Citalopram Sun 20 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Citalopram SUN 20 mg film-coated tablets EFG
(Citalopram hydrobromide)
Read the entire leaflet carefully before you start taking this medicine.
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Package leaflet contents:
- What CITALOPRAM SUN is and what it is used for
- Before taking CITALOPRAM SUN
- How to take CITALOPRAM SUN
- Possible side effects
- Storage of CITALOPRAM SUN
Contents of the pack and other information
1. What Citalopram SUN is and what it is used for
Citalopram SUN is an antidepressant that belongs to the class of SSRIs (selective serotonin reuptake inhibitors).
Citalopram SUN contains citalopram and is used to treat depressive disorders and panic disorders, with or without agoraphobia.
2. WHAT YOU NEED TO KNOW BEFORE STARTING TO TAKE CITALOPRAM SUN
Do not take CITALOPRAM SUN:
- If you are allergic to citalopram or any of the other components of this medicine (listed in section 6).
- In combination with monoamine oxidase inhibitors (MAOIs), including selegiline at doses exceeding 10 mg per day, within two weeks after stopping treatment with irreversible MAO inhibitors (such as tranylcypromine), or before one day after discontinuing moclobemide (used to treat depression) or selegiline (used to treat Parkinson’s disease). Treatment with MAO inhibitors should not be started until at least one week after stopping citalopram. Serious, and sometimes fatal, reactions have been reported in patients treated with SSRIs (a group of medicines to which citalopram also belongs) in combination with MAO inhibitors (such as moclobemide, linezolid, or selegiline). Do not take linezolide (an antibiotic) unless your doctor can strictly monitor your blood pressure.
- If you are taking medications such as pimozide (used to treat mental disorders).
- If you have had or were born with an episode of abnormal heart rhythm (seen on ECG; a test to assess heart function).
If you are taking medications for heart rhythm problems or medicines that may affect heart rhythm, see also the section “Taking Citalopram SUN with other medicines”.
Warnings and precautions:
Talk to your doctor or pharmacist before taking citalopram.
Below are situations when citalopram should only be used under specific circumstances and with special caution. Please consult your doctor about this. This also applies if any of these situations previously applied to you.
Citalopram must not be used:
- In patients receiving concomitant treatment with medicines containing serotonergic active substances (e.g., tramadol, sumatriptan or other triptans, oxitriptan, or tryptophan [serotonin precursors]). Concurrent use may cause the so-called "serotonin syndrome." Possible symptoms include high fever, agitation, confusion, tremors, and sudden muscle spasms. In such cases, consult a doctor immediately.
Special caution is required when taking Citalopram:
- If you have heart problems or have recently had a myocardial infarction.
- If you have a low resting heart rate or know you may experience depletion of mineral salts due to severe and prolonged diarrhea and/or vomiting, or due to the use of diuretics.
- If you experience a rapid or irregular heartbeat, fainting, collapse, or dizziness upon standing, which may indicate abnormal heart rhythm function.
Inform your doctor if you have hepatic or renal impairment. Your doctor may need to adjust your dose (see section 3 “How to take Citalopram?”).
In patients with epilepsy, treatment with citalopram should be discontinued if seizures occur or their frequency increases (see also section 4 “Possible side effects”).
Like other selective serotonin reuptake inhibitors, citalopram may also affect glucose control in diabetic patients. Adjustment of insulin or oral hypoglycemic medication dosage may be necessary.
Rare cases of hyponatremia (reduced sodium concentration in blood), possibly due to inappropriate secretion of antidiuretic hormone (SIADH), have been reported during citalopram treatment. This is usually reversible upon discontinuation of treatment. Most reports involved elderly patients, patients taking diuretics, or patients with volume depletion for other reasons. Signs may include general malaise with muscle weakness and confusion.
If you have bipolar disorder, manic episodes may occur. These episodes are characterized by exuberant and rapidly changing thoughts, exaggerated happiness, and excessive physical activity. In such cases, your doctor should discontinue treatment with Citalopram.
Important information about your illness
As with 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 experience any improvement. At the beginning of treatment, some patients may experience increased anxiety, which usually resolves with continued treatment. In the treatment of panic disorder, improvement typically takes 2 to 4 weeks.
Some patients with panic disorder may experience worsening of anxiety symptoms at the beginning of treatment. However, these symptoms usually resolve spontaneously within 14 days of treatment. To reduce these paradoxical anxiety symptoms, a low initial dose of 10 mg of citalopram during the first week of treatment is recommended (see section 3 "How to take Citalopram?").
It is very important that you follow your doctor's instructions exactly and do not stop treatment or change your dose without consulting them.
Medicines like Citalopram (also known as SSRIs/SNRIs) may cause symptoms of sexual dysfunction (see section 4). In some cases, these symptoms have persisted after stopping treatment.
Withdrawal reactions when stopping treatment with a serotonin reuptake inhibitor
Withdrawal reactions usually occur when stopping treatment, especially if stopped abruptly (see section 4 "Possible side effects"). The risk of withdrawal symptoms may depend on various factors such as duration of treatment, dose, and speed of dose reduction. In general, these symptoms are mild to moderate, but may be severe in some patients. They usually appear in the first few days after stopping treatment and typically resolve on their own within 2 weeks. In some individuals, they may last longer (2–3 months or more). Therefore, when discontinuing Citalopram treatment, it is recommended to gradually reduce the dose over a period of several weeks or months, depending on the patient's needs (see section 3 "How to take Citalopram").
Rarely, bleeding or prolonged bleeding time [e.g., extensive skin hemorrhages] (bruising), gynecological bleeding, gastrointestinal bleeding, and other skin or mucosal bleeding have been reported with medicines like Citalopram. If you are pregnant, see the section "Pregnancy, breastfeeding, and fertility." Caution is advised in patients with a history of bleeding disorders and when used concomitantly with medicines that may increase the risk of bleeding (see also the section "Other medicines and Citalopram").
If you have psychosis with depressive episodes, treatment with Citalopram may increase psychotic symptoms (e.g., hallucinations or delusional experiences).
There is limited clinical experience with the simultaneous use of Citalopram and electroconvulsive therapy, so caution is advised.
Inform your doctor if you have eye problems, such as certain types of glaucoma (increased intraocular pressure). In such cases, Citalopram should be used with caution.
Children and adolescents
Citalopram is generally not recommended for children and adolescents under 18 years of age. Additionally, patients under 18 years of age have a higher risk of experiencing side effects such as suicide attempts, suicidal thoughts, and hostility (mainly aggression, oppositional behavior, and anger) when taking this type of medicine. Despite this, your doctor may prescribe Citalopram to patients under 18 years of age if they consider it the best option for them. If your doctor has prescribed Citalopram to a patient under 18 years of age and you wish to discuss it, please consult them again. You should inform your doctor if any of the aforementioned symptoms appear or worsen when patients under 18 years of age take Citalopram. Furthermore, the long-term safety and behavioral effects of citalopram in this age group have not yet been established.
Patients over 65 years of age
Patients over 65 years of age are more sensitive to the effects of antidepressants, so your doctor may adjust the dose of Citalopram. If you experience any side effects, inform your doctor.
Other medicines and Citalopram Sun
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Only take medicines prescribed by your doctor while taking citalopram.
Please note that this information may also apply to medicines that have been recently used.
Do not take Citalopram
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If you are taking MAO inhibitors (including selegiline at doses exceeding 10 mg per day), as this combination may cause serious side effects (serotonin syndrome). A sufficient time interval must pass when switching between these medicines. This switch can only be done under strict medical supervision. Do not take Citalopram within two weeks after stopping irreversible MAO inhibitors (e.g., tranylcypromine) or before one day after stopping moclobemide (for depression) or selegiline (for Parkinson’s disease). Treatment with MAO inhibitors should not be started until at least one week after stopping Citalopram. Serious, and sometimes fatal, reactions have occurred in patients who received SSRIs together with MAO inhibitors (such as moclobemide, linezolid, or selegiline).
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If you are taking the antibiotic linezolid.
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If you are taking medicines to treat cardiac arrhythmias or medicines that may affect heart rhythm, for example, class IA and III antiarrhythmics, antipsychotics (e.g., phenothiazine derivatives, pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial agents (e.g., sparfloxacin, moxifloxacin, IV erythromycin, pentamidine, antimalarials such as halofantrine), or certain antihistamines (astemizole, mizolastine, etc.). Consult your doctor if you have any further questions.
Citalopram should not be taken together with sumatriptan and similar preparations (medicines for migraine), tramadol and similar medicines (opioids used for severe pain), tryptophan or oxitriptan (precursors of the neurotransmitter serotonin), as this may intensify serotonin-mediated effects.
Individual cases of "serotonin syndrome" (for more information, see section 4 "Possible side effects") have also been reported when combining citalopram with moclobemide or buspirone.
Concomitant use of citalopram and St. John's wort (herbal medicines for depression) should be avoided due to an increased risk of side effects.
Concomitant administration of cimetidine, lansoprazole, and omeprazole (for treatment of stomach ulcers), fluconazole (for treatment of fungal infections), fluvoxamine (an antidepressant), and ticlopidine (to reduce the risk of stroke) may increase the blood concentration of citalopram. Dose adjustment may be necessary.
Caution is advised when taking flecainide or propafenone (medicines for heart conditions), desipramine, clomipramine, and nortriptyline (medicines for depression), or risperidone, thioridazine, and haloperidol (medicines for schizophrenia and psychosis) concomitantly with citalopram. Dose adjustment may be necessary.
Concomitant use of metoprolol (medicines for high blood pressure and heart conditions) increases blood levels of metoprolol. Dose adjustment may be necessary.
Although interactions between citalopram and lithium (used for prevention and treatment of bipolar disorder) have been reported only very rarely to date, treatment should be closely monitored.
Caution is advised when using citalopram concomitantly with anticoagulants, medicines affecting platelet function, or other medicines increasing the risk of bleeding (see also "Warnings and precautions" in section 2). These include non-steroidal anti-inflammatory drugs (NSAIDs), acetylsalicylic acid, dipyridamole, antipsychotics, and ticlopidine.
Caution is advised when using medicines that reduce blood potassium or magnesium levels, as these conditions increase the risk of potentially fatal cardiac arrhythmias.
Caution is advised when using citalopram concomitantly with imipramine and desipramine (both medicines for depression). Dose adjustment of desipramine may be necessary.
Citalopram may lower the seizure threshold. Therefore, caution is required when used concomitantly with medicines that may also lower the seizure threshold, such as mefloquine (antimalarial), bupropion (for depression), tramadol (potent analgesic), neuroleptics (medicines for schizophrenia or psychosis), and antidepressants (SSRIs).
Interactions between citalopram and clozapine (medicines used to treat psychosis) have been reported, which may increase the risk of clozapine-related side effects. The nature of these interactions is not fully understood.
Use of Citalopram SUN with food, drinks, and alcohol:
Citalopram SUN should be taken once daily. Citalopram SUN can be taken at any time of day, with or without food.
Do not drink alcohol while taking Citalopram SUN. Although there is no evidence of direct interaction between citalopram and alcohol, alcohol consumption should be avoided during treatment with Citalopram, as with other medicines acting on the central nervous system.
Pregnancy, breastfeeding, and fertility:
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will decide whether treatment with Citalopram SUN is necessary or whether alternative treatment is possible.
Pregnancy Do not stop your treatment with Citalopram SUN abruptly. Ensure your midwife and/or doctor are informed that you are being treated with Citalopram SUN.
During pregnancy, particularly in the last 3 months, medicines like Citalopram SUN 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.
If you take Citalopram SUN late in 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 SUN so they can advise you.
Breastfeeding
Citalopram passes into breast milk in small amounts.
There is a risk of adverse effects in the breastfed infant. If you are taking Citalopram, consult your doctor before starting breastfeeding.
Fertility Reduced sperm quality has been observed in animal studies with Citalopram. This could theoretically affect fertility, but no impact on human fertility has been demonstrated.
Consult your doctor or pharmacist before taking any medicine.
Driving and use of machines:
This medicine may cause side effects (such as dizziness, drowsiness, confusion, and vision problems) that may affect your concentration and reaction speed. If you experience these side effects, do not drive, operate machinery, or engage in any activity requiring alertness and concentration.
Citalopram SUN contains lactose monohydrate and sodium.
If your doctor has informed you that you have an intolerance to certain sugars, consult them before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially "sodium-free".
3. How to take Citalopram SUN
Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.
How much to take
Unless your doctor prescribes a different dose, the recommended dose is:
Adults
For the treatment of depression
The usual dose is 20 mg daily. Your doctor may increase this dose up to a maximum of 40 mg daily.
Panic disorder with or without agoraphobia
The initial dose is 10 mg daily for the first week before increasing the dose to 20–30 mg daily. Your doctor may increase your dose up to a maximum of 40 mg daily.
Elderly patients (over 65 years of age)
The initial dose should be reduced to half the recommended dose, for example, 10–20 mg daily. Elderly patients should not usually receive a dose higher than 20 mg daily.
Use in patients with special risks
In patients with hepatic insufficiency, the elimination (excretion) of citalopram may be slower. In case of mild to moderate hepatic insufficiency, an initial dose of 10 mg of citalopram daily is recommended for the first two weeks of treatment. Patients with hepatic dysfunction should not take more than 20 mg of citalopram daily. Caution is recommended in patients with severe hepatic insufficiency, and the dose should be increased with particular care.
No dose adjustment is required in case of mild or moderate renal insufficiency. The use of citalopram is not recommended in patients with severe renal impairment (creatinine clearance less than 30 ml/min), as there is no experience available.
Children and adolescents under 18 years of age
Citalopram SUN must not be administered to children and adolescents. For further information, see section 2 “What you need to know before taking Citalopram SUN”.
How and when to take Citalopram SUN
Citalopram SUN is taken daily as a single daily dose. Citalopram SUN may be taken at any time of day, with or without food. Swallow the tablet with a glass of water. Do not chew them (they have a bitter taste).
The score line should not be used to divide the tablet.
Duration of treatment
Please note that Citalopram SUN does not take effect immediately, but after about 2 to 4 weeks. Therefore, improvement should only be expected after a certain period of time.
During treatment of panic disorders with or without agoraphobia, maximum effect is achieved after approximately three months of treatment.
The total duration of treatment is individual (usually at least 6 months) and is determined by the doctor. Continue taking the tablets throughout the treatment, even if you feel better or have no symptoms, to prevent a relapse or recurrence of the illness.
If you take more CITALOPRAM SUN than you should:
If you have taken too many tablets, or if someone has accidentally swallowed some, contact your doctor or go to the nearest hospital. Show the tablet pack. The main symptoms that may occur in case of taking too many tablets (overdose) are: drowsiness, loss of consciousness, seizures, dizziness, nausea, vomiting, cyanosis (bluish skin colour), rapid and deep breathing (hyperventilation), tremors, sweating, agitation, dilated pupils, serotonin syndrome (see section 4 “Possible side effects”), potentially life-threatening disturbances in heart rhythm, increased or decreased heart rate, increased or decreased blood pressure, changes in the ECG, cardiac arrest, and breakdown of skeletal muscle fibres (rhabdomyolysis).
If you forget to take CITALOPRAM SUN:
If you miss a dose, wait until the next scheduled dose. Do not take a double dose to make up for the missed dose.
If you stop taking CITALOPRAM SUN:
If you wish to discontinue treatment, consult your doctor in advance. They will take appropriate measures if necessary. Do not stop taking the medicine without consulting your doctor.
Withdrawal reactions upon discontinuation of citalopram treatment
Sudden discontinuation of treatment should be avoided. When stopping treatment with Citalopram SUN, the dose should be gradually tapered over a period of 1 to 2 weeks to reduce the risk of withdrawal reactions. If severe withdrawal symptoms occur after reducing or stopping the medicine, restarting on the last dose taken should be considered, followed by gradual dose reduction according to the doctor's instructions.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Citalopram SUN may produce adverse effects, although not everyone experiences them.
Adverse effects are most noticeable during the first, or even the first two weeks of treatment, and subsequently disappear as the condition improves.
If you experience any of the following symptoms, you must stop taking your medication and contact your doctor immediately:
- High fever, agitation, confusion, tremors, and sudden muscle spasms may be signs of a condition called "serotonin syndrome," which occurs infrequently and is observed with combined use of antidepressants.
- Swelling of the skin, tongue, lips, or face, difficulty breathing or swallowing (allergic reaction).
- Unusual bleeding, including gastrointestinal bleeding.
- Fast or irregular heartbeats, fainting. These may be symptoms of a potentially life-threatening cardiac arrhythmia called torsade de pointes.
- General malaise with muscle weakness and confusion or difficulty urinating are signs of hyponatremia (decreased concentration of sodium in the blood), which occurs infrequently and may occur during treatment with SSRIs (the group of antidepressants to which citalopram also belongs), especially in elderly patients, patients taking diuretics, or patients with volume depletion due to other reasons.
- Seizures (see section 2 "Warnings and precautions"). Yellowing of the skin and whites of the eyes are signs of liver dysfunction/hepatitis.
The following side effects may occur:
Very common: (more than 1 in 10 patients treated)
- drowsiness
- insomnia
- headaches
- tremors
- dry mouth
- increased sweating
- feeling of weakness
- nausea, constipation
Common: (less than 1 in 10 but more than 1 in 100 patients treated)
- nervousness, anxiety, agitation, abnormal dreams, apathy, decreased appetite, weight loss, confusion, difficulty concentrating.
- dizziness, attention disturbances, sensory disturbances in hands and legs such as tingling (paresthesia), movement and muscle tone disorders (extrapyramidal syndrome disorders).
- diarrhea (loose stools), vomiting, abdominal pain, indigestion, flatulence.
- rhinitis.
- sexual dysfunction, such as ejaculation disorders, absence of ejaculation, impotence, decreased interest in sex, orgasm disorders (in women).
- taste disturbances, visual disturbances, ringing in the ears (tinnitus).
- skin rash, itching.
- muscle pain, joint pain.
- fever.
- difficulty urinating.
- decrease in blood pressure when changing position suddenly, palpitations, tachycardia.
Increased salivation, yawning, altered general well-being, fatigue.
Uncommon: (less than 1 in 100 but more than 1 in 1000 patients treated)
- allergic reactions, urticaria
- increased appetite, weight gain
- euphoria, aggressiveness, feeling of detachment, hallucinations, mania
- seizures
- cough, difficulty breathing
- sensitivity to light
- increased liver enzymes
- slow heart rate
- fainting
- hair loss
- dilation of the pupils
- prolonged menstrual bleeding (in women)
- skin bleeding (bruising)
Swelling of arms and legs (edema)
Rare: (less than 1 in 1000 but more than 1 in 10,000 patients treated)
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decrease in blood sodium concentration (signs may include malaise with muscle weakness and confusion or difficulty urinating).
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increased urination (abnormal secretion of antidiuretic hormone).
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serotonin syndrome (possible signs include high fever, agitation, confusion, tremors, and sudden muscle spasms).
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grand mal seizure.
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liver inflammation (hepatitis).
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psychomotor agitation/acathisia (inability to sit still) (see section 2 "Warnings and precautions").
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involuntary movements (dyskinesia).
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bleeding of the skin or mucous membranes (bruising).
Frequency not known (cannot be estimated from available data)
- suicidal thoughts, suicidal behaviour¹
- QT interval prolongation on ECG² (abnormality in the recording of cardiac impulse conduction)
- fast or irregular heartbeats, fainting. These may be symptoms of a potentially life-threatening cardiac rhythm disorder called Torsade de pointes.
- increased prolactin levels
- decreased platelet levels, which increases the risk of bleeding and bruising
- low potassium levels in blood (signs may include muscle weakness, cramps, and disturbances in heart rhythm)
- pancreatitis
- panic attacks
- nocturnal teeth grinding
- restlessness
- lactation in men and women who are not breastfeeding
- irregular menstrual bleeding, heavy vaginal bleeding shortly after childbirth (postpartum hemorrhage) in women (see section 2 "Pregnancy, breastfeeding and fertility")
- painful erections (in men)
- sudden swelling of the skin or mucous membranes
- nosebleeds
- gastrointestinal bleeding (including rectal bleeding)
- severe allergic (anaphylactic) reaction, with difficulty breathing and dizziness
Movement disorders
1Cases of suicidal thoughts and behaviour have been reported during treatment with citalopram or shortly after discontinuation (see section 2 "Warnings and precautions").
2Cases of QT interval prolongation have been reported since the medicine was launched, mainly in patients with pre-existing heart disease.
An increased risk of bone fractures has been observed in patients treated with this group of medicines.
Withdrawal reactions upon stopping citalopram treatment:
Withdrawal reactions are common when stopping treatment. The most frequent reactions are dizziness, sensory disturbances (including paresthesia), sleep disturbances (including insomnia and vivid dreams), agitation or anxiety, nausea and/or vomiting, tremors, confusion, sweating, headache, diarrhea, palpitations, emotional instability, irritability, and visual disturbances. In general, these symptoms are mild to moderate and resolve spontaneously; however, in some patients they may be severe and persistent. Therefore, it is recommended to gradually reduce the dose when treatment with citalopram is no longer necessary (see sections 2 and 3).
Reporting of side effects
If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Citalopram SUN
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. 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. Medicines and their containers should be returned to a pharmacy’s SIGRE collection point. If in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Citalopram SUN
The active substance is citalopram (hydrobromide).
Each 20 mg coated tablet contains 25 mg of citalopram hydrobromide equivalent to 20 mg of citalopram.
The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, corn starch, copovidone, sodium croscarmellose and magnesium stearate. The components of the coating material, Opadry White 20H 58983, are hypromellose, titanium dioxide (E171), propylene glycol, hydroxypropylcellulose and talc.
Appearance of the product and contents of the pack
Citalopram SUN 20 mg are white, film-coated, round, biconvex tablets with the engraved mark “20” on one side and a score line on the other.
Citalopram SUN 20 mg is available in packs of 1, 14, 20, 28, 30, 50, 56, 98, 100 or 250 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132 JH,
Hoofddorp,
The Netherlands
Manufacturer:
Terapia S.A.
Str. Fabricii nr. 124,
Cluj-Napoca,
Romania
or
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132 JH,
Hoofddorp,
The Netherlands
Local representative
Sun Pharma Laboratorios, S.L.
Rambla de Catalunya 53-55
08007 Barcelona,
Spain
Tel.: +34 342 78 90
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
United Kingdom: Citalopram 20 mg Tablets
Austria: Zyloram 20 mg Filmtabletten
Czech Republic: Zyloram 20 mg Tablety
Germany: Citatopram Basics 20 mg Filmtabletten
Spain: Citalopram SUN 20 mg film-coated tablets EFG
The Netherlands: Citalopram Ranbaxy 20 mg Tablets
This leaflet was last approved in April 2025