Citalopram Teva-Ratiopharm 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Citalopram Teva-ratiopharm 10 mg film-coated tablets

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 effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Citalopram Teva-ratiopharm is and what it is used for

Citalopram 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 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 for other purposes. Ask your doctor if you have any doubts about why citalopram has been prescribed for you.

2. What you need to know before taking Citalopram Teva-ratiopharm

Do not take Citalopram Teva-ratiopharm

• If you are allergic to citalopram or to any of the other components 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 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.

• See also the section “Taking Citalopram Teva-ratiopharm with other medicines” below.

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

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 citalopram may alter glycaemic control. You may need an adjustment in the dose of insulin and/or oral hypoglycaemic agents.
• 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 history of bleeding disorders or 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 you think your body may be losing salt, for example due to severe diarrhoea and vomiting over several days or due to diuretic use (medicines for increasing urine production).

• If you notice your heartbeat is fast or irregular, or if you experience fainting or dizziness when standing up from a sitting or lying position. This could indicate a disturbance in your heart rhythm.
• If you have or have previously had eye problems such as certain types of glaucoma (increased pressure in the eye).
• 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 characterised 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 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 panic disorder, improvement is usually 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 or change your dose without consulting your doctor.

Suicidal thoughts and worsening of depression or anxiety disorder

If you are depressed and/or have anxiety disorders, you may occasionally have thoughts of harming yourself or taking your life. These thoughts may increase when you first start taking antidepressants, as all these medicines require time to take effect—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 harming yourself or taking 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 taking 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.

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 (predominantly aggression, confrontational behaviour, and irritability) when taking this type of medicine. Nevertheless, your doctor may prescribe it to patients under 18 if they decide it is best for them. If your doctor has prescribed citalopram to a patient under 18 and you wish to discuss this decision, please consult your doctor again. Inform your doctor if any of the symptoms described above worsen or complications arise while patients under 18 are taking citalopram.

Furthermore, the long-term effects on safety, growth, puberty, and cognitive and behavioural development of citalopram in this age group have not yet been established.

Taking Citalopram Teva-ratiopharm with other medicines

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

Some medicines may affect the action of others and 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 citalopram. After stopping 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 dose of selegiline 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 and similar medicines (opioids, 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). Blood levels of citalopram may increase, but no increase in adverse effects of citalopram 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 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 cardiac rhythm disturbances.
• Serotonergic medicines, such as buprenorphine, as they may increase the risk of serotonin syndrome.

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.

Taking Citalopram Teva-ratiopharm with food, drinks and alcohol

Citalopram can be taken with or without food (see section 3 “How to take Citalopram Teva-ratiopharm”).

Citalopram has not been shown to increase the effects of alcohol. However, it is advisable to avoid alcohol consumption during treatment with citalopram.

Pregnancy, breastfeeding and fertility

Inform your doctor if you are pregnant, 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 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 this medicine 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 that 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 using machines

Citalopram generally does not cause drowsiness; however, if you feel dizzy or sleepy when starting this medicine, do not drive or operate tools or machinery until these effects subside.

Citalopram Teva-ratiopharm contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult 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 Teva-ratiopharm

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

Adults

Depression

The recommended 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 recommended initial dose is 10 mg daily for the first week before increasing it 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 (OCD)

The recommended initial dose is 20 mg daily. If necessary, your doctor may increase your dose up to a maximum of 40 mg daily.

Elderly patients

Treatment should be started 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 given to children or adolescents. For further information, please see section 2 “What you need to know before taking Citalopram Teva-ratiopharm”.

How and when to take Citalopram Teva-ratiopharm

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).

There are other commercial presentations with the same active substance that allow administration of 20, 30, or 40 mg of citalopram.

Duration of treatment

Like other medicines used 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 this 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 tells you to do so. The underlying illness 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 new depressive episodes.

If you take more Citalopram Teva-ratiopharm 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 telephone number 915.620.420, stating the medicine and the amount taken.

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

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

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

If you forget to take Citalopram Teva-ratiopharm

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 Teva-ratiopharm

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 anxious, headache, dizziness (nausea), vomiting, sweating, restlessness or agitation, tremors, feeling confused or disoriented, feelings of emotion or irritability, diarrhoea (loose stools), visual disturbances, rapid pulse or palpitations. When your treatment period is over, 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 when antidepressants are used in combination.
• 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 contact your doctor immediately.

• Hyponatraemia: low sodium levels in the blood, which may cause tiredness, confusion, and muscle cramps.
• Fast or irregular heartbeat, or feeling faint, as these may 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 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):

• Tendency to feel sleepy
• 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 performance
• Anxiety
• Restlessness
• Confusion
• Abnormal dreams
• Tremors
• Tingling or numbness in hands or feet
• Dizziness
• Difficulty concentrating
• 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
• 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
• Fast heartbeat
• Slow heartbeat
• Hives (urticaria)
• 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"
• Reduced platelet count in blood, increasing the risk of bleeding or bruising (haematoma)
• Hypersensitivity (rash)
• Severe allergic reaction causing difficulty breathing or dizziness
• Increased volume of urine excreted
• Hypokalaemia: low potassium levels in blood, which may cause muscle weakness, cramps, or irregular heartbeat
• Panic attacks
• Teeth grinding
• Restlessness
• Abnormal muscle movements or stiffness
• Akathisia (involuntary muscle movements)
• Vision disturbances
• Low blood pressure
• Nosebleeds
• Bleeding disorders including bleeding of the skin and mucous membranes (bruising, ecchymosis)
• Heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see section 2 ‘Pregnancy, breastfeeding and fertility’ for more information
• Sudden swelling of the skin or mucous membranes
• Painful erections
• Increased levels of prolactin hormone in blood
• 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 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 or pharmacist, even if they are 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 website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Citalopram Teva-ratiopharm

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

Do not use this medicine after the expiry date stated on the packaging, following 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 unused medicines and their containers at the SIGRE point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Citalopram Teva-ratiopharm 10 mg tablets

• The active substance is citalopram (as hydrobromide). Each tablet contains 10 mg of citalopram.
• The other components (excipients) are: corn 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 container

Film-coated tablet. Round, biconvex, white, film-coated tablet.

Presented in packs of 14 and 28 film-coated tablets, packed in blisters.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer:

Industria Química y Farmacéutica VIR, S.A.

C/. Laguna 66-68-70, Poligono Industrial Urtinsa II

28923 ALCORCÓN (Madrid) Spain

or

RIVOPHARM PHARMACEUTICALS LABORATORIES

Via Cantonale, Centro Insema C

Manno - Switzerland

Date of the most recent revision of this leaflet: February 2025

Detailed 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/

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66482/P_66482.html