P atient Information

Citalopram Sandoz 20 mg Film-Coated Tablets

Citalopram Sandoz 30 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, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Citalopram Sandoz is and what it is used for.

2. What you need to know before taking Citalopram Sandoz.

3. How to take Citalopram Sandoz.

4. Possible side effects.

5. Storage of Citalopram Sandoz.

6. Contents of the pack and additional information.

Citalopram is a selective serotonin reuptake inhibitor (SSRI) and belongs to a group ofmedicines known as antidepressants. These medicines help correct certainchemical imbalances in the brain, which 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 Sandoz

-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 (for the treatment of Parkinson's disease), moclobemide (for the treatment of depression), and linezolid (an antibiotic).

-If you have had a heart rhythm disorder since birth or have had an episode of this type at any time (this is seen on an electrocardiogram, a test that evaluates how the heart works).

-If you are taking medicines because you have a heart rhythm disorder.

-If you are taking medicines that can affect the heart rhythm.

• See also the section “Other medicines and Citalopram Sandoz” below.

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

You should wait a day after taking moclobemide.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Citalopram Sandoz.

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 failure. Your doctor may need to adjust the dose.
• If you have diabetes. The treatment with citalopram may affect 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 side effects").
• If you have a history of bleeding disorders, if you develop unusual bleeding 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 (medicines to urinate).
• If you have noticed that your heartbeats are fast or irregular or have had fainting or dizziness 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 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 for the treatment of depression or related illnesses, 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 to 4 weeks to observe any improvement.

At the beginning of treatment, some patients may experience an increase in anxiety, which disappears with continued treatment. Therefore, it is very important that you follow your doctor's instructions exactly and do not interrupt 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 an anxiety disorder, 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 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 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.

Despite this, your doctor may prescribe citalopram for patients under 18 years if they decide it is the best option for the patient. If your doctor has prescribed citalopram and you are a patient under 18 years and want to discuss this decision, please go back to your doctor. You should inform your doctor if any of the symptoms mentioned above worsen or if you experience complications when patients under 18 years are taking this citalopram. At the same time, the long-term effects on safety and related to growth, maturity, and cognitive and behavioral development of this citalopram in this age group have not yet been demonstrated.

Other medicines and Citalopram Sandoz

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

Some medicines can 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) that contain 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 that contain moclobemide (for the treatment of depression).
• The antibiotic linezolid.
• Lithium (for prophylaxis and treatment of manic-depressive disorder) and tryptophan.
• Imipramine and desipramine (for the treatment of depression).
• Irreversible MAO-B inhibitors, which contain selegiline (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 (for the treatment of 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 (for the treatment of migraine) and opioids such as tramadol and buprenorphine (for the treatment of severe pain) increase the risk of adverse effects, if you experience any unusual symptoms when using this combination, you should see your doctor.
• Cimetidine, lansoprazole, and omeprazole (used for the treatment of stomach ulcers), fluconazole (used for the treatment of fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). They may increase the levels of citalopram in the blood, but no increase in citalopram adverse effects has been reported.
• Medicines that affect platelet function (for example, some antipsychotics, aspirin (for pain relief), non-steroidal anti-inflammatory drugs (for arthritis); they 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 (for the treatment of malaria), bupropion (for the treatment of depression), and tramadol (for the treatment of severe pain) due to a possible risk of lowering the threshold for seizures.
• Neuroleptics (medicines for the treatment of schizophrenia, psychosis), due to a possible risk of lowering the threshold for seizures, and antidepressants.
• Class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobials (sparfloxacin, moxifloxacin, erythromycin IV, pentamidine, antimalarial medicines particularly halofantrine), certain antihistamines (astemizol, mizolastine).
• Medicines that lower potassium or magnesium levels in the blood, as they increase the risk of heart rhythm disorders, which are life-threatening. Do not take citalopram if you are taking medicines because you have a heart rhythm disorder or if you are taking medicines that could affect the heart rhythm. If you have any doubts about this, consult your doctor.

Taking Citalopram Sandoz with food, drinks, and alcohol

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

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 medicine.

Women who are pregnant should not normally take citalopram, and mothers should not breastfeed their babies while taking this medicine, unless your doctor has 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 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 taking 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 operating machinery

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 Sandoz contains lactose and sodium

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 1 mmol of sodium (23 mg) per coated tablet; this is, essentially “sodium-free”.

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 or 30 mg per day. Your doctor, if necessary, 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. Your doctor, if necessary, may increase this dose up to a maximum of 40 mg per day.

Advanced age (over 65 years)

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

In general, elderly 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, see section 2 “What you need to know before starting to take Citalopram Sandoz”.

How and when to take Citalopram Sandoz

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).

Treatment duration

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

Never modify the medication dose without talking to your doctor first.

The treatment duration is individual, generally 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 period, and if you stop treatment too soon, your symptoms may reappear.

Patients with recurrent depressions benefit from continued treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.

If you take more Citalopram Sandoz than you should.

If you have taken more Citalopram Sandoz than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.Do this even when you do not observe any discomfort or signs of intoxication. Bring the Citalopram Sandoz packaging with you to the doctor or hospital.

Some symptoms of an overdose may include irregular heartbeats with life-threatening risk, 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 forgot to take Citalopram Sandoz

If you forgot 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 Sandoz

Do not stop taking Citalopram Sandoz until your doctor tells you to. When you have completed your treatment, it is generally 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, tingling sensation, sleep disturbances (intense dreams, nightmares, inability to sleep), anxiety feeling, headache, dizziness (nausea), vomiting, sweating, restlessness or agitation, tremors, feeling of confusion or disorientation, emotional or irritable feelings, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

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

If you have any other doubts 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 skin swelling, 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 patients):

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 note 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 patients):

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

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

• 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.
• Fever.
• Itching skin.
• Weight loss.

Rare side effects (may affect up to 1 in 100 patients):

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

Rare side effects (may affect up to 1 in 1,000 patients):

• 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 output.
• Hypokalemia: low potassium levels in the blood that can cause muscle weakness, cramps, or abnormal heart rhythm.
• Panic attacks.
• 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).
• Sudden skin or mucous membrane swelling.
• Painful erections.
• Increased prolactin levels in the blood.
• Milk flow in men and women who are not breastfeeding.
• Irregular menstrual periods.
• Abundant vaginal bleeding shortly after delivery (postpartum hemorrhage), see "Pregnancy, lactation, and fertility" in section 2 for more information.
• Altered liver function tests.
• Orthostatic hypotension (significant drop in blood pressure when standing up).
• An increased 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 about side effects that do not appear in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is about possible side effects that do not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout 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/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 packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medicines. By doing so, you will help protect the environment.

Citalopram Sandoz 20 mg Film-Coated Tablets Composition:

• The active ingredient is citalopram. Each tablet contains 24.99 mg of citalopram hydrobromide (equivalent to 20 mg of citalopram).

The other components (excipients) are: maize starch, lactose monohydrate, povidone K64, glycerol 85% (E-422), microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch (type A) (derived from potato starch), hypromellose, titanium dioxide (E 171), macrogol 6000, and talc.

Citalopram Sandoz 30 mg Film-Coated Tablets Composition:

• The active ingredient is citalopram. Each tablet contains 37.48 mg of citalopram hydrobromide (equivalent to 30 mg of citalopram).
• The other components (excipients) are: maize starch, lactose monohydrate, povidone K64, glycerol 85% (E-422), microcrystalline cellulose, magnesium stearate, sodium carboxymethyl starch (type A) (derived from potato starch), hypromellose, titanium dioxide (E 171), macrogol 6000, and talc.

Appearance of the Product and Contents of the Package:

Citalopram Sandoz 20 mg are film-coated tablets, white, oblong, biconvex, scored on one side, and marked with “C20” on the other. They are packaged in PVC/Aluminum or Aluminum/PVC/PVDC blisters within cartons of 14, 28, or 56 tablets.

Citalopram Sandoz 30 mg are film-coated tablets, white, oblong, biconvex, scored on one side, and marked with “C30” on the other.

They are packaged in PVC/Aluminum or Aluminum/PVC/PVDC blisters within cartons of 28 or 56 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer:

Marketing Authorization Holder:

Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible Manufacturer:

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

Barleben 39179

Germany

LEK, S.A.

Ul Domaniewska 50 C,

Warsaw, PL 02-672

Poland

Last Review Date of this Leaflet: July 2024

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