Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
What Apremilast is Apremilast contains the active substance 'apremilast'. This belongs to a group of medicines called phosphodiesterase 4 inhibitors, which help to reduce inflammation. What Apremilast is used for Apremilast is used to treat adults with the following conditions: Active psoriatic arthritis - if you cannot use another type of medicine called 'Disease- Modifying Antirheumatic Drugs' (DMARDs) or when you have tried one of these medicines and it did not work. Moderate to severe chronic plaque psoriasis - if you cannot use one of the following treatments or when you have tried one of these treatments and it did not work: phototherapy - a treatment where certain areas of skin are exposed to ultraviolet light systemic therapy - a treatment that affects the entire body rather than just one local area, such as 'ciclosporin', 'methotrexate' or 'psoralen'. Behçet's disease (BD) - to treat the mouth ulcers which is a common problem for people with this illness. Apremilast is used to treat children and adolescents 6 years of age and older and weighing at least 20 kg with the following condition: Moderate to severe plaque psoriasis – if your doctor determines that it is appropriate for you to take a systemic therapy like Apremilast. What psoriatic arthritis is Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by psoriasis, an inflammatory disease of the skin. What plaque psoriasis is Psoriasis is an inflammatory disease of the skin, which can cause red, scaly, thick, itchy, painful patches on your skin and can also affect your scalp and nails.
Package leaflet: Information for the patient
Apremilast 10 mg, 20 mg, 30 mg film-coated tablets
Apremilast 30 mg film-coated tablets
apremilast
What Behçet's disease is Behçet's disease is a rare type of inflammatory disease which affects many parts of the body. The most common problem is mouth ulcers. How Apremilast works Psoriatic arthritis, psoriasis and Behçet's disease are usually lifelong conditions and there is currently no cure. Apremilast works by reducing the activity of an enzyme in the body called 'phosphodiesterase 4', which is involved in the process of inflammation. By reducing the activity of this enzyme, Apremilast can help to control the inflammation associated with psoriatic arthritis, psoriasis and Behçet's disease, and thereby reduce the signs and symptoms of these conditions. In adults with psoriatic arthritis, treatment with Apremilast results in an improvement in swollen and painful joints, and can improve your general physical function. In adults and in children and adolescents from the age of 6 years and weighing at least 20 kg with psoriasis, treatment with Apremilast results in a reduction in psoriatic skin plaques and other signs and symptoms of the disease. In adults with Behçet's disease, treatment with Apremilast reduces the number of mouth ulcers and can stop them completely. It can also reduce the associated pain. Apremilast has also been shown to improve the quality of life in adult and paediatric patients with psoriasis, adult patients with psoriatic arthritis and adult patients with Behçet's disease. This means that the impact of your condition on daily activities, relationships and other factors should be less than it was before.
Apremilast is not recommended for use in children who have moderate to severe plaque psoriasis and are below 6 years of age or weigh less than 20 kg, because it has not been studied in these age and weight groups. Apremilast is not recommend for use in children and adolescents below 18 years of age in other indications, because safety and efficacy have not been established in this age group. Other medicines and Apremilast Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. This is because Apremilast can affect the way some other medicines work. Also some other medicines can affect the way Apremilast works. In particular, tell your doctor or pharmacist before taking Apremilast if you are taking any of the following medicines: rifampicin – an antibiotic used for tuberculosis phenytoin, phenobarbital and carbamazepine - medicines used in the treatment of seizures or epilepsy St John's Wort – a herbal medicine for mild anxiety and depression. Pregnancy and breast-feeding Do not take Apremilast if you are pregnant or think you may be pregnant. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. There is little information about the effects of Apremilast in pregnancy. You should not become pregnant while taking this medicine and should use an effective method of contraception during treatment with Apremilast. It is not known if this medicine passes into human milk. You should not use Apremilast while breastfeeding. Driving and using machines Apremilast has no effect on the ability to drive and use machines. Apremilast contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Apremilast contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free'.
Day Morning Dose Evening Dose Total Daily Dose Day 1 10 mg (yellow) Do not take a dose 10 mg Day 2 10 mg (yellow) 10 mg (yellow) 20 mg Day 3 10 mg (yellow) 20 mg (blue) 30 mg Day 4 20 mg (blue) 20 mg (blue) 40 mg Day 5 20 mg (blue) 30 mg (white to off white) 50 mg Day 6 onwards 30 mg (white to off white) 30 mg (white to off white) 60 mg Children and adolescents 6 years of age and older • The Apremilast dose will be based on body weight. For patients who weigh from 20 kg to less than 50 kg: The recommended dose of Apremilast is 20 mg twice a day, after the titration phase is completed, as shown in the table below - one 20 mg dose in the morning and one 20 mg dose in the evening, approximately 12 hours apart, with or without food. This is a total daily dose of 40 mg.
Weight of 20 kg to less than 50 kg Day Morning Dose Evening Dose Total Daily Dose Day 1 10 mg (yellow) Do not take a dose 10 mg
Day 2 10 mg (yellow) 10 mg (yellow) 20 mg Day 3 10 mg yellow) 20 mg (blue) 30 mg Day 4 20 mg (blue) 20 mg (blue) 40 mg
Weight of 50 kg or more Day Morning Dose Evening Dose Total Daily Dose Day 1 10 mg (yellow) Do not take a dose
Day 2 10 mg (yellow) 10 mg (yellow) 20 mg Day 3 10 mg (yellow) 20 mg (blue) 30 mg Day 4 20 mg (blue) 20 mg (blue) 40 mg
Your treatment will start at a lower dose and will gradually be increased during the first week of treatment (titration phase). The 'treatment initiation pack' will also contain enough tablets for another week at the recommended dose. Once the recommended dose has been reached, you will only get a single tablet strength in your prescribed packs. You will only ever need to go through the stage of gradually increasing your dose once even if you re-start treatment.
Adults The recommended dose of Apremilast for adult patients is 30 mg twice a day after the titration phase is completed, as shown in the table below - one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food. This is a total daily dose of 60 mg.
Day 5 20 mg (blue) 20 mg(blue) 40 mg Day 6 onwards 20 mg (blue) 20 mg (blue) 40 mg For patients who weigh at least 50 kg: The recommended dose of Apremilast is 30 mg twice a day after the titration phase is completed (the same as the adult dose), as shown in the table below - one 30 mg dose in the morning and one 30 mg dose in the evening, approximately 12 hours apart, with or without food. This is a total daily dose of 60 mg.
10 mg
Day 5 20 mg (blue) 30 mg (white to off white)
Day 6 onwards 30 mg (white to off white)
50 mg
30 mg (white to off white)
60 mg
People with severe kidney problems If you are an adult with severe kidney problems, then the recommended dose of Apremilast is 30 mg once a day (morning dose). In children and adolescents 6 years of age and older with severe renal impairment, the recommended dose of Apremilast is 30 mg once a day (morning dose) for patients who weigh at least 50 kg, and 20 mg once a day (morning dose) for children who weigh 20 kg to less than 50 kg. Your doctor will talk to you about how to increase your dose when you first start taking Apremilast. Your doctor may advise that you only take the morning dose shown in the table above that applies to you (for adults or for children/adolescents) and that you skip the evening dose. How and when to take Apremilast Apremilast is for oral use. Swallow the tablets whole, preferably with water. You can take the tablets either with or without food. Take Apremilast at about the same time each day, one tablet in the morning and one tablet in the evening. If your condition has not improved after six months of treatment, you should talk to your doctor. If you take more Apremilast than you should If you take more Apremilast than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack and this leaflet with you. If you forget to take Apremilast If you miss a dose of Apremilast, take it as soon as you remember. If it is close to the time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take a double dose to make up for a forgotten dose. If you stop taking Apremilast You should continue taking Apremilast until your doctor tells you to stop. Do not stop taking Apremilast without talking to your doctor first. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Serious side effects – depression and suicidal thoughts Tell your doctor straight away about any changes in behaviour or mood, feelings of depression, thoughts of suicide or suicidal behaviour (this is uncommon). Very common side effects (may affect more than 1 in 10 people) diarrhoea nausea headache upper respiratory tract infections such as cold, runny nose, sinus infection
Common side effects (may affect up to 1 in 10 people) cough back pain vomiting feeling tired stomach pain loss of appetite frequent bowel movements difficulty sleeping (insomnia) indigestion or heartburn inflammation and swelling of the tubes in your lungs (bronchitis) common cold (nasopharyngitis) depression migraine tension headache Uncommon side effects (may affect up to 1 in 100 people) rash hives (urticaria) weight loss allergic reaction bleeding in the bowel or in the stomach suicidal ideation or behaviour anxiety mood changes Not known side effects (frequency cannot be estimated from the available data): severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing) If you are 65 years of age or older, you might have a higher risk of complications of severe diarrhoea, nausea and vomiting. If your gut problems become severe, you should talk to your doctor. Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Apremilast 30 mg film-coated tablets comes as tablet containing 30mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Apremilast 30 mg film-coated tablets is apremilast.
Medicines with the same active substance, strength and form include: Otezla 30 mg Film-Coated Tablets, Apremilast 30 mg Film-coated Tablet, Apremilast 30 mg film-coated tablets. In total there are 5 equivalent products. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Apremilast 30 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Psoriatic arthritis
Apremilast, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1).
Psoriasis
Apremilast is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).
Behçet's disease
Apremilast is indicated for the treatment of adult patients with oral ulcers associated with Behçet's disease (BD) who are candidates for systemic therapy.
Treatment with apremilast should be initiated by specialists experienced in the diagnosis and treatment of psoriasis, psoriatic arthritis or Behçet's disease. Posology Adult patients with psoriatic arthritis, psoriasis, or Behçet's disease The recommended dose of apremilast for adult patients is 30 mg taken orally twice daily. An initial titration schedule is required as shown below in table 1. Table 1. Dose titration schedule for adult patients Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM AM PM 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg Paediatric patients with moderate to severe plaque psoriasis The recommended dose of apremilast for paediatric patients 6 years of age and older with moderate to severe plaque psoriasis is based on body weight. The recommended dose of apremilast is 20 mg taken orally twice daily for paediatric patients who weigh from 20 kg to less than 50 kg, and 30 mg taken orally twice daily for paediatric patients who weigh at least 50 kg, following the initial titration schedule shown below in table 2. Table 2. Dose titration schedule for paediatric patients Body weight Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM AM PM 20 kg to less than 50 kg 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 50 kg or more 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg All indications (psoriasis in adults and children, psoriatic arthritis, Behçet's disease) No re-titration is required after initial titration. The recommended twice daily apremilast dose should be taken approximately 12 hours apart (morning and evening), with no food restrictions. If patients miss a dose, the next dose should be taken as soon as possible. If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time. During pivotal trials the greatest improvement was observed within the first 24 weeks of treatment for PsA and PSOR and within the first 12 weeks of treatment for BD. If a patient shows no evidence of therapeutic benefit after this time period, treatment should be reconsidered. The patient's response to treatment should be evaluated on a regular basis. Special populations Elderly patients No dose adjustment is required for this patient population (see sections 4.8 and 5.2). Patients with renal impairment Adult patients with psoriatic arthritis, psoriasis, or Behçet's disease No dose adjustment is needed in adult patients with mild and moderate renal impairment. The dose of apremilast should be reduced to 30 mg once daily in adult patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockcroft-Gault equation). For initial dose titration in this group, it is recommended that apremilast be titrated using only the AM schedule listed in Table 1 and the PM doses be skipped (see section 5.2). Paediatric patients with moderate to severe psoriasis No dose adjustment is needed in paediatric patients 6 years of age and older with mild or moderate renal impairment. In paediatric patients 6 years of age and older with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockroft–Gault equation), dose adjustment is recommended. The apremilast dose should be reduced to 30 mg once daily for paediatric patients who weigh at least 50 kg and to 20 mg once daily for paediatric patients who weigh 20 kg to less than 50 kg. For initial dose titration in these groups, it is recommended that apremilast be titrated using only the AM schedule listed in table 2 above for the appropriate body weight category and the PM doses be skipped. Patients with hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2). Paediatric population The safety and efficacy of apremilast have not been established in children with moderate to severe plaque psoriasis below the age of 6 years or with a body weight less than 20 kg, or in other paediatric indications. No data are available. Method of administration Apremilast is for oral use. The film-coated tablets should be swallowed whole, and can be taken either with or without food. <summary id="CONTRAINDICATIONS" data-evt="smpcSectionOpen"
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Pregnancy (see section 4.6). <summary id="CLINICAL_PRECAUTIONS" data-evt="smpcSectionOpen"
Diarrhoea, nausea and vomiting There have been post-marketing reports of severe diarrhoea, nausea, and vomiting associated with the use of apremilast. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalised. Patients 65 years of age or older may be at a higher risk of complications. If patients develop severe diarrhoea, nausea, or vomiting, discontinuation of treatment with apremilast may be necessary . Psychiatric disorders Apremilast is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, altered mood, and depression. Instances of suicidal ideation and behaviour, including suicide, have been observed in patients with or without history of depression (see section 4.8). The risks and benefits of starting or continuing treatment with apremilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended. Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation. If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with apremilast . Severe renal impairment Apremilast should be dose reduced to 30 mg once daily in adult patients with severe renal impairment (see sections 4.2 and 5.2). In paediatric patients 6 years of age and older with severe renal impairment, the dose should be reduced to 30 mg once daily for paediatric patients who weigh at least 50 kg, and to 20 mg once daily for paediatric patients who weigh 20 kg to less than 50 kg (see sections 4.2 and 5.2). Underweight patients Patients who are underweight and paediatric patients who have a borderline to low body mass index at the start of treatment should have their body weight monitored regularly. In the event of unexplained and clinically significant weight loss, these patients should be evaluated by a medical practitioner and discontinuation of treatment should be considered. Lactose content Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially 'sodium-free'. <summary id="INTERACTIONS" data-evt="smpcSectionOpen"
Co-administration of strong cytochrome P450 3A4 (CYP3A4) enzyme inducer, rifampicin, resulted in a reduction of systemic exposure of apremilast, which may result in a loss of efficacy of apremilast. Therefore, the use of strong CYP3A4 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin and St. John's Wort) with apremilast is not recommended. Co-administration of apremilast with multiple doses of rifampicin resulted in a decrease in apremilast area-under-the-concentration time curve (AUC) and maximum serum concentration (C max ) by approximately 72% and 43%, respectively. Apremilast exposure is decreased when administered concomitantly with strong inducers of CYP3A4 (e.g. rifampicin) and may result in reduced clinical response. In clinical studies, apremilast has been administered concomitantly with topical therapy (including corticosteroids, coal tar shampoo and salicylic acid scalp preparations) and UVB phototherapy. There was no clinically meaningful interaction between ketoconazole and apremilast. Apremilast can be co-administered with a potent CYP3A4 inhibitor such as ketoconazole. There was no pharmacokinetic interaction between apremilast and methotrexate in psoriatic arthritis patients. Apremilast can be co-administered with methotrexate. There was no pharmacokinetic interaction between apremilast and oral contraceptives containing ethinyl estradiol and norgestimate. Apremilast can be co-administered with oral contraceptives. <summary id="PREGNANCY" data-evt="smpcSectionOpen"
Women of childbearing potential
Pregnancy should be excluded before treatment can be initiated. Women of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment.
Pregnancy
There are limited data about the use of apremilast in pregnant women.
Apremilast is contraindicated during pregnancy (see section 4.3). Effects of apremilast on pregnancy included embryofoetal loss in mice and monkeys, and reduced foetal weights and delayed ossification in mice at doses higher than the currently recommended highest human dose. No such effects were observed when exposure in animals was at 1.3-fold the clinical exposure (see section 5.3).
Breast-feeding
Apremilast was detected in milk of lactating mice (see section 5.3). It is not known whether apremilast, or its metabolites, are excreted in human milk. A risk to the breastfed infant cannot be excluded, therefore apremilast should not be used during breast-feeding.
Fertility
No fertility data is available in humans. In animal studies in mice, no adverse effects on fertility were observed in males at exposure levels 3-fold clinical exposure and in females at exposure levels 1-fold clinical exposure. For pre-clinical fertility data, see section 5.3.
Apremilast has no or negligible influence on the ability to drive and use machines.
Summary of the safety profile The most commonly reported adverse reactions with apremilast in adults with PsA and PSOR are gastrointestinal (GI) disorders including diarrhoea (15.7%) and nausea (13.9%). The other most commonly reported adverse reactions include upper respiratory tract infections (8.4%), headache (7.9%), and tension headache (7.2%) and are mostly mild to moderate in severity. The most commonly reported adverse drug reactions with apremilast in adults with BD are diarrhoea (41.3%), nausea (19.2%), headache (14.4%), upper respiratory tract infection (11.5%), upper abdominal pain (8.7%), vomiting (8.7%) and back pain (7.7%) and are mostly mild to moderate in severity. The gastrointestinal adverse reactions generally occurred within the first 2 weeks of treatment and usually resolved within 4 weeks. Hypersensitivity reactions are uncommonly observed (see section 4.3). Tabulated list of adverse reactions The adverse reactions observed in adult patients treated with apremilast are listed below by system organ class (SOC) and frequency for all adverse reactions. Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse drug reactions were determined based on data from the apremilast clinical development programme and post-marketing experience in adult patients. The frequencies of adverse drug reactions are those reported in the apremilast arms of the four Phase III studies in PsA (n = 1,945) or the two Phase III studies in PSOR (n = 1184), and in the phase III study in BD (n = 207) the highest frequency from either data pool is represented in table 3). Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); not known (cannot be estimated from the available data). Table 3. Summary of adverse reactions in psoriatic arthritis (PsA), psoriasis (PSOR) and Behçet's disease (BD) System Organ Class Frequency Adverse reaction Infections and infestations Very common Upper respiratory tract infection a Common Bronchitis Nasopharyngitis * Immune system disorders Uncommon Hypersensitivity Metabolism and nutrition disorders Common Decreased appetite * Psychiatric disorders Common Insomnia Depression Uncommon Suicidal ideation and behaviour Anxiety Mood altered Nervous system disorders Very common Headache *, a Common Migraine * Tension headache * Respiratory, thoracic, and mediastinal disorders Common Cough Gastrointestinal disorders Very Common Diarrhoea * Nausea * Common Vomiting * Dyspepsia Frequent bowel movements Upper abdominal pain * Gastroesophageal reflux disease Uncommon Gastrointestinal haemorrhage Skin and subcutaneous tissue disorders Uncommon Rash Urticaria Not known Angioedema Musculoskeletal and connective tissue disorders Common Back pain * General disorders and administration site conditions Common Fatigue Investigations Uncommon Weight decrease * At least one of these adverse reactions was reported as serious a Frequency reported as common in PSA and PSOR Description of selected adverse reactions Psychiatric disorders In clinical studies and post-marketing experience, uncommon cases of suicidal ideation and behaviour, were reported, while completed suicide was reported post-marketing. Patients and caregivers should be instructed to notify the prescriber of any suicidal ideation (see section 4.4). Body weight loss Patient weight was measured routinely in clinical studies. The mean observed weight loss in adult PsA and PSOR patients treated for up to 52 weeks with apremilast was 1.99 kg. A total of 14.3% of patients receiving apremilast had observed weight loss between 5-10% while 5.7% of the patients receiving apremilast had observed weight loss greater than 10%. None of these patients had overt clinical consequences resulting from weight loss. A total of 0.1% of patients treated with apremilast discontinued due to adverse reaction of weight decreased. The mean observed weight loss in adult BD patients treated with apremilast for 52 weeks was 0.52 kg. A total of 11.8% of patients receving apremilast had observed weight loss between 5-10% while 3.8% of the patients receiving apremilast had observed weight loss greater than 10%. None of these patients had overt clinical consequences from weight loss. None of the patients discontinued the study due to adverse reaction of weight decreased. Please see additional warning in section 4.4 for patients who are underweight at beginning of treatment. Special populations Elderly patients From post-marketing experience, elderly patients ≥ 65 years of age may be at a higher risk of complications of severe diarrhoea, nausea and vomiting (see section 4.4). Patients with hepatic impairment The safety of apremilast was not evaluated in PsA, PSOR or BD patients with hepatic impairment. Patients with renal impairment In the PsA, PSOR or BD clinical studies, the safety profile observed in patients with mild renal impairment was comparable to patients with normal renal function. The safety of apremilast was not evaluated in PsA, PSOR or BD patients with moderate or severe renal impairment in the clinical studies. Paediatric patients The safety of apremilast was assessed in a 52-week clinical trial in paediatric patients 6 to 17 years of age with moderate to severe plaque psoriasis (SPROUT study). The safety profile of apremilast observed during the study was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store <summary id="OVERDOSE" data-evt="smpcSectionOpen"
Apremilast was studied in healthy subjects at a maximum total daily dose of 100 mg (given as 50 mg twice daily) for 4.5 days without evidence of dose limiting toxicities. In case of an overdose, it is recommended that the patient is monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment is instituted. In the event of overdose, symptomatic and supportive care is advised.
Ask anything about Apremilast 30 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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