PROSPECTO : INFORMATION FOR THE USER

Citalopram Mabo 10 mg film-coated tablets

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, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Citalopramis a selective serotonin reuptake inhibitor (SSRI) and belongs to a group of medications known as antidepressants.

These medications help correct certain chemical imbalances in the brain that cause symptoms of your illness

Citalopram is indicated for:

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

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 belonging to the group of monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (used in the treatment of Parkinson's disease), moclobemide (used for the treatment of depression) and linezolid (an antibiotic)
• if you have any heart rhythm disorder from birth or have ever had any episodes of this type (this is observed with an electrocardiogram, a test that evaluates how the heart works)
• if you are taking medicines because you have a heart rhythm disorder
• if you are taking medicines that can affect heart rhythm

Also see the section “Use of Citalopram Mabo with other medicines” below.

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

You must wait a day after taking 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 account. In particular, inform your doctor:

• If you have manic episodes or anxiety disorder.

• If you have liver or kidney insufficiency, you may need to adjust the dose.
• If you have diabetes. Treatment with citalopram may alter blood sugar control. You may need to adjust 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 seizure frequency (see also section 4 "Possible side effects")
• If you have bleeding disorders or develop unusual bleeding or bruising, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”)
• If you have low sodium levels 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, 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 (medicines to urinate)
• If you have noticed that your heartbeats are rapid or irregular or have had fainting or dizziness when getting up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.

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

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

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapid changes in ideas, excessive joy and excessive physical activity. If you experience this, contact your doctor.

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

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

Special information related to your illness

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

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

At the beginning 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.

Thoughts of suicide and worsening of your depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts of harming yourself or taking your life. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around 2 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 harming yourself or taking your life.

•If you are a young adult. Clinical trial information has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric illnesses who were treated with an antidepressant.

If at any time you have thoughts of harming yourself or taking your life,contact your doctor or go directly to a hospital.

It may be helpful to tell a family member 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 be used normally in the treatment of children and adolescents under 18 years old. At the same time, you should know that in patients under 18 years old, there is a higher risk of side effects such as suicidal attempts, suicidal thoughts and hostility (mainly aggression, confrontational behavior and irritability) when taking this type of medicine. However, the doctor who prescribes it may prescribe this medicine to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribes it has prescribed this medicine 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 described above progress or if you experience complications when patients under 18 years old 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.

Use of Citalopram Mabo with other medicines

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

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

Inform 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.
• Selective 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 illness) 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 side 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 metoprolol side effects have been observed.
• Sumatriptan and similar medicines (used to treat migraines) and tramadol (used for severe pain) increase the risk of side effects, if you have 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 (for example, some antipsychotics, aspirin (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 side 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 schizophrenia, psychosis), due to a possible risk of lowering the seizure threshold, and antidepressants.
• Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, certain malaria medicines, particularly halofantrine), certain antihistamines (astemizole, mizolastine).
• Medicines that lower potassium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders, which are life-threatening.

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 could affect heart rhythm.

If you are unsure about this, consult your doctor.

Taking Citalopram Mabo with food and drink

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 recommended to avoid consuming alcohol during treatment with this medicine.

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

Pregnancy, breastfeeding and fertility

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

This medicine is not recommended for use during pregnancy and breastfeeding.

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

If you take this medicine during the last 3 months of your pregnancy and until the date of birth, be aware that the following effects may be observed in the newborn baby: difficulty breathing, blue skin, convulsions, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, intense reflexes, tremors, restlessness, irritability, drowsiness and difficulty sleeping. 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 illness in newborn babies, 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 in the final stages of pregnancy, there may be a higher 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 be able to advise you.

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

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

Driving and operating machines

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

Citalopram Mabo contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him 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

4. Possible Adverse Effects

5. Conservation of Citalopram Mabo

6. Contents of the packaging and additional information