Leaflet: information for the user

Prisdal 30 mg film-coated tablets

citalopram

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Prisdal is and for what it is used

2. What you need to know before starting to take Prisdal

3. How to take Prisdal

4. Possible side effects

5. Storage of Prisdal

6. Contents of the pack and additional information

Prisdal is a selective serotonin reuptake inhibitor (SSRI) and belongs to a group of medications known as antidepressants. These medications help correct certain chemical imbalances in the brain that cause symptoms of your illness.

Prisdal 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 Prisdal for any other purpose. Ask your doctor if you have any doubts as to why they have prescribed Prisdal for you.

Do not take Prisdal

• If you are allergic to citalopram or any of the other components of this medication (listed in section 6).
• If you are taking other medications that belong to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medications such as phenelzine, iproniazid, isocarboxazid, nialamide, tranilcipromina, selegiline (used in the treatment of Parkinson's disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).

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

You must wait a day after taking moclobemide.

After finishing Prisdal, you must wait a week before taking any MAOI.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Prisdal.

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 disorder.
• If you have liver or kidney insufficiency. Your doctor may need to adjust the dose.
• If you have diabetes. The treatment with Prisdal may alter blood sugar control. You may need to adjust the dose of insulin and/or oral hypoglycemic agents.

• If you have epilepsy. Treatment with Prisdal should be discontinued if seizures occur or if the frequency of seizures increases (see also section 4 "Possible side effects").
• If you have a history of bleeding disorders or if you develop unusual bleeding or bruising, or if you are pregnant (see 'Pregnancy, breastfeeding, and fertility').
• If you have low sodium levels in the blood.
• If you are receiving electroconvulsive therapy.
• If you have or have had any heart problems or have recently had a heart attack.

If, 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 (medications to urinate).

• If you have noticed that your heartbeats are rapid or irregular or if you have fainted or felt dizzy when getting up from a sitting or lying position. This could indicate that you have an irregular heartbeat.
• If you have or have had eye problems in the past, such as certain types of glaucoma (increased eye pressure).

Consult your doctor, even if any of the above circumstances have occurred at any time.

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

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

Some medications in the group to which Prisdal belongs (called ISRS/IRSN) may cause sexual dysfunction symptoms (see section 4). In some cases, these symptoms persist after stopping treatment.

Special information related to your disease

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

In the treatment of anxiety disorder, it usually takes 2-4 weeks to observe any improvement.

At the beginning of treatment, some patients may experience an increase in anxiety, which will disappear with continued treatment. Therefore, it is very important to follow your doctor's instructions exactly and not interrupt or change the dose without consulting your doctor.

Thoughts of suicide and worsening of 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 taking antidepressants for the first time, as all these medications require time to start working, usually around 2 weeks, although in some cases it may take longer.

Youwould be more prone to having these types of thoughts:

• If you have previously had thoughts of harming yourself or taking your life.
• If you are 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 for you 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

Prisdal should not normally be used in the treatment of children and adolescents under 18 years old. At the same time, you should know that in patients under 18 years old, there is a higher risk of adverse effects such as suicidal attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medication. However, the doctor who prescribes Prisdal to you may prescribe it to patients under 18 years old when they decide it is the best option for the patient. If the doctor who prescribes Prisdal to you has prescribed it to a patient under 18 years old and wants to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above progress or if you experience complications when patients under 18 years old are taking Prisdal. At the same time, the long-term effects of Prisdal on safety and related to growth, maturity, and cognitive and behavioral development

in this age group have not yet been demonstrated.

Use of Prisdal with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Some medications may affect the action of others and may cause severe adverse reactions at times.

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

• Non-selective monoamine oxidase inhibitors (MAOIs) containing phenelzine, iproniazid, isocarboxazid, nialamide, and tranilcipromina as active substances. If you have taken any of these medications, you should wait 14 days before starting to take Prisdal. After finishing treatment with Prisdal, you should wait 7 days before taking any of these medications.
• 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 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); the blood levels of metoprolol increase, but no signs of increased effect or adverse effects of metoprolol have been observed.
• Sumatriptan and similar medications (used to treat migraines) and tramadol and similar medications (opioids, used for severe pain) increase the risk of adverse effects, if you have any unusual symptoms using this combination, you should see your doctor.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (antidepressant), and ticlopidine (used to reduce the risk of stroke). The levels of citalopram in the blood may be increased, but no increased adverse effects of Prisdal have been reported.
• Medications that affect platelet function, such as some antipsychotics, aspirin (used for pain), nonsteroidal anti-inflammatory drugs (used 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 Prisdal may increase the risk of adverse effects.
• Mefloquine (used to treat malaria), bupropion (used to treat depression), and tramadol (used for severe pain) due to a possible risk of lowering the seizure threshold.
• Neuroleptics (medications 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, medications for malaria, particularly halofantrine), certain antihistamines (astemizol, mizolastine).
• Medications that lower potassium or magnesium levels in the blood, as this increases the risk of cardiac arrhythmias, which are life-threatening.

Do not take Prisdal if you are taking medications because you already have a disease that affects the heart rhythm or if you are taking medications that could affect the heart rhythm.

If you are unsure about this, consult your doctor.

Taking Prisdal with food, drinks, and alcohol

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

Prisdal has been observed not to increase the effects of alcohol. However, it is recommended to avoid consuming alcohol during treatment with Prisdal.

Pregnancy, breastfeeding, and fertility

Inform your doctor if you are pregnant or are planning to become pregnant. Pregnant women should not normally take Prisdal, and mothers should not breastfeed their babies while taking this medication, unless you and your doctor have analyzed the risks and benefits involved.

If you take Prisdal 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 sleeping. 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 excessive vaginal bleeding 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 on the baby. If you are taking Prisdal, inform your doctor before starting breastfeeding.

Make sure thatyour midwife and/or doctor are informed that you are being treated with Prisdal.

During pregnancy, particularly in the last 3 months, medications like Prisdal may increase the risk of a serious disease in newborns, called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually start within the first 24 hours after birth. If they appear in your baby, you should contact your midwife and/or doctor immediately.

Citalopram has been shown to reduce sperm quality in animal models. Theoretically, this effect could affect fertility, but until now, it has not been observed in human fertility.

Driving and operating machines

Prisdal usually does not cause drowsiness; however, if you feel dizzy or sleepy when starting to take this medication, do not drive or use tools or machinery until these effects disappear.

Prisdal contains lactose

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

Prisdal contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per 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 recommended dose is 20 mg per day. If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Anxiety disorder

The initial 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 adults (65 years and older)

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

Generally, older adults 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

Prisdal should not be administered to children or adolescents. For additional information, please see section 2 “What you need to know before starting to take Prisdal”.

How and when to take Prisdal

Prisdal should be 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 OCD medications, it may take several weeks to find some improvement. Continue taking Prisdal 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, 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 time, 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 Prisdal than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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

Some symptoms of an overdose may include irregular heartbeats with life-threatening risk, convulsions, 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 Prisdal

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 the treatment with Prisdal

Do not stop taking Prisdal until your doctor tells you to. When you have completed your treatment period, it is generally recommended that the Prisdal 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, headache, dizziness (nausea), vomiting, sweating, 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 generally recommended that the Prisdal 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 Prisdal 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 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 people):

If you have any of the following symptoms, stop taking Prisdal and see your doctor immediately.

• Hyponatremia: low sodium levels in the blood that can cause fatigue, confusion, and muscle cramps.
• Fast and irregular heartbeats or a feeling of dizziness, as they may be symptoms of a serious heart 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 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.
• 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.
• 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.
• Loss of consciousness.
• 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 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 production.
• Hypokalemia: low potassium levels in the blood that can cause muscle weakness, cramps, or irregular heartbeats.
• Panic attack.
• Teeth chattering.
• 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).
• Excessive postpartum bleeding (hemorrhage), see 'Pregnancy, lactation, and fertility' in section 2 for more information.
• Sudden skin or mucous membrane swelling.
• Painful erections.
• Increased prolactin levels in the blood.
• Milk production in men and women who are not breastfeeding.
• Irregular menstrual periods.
• 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's about side effects that don't appear in this leaflet.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it's about possible side effects that don't appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:https: //www.notificaram.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store below 30°C.

Expiration Date

Do not use this medication after the expiration date that appears on the packaging after CAD.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Prisdal

The active ingredient is citalopram (as hydrobromide). Each tablet contains 30 mg of citalopram (as citalopram hydrobromide).

The other components are: maize starch, lactose monohydrate, microcrystalline cellulose, copovidone, 85% glycerol, sodium croscarmellose, magnesium stearate, hypromellose 5, macrogol 400, and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Prisdal 30 mg is presented in the form of film-coated tablets.

The tablets are oval, white, scored, coated, and marked with “C” and “P”.

Prisdal 30 mg is presented in packs of 28 tablets in blisters.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Lundbeck España, SA

Av Diagonal 605

08028 Barcelona

Spain

Responsible for manufacturing

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Date of the last review of this leaflet:October 2023

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