CITALOPRAM ALTER 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Citalopram Alter 20 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.

Contents of the pack

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

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

Citalopram Alter is an antidepressant medicine that belongs to a group of medicines called “selective serotonin reuptake inhibitors”.

Citalopram Alter is indicated for:

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

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

Do not take Citalopram Alter:

• If you are allergic to citalopram or any of the other ingredients of this medicine (listed in section 6).
• If you are being treated with other antidepressant medicines of 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 any episode of this type (this is observed with the electrocardiogram, a test that serves to evaluate how the heart works).
• If you are taking medicines because you have a disease that alters the heart rhythm.
• If you are taking medicines that may affect the heart rhythm.

Also, consult the section on “Interaction of Citalopram Alter with other medicines” which is found below.

Warnings and precautions:

Consult your doctor or pharmacist before starting to take Citalopram Alter.

Some medicines of the group to which Citalopram Alter belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is stopped.

Tell your doctor:

• 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 interrupted.
• 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 medicines that affect blood coagulation, or if you are pregnant (see “Pregnancy and lactation”).
• 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 having salt losses, for example, because you have had intense diarrhea and vomiting for several days or because you have used diuretics (medicines to urinate).
• If you have noticed that your heartbeats are fast or irregular or have suffered faints or dizziness 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-harm, 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-harm is greatest at the start 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-harm. 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.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Animal studies have shown that citalopram reduces sperm quality. Theoretically, this could affect fertility, but the impact on human fertility has not been observed so far.

When treatment is stopped, it is common for withdrawal symptoms to appear, particularly if treatment is stopped abruptly (see section “Possible side effects”).

Children and adolescents under 18 years

Citalopram Alter 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 medicines. Despite this, the doctor may prescribe Citalopram Alter to patients under 18 years when they decide it is most convenient for the patient. If the doctor has prescribed Citalopram Alter 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 Alter. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Citalopram Alter in this age group have not yet been demonstrated.

Interaction of Citalopram Alter with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Do not take Citalopram Alter:

If you are taking medicines because you already have a disease that alters the heart rhythm or if you are taking medicines that may affect the heart rhythm, such as antiarrhythmics class IA and III, antipsychotics (examples derived from phenothiazine, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines, particularly halofantrine), certain antihistamines (astemizole, mizolastine).

If you have 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) and during the two weeks following the end of treatment is contraindicated.

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

Concomitant 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 medicines:

• Carbamazepine (antiepileptic medicine): may cause an increase in carbamazepine blood levels, and it may be necessary to reduce the dose of carbamazepine.
• Lithium (medicine for the treatment of manic-depressive disorder): increases the risk of serotonin syndrome.
• Oral anticoagulants, acetylsalicylic acid, and non-steroidal anti-inflammatory medicines, and other medicines that affect blood coagulation: may increase the risk of bleeding.
• Imipramine (antidepressant): causes an increase in imipramine metabolite blood levels.
• Cimetidine (antiulcer medicine), lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). May increase citalopram blood levels.
• Metoprolol (antihypertensive, antianginal, and antiarrhythmic medicine).
• Preparations containing St. John's Wort: may be more frequent adverse effects.

Citalopram Alter with food, drinks, and alcohol

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

Pregnancy and lactation

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

Make sure your midwife and/or doctor knows that you are taking Citalopram Alter.

When taken during pregnancy, particularly in the last three months of pregnancy, medicines like Citalopram Alter may increase the risk of a serious disease in newborns called persistent pulmonary hypertension of the newborn (PPHN), which makes the baby breathe faster and turn blue. These symptoms usually start during the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take Citalopram Alter 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 to advise you.

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

Driving and using machines

During treatment with Citalopram Alter, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how the treatment with Citalopram Alter affects you.

Citalopram Alter contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Citalopram Alter

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Citalopram Alter. Do not stop treatment before or abruptly, as it may worsen your disease.

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

Citalopram Alter 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 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.

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.

Patients with special risks

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

Patients with renal insufficiency

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

Children

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

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

If you take more Citalopram Alter than you should

If you have taken more Citalopram Alter than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone: 91 5620420, indicating the medicine and the amount taken.

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

If you forget to take Citalopram Alter

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

In case of forgetting a dose, wait for the next one.

If you stop treatment with Citalopram Alter

If treatment with Citalopram is stopped 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 stop treatment with this medicine.

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

4. Possible side effects

Like all medicines, Citalopram Alter can cause side effects, although not everybody 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.

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 movement, 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: fast and irregular heartbeats or a feeling of fainting, as they could be symptoms of a serious heart problem known as torsades de pointes, tachycardia, dizziness when standing up due to a drop in blood pressure, slowing of the heart rate in some patients.
• Reproductive system and breast disorders: sexual desire disorders.
• Renal and urinary disorders: urination disorders.
• 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 bleeding, and gastrointestinal bleeding, have been observed.

With an unknown frequency, postpartum hemorrhage (abundant vaginal bleeding shortly after delivery) has been reported (see “Pregnancy and lactation” in section 2 for more information).

Reporting of side effects

If you experience any side effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Citalopram Alter

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date that appears on the packaging, after the abbreviation CAD. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and medicines you no longer need in the SIGRE collection point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Container Content and Additional Information

Composition of Citalopram Alter 20 mg

• The active ingredient is citalopram (hydrobromide). Each tablet contains 20 mg of citalopram.
• The other components (excipients) are: lactose monohydrate, gluten-free corn starch, microcrystalline cellulose, copovidone, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide, and glycerol triacetate.

Product Appearance and Container Content

Citalopram Alter 20 mg are film-coated tablets. The tablets are white, round, coated, and lenticular. They are available in packs of 28 or 56 tablets.

Other Presentations:

Citalopram Alter 30 mg film-coated tablets EFG

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

The last revision of this leaflet was in January 2021

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/