Citalvir 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user.

CITALVIR 20 mg film-coated tablets EFG

Citalopram

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these are effects not listed in this leaflet. See section 4.

In this leaflet:

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

1. What Citalvir is and what it is used for

CITALVIR is an antidepressant medicine that belongs to the group of "selective serotonin reuptake inhibitors".

CITALVIR is indicated for:

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

2. What you need to know before taking Citalvir

Do not take CITALVIR:

• 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 antidepressant 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 were born with a heart rhythm disorder or have ever experienced episodes of such a disorder (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.

See also the section “Use of Citalvir with other medicines” below.

Even if you have finished treatment with MAOIs, you must wait 2 weeks before starting treatment with CITALVIR.

You must wait 1 day after taking moclobemide.

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Citalvir.

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 CITALVIR may affect blood glucose control. You may need adjustment of your insulin and/or oral hypoglycemic doses.
• If you have epilepsy. Treatment with CITALVIR 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 if you 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 if you think your body may be losing salt, for example due to severe diarrhea and vomiting over several days or due to diuretic use (medicines to increase urination).
• 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).

Talk to your doctor, even if any of the above circumstances 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 group as CITALVIR (called SSRIs/SNRIs) may cause sexual dysfunction symptoms (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 does not occur immediately. After starting treatment with CITALVIR, it may take several weeks before you notice any improvement.

In the treatment of panic disorder, improvement is typically 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 to follow your doctor’s instructions exactly and 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 of harming yourself or ending your life. These thoughts may increase when starting antidepressants, as all such medicines take time to become effective—usually about 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 self-harm or suicide.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years of age) with psychiatric disorders treated with an antidepressant.

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

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 may ask them to monitor whether your depression or anxiety disorder worsens or if they are concerned about changes in your behaviour.

Use in children and adolescents

CITALVIR 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 ideation, and hostility (mainly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe CITALVIR to patients under 18 years of age if they consider it the most appropriate treatment. If your doctor has prescribed CITALVIR to a patient under 18 years of age and you wish to discuss this decision, please consult your doctor again. Inform your doctor if any of the symptoms listed above worsen or become complicated while a patient under 18 years of age is taking CITALVIR. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of CITALVIR in this age group have not yet been fully established.

Use of CITALVIR with other medicines

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

Some medicines may 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 CITALVIR. After stopping CITALVIR, you must wait 7 days before taking any of these.

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 effects of metoprolol have been observed.
• Sumatriptan and similar medicines (used to treat migraine) and tramadol (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 CITALVIR 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 CITALVIR 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 potassium or magnesium levels in blood, as this increases the risk of life-threatening heart rhythm disturbances.

Do not take CITALVIR

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 CITALVIR with food, drinks, and alcohol

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

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

Pregnancy, breastfeeding and fertility

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

Pregnancy

If you take CITALVIR 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, strong reflexes, tremors, restlessness, irritability, lethargy, constant crying, drowsiness, and sleep difficulties. If your newborn baby shows any of these symptoms, contact your doctor immediately.

If you take citalopram in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after childbirth, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking CITALVIR.

Breastfeeding

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

Ensure that your midwife and/or doctor are aware that you are being treated with CITALVIR. During pregnancy, particularly in the last 3 months, medicines like CITALVIR 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 your baby develops these symptoms, 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

Generally, CITALVIR does not cause drowsiness; however, if you feel dizzy or sleepy when you start taking this medicine, do not drive or operate tools or machinery until these effects subside.

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

CITALVIR contains sodium

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

3. How to take CITALVIR

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

Remember to take your medicine.

Your doctor will tell you how long to take CITALVIR. Do not stop treatment early or abruptly, as this could worsen your condition.

You should continue taking your medicine even if you do not notice improvement, since it may take several weeks for the medicine to start working.

CITALVIR is for oral administration. The tablets can be taken at any time of day, regardless of meals, and as a single daily dose. They must be swallowed with sufficient liquid (a glass of water) and must not be chewed.

Recommended dose

Adults:

Depression

The usual dose is 20 mg per day. If your doctor considers it necessary, this dose may be increased 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 it to 20–30 mg daily. If your doctor considers it necessary, this dose may be increased up to a maximum of 40 mg per day.

Obsessive-compulsive disorder (OCD)

The initial dose is 20 mg per day. If your doctor considers it necessary, the dose may be increased in increments of 20 mg up to a maximum of 40 mg per day.

Elderly patients (over 65 years of age)

Treatment in elderly patients 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.

Children

The safety and efficacy of CITALVIR 10 mg have not been established in children and adolescents under 18 years of age, and therefore its use is not recommended in this population group.

Patients with special risks

Patients with hepatic impairment:

It is recommended not to exceed a dose of 20 mg per day.

Patients with renal impairment:

The use of citalopram is not recommended in patients with severe renal impairment.

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

If you take more CITALVIR than you should

If you think that you or someone else has taken more CITALVIR than you should, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested.

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

Take the CITALVIR packaging with you if you go to the doctor or hospital.

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

If you forget to take CITALVIR

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 the missed dose.

If you stop taking CITALVIR

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

Abrupt discontinuation of the medication may cause some mild and transient disturbances such as dizziness, tingling sensations, sleep disturbances (vivid dreams, nightmares, inability to sleep), feeling of anxiety, headache, feeling of 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 CITALVIR 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, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may 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 therefore will 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 CITALVIR 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 CITALVIR 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 achieving orgasm.
• Fatigue.
• Fever.
• Skin irritation.
• Weight loss.

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

• Bleeding disorders of the skin (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 (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 blood platelets, increasing the risk of bleeding or bruising (haematoma).

• Hypersensitivity (rash).

• Severe allergic reaction causing difficulty breathing or dizziness.

• Increased urine output.

• Hypokalemia: low potassium levels in 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 from 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 the skin or mucous membranes.

• Painful erections.

• Milk production 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, pharmacist, or nurse, 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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citalvir

This medicine does not require any special storage conditions.

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

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 must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of CITALVIR:

The active substance in CITALVIR 20 mg is citalopram (hydrobromide). Each tablet contains 24.98 mg of citalopram hydrobromide (equivalent to 20 mg of citalopram).

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

Appearance of the product and contents of the container

CITALVIR 20 mg is presented as film-coated tablets. The coated tablets are white, oval-shaped, biconvex, and scored.

CITALVIR 20 mg is available in blister packs containing 14, 28, 30, and 56 tablets.

Only some pack sizes may be marketed.

Other presentations:

CITALVIR 10 mg tablets.

CITALVIR 40 mg tablets.

Marketing Authorization Holder and Manufacturer

Holder:

ABABOR PHARMACEUTICALS, S.L.

Chile, 4 - Building 1 - Office 1 - Las Matas

28290- Las Rozas

Spain

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

Laguna 66-68-70 Street, 28923 ALCORCÓN (Madrid)

Spain

Tel.: 91 486 29 90 Fax: 91 486 29 91

Or

RIVOPHARM PHARMACEUTICALS LABORATORIES

Via Cantonale, Centro Insema C

CH-6928 Manno, Switzerland

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

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/