Package Leaflet: Information for the Patient

Citalopram Normon 30 mg Film-Coated Tablets EFG

Citalopram (hydrobromide)

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

• Keep this leaflet, as 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. Do not pass it on to others even if they have the same symptoms as you, as 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.

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

2. What you need to know before you start taking Citalopram Normon

3. How to take Citalopram Normon

4. Possible side effects

5. Storage of Citalopram Normon

6. Contents of the pack and additional information

Citalopram is an antidepressant medication that belongs to a group of medications called “selective serotonin reuptake inhibitors”.

Citalopram Normon is indicated for:

-Treatment of depression and prevention of relapses.

-Treatment of anxiety disorder with or without agoraphobia.

-Treatment of obsessive-compulsive disorder.

Do not take Citalopram Normon

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

-If you are being treated with other antidepressant medications in the group of monoamine oxidase inhibitors (MAOIs) or if you have been treated with such medications in the past two weeks.

-If you have any type of heart rhythm disorder since birth or have ever experienced such an episode (this can be observed with an electrocardiogram, a test that evaluates how the heart functions).

-If you are taking medications for any disease that affects the heart rhythm.

-If you are taking medications that can affect the heart rhythm.

Also see the section “Use of other medications” below.

Warnings and precautions

-If you have severe liver or kidney failure.

-If you have had manic episodes.

-If you have epilepsy or have a history of it. In case of seizures or an increase in seizure frequency, the treatment with citalopram should be discontinued.

-If you have diabetes, as you may need to adjust your insulin or oral antidiabetic medication dosage.

-If you have any bleeding disorder or are being treated with medications that affect blood clotting, or if you are pregnant (see section “Pregnancy, breastfeeding, and fertility”).

-If you have or have had any heart problems or have recently had a heart attack.

-If, when at rest, your heart beats slowly (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 rapid or irregular or have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate a heart rhythm disorder.

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

You would be more prone to having these types of thoughts:

• If you previously had thoughts of self-harm or suicide.
• If you are a young adult. Clinical trial information has shown an increase in the risk of suicidal behavior in young adults (under 25 years old) with psychiatric disorders treated with an antidepressant.

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

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

There has been an observed increase in the risk of bone fractures in patients treated with this type of medication.

Some medications in the group to which Citalopram Normon belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after discontinuing treatment.

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

Children and adolescents

Citalopram Normon should not be used for the treatment of children and adolescents under 18 years old. However, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal thoughts, suicidal ideation, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes Citalopram Normon may decide that it is the best option for the patient. If your doctor has prescribed Citalopram Normon to a patient under 18 years old and wants to discuss this decision, please return 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 old are taking Citalopram Normon. Additionally, the long-term effects of Citalopram Normon on the safety of growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Other medications and Citalopram Normon

Inform your doctor or pharmacist that you are using, have used recently, or may need to use any other medication.

Citalopram Normon is contraindicated when administered simultaneously with non-selective or selective B monoamine oxidase inhibitors (MAOIs) (such as selegiline, an antiparkinsonian medication) or 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). 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 cause an increase in carbamazepine levels in the blood, and it may be necessary to reduce the carbamazepine dosage.

-Lithium (medication for the treatment of manic-depressive disorder): increases the risk of serotonin syndrome.

-Oral anticoagulants, aspirin, and non-steroidal anti-inflammatory drugs, and other medications that affect blood clotting: may increase the risk of bleeding.

-Imipramine (antidepressant): may cause an increase in the levels of imipramine 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 (anti-hypertensive, anti-anginal, and anti-arrhythmic medication).

-Preparations containing St. John's Wort: may cause more frequent side effects.

Do not take Citalopram Normon if you are taking medications because you already have a disease that affects the heart rhythm or if you are taking medications that could affect the heart rhythm, for example, anti-arrhythmic class IA and III, antipsychotics (e.g., derivatives of phenothiazine, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medications against malaria, particularly halofantrine), certain antihistamines (astemizol, mizolastine). If you are unsure about this, consult your doctor.

Taking Citalopram Normon with food, drinks, and alcohol

It is recommended 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.

Make sure your midwife and/or doctor know that you are taking Citalopram Normon. When taken during pregnancy, particularly in the last three months of pregnancy, medications like Citalopram Normon 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.

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

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.

Driving and operating machines

During treatment with citalopram, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how citalopram affects you.

Citalopram Normon contains lactose and sodium

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.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. 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 Normon. Do not stop treatment before or abruptly, as this could worsen your condition. You must continue taking your medication even if you do not notice improvement, as several weeks may be needed for the medication to start acting.

Citalopram Normon 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 not chewed.

What amount should you 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.

Anxiety disorder (panic):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.

Older adults (over 65 years):In older adults, treatment should be initiated with half the recommended dose, for example 10-20 mg per day. In general, older adults should not take more than 20 mg per day.

Use in children and adolescents

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

Patients with special risks

Patients with liver disease should not take more than 20 mg per day. Citalopram is not recommended for use in patients with severe renal insufficiency.

If you estimate that the action of Citalopram Normon is too strong or too weak, inform your doctor or pharmacist.

If you take more Citalopram Normon than you should

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

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

If you forgot to take Citalopram Normon

Do not take a double dose to compensate for the missed doses. Take your doses as soon as you remember and, the next day, take it at the usual time.

If you interrupt treatment with Citalopram Normon

If treatment with Citalopram Normon is stopped abruptly, some withdrawal symptoms 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. These symptoms are usually mild or moderate, but 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 Normon.

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

Like all medications, Citalopram Normon can produce adverse effects, although not everyone will experience them.

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

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

-Fast and irregular heartbeats or a feeling of dizziness, as they may be symptoms of a serious heart condition known as torsade de pointes.

The following adverse effects have been described:

Neuropsychiatric Disorders:nervousness, drowsiness, weakness, headaches, dizziness, sleep disorders, memory loss, suicidal tendencies, and a serotonin syndrome characterized by symptoms such as agitation, confusion, increased sweating, hallucinations, increased reflex response, involuntary movements, chills, tachycardia, and tremors, psychomotor agitation/akathisia (characterized by restlessness and a need to be in motion, often accompanied by difficulty sitting or remaining at rest. Its appearance is more likely during the first weeks of treatment).

Gastrointestinal Disorders: nausea, vomiting, diarrhea, constipation, dry mouth.

Dermatological Disorders:eruptions, itching, increased sweating.

Visual Disorders:visual disorders.

Metabolic Disorders: weight loss or gain.

Cardiovascular Disorders: tachycardia, dizziness when standing due to a drop in blood pressure, slowing of heart rate in some patients.

Reproductive and Mammary System Disorders:alterations in sexual desire.

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.

Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information. (Unknown frequency).

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

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

No special storage conditions are required. Store in the original packaging.

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 drains or in the trash. Dispose of the packaging and medications you no longer need at the Sigre collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Citalopram Normon Composition

The active ingredient is citalopram (hydrobromide). Each film-coated tablet contains 30 mg of citalopram.

The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, titanium dioxide (E-171), hypromellose, talc, and macrogol 6000.

Appearance of the product and contents of the packaging

Citalopram Normon 30 mg are film-coated tablets. The film-coated tablets are white or almost white, elongated, biconvex, and scored on one side. They are presented in blisters of PVC/Aluminum containing 28 or 56 film-coated tablets.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos – Madrid (SPAIN)

Date of the last review of this leaflet:August 2021

“Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es”