Citalopram Mabo 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Citalopram Mabo 20 mg film-coated tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Citalopram Mabo

3. How to take Citalopram Mabo

4. Possible side effects

5. How to store 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 correct certain chemical imbalances in the brain that cause the symptoms of your illness.

Citalopram Mabo is indicated for:

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

2. What you need to know before taking Citalopram MABO

Do not take Citalopram MABO

• if you are allergic (hypersensitive) to citalopram or to any of the other ingredients of this medicine (listed in section 6)
• if you are being treated with other antidepressant medicines from 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 a congenital condition affecting your heart rhythm or have ever experienced such an episode (this can be detected by an electrocardiogram, a test used to assess heart function)
• if you are taking medicines for a condition that affects your heart rhythm
• if you are taking medicines that may affect your heart rhythm

See also the section “Use of Citalopram MABO with other medicines” below.

Even if you have completed treatment with MAOIs, you must wait 2 weeks before starting treatment with this medicine.

You must wait one day after taking moclobemide.

After stopping citalopram, you must wait one week before taking any MAOI.

Warnings and precautions

Talk to your doctor or pharmacist before taking this medicine.

Please inform your doctor if you have any other condition or illness, as your doctor may need to take this into account. In particular, tell your doctor:

• if you have manic episodes or panic disorder.
• if you have liver or kidney impairment. Your doctor may need to adjust your dose.
• if you have diabetes. Treatment with this medicine may alter glucose control. You may need an adjustment in 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 bruising, or if you are pregnant (see section “Pregnancy, breastfeeding and fertility”).
• if you have low sodium levels in your blood.
• if you are receiving electroconvulsive therapy.
• if you have or have had heart problems or have recently suffered a heart attack
• if your heart beats slowly at rest (known as bradycardia) and/or if you think your body may be losing salts, for example due to severe diarrhea and vomiting over several days or if you are taking diuretics (medicines to increase urination)
• if you notice your heartbeat is fast or irregular, or if you experience fainting or dizziness when standing up from sitting or lying down. This could indicate a heart rhythm disorder
• if you have or have previously had eye problems, such as certain types of glaucoma (increased pressure in the eye).

Consult your doctor, even if any of the above circumstances occurred in the past.

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and disorganized thinking, excessive happiness, and increased 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 in the same group as this one (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 disorders, improvement does not occur immediately. After starting treatment with this medicine, it may take several weeks before you notice any improvement.

In the treatment of panic disorder, improvement is typically seen after 2–4 weeks.

At the beginning of treatment, some patients may experience increased anxiety, which will resolve with continued treatment. Therefore, it is very important that you follow your doctor’s instructions exactly and do not stop or change your dose without consulting your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have an anxiety disorder, you may occasionally have thoughts about harming yourself or ending your life. These thoughts may increase when starting antidepressants, as all such medicines take time to begin working—usually about two weeks, although in some cases it may take longer.

You are more likely to have such thoughts:

• if you have previously had thoughts about harming yourself or ending your life.
• if you are a young adult. Clinical trial data have 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 about harming yourself or ending your life, contact your doctor or go directly to a hospital.

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

Children and adolescents

This medicine should not normally be used in the treatment of children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may decide to prescribe this medicine to patients under 18 years if they consider it to be in the patient’s best interest. If your doctor has prescribed this medicine to a patient under 18 years and you wish to discuss this decision, please contact your doctor again. You must inform your doctor if any of the symptoms described above worsen or develop complications while a patient under 18 years is taking this medicine. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of this medicine in this age group have not yet been fully established.

Use of Citalopram MABO with other medicines

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

Some medicines may affect each other’s action, sometimes causing serious adverse reactions.

Inform your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active substances. If you have taken any of these medicines, you must wait 14 days before starting this medicine. After stopping citalopram, you must wait 7 days before taking any of these medicines.
• Reversible selective MAO-A inhibitors containing moclobemide (used for the treatment of depression).
• The antibiotic linezolid.
• Lithium (used for prophylaxis and treatment of bipolar 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 selegiline dose must not exceed 10 mg per day.
• Metoprolol (used for high blood pressure and/or heart disease); blood levels of metoprolol may 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 while taking this combination, see your doctor.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). Blood levels of citalopram may be increased.
• Medicines that affect platelet function (e.g., some antipsychotics, acetylsalicylic acid (used for pain), non-steroidal anti-inflammatory drugs (used for arthritis)); these slightly increase the risk of bleeding disorders.
• St. John’s wort (Hypericum perforatum) (a herbal remedy used for depression); concomitant use with this medicine 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 to treat 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 antimicrobial agents (sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), certain antihistamines (astemizole, mizolastine).
• Medicines that reduce potassium or magnesium levels in blood, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take this medicine if you are taking medicines for a condition that affects your heart rhythm or if you are taking medicines that may themselves affect your heart rhythm.

If you have any doubts about this, consult your doctor.

Taking Citalopram MABO with food and drink

This medicine may 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 alcohol consumption during treatment with 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 during pregnancy and breastfeeding is not recommended.

Ensure that your midwife and/or doctor knows that you are taking citalopram.

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

When taken during pregnancy, particularly during the last 3 months, medicines like citalopram may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and turn blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.

If you take citalopram late in pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking citalopram so they can advise you appropriately.

Citalopram passes into breast milk in small amounts. There is a risk of effects on the infant. 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 no impact on human fertility has been observed to date.

Driving and using machines

During treatment with this medicine, you may feel drowsy or dizzy. Do not drive or operate tools or machinery 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; hence, it is essentially “sodium-free”.

3. How to take Citalopram Mabo

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults:

Depression

The recommended dose is 20 mg daily. If your doctor considers it necessary, they may increase your dose up to a maximum of 40 mg per day.

Panic disorder

The recommended starting dose is 10 mg daily for the first week, before increasing it to 20–30 mg daily. If your doctor considers it necessary, they may increase your dose up to a maximum of 40 mg per day.

Obsessive-compulsive disorder (OCD)

The recommended starting dose is 20 mg daily. If your doctor considers it necessary, they may increase your dose up to a maximum of 40 mg per day.

Elderly patients (aged over 65 years)

In elderly patients, treatment should be initiated at half the recommended dose, for example 10–20 mg daily.

In general, elderly patients should not take more than 20 mg daily.

Patients with special risks

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

How and when to take this medicine

This medicine is taken daily as a single daily dose.

The tablets may be taken at any time of day, with or without food.

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

Duration of treatment

Like other medicines for depression, panic 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 better.

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

The duration of treatment is individual, but generally at least 6 months. Continue taking the tablets for the length of time recommended by your doctor. Do not stop taking them even if you feel better, unless your doctor tells you to do so. The underlying condition may persist for a long time, and if you stop treatment too early, your symptoms may return.

Patients with recurrent depression benefit from continuation treatment, sometimes for several years, to prevent new depressive episodes.

If you take more Citalopram Mabo than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, stating the medicine and the amount taken.

Do this even if you do not notice any discomfort or signs of poisoning.

Some symptoms of an overdose may include irregular heartbeats that may be life-threatening, seizures, changes in heart rhythm, drowsiness, coma, vomiting, tremors, decreased blood pressure, increased blood pressure, nausea (feeling sick), 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

If you miss a dose, take the next dose at your usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Citalopram Mabo

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

Stopping the medication abruptly may cause some mild or transient disturbances such as dizziness, tingling sensations, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache, dizziness (nausea), vomiting, sweating, restlessness or agitation, tremors, feelings of confusion or disorientation, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

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

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

4. Possible adverse effects

Like all medicines, citalopram may produce adverse effects, although not everyone experiences them.

Adverse effects usually disappear after a few weeks of treatment. Please note that many of these effects may also be symptoms of your illness and therefore will improve as you start to feel better.

Some patients have reported the following serious adverse effects.

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

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

Rare but serious adverse effects (may affect up to 1 in 1,000 people):

If you experience any of the following symptoms, you must stop taking this medicine and contact your doctor immediately.

• Hyponatraemia: low sodium levels in the blood, which may cause fatigue, confusion, and muscle spasms.
• Rapid or irregular heartbeat, or feeling faint, as these could be symptoms of a serious heart problem known as torsade de pointes.

The following adverse effects are generally mild and usually disappear after a few days of treatment. Please be aware that several of the effects listed below may be symptoms of your illness and will therefore improve as you start to feel better.

If adverse effects are troublesome 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 often than usual.

Very common adverse effects (may affect more than 1 in 10 people):

• Tendency to feel sleepy.
• Difficulty sleeping.
• Increased sweating.
• Dry mouth.
• Nausea (feeling sick).
• Headache.

Common adverse effects (may affect up to 1 in 10 people):

• Decreased appetite.
• Agitation.
• Decreased sexual activity.
• Anxiety.
• Restlessness.
• Confusional state.
• Abnormal dreams.
• Tremors.
• Tingling or numbness in 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.
• Skin irritation.
• Weight decrease.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Bleeding disorders of the skin (easy bruising).
• Increased appetite.
• Aggressiveness.
• Depersonalization.
• Hallucinations.
• Mania.
• Fainting.
• Dilated pupils.
• Rapid heartbeat.
• Slow heartbeat.
• Hives (urticaria).
• Hair loss.
• Skin rash.
• Light sensitivity.
• 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 available data):

• Thoughts of harming yourself or thoughts about suicide; see also section "Warnings and precautions".
• Reduction in platelets in the blood, increasing the risk of bleeding or bruising (haematoma).
• Hypersensitivity (rash).
• Severe allergic reaction causing difficulty breathing or dizziness.
• Increased volume of urine excreted.
• Hypokalaemia: low potassium levels in the blood, which may cause muscle weakness, cramps, or abnormal heart rhythm.
• Panic attacks.
• Teeth grinding.
• Restlessness.
• Abnormal muscle movements or stiffness.
• Akathisia (involuntary muscle movements).
• Vision disturbances.
• Low blood pressure.
• Nosebleeds.
• Bleeding disorders including bleeding of the skin and mucous membranes (ecchymoses).
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see 'Pregnancy, breastfeeding and fertility' in section 2 for more information.
• Sudden swelling of the skin or mucous membranes.
• Painful erections.
• Milk discharge in men and in women who are not breastfeeding.
• Irregular menstrual periods.
• Abnormal liver function tests.
• Orthostatic hypotension (a significant drop in blood pressure occurring when standing up).
• An increased risk of bone fractures has been observed in patients treated with this type of medicine.
• Abnormal heart rhythm.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citalopram Mabo

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

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Citalopram Mabo 20 mg

• The active substance is citalopram. Each tablet contains 20 mg of citalopram (hydrobromide).
• The other components (excipients) are: core: corn starch, monohydrate lactose, copovidone, glycerol (E-422), microcrystalline cellulose, sodium croscarmellose, and magnesium stearate; coating: hypromellose 5, macrogol 400, titanium dioxide (E-171).

Appearance of the medicinal product and contents of the container

Citalopram Mabo 20 mg are film-coated tablets. The coated tablets are oval, biconvex, scored, white in colour.

Available in packs of 14 and 28 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Mabo-Farma S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain

Manufacturer responsible

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 most recent revision of this package leaflet: March 2022

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