PROSPECTO : INFORMATION FOR THE USER

Citalopram Mabo 20 mg Film-Coated Tablets

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

6. Contents of the pack and additional information

Citalopram is 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 Mabo is indicated for:

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

Do not take Citalopram Mbo

• if you are allergic (hypersensitive) 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, tranylcypromine, selegiline (used in the treatment of Parkinson's disease), moclobemide (used for the treatment of depression) and linezolid (an antibiotic)
• if you have had a heart rhythm disorder since birth or have ever had an episode 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 the 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. Your doctor may need to adjust the dose
• if you have diabetes. Treatment with this medicine 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 if you 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 taken diuretics (medicines to urinate)
• if you have noticed that your heartbeats are fast 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 this medicine 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 condition

Like other medicines used to treat depression or related conditions, improvement is not immediate. After starting treatment with this medicine, 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 exactly your doctor's instructions and do not interrupt treatment or change the dose without consulting your doctor.

Thoughts of self-harm and worsening of depression or anxiety

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. Information from clinical trials 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 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 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 adverse effects such as suicidal attempts, suicidal thoughts and hostility (mainly aggression, confrontational behavior and irritability) when taking this class of medicines. However, the doctor who prescribes this medicine to you may prescribe it to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribes this medicine to you has prescribed it to a patient under 18 years old and wants to discuss this decision, please go back 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 of this medicine on safety and related to growth, maturity and cognitive and behavioral development 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 sometimes 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 this medicine. 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 adverse effects. The dose of selegiline should not exceed 10 mg per day.
• Metoprolol (used for high blood pressure and/or heart disease); the blood levels of metoprolol are increased but no signs of increased effect or adverse effects of metoprolol have been observed.
• Sumatriptan and similar medicines (used to treat migraines) and tramadol (used for severe pain) increase the risk of adverse effects, if you have any unusual symptoms when 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). The levels of citalopram in the blood 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 this medicine may increase the risk of adverse effects.
• Mefloquine (used to treat malaria), bupropion (used to treat depression) and tramadol (used for severe pain) due to a possible risk of lowering the threshold for seizures.
• Neuroleptics (medicines for schizophrenia, psychosis), due to a possible risk of lowering the threshold for seizures, and antidepressants.
• Class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, certain antimalarial drugs, particularly halofantrine), certain antihistamines (astemizol, 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 the heart rhythm.

If you are unsure 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 recommended to avoid alcohol consumption during treatment with 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.

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 falling asleep. 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 may increase the risk of a serious disease in the newborn baby, 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 the quality of sperm. Theoretically, this could affect fertility, but 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 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’’.

Follow exactly the administration instructions of this medication 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.

Older adults (65 years and older)

In older adults, treatment should be initiated with half the recommended dose, for example 10-20 mg per day.

Generally, older adults 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.

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 starting to take Citalopram Mabo”.

How and when to take this medication

This medication should be taken once a day as a single daily dose.

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

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

Treatment duration

Like other depression, anxiety disorder, and OCD medications, it may take several weeks to find some improvement. Continue taking citalopram even if it takes some time to feel any improvement in your condition.

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

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

Patients with recurrent depressions 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

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

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

If you forgot to take Citalopram Mabo

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

If you interrupt the treatment with Citalopram Mabo

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

Abrupt withdrawal of the medication may cause some mild or transient disturbances such as dizziness, feeling of pins and needles, 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 irritability, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

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

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

Like all medicines, citalopram can cause side effects, although not everyone will experience them.

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

Some patients have reported the following serious side effects.

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

• High fever, agitation, confusion, tremors, and sudden muscle contractions; they may be signs of a rare condition called serotonin syndrome, which has been reported with the combined use of antidepressants.
• If you notice swelling of the skin, 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, stop taking this medicine and see your doctor immediately.

• Hypontremia: low sodium levels in the blood that can cause fatigue, confusion, and muscle cramps.
• 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 side effects are generally mild and usually disappear after a few days of treatment. Please note that several of the effects mentioned below can be symptoms of your illness and will therefore improve when you start to feel better.

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

Dry mouth increases the risk of tooth decay. Therefore, you should brush your teeth more frequently than usual.

Very common side effects (May affect more than 1 in 10 people):

• Tendency to sleep.
• 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.
• Confusion.
• Abnormal dreams.
• Tremors.
• Numbness or tingling in hands or feet.
• Dizziness.
• Alteration of attention.
• Tinnitus (ringing in the ears).
• 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 skin.
• Weight loss.

Rare side effects (May affect up to 1 in 100 people):

• Cutaneous hemorrhagic disorders (easy bruising).
• Increased appetite.
• Aggression.
• Depersonalization.
• Hallucinations.
• Mania.
• Blackouts.
• Dilated pupils.
• Fast heartbeats.
• Slow heartbeats.
• Urticaria.
• Hair loss.
• Cutaneous eruption.
• Photophobia.
• Urination difficulties.
• Excessive menstrual bleeding.
• Swelling of arms and legs.
• Weight gain.

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

• Seizures.
• Involuntary movements.
• Alterations in taste.
• Bleeding.
• Hepatitis.
• Fever.

Frequency not known (Cannot be estimated from available data):

• Thoughts of self-harm or thoughts of suicide, see also the "Warnings and precautions" section
• Reduction of platelets in the blood, which increases the risk of bleeding or bruising (hematoma).
• Hypersensitivity (rash).
• Severe allergic reaction that causes difficulty breathing or dizziness.
• Increased urine output.
• Hypokalemia: low potassium levels in the blood that can cause muscle weakness, cramps, or irregular heartbeats.
• Panic attack.
• Clicking of teeth.
• Restlessness.
• Abnormal muscle movements or stiffness.
• Acatisia (involuntary muscle movements).
• Visual disturbances.
• Low blood pressure.
• Nasal bleeding.
• Bleeding disorders, including skin and mucous membrane bleeding (ecchymosis).
• Excessive postpartum bleeding (hemorrhage), see 'Pregnancy, lactation, and fertility' in section 2 for more information.
• Sudden skin or mucous membrane swelling.
• Painful erections.
• Milk flow in men and women who are not breastfeeding.
• Irregular menstrual periods.
• Altered liver function tests.
• Orthostatic hypotension (significant drop in blood pressure when standing up).
• A higher 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's about side effects that don't appear in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's about possible side effects that don't appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the 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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Citalopram Mabo 20 mg

• The active ingredient is citalopram. Each tablet contains 20 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 content of the container

Citalopram Mabo 20 mg are film-coated tablets. The film-coated tablets are ovoid, biconvex, scored, and white in color.

They are presented in containers of 14 and 28 tablets.

Only some container sizes may be commercially available.

Holder of the marketing authorization

Mabo-Farma S.A.

Vía de los Poblados, 3, Building 6

28033 Madrid,

Spain.

Responsible for manufacturing

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

Last review date of this leaflet:March 2022

The detailed information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS):http://www.aemps.gob.es/