CITALOPRAM COMBIX 10 mg FILM-COATED TABLETS

2. What you need to know before you take Citalopram Combix

Do not take Citalopram Combix

• 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, and tranylcypromine (used in the treatment of depression), selegiline (used in the treatment of Parkinson's disease), and linezolid (an antibiotic).
• If you have been born with any heart rhythm problems or have ever had any heart rhythm problems (this can be seen on an electrocardiogram, a test that checks how your heart is working).
• If you are taking medicines because you have a heart condition that affects your heart rhythm.
• If you are taking medicines that may affect your heart rhythm.
• Also, see the section "Other medicines and Citalopram Combix" below.

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

A day must pass after taking moclobemide.

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Citalopram Combix.

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

• If you have had manic episodes or anxiety disorders.
• If you have liver or kidney problems. Your doctor may need to adjust the dose.
• If you have diabetes. Treatment with citalopram may affect blood sugar control. You may need to adjust the dose of insulin and/or oral hypoglycemics.
• If you have epilepsy. 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 any bleeding disorders or if you are pregnant (see "Pregnancy").

• 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 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 heart beats quickly or irregularly 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 problem.
• If you have a problem with the dilation of the pupils (mydriasis).

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

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

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

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

Special information related to your illness

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

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

At the start 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 stop treatment or change the dose without consulting your doctor.

Suicidal thoughts and worsening of your depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may sometimes have thoughts of harming or killing yourself. These may increase when you first start taking antidepressants, as these medicines take time to start working, usually around 2 weeks, although in some cases it may be longer.

Youwould be more likely to have these thoughts:

• If you have previously had thoughts of killing or harming yourself.
• If you are a young 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 at any time you have thoughts of harming or killing yourself, contact your doctor or go directly to a hospital.

It may be helpful for you to tell a relative 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 gotten worse or if they are worried 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 greater risk of adverse effects such as suicidal attempts, suicidal ideas, and hostility (mainly aggression, confrontational behavior, and irritation) when taking this type of medicine. Nevertheless, the doctor who prescribes it to you may prescribe citalopram to patients under 18 years when they decide it is the most convenient for the patient. If the doctor who prescribes it to you has prescribed citalopram to a patient under 18 years and you want to discuss this decision, please go back to your doctor. You must inform your doctor if any of the symptoms mentioned 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, growth, maturity, and cognitive and behavioral development of citalopram in this age group have not yet been demonstrated.

Other medicines and Citalopram Combix:

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Some medicines can affect the action of other medicines and can cause serious side effects.

Tell 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 must wait 14 days before starting to take citalopram. After finishing treatment with citalopram, you must wait 7 days before taking any of these medicines.
• Reversible selective inhibitors (MAO A containing moclobemide (used for the treatment of depression).
• The antibiotic linezolid.
• Lithium (used for the prophylaxis and treatment of manic-depressive disorder) 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); 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 migraine) and tramadol (used for 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 to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase the levels of citalopram in the blood.
• Medicines that affect platelet function, for example, some antipsychotic drugs, acetylsalicylic acid (used for pain), non-steroidal anti-inflammatory drugs (used for arthritis); these slightly increase the risk of bleeding disorders.
• St. John's Wort (Hypericum perforatum) (a herbal remedy used for depression); concomitant administration with citalopram may increase the risk of adverse effects.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used to treat severe pain) due to a possible risk of lowering the threshold for seizures.
• Neuroleptics (medicines for treating schizophrenia, psychosis), due to a possible risk of lowering the threshold for seizures, and antidepressants.
• Antiarrhythmics class IA and III, 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 that lower potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disorders.

Do not take citalopram

if you are taking medicines because you already have a heart condition that affects your heart rhythm or if you are taking medicines that may affect your heart rhythm.

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

Using Citalopram Combix with food, drinks, and alcohol:

Citalopram can be taken with or without food (see section 3. "How to take Citalopram Combix").

It has been observed that citalopram does not increase the effects of alcohol. However, it is advisable to avoid consuming alcohol during treatment with citalopram.

Pregnancy, breastfeeding, and fertility:

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Pregnant women should not normally take citalopram, nor should breastfeeding mothers, unless you and your doctor have discussed the risks and benefits involved.

Pregnancy

If you take citalopram during the last 3 months of your pregnancy and up to the date of delivery, be aware that the following effects may be seen in the newborn baby: difficulty breathing, blue skin, seizures, changes in body temperature, difficulty feeding, vomiting, low blood sugar, muscle stiffness or floppiness, intense reflexes, tremors, restlessness, irritability, lethargy, constant crying, and difficulty sleeping. If your newborn baby has any of these symptoms, please contact your doctor immediately.

If you take Citalopram Combix in the final stage of pregnancy, there may be a greater 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 Combix so they can advise you.

Breastfeeding

Citalopram passes into breast milk in small amounts. There is a risk of effects on 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 (PPHN), in which the baby breathes quickly and turns blue. These symptoms usually start during 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. This effect could theoretically affect fertility, but to date, no impact on human fertility has been observed.

Driving and using machines

During treatment with citalopram, you may feel drowsy or dizzy. Do not drive or operate tools or machines until you know how the treatment with citalopram affects you.

This medicine contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

3. How to take Citalopram Combix

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

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.

Elderly patients (over 65 years old)

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

Generally, 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, please see section 2 "What you need to know before taking Citalopram Combix".

How and when to take Citalopram Combix

Citalopram is taken every day as a single daily dose.

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

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

Duration of treatment

Like other medications for depression, anxiety disorder, and obsessive-compulsive disorder, it may take several weeks before you notice any improvement. Continue taking citalopram even if it takes some time before you feel any improvement in your condition.

Never change the dose of the medication without talking to your doctor first.

The duration of treatment is individual, generally at least 6 months. Continue taking the tablets for the time recommended by your doctor. Do not stop taking them even if you feel better, unless your doctor has told you to do so. The underlying disease may persist for a long time, and if you interrupt your treatment too early, 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 Combix than you should:

If you think you or someone else has taken more citalopram than you should, contact your doctor or pharmacist immediately, go to the emergency department of the nearest hospital, or call the Toxicology Information Service, phone: 91 562 0420, indicating the medication and the amount ingested.

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

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

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

If you forget to take Citalopram Combix

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Citalopram Combix:

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

Sudden withdrawal of the medication can produce some mild or transient disorders, such as dizziness, tingling sensation, 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 irritation, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

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

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

4. Possible side effects

Like all medications, this medication can produce side effects, although not all people 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 disease 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, you should stop taking citalopram and see your doctor immediately.

• High fever, agitation, confusion, tremors, and sudden muscle contractions; 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 swelling, 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, you should stop taking Seropram and go to your doctor immediately.

• Hyponatremia: low sodium level in the blood, which can cause fatigue, confusion, and muscle contractions.
• Rapid and irregular heartbeats or feeling of fainting, as they could 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 be aware that several of the effects mentioned below can be symptoms of your disease 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 often than usual.

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

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

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

• Decreased appetite.
• Agitation.
• Decreased sexual behavior.
• Anxiety.
• Nervousness.
• Confusional state.
• Abnormal dreams.
• Tremors.
• Tingling or numbness of hands or feet.
• Dizziness.
• Attention disturbance.
• Ringing in the ears (tinnitus).
• 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 of the skin.
• Weight loss.

Uncommon side effects (may affect up to 1 in 100 people):

• Bleeding disorders (easy bruising).
• Increased appetite.
• Aggressiveness.
• Depersonalization.
• Hallucinations.
• Mania.
• Fainting.
• Dilated pupils.
• Rapid heartbeats.
• Slow heartbeats.
• Hives.
• Hair loss.
• Skin rash.
• Sensitivity to light.
• Difficulty urinating.
• Excessive menstrual bleeding.
• Swelling of arms and legs.
• Weight gain.

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

• Seizures.
• Involuntary movements.
• Taste disturbances.
• Bleeding.
• Hepatitis.
• Fever.

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

• Thoughts of self-harm or suicidal thoughts, see also section "Warnings and precautions".
• Reduced platelet count in blood, which increases the risk of bleeding or bruising.
• Hypersensitivity (rash).
• Severe allergic reaction that causes difficulty breathing or dizziness.
• Increased urine production.
• Hypokalemia: low potassium level in the blood, which can cause muscle weakness, contractions, or abnormal heart rhythm.
• Panic attack.
• Teeth grinding.
• Restlessness.
• Abnormal muscle movements or stiffness.
• Akathisia (involuntary muscle movements).
• Visual disturbances.
• Low blood pressure.
• Nosebleeds.
• Bleeding disorders, including skin and mucous membrane bleeding (ecchymosis).
• Sudden swelling of the skin or mucous membranes.
• Painful erections.
• Milk flow in men and in women who are not breastfeeding.
• Irregular menstrual period.
• Abnormal liver function tests.
• Orthostatic hypotension (significant drop in blood pressure that occurs when an individual stands up).
• An increased risk of bone fractures has been observed in patients treated with this type of medication.

• Abnormal heart rhythm.
• Excessive vaginal bleeding shortly after childbirth (postpartum hemorrhage), see "Pregnancy" in section 2 for more information.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Citalopram Combix

This medication does not require special storage conditions.

Keep this medication out of sight and reach of children.

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

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Citalopram Combix:

The active ingredient is citalopram (hydrobromide). Each tablet contains 10 mg of citalopram.

The other components (excipients) are:

Core: cornstarch without gluten, microcrystalline cellulose, copovidone, sodium croscarmellose, magnesium stearate, glycerol, lactose monohydrate.

Coating: hypromellose E5, macrogol 400, titanium dioxide (E-171).

Appearance of the product and package contents:

Citalopram Combix is presented in the form of film-coated tablets, white, round, biconvex, smooth on both sides. It is available in packages of 14 and 28 tablets and a clinical package of 500 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/Laguna 66-70. Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Date of the last revision of this prospectus:December 2020

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