Citalopram Vir 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Citalopram VIR 20 mg film-coated tablets EFG

Citalopram

Read the entire leaflet carefully before you start taking this medicine

• 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 and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

1. What Citalopram VIR 20 mg tablets are and what they are used for
2. Before taking Citalopram VIR 20 mg tablets
3. How to take Citalopram VIR 20 mg tablets
4. Possible side effects
5. How to store Citalopram VIR 20 mg tablets
6. Further information

1. What Citalopram VIR 20 mg tablets are and what they are used for

Citalopram VIR is a Selective Serotonin Reuptake Inhibitor (SSRI) and belongs to a group of medicines known as antidepressants. These medicines help to normalize serotonin levels in the brain. Imbalances in brain serotonin are a key factor in the development of depression and related disorders.

Citalopram is indicated for:

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

2. Before taking Citalopram VIR 20 mg tablets

Do not take Citalopram VIR

• If you are allergic (hypersensitive) to citalopram or to any of the other components of
  Citalopram VIR.

• If you are currently taking monoamine oxidase inhibitors (also known as
  MAOIs, for example, selegiline or moclobemide) or have taken them within the past two weeks.

• Your doctor will advise you on how to start taking citalopram after stopping MAOIs
  (see “Use of other medicines”).

• If you are currently taking pimozide (see “Use of other medicines”).

• If you have a congenital heart rhythm disorder or have ever experienced an episode of this type (this can be detected by an 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 consult the section “Use of other medicines” below.

Take special care with Citalopram VIR

Use in children and adolescents under 18 years of age:

Citalopram VIR is generally not recommended for use in children and adolescents under 18 years of age. You should also be aware that patients under 18 years of age taking this type of medicine have an increased risk of side effects such as suicide attempts, suicidal thoughts, and hostility (particularly aggression, confrontational behavior, and anger). Nevertheless, your doctor may prescribe Citalopram VIR to patients under 18 years of age if they consider it to be in their best interest. If your doctor has prescribed Citalopram VIR for a patient under 18 years of age and you wish to discuss this, inform your doctor. You must inform your doctor if the symptoms described above appear or worsen in patients under 18 years of age taking Citalopram VIR.

In this age group, the long-term safety of Citalopram VIR with regard to growth, maturation, and cognitive and behavioral development has not been established.

• If you are being treated for panic attacks; you may experience an increase in anxiety symptoms at the beginning of treatment. Your doctor will adjust your treatment (see section 3 “How to take Citalopram VIR”).
• If you have epilepsy; there is a potential risk of seizures with antidepressant medicines. If the frequency of seizures increases, treatment with Citalopram VIR should be discontinued.
• If you have a history of mania/hypomania; Citalopram VIR should be used with caution and discontinued if a manic phase occurs.
• If you have diabetes; treatment with Citalopram VIR may alter glucose control. It may be necessary to adjust the dose of insulin and/or oral hypoglycemic agents.
• If you develop symptoms such as unpleasant restlessness or agitation, psychomotor agitation, and an urge to move, often accompanied by an inability to sit or stand still, and usually associated with subjective distress (akathisia). These symptoms are more likely to occur during the first few weeks of treatment. In patients who develop these symptoms, increasing the dose may be harmful and could worsen symptoms.
• If you have a bleeding disorder. Citalopram VIR may cause bleeding (e.g., skin and mucous membrane bleeding) or if you are pregnant (see “Pregnancy”).
• If you are taking medicines that affect blood clotting (see “Use of other medicines”).
• If you have a stomach ulcer or have previously experienced stomach or intestinal bleeding.
• If you are undergoing electroconvulsive therapy. Caution is recommended as there is limited experience.
• If you have serotonin syndrome. This condition may develop as a combination of symptoms: agitation, tremor, muscle contractions, and hyperthermia. Treatment with Citalopram VIR must be stopped immediately.
• If you are taking herbal preparations containing St. John’s wort (Hypericum perforatum). Concurrent use may increase the incidence of adverse reactions (see section “Use of other medicines”).
• If you have severe kidney or liver problems. Citalopram VIR should not be used in patients with severe kidney dysfunction. In patients with severe liver problems, a reduced dose of Citalopram VIR is recommended.
• If you have psychosis with depressive episodes.
• If you are susceptible to certain disorders (prolongation of the so-called QT interval on the electrocardiogram - ECG), or if you are suspected of having congenital long QT syndrome, or have low levels of potassium or magnesium (hypokalemia/hypomagnesemia).
• If treatment is discontinued, as withdrawal reactions may occur (see “If you stop taking Citalopram VIR”).

Withdrawal reactions include: dizziness, pins and needles or numbness, headache, nausea, and anxiety. Most withdrawal reactions are mild and self-limiting. If treatment is to be discontinued, it is recommended to gradually reduce the dose over 1-2 weeks.

• If you have heart problems or have recently had a heart attack.
• If your heart beats slowly at rest (this is known as bradycardia) and/or you suspect your body may be losing salts, for example, due to severe diarrhea and vomiting over several days or due to the use of diuretics (medicines to increase urination).
• If you have noticed your heartbeat is fast or irregular, or have experienced fainting or dizziness when standing up from a sitting or lying position. This could indicate a heart rhythm disorder.

An increased risk of bone fractures has been observed in patients treated with this type of medicine.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may sometimes have thoughts of harming yourself or of suicide. These thoughts may increase when you first start taking antidepressants, as all these medicines require time to take effect, usually two weeks, but sometimes longer.

You are more likely to have such thoughts:

• if you have previously had thoughts of self-harm or suicide.
• if you are a young adult. Data from clinical trials have shown an increased risk of suicidal behavior 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 family member or close friend that you are depressed or have an anxiety disorder, and ask them to read this leaflet. You could ask them to tell you if they notice your depression or anxiety worsening, or if they are concerned about changes in your behavior.

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

Use of other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Note that this may apply to medicines you took some time ago or those you may take in the future.

Some medicines may cause problems if taken with Citalopram VIR:

• Antidepressants of the type called monoamine oxidase inhibitors (MAOIs), such as phenelzine, isocarboxazid, and tranylcypromine. Do not take citalopram until 14 days after stopping treatment with an irreversible MAOI. Do not take citalopram until the specified time after stopping treatment with a
  reversible MAOI (e.g., moclobemide), as described in the reversible MAOI’s package leaflet. Do not take an MAOI until 7 days after stopping citalopram.
• Do not use citalopram if you are taking more than 10 mg/day of the MAO inhibitor selegiline.
• Do not take citalopram if you are taking pimozide (for psychiatric conditions).
• Medicines for depression, for example, fluoxetine, fluvoxamine, paroxetine, sertraline, venlafaxine, bupropion, tricyclic antidepressants such as nortriptyline, desipramine, clomipramine, and St. John’s wort (Hypericum perforatum).
• Medicines for migraine, for example, sumatriptan and other triptans.
• Medicines for pain, such as tramadol.
• Medicines for pain and inflammation, such as non-steroidal anti-inflammatory drugs (NSAIDs), for example, ibuprofen, ketoprofen, and diclofenac.
• Medicines for infections, for example, the antibiotic linezolid.
• Medicines to prevent blood clotting (anticoagulants), for example, warfarin, acetylsalicylic acid, dipyridamole, ticlopidine.
• Medicines for irregular heartbeat, for example, propafenone, flecainide.
• Medicines for heart failure, such as metoprolol.
• Medicines for stomach ulcers, such as omeprazole, lansoprazole, cimetidine.
• Medicines for psychiatric disorders, for example, lithium, risperidone, chlorpromazine, thioridazine, chlorprothixene, haloperidol, phenothiazine derivatives.
• Medicines for malaria, for example, mefloquine and particularly halofantrine.
• Other medicines with serotonergic effects such as oxitriptan or tryptophan.
• Medicines that prolong the QT interval or reduce potassium/magnesium levels in the blood.
• Medicines for fungal infections, for example, fluconazole.

Do not take Citalopram VIR

If you are taking medicines for a heart rhythm disorder or medicines that may affect heart rhythm, for example, 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).

If you have any doubts about this, consult your doctor.

Taking Citalopram VIR with food and drinks

It is advised not to drink alcohol during treatment with Citalopram VIR.

Citalopram VIR may be taken with or without food.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Animal studies have shown that citalopram reduces sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed so far.

Pregnancy

Experience with the use of Citalopram VIR during pregnancy is limited. Do not take Citalopram VIR if you are pregnant or planning to become pregnant unless your doctor considers it absolutely necessary. Do not stop treatment with Citalopram VIR abruptly.

Inform your doctor if you are taking Citalopram VIR during the last 3 months of pregnancy, as the baby may experience some symptoms at birth. These symptoms usually appear within the first 24 hours after birth. They include: inability to sleep or feed properly, breathing problems that may become faster (a symptom along with bluish skin of persistent pulmonary hypertension of the newborn - PPHN), bluish or abnormally hot or cold skin, discomfort, continuous crying, stiff or floppy muscles, lethargy, tremors, tics, or seizures. If the baby shows any of these symptoms, contact your doctor immediately for advice.

If you take Citalopram VIR 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 VIR so they can advise you.

Breastfeeding

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

Driving and using machines

Citalopram may affect your ability to drive or operate machinery.

Do not drive or operate machinery until you know how citalopram affects you. Consult your doctor or pharmacist if you have any doubts.

Important information about some of the components of this medicine:

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

This medicine does not contain gluten.

3. How to take Citalopram VIR 20 mg tablets

Follow exactly the administration instructions for Citalopram VIR as given by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Citalopram VIR 20 mg are tablets for oral use. The tablets can be taken at any time of day, regardless of meals, and as a single daily dose. They should be swallowed with sufficient liquid (a glass of water) and must not be chewed.

The usual dose is:

Adults:

Depression

The usual dose is 20 mg per day. Depending on the individual patient's response and the severity of the depression, your doctor may gradually increase the dose up to a maximum of 40 mg per day.

Panic disorder

The recommended initial dose is 10 mg per day for the first week. Afterwards, the dose is increased 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 recommended initial dose is 20 mg per day. If necessary, your doctor may increase this dose up to a maximum of 40 mg per day.

Elderly patients (over 65 years of age)

Treatment should be initiated at half the recommended dose, for example 10–20 mg per day.

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

Patients at special risk

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

Caution is advised and careful dosing is recommended in patients with severe liver dysfunction.

Patients with impaired liver function should be clinically monitored.

Renal impairment

Your doctor may decide to prescribe a lower dose than those described above.

In patients with severe impairment of kidney function, the use of citalopram is not recommended, as there is no information available on its use in these patients.

Use in children and adolescents under 18 years of age

Citalopram VIR must not be used in the treatment of children and adolescents under 18 years of age (see “Take special care with Citalopram VIR”).

Oral use.

Citalopram VIR should be taken as a single daily dose, either in the morning or in the evening. The tablets may be taken with or without food.

The tablets must be swallowed whole with water or another liquid.

Duration of treatment:

Citalopram VIR does not act immediately. It may take 2–4 weeks before you notice improvement. This is normal with this type of medication.

For the treatment of panic disorders, a full therapeutic response may take up to 3 months. It may be necessary to continue treatment for several months.

Continue taking the tablets for as long as your doctor advises. Do not stop taking them, even if you start to feel better, unless your doctor tells you to do so. Do not change the dose of the medicine without first consulting your doctor.

Withdrawal symptoms observed after discontinuation of treatment:

Abrupt discontinuation of treatment should be avoided. When stopping treatment with citalopram, the dose should be gradually reduced over one to two weeks to minimize the risk of withdrawal reactions (see sections “If you stop taking Citalopram VIR” and “Possible side effects”).

If you notice that the effect of citalopram is too strong or too weak, inform your doctor or pharmacist.

If you take more Citalopram VIR 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 medication and the amount taken.

Symptoms in case of overdose:

Drowsiness, a state close to unconsciousness with apparent mental inactivity and reduced ability to respond to stimuli (coma, stupor), seizures, changes in heart rhythm (e.g., prolonged QT interval), nausea, vomiting, sweating, bluish discoloration of the skin due to inadequate oxygen in the blood (cyanosis), hyperventilation. Features of serotonin syndrome may occur (see “Possible side effects”), especially if other medicines are taken simultaneously.

If you forget to take Citalopram VIR

If you forget to take a dose, do not take a double dose to make up for the missed dose.

If you stop taking Citalopram VIR

Do not stop taking Citalopram VIR unless your doctor tells you to do so.

It is recommended that the dose be gradually reduced over 1–2 weeks, as withdrawal reactions may occur when treatment is stopped.

Withdrawal reactions include: dizziness, electric shock-like sensations or numbness, headache, nausea, and anxiety. Most withdrawal reactions are mild and self-limiting. It is recommended that the dose be gradually reduced over 1–2 weeks when treatment is to be discontinued.

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

4. Possible adverse effects

Like all medicines, Citalopram VIR may cause adverse effects, although not everyone will experience them.

If any of the following adverse effects occur, stop taking Citalopram VIR and inform your doctor immediately or go to the nearest hospital:

• Rapid or irregular heartbeat or fainting sensation, which could be
• symptoms of a serious heart problem known as torsade de pointes.
• Serotonin syndrome has been reported in patients treated with this type of antidepressant (SSRIs). Inform your doctor if you experience high fever, tremor, muscle stiffness, and anxiety, as these symptoms may indicate the onset of this syndrome. Treatment with Citalopram VIR must be stopped immediately.
• You must contact your doctor immediately if you experience symptoms such as swelling of the face, tongue and/or throat and/or difficulty swallowing, or hives and breathing difficulties (angioedema).

These are very serious adverse effects. If you experience any of these, you may have suffered a severe allergic reaction to Citalopram VIR. You may require urgent medical attention or hospitalization.

• All of these very serious adverse effects are very rare.

The following adverse effects have been reported at the frequencies indicated:

Very common (in more than 1 in 10 patients):

• Changes in heart rhythm
• Headache, tremor, dizziness
• Blurred vision
• Nausea, dry mouth, constipation, diarrhea
• Increased sweating
• Feeling of weakness (lethargy)
• Drowsiness, difficulty sleeping, agitation, nervousness

Common (in between 1 and 10 of every 100 treated patients):

• Rapid heartbeat
• Weight decrease, weight increase
• Migraine, muscle cramps or numbness
• Abnormal vision
• Runny nose, sinus inflammation
• Indigestion/heartburn, vomiting, stomach pain, flatulence, increased salivation
• Problems with urine elimination (urinary disorders), excessive urine production
• Rash, itching
• Dizziness upon standing quickly, low blood pressure, high blood pressure
• Fatigue, yawning, taste disturbances
• Inability of women to achieve orgasm, menstrual pain, impotence, ejaculation failure
• Sleep disorders, difficulty concentrating, abnormal dreams, memory loss, anxiety, decreased libido, increased appetite, loss of appetite, absence of emotion or enthusiasm, confusion.

Uncommon (in between 1 and 10 of every 1,000 treated patients):

• Slow heartbeat
• Motor system disturbances (extrapyramidal disorders), seizures
• Ringing in the ears (tinnitus)
• Cough
• Light sensitivity
• Muscle pain
• Allergic reactions, fainting, general malaise
• Increased liver enzymes
• Feeling of optimism, joy and well-being (euphoria), increased sexual desire.

Rare (in between 1 and 10 of every 10,000 treated patients):

• Bleeding (e.g., vaginal, gastrointestinal, skin and mucous membrane bleeding)
• Low sodium levels in blood (hyponatremia), and a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion), particularly in elderly patients
• Serotonin syndrome
• Suicidal thoughts or suicidal behaviour, inability to sit still and
• restlessness

Very rare (in less than 1 in 10,000 treated patients), frequency not known (cannot be estimated from available data):

• Abnormal heart rhythm or rate (arrhythmia)
• Swelling and itching (angioedema) of the skin or of tissues surrounding internal body cavities
• (mucous membranes)
• Joint pain
• Severe, sudden allergic reaction characterized by a sharp drop in blood pressure, skin itching, rash, and breathing difficulties
• Abnormal milk secretion from the breast (galactorrhea)
• Hallucinations, persistent hyperactivity and rapid shifts in mood and thoughts, loss of contact with personal reality, accompanied by feelings of unreality and eccentricity, panic attacks
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage), see "Pregnancy" in section 2 for more information.

Hypersensitivity reactions:

Shock (severe drop in blood pressure, pallor, agitation, weak and rapid pulse, cold and clammy skin, reduced consciousness) caused by sudden and intense dilation of blood vessels due to severe hypersensitivity to certain substances (anaphylactic reactions).

Withdrawal symptoms observed after discontinuation of treatment:

It is recommended to gradually reduce the dose over 1–2 weeks, as withdrawal reactions may occur after stopping treatment. Withdrawal reactions include: dizziness, muscle cramps or numbness, headache, nausea, and anxiety. Most withdrawal reactions are mild in nature and self-limiting. If treatment is to be discontinued, it is advised to gradually reduce the dose over 1–2 weeks.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if

it is a possible adverse effect not listed in this leaflet. You may 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 Citalopram VIR 20 mg tablets

Keep out of the reach and sight of children.

Do not use Citalopram VIR after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Additional Information

Composition of Citalopram VIR 20 mg tablets

• The active substance is citalopram. One tablet contains 20 mg of citalopram (as citalopram hydrobromide).
• The other components (excipients) are: gluten-free maize starch, lactose monohydrate, sodium croscarmellose, glycerol, copovidone, magnesium stearate, microcrystalline cellulose, hypromellose 5, macrogol 400 and titanium dioxide (E-171).

Appearance of the product and contents of the pack
Film-coated tablet. White, oval, biconvex, film-coated tablet with a score line.

Packaged in packs of 14, 28 and 56 film-coated tablets, presented in blisters.

Only some pack sizes may be commercially available.

Other presentations:

Citalopram VIR 10 mg tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Industria Química y Farmacéutica VIR, S.A.

C/. Laguna 66-68-70, 28923 ALCORCÓN (Madrid) Spain

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/. Laguna 66-68-70, 28923 ALCORCÓN (Madrid) - Spain

Or

RIVOPHARM PHARMACEUTICALS LABORATORIES

Via Cantonale, Centro Insema CManno - Switzerland

This leaflet was last reviewed in December 2020

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/