CITALOPRAM KERN PHARMA 20 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Citalopram KERN PHARMA 20 mg film-coated tablets EFG

Citalopram

Contents of the pack:

1. What Citalopram KERN PHARMA 20 mg is and what it is used for
2. Before you take Citalopram KERN PHARMA 20 mg
3. How to take Citalopram KERN PHARMA 20 mg
4. Possible side effects
5. Storage of Citalopram KERN PHARMA 20 mg
6. Further information

1. What Citalopram Kern Pharma 20 mg is and what it is used for

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

Citalopram Kern Pharma 20 mg is indicated for:

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

2. Before you take Citalopram Kern Pharma 20 mg

Do not take Citalopram Kern Pharma 20 mg

• If you are allergic to citalopram or any of the other ingredients of this medicine.
• 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 been born with any type of heart rhythm disorder or have ever suffered from any episode of this type (this is observed with an electrocardiogram, a test that serves to evaluate how the heart works).
• If you are taking medications because you have a disease that alters the heart rhythm.
• If you are taking medications that may affect the heart rhythm.

Also, consult the section "Use of other medications" which is located further down.

Be careful with Citalopram Kern Pharma 20 mg

• If you have liver or severe kidney failure.
• If you have had manic episodes.
• If you have or have a history of epilepsy. In case of developing seizures or increasing the frequency of attacks, treatment with citalopram should be discontinued.
• If you have diabetes, as you may need to adjust the dose of insulin or oral antidiabetics.
• If you have any bleeding disorder or are being treated with medications that affect blood coagulation, or if you are pregnant (see "Pregnancy").
• If you have or have had any heart problems or have recently suffered a heart attack.
• If your heart beats slowly when you are at rest (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 fast 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 from the group to which Citalopram Kern Pharma belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

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 must be closely monitored during this period. Clinical experience indicates that the risk of self-aggression is maximum at the beginning of the depressive process and that it 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 the start of treatment have a higher risk of suicidal ideation or suicide attempt during treatment.

When treatment is discontinued, it is common for withdrawal symptoms to appear, particularly if treatment is discontinued abruptly (see section "POSSIBLE SIDE EFFECTS").

Use of other medications

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

It is contraindicated to administer citalopram simultaneously with non-selective or selective B monoamine oxidase inhibitors (MAOIs) (such as selegiline, an antiparkinsonian medication) and during the two weeks following the end of treatment.

It is not recommended to administer citalopram simultaneously with selective A monoamine oxidase inhibitors (MAOIs) (such as moclobemide, an antidepressant medication).

Simultaneous administration of citalopram with MAOIs involves a risk of serotonin syndrome (see section "POSSIBLE SIDE EFFECTS").

Do not take Citalopram Kern Pharma 20 mgif you are taking medications because you already have a disease that alters the heart rhythm or if you are taking medications that may affect the heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medications, particularly halofantrine), certain antihistamines (astemizole, 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, and it may be necessary to reduce the dose of carbamazepine.
• Lithium (medication for the treatment of manic-depressive disorder): increases the risk of serotonin syndrome.
• Oral anticoagulants, acetylsalicylic acid, and non-steroidal anti-inflammatory medications, and other medications that affect blood coagulation: may increase the risk of bleeding.
• Imipramine (antidepressant medication): causes an increase in the levels of imipramine's 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 (antihypertensive, antianginal, and antiarrhythmic medication).
• Preparations containing St. John's Wort: may be more frequent side effects.

Taking Citalopram Kern Pharma 20 mg with food and drinks

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using a medication.

The use of citalopram is not recommended during pregnancy and breastfeeding.

Pregnancy1

If you take Citalopram Kern Pharma in the final stage of pregnancy, there may be a higher risk of abundant 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 advise you.

Use in children and adolescents under 18 years

Citalopram Kern Pharma 20 mg should not be used normally in the treatment of children and adolescents under 18 years. At the same time, you should know that in patients under 18 years, there is a higher risk of adverse effects such as suicide attempts, suicidal ideas, and hostility (predominantly aggression, confrontational behavior, and irritation) when ingesting this class of medications. Nevertheless, the doctor may prescribe Citalopram Kern Pharma 20 mg to patients under 18 years when deemed convenient for the patient. If the doctor has prescribed Citalopram Kern Pharma 20 mg to a patient under 18 years and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms mentioned above progress or experience complications when patients under 18 years are taking Citalopram Kern Pharma 20 mg. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Citalopram Kern Pharma 20 mg in this age group have not yet been demonstrated.

Driving and using machines

Like other psychotropic medications, citalopram may cause drowsiness and, consequently, decrease the ability to drive vehicles and use machines.

Important information about some of the components of Citalopram Kern Pharma 20 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 them before taking this medication.

3. How to take Citalopram Kern Pharma 20 mg

Follow exactly the administration instructions of Citalopram Kern Pharma 20 mg indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Your doctor will indicate the duration of your treatment with Citalopram Kern Pharma 20 mg.

Do not discontinue treatment before or abruptly, as it may worsen your illness.

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

Citalopram Kern Pharma 20 mg are tablets for oral administration. The tablets can be taken at any time of the day, regardless of meals, and in a single dose.

They should be swallowed with a sufficient amount of liquid (a glass of water) and without chewing.

How much to 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 recommended initial dose is 10 mg per day during 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 recommended initial dose is 20 mg per day. If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Elderly patients (over 65 years)

In elderly patients, treatment should be started with half the recommended dose, for example, 10-20 mg per day.

Generally, elderly patients should not take more than 20 mg per day.

Children

The safety and efficacy of Citalopram Kern Pharma 20 mg have not been established in children and adolescents under 18 years, so its use is not recommended in this population.

Patient with liver failure

Should not exceed the dose of 20 mg per day.

Patient with kidney failure

The use of citalopram is not recommended in patients with severe kidney failure.

If you think the action of Citalopram Kern Pharma 20 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Citalopram Kern Pharma 20 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 frequent symptoms in case of overdose are: fatigue, dizziness, tremors of the hands, nausea, drowsiness.

If you forget to take Citalopram Kern Pharma 20 mg

Do not take a double dose to make up for forgotten doses.

If you interrupt treatment with Citalopram Kern Pharma 20 mg

If treatment with citalopram is discontinued abruptly, some disorders due to withdrawal 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; however, in some patients, they may 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 questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Citalopram Kern Pharma 20 mg can cause side effects, although not everyone gets them.

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

If you notice any of the following symptoms, stop taking Citalopram Kern Pharma 20 mg and go to your doctor immediately:

• Neuropsychiatric disorders: nervousness, drowsiness, weakness, headaches, dizziness, sleep disturbances, memory loss, suicidal tendency, and serotonin syndrome (characterized by symptoms such as agitation, confusion, increased sweating, hallucinations, increased reflex response, involuntary movements, chills, tachycardia, and tremor), psychomotor agitation/akathisia (characterized by restlessness and a need to be in motion, often accompanied by difficulty sitting or staying still. Its appearance is more likely during the first weeks of treatment).
• Gastrointestinal disorders: nausea, vomiting, diarrhea, constipation, dry mouth.
• Skin disorders: rash, itching, increased sweating.
• Visual disorders: adaptation disorders.
• Metabolic disorders: weight loss or gain.
• Cardiovascular disorders: tachycardia, dizziness when standing up due to a drop in blood pressure, slowing of the heart rate in some patients. Fast and irregular heartbeats or a feeling of fainting, as they could be symptoms of a serious heart problem known as torsades de pointes.
• Reproductive system 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 bleeding in the skin and mucous membranes, such as skin hemorrhages, vaginal hemorrhages, and gastrointestinal bleeding, have been observed.

Frequency not known

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

5. Storage of Citalopram Kern Pharma 20 mg

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use Citalopram Kern Pharma 20 mg after the expiration date that appears on the packaging after "Expiration". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your doctor or pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Further information

Composition of Citalopram Kern Pharma 20 mg tablets

• The active ingredient is citalopram (hydrobromide). Each tablet contains 20 mg of citalopram.
• The other ingredients are cornstarch without gluten, lactose monohydrate, povidone, glycerol (E-422), microcrystalline cellulose (E-460i), magnesium stearate (E-470b), sodium starch glycolate, hydroxypropyl methylcellulose (E-464), titanium dioxide (E-171), polyethylene glycol 6000, talc.

Appearance of the product and packaging content

Citalopram Kern Pharma 20 mg are film-coated tablets, white, round, biconvex, and scored on one side. They are presented in blisters, in packages of 14, 28, and 56 tablets.

Other presentations:

Citalopram Kern Pharma 30 mg film-coated tablets EFG.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Spain

This leaflet was revised in January 2021