PATIENT INFORMATION LEAFLET

Citalopram Teva-ratiopharm 10 mg Film-Coated Tablets

Read this leaflet carefully before you start to take 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. Do not give it 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 leaflet. See section 4.

Citalopram is a selective serotonin reuptake inhibitor (SSRI), and it 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 is 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 for you.

Do not take Citalopram Teva-ratiopharm

• 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 that belong 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 observed with an electrocardiogram, a test that evaluates how the heart functions).
• If you are taking medicines because you have a disease that alters the heart rhythm.
• If you are taking medicines that can affect the heart rhythm.

• Also see the section “Taking Citalopram Teva-ratiopharm with other medicines” 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 Teva-ratiopharm.

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

• If you have manic episodes or anxiety disorder.
• If you have liver or kidney disease. 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 the frequency of seizures increases (see also section 4 "Possible side 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 your heart beats slowly when you are at rest (this is known as bradycardia) and/or if 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 (medicines to urinate).

• If you have noticed that your heartbeats are rapid or irregular or if you 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 or have had eye problems in the past, such as certain types of glaucoma (increased pressure in the eye).
• Consult your doctor, even if any of the above circumstances 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 medicines 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 stopping treatment.

Special information related to your disease

Like other medicines used to treat depression or related diseases, improvement does not occur immediately. After starting treatment with citalopram, it may take several weeks before you experience any improvement.

In the treatment of anxiety disorder, it usually takes 2-4 weeks before any improvement is observed.

At the beginning of treatment, some patients may experience an increase in anxiety, which will disappear with continued treatment. Therefore, it is very important that you follow exactly your doctor's instructions and do 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 anxiety disorders, you may occasionally have thoughts of harming yourself or taking your life. These may increase when you first start taking antidepressants, as all these medicines take time to start working, usually around 2 weeks, although in some cases it may take longer.

You would be more prone to having these types of thoughts

• If you have previously had thoughts of harming yourself or taking your life.
• If you are a young adult. Information obtained from clinical trials has shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric diseases 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 for you 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 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 attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when they take this type of medicine. Despite this, the doctor who prescribes it may prescribe it to patients under 18 years old when they decide it is best for them. 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 of citalopram in terms of safety and related to growth, maturity, and cognitive and behavioral development in this age group have not yet been demonstrated.

Taking Citalopram Teva-ratiopharm with other medicines

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

Some medicines may affect the action of others and may cause sometimes severe adverse reactions.

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

• Non-selective monoamine oxidase inhibitors (MAOIs), containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine as active substances. If you have taken any of these medicines, 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 medicines.
• Selective reversible MAO-A inhibitors containing moclobemide (used for the treatment of depression).
• The antibiotic linezolid.
• Lithium (used for the prophylaxis and treatment of manic-depressive illness) 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 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 medicines (used to treat migraines) and tramadol and similar medicines (opioids, 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 increase in citalopram adverse effects has been reported.
• Medicines that affect platelet function, for example, some antipsychotics, aspirin (used for pain), non-steroidal anti-inflammatory drugs (used for arthritis); 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 to treat severe pain) due to a possible risk of lowering the seizure threshold.
• Neuroleptics (medicines for 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 antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, medicines against malaria, particularly halofantrine), certain antihistamines (astemizole, mizolastine).
• Medicines that decrease potassium or magnesium levels in the blood, as this increases the risk of cardiac arrhythmias, which are life-threatening.
• Medicines that are serotonergic, such as buprenorphine, as they may increase the risk of serotonin syndrome.

Do not takecitalopramif you are taking medicines because you already have a disease that alters the heart rhythm.

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

Taking Citalopram Teva-ratiopharm with food, drinks, and alcohol

Citalopram can be taken with or without food (see section 3. “How to take Citalopram Teva-ratiopharm).

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

Inform your doctorif you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Pregnant women should not normally take citalopram, and mothers should not breastfeed their babies while taking this medicine, 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, intense 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 stage 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 know that you are taking it so they can 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, medicines like citalopram may increase the risk of a serious disease 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, you should 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 until now, it has not been observed in human fertility.

Driving and operating machines

Generally, citalopram does not cause drowsiness; however, if you feel dizzy or drowsy when you start taking this medicine, do not drive or use tools or machinery until these effects disappear.

Citalopram Teva-ratiopharm contains lactose and sodium

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

Follow the medication administration instructions exactly. If in doubt, consult your doctor or pharmacist again.

Adults

Depression

The recommended 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 recommended 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 the dose up to a maximum of 40 mg per day.

Obsessive-compulsive disorder (OCD)

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

Older patients

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

In general, older patients should not take more than 20 mg per day.

Patients with special risks

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

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 starting to take Citalopram Teva-ratiopharm”.

How and when to take Citalopram Teva-ratiopharm

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 them (they have a bitter taste).

There are other commercial presentations with the same active ingredient that allow administering 20, 30 or 40 mg of citalopram.

Treatment duration

Like other depression, anxiety disorder, and obsessive-compulsive disorder medications, it may take several weeks to find 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 Teva-ratiopharm 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 room, or call the Toxicology Information Service, phone 915.620.420, indicating the medication and the amount taken.

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

Bring the citalopram packaging with you if you visit the doctor or hospital.

Some symptoms of an overdose may include irregular heartbeats with a risk to life, 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, blue skin, hyperventilation (increased respiratory rate).

If you forget to take Citalopram Teva-ratiopharm

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 interrupt treatment with Citalopram Teva-ratiopharm

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

Abrupt withdrawal of the medication may cause some mild or transient disturbances such as dizziness, feeling of pins and needles, 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 to gradually reduce the citalopram dose 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 side effects can also be symptoms of your illness and will therefore improve when 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 that has been reported with the combined use of antidepressants.
• If you notice swelling of the skin, tongue, lips, or face, or have difficulty breathing or swallowing (allergic reaction).
• Unusual bleeding, including gastrointestinal bleeding.

Rare but serious side effects (May affect up to 1 in 1,000 people):

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 dizziness, as they may be symptoms of a serious heart problem known as torsade de pointes.

The following side effects are generally mild and usually disappear after a few days of treatment. Please note that several of the side effects mentioned below may be symptoms of your illness and will therefore improve when 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 side effects (May affect more than 1 in 10 people):

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

Common side effects (May affect up to 1 in 10 people):

• Loss of appetite
• Agitation
• Decreased libido
• Anxiety
• Nervousness
• Confusion
• Abnormal dreams
• Tremors
• Numbness or tingling in hands or feet
• Dizziness
• Alteration of attention
• 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 side effects (May affect up to 1 in 100 people):

• Cutaneous hemorrhagic disorders (easy bruising)
• Increased appetite
• Aggression
• Depersonalization
• Hallucinations
• Mania
• Syncopes
• Dilated pupils
• Fast heartbeats
• Slow heartbeats
• Urticaria
• Hair loss
• Cutaneous eruption
• Photophobia
• Urinary 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 of taste
• Bleeding
• Hepatitis
• Fever

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

• Thoughts of self-harm or thoughts of suicide, see also the "Warnings and precautions" section
• Reduction of platelets in the blood, which increases the risk of bleeding or ecchymosis (hematoma).
• Hypersensitivity (rash)
• Severe allergic reaction that causes difficulty breathing or dizziness
• Increased urine output
• Hypokalemia: low potassium levels in the blood that can cause muscle weakness, cramps, or irregular heartbeats
• Panic attack
• Chattering of teeth
• Restlessness
• Abnormal muscle movements or stiffness
• Akathisia (involuntary movements of the muscles)
• Visual disturbances
• Low blood pressure
• Nasal bleeding
• Bleeding disorders, including skin and mucous membrane bleeding (ecchymosis)
• Heavy vaginal bleeding shortly after delivery (postpartum hemorrhage), see 'Pregnancy, lactation, 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 flow in men and women who are not breastfeeding
• Irregular menstrual periods
• Altered liver function tests
• Orthostatic hypotension (significant drop in blood pressure when standing)
• A higher risk of bone fractures has been observed in patients treated with this type of medication
• Abnormal heart rhythm

If you experience side effects, consult your doctor or pharmacist, even if it is side effects that do not appear in this leaflet.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use website: 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.

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

This medication does not require special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Citalopram Teva-ratiopharm 10 mg tablet composition

• The active ingredient is citalopram (as hydrobromide). One tablet contains 10 mg of citalopram.
• The other components (excipients) are: cornstarch, lactose monohydrate, sodium croscarmellose, glycerol, copovidone, magnesium stearate microcrystalline cellulose, hypromellose 5, macrogol 400, and titanium dioxide (E-171).

Product appearance and packaging contents

Coated tablet. Coated, round, biconvex, white tablet.

It is presented in packaging of 14 and 28 coated tablets, conditioned in blisters.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder :

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/. Laguna 66-68-70, Industrial Park Urtinsa II

28923 ALCORCÓN (Madrid) Spain

or

RIVOPHARM PHARMACEUTICALS LABORATORIES

Via Cantonale, Centro Insema C

Manno-Switzerland

Last review date of this leaflet: February 2025

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