Package Leaflet: Information for the User

Citalopram Teva-ratiopharm 20 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Citalopram Teva-ratiopharm is and what it is used for

2. What you need to know before you start taking Citalopram Teva-ratiopharm

3. How to take Citalopram Teva-ratiopharm

4. Possible side effects

5. Storage of Citalopram Teva-ratiopharm

6. Contents of the pack and additional information

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 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.

Do not take CitalopramTeva-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 had any heart rhythm disorder since birth or have ever had any episode of this type (this is observed with an electrocardiogram, a test that evaluates how the heart works),
• 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 “Other medicines and Citalopram Teva-ratiopharm” 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.

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 disorders.
• If you have liver or kidney failure. Your doctor may need to adjust the dose.
• If you have diabetes. Citalopram treatment may alter blood sugar control. You may need to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you have epilepsy. Citalopram treatment 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 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 intense diarrhea and vomiting for several days or because you have used diuretics (medicines 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 haveor 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 at some 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 illness

Like other medicines used to treat depression or related illnesses, improvement is not immediate. After starting citalopram treatment, 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 your doctor's instructions exactly and do not interrupt treatment or change the dose without consulting your doctor.

Thoughts of suicide and worsening of your depression or anxiety disorder

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 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 illnesses who were treated with an antidepressant.

If at any time you 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 disorder 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.

At the same time, you should know that in patients under 18 years, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behavior, and irritability) when taking this type of medicine. However, the doctor who prescribes it may prescribe it to patients under 18 years when they decide what is best for them. If the doctor who prescribes it has prescribed citalopram to a patient under 18 years 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 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 medicines and Citalopram Teva-ratiopharm

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 this can sometimes cause 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 citalopram treatment, 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 for the treatment of 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 are increased but no signs of increased effect or adverse effects of metoprolol have been observed.
• Sumatriptan and similar medicines (used for migraines) and tramadol and similar medicines (opioids used for severe pain) increase the risk of adverse effects, if you have any unusual symptoms when using this combination, you should see your doctor.
• Cimetidine, lansoprazole, and omeprazole (used for stomach ulcers), fluconazole (used for 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 antiplatelet drugs, 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); concomitant administration with citalopram may increase the risk of adverse effects.
• Mefloquine (used for malaria), bupropion (used for depression), and tramadol (used for 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, antimalarial drugs particularly halofantrine), certain antihistamines (astemizole, mizolastine).
• Medicines thatlower sodium or magnesium levels in the blood, as this increases the risk of heart rhythm disorders, which are life-threatening.
• Medicines thatserotoninergic, such as buprenorphine, as they may increase the risk of serotonin syndrome.

Do not take citalopram

If you are taking medicines because you already have a disease that alters the heart rhythm or if you are taking medicines that could affect the heart rhythm.

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

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

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

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

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 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 up to 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 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 know that you are taking this medicine 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 illness 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 using machines

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

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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.

Panic Disorder

The recommended 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 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 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 Teva-ratiopharm”.

How and When to Take Citalopram Teva-ratiopharm

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

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

The tablets should be swallowed with a glass of water. Do not chew (has a bitter taste).

There are other commercial presentations with the same active ingredient that allow administering 10, 20, or 40 mg of citalopram.

Treatment Duration

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

Never 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, consult your doctor or pharmacist immediately, go to the nearest hospital emergency department, or contact the Toxicology Information Service, phone 915620420, 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, 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 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 Stop 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 that the citalopram dose be gradually reduced over several weeks.

Stopping the medication abruptly 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 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, which 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.

• Hypontremia: 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 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 side effects mentioned below can 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):

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

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

• Decreased appetite.
• Agitation.
• Decreased sexual behavior.
• Anxiety.
• Nervousness
• Confusional state.
• Abnormal dreams.
• Tremors.
• Tickling or numbness of 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.
• Fever.
• 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.
• 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 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 section "Warnings and precautions"
• 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 abnormal heart rhythm.
• Panic attack.
• Clicking 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).
• Excessive postpartum bleeding (hemorrhage), see 'Pregnancy, lactation, and fertility' in section 2 for more information

• Sudden skin or mucous membrane swelling.
• Painful erections.
• Increased levels of prolactin hormone in the blood.
• Milk flow in men and in women who are not breastfeeding.
• Irregular menstrual periods.
• Altered liver function tests.
• Orthostatic hypotension (significant drop in blood pressure when an individual stands up).
• 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 they are side effects that do not appear in this leaflet.

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 the abbreviation CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

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Composition of Citalopram Teva-ratiopharm 20 mg coated tablets

The active ingredient is citalopram.

Each coated tablet contains 24.99 mg of citalopram hydrobromide equivalent to 20 mg of citalopram.

The other components (excipients) are: mannitol (E-421), microcrystalline cellulose, magnesium stearate, anhydrous colloidal silica, hypromellose, macrogol 6000, and titanium dioxide (E-171).

Appearance of the product and content of the container

Citalopram Teva-ratiopharm 20 mg are coated tablets. The coated tablets are round, white, and scored.

Containers of 14, 28, 56, and 500 (clinical container) coated tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Teva Pharma, S.L.U.

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

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing

Merckle GmbH

Ludwig Merckle Strasse 3

89143 – Blaubeuren (Germany)

Last review date of this leaflet: April 2025

The detailed and updated information on this medication is available on the website of

the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/