CITALOPRAM NORMON 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Citalopram Normon 20 mg Film-Coated Tablets EFG

Citalopram (Hydrobromide)

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

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

Citalopram is an antidepressant medicine that belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs).

Citalopram Normon 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 Normon

Do not take Citalopram Normon

• 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 treated with MAOIs in the last two weeks.
• If you have been born with any heart rhythm disorder or have ever had any episode of this type (this can be seen on an electrocardiogram, a test used to evaluate how the heart works).
• If you are taking medicines because you have a disease that affects the heart rhythm.
• If you are taking medicines that can affect the heart rhythm.

Also, consult the section "Use of other medicines" below.

Warnings and precautions

• 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 occur 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 medicines 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 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 (medicines to urinate).
• If you have noticed that your heart beats quickly or irregularly 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.
• Suicidal thoughts and worsening of your 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 medicines require time to start working, usually around two weeks, although in some cases it may take longer.

You would be 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 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.

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

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

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

Citalopram Normon should not normally be used in the treatment of children and adolescents under 18 years of age. At the same time, you should know that in patients under 18 years of age, there is a greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this class of medicines. Nevertheless, the doctor who corresponds to you may prescribe Citalopram Normon to patients under 18 years of age when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed Citalopram Normon to a patient under 18 years of age 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 of age are taking Citalopram Normon. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of Citalopram Normon in this age group have not yet been demonstrated.

Other medicines and Citalopram Normon

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

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 levels in the blood, 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 clotting: may increase the risk of bleeding.
• Imipramine (antidepressant): causes an increase in 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 stroke). May increase citalopram levels in the blood.
• Metoprolol (antihypertensive, anti-anginal, and anti-arrhythmic medicine).
• Preparations containing St. John's Wort: may be more frequent adverse effects.

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

Taking Citalopram Normon with food, drinks, and alcohol

It is advisable to avoid consuming alcohol 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.

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

Driving and using machines

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

Citalopram Normon contains lactose and sodium

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

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Citalopram Normon

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 Normon. Do not stop treatment before or abruptly, as this 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 Normon 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.

How much to 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.

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.

Use in children and adolescents

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

Patient with special risks

Patient with liver disease should not take more than 20 mg per day. The use of citalopram is not recommended in patients with severe kidney failure.

If you think the action of Citalopram Normon is too strong or too weak, tell 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 medicine and the amount ingested.

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

If you forget to take Citalopram Normon

Do not take a double dose to make up for forgotten doses. Take your doses as soon as you remember and, the next day, take it at the corresponding time.

If you stop taking Citalopram Normon

If treatment with Citalopram Normon 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 feeling 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 serious. 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 Citalopram Normon.

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 Normon 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.

If you notice any of the following symptoms, stop taking Citalopram Normon 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.

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:visual disturbances.

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.

Reproductive system and breast disorders: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 bleeding, and gastrointestinal bleeding, have been observed.

Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, breastfeeding, and fertility" in section 2 for more information. (Frequency not known).

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

5. Storage of Citalopram Normon

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

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

Do not use this medicine after the expiration date that appears on the packaging after CAD. The expiration 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 that you no longer need in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This way, you will help protect the environment.

6. Packaging Content and Additional Information

Composition of Citalopram Normon

The active ingredient is citalopram (hydrobromide). Each film-coated tablet contains 20 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 Packaging Content

Citalopram Normon 20 mg are film-coated tablets. The film-coated tablets are white or almost white, round, biconvex, and scored on one side. They are available in packs of 14, 28, or 56 film-coated tablets in PVC/Aluminum blister packs and 500 tablets (clinical packaging) in PVC/Aluminum blister packs.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the Last Revision of this Leaflet:August 2021

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