Citalopram Bexal 30 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, 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 should not give it to other people, even if they have the same symptoms as you, since it could 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 ingredients 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 (used to treat Parkinson's disease), moclobemide (used to treat depression), and linezolid (an antibiotic).
• If you have a congenital heart rhythm disorder 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 “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 taking 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 panic disorder.

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

• If you have diabetes. Treatment with citalopram may affect blood glucose control. You may need adjustments in your 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 your 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 to increase urine production).

• If you notice your heartbeat is fast or irregular, or if you experience 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 pupil dilation (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 shifts 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 citalopram, it may take several weeks before you notice any improvement.

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

At the beginning of treatment, some patients may experience increased anxiety, which usually resolves with continued treatment. Therefore, it is very important to follow your doctor's instructions exactly and 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 of harming yourself or ending your life. These thoughts may increase when starting antidepressants, as all such medicines take time to become effective—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 of self-harm or suicide.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years) with psychiatric disorders treated with an antidepressant.

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

It may be helpful to inform 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 behaviour.

Children and adolescents

Citalopram is not normally used to treat children and adolescents under 18 years of age. Also, 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 behaviour, and irritability) when taking this type of medicine.

Nevertheless, your doctor may prescribe citalopram to patients under 18 years of age if they decide it is in the patient’s best interest. 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 are taking citalopram. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural 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 actions, 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 (used to treat depression).
• The antibiotic linezolid.
• Lithium (used for prophylaxis and treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (used to treat depression).
• Irreversible MAO-B inhibitors containing selegiline (used to treat Parkinson’s disease); these increase the risk of adverse effects. The dose of selegiline should not exceed 10 mg per day.
• Metoprolol (used to treat high blood pressure and/or heart disease); metoprolol blood levels may increase, but no signs of increased metoprolol effects or adverse reactions have been observed.
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used to treat severe pain); these increase the risk of adverse effects. If you experience any unusual symptoms while taking these together, 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 citalopram blood levels, but no increase in citalopram adverse effects has been reported.
• Medicines that affect platelet function (e.g., some antipsychotics, acetylsalicylic acid (used to treat pain), non-steroidal anti-inflammatory drugs (used to treat 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 (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 used 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), and 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 can be taken with or without food (see section 3, “How to take Citalopram Bexal”).

It has been observed that citalopram does not increase 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 are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnant women should not normally 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, drowsiness, and sleep disturbances. 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 informed that you are taking citalopram so they can advise you.

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 your midwife and/or doctor are aware 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 appears blue. These symptoms usually begin within the first 24 hours after birth. If your baby develops these symptoms, 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 told 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; hence, it is essentially “sodium-free”.

3. How to use Citalopram Bexal

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

Adults

Depression

The usual dose is 20 mg once daily. If necessary, your doctor 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 (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 should 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 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 modify the dose of the 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 has instructed you to do so. The underlying condition may persist for a long period, 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 the occurrence of 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 number: 91 562 04 20, indicating the medicine and the amount taken. Do this even if you do not observe any discomfort or signs of poisoning. Take the Citalopram Bexal packaging with you to the doctor or hospital.

Some symptoms of an overdose may include irregular, life-threatening heartbeats, 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.

Abrupt discontinuation of the medication may cause some mild or transient disturbances such as dizziness, tingling sensations, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache, feeling of dizziness (nausea), vomiting, sweating, feeling restless or agitated, tremors, feeling confused or disoriented, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

When the treatment period is completed, 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 cause adverse effects, although not everyone will experience them.

Adverse effects usually disappear after a few weeks of treatment. Keep in mind 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 symptoms listed below, 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.

• Hyponatremia: low sodium levels in the blood, which may cause fatigue, confusion, and muscle cramps.
• 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 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 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.
• Decreased sexual drive.
• Anxiety.
• Nervousness.
• Confusional state.
• Abnormal dreams.
• Tremor.
• 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.
• 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.
• Depersonalization.
• 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 platelets in the blood, increasing the risk of bleeding or bruising.
• Hypersensitivity (rash).
• Severe allergic reaction causing difficulty breathing or dizziness.
• Increased amount of urine excreted.
• Hypokalemia: low potassium levels in the blood, which may cause muscle weakness, cramps, or irregular heartbeat.
• 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 (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 hemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.
• Abnormal liver function tests.
• Orthostatic hypotension (significant drop in blood pressure upon standing).
• 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 the SIGRE Point in your pharmacy. If you have any doubts, 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, lactose monohydrate, 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, lactose monohydrate, 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 white, oblong, biconvex, film-coated tablets, scored on one side and marked with “C20”. They are packaged in PVC/Aluminium or Aluminium/PVC/PVDC blisters in pack sizes of 14, 28 or 56 tablets.

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

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 revision of the package leaflet: February 2023.

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/