CITALOPRAM TARBIS 20 mg FILM-COATED TABLETS

2. What you need to know before taking Citalopram TARBIS

Do not take Citalopram TARBIS 20 mg:

-If you are allergic to citalopram or any of the other components of this medication (listed in section 6).

-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 any episode of this type (this is observed with an electrocardiogram, a test used to evaluate how the heart works).

-If you are taking medications because you have a disease that affects heart rhythm.

-If you are taking medications that may affect heart rhythm.

Also, consult the section "Taking Citalopram TARBIS with other medications" below.

Warnings and Precautions

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

• If you have liver or severe kidney problems.
• 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 any bleeding disorder or are being treated with medications that affect blood coagulation, or if you are pregnant (see "Pregnancy, Breastfeeding, and Fertility").

-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 TARBIS belongs (called ISRS/IRSN) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after treatment is discontinued.

It has been observed that there is an increased risk of bone fractures in patients treated with this type of medication.

Suicidal Thoughts and Worsening of Depression or Anxiety Disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of self-harm or suicide. These can increase when taking antidepressants for the first time, as all these medications require time to start taking effect, usually around two weeks, although in some cases it may take longer.

You are more likely to have these thoughts:

• If you have previously had thoughts of self-harm or suicide.
• If you are a young adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this package leaflet. You can ask them if they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behavior.

When treatment is discontinued, it is common for withdrawal symptoms to appear, particularly if the treatment is discontinued abruptly (see section "Possible Side Effects").

Use in Children and Adolescents Under 18 Years

Citalopram TARBIS 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 suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medications. Nevertheless, the doctor may prescribe Citalopram TARBIS 20 mg to patients under 18 years when they decide it is most convenient for the patient. If the doctor has prescribed Citalopram TARBIS 20 mg to a patient under 18 years and you want to discuss this decision, please go back 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 TARBIS 20 mg. Also, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Citalopram TARBIS 20 mg in this age group have not yet been demonstrated.

Taking Citalopram TARBIS with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Do not take Citalopram TARBIS:

If you are taking medications because you already have a disease that affects heart rhythm or if you are taking medications that may affect 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.

The simultaneous administration of citalopram 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 is contraindicated.

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 "Possible Side Effects" section).

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, 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 adverse effects.

Taking Citalopram TARBIS with Food, Drinks, and Alcohol

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 TARBIS 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 TARBIS to advise you.

Make sure your midwife and/or doctor knows that you are taking Citalopram TARBIS. When taken during pregnancy, particularly in the last 3 months of pregnancy, medications like Citalopram TARBIS 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 within the first 24 hours after the baby is born. If this happens to your baby, contact your midwife and/or doctor immediately.

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

Driving and Using Machines

During treatment with Citalopram TARBIS, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with Citalopram TARBIS 20 mg affects you.

Citalopram TARBIS 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 TARBIS

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Citalopram TARBIS. Do not discontinue treatment before or abruptly, as it may 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 TARBIS 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.

The recommended dose is:

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 usual 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 TARBIS 20 mg have not been established in children and adolescents under 18 years, so its use is not recommended in this population.

If you think the effect of Citalopram TARBIS 20 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Citalopram TARBIS than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

If you forget to take Citalopram TARBIS

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

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

If you interrupt treatment with Citalopram TARBIS

If treatment with Citalopram TARBIS 20 mg 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, but in some patients, they can be severe. Usually, 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 medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience 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 reported. If you notice any of the following symptoms, stop taking Citalopram TARBIS and consult 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.
• Dermatological Disorders: rash, itching, increased sweating.
• Visual Disorders: adaptation disorders.
• Metabolic Disorders: weight loss or gain.
• Cardiovascular Disorders: rapid 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: alterations in sexual desire, abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, Breastfeeding, and Fertility" in section 2 for more information (frequency not known).
• Renal and Urinary Disorders: alterations in urination.

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

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 is not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications, Website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Citalopram TARBIS

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

No special storage conditions are required.

Expiry Date

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Citalopram TARBIS 20 mg Tablets

• The active ingredient is citalopram (hydrobromide). Each tablet contains 20 mg of citalopram.

• The other ingredients (excipients) are: corn starch, lactose monohydrate, sodium croscarmellose, glycerol, copovidone, magnesium stearate, microcrystalline cellulose, hypromellose 5, macrogol 400, and titanium dioxide (E-171).

Appearance of the Product and Package Contents

Citalopram TARBIS 20 mg are film-coated tablets, white, oval, biconvex, and scored. They are available in packs of 14, 28, 56, and 500 (clinical pack) tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

TARBIS FARMA, S.L.

Gran vía Carlos III, 94

08028 – Barcelona

Spain

Manufacturer

Toll Manufacturing Services, S.L.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of Last Revision of this Leaflet: December 2020

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