Citalopram Alter 30 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Citalopram Alter 30 mg film-coated tablets EFG

Read the entire 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Citalopram Alter is and what it is used for.
2. What you need to know before taking Citalopram Alter.
3. How to take Citalopram Alter.
4. Possible side effects.
5. How to store Citalopram Alter.
6. Contents of the pack and other information.

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

Citalopram Alter is a "selective serotonin reuptake inhibitor" (SSRI) and belongs to the group of antidepressant medicines. These medicines help correct certain chemical imbalances in the brain that cause the symptoms of your illness.

Citalopram Alter is indicated for:

• Depression and prevention of relapses and recurrences.
• Treatment of panic disorder with or without agoraphobia.
• Treatment of obsessive-compulsive disorder (OCD).

However, your doctor may prescribe this medicine for any other purpose. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What you need to know before taking Citalopram Alter

Do not take Citalopram Alter:

• If you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6).
• If you are being treated with other antidepressant medicines belonging to the group of 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 were born with a heart rhythm disorder or have ever experienced an episode of this type (this is detected by electrocardiogram, a test used to assess heart function).
• If you are taking medicines for a condition that affects your heart rhythm.
• If you are taking medicines that may affect your heart rhythm.

Also refer to the section “Taking Citalopram Alter with other medicines” below.

Even if you have completed treatment with MAOIs, you must wait 2 weeks before starting citalopram treatment.

You must wait 1 day after taking moclobemide.

After stopping citalopram, you must wait 1 week before taking any MAOI.

Warnings and precautions:

Talk to your doctor or pharmacist before taking Citalopram Alter.

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

If you have manic episodes or panic disorder

• If you have hepatic impairment or severe renal impairment. Your doctor may need to adjust your dose.

• If you have had manic episodes.

• If you have or have a history of epilepsy. 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 seizures develop or the frequency of seizures increases, treatment with citalopram should be stopped.

• If you have diabetes. Treatment with citalopram may affect blood glucose control. You may need an adjustment in the dose of insulin and/or oral hypoglycemic agents, as you may require a change in insulin or oral antidiabetic dosage.

• If you have a history of bleeding disorders or if you develop unusual bruising, or if you are being treated with medicines that affect blood clotting, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).

• If you have low sodium levels in your blood.

• If you are receiving electroconvulsive therapy.

• If you have or have had heart problems or have recently suffered a heart attack.

• If your heart beats slowly at rest (known as bradycardia) and/or if you think your body may be losing salts, for example due to severe diarrhea and vomiting over several days or because you have used diuretics (medicines that increase urine production).

• If you have noticed that your heartbeat is fast or irregular, or if you have experienced fainting or dizziness when standing up from a sitting or lying position. This could indicate a heart rhythm disorder.

• If you have or have previously had eye problems such as certain types of glaucoma (increased pressure in the eye).

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

Some patients with bipolar disorder may enter a manic phase. This is characterized by unusually rapid and frequent changes in thoughts, excessive happiness, 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 same group as citalopram (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Special information regarding your condition

Like other medicines used to treat depression or related disorders, improvement is not immediate. After starting treatment with Citalopram Alter, it may take several weeks before you notice any improvement.

In the treatment of panic disorder, improvement is usually observed after 2–4 weeks.

At the beginning of treatment, some patients may experience increased anxiety, which will resolve with continued treatment. Therefore, it is very important that you follow your doctor’s instructions exactly and do not stop treatment or change your dose without consulting your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from an anxiety disorder, you may occasionally have thoughts about harming yourself or ending your life. These may increase when starting antidepressants for the first time, as all these medicines require time to start working—usually about two weeks, although in some cases it may take longer.

You would be more likely to have these types of thoughts:

• If you have previously had thoughts about harming yourself or ending your life.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years) with psychiatric disorders who were treated with an antidepressant.

If at any time you have thoughts about harming yourself or ending your life, contact your doctor or go directly to a hospital.

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

Children and adolescents under 18 years of age

Citalopram Alter should not normally be used in the treatment of children and adolescents under 18 years of age. Also, you should be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal ideation, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Citalopram Alter to patients under 18 years of age if they decide it is the most appropriate treatment for the patient. If your doctor has prescribed Citalopram Alter to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. You should inform your doctor if any of the symptoms mentioned above worsen or develop complications while patients under 18 years of age are taking Citalopram Alter. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioural development of Citalopram Alter in this age group have not yet been established.

Taking Citalopram Alter with other medicines

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

Some medicines may affect the action of others and this can sometimes cause serious adverse reactions.

Tell your doctor if you are taking any of the following medicines:

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, or tranylcypromine as active substances. If you have taken any of these medicines, you must wait 14 days before starting citalopram. After stopping citalopram, you must wait 7 days before taking any of these medicines.
• Reversible selective MAO-A inhibitors containing moclobemide (used for the treatment of depression).
• The antibiotic linezolid.
• Lithium (used for prophylaxis and treatment of bipolar 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 must not exceed 10 mg per day.
• Metoprolol (used for high blood pressure and/or heart disease); blood levels of metoprolol may 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 and similar medicines (opioids, used for severe pain) increase the risk of adverse effects; if you experience any unusual symptoms while taking this combination, you should see your doctor.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). Blood levels of citalopram may be increased, but no increase in citalopram adverse effects has been reported.
• Medicines that affect platelet function, for example certain antipsychotics, 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 use 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 used to treat 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 antimicrobial agents (sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials particularly halofantrine), certain antihistamines (astemizole, mizolastine).
• Medicines that reduce potassium or magnesium levels in blood, as this increases the risk of life-threatening heart rhythm disturbances.

Taking Citalopram Alter with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnant women should not normally take citalopram, nor should mothers breastfeed while taking this medicine, unless you and your doctor have discussed the risks and benefits involved.

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

If you take Citalopram Alter in late 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 be aware that you are taking citalopram so they can advise you.

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

Make sure your midwife and/or doctor knows that you are taking citalopram. During pregnancy, particularly in the last 3 months, medicines like Citalopram Alter could increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear bluish. These symptoms usually begin within the first 24 hours after birth.

If these symptoms occur in your baby, 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 to date, no impact on human fertility has been observed.

Driving and using machines

During treatment with Citalopram Alter, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this medicine affects you.

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

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

3. How to take Citalopram Alter

Follow exactly the dosing instructions for this medicine as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults:

Depression

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

Panic disorder

The initial dose is 10 mg daily for the first week, before increasing it to 20–30 mg daily. 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 daily. If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Elderly patients (over 65 years of age)

Treatment in elderly patients should be initiated at half the recommended dose, for example 10–20 mg daily.

In general, elderly patients should not take more than 20 mg daily.

Patients with special risks

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

Use in children and adolescents

This medicine must not be administered to children or adolescents. For further information, please see section 2, “What you need to know before taking Citalopram Alter”.

How and when to take Citalopram Alter

Citalopram is taken every day as a single daily dose. The tablets may be taken at any time of day, regardless of meals. The tablets should be swallowed with a glass of water. Do not chew them.

Duration of treatment

Like other medicines for depression, panic 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 better.

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

The duration of treatment is individual, but generally at least 6 months. Continue taking the tablets for as long as recommended by your doctor. Do not stop taking them, even if you feel better, unless your doctor tells you to do so. The underlying condition may persist for a long time, and if you stop treatment too early, your symptoms may return.

Patients with recurrent depression benefit from continuation treatment, sometimes for several years, to prevent the recurrence of depressive episodes.

If you take more Citalopram Alter than you should

If you have taken more citalopram than you should, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 5620420, indicating the medicine and the amount ingested.

Do this even if you do not notice any discomfort or signs of poisoning. Take the medicine’s packaging with you if you go to the doctor or hospital.

Some symptoms of an overdose may include life-threatening irregular heartbeats, seizures, changes in heart rhythm, drowsiness, coma, vomiting, tremors, increased or decreased blood pressure, nausea (feeling sick), serotonin syndrome (see section 4, “Possible side effects”), agitation, dizziness, dilated pupils, sweating, bluish skin, hyperventilation (increased breathing rate).

If you forget to take Citalopram Alter

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

If you stop taking Citalopram Alter

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.

Stopping the medication abruptly may cause some mild or transient disturbances, such as dizziness, tingling sensations, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling anxious, headache, feeling lightheaded (nausea), vomiting, sweating, restlessness or agitation, tremors, feelings of confusion or disorientation, emotional or irritable feelings, diarrhoea (loose stools), visual disturbances, rapid pulse or palpitations.

When your treatment period ends, it is generally recommended that the dose of this medicine be gradually reduced over a couple of weeks rather than stopped abruptly.

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

4. Possible adverse effects

Like all medicines, Citalopram Alter may cause adverse effects, although not everyone experiences them.

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

Some patients have reported the following serious adverse effects.

If you experience any of the following symptoms, you must stop taking citalopram and see your doctor immediately:

• High fever, agitation, confusion, tremors, and sudden muscle contractions; these 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 adverse effects (may affect up to 1 in 1,000 patients):

If you experience any of the following symptoms, you must stop taking citalopram and contact your doctor immediately:

• Hyponatraemia: low sodium levels in the blood, which may cause tiredness, confusion, and muscle spasms.

• Rapid or irregular heartbeat, or feeling faint, as these could be symptoms of a serious heart condition known as Torsade de Pointes.

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

If adverse effects are troublesome 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 adverse effects (may affect more than 1 in 10 patients):

• Tendency to feel sleepy.
• Difficulty sleeping.
• Increased sweating.
• Dry mouth.
• Nausea (feeling sick).
• Headache.

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

• Decreased appetite.
• Agitation.
• Reduced sexual drive or performance.
• Anxiety.
• Restlessness.
• Confusional state.
• Abnormal dreams.
• Tremors.
• Tingling or numbness in hands or feet.
• Dizziness.
• Impaired attention.
• Ringing in the ears (tinnitus).
• Yawning.
• Diarrhoea.
• Vomiting.
• Constipation.
• Rash.
• Muscle and joint pain.
• Men may experience problems with ejaculation and erection.
• Women may experience difficulty reaching orgasm.
• Fatigue.
• Skin irritation.
• Weight loss.

Uncommon adverse effects (may affect up to 1 in 100 patients):

• Bleeding disorders of the skin (easy bruising).
• Increased appetite.
• Aggressiveness.
• Depersonalisation.
• Hallucinations.
• Mania.
• Fainting.
• Dilated pupils.
• Rapid heartbeat.
• Slow heartbeat.
• Hives (urticaria).
• Hair loss.
• Skin rash.
• Light sensitivity.
• Difficulty urinating.
• Difficulty starting to urinate, reduced urination.
• Excessive menstrual bleeding.
• Swelling of arms and legs.
• Weight gain.

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

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

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

• Thoughts of harming yourself or thoughts of suicide; see also section "Warnings and precautions".
• Reduction in blood platelets, increasing the risk of bleeding or bruising.
• Hypersensitivity (rash).
• Severe allergic reaction causing difficulty breathing or dizziness.
• Hypokalaemia: low potassium levels in the blood, which may cause muscle weakness, cramps, or abnormal heart rhythm.
• Panic attacks.
• Teeth grinding.
• Restlessness.
• Abnormal muscle movements or stiffness.
• Akathisia (involuntary muscle movements).
• Vision disturbances.
• Low blood pressure.
• Nosebleeds.
• Bleeding disorders including bleeding from the skin and mucous membranes (bruising).
• Excessive vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 “Pregnancy, breastfeeding and fertility” for more information.
• Sudden swelling of the skin or mucous membranes.
• Painful erections.
• Increased levels of prolactin hormone in the blood.
• Milk discharge in men and in women who are not breastfeeding.
• Irregular menstrual periods.
• Abnormal liver function tests.
• Orthostatic hypotension (a significant drop in blood pressure when standing up).
• An increased risk of bone fractures has been observed in patients treated with this type of medicine.
• Abnormal heart rhythm.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a side effect not mentioned in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citalopram Alter

Keep out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiry date stated on the container, following the abbreviation EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unused containers and medicines should be handed in at the pharmacy's SIGRE collection point . If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Citalopram Alter 30 mg

• The active substance is citalopram (hydrobromide). Each tablet contains 30 mg of citalopram (as citalopram hydrobromide).
• The other components (excipients) are: monohydrate lactose, corn starch, microcrystalline cellulose, copovidone, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide, and glyceryl triacetate.

Appearance of the product and contents of the pack

Citalopram Alter 30 mg are film-coated tablets. The tablets are white, round, coated, and biconvex. They are available in packs of 28 or 56 tablets.

Other presentations:

Citalopram Alter 20 mg film-coated tablets EFG.

Marketing Authorization Holder and Manufacturer Responsible

Laboratorios Alter, S.A.

C/Mateo Inurria, 30

28036 Madrid

Spain

Date of the most recent review of this leaflet: October 2025

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