CITALOPRAM MABO 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Citalopram Mabo 10 mg film-coated tablets

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

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

Citalopram is a selective serotonin reuptake inhibitor (SSRI) and belongs to a group of medicines known as antidepressants.

These medicines help to correct certain chemical imbalances in the brain that cause the symptoms of your illness.

Citalopram is indicated for:

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

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

Do not take Citalopram Mabo

• 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). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine, used for the treatment of depression, and selegiline, used for the treatment of Parkinson's disease.
• if you have been born with any heart rhythm disorder or have had any episode of this type (this is observed with an electrocardiogram, a test that evaluates how the heart works).
• if you are taking medicines for any heart rhythm disorder.
• if you are taking medicines that may affect the heart rhythm.

Also, consult the section "Using Citalopram Mabo with other medicines" below.

Even if you have finished treatment with MAOIs, you will need to wait 2 weeks before starting treatment with this medicine.

A day must have passed since you took moclobemide.

After finishing citalopram, you must wait a week before taking any MAOI.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine.

Please inform your doctor if you have any other condition or disease, as your doctor may need to take it into consideration. In particular, inform your doctor:

• If you have manic episodes or anxiety disorders.

• if you have liver or kidney failure, you may need to adjust the dose.
• If you have diabetes. Treatment with citalopram may alter glucose control. You may need an adjustment of the dose of insulin and/or oral hypoglycemic agents.
• If you have epilepsy. Treatment with citalopram should be discontinued if seizures occur or if there is an increase in the frequency of seizures (see also section 4 "Possible side effects").
• If you have bleeding disorders or if you develop unusual bruises, or if you are pregnant (see section "Pregnancy, breastfeeding, and fertility").
• If you have a low sodium level in the blood.
• If you are receiving electroconvulsive therapy.
• 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 if you have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have some heart rhythm disorder.

• If you have had eye problems before, such as certain types of glaucoma (increased pressure in the eye).

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Some patients with manic-depressive illness may enter a manic phase. This is characterized by a change of ideas that is uncommon and rapid, disproportionate joy, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing still (akathisia) may also occur during the first weeks of treatment. Inform your doctor immediately if you experience these symptoms.

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

Special information related to your illness

Like other medicines used to treat depression or related illnesses, improvement is not achieved immediately. After starting treatment with citalopram, it may take several weeks before you experience any improvement.

In the treatment of anxiety disorders, it usually takes 2-4 weeks before any improvement is observed.

At the start of treatment, some patients may experience an increase in anxiety, which will disappear with continued treatment. Therefore, it is very important that you follow your doctor's instructions exactly and do not interrupt treatment or change the dose without consulting your doctor.

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 harming or killing yourself. These may increase when you first start taking antidepressants, as these medicines take time to start working, usually around two weeks, although in some cases it may be longer.

You would be more likely to have these thoughts:

• If you have previously had thoughts of killing or harming yourself.

• 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 harming or killing yourself, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a relative or close friendthat 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 attitude.

Children and adolescents

This medicine 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 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 this medicine to patients under 18 years when they decide it is most convenient for the patient. If the doctor who corresponds to you has prescribed this medicine to a patient under 18 years and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years are taking this medicine. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of this medicine in this age group have not yet been demonstrated.

Using Citalopram Mabo with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Some medicines may affect the action of others and may cause serious adverse reactions.

Tell your doctor if you are using any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, you should wait 14 days before starting to take citalopram. After finishing treatment with citalopram, you should wait 7 days before taking any of these medicines.
• Reversible MAO-A inhibitors containing moclobemide (used for the treatment of depression).
• The antibiotic linezolid.
• Lithium (used for the prophylaxis and treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Irreversible MAO-B inhibitors containing selegiline (used for the treatment of Parkinson's disease); these increase the risk of adverse effects. The dose of selegiline should not exceed 10 mg per day.
• Metoprolol (used for high blood pressure and/or heart disease); blood levels of metoprolol increase but no signs of increased effect or adverse effects of metoprolol have been observed.
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain) increase the risk of adverse effects. If you experience any unusual symptoms using this combination, you should see your doctor.
• 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). Citalopram blood levels may be increased.
• Medicines that affect platelet function (e.g., some antipsychotic drugs, acetylsalicylic acid (used for pain), non-steroidal anti-inflammatory drugs (used for arthritis); slightly increase the risk of bleeding disorders.
• St. John's Wort (Hypericum perforatum) (a herbal remedy used for depression); concomitant administration with citalopram may increase the risk of adverse effects.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to a possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for treating schizophrenia, psychosis), due to a possible risk of lowering the seizure threshold, and antidepressants.
• Antiarrhythmic drugs class IA and III, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medicines against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine).
• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disorders.

Do not take this medicine if you are taking medicines because you already have a heart rhythm disorder or if you are taking medicines that may affect the heart rhythm.

If you have doubts about this, consult your doctor.

Taking Citalopram Mabo with food and drinks

This medicine can be taken with or without food (see section 3. "How to take citalopram").

It has been observed that this medicine does not increase the effects of alcohol. However, it is advisable to avoid consuming alcohol during treatment with this medicine.

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.

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

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

If you take this medicine during the last 3 months of your pregnancy and up to the date of birth, be aware that the following effects may be observed in the newborn baby: breathing difficulties, blue skin, seizures, changes in body temperature, feeding difficulties, vomiting, low blood sugar, muscle stiffness or floppiness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and sleep difficulties. If your newborn baby has any of these symptoms, please contact your doctor immediately.

When taken during pregnancy, particularly in the last 3 months of pregnancy, medicines like Citalopram Mabo may increase the risk of a serious disease in babies 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 in the final stage of pregnancy, there may be a greater risk of heavy 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.

Citalopram passes into breast milk in small amounts. There is a risk of effects on the child. If you are taking this medicine, inform your doctor before starting breastfeeding.

Animal studies have shown that citalopram reduces sperm quality. This could theoretically affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

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

Citalopram Mabo contains lactose

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

Citalopram Mabo contains sodium

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

3. How to Take Citalopram Mabo

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

Adults:

Depression

The recommended 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 recommended starting 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 recommended starting 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 old)

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.

Patient with Special Risks

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

Use in Children and Adolescents

This medication should not be administered to children or adolescents. For additional information, please see section 2 "What you need to know before taking Citalopram MABO".

How and When to Take this Medication

This medication is taken once a day as a single daily dose.

The tablets can be taken at any time of day, regardless of meals.

The tablets should be swallowed with a glass of water. Do not chew them (they have a bitter taste).

Duration of Treatment

Like other medications for depression, anxiety disorder, and obsessive-compulsive disorder, it may take several weeks before you notice any improvement. Continue taking citalopram even if it takes some time before you feel any improvement in your condition.

Never change the dose of the medication without talking to your doctor first.

The duration of treatment is individual, generally at least 6 months. Continue taking the tablets for the time recommended by your doctor. Do not stop taking them even if you feel better, unless your doctor has indicated so. The underlying disease may persist for a long period, and if you interrupt your treatment too early, your symptoms may reappear.

Patients with recurrent depression benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.

If You Take More Citalopram Mabo Than You Should

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

Do this even if you do not observe discomfort or signs of intoxication.

Some symptoms of an overdose may include irregular heartbeats with life risk, convulsions, changes in heart rhythm, drowsiness, coma, vomiting, tremors, decrease in blood pressure, increase in blood pressure, nausea (feeling dizzy), serotonin syndrome (see section 4 "Possible side effects"), agitation, dizziness, dilated pupils, sweating, bluish skin, hyperventilation (increased respiratory rate).

If You Forget to Take Citalopram Mabo

In case of forgetting a dose, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If You Interrupt Treatment with Citalopram Mabo

Do not stop taking citalopram until your doctor tells you to do so. When you have completed your treatment period, it is generally recommended that the dose of citalopram be gradually reduced over several weeks.

Sudden withdrawal of the medication can produce some mild or transient disorders such as dizziness, tingling sensation, sleep disturbances (intense dreams, nightmares, inability to sleep), feeling of anxiety, headache, feeling of dizziness (nausea), vomiting, sweating, feeling of restlessness or agitation, tremors, feeling of confusion or disorientation, feelings of emotion or irritation, diarrhea (loose stools), visual disturbances, rapid or palpitations.

When you have finished your treatment period, it is generally recommended that the dose of citalopram be gradually reduced over a couple of weeks instead of being stopped abruptly.

Your doctor will advise you on how to gradually stop treatment with this medication.

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

4. Possible Side Effects

Like all medications, citalopram can produce side effects, although not all people suffer from them.

Side effects usually disappear after a few weeks of treatment. Please note that many of the effects can also be symptoms of your disease and therefore will improve when you start feeling better.

Some patients have reported the following serious side effects.

If you have any of the following symptoms, you should stop taking this medication and see your doctor immediately:

• High fever, agitation, confusion, tremors, and sudden muscle contractions; may be signs of a rare condition called serotonin syndrome, which has been reported with the combined use of antidepressants.
• If you notice skin swelling, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction).

Unusual bleeding, including gastrointestinal bleeding.

Rare but Serious Side Effects (May affect up to 1 in 1,000 people):

If you have any of the following symptoms, you should stop taking this medication and see your doctor immediately.

• Hyponatremia: low sodium level in the blood, which can cause fatigue, confusion, and muscle contraction.
• Rapid 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 are generally mild and usually disappear after a few days of treatment. Please be aware that several of the effects mentioned below can be symptoms of your disease and will therefore improve when you start feeling better.

If the side effects are bothersome or last more than a few days, consult your doctor.

Dry mouth increases the risk of cavities. Therefore, you should brush your teeth more often than usual.

Very Common Side Effects (May affect more than 1 in 10 people):

• Sleepiness.
• Difficulty sleeping.
• Increased sweating.
• Dry mouth.
• Nausea (feeling dizzy).
• Headache.

Common Side Effects (May affect up to 1 in 10 people):

• Decreased appetite.
• Agitation.
• Decreased sexual behavior.
• Anxiety.
• Nervousness.
• Confusional state.
• Abnormal dreams.
• Tremors.
• Tingling or numbness of hands or feet.
• Dizziness.
• Attention disturbance.
• Ringing in the ears (tinnitus).
• Yawning.
• Diarrhea.
• Vomiting.
• Constipation.
• Rash.
• Muscle and joint pain.
• Men may experience problems with ejaculation and erection.
• Women may experience difficulty reaching orgasm.
• Fatigue.
• Itching of the skin.
• Weight loss.

Uncommon Side Effects (May affect up to 1 in 100 people):

• Bleeding disorders (easy bruising).
• Increased appetite.
• Aggression.
• Depersonalization.
• Hallucinations.
• Mania.
• Fainting.
• Dilated pupils.
• Fast heartbeats.
• Slow heartbeats.
• Hives.
• Hair loss.
• Skin rash.
• Sensitivity to light.
• Difficulty urinating.
• Excessive menstrual bleeding.
• Swelling of arms and legs.
• Weight gain.

Rare (May affect up to 1 in 1,000 people):

• Seizures.
• Involuntary movements.
• Taste disturbances.
• Bleeding.
• Hepatitis.
• Fever.

Frequency Not Known (Cannot be estimated from the available data):

• Thoughts of self-harm or thoughts of suicide, see also the section "Warnings and Precautions".
• Decreased platelet count in the blood, which increases the risk of bleeding or bruising.
• Hypersensitivity (rash).
• Severe allergic reaction that causes difficulty breathing or dizziness.
• Increased urine output.
• Hypokalemia: low potassium level in the blood, which can cause muscle weakness, contractions, or abnormal heart rhythm.
• Panic attack.
• Teeth grinding.
• Restlessness.
• Abnormal muscle movements or stiffness.
• Akathisia (involuntary muscle movements).
• Visual disturbances.
• Low blood pressure.
• Nosebleeds.
• Bleeding disorders, including skin and mucous membrane bleeding (ecchymosis).
• Abundant vaginal bleeding shortly after childbirth (postpartum hemorrhage), see 'Pregnancy, Lactation, and Fertility' in section 2 for more information.
• Sudden swelling of the skin or mucous membranes.
• Painful erections.
• Milk flow in men and in women who are not breastfeeding.
• Irregular menstrual period.
• Abnormal liver function tests.
• Orthostatic hypotension (significant drop in blood pressure that occurs when an individual stands up).
• An increased risk of bone fractures has been observed in patients treated with this type of medication.
• Abnormal heart rhythm.

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Citalopram Mabo

Keep this medication out of sight and reach of children.

No special storage conditions are required.

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 thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

• The active ingredient is citalopram. Each tablet contains 10 mg of citalopram (hydrobromide).

• The other components (excipients) are: core: cornstarch, lactose monohydrate, copovidone, glycerol (E-422), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate, coating: hypromellose 5, macrogol 400, titanium dioxide (E-171).

Appearance of the Product and Package Contents

Citalopram Mabo 10 mg are film-coated tablets. The film-coated tablets are round, biconvex, and white in color. They are available in packages of 28 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder

Mabo-Farma S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain.

Manufacturer

Meiji Pharma Spain, S.A.

Avda. de Madrid, 94,

28802, Alcala de Henares, Madrid

Spain

or

Medreich PLC.

Warwick House, Plane Tree Crescent,

Feltham, TW13 7HF. United Kingdom

Date of the Last Revision of this Prospectus:March 2022

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