Citalopram Stada 30 mg film-coated tablets EFG

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

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

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

Citalopram Stada is an antidepressant medicine belonging to the group known as "selective serotonin reuptake inhibitors" (SSRIs). These medicines help correct certain chemical imbalances in the brain that cause the symptoms of your illness.

Citalopram is indicated for:

• Treatment of depression and prevention of relapse and recurrence.
• Treatment of panic disorder with or without agoraphobia.
• Treatment of obsessive-compulsive disorder (OCD).

However, your doctor may prescribe citalopram for any other purpose. Ask your doctor if you have any doubts as to why citalopram has been prescribed for you.

2. What you need to know before taking Citalopram Stada

Do not take Citalopram Stada

• If you are allergic to citalopram or to any of the other components 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, isocarboxazide, 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 an episode of this type (this is detected by electrocardiogram, a test used to evaluate 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.

See also the section “Use of Citalopram Stada 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 starting citalopram.

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

• If you have manic episodes or panic disorder.
• If you have liver or kidney impairment. Your doctor may need to adjust the dose.
• If you have diabetes. Treatment with citalopram may alter glycaemic control. You may need an adjustment in the dose of insulin and/or oral hypoglycaemic agents.
• If you have 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 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 the blood.
• If you are receiving electroconvulsive therapy.
• If you have or have had heart problems or have recently had 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 diarrhoea and vomiting over several days or due to diuretic use (medicines that increase urine production).
• If you have noticed 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 a problem with dilation of the eye pupils (mydriasis).
• 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 medicines in the same group as citalopram (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.

Some patients with bipolar disorder may enter a manic phase. This is characterised by unusual and rapid thought changes, disproportionate 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 weeks of treatment. Inform your doctor immediately if you experience these symptoms.

Special information related to your condition

Like other medicines used to treat depression or related conditions, improvement is not immediate. After starting treatment with citalopram, 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 the 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 of harming yourself or taking your life. These thoughts may increase when starting antidepressants, as all these medicines require time to take effect—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 of harming yourself or taking 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 of harming yourself or taking your life, contact your doctor or go directly to a hospital.

It may help 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 behaviour.

Children and adolescents

Citalopram should not normally be used in the treatment of children and adolescents under 18 years of age. In addition, you should know that in patients under 18 years of age, there is an increased risk of adverse effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe citalopram to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed citalopram to a patient under 18 years of age and you wish to discuss this decision, please return to your doctor. You should inform your doctor if any of the symptoms described above worsen or complications arise while patients under 18 years of age are taking citalopram. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of citalopram in this age group have not yet been established.

Use of Citalopram Stada 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 can affect each other’s action, which 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, isocarboxazide, 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 selegiline dose 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 reactions 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 increase, but no increase in citalopram adverse effects has been reported.
• Medicines that affect platelet function (e.g., 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 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 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, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), certain antihistamines (astemizole, mizolastine).
• Medicines that reduce potassium or magnesium levels in the blood, as this increases the risk of life-threatening heart rhythm disturbances. Do not take citalopram if you are taking medicines for a condition that already affects your heart rhythm or if you are taking medicines that may themselves affect your heart rhythm. If you have any doubts about this, consult your doctor.

Taking Citalopram Stada with food, drinks and alcohol

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

Citalopram has not been shown to 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 normally not take citalopram, and mothers should not 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 difficulty sleeping. 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 informed 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 citalopram, inform your doctor before starting breastfeeding.

Ensure that your midwife and/or doctor are aware 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 condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and appears blue. These symptoms usually begin within the first 24 hours after birth. If they 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 use of machines

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

Citalopram Stada contains lactose

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

Citalopram Stada contains sodium

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

3. How to take Citalopram Stada

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

Adults

Depression

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

Panic disorder

The recommended starting dose is 10 mg daily for the first week, before increasing to 20–30 mg daily. If your doctor considers it necessary, they may increase your dose up to a maximum of 40 mg daily.

Obsessive-compulsive disorder (OCD)

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

Elderly patients (over 65 years of age)

In elderly patients, treatment 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

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

How and when to take Citalopram Stada

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 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 your 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 has told 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 the occurrence of new depressive episodes.

If you take more Citalopram Stada than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

Some symptoms of overdose may include irregular heartbeats with life-threatening risk, seizures, changes in heart rhythm, drowsiness, coma, vomiting, tremors, decreased blood pressure, increased blood pressure, nausea (feeling 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 Citalopram Stada

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 forgotten doses.

If you stop taking Citalopram Stada

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 of anxiety, headache, dizziness (nausea), vomiting, sweating, feeling restless or agitated, tremors, feeling confused or disoriented, feelings of emotional upset or irritability, diarrhoea (loose stools), visual disturbances, rapid pulse or palpitations.

When you have completed your treatment period, it is generally recommended that the dose of citalopram 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 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 when antidepressants are used in combination.
• Swelling of the skin, tongue, lips, or face, or 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 citalopram and contact your doctor immediately:

• Hyponatremia: low levels of sodium 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.
• Anxiety.
• Restlessness.
• Confusional state.
• Abnormal dreams.
• Tremors.
• Tingling or numbness in hands or feet.
• Dizziness.
• Impaired attention.
• 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):

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

Rare adverse 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 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 (haematoma).
• Hypersensitivity (rash).
• Severe allergic reaction causing difficulty breathing or dizziness.
• Increased urine output.
• Hypokalemia: low levels of potassium in the blood, which may cause muscle weakness, cramps, or irregular heartbeat.
• 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 haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.
• Sudden swelling of the skin or mucous membranes.
• Painful erections.
• Increased levels of prolactin hormone in the blood.
• Lactation in men and in women who are not breastfeeding.
• Irregular menstrual periods.
• Abnormal liver function tests.
• Orthostatic hypotension (a significant drop in blood pressure upon standing).
• 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 possible adverse effect not listed in this leaflet. You can also report them 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 Citalopram Stada

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Unwanted medicines and their containers should be returned to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Citalopram Stada

• The active substance is citalopram (hydrobromide). Each tablet contains 30 mg of citalopram.
• The other components (excipients) are: monohydrate lactose, gluten-free corn starch, microcrystalline cellulose, copovidone, sodium croscarmellose, magnesium stearate, hypromellose, titanium dioxide (E171), and glyceryl triacetate.

Appearance of the product and contents of the pack

Citalopram Stada 30 mg are film-coated tablets. The tablets are white, round, coated, biconvex, and have a score line on one side. They are available in packs of 28 or 56 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

Spain

Date of the most recent review of this leaflet: September 2024

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