PATIENT INFORMATION LEAFLET

Citalopram KERN PHARMA 30 mg Film-Coated Tablets

Citalopram

1. What Citalopram KERN PHARMA 30 mg is and what it is used for

2. Before taking Citalopram KERN PHARMA 30 mg

3. How to take Citalopram KERN PHARMA 30 mg

4. Possible side effects

5. Storage of Citalopram KERN PHARMA 30 mg

6. Further information

Citalopram is an antidepressant medication that belongs to the group of "selective serotonin reuptake inhibitors".

Citalopram Kern Pharma 30 mg is indicated for:

• Treatment of depression and prevention of relapses.
• Treatment of anxiety disorder with or without agoraphobia.
• Treatment of obsessive-compulsive disorder.

Do not take Citalopram Kern Pharma 30 mg

• If you are allergic to citalopram or any of the excipients of the medication.
• If you are being treated with other antidepressant medications from the group of monoamine oxidase inhibitors (MAOIs) or if you have been under such treatment in the last two weeks.
• If you have any type of heart rhythm disorder since birth or have ever experienced such an episode (this is observed with an electrocardiogram, a test that evaluates how the heart functions).
• If you are taking medications for a disease that alters the heart rhythm.
• If you are taking medications that can affect the heart rhythm.

Also see the section “Use of other medications” located below.

Be especially careful with Citalopram Kern Pharma 30 mg

• If you have severe liver or kidney insufficiency.
• If you have had manic episodes.
• If you have epilepsy or have a history of it. In case of developing seizures or increasing the frequency of attacks, the treatment with citalopram should be interrupted.
• If you have diabetes, as you may need to adjust the dose of insulin or oral antidiabetic medications.
• If you have any bleeding disorder or are being treated with medications that affect blood coagulation, or if you are pregnant (see “Pregnancy” 1).
• If you have or have had any heart problems or have recently had a heart attack.
• If, when at rest, your heart beats slowly (this is known as bradycardia) and/or you think your body may be losing salt, for example, because you have had intense diarrhea and vomiting for several days or because you have used diuretics (medications to urinate).
• If you have noticed that your heartbeats are rapid or irregular or have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have some heart rhythm disorder.

Some medications in the group to which Citalopram Kern Pharma belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuing treatment.

Depression is associated with an increased risk of suicidal ideation, self-aggression, and suicide. This risk persists until significant improvement is achieved. Since such improvement may not be achieved during the first weeks or more of treatment, patients should be closely monitored during that period. Clinical experience indicates that the risk of self-aggression is highest at the beginning of the depressive process and may increase again when the clinical picture begins to improve..Additionally, antidepressants may, rarely, increase the risk of suicidal ideation and self-aggression. Patients with a history of suicidal behavior and those who present a significant degree of suicidal ideation prior to starting treatment have a higher risk of suicidal ideation or attempted suicide during treatment.

When treatment is discontinued, withdrawal symptoms are common, particularly if treatment is discontinued abruptly (see section “POSSIBLE ADVERSE EFFECTS”).

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Concomitant administration of citalopram with non-selective or selective B monoamine oxidase inhibitors (MAOIs) is contraindicated, as well as during the two weeks following the end of treatment.

Simultaneous administration of citalopram with selective A monoamine oxidase inhibitors (MAOIs) is not recommended.

Concomitant administration of citalopram with MAOIs carries a risk of serotonin syndrome (see section “POSSIBLE ADVERSE EFFECTS”).

Do not take Citalopram Kern Pharma 30 mgif you are taking medications because you already have a disease that alters the heart rhythm or if you are taking medications that could affect the heart rhythm, for example, antiarrhythmic class IA and III, antipsychotics (e.g., derivatives of phenothiazine, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizol, mizolastine).

If you have doubts about this, consult your doctor.

Precautions should be taken if citalopram is administered with any of the following medications:

• Carbamazepine (antiepileptic medication): may cause an increase in carbamazepine levels in the blood, requiring a reduction in carbamazepine dose.
• Lithium (medication for the treatment of manic-depressive disorder): increases the risk of serotonin syndrome.
• Oral anticoagulants, acetylsalicylic acid, and nonsteroidal anti-inflammatory drugs, and other medications that affect blood coagulation: may increase the risk of bleeding.
• Imipramine (antidepressant medication): causes an increase in the levels of imipramine metabolite in the blood.
• 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 cerebrovascular accidents). May increase citalopram levels in the blood.
• Metoprolol (anti-hypertensive, anti-anginal, and anti-arrhythmic medication).
• Preparations containing St. John's Wort: may increase the frequency of adverse effects.

Take Citalopram Kern Pharma 30 mg with food and beverages

It is recommended to avoid consuming alcohol while taking this medication.

Pregnancy and lactation

Consult your doctor or pharmacist before using a medication.

Citalopram is not recommended for use during pregnancy and lactation.

Pregnancy1

If you take Citalopram Kern Pharma in the final stages of pregnancy, there may be an increased risk of excessive 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 Kern Pharma to be able to advise you.

Use in children and adolescents under 18 years

Citalopram Kern Pharma 30 mg should not be used for the treatment of children and adolescents under 18 years. However, you should know that in patients under 18 years, there is a higher risk of adverse effects such as suicidal attempts, suicidal ideation, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. Nevertheless, the doctor who prescribes Citalopram Kern Pharma 30 mg may decide that it is the most suitable option for the patient. If the doctor who prescribes Citalopram Kern Pharma 30 mg to a patient under 18 years wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above progress or if you experience complications when patients under 18 years are taking Citalopram Kern Pharma 30 mg. Additionally, the long-term effects of Citalopram Kern Pharma 30 mg on the safety of this age group, including growth, maturity, and cognitive and behavioral development, have not yet been demonstrated.

Driving and operating machinery

Like other psychotropic medications, citalopram may cause drowsiness and, consequently, reduce the ability to drive vehicles and operate machinery.

Important information about some components of Citalopram Kern Pharma 30 mg

This medication does not contain gluten.

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for Citalopram Kern Pharma 30 mg as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will inform you of the duration of your treatment with Citalopram Kern Pharma 30 mg.

Do not discontinue treatment before or abruptly, as this could worsen your condition.

You must continue taking your medication even if you do not notice improvement, as it may take several weeks for the medication to start acting.

Citalopram Kern Pharma 30 mg are oral tablets for administration. The tablets can be taken at any time of the day, regardless of meals, and in a single dose.

They should be taken with a sufficient amount of liquid (a glass of water) and not chewed.

How much should you take

Adults

Depression

The usual dose is 20 mg per day. If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Panic disorder

The initial dose is 10 mg per day for the first week before increasing it to 20-30 mg per day.

If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Obsessive-compulsive disorder (OCD)

The initial dose is 20 mg per day. If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Older adults (65 years and older)

In older adults, treatment should be initiated with half the recommended dose, for example 10-20 mg per day.

Generally, older adults should not take more than 20 mg per day.

Children

The safety and efficacy of Citalopram Kern Pharma 30 mg have not been established in children and adolescents under 18 years, so it is not recommended for use in this population.

Patients with liver insufficiency

They should not exceed a dose of 20 mg per day.

Patients with renal insufficiency

Citalopram is not recommended for use in patients with severe renal insufficiency.

If you estimate that the action of Citalopram Kern Pharma 30 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Citalopram Kern Pharma 30 mg than you should

If you have taken more citalopram than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

The most common symptoms in case of overdose are: fatigue, dizziness, hand tremors, nausea, drowsiness.

If you forgot to take Citalopram Kern Pharma 30 mg

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Citalopram Kern Pharma 30 mg

If treatment with citalopram is discontinued abruptly, some withdrawal symptoms may occur, such as dizziness, nausea, sweating, sensory disturbances, sleep disturbances, headache, agitation or anxiety, and a sensation of tingling in the hands or feet. The risk of withdrawal reactions depends on several factors, including the duration of treatment, the dose used, and the rate of dose reduction. Generally, these symptoms are mild or moderate, but in some patients they can be severe. Normally, these symptoms are self-limiting and resolve within two weeks, although in some patients their duration may be prolonged.

Your doctor will advise you on how to gradually discontinue treatment with this medication.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Citalopram Kern Pharma 30 mg may produce adverse effects, although not everyone will experience them.

Adverse effects are generally of mild or moderate intensity. They will be evident during the first and even the first two weeks of treatment, and will subsequently disappear as the disease improves.

If you notice any of the following symptoms, stop taking Citalopram Kern Pharma 30 mg and consult your doctor immediately:

• Neuropsychiatric disorders : nervousness, drowsiness, weakness, headaches, dizziness, sleep disorders, memory loss, suicidal tendencies, and serotonin syndrome (characterized by symptoms such as agitation, confusion, increased sweating, hallucinations, increased reflex response, involuntary movements, chills, tachycardia, and tremors), psychomotor agitation/akathisia (characterized by restlessness and a need to be in motion, often accompanied by difficulty sitting or remaining at rest. Its appearance is more likely during the first weeks of treatment).
• Gastrointestinal disorders : nausea, vomiting, diarrhea, constipation, dry mouth.
• Dermatological disorders : rash, itching, increased sweating.
• Visual disorders : adaptation disorders.
• Metabolic disorders : weight loss or gain.
• Cardiovascular disorders : tachycardia, dizziness when standing due to a drop in blood pressure, slowing of heart rate in some patients. Rapid and irregular heartbeats or feeling of fainting, as they may be symptoms of a serious heart condition known as torsades de pointes.
• Reproductive and breast disorders : alterations in sexual desire.
• Renal and urinary disorders : alterations in urination.
• Hepatic disorders: exceptional cases of increased liver enzymes have been reported.

Rarely, cases of skin and mucous membrane bleeding, such as skin hemorrhages, vaginal bleeding, and gastrointestinal bleeding, have been observed.

Unknown frequency

• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

No requires special conditions for conservation.

Keep out of reach and sight of children.

Do not use Citalopram Kern Pharma 30 mg after the expiration date that appears on the packaging after “Expiration Date”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your doctor or pharmacist how to dispose of the packaging and medicines that you do not need. In this way, you will help protect the environment.

Citalopram Kern Pharma 30 mg Tablets Composition

• The active ingredient is citalopram (hydrobromide). Each tablet contains 30 mg of citalopram.
• The other components are cornstarch without gluten, lactose monohydrate, povidone (E-1201), glycerol (E-422), microcrystalline cellulose (E-460i), magnesium stearate (E-470b), sodium starch glycolate, hydroxypropylmethylcellulose (E-464), titanium dioxide (E-171), polyethylene glycol 6000, talc.

Product Appearance and Packaging Contents

Citalopram Kern Pharma 30 mg are film-coated, white, round, biconvex, and scored tablets on one face. They are presented in blisters, in packs of 28 and 56 tablets.

Other presentations:

Citalopram Kern Pharma 20 mg film-coated tablets EFG.

Marketing Authorization Holder and Responsible Manufacturer

Kern Pharma, S.L.

Colón II Industrial Estate

Venus, 72

08228 Terrassa (Barcelona)

Spain

This leaflet was revised in January 2021