


Ask a doctor about a prescription for CITALOPRAM SUN 20 mg FILM-COATED TABLETS
Package Leaflet: Information for the User
Citalopram SUN 20 mg film-coated tablets EFG
(Citalopram hydrobromide)
Read all of this leaflet carefully before you start taking this medicine.
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Contents of the pack and other information:
Contents of the pack and additional information
Citalopram Sun is an antidepressant belonging to the class of SSRIs (selective serotonin reuptake inhibitors).
Citalopram Sun contains citalopram and is used to treat depressive disorders and panic disorders, with or without agoraphobia.
Do not take CITALOPRAM SUN:
If you are taking medicines for heart rhythm problems or that may affect heart rhythm. See also the section “Taking Citalopram SUN with other medicines”.
Warnings and precautions:
Consult your doctor or pharmacist before taking citalopram.
Below is described when you should use citalopram only under certain circumstances and with special caution. Consult your doctor about this. This also applies if this information has been applicable to you in the past.
Citalopram should not be used:
Special caution is required when taking Citalopram:
Tell your doctor if you have liver or kidney failure. Your doctor may adjust your dose (see section 3 "How to take Citalopram?").
In patients with epilepsy, treatment with citalopram should be discontinued if seizures occur or their frequency increases (see also section 4 "Possible side effects").
As has been described with other serotonin reuptake inhibitors, citalopram may also affect blood glucose control in patients with diabetes. It may be necessary to adjust the dose of insulin or oral hypoglycemic medication.
During treatment with citalopram, rare cases of hyponatremia (decreased sodium concentration in the blood) have been reported, possibly caused by inadequate secretion of the antidiuretic hormone (SIADH), which was generally reversible after discontinuation of treatment. Most reports referred to elderly patients, patients taking diuretics, or patients with volume deficiency for other reasons. The signs of this may include general malaise with muscle weakness and confusion.
If you have a manic-depressive disorder, manic phases may occur. These phases are characterized by exuberant and rapidly changing ideas, exaggerated joy, and excessive physical activity. In this case, your doctor should discontinue treatment with Citalopram.
Important information about your disease
As with other medicines used to treat depression or related diseases, improvement is not observed immediately. After starting treatment with Citalopram, it may take several weeks before you experience any improvement. At the beginning of treatment, some patients may experience an increase in anxiety, which will disappear with continued treatment. In the treatment of panic disorder, improvement usually takes 2 to 4 weeks.
Some patients with panic disorder experience an increase in anxiety symptoms at the start of treatment. However, these symptoms usually disappear on their own after 14 days of treatment. To reduce these paradoxical anxiety symptoms, a low initial dose of 10 mg of citalopram is recommended during the first week of treatment (see section 3 "How to take Citalopram?").
It is very important that you follow your doctor's instructions exactly and do not interrupt treatment or change the dose without consulting them.
Medicines like Citalopram (also known as SSRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have continued after discontinuation of treatment.
Withdrawal reactions when stopping treatment with a serotonin reuptake inhibitor
Withdrawal reactions usually appear when treatment is stopped, especially if it is stopped abruptly (see section 4 "Possible side effects"). The risk of withdrawal symptoms may depend on various factors, such as the duration of treatment, the dose, and the speed of dose reduction. In general, these symptoms are mild to moderate but can be severe in some patients. They usually appear in the first few days after treatment is stopped. Generally, these symptoms resolve on their own and disappear within 2 weeks. In some people, they may last longer (2-3 months or more). Therefore, when stopping treatment with Citalopram, it is recommended to gradually reduce the dose over a period of several weeks or months, depending on the patient's needs (see section 3 "How to take Citalopram").
In relation to the use of medicines like Citalopram, rare cases of bleeding or prolonged bleeding times [e.g., extensive skin bleeding (ecchymosis), gynecological bleeding, gastrointestinal bleeding, and other skin or mucous membrane bleeding] have been reported. If you are pregnant, see the section "Pregnancy, breastfeeding, and fertility". Caution is recommended in patients with a history of bleeding disorders and during concomitant use of medicines that may increase the risk of bleeding (see also the section "Other medicines and Citalopram").
If you have psychotic depression, treatment with Citalopram may increase psychotic symptoms (e.g., hallucinations or delusional experiences).
Currently, there is limited clinical experience with the simultaneous use of Citalopram and electroconvulsive therapy, so caution is recommended.
Tell your doctor if you have eye problems, such as certain types of glaucoma (increased intraocular pressure). In this case, Citalopram should be used with caution.
Children and adolescents
Citalopram should not normally be given to children and adolescents under 18 years. Also, you should know that patients under 18 years have a higher risk of suffering from side effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, oppositional behavior, and anger) when taking this type of medicine. Nevertheless, your doctor may prescribe Citalopram to patients under 18 years if they consider it best for them. If your doctor has prescribed Citalopram to a patient under 18 years and you wish to consult them, go back to consult them. You must inform your doctor if any of the above symptoms appear or worsen when patients under 18 years take Citalopram. Additionally, the long-term safety and behavioral effects of citalopram in this age group have not yet been established.Patient over 65 years
Patient over 65 years are more sensitive to the effects of antidepressants, so your doctor will adjust the dose of Citalopram. If you experience any side effects, inform your doctor.
Other medicines and Citalopram Sun
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Only take medicines prescribed by your doctor at the same time as citalopram.
Note that this information may also apply to medicines that have been used recently.
Do not take Citalopram
Citalopram should not be taken with sumatriptan and similar preparations (medicines for the treatment of migraine), tramadol, and similar medicines (opioids used for severe pain), tryptophan, or oxitriptan (serotonin precursors), as this may lead to an intensification of serotonin-mediated effects.
Individual cases of "serotonin syndrome" (for more information, see section 4 "Possible side effects") have also been described when combining citalopram with moclobemide or buspirone.
Concomitant administration of citalopram and St. John's Wort preparations (herbal medicines for the treatment of depression) should be avoided due to the increased risk of side effects.
Concomitant administration of cimetidine, lansoprazole, and omeprazole (for the treatment of stomach ulcers), fluconazole (for the treatment of fungal infections), fluvoxamine (antidepressant), and ticlopidine (to reduce the risk of stroke) may cause an increase in citalopram blood levels. A dose adjustment may be necessary.
Caution is recommended when taking flecainide or propafenone (medicines for the treatment of heart diseases), desipramine, clomipramine, and nortriptyline (medicines for the treatment of depression), or risperidone, thioridazine, and haloperidol (medicines for the treatment of schizophrenia and psychosis) concomitantly. A dose adjustment may be necessary.
Concomitant use of metoprolol (medicines for the treatment of high blood pressure and heart diseases) causes an increase in metoprolol blood levels. A dose adjustment may be necessary.
Although interactions with concomitant use of citalopram and lithium (for the prevention and treatment of manic-depressive disorders) have only been reported in very rare cases to date, treatment should be carefully monitored.
Caution is recommended when taking citalopram concomitantly with anticoagulants, medicines affecting platelet function, or other medicines that increase the risk of bleeding (see also "Warnings and precautions" in section 2). These medicines include non-steroidal anti-inflammatory drugs, acetylsalicylic acid, dipyridamole, antipsychotics, and ticlopidine.
Caution is recommended when taking medicines that reduce blood potassium or magnesium levels concomitantly, as these conditions increase the risk of potentially fatal heart arrhythmias.
Caution is recommended when taking imipramine and desipramine (both medicines for the treatment of depression) concomitantly. A dose adjustment of desipramine may be necessary.
Citalopram may reduce the seizure threshold. For this reason, caution is recommended during concomitant treatment with medicines that may also reduce the seizure threshold, such as mefloquine (antimalarial), bupropion (for the treatment of depression), tramadol (potent analgesic), neuroleptics (medicines for the treatment of schizophrenia or psychosis), and medicines for the treatment of depression (SSRIs).
Interactions between citalopram and clozapine (medicines used to treat psychosis) have been reported, which may increase the risk of side effects associated with clozapine. The nature of these interactions is not fully understood.
Using Citalopram SUN with food, drinks, and alcohol:
Citalopram SUN should be taken once a day. Citalopram SUN can be taken at any time of the day with or without food.
Do not take alcohol while taking Citalopram SUN. Although there is no evidence of interactions between citalopram and alcohol, alcohol consumption should be avoided during treatment with Citalopram, as with other medicines that act on the central nervous system.
Pregnancy, breastfeeding, and fertility:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide whether treatment with Citalopram SUN is necessary or if there is an alternative treatment possible.
PregnancyDo not stop taking Citalopram SUN abruptly. Make sure your midwife and/or doctor are informed that you are being treated with Citalopram SUN.
During pregnancy, particularly in the last 3 months, medicines like Citalopram SUN may increase the risk of a serious disease in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start during the first 24 hours after birth. If they appear in your baby, you must contact your midwife and/or doctor immediately.
If you take Citalopram SUN in the final stage of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Citalopram SUN so that they can advise you.
Breastfeeding
Citalopram passes into breast milk in small amounts.
There is a risk of side effects for the breastfed baby. If you are taking Citalopram, consult your doctor before you start breastfeeding your child.
FertilityCitalopram has been observed to reduce sperm quality in animal studies. Theoretically, this could affect fertility, but no impact on human fertility has been observed.
Consult your doctor or pharmacist before taking any medicine.
Driving and using machines:
This medicine may cause side effects (such as dizziness, drowsiness, confusion, and vision problems) that affect your concentration and reaction speed. If you experience these side effects, do not drive, do not use machines, or do anything that requires you to be alert and focused.
Citalopram SUN contains lactose monohydrate and sodium.
If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially "sodium-free".
Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
How much to take
Unless a doctor prescribes a different dose, the recommended dose is:
Adults
For the treatment of depression
The usual dose is 20 mg per day. This may be increased by your doctor up to a maximum of 40 mg per day.
Panic disorder with or without agoraphobia
The initial dose is 10 mg per day for the first week before increasing the dose to 20-30 mg per day. Your doctor may increase the dose up to a maximum of 40 mg per day.
Elderly patients (over 65 years old)
The initial dose should be reduced to half of the recommended dose, for example, 10-20 mg per day. Elderly patients should not normally receive a dose greater than 20 mg per day.
Use in patients with special risks
In patients with hepatic insufficiency, the elimination (excretion) of citalopram may be slower. In cases of mild or moderate hepatic insufficiency, an initial dose of 10 mg of citalopram per day is recommended for the first two weeks of treatment. Patients with hepatic dysfunction should not take more than 20 mg of citalopram per day. Caution is recommended in patients with severe hepatic insufficiency, and the dose should be increased with special caution.
No dose adjustment is required in cases of mild or moderate renal insufficiency. The use of citalopram is not recommended in patients with severe renal insufficiency (creatinine clearance less than 30 ml/min), as there is no experience with it.
Children and adolescents under 18 years old
Citalopram SUN should not be administered to children and adolescents. For more information, see section 2 "What you need to know before taking Citalopram SUN".
How and when to take Citalopram SUN
Citalopram SUN is taken every day as a single daily dose. Citalopram SUN can be taken at any time of day with or without food. Swallow the tablet with a glass of water. Do not chew them (they have a bitter taste).
The score line should not be used to divide the tablet.
Duration of treatment
Note that Citalopram Sun does not take effect immediately, but after about 2 to 4 weeks. Therefore, you should only expect an improvement after a certain period of time.
During the treatment of panic disorders with and without agoraphobia, the maximum effect is achieved after approximately three months of treatment.
The total duration of treatment is individual (generally at least 6 months) and is determined by the doctor. Continue taking the tablets throughout the treatment, even if you feel better or do not have symptoms, to avoid a new worsening or recurrence of the disease.
If you take more CITALOPRAM SUN than you should:
If you have taken too many tablets, or if someone has accidentally swallowed some, contact your doctor or go to the nearest hospital. Show the box of tablets. The main symptoms that may appear in case of taking too many tablets (overdose) are: drowsiness, loss of consciousness, convulsions, dizziness, nausea, vomiting, cyanosis (bluish discoloration of the skin), rapid and deep breathing (hyperventilation), tremors, sweating, agitation, dilated pupils, serotonin syndrome (see section 4 "Possible side effects"), potentially fatal heart rhythm disturbances, acceleration or deceleration of heart rate, increase or decrease in blood pressure, changes in the ECG, cardiac arrest, and dissolution of skeletal muscle fibers (rhabdomyolysis).
If you forget to take CITALOPRAM SUN:
In case of forgetting a dose, wait for the next one. But do not take a double dose to make up for the forgotten dose.
If you interrupt treatment with CITALOPRAM SUN:
If you want to interrupt your treatment, consult your doctor in advance. He or she will take the necessary measures if necessary. Do not stop the medication without consulting your doctor.
Withdrawal reactions when stopping treatment with citalopram
Abrupt discontinuation of treatment should be avoided. When stopping treatment with Citalopram SUN, the dose should be discontinued gradually over a period of 1 to 2 weeks to reduce the risk of withdrawal reactions. If severe withdrawal symptoms occur after reducing or stopping the medication, it should be considered to restart the last dose taken and reduce it gradually according to the doctor's instructions.
If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.
Like all medications, Citalopram SUN can cause side effects, although not all people experience them.
Side effects are most evident during the first or even the first two weeks of treatment and then disappear as the disease improves.
If you experience any of the following symptoms, stop your medication and go to your doctor immediately:
The following side effects may occur:
Very common: (more than 1 in 10 patients treated)
Common: (less than 1 in 10 but more than 1 in 100 patients treated)
increased salivation, yawning, general well-being disorder, fatigue.
Uncommon: (less than 1 in 100 but more than 1 in 1000 patients treated)
swelling of arms and legs (edema)
Rare: (less than 1 in 1000 but more than 1 in 10,000 patients treated)
Frequency not known (cannot be estimated from available data)
movement disorders
There have been reports of suicidal thoughts and behaviors during treatment with citalopram or shortly after stopping it (see section 2 "Warnings and precautions").
There have been reports of QT interval prolongation since its launch, mainly in patients with pre-existing heart disease.
An increased risk of bone fractures has been observed in patients treated with this group of medications.
Withdrawal reactions when stopping treatment with citalopram:
Withdrawal reactions are common when stopping treatment. The most frequent reactions are dizziness, sensory disturbances (including paresthesia), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, and visual disturbances. In general, these symptoms are mild to moderate and resolve on their own; however, in some patients, they can be severe and persistent. Therefore, it is recommended to gradually reduce the dose when treatment with citalopram is no longer necessary (see sections 2 and 3).
Reporting of side effects
If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medication.
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Keep this medication out of sight and reach of children.
Do not use this medication after the expiration date shown on the box and blister. The expiration date is the last day of the month indicated.
This medication does not require special storage conditions.
Medications should not be thrown away in drains or trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.
Composition of Citalopram SUN
The active ingredient is citalopram (hydrobromide).
Each 20 mg film-coated tablet contains 25 mg of citalopram hydrobromide, equivalent to 20 mg of citalopram.
The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, cornstarch, copovidone, sodium croscarmellose, and magnesium stearate. The components of the coating material, Opadry White 20H 58983, are hypromellose, titanium dioxide (E171), propylene glycol, hydroxypropylcellulose, and talc.
Appearance of the product and package contents
Citalopram SUN 20 mg are white, circular, biconvex film-coated tablets with the inscription "20" in low relief on one side and a score line on the other side.
Citalopram SUN 20 mg is available in packages of 1, 14, 20, 28, 30, 50, 56, 98, 100, or 250 tablets.
Not all package sizes may be marketed.
Marketing authorization holder and manufacturer
Holder:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132 JH,
Hoofddorp,
Netherlands
Manufacturer:
Terapia S.A.
Str. Fabricii nr. 124,
Cluj, Napoca,
Romania
or
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132 JH,
Hoofddorp,
Netherlands
Local representative
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona.
Spain
Tel.:+34 342 78 90
This medication is authorized in the Member States of the European Economic Area under the following names
United Kingdom: Citalopram 20 mg Tablets
Austria: Zyloram 20 mg Filmtabletten
Czech Republic: Zyloram 20 mg Tablets
Germany: Citatopram Basics 20 mg Filmtabletten
Spain: Citalopram SUN 20 mg film-coated tablets EFG
Netherlands: Citalopram Ranbaxy 20 mg Tablets
This leaflet was approved in April 2025
The average price of CITALOPRAM SUN 20 mg FILM-COATED TABLETS in November, 2025 is around 2.56 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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