Package Insert: Information for the User

Citalopram Viatris 30 mg Film-Coated Tablets EFG

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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 symptoms of your illness.

Citalopram Viatrisis indicated for the treatment of:

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

Your doctor may, however, prescribe citalopram for any other purpose. Ask your doctor if you have any doubt as to why they have prescribed citalopram.

Do not take Citalopram Viatris

• If you are allergic to citalopram or any of the other ingredients of this medication (listed in section 6).
• If you are taking other medications that belong to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medications 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 experienced an episode of this type (this is observed with an electrocardiogram, a test that evaluates how the heart functions).
• If you are taking medications for a disease that alters the heart rhythm.
• If you are taking medications that can affect the heart rhythm.

Also see the section “Other Medications and Citalopram Viatris” below.

Even if you have finished treatment with MAOIs, you will need to wait 2 weeks before starting your treatment with citalopram.

You must wait a day after taking moclobemide.

After finishing citalopram, you must wait a week before taking any MAOI.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Citalopram Viatris

Please inform your doctor if you have any other condition or disease, as your doctor may need to take it into consideration. In particular, inform your doctor:

• If you have manic episodes or anxiety disorder.
• If you have liver or kidney insufficiency. Your doctor may need to adjust the dose.
• If you have diabetes. The treatment with citalopram may alter blood sugar control. You may need to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you have epilepsy. The treatment with citalopram should be discontinued if seizures occur or if there is an increase in seizure frequency (see also section 4 "Possible Adverse Effects").
• If you have a history of bleeding disorders or if you develop unusual bleeding or 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 any heart problems or have recently had a heart attack.
• If, when at rest, your heart beats slowly (this is known as bradycardia) and/or you think your body may be losing salt, for example, because you have had diarrhea and vomiting for several days or because you have taken diuretics (medications to urinate).
• If you have noticed that your heartbeats are rapid or irregular or have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.
• If you have a problem with pupil dilation (mydriasis).

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Some patients with manic-depressive illness may enter a manic phase. This is characterized by unusual and rapid changes in ideas, excessive joy, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or staying upright (akathisia) may also occur during the first weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Some medications in the group to which citalopram belongs (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after discontinuing treatment.

Angle-Closure Glaucoma

SSRIs, including citalopram, may have an effect on pupil size, causing mydriasis. This mydriatic effect has the potential to reduce the angle of the eye, leading to increased intraocular pressure and angle-closure glaucoma, especially in predisposed patients. Therefore, citalopram should be used with caution in patients with angle-closure glaucoma or a history of glaucoma.

Special Information Related to Your Condition

Like other medications used to treat depression or related conditions, improvement is not immediate. After starting treatment with citalopram, it may take several weeks to experience any improvement.

In the treatment of anxiety disorder, it usually takes 2-4 weeks to observe any improvement.

At the beginning of treatment, some patients may experience an increase in anxiety, which will disappear with continued treatment. Therefore, it is very important to follow your doctor's instructions exactly and not interrupt treatment or change the dose without consulting your doctor.

Thoughts of Suicide and Worsening of Depression or Anxiety

If you are depressed and/or have an anxiety disorder, you may, at times, have thoughts of harming yourself or taking your life. These may increase when you first start taking antidepressants, as all these medications require time to start working, usually around 2 weeks, although in some cases it may take longer.

You are more likely to have these thoughts:

• If you have previously had thoughts of harming yourself or taking your life.
• If you are ayoung adult. Information from clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric conditions who were treated with an antidepressant.

If you ever have thoughts of harming yourself or taking your life, contact your doctor or go directly to a hospital.

It may be helpful to tell a family member or close friendthat you are depressed or have an anxiety disorder and ask them to read this leaflet. You can ask them if they think your depression or anxiety has worsened, or if they are concerned about changes in your attitude.

Children and Adolescents

Citalopram should not normally be used in the treatment of children and adolescents under 18 years old. At the same time, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal behavior, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes it may prescribe citalopram to patients under 18 years old when they decide it is best for the patient. If the doctor who prescribes it has prescribed citalopram to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years old are taking citalopram. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of citalopram in this age group have not yet been demonstrated.

Other Medications and Citalopram Viatris

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications may affect the action of others and may cause adverse reactions at times.

Inform your doctor if you are using any of the following medications:

• Non-selective monoamine oxidase inhibitors (MAOIs), containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medications, you should wait 14 days before starting to take citalopram. After finishing treatment with citalopram, you should wait 7 days before taking any of these medications.
• Reversible selective MAO-A inhibitors, containing moclobemide (used for the treatment of depression).
• The antibiotic linezolid.
• Lithium (used for the prophylaxis and treatment of manic-depressive disorder), tryptophan, opioids (such as buprenorphine). These medications may interact with citalopram and you may experience symptoms such as involuntary muscle contractions, including those that control eye movement, agitation, hallucinations, coma, excessive sweating, tremors, exaggerated reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when 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 should not exceed 10 mg per day.
• Metoprolol (used for high blood pressure and/or heart disease); the blood levels of metoprolol increase, but no signs of increased effect or adverse effects of metoprolol have been observed.
• Sumatriptan and similar medications (used to treat migraines) and tramadol (used for severe pain) increase the risk of adverse effects, if you experience any unusual symptoms using this combination, you should see your doctor.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke).The levels of citalopram in the blood may be increased, but no increased adverse effects of citalopram have been reported.
• Medications that affect platelet function, for example, some antipsychotics, aspirin (used for pain), non-steroidal anti-inflammatory drugs (used for arthritis); they slightly increase the risk of bleeding disorders.
• St. John's Wort (Hypericum perforatum) (a herbal remedy used for depression); the concomitant administration with citalopram may increase the risk of adverse effects.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for severe pain), due to a possible risk of lowering the seizure threshold.
• Neuroleptics (medications for schizophrenia, psychosis), due to a possible risk of lowering the seizure threshold, and antidepressants.
• Class IA and III antiarrhythmics, antipsychotics (for example, phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (esparfloxacine, moxifloxacine, intravenous erythromycin, pentamidine, medications for malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine).
• Medications that lower potassium or magnesium levels, due to a possible risk of malignant arrhythmias.

Do not take citalopram if you are taking medications because you already have a disease that alters the heart rhythm or if you are taking medications that could affect the heart rhythm.

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

Taking Citalopram Viatris with Food and Alcohol

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

Citalopram has been observed not to increase the effects of alcohol. However, it is recommended to avoid alcohol consumption during treatment with citalopram.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication. Pregnant women should not normally take citalopram, and mothers should not breastfeed their babies while taking this medication, unless you and your doctor have analyzed the risks and benefits involved.

If you take citalopram during the last 3 months of your pregnancy and until the date of birth, be aware that the following effects may be observed in the newborn baby: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or weakness, exaggerated reflexes, tremors, restlessness, irritability, drowsiness, and difficulty falling asleep. If your newborn baby has any of these symptoms, please contact your doctor immediately.

If you take citalopram in the final stages of pregnancy, there may be an increased risk of excessive vaginal bleeding after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should know that you are taking citalopram to be able to advise you.

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

Make sure your midwife and/or doctor are informed that you are being treated with citalopram. During pregnancy, particularly in the last 3 months, medications 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 start within the first 24 hours after birth. If they appear 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 the impact on human fertility has not been observed so far.

Driving and Using Machines

Generally, citalopram does not cause drowsiness; however, if you feel dizzy or drowsy when starting to take this medication, do not drive or use tools or machinery until these effects disappear.

Citalopram Viatris contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor.In case of doubt, consult your doctor or pharmacist again.

Adults

Depression

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

Anxiety disorder

The initial dose is 10 mg per day for the first week before increasing it to 20-30 mg per day.

If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Obsessive-compulsive disorder (OCD)

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

Older adults (65 years and older)

In older adults, treatment should be initiated with half the recommended dose, for example, 10-20 mg per day.

Generally, older adults should not take more than 20 mg per day.

Patients with special risks

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

Use in children and adolescents

Citalopram should not be administered to children or adolescents. For additional information, please see section 2 “What you need to know before taking Citalopram Viatris”.

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How and when to take citalopram

Citalopram is taken once a day as a single daily dose.

Tablets can be taken at any time of the day regardless of meals.

Tablets should be swallowed with a glass of water. Do not chew.

The groove is only for breaking the tablet if it is difficult to swallow whole.

Treatment duration

Like other depression, anxiety disorder, and obsessive-compulsive disorder medications, it may take several weeks to feel some improvement. Continue taking citalopram even if you do not feel any improvement in your condition.

Do not change the medication dose without talking to your doctor first.

The treatment duration is individual, usually at least 6 months. Continue taking the tablets for the recommended time by your doctor. Do not stop taking them unless your doctor tells you to. The underlying disease may persist for a long time, and if you stop treatment too soon, your symptoms may reappear.

Patients with recurrent depression benefit from continued 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 you or someone else has taken more citalopram than they should, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

Do this even if you do not observe any symptoms or signs of overdose.

Bring the citalopram packaging with you to the doctor or hospital.

Some symptoms of an overdose may include irregular heartbeats with life-threatening risk, convulsions, changes in heart rhythm, drowsiness, coma, vomiting, tremors, decreased blood pressure, increased blood pressure, nausea (feeling dizzy), serotonin syndrome (see section 4. “Possible side effects”), agitation, dizziness, dilated pupils, sweating, blue 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 compensate for the missed doses.

If you stop taking Citalopram Viatris

Do not stop taking citalopram until your doctor tells you to. When you have completed your treatment period, it is usually recommended that the citalopram dose be gradually reduced over several weeks.

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

When you have finished your treatment period, it is usually recommended that the citalopram dose be gradually reduced over a couple of weeks instead of stopping it abruptly.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Some patients have reported the following serious side effects.

If you have any of the following symptoms, stop taking citalopram and see your doctor immediately.

• High fever, agitation, confusion, tremors, and sudden muscle contractions; they may be signs of a rare condition called serotonin syndrome, which has been reported with the combined use of antidepressants.
• If you notice skin swelling, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction).

• Unusual bleeding, including gastrointestinal bleeding.

Rarebut serious(may affect up to1 in every1,000people)

If you have any of the following symptoms, stop taking citalopram and see your doctor immediately.

• Hyponatremia: low sodium levels in the blood that can cause fatigue, confusion, and muscle cramps.
• Fast and irregular heartbeats or a feeling of fainting, as they may be symptoms of a serious heart condition known as torsade de pointes.

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

If the side 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 frequently than usual.

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

• Tendency to sleep.
• Difficulty sleeping.
• Increased sweating.
• Dry mouth.
• Nausea (feeling dizzy).
• Headache.

• Common(may affect up to1 in 10people)Decreased appetite.
• Agitation.
• Decreased sexual behavior.
• Anxiety.
• Nervousness.
• Confusion.
• Abnormal dreams.
• Tremors.
• Numbness or tingling in hands or feet.
• Dizziness.
• Attention alteration.
• Tinnitus (ringing in the ears).
• Yawning.
• Diarrhea.
• Vomiting.
• Constipation.
• Rash.
• Muscle and joint pain.
• Men may experience problems with ejaculation and erection.
• Women may experience difficulty reaching orgasm.
• Fatigue.
• Itching skin.
• Weight loss.

Uncommon(may affect up to1 in 1,000 people)

• Bleeding disorders (easy bruising).
• Increased appetite.
• Aggression.
• Depersonalization.
• Hallucinations.
• Mania.
• Fainting.
• Dilated pupils.
• Fast heartbeats.
• Slow heartbeats.
• Urticaria.
• Hair loss.
• Skin rash.
• Photophobia.
• Urination difficulties.
• Excessive menstrual bleeding.
• Swelling of arms and legs.
• Weight gain.

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

• Seizures.
• Involuntary movements.
• Alterations in taste.
• Bleeding.
• Hepatitis.
• Fever.

Frequency not known(cannot be estimated from available data)

• Thoughts of self-harm or suicidal thoughts, see also the "Warnings and precautions" section.
• Reduction of platelets in the blood, which increases the risk of bleeding or bruising (hematoma).
• Hypersensitivity (rash).
• Severe allergic reaction that causes difficulty breathing or dizziness.
• Increased urine production.
• Hypokalemia: low potassium levels in the blood that can cause muscle weakness, cramps, or irregular heartbeats.
• Panic attack.
• Chattering teeth.
• Restlessness.
• Abnormal muscle movements or stiffness.
• Akathisia (involuntary muscle movements).

• Visual disturbances.
• Low blood pressure.
• Nasal bleeding.
• Bleeding disorders, including skin and mucous membrane bleeding (ecchymosis).
• Excessive postpartum bleeding (hemorrhage), see 'Pregnancy, lactation, and fertility' in section 2 for more information.
• Sudden skin or mucous membrane swelling.
• Painful erections.
• Increased prolactin levels in the blood.
• Milk production in men and women who are not breastfeeding.
• Irregular menstrual periods.
• Altered liver function tests.
• Orthostatic hypotension (significant drop in blood pressure when standing up).
• There has been an increased risk of bone fractures in patients treated with this type of medication.
• Abnormal heart rhythm.

Reporting of side effects:

If you experienceany type ofside effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Citalopram Viatris Composition

• The active ingredient is citalopram (hydrobromide). Each tablet contains30 mg of citalopram.The other components (excipients) are lactose monohydrate, microcrystalline cellulose, cornstarch, povidone K30, crospovidone, magnesium stearate, hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide, purified water.

Product appearance and packaging contents

Citalopram Viatris 30 mg is presented in the form of film-coated, white, oval, convex, scored, and marked with “CM/30” on one side and “G” on the other.

It is presented in packaging of 28 or 56 tablets in blisters.

Only some packaging sizes may be commercially available.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/General Aranaz, 86

28027 - Madrid

Spain

Manufacturer:

Mylan Hungary Kft

H-2900 Komárom

Mylan utca 1

Hungary

Last review date of this leaflet:January 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/