Citalopram Tarbis 20 mg film-coated tablets EFG
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Citalopram TARBIS 20 mg film-coated tablets EFG
Citalopram (hydrobromide)
Please read all of this 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 further 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 be harmful to them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Leaflet Contents
- What Citalopram TARBIS is and what it is used for
- What you need to know before taking Citalopram TARBIS
- How to take Citalopram TARBIS
- Possible adverse effects
- How to store Citalopram TARBIS
- Contents of the pack and other information
1. What Citalopram TARBIS is and what it is used for
Citalopram is an antidepressant medicine that belongs to a group of medicines known as "selective serotonin reuptake inhibitors".
Citalopram TARBIS 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 starting to take Citalopram TARBIS
Do not take Citalopram TARBIS 20 mg:
-If you are allergic to citalopram or to any of the other ingredients of this medicine (listed in section 6).
-If you are being treated with other antidepressant medicines from the group of monoamine oxidase inhibitors (MAOIs) or if you have been receiving such treatment within the last two weeks.
**-If you have had any type of heart rhythm disorder since birth or have ever experienced an episode of this kind (this is detected by an electrocardiogram, a test used to assess how the heart is functioning). **
-If you are taking medications because you have a condition that affects your heart rhythm.
-If you are taking medications that may affect heart rhythm.
Also consult the section “Taking Citalopram TARBIS with other medicines” below.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Citalopram TARBIS.
- If you have severe liver or severe kidney problems.
- If you have experienced manic episodes.
- If you have epilepsy or a history of epilepsy. If seizures occur or the frequency of seizures increases, treatment with citalopram should be discontinued.
- If you have diabetes, as you may require adjustment of insulin or oral antidiabetic dosage.
- If you have a bleeding disorder or are being treated with medications that affect blood coagulation, or if you are pregnant (see “Pregnancy, breastfeeding and fertility”).
-If you have or have had any heart problems or have recently suffered a heart attack.
-If your heart beats slowly while at rest (this is known as bradycardia) and/or you think your body may be losing salts, for example because you have had severe diarrhea and vomiting for several days or because you have used diuretics (medicines that make you urinate).
-If you have noticed that your heartbeat is fast or irregular, or if you have experienced fainting or dizziness when standing up from a sitting or lying position. This could indicate that you have a heart rhythm disorder.
-Some medicines in the group to which Citalopram TARBIS belongs (called SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms persist after stopping treatment.
An increased risk of bone fractures has been observed in patients treated with this type of medicine.
Suicidal thoughts and worsening of depression or anxiety disorder
If you are depressed and/or suffer from an anxiety disorder, you may sometimes experience thoughts of self-harm or suicide. These may increase when you first start taking 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 these types of 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 who were treated with an antidepressant.
If at any time you experience thoughts of self-harm or suicide, contact your doctor or go directly to a hospital.
It may be helpful for you to tell a close friend or family member that you are depressed or have an anxiety disorder and ask them to read this leaflet. You may wish to ask them whether they think your depression or anxiety disorder has worsened, or if they are concerned about changes in your behaviour.
When treatment is stopped, withdrawal symptoms are common, particularly if discontinuation is abrupt (see section “Possible side effects”).
Use in children and adolescents under 18 years
Citalopram TARBIS 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 class of medicines. Nevertheless, your doctor may prescribe Citalopram TARBIS 20 mg to patients under 18 years of age if they decide it is in the patient’s best interest. If your doctor has prescribed Citalopram TARBIS 20 mg 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 symptoms mentioned above worsen or become complicated while patients under 18 years of age are taking Citalopram TARBIS 20 mg. In addition, the long-term effects on safety, as well as on growth, maturation, and cognitive and behavioural development of Citalopram TARBIS 20 mg in this age group have not yet been established.
Taking Citalopram TARBIS with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take Citalopram TARBIS:
If you are taking medicines for a pre-existing condition that affects your heart rhythm, or if you are taking medicines that could themselves affect heart rhythm, for example class IA and III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (sparfloxacin, moxifloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), certain antihistamines (astemizole, mizolastine).
If you have any doubts about this, consult your doctor.
Concomitant administration of citalopram with non-selective or selective B monoamine oxidase inhibitors (MAOIs) (such as selegiline, an antiparkinsonian medicine) is contraindicated, as is administration within two weeks following discontinuation of such treatment.
Concomitant administration of citalopram with selective A MAOIs (such as moclobemide, an antidepressant medicine) is not recommended.
Concomitant administration of citalopram with MAOIs carries a risk of serotonin syndrome (see section “Possible side effects”).
Precautions should be taken if citalopram is administered together with any of the following medicines:
- Carbamazepine (an antiepileptic medicine): blood levels of carbamazepine may increase, and a dose reduction of carbamazepine may be necessary.
- Lithium (a medicine used to treat bipolar disorder): increased risk of serotonin syndrome.
- Oral anticoagulants, acetylsalicylic acid, non-steroidal anti-inflammatory drugs, and other medicines affecting blood coagulation: increased risk of bleeding.
- Imipramine (an antidepressant medicine): increased blood levels of imipramine’s metabolite.
- 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): may increase blood levels of citalopram.
- Metoprolol (an antihypertensive, antianginal, and antiarrhythmic medicine).
- Herbal preparations containing St. John’s wort: adverse effects may occur more frequently.
Taking Citalopram TARBIS with food, drinks, and alcohol
It is advisable to avoid alcohol consumption while taking this medicine.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
The use of citalopram during pregnancy and breastfeeding is not recommended.
If you take Citalopram TARBIS in the late stages of pregnancy, there may be an increased risk of heavy vaginal bleeding shortly after delivery, especially if you have a history of bleeding disorders. Your doctor or midwife should be aware that you are taking Citalopram TARBIS so they can advise you.
Ensure that your midwife and/or doctor knows that you are taking Citalopram TARBIS. Medicines such as Citalopram TARBIS, when taken during pregnancy, particularly during the last three months, may increase the risk of a serious condition in newborns called persistent pulmonary hypertension of the newborn (PPHN), which causes the baby to breathe faster and appear blue. These symptoms usually begin within the first 24 hours after birth. If this happens to your baby, contact your midwife and/or doctor immediately.
Animal studies have shown that citalopram reduces sperm quality. Theoretically, this could affect fertility, but no impact on human fertility has been observed to date.
Driving and use of machines
During treatment with Citalopram TARBIS, you may feel drowsy or dizzy. Do not drive or operate tools or machinery until you know how this treatment affects you.
Citalopram TARBIS contains lactose
This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with them before taking this medicine.
3. How to take Citalopram TARBIS
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, please consult your doctor or pharmacist again.
Remember to take your medicine.
Your doctor will tell you how long your treatment with Citalopram TARBIS should last. 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, as it may take several weeks for the medicine to start working.
Citalopram TARBIS are tablets for oral administration. The tablets can be taken at any time of day, regardless of meals, and should be taken as a single dose. They must be swallowed with sufficient liquid (a glass of water) and must not be chewed.
The recommended dose is:
Adults:
Depression
The usual dose is 20 mg daily. If deemed necessary, your doctor may increase this dose 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 deemed necessary, your doctor may increase this dose up to a maximum of 40 mg per day.
Obsessive-compulsive disorder (OCD)
The usual dose is 20 mg daily. If deemed necessary, your doctor may increase this dose up to a maximum of 40 mg per day.
Elderly patients (aged over 65 years)
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 at special risk
Patients with liver disease should not take more than 20 mg daily.
Patients with renal impairment:
The use of citalopram is not recommended in patients with severe renal impairment.
Children
The safety and efficacy of Citalopram TARBIS 20 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.
If you feel that the effect of Citalopram TARBIS 20 mg is too strong or too weak, inform your doctor or pharmacist.
If you take more Citalopram TARBIS than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.
The most common symptoms in case of overdose are: nausea, vomiting, sweating, drowsiness, bluish discoloration of the skin, tremors, seizures, loss of consciousness, and palpitations.
If you forget to take Citalopram TARBIS
If you miss a dose, wait until the next scheduled dose.
Do not take a double dose to make up for missed doses.
If you stop taking Citalopram TARBIS
If treatment with Citalopram TARBIS 20 mg is stopped abruptly, withdrawal symptoms may occur, such as dizziness, nausea, sweating, sensory disturbances, sleep disturbances, headache, agitation or anxiety, and tingling sensations in the hands or feet. The risk of withdrawal reactions depends on several factors, including the duration of treatment, the dose used, and the rate of dose reduction. Generally, these symptoms are mild or moderate, but in some patients they may be severe. Usually, these symptoms are self-limiting and resolve within two weeks, although in some patients they may last longer. Your doctor will advise you on how to gradually discontinue treatment with this medicine.
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.
The adverse effects are generally mild or moderate in intensity. They usually become apparent during the first, or even during the first two weeks of treatment, and subsequently disappear as the disease improves.
The following adverse effects have been reported. If you notice any of the following symptoms, stop taking Citalopram TARBIS and contact your doctor immediately:
- Neuropsychiatric disorders: nervousness, drowsiness, weakness, headaches, dizziness, sleep disturbances, memory loss, suicidal ideation, and serotonin syndrome (characterized by symptoms such as agitation, confusion, increased sweating, hallucinations, increased reflex responses, involuntary movements, chills, tachycardia, and tremor), psychomotor agitation/acathisia (characterized by restlessness and an urge to move, frequently accompanied by difficulty sitting still or remaining at rest; these are more likely to occur during the first weeks of treatment).
- Gastrointestinal disorders: nausea, vomiting, diarrhoea, constipation, dry mouth.
- Skin disorders: rash, itching, increased sweating.
- Visual disorders: disturbances in adaptation.
- Metabolic disorders: weight loss or weight gain.
- Cardiovascular disorders: rapid or irregular heartbeat, or feeling faint, as these could be symptoms of a serious heart problem known as torsades de pointes, tachycardia, dizziness upon standing due to a drop in blood pressure, slowed heart rate in some patients.
- Reproductive system and breast disorders: changes in sexual desire, heavy vaginal bleeding shortly after childbirth (postpartum haemorrhage); see "Pregnancy, breastfeeding and fertility" in section 2 for further information (frequency not known).
- Renal and urinary disorders: urinary disturbances.
Rarely, cases of bleeding in the skin and mucous membranes have been observed, such as skin haemorrhages, vaginal bleeding, and gastrointestinal bleeding.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products, Website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Citalopram TARBIS
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Expiry
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 medicines and their containers at the SIGRE Point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Citalopram TARBIS 20 mg tablets
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The active substance is citalopram (hydrobromide). Each tablet contains 20 mg of citalopram.
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The other components (excipients) are: maize starch, monohydrate lactose, sodium croscarmellose, glycerol, copovidone, magnesium stearate, microcrystalline cellulose, hypromellose 5, macrogol 400 and titanium dioxide (E-171).
Appearance of the product and contents of the pack
Citalopram TARBIS 20 mg are white, oval, biconvex, film-coated tablets with a score line. They are available in packs of 14, 28, 56 and 500 (hospital pack) tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
TARBIS FARMA, S.L.
Gran vía Carlos III, 94
08028 – Barcelona
Spain
Manufacturer
Toll Manufacturing Services, S.L.
C/Aragoneses, 2
28108 Alcobendas (Madrid)
Spain
Date of the most recent review of this leaflet: December 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/