Citalopram Kern Pharma 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Citalopram Kern Pharma 20 mg film-coated tablets EFG

Citalopram Kern Pharma 30 mg film-coated tablets EFG

Package leaflet:

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

1. What Citalopram Kern Pharma 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 Kern Pharma 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. If you have any doubts about why this medicine has been prescribed for you, ask your doctor.

2. What you need to know before taking Citalopram Kern Pharma

Do not take Citalopram Kern Pharma

• If you are allergic to citalopram or any of the 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 (used in the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).
• If you have a congenital heart rhythm disorder or have ever had an episode of this type (this is detected by electrocardiogram, a test used to assess how the heart functions).
• If you are taking medicines for a condition that affects your heart rhythm.
• If you are taking medicines that may affect your heart rhythm.
• Also refer to the section “Use of other medicines” below.

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

You must wait 1 day after taking moclobemide.

After stopping Citalopram Kern Pharma, you must wait 1 week before taking any MAOI.

Warnings and precautions

Talk to your doctor or pharmacist before taking Citalopram Kern Pharma.

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

• If you have manic episodes or panic disorder.
• If you have hepatic or renal insufficiency. Your doctor may need to adjust the dose.
• If you have diabetes. Treatment with citalopram may alter glycaemic control. You may require adjustment of the dose of insulin and/or oral hypoglycaemic 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 a history of bleeding disorders or if you develop unusual bruising, or if you 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 have 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 diarrhoea and vomiting over several days or due to the use of diuretics (medicines to increase urination).

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

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

Some patients with bipolar disorder may enter a manic phase. This is characterised by unusual and rapid thought changes, disproportionate 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 class as Citalopram Kern Pharma (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after discontinuation of 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 Citalopram Kern Pharma, it may take several weeks before you notice any improvement.

In the treatment of panic disorder, improvement is usually observed after 2–4 weeks.

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

Suicidal thoughts and worsening of your 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 such medicines require time to begin working—usually around 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 behaviour 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 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 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 Kern Pharma should not normally be used in the treatment of 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 ideation, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Citalopram Kern Pharma to patients under 18 years of age if they decide it is most appropriate for the patient. If your doctor has prescribed Citalopram Kern Pharma to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You must inform your doctor if any of the symptoms described above worsen or complications arise while patients under 18 years of age are taking this medicine. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of Citalopram Kern Pharma in this age group have not yet been established.

Use of other medicines

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

Some medicines may affect the action of others and this may sometimes cause 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 Kern Pharma, 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 dose of selegiline 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 and similar medicines (opioids, used for severe pain) increase the risk of adverse effects. If you experience any unusual symptoms while using this combination, you should 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 increase, but no increase in adverse effects of Citalopram Kern Pharma has been reported.
• Medicines that affect platelet function, for example, certain 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 administration 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 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 blood potassium or magnesium levels, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take Citalopram Kern Pharma 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 Kern Pharma with food, drinks and alcohol

Citalopram Kern Pharma can be taken with or without food (see section 3, “How to take Citalopram Kern Pharma”).

It has been observed that Citalopram Kern Pharma does not increase the effects of alcohol. However, it is advisable to avoid alcohol consumption during treatment with this medicine.

Pregnancy, breastfeeding and fertility

Inform your doctor if you are pregnant or planning to become pregnant. Pregnant women should not normally take Citalopram Kern Pharma, nor should mothers breastfeed while taking this medicine, unless you and your doctor have discussed the risks and benefits involved.

If you take Citalopram Kern Pharma during the last 3 months of pregnancy and up to the date of birth, 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, please contact your 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.

Citalopram passes into breast milk in small amounts. There is a risk of effects on the infant. If you are taking Citalopram Kern Pharma, inform your doctor before starting breastfeeding.

Ensure that your midwife and/or doctor know that you are being treated with Citalopram Kern Pharma.

During pregnancy, particularly in the last 3 months, medicines like Citalopram Kern Pharma 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 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 Kern Pharma contains lactose

This medicine contains lactose. 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 tablet, i.e., essentially "sodium-free".

3. How to take Citalopram Kern Pharma

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 recommended dose is 20 mg daily. If deemed 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 it to 20–30 mg daily.

If deemed 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 deemed 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 10–20 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

This medicine must not be given to children or adolescents. For further information, please see section 2, “What you need to know before taking Citalopram Kern Pharma”.

How and when to take Citalopram Kern Pharma

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. The tablet may be divided into equal doses.

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 this medicine 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 has told 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 maintenance treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.

If you take more Citalopram Kern Pharma than you should

In case of overdose or accidental ingestion, 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.

Some symptoms of overdose may include irregular heartbeats with life-threatening risk, seizures, changes in heart rhythm, drowsiness, coma, vomiting, tremors, increased or decreased blood pressure, nausea (feeling dizzy), 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 Kern Pharma

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

If you stop taking Citalopram Kern Pharma

Do not stop taking this medicine until your doctor tells you to do so. When you have completed your treatment period, it is generally recommended that the dose of this medicine 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, feeling restless or agitated, tremors, feeling confused or disoriented, 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 dose of this medicine 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 Kern Pharma 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 will therefore 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, stop taking Citalopram Kern Pharma and contact 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 Citalopram Kern Pharma 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 condition 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):

• Drowsiness.
• 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 drive.
• Anxiety.
• Restlessness.
• 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.
• Skin irritation.
• Weight loss.

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.
• 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 blood platelets, 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 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).
• Visual disturbances.
• Low blood pressure.
• Nosebleeds.
• Bleeding disorders including bleeding from the skin and mucous membranes (ecchymosis).
• 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.
• Increased levels of prolactin hormone in blood.
• Lactation in men and in women who are not breastfeeding.
• Irregular menstrual periods.
• Abnormal liver function tests.
• Orthostatic hypotension (a 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 type of adverse effect, talk to your doctor, pharmacist, or nurse, 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 Kern Pharma 30 mg

No special storage conditions are required.

Keep out of the reach and sight of children.

Do not use this medicinal product after the expiry date stated on the packaging after 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 collection point at your pharmacy. If you are in doubt, ask your doctor or pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Additional Information

Composition of Citalopram Kern Pharma 20 mg tablets

• The active substance is citalopram (hydrobromide). Each tablet contains 20 mg of citalopram.

• The other components are corn starch, monohydrate lactose, povidone, glycerol (E 422), microcrystalline cellulose (E 460i), magnesium stearate (E 470b), sodium carboxymethylstarch, hydroxypropylmethylcellulose (E 464), titanium dioxide (E 171), polyethylene glycol 6000 and talc.

Composition of Citalopram Kern Pharma 30 mg tablets

• The active substance is citalopram (hydrobromide). Each tablet contains 30 mg of citalopram.

• The other components are corn starch, monohydrate lactose, povidone (E 1201), glycerol (E 422), microcrystalline cellulose (E 460i), magnesium stearate (E 470b), sodium carboxymethylstarch, hydroxypropylmethylcellulose (E 464), titanium dioxide (E 171), polyethylene glycol 6000 and talc.

Appearance of the medicinal product and contents of the pack

Citalopram Kern Pharma 20 mg are film-coated tablets, white, round, biconvex and scored on one side. They are available in blisters, in pack sizes of 14, 28 and 56 tablets.

Citalopram Kern Pharma 30 mg are film-coated tablets, white, round, biconvex and scored on one side. They are available in blisters, in pack sizes of 28 and 56 tablets.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent review of this leaflet: March 2026.

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/).