What are the effects of citalopram
Citalopram AbZ 20mg film-coated tablets
Patient information for Citalopram AbZ 20mg film-coated tablets
1. What is Citalopram AbZ 20 mg film-coated tablets and what is it used for?
1.1 What are the properties of the medicinal product?
Citalopram AbZ 20mg film-coated tablets contains the active ingredient citalopram, a drug from the group of so-called antidepressants and selective serotonin reuptake inhibitors (SSRI). Serotonin plays an important role as a messenger substance in processes in the brain that influence the psyche and can improve mood and psychological driving force.
Citalopram is a potent serotonin (5-HT) reuptake inhibitor (SSRI). Tolerance to 5-HT resumption does not develop during long-term treatment with citalopram.
Citalopram is the most selective SSRI described to date with minimal effect on norepinephrine (NA), dopamine (DA) and gamma-aminobutyric acid (GABA) uptake.
Citalopram is usually used in the salt form as citalopram hydrobromide.
Citalopram requires a prescription and should only be used on medical advice.
1.2 What strengths and dosage forms are there?
Oral citalopram is usually available as
- Film-coated tablets containing 10 mg, 20 mg, 30 mg or 40 mg citalopram (as citalopram hydrobromide).
Your doctor will determine which strength and dosage form are suitable for your treatment.
1.3 Citalopram is used for
- treatment of depressive illnesses (major depressive episodes),
Treatment of panic disorder with or without agoraphobia (e.g. severe fear of leaving the house, entering shops or fear of public places)
2. What should you know before you take Citalopram AbZ 20 mg film-coated tablets?
2.1 Citalopram AbZ 20mg film-coated tablets must not be used
- if you are hypersensitive (allergic) to citalopram or any of the other ingredients
- if you are also taking monoamine oxidase (MAO) inhibitors:
- for example the antidepressant moclobemide or:
- if you are being treated with the non-selective MAO-inhibitor linezolid (an antibiotic), unless there are ways to monitor and control your blood pressure closely;
- the irreversible MAO inhibitor selegiline (used to treat Parkinson's disease) may only be used in combination with citalopram in doses of up to 10 mg selegiline per day;
- if you have taken irreversible MAO-inhibitors within the last 2 weeks or have used a reversible MAO-inhibitor (RIMA) within the time stated in the package insert;
- Treatment with an MAOI should not be started until 7 days after stopping citalopram.
- if you have congenital irregular heartbeat or have had episodes of irregular heartbeat (seen on an ECG; this is an examination to assess how the heart is working)
- if you are taking medicines to treat irregular heartbeat or medicines that can affect the rhythm of the heart.
2.2 Special care is required when taking Citalopram AbZ 20 mg film-coated tablets
- Thoughts of suicide and worsening of your depression / anxiety disorder
When you are depressed or have anxiety disorders you can sometimes have thoughts of harming or killing yourself. These thoughts may be aggravated the first time you use antidepressants because all of these medicines take some time to work, usually about two weeks, sometimes longer.
Such thoughts are more likely to occur:
- if you have had thoughts of killing or harming yourself in the past
- if you are a young adult. Results from clinical trials have shown an increased risk of suicidal behavior in young adults aged 25 and under with a psychiatric illness who were treated with an antidepressant.
Contact your doctor or go to a hospital straight away if you have thoughts of harming or killing yourself at any time.
It can be helpful to tell a friend or relative that you are depressed or have an anxiety disorder. Ask them to read this leaflet. Ask them to tell you if they think your depression or anxiety is getting worse, or if they are worried about changes in your behavior.
- Restlessness / difficulty sitting or standing still
Symptoms such as restlessness, e.g. when you cannot sit or stand still, can occur during the first few weeks of treatment. Tell your doctor straight away if you get these symptoms. Adjusting the dose can be helpful in these cases.
- Increased fear
When treating panic disorder, it usually takes 2 to 4 weeks to see improvement. Some patients may experience increased anxiety at the beginning of treatment, which will subside as treatment continues. It is therefore very important that you carefully follow your doctor's instructions. Do not stop treatment or change the dose without consulting your doctor.
- mania (overactive behavior or racing thoughts)
If you get into a manic phase characterized by unusual and rapidly changing ideas, excessive happiness and excessive physical activity, please contact your doctor.
- Withdrawal reactions upon discontinuation of selective serotonin reuptake inhibitor treatment
If you stop treatment, especially if it happens suddenly, you may get withdrawal symptoms. These are common when treatment is stopped. The risk is greater if Citalopram AbZ 20 mg film-coated tablets has been taken over a long period of time or in high doses, or if the dose is reduced too quickly. Most people find that symptoms are mild and go away on their own within two weeks. However, in some patients they can be severe or longer lasting (2 to 3 months or more).
If you develop severe discontinuation symptoms when stopping treatment with Citalopram AbZ 20 mg film-coated tablets, please contact your doctor. He may ask you to take the tablets again and then come off more slowly.
Tell your doctor if:
- you develop a fever, muscle stiffness or tremors and are very agitated. You may have a condition called serotonin syndrome. Although this syndrome is rare, it can develop into a potentially life-threatening condition. Contact your doctor immediately; treatment with Citalopram AbZ 20 mg film-coated tablets may have to be stopped.
- you are using herbal remedies that contain St. John's wort (Hypericum perforatum).
- you are being treated with serotonergic medicines, e.g. sumatriptan or other triptans, tramadol, oxitriptan and tryptophan.
- You are sensitive to an abnormal heart rhythm (prolongation of the QT interval) or you are suspected of having a long QT syndrome or if your blood potassium or magnesium levels are low (hypokalaemia / hypomagnesaemia).
- you are at risk of low sodium in the blood (hyponatremia), e.g. due to medicines you are taking at the same time or due to cirrhosis. In rare cases, especially in elderly patients, hyponatremia in connection with the syndrome of inadequate secretion of antidiuretic hormone (SIADH) has been reported in connection with Citalopram AbZ 20 mg film-coated tablets.
- you have diabetes. The dose of your anti-diabetic medicine may need to be adjusted.
- you have epilepsy. If seizures occur, treatment must be stopped. Contact your doctor.
- you have bleeding abnormalities, for example gynecological or stomach bleeding, or you are taking medicines that affect blood clotting or make it more likely to bleed, as treatment with citalopram may increase the risk of bleeding.
- You are pregnant (AkdÄ Drug Safety Mail; 2020/62).
- sleep disorders or excitement occur at the start of treatment. Your doctor may adjust the dose.
- you suffer or have suffered from heart problems or have recently had a heart attack.
- You have a low resting heart rate and / or you know that you may have salt depletion as a result of prolonged severe diarrhea and vomiting, or as a result of taking diuretics (water tablets).
- if your heartbeat is fast or uneven, fainting, collapsing or feeling dizzy when you stand up, which may indicate an abnormal heart rate.
- you are undergoing electroconvulsive therapy.
- you have a condition called psychosis with depressive episodes, as the psychotic symptoms could get worse.
- you have or have had panic disorder.
- you have problems with your eyes such as certain types of glaucoma.
Note on other ingredients:
Oral medicines can contain different types of sugar. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should therefore only take medicinal products after consulting their doctor.
Drops: This medicinal product also contains methyl 4-hydroxybenzoate (Ph. Eur.) (E 218) and propyl 4-hydroxybenzoate (Ph. Eur.) (E 216), which can cause hypersensitivity reactions, including late reactions.
Citalopram AbZ 20 mg film-coated tablets should normally not be used in children and adolescents under 18 years of age. In addition, patients under 18 years of age treated with drugs of this class are at an increased risk of side effects such as suicide attempt, suicidal ideation, and hostility (predominantly aggression, oppositional behavior, and anger).
Nevertheless, the doctor can prescribe Citalopram AbZ 20mg film-coated tablets for patients under the age of 18 if he decides that this is in the best interests of the patient. If the doctor has prescribed Citalopram AbZ 20 mg film-coated tablets for a patient under the age of 18 and you would like to discuss this, please contact your doctor. Notify your doctor if any of the above symptoms develop or worsen in a patient under 18 years of age treated with Citalopram AbZ 20 mg film-coated tablets. In addition, no data are yet available on the long-term safety-relevant effects of Citalopram AbZ 20mg film-coated tablets with regard to growth, maturation and cognitive and behavioral development in this age group.
2.2.b) Elderly patients
Older patients are more sensitive to the effects of antidepressants, so your doctor will adjust the dosage. If you have any side effects, please inform your doctor.
The maximum dose of citalopram in elderly patients is 20 mg daily.
Ask your doctor or pharmacist for advice before taking any medicine.
Experience with the use of citalopram during pregnancy is limited. Do not take Citalopram AbZ 20 mg film-coated tablets if you are pregnant or planning to become pregnant unless your doctor deems the treatment to be absolutely necessary.
If you take Citalopram AbZ 20mg film-coated tablets towards the end of your pregnancy, the risk of heavy vaginal bleeding shortly after birth may be increased, especially if you have a history of bleeding disorders. Your doctor or midwife should be informed that you are taking Citalopram AbZ 20 mg film-coated tablets so that they can advise you accordingly (AkdÄ Drug Safety Mail; 2020/62).
Do not stop treatment with Citalopram AbZ 20 mg film-coated tablets suddenly.
Please make sure that your midwife and / or doctor have been informed that you are being treated with Citalopram AbZ 20 mg film-coated tablets.
If you take Citalopram AbZ 20 mg film-coated tablets in the last three months of pregnancy, your child may show certain symptoms after the birth. These symptoms usually start within 24 hours of giving birth. These symptoms include difficulty sleeping or feeding, breathing problems, bluish discoloration of the skin, or being overheated or hypothermic, vomiting, increased crying, stiff or slack muscles, listlessness, tremors, twitching, or seizures. If you notice these symptoms in your child after birth, please contact your midwife and / or doctor immediately, who will be able to advise you accordingly.
Medicines such as Citalopram AbZ 20mg film-coated tablets, if they are taken during pregnancy, especially in the last three months of pregnancy, can lead to a serious health impairment of the newborn, which is called primary or persistent pulmonary hypertension of the newborn (PPHN) and which is it shows that the newborn is breathing faster and that the skin is blue. These symptoms usually begin during the first 24 hours after giving birth. In such a case, please inform your midwife and / or doctor immediately.
Small amounts of Citalopram AbZ 20 mg film-coated tablets pass into breast milk. The risk of effects on the infant cannot be excluded. If you are taking Citalopram AbZ 20 mg film-coated tablets, please consult your doctor before breastfeeding.
2.2.e) Ability to drive and use machines
In some people, Citalopram AbZ 20mg film-coated tablets can cause side effects that can affect safety at work and the ability to safely drive a vehicle.
2.3 Which interactions with other medicinal products have to be considered?
Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.
Citalopram AbZ 20mg film-coated tablets must not be taken:
- if you are taking drugs to treat cardiac arrhythmias or drugs that can affect the heart rhythm, e.g. class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (e.g. sparfloxacin, moxifloxacin, Erythromycin IV, pentamidine, antimalarials such as halofantrine in particular), certain antihistamines (astemizole, mizolastine, etc.). If you have any further questions about this, contact your doctor.
Citalopram AbZ 20mg film-coated tablets can affect certain other drugs and vice versa. Some of these medicines are:
- Desipramine (used to treat depression). Desipramine levels in the blood may be increased and the dose of desipramine may need to be reduced.
- Neuroleptics (used to treat mental illness). An increase in side effects cannot be ruled out.
- metoprolol (for example if you have heart disease). Flecainide and propafenone (used to treat an irregular heartbeat), other medicines used to treat depression (clomipramine, nortriptyline) or medicines used to treat psychosis (risperidone, thioridazine, haloperidol). An increase in the blood concentration of these drugs has been reported or is possible.
- pimozide (medicine used to treat psychosis). Citalopram must not be used at the same time as pimozide because it affects the function of the heart.
- Medicines that affect the heart rhythm (QT interval prolongation) or reduce the concentration of potassium or magnesium in the blood. Citalopram also has such an effect.
- Medicines that lower the seizure threshold, e.g. other antidepressants (tricyclics, SSRIs), medicines for the treatment of psychoses (e.g. phenothiazines, thioxanthenes, butyrophenones), mefloquine, bupropion and tramadol (pain relievers).
2.3.a) Enhancement of the serotonergic effects of Citalopram AbZ 20mg film-coated tablets and side effects
- MAOIs (used to treat depression or Parkinson's disease) (e.g. moclobemide and selegiline or linezolid, an antibiotic). With the exception of selegiline in a dose of up to 10 mg / day, you must not take Citalopram AbZ 20 mg film-coated tablets at the same time as MAO inhibitors, as this could lead to serious and even fatal reactions (serotonin syndrome). There must be a treatment-free period between the two treatments. Ask your doctor.
- Oxitriptan and tryptophan (serotonin precursors)
- lithium (used to treat mental illness)
- sumatriptan and other triptans (used to treat migraines)
- tramadol (used to treat severe pain)
- St. John's wort (Hypericum perforatum)
- Cimetidine (used to treat stomach problems) and other medicines used to treat stomach ulcers, e.g. omeprazole, esomeprazole, lansoprazole, or fluvoxamine (another medicine used to treat depression). The combination with citalopram can cause the concentration of citalopram in the blood to rise.
2.3.b) Increase in the risk of bleeding
- Warfarin and other blood thinning medicines
- Acetylsalicylic acid and other pain relievers from the NSAID group (non-steroidal anti-inflammatory drugs, e.g. ibuprofen)
- Dipyridamole and ticlopidine (heart medicines)
- Phenothiazines and atypical neuroleptics (used to treat mental illness)
- Tricyclic antidepressants (used to treat depression such as imipramine)
Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines that are not available on prescription, natural remedies or high-dose vitamin or mineral supplements.
2.4 What should be considered when taking Citalopram AbZ 20mg film-coated tablets together with food, luxury foods and beverages?
Food has no influence on the effectiveness of Citalopram AbZ 20mg film-coated tablets. Alcohol should be avoided during treatment with Citalopram AbZ 20 mg film-coated tablets.
3. How should Citalopram AbZ 20 mg film-coated tablets be taken?
Always take Citalopram AbZ 20 mg film-coated tablets exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.
3.1 Nature and duration of ingestion
Citalopram is taken once a day in the morning or in the evening.
Take the tablets with a glass of water.
The drops are for oral use after mixing with water.
Citalopram can be taken at any time of the day with or without food.
Major depressive episodes: Antidepressant effects are not expected for at least two weeks after starting treatment. Treatment should be continued until the patient is symptom-free for 4-6 months to ensure adequate protection against possible relapse. Citalopram should be stopped slowly. It is advisable to gradually reduce the dose over a period of 1 to 2 weeks.
Panic Disorder: Patients with panic disorder must be treated for a long enough period to make sure they are symptom-free. This period can be several months or even longer.
Sudden discontinuation of therapy should be avoided. When stopping treatment with Citalopram AbZ 20 mg film-coated tablets, the dose should be reduced gradually over a period of at least one to two weeks in order to reduce the risk of withdrawal symptoms. If severely debilitating withdrawal symptoms occur after reducing the dose or discontinuing the drug, consideration should be given to taking the last dose again and then reducing it in smaller steps as instructed by the doctor.
3.2 Unless otherwise prescribed by the doctor, the usual dose is
3.2.a) Major depressive episodes
Citalopram should be taken as a single dose of 20 mg once daily. Depending on the individual response of the patient, the dose can be increased to a maximum of 40 mg daily.
3.2.b) Panic disorder
The starting dose should be 10 mg daily for the first week and, depending on the patient's response, increased up to the recommended dose of 20 mg daily. It is recommended to start with a low starting dose. If after a few weeks at the recommended dose there is no adequate response, gradually increasing the dose to a maximum of 40 mg daily may be beneficial in some patients, although higher doses may increase the potential for side effects. The dosage should be adjusted carefully depending on the individual response in order to obtain the lowest possible effective dose for the respective patient.
3.2.c) Elderly patients (> 65 years)
In the elderly, the dose should be reduced to half the recommended dose. The maximum recommended dose for elderly patients is 20 mg once a day.
3.2.d) Impaired liver function
In patients with mildly or moderately impaired liver function, a starting dose of 10 mg once daily is recommended for the first two weeks of treatment. Depending on the patient's individual response, the dose can be increased to a maximum of 20 mg once daily. Caution should be exercised in patients with severe hepatic impairment and particular caution should be exercised in dose titration.
3.2.e) Impaired kidney function
No dose adjustment is required in patients with mild or moderate renal impairment. For use in patients with severely impaired renal function (creatinine clearance < 20="" ml/min)="" stehen="" keine="" daten="" zur="" verfügung.="">
3.3 If you take more Citalopram AbZ 20 mg film-coated tablets than you should
If you have taken more Citalopram AbZ 20 mg film-coated tablets than stated in this leaflet or prescribed by your doctor, please contact your doctor, the emergency room or a pharmacy.
Symptoms of an overdose include nausea, vomiting, sweating, rapid pulse rate, drowsiness and convulsions.
3.4 If you forget to take Citalopram AbZ 20 mg film-coated tablets
If you forget to take Citalopram AbZ 20 mg film-coated tablets, simply continue with the usual schedule - do not take a double dose.
3.5 Effects if treatment with Citalopram AbZ 20 mg film-coated tablets is discontinued
Abrupt termination of treatment should be avoided. When stopping treatment with Citalopram AbZ 20 mg film-coated tablets, the dose should be reduced gradually over a period of at least one to two weeks in order to reduce the risk of withdrawal reactions.
If severely debilitating withdrawal symptoms occur after reducing the dose or discontinuing the drug, your doctor may ask you to take the tablets again and then withdraw them more slowly.
4. What are the possible side effects?
Like all medicines, Citalopram AbZ 20mg film-coated tablets can cause side effects, although not everybody gets them.
When evaluating side effects, the following frequencies are used as a basis:
- very common: more than 1 in 10 people
- common: less than 1 in 10, but more than 1 in 100 patients
- uncommon: less than 1 in 100, but more than 1 in 1,000 patients
- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated
- very rare: less than 1 in 10,000 patients, including isolated cases
- Frequency not known: frequency cannot be calculated from the available data
4.1 Which side effects can occur in detail?
4.1.a) Contact your doctor or the nearest hospital emergency department immediately
If you notice any of the following symptoms, you should stop taking Citalopram 20 mg film-coated tablets:
Serious cardiac arrhythmias with a fast, irregular pulse.
Severe itching of the skin (with bumps).
Nausea, muscle weakness, confusion, tiredness and muscle twitching due to low levels of sodium in your blood. In some patients this can lead to a serious side effect. Talk to your doctor. Inflammation of the liver, jaundice. History of seizures which are now more common.
Sudden allergic reaction (within minutes to hours) such as rash, difficulty breathing, dizziness and fainting (anaphylactic reaction). Skin rash (hives) and swelling. Cases involving the face, lips and tongue can be life-threatening (angioedema).
Side effects with a frequency of "Not known" (frequency cannot be estimated from the available data)
Suicidal thoughts, suicidal behavior. Cases of suicidal ideation and behavior have been reported during therapy with citalopram or shortly after stopping treatment. See your doctor or a hospital emergency room.
High fever, tremors and sudden muscle twitching, confusion, pathological elation and agitation.
Decrease in the number of platelets in the blood, which increases the risk of bleeding and bruising.
Unusual bleeding, including bleeding from the gastrointestinal tract (vomiting blood and / or black stools due to bleeding in the stomach and intestines) and bleeding from the uterus.
Fast, irregular heartbeat, fainting. These could be symptoms of a life-threatening irregular heartbeat called torsade de pointes.
Seizures that are happening for the first time.
4.1.b) Other side effects
Palpitations, tremors, increased sweating, lethargy (urge to sleep), drowsiness, weakness and frailty, sleep disorders, psychomotor restlessness (agitation), nervousness, dizziness, blurred vision (difficulty reading the small print).
Dry mouth, which can increase the risk of tooth decay (you should therefore brush your teeth more often than usual while taking Citalopram AbZ 20 mg film-coated tablets).
Nausea, constipation, headache.
Decreased appetite, weight loss, increased appetite, taste disturbances, diarrhea, vomiting, indigestion (including acid reflux, heartburn), stomach pain, gas, increased salivation.
High blood pressure: talk to your doctor. High blood pressure should be treated. Severely high blood pressure is serious.
Dizziness and possibly fainting (possibly only when standing up) due to low blood pressure, low blood pressure, fever, tingling, tingling or numbness on the skin, tiredness, trouble sleeping, unusual dreams, migraines, ringing in the ears (tinnitus), visual disturbances, runny nose, sinusitis, Yawning, difficulty urinating, itching, rash, muscle pain, joint pain, ejaculation disorders, impotence (erectile dysfunction), menstrual pain, orgasmic disorders, decreased libido, feelings of anxiety, confusion, indifference, impaired concentration, attention disorders, abnormal dreams, memory loss, pathologically increased urine output (polyuria) .
Hallucinations. These could be serious. See a doctor or an ambulance.
Fainting, seizures, movement disorders and involuntary movements, dilated pupils, cough, difficulty urinating, possibly urinary retention. This can be or become serious. Talk to your doctor.
Edema (fluid retention), hair loss, hives, itchy rash, increased sensitivity of the skin to light (photosensitivity), unusually heavy menstrual bleeding. Aggression (threatening, possibly violent behavior), loss of reality or experience of alienation, pathological elation (mania), elation (euphoria), increased libido. Loss of appetite, malaise, weight gain, slow pulse.
Involuntary movements, bleeding, inability to sit still. Restless legs.
Discharge of milk from the chest.
4.1.b.6. Side effects with the frequency "Not known" (frequency cannot be estimated from the available data)
Weakness, decreased muscle strength, tremors and abnormal heart rhythm due to low levels of potassium in the blood (hypokalaemia). This can become a serious side effect in some patients. Talk to your doctor.
Epistaxis, blood stains under the skin, irregular, heavy menstrual bleeding. Persistent painful erection. Contact your doctor or a hospital emergency room as soon as possible.
Severe vaginal bleeding shortly after birth (postpartum hemorrhage) (AkdÄ Drug Safety Mail; 2020/62).
Panic attack, grinding of teeth.
An increased risk of fractures has been observed in elderly patients treated with this group of medicines.
In addition, Citalopram AbZ 20 mg film-coated tablets can cause side effects that you normally do not notice. The results of certain laboratory tests, such as liver tests, may be changed and will return to normal when treatment is stopped.
Withdrawal reactions when stopping treatment with Citalopram AbZ 20 mg film-coated tablets: Withdrawal reactions occur frequently when treatment with Citalopram AbZ 20 mg film-coated tablets is stopped. Dizziness, skin sensation disorders, difficulty sleeping (including insomnia and intense dreams), agitation or anxiety, nausea and / or vomiting, tremors and headache have been reported. In general, these symptoms are mild to moderate and go away on their own, but in some patients they can be severe and last longer. It is therefore advisable to reduce the dose gradually when treatment with Citalopram AbZ 20 mg film-coated tablets is no longer required.
4.2 What countermeasures should be taken if side effects occur?
Let your doctor know if you experience any side effects. He will decide on possible measures.
If you experience a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can under certain circumstances have serious consequences. In such cases, do not continue to take the medicine without doctor's advice.
Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert.
You can also report side effects directly to the Federal Institute for Drugs and Medical Devices Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn (website: www.bfarm.de). By reporting side effects you can help provide more information on the safety of this medicine.
5. How should Citalopram AbZ 20 mg film-coated tablets be stored?
Store Citalopram AbZ 20mg film-coated tablets at normal room temperature and keep the medicine in the original packaging protected from light and moisture.
Medicines should generally be kept out of the reach of children.
Do not use the medicine after the expiry date stated on the pack.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.
6. Source and processing status
Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices
Copyright by ePrax GmbH, Munich; November 2020 (8)
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