Citalopram Viatris 30 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Citalopram Viatris 30 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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 must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet Contents

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

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

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

However, your doctor may prescribe citalopram for any other purpose. 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 Viatris

Do not take Citalopram Viatris

• If you are allergic to citalopram or to 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 in the treatment of Parkinson’s disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).
• If you were born with a certain type of heart rhythm disorder or have ever experienced an episode of this kind (this is observed with an electrocardiogram, a test used to assess how the heart is functioning).
• 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 Viatris” below.

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

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 to take Citalopram Viatris.

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 citalopram may alter glycaemic control. You may need an adjustment of your insulin and/or oral hypoglycaemic agent dosage.
• 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 develop unusual bruising, or if you 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 have recently suffered a heart attack.
• If your heart beats slowly at rest (this is known as bradycardia) and/or if you think your body may be losing salts, for example, due to severe diarrhoea and vomiting over several days or because you have used diuretics (medicines to increase urine production).
• If you have noticed that your heartbeat is fast or irregular, or if you 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 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 characterised by unusually rapid and frequent changes in thoughts, 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 (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Special information related to your illness

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 experience 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 disappear 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 suffer from an anxiety disorder, you may occasionally have thoughts of harming yourself or taking your own life. These 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 of harming yourself or taking your own 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 who were treated with an antidepressant.

If at any time you have thoughts of harming yourself or taking your own 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 behaviour.

Children and adolescents

Citalopram should not normally be used to treat children and adolescents under 18 years of age. Also, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly 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 the most appropriate treatment for the patient. If your doctor has prescribed citalopram to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms described above worsen or become complicated while patients under 18 years of age are taking citalopram. In addition, the long-term effects on safety and on growth, maturation, and cognitive and behavioural development of citalopram in this age group have not yet been established.

Other medicines and Citalopram Viatris

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take 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 citalopram. 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), tryptophan, opioids (e.g., buprenorphine). These medicines may interact with citalopram and you may experience symptoms such as rhythmic involuntary muscle contractions, including muscles controlling eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor if you experience these symptoms.
• 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), 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, 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, but no increase in adverse effects of citalopram has been reported.
• Medicines that affect platelet function, for example, 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 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, IV 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 citalopram 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 Viatris with food, drinks and alcohol

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

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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Pregnant women should normally not take citalopram, and mothers should not breastfeed while taking this medicine, unless you and your doctor have discussed the risks and benefits involved.

If you take citalopram during the last 3 months of pregnancy and up to the time 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, strong reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and difficulty sleeping. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

If you take citalopram in the late stages of 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, 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.

Animal studies have shown that citalopram reduces sperm quality. Theoretically, this could affect fertility, but no effect on human fertility has been observed so far.

Driving and using machines

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

Citalopram Viatris contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Citalopram Viatris

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

Adults

Depression

The usual 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 (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.

Use in children and adolescents

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

How and when to take citalopram

Citalopram is taken every day as a single daily dose.

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

The tablets should be swallowed with a glass of water. Do not chew them.

The score line is intended solely for breaking the tablet if you find it difficult to swallow it whole.

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 any improvement in your condition.

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

The duration of treatment is individual, usually 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 Viatris than you should

If you think that you or someone else has taken more citalopram than you should, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

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

Take the citalopram packaging with you if you go to the doctor or hospital.

Some of the 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 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 Viatris

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 Viatris

Do not stop taking citalopram until your doctor tells you to do so. When you have completed your treatment period, 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, dizziness (nausea), vomiting, sweating, feeling restless or agitated, tremors, feeling confused or disoriented, feelings of emotion or irritability, diarrhoea (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 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. 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 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 (may affect up to 1 in 1,000 people)

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 (may affect more than 1 in 10 people)

• Drowsiness.

• Difficulty sleeping.

• Increased sweating.

• Dry mouth.

• Nausea (feeling sick).

• Headache.

• Common (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.

• Diarrhoea.

• Vomiting.

• Constipation.

• Rash.

• Muscle and joint pain.

• Men may experience problems with ejaculation and erection.

• Women may have difficulty reaching orgasm.

• Fatigue.

• Skin irritation.

• Weight loss.

Uncommon (may affect up to 1 in 1,000 people)

• Bleeding disorders of the skin (bruising easily).
• Increased appetite.
• Aggression.
• Depersonalisation.
• Hallucinations.
• Mania.
• Fainting.
• Dilated pupils.
• Rapid heartbeat.
• Slow heartbeat.
• Urticaria.
• Hair loss.
• Skin rash.
• Light sensitivity.
• Difficulty urinating.
• Difficulty starting to urinate, reduced urination.
• 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 the 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 (haematoma).

• Hypersensitivity (rash).

• Severe allergic reaction causing difficulty breathing or dizziness.

• Hypokalaemia: 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).

• 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 the blood.

• 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 upon standing).

• An increased risk of bone fractures has been observed in patients treated with this type of medicine.

• Abnormal heart rhythm.

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 Viatris

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If 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 pack and other information

Composition of Citalopram Viatris

• The active substance is citalopram (hydrobromide). Each tablet contains 30 mg of citalopram. The other components (excipients) are monohydrate lactose, microcrystalline cellulose, corn starch, povidone K30, crospovidone, magnesium stearate, hypromellose, monohydrate lactose, macrogol 4000, titanium dioxide, purified water.

Appearance of the product and contents of the pack

Citalopram Viatris 30 mg is presented as white, oval-shaped, biconvex, film-coated tablets, scored on one side and marked “CM/30” on one side and “G” on the other.

It is available in packs of 28 or 56 tablets, presented in blister packs.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

Date of the most recent revision of this leaflet: January 2026

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