Citalopram Combix 30 mg film-coated tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Citalopram Combix is and what it is used for.
2. What you need to know before taking Citalopram Combix.
3. How to take Citalopram Combix.
4. Possible side effects.
5. How to store 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 medicine that belongs to the group known as "selective serotonin reuptake inhibitors".

Citalopram Combix is indicated for the treatment of:

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

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

Do not take Citalopram Combix:

• if you are allergic to citalopram or to any of the other components of this medicine (listed in section 6).
• if you are taking other antidepressant medicines of the monoamine oxidase inhibitor (MAOI) group, or if you have been treated with such medicines within the last two weeks.
• if you have a congenital heart rhythm disorder or have ever experienced an episode of this type (this can be detected by electrocardiogram, a test used to assess how the heart is functioning).
• if you are taking medicines for a condition that affects your heart rhythm.
• if you are taking medicines that may affect your heart rhythm.

Also refer to the section "Taking Citalopram Combix with other medicines" below.

Warnings and precautions

Talk to 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").

Take special care with Citalopram Combix:

• if you have hepatic insufficiency or severe renal insufficiency.
• if you have experienced manic episodes.
• if you have epilepsy or a history of epilepsy. If seizures occur or the frequency of seizures increases, treatment with citalopram should be discontinued.
• if you have diabetes, as you may need an adjustment in your insulin or oral antidiabetic dosage.
• if you have a bleeding disorder or are being treated with medicines that affect blood coagulation.
• if you have heart problems or have recently had a heart attack.
• if your heart beats slowly at rest (known as bradycardia) and/or if you think your body may be losing salts, for example due to prolonged severe diarrhoea and vomiting or due to the use of diuretics (medicines to increase urine production).
• if you have noticed that your heartbeat is fast or irregular, or if you have experienced fainting or dizziness when standing up from a sitting or lying position. These symptoms may indicate a heart rhythm disorder.

Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide. This risk persists until significant improvement occurs. Since such improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored during this period. Clinical experience indicates that the risk of self-harm is highest at the beginning of the depressive episode and may increase again when clinical improvement begins. In addition, antidepressants may rarely increase the risk of suicidal thoughts and self-harm. Patients with a history of suicidal behaviour and those who have significant suicidal ideation before starting treatment are at greater risk of suicidal thoughts or suicide attempts during treatment.

When treatment is discontinued, withdrawal symptoms frequently occur, particularly if discontinuation is abrupt (see section "Possible side effects").

Children and adolescents under 18 years of age:

Citalopram Combix should not normally be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts and hostility (predominantly aggression, confrontational behaviour and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Citalopram Combix to patients under 18 years of age if they decide it is the most appropriate option for the patient. If your doctor has prescribed Citalopram Combix to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms mentioned above worsen or become complicated while patients under 18 years of age are taking Citalopram Combix. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of Citalopram Combix in this age group have not yet been established.

Taking Citalopram Combix with other medicines

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

Do not take Citalopram Combix:

• if you are taking medicines for a condition that affects your heart rhythm or if you are taking medicines that may affect your heart rhythm, for example class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials particularly halofantrine), certain antihistamines (astemizole, mizolastine). If you have any doubts about this, consult your doctor.

Concomitant administration of citalopram with non-selective or selective B monoamine oxidase inhibitors (MAOIs) (such as selegiline, an antiparkinsonian medicine) is contraindicated, as is administration during the two weeks following discontinuation of MAOI treatment.

Concomitant administration of citalopram with selective A MAOIs (such as moclobemide, an antidepressant medicine) is not recommended.

Concomitant administration of citalopram with MAOI medicines carries a risk of serotonin syndrome (see section "Possible side effects").

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

• Carbamazepine (antiepileptic medicine): blood levels of carbamazepine may increase, possibly requiring a reduction in carbamazepine dosage.
• Lithium (medicine for the treatment of bipolar disorder): increased risk of serotonin syndrome.
• Oral anticoagulants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), and other medicines affecting blood coagulation: increased risk of bleeding.
• Imipramine (antidepressant medicine): increased blood levels of the imipramine metabolite.
• Cimetidine (anti-ulcer medicine) or fluconazole (medicines for treating fungal infections): increased blood levels of citalopram may occur.
• Metoprolol (antihypertensive, antianginal and antiarrhythmic medicine).
• Preparations containing St. John's wort: adverse effects may be more frequent.

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 alcohol consumption while taking this medicine.

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 medicine.

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

If you take Citalopram Combix in the late stages 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 be aware that you are taking Citalopram Combix so they can advise you appropriately.

Driving and using machines

Like other psychotropic medicines, citalopram may cause drowsiness and, consequently, may impair the ability to drive vehicles or operate machinery.

Citalopram Combix contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Citalopram Combix

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will indicate the duration of your treatment with Citalopram Combix. Do not stop the treatment prematurely or abruptly, as this could worsen your condition.

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 are tablets for oral administration. The tablets can be taken at any time of day, regardless of meals, and in a single dose. They should be swallowed with sufficient liquid (a glass of water) and without chewing.

Adults:

Depression

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

Panic disorder

The initial dose is 10 mg daily for the first week before increasing it to 20–30 mg daily. If deemed necessary, your doctor may increase this dose up to a maximum of 40 mg daily.

Obsessive-compulsive disorder (OCD)

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

Elderly patients (over 65 years of age)

In elderly patients, treatment should be initiated at half the recommended dose, for example 10–20 mg daily.

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

Patients at special risk

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

Patients with renal impairment:

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

Use in children and adolescents

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

If you feel that the effect of Citalopram Combix is too strong or too weak, inform your doctor or pharmacist.

If you take more Citalopram Combix than you should

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

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

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 5620420.

If you forget to take Citalopram Combix

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

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

If you stop taking Citalopram Combix

If treatment with Citalopram Combix is stopped abruptly, withdrawal symptoms may occur, such as dizziness, nausea, sweating, sensory disturbances, sleep disturbances, headache, agitation or anxiety, and tingling sensations 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, although in some patients they may be severe. Usually, these symptoms are self-limiting and resolve within two weeks, although in some patients they may last longer.

Your doctor will advise you on how to gradually discontinue treatment with Citalopram Combix.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects are generally mild or moderate in intensity. They usually occur during the first, or even the first two, weeks of treatment and subsequently disappear as the condition improves.

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

• Rapid or irregular heartbeat or feeling faint, as these could be symptoms of a serious heart problem known as torsade de pointes.

In addition, the following adverse effects have been reported:

• Neuropsychiatric disorders: nervousness, drowsiness, weakness, headache, dizziness, sleep disorders, memory loss, suicidal ideation, and serotonin syndrome (characterized by symptoms such as agitation, confusion, increased sweating, hallucinations, increased reflex response, involuntary movements, chills, tachycardia, and tremor). Psychomotor agitation/acathisia (characterized by restlessness and an urge to move, frequently accompanied by difficulty sitting still or remaining at rest. This is more likely to occur during the first weeks of treatment).
• Gastrointestinal disorders: nausea, vomiting, diarrhea, constipation, dry mouth.
• Skin disorders: rash, itching, increased sweating.
• Visual disorders: disturbances in adaptation.
• Metabolic disorders: weight loss or weight gain.
• Cardiovascular disorders: tachycardia, dizziness upon standing due to a drop in blood pressure, slowed heart rate in some patients.
• Reproductive system and breast disorders: disturbances in sexual desire.
• Renal and urinary disorders: urinary disturbances.

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

Frequency not known:

• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage). See "Pregnancy, breastfeeding and fertility" in section 2 for more information.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citalopram Combix

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Citalopram Combix 30 mg film-coated tablets EFG

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

microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, corn starch, glycerol, copovidone, magnesium stearate, Sepifilm® 752 white (hypromellose, microcrystalline cellulose, polyethylene glycol 40 stearate, titanium dioxide (E-171)).

Appearance of the product and contents of the container

Oval, biconvex, white, film-coated tablets with a score line.

Pack sizes of 28 and 56 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)

Tel: 91 486 29 90

Date of the most recent review of this leaflet: April 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/