Citalopram Combix 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Citalopram Combix 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since 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:

1. What Citalopram Combix is and what it is used for
2. What you need to know before taking Citalopram Combix
3. How to take Citalopram Combix
4. Possible side effects
5. How to store Citalopram Combix

Pack contents and additional information

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

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

Citalopram Combix is indicated for the treatment of:

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

However, your doctor may prescribe Citalopram Combix for other purposes. Ask your doctor if you have any questions about why Citalopram Combix has been prescribed for you.

2. What you need to know before starting to take Citalopram Combix

Do not take CitalopramCombix :**

• If you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6).

• If you are taking other medicines belonging to a group called monoamine oxidase inhibitors (MAOIs). MAOIs include medicines such as phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine, selegiline (used in the treatment of Parkinson’s disease), moclobemide (used for the treatment of depression), and linezolid (an antibiotic).

• If you have a congenital condition affecting your heart rhythm or have ever experienced such an episode (this can be detected by an 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 "Other medicines and Citalopram Combix" below.

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

You must wait one day after taking moclobemide.

After stopping citalopram, you must wait one week before taking any MAOI.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Citalopram Combix.

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

• If you have manic episodes or anxiety disorders.

• If you have liver or kidney impairment. Your doctor may need to adjust your dose.

• If you have diabetes. Treatment with citalopram may alter glucose control. You may require adjustment of insulin and/or oral hypoglycemic doses.

• 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 any bleeding disorder, 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 any heart problems or have recently suffered a heart attack.

• If your heart beats slowly at rest (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 diuretic use (medicines for increasing urine output).

• 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 disturbance in your heart rhythm.

• If you have a problem with dilation of the pupils (mydriasis).

Consult 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 citalopram (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 conditions, improvement is not immediate. After starting treatment with citalopram, it may take several weeks before you notice any improvement.

In the treatment of anxiety disorder, improvement is typically seen after 2–4 weeks.

At the beginning of treatment, some patients may experience increased anxiety, which will resolve with continued treatment. Therefore, it is very important that you follow your doctor’s instructions exactly and do not stop treatment 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 these medicines require time to begin working—usually around two weeks, although in some cases it may take longer.

You are more likely to have such thoughts:

• If you have previously had thoughts of harming yourself or ending your life.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behavior in young adults (under 25 years) with psychiatric disorders treated with an antidepressant.

If at any time you have thoughts of harming yourself or ending your life**, contact your doctor or go directly to a hospital.**

It may help to tell 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 whether they are concerned about changes in your behavior.

Children and adolescents

Citalopram should not normally be used in the treatment of children and adolescents under 18 years of age.

Also, 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 behavior, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe citalopram to patients under 18 years if they decide it is the most appropriate treatment. If your doctor has prescribed citalopram to a patient under 18 years and you wish to discuss this decision, please return to your doctor. You must inform your doctor if any of the symptoms listed above worsen or become complicated while patients under 18 years are taking citalopram. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioral development of citalopram in this age group have not yet been established.

Other medicines and Citalopram Combix

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Some medicines may affect the action of others, sometimes causing 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 citalopram. After finishing citalopram treatment, 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); metoprolol blood levels increase, but no signs of enhanced effect or adverse effects of metoprolol have been observed.

• Sumatriptan and similar medicines (used to treat migraine) and tramadol (used for severe pain) increase the risk of adverse effects. If you experience any unusual symptoms while using 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). These may increase citalopram blood levels.

• Medicines affecting platelet function, such as certain 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, 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 citalopram if you are taking medicines for a condition that 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.

Use of Citalopram Combix with food, drinks and alcohol

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

It has been observed that citalopram does not 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 plan 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 sleep difficulties. If your newborn baby shows any of these symptoms, please contact your doctor immediately.

If you take Citalopram Combix in late pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Citalopram Combix so they can advise you.

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 your midwife and/or doctor know 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 turns 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.

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.

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

3. How to take Citalopram Combix

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

Adults

Depression

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

Panic disorder

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

Obsessive-compulsive disorder

The initial dose is 20 mg daily. If your doctor considers it necessary, your dose may be increased 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 administered to children or adolescents. For further information, please see section 2 “What you need to know before taking Citalopram Combix”.

How and when to take Citalopram Combix

Citalopram is taken every day as a single daily dose.

The tablets may 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).

The tablet may be divided into equal doses.

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 the 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 maintenance treatment, sometimes for several years, to prevent new depressive episodes.

If you take more Citalopram Combix than you should:

If you think that you or someone else has taken more citalopram than prescribed, contact your doctor or pharmacist immediately, go to the nearest hospital emergency department, or call the Toxicology Information Service at: 91 562 0420, indicating the medicine and the amount ingested.

Do this even if no discomfort or signs of poisoning are observed.

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

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

If you forget to take Citalopram Combix:

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Citalopram Combix:

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 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 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 symptoms listed below, 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 with combined use of antidepressants.
• 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 consult your doctor immediately.

• Hyponatremia: low sodium levels in the blood, which may cause tiredness, confusion, and muscle cramps.
• Rapid or irregular heartbeat, or feeling faint, as these could be symptoms of a serious heart condition 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 troublesome 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)
• Headaches

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

• Decreased appetite
• Agitation
• Reduced sexual 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 skin 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 (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 blood, increasing the risk of bleeding or bruising (haematoma)
• Hypersensitivity (rash)
• Severe allergic reaction causing difficulty breathing or dizziness
• Increased amount of urine excreted
• Hypokalaemia: 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)
• Sudden swelling of skin or mucous membranes
• Painful erections
• Milk discharge in men and in women who are not breastfeeding
• Irregular menstrual periods
• Abnormal liver function tests
• Orthostatic hypotension (a significant drop in blood pressure upon standing)
• An increased risk of bone fractures has been observed in patients treated with this type of medicine
• Abnormal heart rhythm
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see “Pregnancy, breastfeeding and fertility” in section 2 for more information

Reporting of adverse effects

If you experience any adverse effect, consult 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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citalopram Combix

This medicine does not require 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 unused containers and medicines at the SIGRE point located at the pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Additional Information

Composition of CitalopramCombix:

The active substance is citalopram (hydrobromide). Each tablet contains 20 mg of citalopram.

The other components (excipients) are:

Core: gluten-free maize starch, microcrystalline cellulose, copovidone, sodium croscarmellose, magnesium stearate, glycerol, lactose monohydrate.

Coating: hypromellose E5, macrogol 400, titanium dioxide (E-171).

Appearance of the product and contents of the pack:

Citalopram Combix is presented as white, oval, biconvex, film-coated tablets with a score line. It is available in packs of 14, 28 or 56 tablets, and in a clinical pack of 500 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70

28923 Alcorcón (Madrid)

Spain

Date of the most recent review of this package leaflet: January 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/