Citalopram Combix 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Citalopram Combix 10 mg film-coated tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions 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.
6. Contents of the pack and other 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 to you.

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

Do not take Citalopram Combix

• 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 heart rhythm disorder or have ever experienced such an episode (this is detected by 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 refer to the section "Other medicines and Citalopram Combix" below.

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

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, inform your doctor:

• If you have manic episodes or panic disorder

• If you have hepatic or renal insufficiency. Your doctor may need to adjust your dose.

• If you have diabetes. Treatment with citalopram may alter glycaemic control. You may need adjustment of insulin and/or oral hypoglycaemic agent 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 a bleeding disorder or if you are pregnant (see "Pregnancy").

• If you have or have had heart problems or 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 salts, for example due to severe diarrhoea and vomiting over several days or due to use of diuretics (medicines for urination).

• If you have noticed rapid or irregular heartbeats or have experienced fainting or dizziness when standing up from sitting or lying down. This could indicate a heart rhythm disorder.

• If you have a problem with dilation of the eye 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, disproportionate happiness, and excessive physical activity. If you experience this, contact your doctor.

Symptoms such as restlessness or difficulty sitting or standing still (akathisia) may also occur during the first 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 symptoms of sexual dysfunction (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 does not occur immediately. After starting treatment with citalopram, it may take several weeks before you notice any improvement.

In the treatment of panic disorder, improvement is usually observed after 2–4 weeks.

At the beginning of treatment, some patients may experience increased anxiety, which will resolve with continued treatment. Therefore, it is very important that you follow your doctor's instructions exactly and do not interrupt 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 may increase when starting antidepressants, as all such medicines require time to take effect—usually around two weeks, although in some cases it may take longer.

You are more likely to have such thoughts:

• If you have previously had thoughts of harming yourself or ending your life.
• If you are a young adult. Clinical trial data have shown an increased risk of suicidal behaviour in young adults (under 25 years) with psychiatric disorders 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 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 whether they think your depression or anxiety disorder has worsened or if they are concerned about changes in your behaviour.

Children and adolescents

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

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 ideation, and hostility (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe citalopram to patients under 18 years of age if they decide it is 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 must inform your doctor if any of the above-mentioned symptoms worsen or complications arise while patients under 18 years of age are taking citalopram. In addition, the long-term effects on safety, growth, maturation, and cognitive and behavioural development of citalopram in this age group have not yet been established.

Other medicines and Citalopram Combix:

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicine.

Some medicines may affect the action of others and this 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, and tranylcypromine as active substances. If you have taken any of these medicines, you must wait 14 days before starting citalopram. After completing treatment with citalopram, you must wait 7 days before taking any of these medicines.
• Reversible selective MAO-A inhibitors containing moclobemide (used for the treatment of depression).
• The antibiotic linezolid.
• Lithium (used for prophylaxis and treatment of bipolar disorder) and tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Irreversible MAO-B inhibitors containing selegiline (used for the treatment of Parkinson's disease); these increase the risk of adverse effects. The selegiline dose must not exceed 10 mg per day.
• Metoprolol (used for high blood pressure and/or heart disease); blood levels of metoprolol 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, you should see your doctor.
• Cimetidine, lansoprazole, and omeprazole (used to treat stomach ulcers), fluconazole (used to treat fungal infections), fluvoxamine (an antidepressant), and ticlopidine (used to reduce the risk of stroke). These may increase citalopram blood levels.
• Medicines affecting platelet function, for example some antipsychotic drugs, 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 administration 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 blood potassium or magnesium levels, 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 not normally take citalopram, nor should mothers breastfeed while taking this medicine, unless you and your doctor have discussed the risks and benefits involved.

Pregnancy

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.

Breastfeeding

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

Ensure that your midwife and/or doctor are informed that you are being treated with citalopram.

During pregnancy, particularly in the last 3 months, medicines like citalopram may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), in which the baby breathes rapidly and 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 the treatment 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 dosage instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

Adults

Depression

The usual dose is 20 mg daily. 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 daily for the first week before increasing 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 daily. If your doctor considers it necessary, this dose may be increased up to a maximum of 40 mg per day.

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 should 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).

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 instructed you to do so. The underlying condition may persist for a long period, and if you stop treatment too early, your symptoms may return.

Patients with recurrent depression benefit from continuation treatment, sometimes for several years, to prevent the occurrence of new depressive episodes.

If you take more Citalopram Combix than you should:

If you think that you or someone else has taken more citalopram than you should, 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 overdose may include irregular heartbeats that may be life-threatening, 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 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 the missed dose.

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, restlessness or agitation, 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 experiences 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 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 Seropram and consult 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 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 drive or performance.
• Anxiety.
• Restlessness.
• Confusional state.
• Abnormal dreams.
• Tremors.
• Tingling or numbness in hands or feet.
• Dizziness.
• Attention disturbances.
• Ringing in the ears (tinnitus).
• Yawning.
• Diarrhea.
• Vomiting.
• Constipation.
• Rash.
• Muscle and joint pain.
• Men may experience problems with ejaculation and erection.
• Women may experience difficulty reaching orgasm.
• Fatigue.
• 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 platelets in the blood, increasing the risk of bleeding or bruising (hematoma).

• Hypersensitivity (rash).

• Severe allergic reaction causing difficulty breathing or dizziness.

• Increased amount of urine excreted.

• Hypokalemia: low potassium levels in the 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 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.

• Heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage); see "Pregnancy" in section 2 for more information.

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: 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 is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Citalopram Combix:

The active substance is citalopram (hydrobromide). Each tablet contains 10 mg of citalopram.

The other components (excipients) are:

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

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

Appearance of the product and contents of the pack:

Citalopram Combix is presented as white, film-coated, round, biconvex tablets, smooth on both sides. It is available in packs of 14 and 28 tablets, and hospital pack of 500 tablets.

Only certain pack sizes may be marketed.

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 66-70. Polígono Industrial URTINSA II

28923 Alcorcón (Madrid)

Spain

Date of the most recent revision of this leaflet: 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/