Citalopram Bexal 20 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the user

Citalopram Bexal 20 mg film-coated tablets EFG

Citalopram Bexal 30 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Citalopram Bexal 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 is indicated for the treatment of:

• Depression and prevention of relapse and recurrence.
• Panic disorder with or without agoraphobia.
• Obsessive-compulsive disorder (OCD).

However, your doctor may prescribe citalopram for other purposes. Ask your doctor if you have any doubts about why citalopram has been prescribed for you.

2. What you need to know before taking Citalopram Bexal

Do not take Citalopram Bexal

• If you are allergic to citalopram or any of the other components of this medicine (listed in section 6).
• If you are taking other medicines belonging to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (for the treatment of Parkinson's disease), moclobemide (for the treatment of depression), and linezolid (an antibiotic).
• If you have a congenital heart rhythm disorder or have ever experienced such an episode (this is detected by electrocardiogram, a test used to assess heart function).
• If you are taking medicines for a heart rhythm disorder.
• If you are taking medicines that may affect heart rhythm.
  • See also the section “Other medicines and Citalopram Bexal” below.

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

You must wait 1 day after taking moclobemide.

After stopping citalopram, you must wait 1 week before taking any MAOI.

Warnings and precautions

Talk to your doctor or pharmacist before starting Citalopram Bexal.

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

• If you have manic episodes or anxiety disorder.

• If you have liver or kidney impairment. Your doctor may need to adjust the dose.

• If you have diabetes. Treatment with citalopram may alter glucose control. You may require adjustment of insulin and/or oral hypoglycemic agent doses.

• 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 a history of bleeding disorders, develop unusual bruising, or are pregnant (see “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 heart problems or recently suffered a heart attack.

• If your heart beats slowly at rest (known as bradycardia) and/or you suspect your body may be losing salts, for example due to severe diarrhea and vomiting over several days or due to diuretic use (medicines that increase urine production).

• If you notice rapid or irregular heartbeats, or have experienced fainting or dizziness when standing up from a sitting or lying position. This could indicate a heart rhythm disorder.

• If you have a problem with dilation of the eye pupils (mydriasis).

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 frequent changes in thoughts, excessive happiness, 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 few weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Some medicines in the same group as citalopram (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 does not occur immediately. After starting treatment with citalopram, it may take several weeks before you notice any improvement.

In the treatment of anxiety disorder, improvement is typically observed after 2 to 4 weeks.

At the beginning of treatment, some patients may experience increased anxiety, which usually subsides with continued treatment. Therefore, it is very important to follow your doctor's instructions exactly and not stop treatment or change the dose without consulting your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts about harming yourself or ending your life. These thoughts may increase when starting antidepressants, as all these medicines require 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 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 be helpful to tell a family member or close 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

Citalopram is not normally used to treat children and adolescents under 18 years of age. In addition, you should know 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 prescribe citalopram to patients under 18 years of age if they consider it appropriate. If your doctor has prescribed citalopram and you are under 18 and wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the previously mentioned symptoms worsen or complications arise while patients under 18 years of age are taking citalopram. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of citalopram in this age group have not yet been established.

Other medicines and Citalopram Bexal

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 citalopram. After stopping citalopram, you must wait 7 days before taking any of these medicines.
• Reversible selective MAO-A inhibitors containing moclobemide (for the treatment of depression).
• The antibiotic linezolid.
• Lithium (for prophylaxis and treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (for the treatment of depression).
• Irreversible MAO-B inhibitors containing selegiline (for the treatment of Parkinson's disease); these increase the risk of adverse effects. The selegiline dose should not exceed 10 mg per day.
• Metoprolol (for the treatment of high blood pressure and/or heart disease); blood levels of metoprolol increase, but no signs of enhanced effect or adverse effects of metoprolol have been observed.
• Sumatriptan and similar medicines (for the treatment of migraine) and tramadol (for the treatment of severe pain) increase the risk of adverse effects. If you experience any unusual symptoms while using 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). These may increase blood levels of citalopram, but increased adverse effects of citalopram have not been reported.
• Medicines affecting platelet function (e.g., some antipsychotics, acetylsalicylic acid (for pain relief), non-steroidal anti-inflammatory drugs (for the treatment of arthritis)); these slightly increase the risk of bleeding disorders.
• St. John's wort (Hypericum perforatum) (a herbal remedy used for depression); concomitant use with citalopram may increase the risk of adverse effects.
• Mefloquine (for the treatment of malaria), bupropion (for the treatment of depression), and tramadol (for the treatment of severe pain) due to a possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for the treatment of 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, IV erythromycin, pentamidine, antimalarials particularly halofantrine), certain antihistamines (astemizole, mizolastine).
  • Medicines that reduce blood potassium or magnesium levels, as they increase the risk of life-threatening heart rhythm disturbances. Do not take citalopram if you are taking medicines for a heart rhythm disorder or medicines that may themselves affect heart rhythm. If you have any doubts about this, consult your doctor.

Taking Citalopram Bexal with food, drinks, and alcohol

Citalopram may be taken with or without food (see section 3, “How to take Citalopram Bexal”).

It has been observed that citalopram does not enhance the effects of alcohol. However, it is advisable to avoid alcohol consumption during treatment with citalopram.

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.

Pregnant women should generally not take citalopram, and mothers should not breastfeed while taking this medicine, unless your doctor has evaluated the risks and benefits involved.

If you take citalopram 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, sleepiness, and difficulty sleeping. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

If you take citalopram in late 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 citalopram, inform your doctor before starting breastfeeding.

Ensure that your midwife and/or doctor are informed that you are being treated with citalopram.

During pregnancy, particularly in 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), in which the baby breathes rapidly and turns blue. These symptoms usually begin within the first 24 hours after birth. If these occur in your baby, contact your midwife and/or doctor immediately.

Citalopram has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

Generally, citalopram does not cause drowsiness; however, if you feel dizzy or sleepy when starting this medicine, do not drive or operate tools or machinery until these effects subside.

Citalopram Bexal contains lactose and sodium

If your doctor has informed 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 film-coated tablet; essentially "sodium-free".

3. How to take Citalopram Bexal

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

Adults

Depression

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

Panic disorder

The initial dose is 10 mg daily for the first week, before increasing to 20 or 30 mg daily. If necessary, your doctor may increase this dose up to a maximum of 40 mg daily.

Obsessive-compulsive disorder (OCD)

The initial dose is 20 mg daily. If necessary, your doctor may increase this dose up to a maximum of 40 mg daily.

Elderly patients (over 65 years of age)

In elderly patients, treatment should be initiated at half the recommended dose, for example 10 or 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.

Use in children and adolescents

Citalopram must not be administered to children or adolescents. For further information, see section 2 “What you need to know before taking Citalopram Bexal”.

How and when to take Citalopram Bexal

Citalopram is taken every day as a single daily dose.

The tablets may 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 medicines used 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 maintenance treatment, sometimes for several years, to prevent new depressive episodes.

If you take more Citalopram Bexal than you should

If you have taken more Citalopram Bexal than you should, 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. Take the Citalopram Bexal packaging with you to the doctor or hospital.

Some symptoms of 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 nauseated), 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 Bexal

If you forget to take a dose, take the next dose at the usual time.

Do not take a double dose to make up for missed doses.

If you stop taking Citalopram Bexal

Do not stop taking Citalopram Bexal until your doctor tells you to do so. When you have completed your treatment, 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 anxious, headache, dizziness (nausea), vomiting, sweating, restlessness or agitation, tremors, feelings of confusion or disorientation, emotional or irritable feelings, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

When finishing 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can produce adverse effects, although not everyone will experience 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 will therefore 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 citalopram 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 patients):

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

• Hyponatraemia: low sodium levels in the blood, which may cause tiredness, 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 patients):

• Drowsiness.
• Difficulty sleeping.
• Increased sweating.
• Dry mouth.
• Nausea (feeling sick).
• Headache.

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

• Decreased appetite.
• Restlessness.
• Reduced sexual performance.
• Anxiety.
• Nervousness.
• Confusional state.
• Abnormal dreams.
• Tremor.
• Tingling or numbness in hands or feet.
• Dizziness.
• Attention disturbance.
• Ringing in the ears (tinnitus).
• Yawning.
• Diarrhoea.
• Vomiting.
• Constipation.
• Rash.
• Muscle and joint pain.
• Men may experience problems with ejaculation and erection.
• Women may experience difficulty reaching orgasm.
• Fatigue.
• Fever.
• Skin irritation.
• Weight loss.

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

• Bleeding disorders of the skin (easy bruising).
• Increased appetite.
• Aggression.
• Depersonalisation.
• Hallucinations.
• Mania.
• Fainting.
• Dilated pupils.
• Rapid heartbeat.
• Slow heartbeat.
• Hives.
• Hair loss.
• Skin rash.
• Light sensitivity.
• Difficulty urinating.
• Excessive menstrual bleeding.
• Swelling of arms and legs.
• Weight gain.

Rare adverse effects (may affect up to 1 in 1,000 patients):

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

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

• Thoughts of harming yourself or thoughts of suicide; see also section "Warnings and precautions".
• Reduction in blood platelets, increasing the risk of bleeding or bruising (haematoma).
• Hypersensitivity (rash).
• Severe allergic reaction causing difficulty breathing or dizziness.
• Increased amount 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 from the skin and mucous membranes (ecchymosis).
• Sudden swelling of the skin or mucous membranes.
• Painful erections.
• Milk production in men and in women who are not breastfeeding.
• Irregular menstrual periods.
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.
• Abnormal liver function tests.
• Orthostatic hypotension (a significant drop in blood pressure 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 adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 Bexal

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 CAD/EXP. The expiry date refers to the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Citalopram Bexal 20 mg film-coated tablets:

• The active substance is citalopram.

Each tablet contains 24.99 mg of citalopram hydrobromide (equivalent to 20 mg of citalopram).

The other components (excipients) are: maize starch, monohydrate lactose, povidone, glycerol 85% (E-422), microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch (type A) (derived from potato starch), hypromellose, titanium dioxide (E 171), macrogol 6000 and talc.

Composition of Citalopram Bexal 30 mg film-coated tablets:

• The active substance is citalopram. Each tablet contains 37.48 mg of citalopram hydrobromide (equivalent to 30 mg of citalopram).
• The other components (excipients) are: maize starch, monohydrate lactose, povidone, glycerol 85% (E-422), microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch (type A) (derived from potato starch), hypromellose, titanium dioxide (E 171), macrogol 6000 and talc.

Appearance of the product and contents of the pack

Citalopram Bexal 20 mg are film-coated, white, oblong, biconvex tablets, scored on one side and marked with “C20”. They are packaged in PVC/Aluminum blisters or Aluminum/PVC/PVDC blisters, in pack sizes of 14, 28 or 56 tablets.

Citalopram Bexal 30 mg are film-coated, white, oblong, biconvex tablets, scored on one side and marked with “C30”.

They are packaged in PVC/Aluminum blisters or Aluminum/PVC/PVDC blisters, in pack sizes of 28 or 56 tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bexal Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Salutas Pharma GmbH

Otto-von Guericke Allee 1

Barleben 39179 Germany

LEK, S.A.

Domaniewska 50 C

02-672 Warsaw

Poland

Date of the most recent review of this leaflet: February 2023.

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