Citalopram Tarbis Farma 20 mg film-coated tablets EFG: detailed information

Patient Information Leaflet

Introduction

Package leaflet: Information for the patient

Citalopram Tarbis Farma 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as 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, pharmacist, or nurse.
This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, because it could 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

What Citalopram Tarbis Farma is and what it is used for
What you need to know before taking Citalopram Tarbis Farma
How to take Citalopram Tarbis Farma
Possible adverse effects
How to store Citalopram Tarbis Farma
Contents of the pack and other information

1. What Citalopram Tarbis Farma is and what it is used for

Citalopram belongs to a group of antidepressants known as selective serotonin reuptake inhibitors (SSRIs). Citalopram is used in the treatment of:

Depressive disorders (major depressive episodes).
Panic disorders with or without agoraphobia (e.g., intense anxiety about leaving home, entering shops, or fear of public spaces).

2. What you need to know before taking Citalopram Tarbis Farma

Do not take Citalopram Tarbis Farma

If you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6).
If you are taking MAO inhibitors (monoamine oxidase inhibitors):
- e.g.: the antidepressant moclobemide or if you are being treated with a non-selective MAO inhibitor - linezolid (an antibiotic), unless under close supervision and monitoring of blood pressure.
- irreversible MAO inhibitor selegiline (a medicine for Parkinson’s disease) may be used in combination with citalopram at daily doses not exceeding 10 mg of selegiline per day (see “Taking Citalopram Tarbis Farma with other medicines”).
- if you have taken irreversible MAO inhibitors within the last two weeks or if you have taken reversible MAO inhibitors (RIMA) within the period specified in their respective package leaflet (see “Taking Citalopram Tarbis Farma with other medicines”).
- if you stop taking citalopram and wish to start using MAO inhibitors, you must wait at least 7 days (see “Taking Citalopram Tarbis Farma with other medicines”).
If you have or have had an episode of irregular heartbeat (detected on ECG; a test to assess heart function).
If you are taking medicines for heart rhythm problems or that may affect heart rhythm.

Also refer to section “Taking Citalopram Tarbis Farma with other medicines” below.

Warnings and precautions

Consult your doctor or pharmacist before starting to take citalopram.

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

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or suffer from anxiety disorders, you may sometimes have thoughts of self-harm or suicide. These may increase when first starting antidepressants, as all these medicines require time to take effect, usually about two weeks, but in some cases longer.

You may be more likely to have such thoughts:

If you have previously had thoughts of self-harm or suicide.
If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in psychiatric patients under 25 years of age treated with an antidepressant.

If you have thoughts of self-harm or suicide at any time, contact your doctor or go to hospital immediately.

It may help to inform 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.

Restlessness/difficulty staying still or stopping

Symptoms such as restlessness, for example difficulty staying still or stopping (akathisia), may occur during the first weeks of treatment. Consult your doctor immediately if you experience these symptoms. A dose adjustment may be necessary.

Increased anxiety

In the treatment of panic disorder, it usually takes 2–4 weeks before any improvement is noticed. Some patients may initially experience increased anxiety at the beginning of treatment, which will disappear during 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.

Mania (hyperactive behaviour or thinking)

If you enter a manic phase characterised by unusually rapid and frequent changes of thought, inappropriate happiness, and excessive physical activity, please contact your doctor.

Withdrawal symptoms observed when stopping treatment with a Selective Serotonin Reuptake Inhibitor (SSRI)

When stopping treatment with citalopram, especially if abruptly, you may experience withdrawal symptoms (see “How to take Citalopram Tarbis Farma” and “Possible side effects”). These are common when stopping treatment. The risk is higher when citalopram has been used for a long time, at high doses, or when the dose is reduced too quickly. Many people find that symptoms are mild and resolve on their own within two weeks. However, in some patients symptoms may be severe or prolonged (2–3 months or more). If you experience severe withdrawal symptoms when stopping citalopram treatment, please contact your doctor. They may ask you to restart your tablets and taper off more gradually.

Children and adolescents under 18 years of age

Antidepressants should not normally be used in 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 (mainly aggression, confrontational behaviour, and irritability) when taking these medicines.

Nevertheless, your doctor may prescribe citalopram to patients under 18 years of age if they decide it is most appropriate for the patient. 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 listed above progress or worsen when patients under 18 years of age are taking citalopram. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioural development of citalopram in this age group have not yet been established.

Consult your doctor if:

You develop fever, muscle stiffness, or tremor and extreme agitation; you may be experiencing what is known as serotonin syndrome. Although this syndrome is rare, it can be life-threatening. Contact your doctor immediately; discontinuation of citalopram may be necessary.
You are taking herbal preparations containing St. John’s wort (Hypericum perforatum, see “Taking Citalopram Tarbis Farma with other medicines”).
You are taking serotonergic medicines such as sumatriptan or other triptans, tramadol, oxitriptan, and tryptophan (see “Taking Citalopram Tarbis Farma with other medicines”).
You are prone to heart rhythm disturbances (QT interval prolongation) or have suspected congenital long QT syndrome or low levels of potassium and magnesium (hypokalaemia/hypomagnesaemia).
You suffer or have suffered from heart problems or have recently had a heart attack.
You have a low resting heart rate and/or know you may have decreased salt levels due to severe and prolonged diarrhoea and vomiting (feeling dizzy) or due to use of diuretics.
You experience a fast or irregular heartbeat, fainting, syncope, or dizziness upon standing, which may indicate abnormal heart rate function.
You are at risk of low sodium levels in the blood (hyponatraemia), e.g.: due to concomitant medicines and cirrhosis. Hyponatraemia associated with the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) has been rarely reported during citalopram treatment, especially in elderly patients.
You have diabetes. You may require adjustment of your antidiabetic treatment.
You have epilepsy. Treatment should be discontinued in case of seizures. Contact your doctor.
You have a bleeding disorder, e.g.: gynaecological or gastric bleeding, or if you are using medicines that affect blood clotting or increase the risk of bleeding (see “Taking Citalopram Tarbis Farma with other medicines”), as the use of citalopram may increase the risk of bleeding.
At the beginning of treatment you develop difficulty sleeping or agitation. Your doctor may adjust your dose.
You are receiving electroconvulsive therapy.
You have psychosis with depressive episodes, as psychotic symptoms may increase.
You have or have had panic attacks.
You have eye problems, such as certain types of glaucoma.
You have severe kidney problems. Use of citalopram is not recommended in patients with severe renal impairment.
You have hepatic insufficiency. Your doctor should monitor your liver function. Caution and extremely careful dosing are recommended if you have severe liver problems.

Taking Citalopram Tarbis Farma with other medicines

DO NOT TAKE citalopram if you are taking medicines for heart rhythm problems or medicines that may affect heart rhythm, e.g.: Class IA and III antiarrhythmics, antipsychotics (e.g.: phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g.: sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarial treatment especially halofantrine), certain antihistamines (astemizole, mizolastine). If you have any questions about this, you should consult your doctor.

Citalopram may affect or be affected by other medicines. Some of these medicines are listed below:

Desipramine (for depression). Blood levels of desipramine may increase; a reduction in desipramine dose may be necessary.
Metoprolol (e.g.: for heart failure), flecainide and propafenone (for treating irregular heart rate), other medicines for treating depression (clomipramine, nortriptyline), or medicines for treating psychosis (risperidone, thioridazine, haloperidol). Increased blood levels of these medicines may be reported or are possible.
Pimozide (an antipsychotic medicine). Concomitant treatment with citalopram and pimozide is contraindicated due to the influence of this combination on cardiac function.
Medicines that reduce blood levels of potassium and magnesium, as these changes increase the risk of developing a life-threatening heart rhythm disturbance (QT prolongation, Torsades de Pointes).
Medicines that lower the seizure threshold, e.g.: other antidepressants (SSRIs), antipsychotic medicines (e.g.: butyrophenones, thioxanthenes), mefloquine, bupropion and tramadol (analgesic).

The following medicines may increase the serotonergic effect of citalopram and cause an increase in adverse effects:

MAO inhibitors (for depression or Parkinson’s disease) (e.g.: moclobemide and selegiline or linezolid, an antibiotic). You must not use citalopram concomitantly with MAO inhibitors as serious or even fatal reactions (serotonin syndrome) may occur, except for selegiline at doses not exceeding 10 mg/day. There must be a washout period between treatments (see section “Do not take Citalopram Tarbis Farma”). Consult your doctor.
Oxitriptan and tryptophan (serotonergic precursors).
Lithium (for mental illnesses).
Sumatriptan and other triptans (for migraines).
Tramadol (for severe pain).
St. John’s wort (Hypericum perforatum).
Cimetidine (for stomach problems) and other medicines for treating stomach ulcers, e.g.: omeprazole, esomeprazole, lansoprazole, fluconazole (used to treat fungal infections), ticlopidine or fluvoxamine (another medicine for treating depression). Combination with citalopram may cause increased blood levels of citalopram.

The following medicines increase the risk of bleeding:

Warfarin and other anticoagulant medicines.
Acetylsalicylic acid and other analgesic NSAIDs (non-steroidal anti-inflammatory drugs) (e.g.: ibuprofen).
Dipyridamole and ticlopidine (for the heart).
Atypical antipsychotics (for mental disorders).

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

Citalopram Tarbis Farma with food, drinks and alcohol

Food does not influence the effect of citalopram. Consumption of alcohol is not recommended.

Pregnancy, breastfeeding and fertility

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

Pregnancy

Do not take citalopram if you are pregnant or planning to become pregnant unless you and your doctor have discussed the risks and benefits.

Do not stop treatment with citalopram abruptly during pregnancy. Consult your doctor if you wish to stop or discontinue treatment.

Ensure that your midwife and/or doctor knows you are being treated with citalopram. When medicines such as citalopram are taken during pregnancy, particularly during the last 3 months, there may be an increased risk of the baby developing a serious condition called persistent pulmonary hypertension of the newborn (PPHN), causing the baby to breathe faster and appear blue. These symptoms usually appear within the first 24 hours after birth. If this happens to your baby, you must contact your midwife and/or doctor immediately.

If you are taking citalopram during the last 3 months of pregnancy up to the day of your child’s birth, your baby may experience serious adverse effects or withdrawal symptoms such as breathing difficulties, blue skin/lips, irregular breathing with breathing pauses, temperature fluctuations, seizures, lethargy, difficulty sleeping, feeding problems, vomiting, low blood sugar, rigid or floppy muscles, abnormally increased reflexes, tremor, extreme nervousness or nervous agitation, irritability, constant crying, and drowsiness.

If your newborn baby experiences any of these symptoms, contact your doctor immediately; they will be able to advise you.

If you take citalopram in the late stages of 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.

Breastfeeding

Citalopram is excreted in 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.

Fertility

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

Citalopram has a mild to moderate influence on the ability to drive and use machines. Do not drive or operate machinery until you know how this medicine affects you. Normally, citalopram does not affect the ability to perform normal daily activities. However, if you feel dizzy or drowsy when starting this medicine, you should be cautious when driving, operating machinery, or performing work requiring alertness until these effects disappear. If you are unsure, consult your doctor whether you can carry out the aforementioned activities.

This medicine contains sodium

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

This medicine contains lactose

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

3. How to take Citalopram Tarbis Farma

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

Please note that it may take 2–4 weeks before you notice improvement. Treatment should continue until symptoms have been absent for 4–6 months. When you are going to stop treatment with citalopram, the dose should be gradually reduced over a period of at least 1–2 weeks.

Take citalopram once daily, either in the morning or in the evening. Drink a glass of water with this medicine; it can be taken with or without food. For dosages that cannot be achieved with this strength, other more suitable strengths of this medicine are available.

How much to take

Adults:

Depression

The recommended dose is 20 mg per day. Your doctor may increase this dose up to a maximum of 40 mg per day.

Panic disorder

The initial dose is 10 mg per day for the first week before increasing to 20–30 mg daily. Your doctor may increase this dose up to a maximum of 40 mg per day. A full therapeutic response may take up to 3 months.

Elderly patients (over 65 years of age):

Depression and panic disorder

Treatment should be started at half the recommended dose, e.g., 10–20 mg per day. Elderly patients should generally not take more than 20 mg per day.

Use in children and adolescents under 18 years of age:

Citalopram is generally not recommended for use in children and adolescents under 18 years of age (see "Warnings and precautions").

Hepatic impairment:

The usual starting dose is 10 mg once daily. Patients with liver disease should not take more than 20 mg per day.

Renal impairment:

Dosage adjustment may be necessary. Follow your doctor's recommendations.

If you take more Citalopram Tarbis Farma than you should

If you have taken more citalopram than indicated in this leaflet or more than prescribed by your doctor, contact your doctor, emergency services, or pharmacist immediately. Some symptoms of overdose may be life-threatening.

Depending on the ingested dose, citalopram overdose may present with symptoms such as irregular heartbeat, seizures, changes in heart rhythm (faster or slower heartbeat), dizziness (nausea), vomiting, sweating, drowsiness, loss of consciousness, tremor, changes in blood pressure (which may increase or decrease), serotonin syndrome (see section 4), agitation, vertigo, dilated pupils, bluish skin, abnormally rapid breathing, cardiac arrest, coma.

In case of overdose or accidental ingestion, seek immediate medical advice from your doctor or pharmacist, or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested.

If you forget to take Citalopram Tarbis Farma

Do not take a double dose to make up for forgotten doses.

If you stop taking Citalopram Tarbis Farma

Abrupt discontinuation should be avoided. When stopping treatment with citalopram, the dose should be gradually reduced over a period of at least 1–2 weeks to reduce the risk of withdrawal reactions. If intolerable symptoms occur following dose reduction or after stopping treatment, reinitiation of the previously prescribed dose may be considered. Subsequently, your doctor may continue to reduce the dose, but at a slower rate.

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. Several of the effects listed below may also be symptoms of your illness and may resolve as you start to feel better.

If you experience one or more of the following adverse effects, you must stop treatment with citalopram and contact your doctor or emergency services immediately.

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

Intense itching of the skin (with raised bumps).

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

Nausea, muscle weakness, confusion, fatigue, muscle spasms due to low levels of sodium in the blood. In some patients, this may trigger a serious adverse reaction. Consult your doctor.
Hepatitis, jaundice.
Past seizures become more frequent.

Very rare adverse effects (may affect up to 1 in 10,000 people)

Sudden allergic reaction (within minutes to hours), e.g.: rash, difficulty breathing, dizziness and fainting (anaphylactic reaction).
Rash (hives) and edema. Cases involving swelling of the face, lips, and tongue may be life-threatening (angioedema).

Adverse effects with unknown frequency (cannot be estimated from available data)

Suicidal thoughts and behaviours. Cases of suicidal ideation and behaviour have been reported during treatment with citalopram or shortly after discontinuation of treatment (see “Warnings and precautions”). Contact your doctor or emergency services.
Severe disturbances in heart rhythm with rapid and irregular pulse.
High fever, chills and sudden muscle spasms, confusion, pathological euphoria and agitation.
Decrease in platelet count, leading to an increased risk of bleeding and bruising.
Unusual bleeding, including gastrointestinal bleeding (vomiting blood and/or black stools as a result of bleeding in the stomach and intestines), and uterine bleeding.
Rapid and irregular heartbeat, fainting which could be symptoms of a potentially life-threatening condition called Torsade de Pointes.
New onset of seizures.

The following adverse effects have also been reported:

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

Palpitations, restlessness, increased sweating.
Lethargy (urge to sleep), drowsiness, weakness and fragility.
Difficulty sleeping.
Restless agitation, nervousness.
Dizziness.
Blurred vision (difficulty reading small print).
Dry mouth, which may increase the risk of dental caries – you should therefore brush your teeth more frequently than usual while taking citalopram.
Nausea, constipation.
Headache.

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

Decreased appetite, weight loss, increased appetite, taste disturbances.
Diarrhea, vomiting, gastric discomfort (including acid reflux and heartburn), stomach pain, flatulence, increased salivation.
High blood pressure. Inform your doctor. High blood pressure should be treated. Severely elevated blood pressure is serious.
Dizziness and risk of fainting (likely upon standing) due to low blood pressure.
Low blood pressure.
Fever.
Sensation of tingling, numbness, or prickling of the skin.
Fatigue, difficulty breathing, unusual dreams.
Migraine, ringing in the ears (tinnitus).
Visual disturbances.
Runny nose, sinusitis, yawning.
Difficulty urinating.
Itching, rash.
Muscle and joint pain.
Ejaculation problems, impotence (erectile dysfunction).
Menstrual pain, difficulty achieving orgasm.
Reduced libido.
Anxiety, confusion, indifference.
Impaired concentration, attention disorders, unusual dreams, memory loss.
Excessive urine production (polyuria).

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

Hallucinations, which may be severe. Contact your doctor or emergency services.
Fainting.
Seizures.
Movement disorders and involuntary movements.
Dilated pupils.
Cough.
Difficulty urinating, possibly urinary retention. This may be or become serious. Consult your doctor.
Edema (fluid retention).
Hair loss.
Hives, itchy rash, rash, increased skin sensitivity to light (photosensitivity).
Small bleedings of the skin and mucous membranes (purpura).
Heavy and unusual menstrual bleeding.
Aggression (threatening, possibly violent behaviour), feeling of unreality or detachment from oneself.
Pathological euphoria (mania).
Euphoria.
Increased libido.
Anorexia.
Malaise.
Weight gain.
Slower heartbeats.

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

Involuntary movements.
Bleeding (e.g. gynecological bleeding, gastrointestinal bleeding, bruising, and other forms of skin bleeding or bleeding from mucous membranes).
Inability to remain still. Restless legs.

Very rare adverse effects (may affect up to 1 in 10,000 people)

Breast milk production.

Adverse effects with unknown frequency (cannot be estimated from available data)

Weakness, limited muscle strength, tremulous and abnormal heart rhythm due to low potassium levels in blood (hypokalemia). In some patients, this may lead to a serious adverse reaction. Inform your doctor.
Nosebleeds.
Blood spots under the skin.
Irregular and heavy menstrual bleeding.
Persistent and painful erection. Contact your doctor or emergency services as soon as possible.
Panic attack.
Teeth grinding.
An increased risk of bone fractures has been observed in patients taking this type of medicine.
Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information.

In addition, citalopram may cause adverse effects that you normally will not notice. These are changes in certain laboratory test results, such as liver function tests, which return to normal once treatment is stopped.

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 directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citalopram Tarbis Farma

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

Do not use this medicine after the expiry date stated on the carton and blister pack after EXP. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If in doubt, 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 Tarbis Farma

The active substance is citalopram.

Each film-coated tablet contains 20 mg of citalopram (as citalopram hydrobromide).

The other components are:

Tablet core: Monohydrate lactose, corn starch, copovidone (E1208), microcrystalline cellulose (ph 102) (E460), sodium croscarmellose, and magnesium stearate.

Tablet coating: Titanium dioxide (E171), hypromellose 3 and 6 mPas (E464), macrogol (E1521), Polysorbate 80 (E433).

Appearance of the product and contents of the pack

Film-coated tablet.

Citalopram Tarbis Farma 20 mg film-coated tablets EFG

Biconvex oval film-coated tablets, white to off-white in colour, marked with "Z and 7" on one side of the score line and "H" on the other side. The tablet can be divided into equal doses.

This medicine is available in blisters containing 20, 28, 30, 50, 56 and 100 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Tarbis Farma S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Amarox Pharma B.V.

Rouboslaan 32

Voorschoten, 2252TR

The Netherlands

This medicinal product is authorised in the European Economic Area member states under the following names:

Germany: Citalopram Amarox 10 mg/20 mg/30 mg/40 mg Filmtabletten

Spain: Citalopram Tarbis Farma 10 mg/20 mg/30 mg film-coated tablets EFG

The Netherlands: Citalopram Amarox 10 mg/20 mg/30 mg/40 mg filmomhulde tabletten

Date of the most recent review of this leaflet: August 2021

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