CITALOPRAM COMBIX 30 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Citalopram Combix 30 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Citalopram Combix is and what it is used for.
2. What you need to know before you take Citalopram Combix.
3. How to take Citalopram Combix.
4. Possible side effects.
5. Storing Citalopram Combix.
6. Contents of the pack and other information.

1. What Citalopram Combix is and what it is used for

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

Citalopram Combix is indicated for the treatment of:

• Depression and prevention of relapse.
• Anxiety disorder with or without agoraphobia.
• Obsessive-compulsive disorder (OCD).

2. What you need to know before you take Citalopram Combix

Do not take Citalopram Combix:

• if you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
• if you are taking other antidepressant medicines from the group of monoamine oxidase inhibitors (MAOIs) or if you have taken them in the last two weeks.
• if you have been born with any type of heart rhythm disorder or have ever had an 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 "Taking Citalopram Combix with other medicines" which is below.

Warnings and precautions

Consult your doctor before starting to take Citalopram Combix, especially if you have a history of bleeding disorders or if you are pregnant (see "Pregnancy, breastfeeding, and fertility").

Be careful with Citalopram Combix:

• if you have liver or severe kidney failure.
• if you have had manic episodes.
• if you have or have a history of epilepsy. If seizures develop or the frequency of attacks increases, 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 a bleeding disorder or are being treated with medications that affect blood coagulation.
• if you have or have had any heart problems or have recently had 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.

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 this period. Clinical experience indicates that the risk of self-aggression is maximum 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 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").

Children and adolescents under 18 years:

Citalopram Combix should not normally be used 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 taking this class of medications. Nevertheless, your doctor may prescribe Citalopram Combix to patients under 18 years when they decide it is most convenient for the patient. If your doctor has prescribed Citalopram Combix to a patient under 18 years and you want 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 Combix. At the same time, the long-term effects regarding safety and related to growth, maturity, and cognitive and behavioral development of Citalopram Combix in this age group have not yet been demonstrated.

Taking Citalopram Combix with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Do not take Citalopram Combix:

• If 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, such as antiarrhythmics class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medications, particularly halofantrine), certain antihistamines (e.g., astemizole, mizolastine). If you have doubts about this, consult your doctor.

The simultaneous administration of citalopram with non-selective or selective B monoamine oxidase inhibitors (MAOIs) (such as selegiline, an antiparkinsonian medication) is contraindicated, as well as during the two weeks following the end of treatment.

The simultaneous administration of citalopram with selective A monoamine oxidase inhibitors (MAOIs) (such as moclobemide, an antidepressant medication) is not recommended.

The simultaneous administration of citalopram with MAOIs carries a risk of serotonin syndrome (see section "Possible side effects").

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

• Carbamazepine (antiepileptic medication): may increase 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): increases the levels of imipramine's metabolite in the blood.
• Cimetidine (antiulcer medication) or fluconazole (antifungal medications): may increase citalopram levels in the blood.
• Metoprolol (antihypertensive, antianginal, and antiarrhythmic medication).
• Preparations containing St. John's Wort: may be more frequent adverse effects.

Taking Citalopram Combix with food, drinks, and alcohol

Citalopram Combix can be taken with or without food (see section 3 "How to take Citalopram Combix").

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

If you take Citalopram Combix in the final stage of pregnancy, there may be an increased risk of vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking Citalopram Combix to advise you.

Driving and using machines

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

Citalopram Combix contains lactose

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 Combix

Follow the instructions for administration of the medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Citalopram Combix. Do not stop 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 Combix is a tablet 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.

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.

Anxiety disorder

The 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 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.

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

Patient with special risks:

Patients with liver disease should not take more than 20 mg per day.

Patient with renal insufficiency:

The use of citalopram is not recommended in patients with severe renal insufficiency.

Use in children and adolescents

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

If you think the action of Citalopram Combix is too strong or too weak, tell your doctor or pharmacist.

If you take more Citalopram Combix than you should

If you have taken more Citalopram Combix than you should, consult your doctor or pharmacist immediately.

The most frequent symptoms in case of overdose are: nausea, vomiting, sweating, drowsiness, bluish discoloration of the skin, tremors, convulsions, loss of consciousness, and palpitations.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 5620420.

If you forget to take Citalopram Combix

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

Take your dose as soon as you remember and, the next day, take it at the corresponding time.

If you stop taking Citalopram Combix

If you stop taking Citalopram Combix abruptly, you may experience some disorders due to withdrawal, 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 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 Citalopram Combix.

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

4. Possible side effects

Like all medications, this medication 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 illness improves.

If you notice any of the following symptoms, stop taking Citalopram Combix and go to your doctor immediately:

• Fast and irregular heartbeats or feeling of fainting, as they could be symptoms of a serious heart problem known as torsades de pointes.

Additionally, the following side effects have been described:

• 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 disturbances: 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.
• Disorders of the reproductive system and breast: alterations in sexual desire.
• Renal and urinary disorders: alterations in urination.

Rarely, cases of bleeding in the skin and mucous membranes, such as purpura, vaginal hemorrhages, and gastrointestinal bleeding, have been observed.

Frequency not known:

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

If you consider that any of the side effects you suffer is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storing Citalopram Combix

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in 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.

6. Contents of the pack and other information

Composition of Citalopram Combix 30 mg film-coated tablets EFG

• The active ingredient is citalopram. Each tablet contains 37.47 mg of citalopram hydrobromide, equivalent to 30 mg of citalopram.
• The other ingredients (excipients) are:

microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, cornstarch, glycerol, copolyvidone, magnesium stearate, Sepifilm 752 white (hypromellose, microcrystalline cellulose, polyoxyethylene 40 stearate, titanium dioxide (E-171)).

Appearance of the product and packaging contents

film-coated tablets, oval, biconvex, white, and scored.

Packaging of 28 film-coated tablets.

Marketing authorization holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Industria Química y Farmacéutica VIR S.A.

C/ Laguna 66-70, P.I. URTINSA II, 28923 Alcorcón (Madrid)

Phone: 91 486 29 90

Date of the last revision of this leaflet:April 2022

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/