Prisdal 30 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prisdal 30 mg film-coated tablets

citalopram

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

1. What Prisdal is and what it is used for

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

Prisdal is indicated for the treatment of:

• Depression and prevention of relapse and recurrence.
• Panic disorder with or without agoraphobia.
• Obsessive-compulsive disorder (OCD).

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

2. What you need to know before taking Prisdal

Do not take Prisdal

• If you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6).
• If you are taking other medicines belonging to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (used in the treatment of Parkinson’s disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).
• If you have a congenital heart rhythm disorder or have ever experienced episodes of such a disorder (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 “Use of Prisdal with other medicines” below.

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

You must wait 1 day after taking moclobemide.

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Prisdal.

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 liver or kidney impairment. Your doctor may need to adjust your dose.
• If you have diabetes. Treatment with Prisdal may affect blood glucose control. You may need an adjustment in the dose of insulin and/or oral hypoglycemic agents.
• If you have epilepsy. Treatment with Prisdal should be discontinued if seizures occur or if there is an increase in seizure frequency (see also section 4 “Possible side effects”).
• If you have a history of bleeding disorders or develop unusual bruising, 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 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 to increase urination).

• If you notice rapid or irregular heartbeats, or 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 had eye problems previously, such as certain types of glaucoma (increased pressure in the eye).

Consult your doctor, even if any of the above conditions 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 class as Prisdal (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Special information related to your condition

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

In the treatment of panic disorder, improvement is usually seen 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 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 thoughts may increase when starting antidepressants, as all these medicines require time to begin working—usually around two weeks, although in some cases it may take longer.

You are more likely to have such thoughts:

• If you have previously had thoughts about self-harm or suicide.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders treated with antidepressants.

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 family member or close 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 behavior.

Children and adolescents

Prisdal should not normally be used to treat children and adolescents under 18 years of age. You should also be aware that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (predominantly aggression, confrontational behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe Prisdal to patients under 18 years of age if they consider it to be in the patient’s best interest. If your doctor has prescribed Prisdal 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 described above worsen or develop complications while a patient under 18 years of age is taking Prisdal. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioral development, of Prisdal in this age group have not yet been established.

Use of Prisdal with other medicines

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

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

Inform 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 Prisdal. After stopping Prisdal, 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 enhanced 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, 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 increase, but no increase in adverse effects of Prisdal has been reported.
• Medicines that affect platelet function, for example, some 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 Prisdal 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 for treating 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 blood potassium or magnesium levels, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take Prisdal if you are taking medicines for a heart rhythm disorder or if you are taking medicines that may themselves affect your heart rhythm.

If you have any doubts 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”).

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

Pregnancy, breastfeeding and fertility

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

If you take Prisdal during the last 3 months of pregnancy and up to the time of birth, 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 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 appropriately.

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

Ensure that your midwife and/or doctor are informed that you are being treated with Prisdal.

During pregnancy, particularly in the last 3 months, medicines like Prisdal may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and turns blue. These symptoms usually begin within the first 24 hours after birth. If these 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

Prisdal generally does not cause drowsiness; however, if you feel dizzy or sleepy when starting this medicine, do not drive or operate tools or machinery until these effects subside.

Prisdal contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Prisdal contains sodium

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

3. How to take Prisdal

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, please consult your doctor or pharmacist again.

Adults

Depression

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

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 daily.

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 daily.

Elderly patients (over 65 years of age)

In elderly patients, treatment should be started 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

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

How and when to take Prisdal

Prisdal is taken every day as a single daily dose.

Tablets may be taken at any time of day, regardless of meals.

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

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 Prisdal 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 the length of time 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 period, 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 new depressive episodes.

If you take more Prisdal than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

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

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

If you forget to take Prisdal

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 Prisdal

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

Sudden discontinuation of the medication may cause some mild or transient disturbances such as dizziness, tingling sensations, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache, dizziness (nausea), vomiting, sweating, feeling restless or agitated, tremors, feeling confused or disoriented, feelings of emotion or irritability, diarrhea (loose stools), visual disturbances, rapid pulse or palpitations.

When you have completed your treatment period, it is generally recommended that the dose of Prisdal 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, this medicine can cause adverse effects, although not everyone will experience 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 Prisdal 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 people):

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

• Hyponatremia: 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 problem 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 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 adverse effects (may affect more than 1 in 10 people):

• Drowsiness.
• Difficulty sleeping.
• Increased sweating.
• Dry mouth.
• Nausea (feeling sick).
• Headache.

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

• Decreased appetite.
• Agitation.
• Reduced sexual drive or performance.
• Anxiety.
• Restlessness.
• Confusional state.
• Abnormal dreams.
• Tremors.
• Tingling or numbness in hands or feet.
• Dizziness.
• Attention disturbance.
• Ringing in the ears (tinnitus).
• Yawning.
• Diarrhea.
• 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 people):

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

Rare (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 harming yourself or thoughts of suicide; see also section "Warnings and precautions".
• Reduction in platelets in the blood, increasing the risk of bleeding or bruising (hematoma).
• Hypersensitivity (rash).
• Severe allergic reaction causing difficulty breathing or dizziness.
• Hypokalemia: 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 of the skin and mucous membranes (ecchymosis).
• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see 'Pregnancy, breastfeeding and fertility' in section 2 for more information.
• Sudden swelling of 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 adverse effects not listed in this leaflet.

Reporting of adverse effects

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

5. Storage of Prisdal

Keep this medicine out of sight and reach of children.

Store below 30°C.

Expiry

Do not use this medicine after the expiry date stated on the packaging after EXP.

The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If 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 Prisdal

The active substance 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, glycerol 85%, sodium croscarmellose, magnesium stearate, hypromellose 5, macrogol 400 and titanium dioxide (E-171).

Appearance of the product and contents of the pack

Prisdal 30 mg is presented as film-coated tablets.

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

Prisdal 30 mg is available in packs of 28 tablets in blister packs.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Lundbeck España, S.A.

Av. Diagonal 605

08028 Barcelona

Spain

Manufacturer

• Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Date of the most recent revision of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/