatment should be avoided during pregnancy.

Escitalopram is expected to be excreted in breast milk.

Citalopram, a medicine similar to escitalopram, has been shown in animal studies to reduce the quality of sperm. In theory, this could affect fertility, but the impact on human fertility has not yet been observed.

Driving and using machines

We advise you not to drive or use machines until you know what influence Cipralex has on you.

How to take Cipralex

Always take this medicine exactly as your doctor has told you. If in doubt, consult your doctor or pharmacist.

Adults

Depression

The usual recommended dose of Cipralex is 10 mg per day, as a single dose. This dose can be increased by your doctor up to a maximum of 20 mg per day.

Panic Disorder

The starting dose of Cipralex for the first week of treatment is 5 mg per day and then increased to 10 mg per day. Your doctor may increase this dose to a maximum of 20 mg per day.

Social anxiety disorder

The normally recommended dose of Cipralex is 10 mg per day, as a single dose.

Your doctor may decrease the dose to 5 mg per day or increase it to a maximum of 20 mg per day, based on your individual response to treatment.

Generalized anxiety disorder

The normally recommended dose of Cipralex is 10 mg per day, as a single dose. This dose can be increased by your doctor up to a maximum of 20 mg.

Elderly patients (over 65 years of age)

The recommended starting dose of Cipralex is 5 mg per day, as a single dose. This dose can be
increased by your doctor up to 10 mg per day.

Use in children and adolescents

Cipralex should normally not be taken by children and adolescents. For further information see section 2 “Warnings and precautions”.

How to take the tablets

Cipralex can be taken regardless of food intake. Swallow the tablets with a glass of water. Do not chew them, as the taste is bitter.

If necessary, the tablets can be broken by placing them on a flat surface with the score upwards. Tablets can be broken by pressing down on each tablet edge, using both index fingers as seen in the drawing.

Duration of treatment

It may take a couple of weeks for you to feel any improvement. Continue to take Cipralex even if your disease does not improve immediately.

The dosage should never be changed without first consulting your doctor.

Continue to take Cipralex for as long as your doctor recommends. If treatment is stopped too soon, symptoms may reappear. It is recommended to continue treatment for at least six months after symptoms resolve.

If you take more Cipralex than you should

If you have taken more Cipralex than prescribed, you should contact your doctor or go to the nearest hospital emergency department immediately, do so even if you have no signs of being unwell. Some of the overdose symptoms may be dizziness, tremor, agitation, convulsions, coma, nausea, vomiting, heart rhythm disturbance, decrease in blood pressure and change in electrolyte balance. Take the Cipralex box / container with you when you go to a doctor or hospital.

If you forget to take Cipralex

If you forget to take a dose of Cipralex, do not take a double dose. If you forget to take a dose of Cipralex, and remember it before going to bed, take it straight away. Continue taking it as usual the next day. If, on the other hand, you remember it during the night or the next day, skip the missed dose and continue with your normal dosage.

If you stop taking Cipralex

Do not stop taking Cipralex until your doctor tells you to. When you have completed your treatment with Cipralex, it is generally recommended that the dose of Cipralex be gradually reduced over a couple of weeks.

When you stop taking Cipralex, especially if you stop suddenly, you may experience withdrawal symptoms. These are common when treatment with Cipralex is stopped. The risk is higher if you have taken Cipralex for a long time or in high doses or if the dose is reduced too quickly. Most patients have found that these symptoms are mild and usually disappear spontaneously within a couple of weeks. However, in some patients, withdrawal symptoms may be severe in intensity or may be prolonged (2-3 months or more). If you experience severe withdrawal symptoms when you stop taking Cipralex, please tell your doctor. He may ask you to restart the treatment and continue reducing the doses more gradually.

Withdrawal symptoms include: dizziness (feeling unbalanced or unbalanced), pins and needles feeling, burning sensation (less common), electric shock sensation, including in the head, sleep disturbances (vivid dreams, nightmares, difficulty sleep), anxiety, headache, malaise (nausea), sweating (including night sweats), restlessness or agitation, tremor (shaking), confusion or disorientation, excessive emotionality or irritability, diarrhea (runny stools), visual disturbances, troubled throbbing heart (palpitations).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Cipralex can cause side effects, although not everybody gets them. The side effects usually disappear after a few weeks of treatment. Keep in mind that many of the side effects can also be symptoms of your disease and therefore lessen as you start to feel better.

If you experience any of the following symptoms you should contact your doctor or go to a hospital immediately:

Uncommon (may affect up to 1 in 100 people):

  • abnormal bleeding, including gastrointestinal haemorrhage.

Rare (may affect up to 1 in 1000 people):

  • Swelling of the skin, tongue, lips, pharynx or face, hives or difficulty breathing or choking (severe allergic reaction);
  • high fever, agitation, confusion, tremor and sudden muscle twitching can be symptoms of a rare condition called serotonin syndrome.

Not known (frequency cannot be estimated from the available data):

  • urinary difficulties;
  • convulsions (fits), see also section “Warnings and precautions”;
  • yellowing of the skin and whites of the eyes are signs of impaired liver function / hepatitis;
  • rapid, irregular heartbeat, feeling faint, which may be symptoms of a life-threatening condition known as Torsade de Pointes;
  • thoughts of harming (harming yourself) or suicide. See also paragraph “Warnings and precautions”;
  • sudden swelling of the skin or mucous membranes (angioedema).

In addition to the side effects mentioned above, the following have also been reported:

Very common (may affect more than 1 in 10 people):

  • malaise (nausea);
  • headache;
  • common (may affect up to 1 in 10 people);
  • blocked nose or nasal discharge (sinusitis);
  • decreased or increased appetite;
  • anxiety, restlessness, abnormal dreams, difficulty falling asleep, sleepiness, dizziness, yawning, tremors, skin changes;
  • diarrhea, constipation, vomiting, dry mouth;
  • increased sweating;
  • muscle and joint pain (arthralgia and myalgia);
  • sexual disorders (delayed ejaculation, erection problems, decreased sexual urges and women may have difficulty reaching orgasm);
  • fatigue, fever;
  • weight gain.

Uncommon (may affect up to 1 in 100 people):

  • hives, rashes, itching;
  • teeth grinding, agitation, nervousness, panic attacks, confusion;
  • disturbed sleep, taste changes, fainting (syncope);
  • dilation of the pupils (mydriasis), visual disturbances, ringing in the ears (tinnitus);
  • hair loss;
  • increased menstrual flow;
  • irregular menstrual cycle;
  • weight loss;
  • increased heart rate;
  • swelling of arms or legs;
  • nasal bleeding.

Rare (may affect up to 1 in 1000 people):

  • aggression, depersonalization, hallucinations;
  • slow heart rate

Not known (frequency cannot be estimated from the available data):

  • decrease in the level of sodium in the blood (symptoms are feeling unwell with muscle weakness or confusion);
  • dizziness when standing up due to a drop in blood pressure;
  • arterial (orthostatic hypotension);
  • changes in liver function values ​​(increase in the amount of liver enzymes in the blood);
  • movement disorders (involuntary muscle movements);
  • painful erections (priapism);
  • signs of abnormal bleeding, for example from the skin and mucous membranes (bruising);
  • increased production of a hormone called ADH, which causes water retention and thinning of the blood, resulting in a reduction in sodium (inappropriate ADH secretion);
  • secretion of milk in men and in women who are not breastfeeding;
  • mania;
  • an increased risk of bone fractures has been observed in patients taking this type of medicines;
  • altered heart rhythm (called ‘QT prolongation’, evaluated by an ECG which records the electrical activity of the heart).

Also, a number of side effects are known for drugs that act like escitalopram (active ingredient in Cipralex). They are:

  • motor restlessness (akathisia);
  • loss of appetite.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at: http://www.aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects you can help provide more information on the safety of this medicine.

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 carton and blister after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw any medicines via wastewater or household waste.Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

Contents of the pack and other information

What Cipralex contains

The active ingredient is escitalopram. Each Cipralex tablet contains 5 mg, 10 mg, 15 mg or 20 mg of escitalopram (as oxalate).

The other excipients are:

Tablet core: microcrystalline cellulose, anhydrous colloidal silica, talc, croscarmellose sodium and magnesium stearate.

Coating: hypromellose, macrogol 400, titanium dioxide (E 171).

What Cipralex looks like and contents of the pack

Cipralex is available as 5 mg, 10 mg, 15 mg and 20 mg film-coated tablets. The tablets are described below.

Cipralex 5 mg: 6 mm round, white, film-coated tablet with “EK” on one side of the tablet.

Cipralex 10 mg: white, scored, film-coated, 8 × 5.5 mm oval tablet with “E” and “L” on each side of the tablet.

Cipralex 15 mg: 9.8 × 6.3 mm, white, scored, film-coated oval tablet with “E” and “M” on each side of the tablet.

Cipralex 20 mg: 11.5 × 7 mm oval, white, scored, film-coated tablet with “E” and “N” on each side of the tablet.

Cipralex is available in the following packages:

Blister (transparent) with outer carton box

5 mg, 10 mg, 15 mg and 20 mg: 14, 28, 56 and 98 tablets

Blister (white / opaque) with outer carton box

5 mg, 10 mg, 15 mg and 20 mg: 14, 20, 28, 50, 100 and 200 tablets

Polyethylene container

15 mg and 20 mg: 100 tablets

5 mg and 10 mg: 100 and 200 tablets

Single dose

5 mg, 10 mg, 15 mg and 20 mg: 49 × 1, 56 × 1, 98 × 1, 100 × 1 and 500 × 1 tablets.

Not all pack sizes may be marketed.

 

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