Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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Jorveza 1mg orodispersible tablets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Budesonide may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Budesonide
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

Jorveza contains the active substance budesonide, a corticosteroid medicine that reduces inflammation. It is used in adults (older than 18 years of age) to treat eosinophilic oesophagitis, which is an inflammatory condition of the gullet (food pipe) that causes problems with swallowing food. 2.

What you need to know before you take it

e Jorveza

Do not take Jorveza − if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Jorveza if you have: − tuberculosis − high blood pressure − diabetes, or if somebody in your family has diabetes − weakening of the bones (osteoporosis) − ulcers in the stomach or first part of the small intestine (peptic ulcer) − increased pressure in your eye (which can cause glaucoma) or eye problems such as clouding of the lens (cataracts) or if somebody in your family has glaucoma − liver disease. If you have any of the conditions mentioned above you may be at increased risk of side effects. Your doctor will decide on the appropriate measures and if it is still all right for you to take this medicine. If you develop swelling of your face, particularly around your mouth (lips, tongue or throat) and/or difficulties to breathe or swallow, stop taking Jorveza and contact your doctor immediately. These may be signs of an allergic reaction, which may also include rash and itching (see also section 4).

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Jorveza may cause typical side effects of corticosteroid medicines and may affect all parts of the body, particularly when you take this medicine at high doses and over a long time (see section 4). Further precautions during treatment with Jorveza − Contact your doctor if you get blurred vision or have other problems with your vision. Take the following precautions during treatment with Jorveza because your immune system may be weakened: − Tell your doctor if you get fungal infections in the mouth, throat and gullet or if you think you have any infection during treatment with this medicine. Symptoms of fungal infection can be white spots in the mouth and throat and difficulty in swallowing. The symptoms of some infections can be unusual or less noticeable. − Keep away from people who have chickenpox or herpes zoster (shingles) if you have not had these infections. The effects of these illnesses can be much more severe during treatment with this medicine. If you do come into contact with chickenpox or shingles, see your doctor straight away. Please also report your vaccination status to your doctor. − Tell your doctor if you have not yet had measles and/or if and when you have received your last vaccination for this disease. − If you need to be vaccinated please speak to your doctor first. − If you know that you are due to have an operation please tell your doctor that you are taking Jorveza. Jorveza could affect the results of adrenal function tests (ACTH stimulation test) ordered by your doctor or in hospital. Tell your doctors that you are taking Jorveza before you have any tests. Children and adolescents Jorveza should not be used in children and adolescents under 18 years of age. The use of this medicine in children younger than 18 years of age has not yet been studied. Other medicines and Jorveza Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some of these medicines may increase the effects of Jorveza and your doctor may wish to monitor you carefully if you are taking these medicines. In particular: − ketoconazole or itraconazole (to treat fungal infections) − clarithromycin, an antibiotic medicine used to treat infections − ritonavir and cobicistat (to treat HIV infections) − oestrogens (used for hormone replacement therapy or contraception) − cardiac glycosides such as digoxin (medicines used to treat heart conditions) − diuretics (to remove excess fluid from the body). Jorveza with food and drink You should not drink grapefruit juice whilst you are taking this medicine as this can worsen its side effects. Pregnancy and breast-feeding 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. Do not take this medicine during pregnancy without checking with your doctor first. Do not take this medicine if you are breast-feeding unless you have checked with your doctor. Budesonide passes in small amounts into the breast milk. Your doctor will help you decide whether you should continue treatment and not breast-feed or if you should stop treatment over the period your baby is being breast-fed.

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Driving and using machines Jorveza is not expected to affect your ability to drive or use machines. Jorveza contains sodium This medicine contains 52 mg sodium (main component of cooking/table salt) per daily dose. This is equivalent to 2.6% of the recommended maximum daily dietary intake of sodium for an adult. 3.

How to take it

Jorveza

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose for treatment of acute episodes is two 1 mg orodispersible tablets (2 mg budesonide) per day. Take one 1 mg orodispersible tablet in the morning and one 1 mg orodispersible tablet in the evening. The recommended dose for prevention of further episodes is two 0.5 mg orodispersible tablets (1 mg budesonide) per day or two 1 mg orodispersible tablets (2 mg budesonide) per day, depending on your body's response to the treatment. Take one orodispersible tablet in the morning and one orodispersible tablet in the evening. Method of administration Take the orodispersible tablet immediately once removed from the blister package. Take the orodispersible tablet after a meal. Place the orodispersible tablet on the tip of your tongue and close your mouth. Press it gently against the roof of your mouth with your tongue until it has disintegrated completely (this usually takes at least two minutes but may take up to 20 minutes). Swallow the disintegrated material with saliva little by little, as the orodispersible tablet breaks up. Do NOT take any liquid with the orodispersible tablet. Do not chew or swallow the undisintegrated orodispersible tablet. Do not eat, drink, brush your teeth or rinse your mouth for at least 30 minutes after you have taken the orodispersible tablet. Do not use any oral solutions, sprays or chewable tablets for at least 30 minutes before or after administration of the orodispersible tablet. This will ensure that your medicine works properly. Kidney and liver problems If you have any problem with your kidney or liver, talk to your doctor. If you have a kidney problem, your doctor will decide if Jorveza is suitable for you. In case your kidney problems are severe, you should not take Jorveza. If you have any liver disease, you should not take Jorveza. Duration of treatment Initially, your treatment should last about 6 to 12 weeks. After treatment of the acute episode, your doctor will decide how long and with which dose you are to continue the treatment, depending on your condition and your response to the treatment. If you take more Jorveza than you should If you have taken more orodispersible tablets than you should, take your next dose as prescribed. Do not take a smaller amount. Ask your doctor or pharmacist if you are in doubt. Take the carton and this leaflet with you if possible. If you forget to take Jorveza

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If you miss a dose, just take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking Jorveza Speak to your doctor if you want to interrupt or end your treatment early. It is important that you do not stop taking your medicine without talking to your doctor. Keep taking your medicine until your doctor tells you to stop, even if you feel better. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Stop using Jorveza and seek medical attention immediately if you notice any of the following symptoms: − swelling of the face, particularly of the eyelids, lips, tongue or throat (angioedema) which may be symptoms of an allergic reaction. The following side effects have been reported during the use of Jorveza: Very common: may affect more than 1 in 10 people − fungal infections in the gullet (which can cause pain or discomfort when swallowing) − fungal infections in the mouth and throat (symptoms can be white spots) Common: may affect up to 1 in 10 people − headache − heartburn − indigestion − feeling sick (nausea) − tingling or numbness in your mouth, dry mouth − taste disorder, burning tongue − upper abdominal (belly) pain − tiredness − decreased amount of the hormone cortisol in your blood − dry eyes. − difficulty in sleeping − problems with tongue − cold sore (oral herpes) Uncommon: may affect up to 1 in 100 people − anxiety, agitation − dizziness − high blood pressure − cough, dry throat, sore throat, common cold − abdominal (belly) pain, abdominal distension (bloating) − difficulty swallowing − inflammation of the stomach, ulcers in the stomach − swelling of the lips − rash, itching rash − sensation of foreign body − pain in the mouth or throat − painful gums, paluk-bul-en4-nov23-print-clean

4

−

decreased level of osteocalcin, weight gain.

The following side effects have been reported and are typical with medicines similar to Jorveza (corticosteroids), and can therefore also occur with this medicine. The frequency of these events is currently not known: − increased risk of infection − Cushing's syndrome, which is associated with too much corticosteroid and causes roundness of the face, weight gain, high blood sugar, build-up of fluid in the tissues (e.g. swollen legs), reduced potassium level in the blood (hypokalaemia), irregular periods in women, unwanted body hair in women, impotence, stretch marks on the skin, acne. − slowed growth in children − mood changes, such as depression, irritability or euphoria − restlessness with increased physical activity, aggression − increased pressure in the brain, possibly with increased pressure in the eye (swelling of the optic disk) in adolescents − blurred vision − increased risk of blood clots, inflammation of the blood vessels (which can happen when the medicine is stopped after long-term use) − constipation, ulcers in the small intestine − inflammation of the pancreas, which causes severe pain in the belly and back − rash, red spots from bleeding in the skin, delayed wound healing, skin reactions such as contact dermatitis, bruising − muscle and joint pain, muscle weakness, muscle twitching − weakening of the bones (osteoporosis), bone damage due to poor circulation of blood (osteonecrosis) − general feeling of being ill. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly: 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. 5.

How to store it

Jorveza

Keep this medicine out of the sight and reach of children. Do not take this medicine after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of that month. Do not store above 25 °C. Store in the original package in order to protect from light and moisture. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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6.

Contents of the pack and other information

What Jorveza contains Jorveza 0.5 mg orodispersible tablet –

The active substance is budesonide. Each orodispersible tablet contains 0.5 mg of budesonide.

–

The other ingredients are disodium hydrogen citrate, docusate sodium, macrogol (6000), magnesium stearate, mannitol (E 421), anhydrous monosodium citrate, povidone (K25), sodium hydrogen carbonate and sucralose (see also section 2, "Jorveza contains sodium").

Jorveza 1 mg orodispersible tablet –

The active substance is budesonide. Each orodispersible tablet contains 1 mg of budesonide.

–

The other ingredients are disodium hydrogen citrate, docusate sodium, macrogol (6000), magnesium stearate, mannitol (E 421), anhydrous monosodium citrate, povidone (K25), sodium hydrogen carbonate and sucralose (see also section 2, "Jorveza contains sodium").

What Jorveza looks like and contents of the pack Jorveza 0.5 mg orodispersible tablet Jorveza 0.5 mg orodispersible tablets are white, round, biplane. They are debossed with "0.5" on one side. They come in blisters in packs with 20, 60, 90, 100 or 200 orodispersible tablets. Jorveza 1 mg orodispersible tablet Jorveza 1 mg orodispersible tablets are white, round, biplane. They come in blisters in packs with 20, 30, 60, 90, 100 or 200 orodispersible tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Dr. Falk Pharma GmbH Leinenweberstr. 5 79108 Freiburg Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Dr. Falk Pharma GmbH Tel: +49 761 1514 0 [email protected] This leaflet was last revised in 11/2023. Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

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Frequently asked questions about Jorveza 1mg orodispersible tablets

How do I take Jorveza 1mg orodispersible tablets?

Jorveza 1mg orodispersible tablets comes as tablet containing 1mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Jorveza 1mg orodispersible tablets?

The active substance in Jorveza 1mg orodispersible tablets is budesonide.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Jorveza 1mg orodispersible tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Jorveza 1mg orodispersible tablets without a prescription?

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.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Budesonide (38 medicines)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).

4.2. Posology and method of administration

The treatment with this medicinal product should be initiated by a gastroenterologist or a physician experienced in the diagnosis and treatment of eosinophilic esophagitis.

Posology

Induction of remission

The recommended daily dose is 2 mg budesonide as one 1-mg-tablet in the morning and one 1-mg-tablet in the evening.

The usual duration of induction treatment is 6 weeks. For patients who are not appropriately responding during 6 weeks the treatment can be extended to up to 12 weeks.

Maintenance of remission

The recommended daily dose is 1 mg budesonide as one 0.5-mg-tablet in the morning and one 0.5-mg-tablet in the evening or 2 mg budesonide as one 1-mg-tablet in the morning and one 1-mg-tablet in the evening, depending on the individual clinical requirement of the patient.

A maintenance dose of 1 mg budesonide twice daily is recommended for patients with a long standing disease history and/or high extent of esophageal inflammation in their acute disease state, see also section 5.1.

The duration of maintenance therapy is determined by the treating physician.

Special populations

Renal impairment

There are currently no data available for patients with renal impairment. Because budesonide is not excreted via the kidneys, patients with mild to moderate impairment may be treated with caution with the same doses as patients without renal impairment.

Budesonide is not recommended for use in patients with severe renal impairment.

Hepatic impairment

During treatment of patients with hepatic impairment with other budesonide containing medicinal products, budesonide levels were increased. However, no systematic study investigating different levels of hepatic impairment is available. Patients with hepatic impairment should not be treated (see sections 4.4 and 5.2).

Paediatric population

The safety and efficacy of Jorveza in children and adolescents under the age of 18 years have not been established. No data are available.

Method of administration

Oral use.

The orodispersible tablet should be taken immediately once removed from the blister package.

The orodispersible tablet should be taken after a meal.

It should be placed on the tip of the tongue and gently pressed against the top of the mouth, where it will disintegrate. This will usually take at least two minutes but can take up to 20 minutes. The effervescence process of the tablet starts after Joreveza comes into contact with saliva and stimulates the production of further saliva. The budesonide-loaded saliva should be swallowed little by little while the orodispersible tablet disintegrates. The orodispersible tablet should not be taken with liquid or food. There should be at least 30 minutes before eating or drinking or performing oral hygiene. Any oral solutions, sprays or chewable tablets should be used at least 30 minutes before or after administration of Jorveza.

The orodispersible tablet should not be chewed or swallowed undissolved. These measures ensure optimal exposure of the esophageal mucosa to the active substance by using the adhesive characteristics of mucins in the saliva.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Infections

Suppression of the inflammatory response and immune function increases the susceptibility to infections and their severity. Symptoms of infections can be atypical or masked.

In clinical studies conducted with Jorveza oral, oropharyngeal and esophageal candida infections have been observed with a high frequency (see section 4.8). If indicated, symptomatic candidiasis of the mouth and throat can be treated with topical or systemic anti-fungal therapy whilst still continuing treatment with Jorveza. Chickenpox, herpes zoster and measles can have a more serious course in patients treated with glucocorticosteroids. In patients who have not had these diseases, the vaccination status should be checked, and particular care should be taken to avoid exposure.

Vaccines

The co-administration of live vaccines and glucocorticosteroids should be avoided as this is likely to reduce the immune response to vaccines. The antibody response to other vaccines may be diminished.

Special populations

Patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataract, family history of diabetes or family history of glaucoma may be at higher risk of experiencing systemic glucocorticosteroid adverse reactions (see below and section 4.8) and should therefore be monitored for the occurrence of such effects.

Reduced liver function may affect the elimination of budesonide, causing higher systemic exposure. The risk of adverse reactions (systemic glucocorticosteroid effects) will be increased. However, no systematic data are available. Patients with hepatic impairment should therefore not be treated.

Systemic effects of glucocorticosteroids

Systemic effects of glucocorticosteroids (e.g., Cushing's syndrome, adrenal suppression, growth retardation, cataract, glaucoma, decreased bone mineral density and a wide range of psychiatric effects) may occur (see also section 4.8). These adverse reactions depend on the duration of treatment, concomitant and previous glucocorticosteroid treatment and the individual sensitivity.

Angioedema

Angioedema has been reported with the use of Jorveza, mostly as part of allergic reactions which included rash and itching. If signs of angioedema are observed, the treatment should be stopped.

Visual disturbance

Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.

Others

Glucocorticosteroids may cause suppression of the hypothalamic–pituitary–adrenal (HPA) axis and reduce the stress response. When patients are subject to surgery or other stresses, supplementary systemic glucocorticosteroid treatment is therefore recommended.

Concomitant treatment with ketoconazole or other CYP3A4 inhibitors should be avoided (see section 4.5).

Interference with serological testing

Because adrenal function may be suppressed by treatment with budesonide, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values).

Sodium content

Jorveza 0.5 mg and 1 mg orodispersible tablets contain 52 mg of sodium per daily dose, equivalent to 2.6% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

4.5. Interaction with other medicinal products and other forms of interaction

CYP3A4 inhibitors

Co-treatment with potent CYP3A inhibitors such as ketoconazole, ritonavir, itraconazole, clarithromycin, cobicistat and grapefruit juice may cause a marked increase of the plasma concentration of budesonide and is expected to increase the risk of systemic adverse reactions. Therefore, concomitant use should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid adverse reactions, in which case patients should be monitored for systemic corticosteroid adverse reactions.

Ketoconazole 200 mg once daily orally increased the plasma concentration of budesonide (3 mg single dose) approximately 6-fold during concomitant administration. When ketoconazole was administered approximately 12 hours after budesonide, the plasma concentration of budesonide increased approximately 3-fold.

Oestrogens, oral contraceptives

Elevated plasma concentrations and enhanced effects of glucocorticosteroids have been reported in women also receiving oestrogens or oral contraceptives. No such effect has been observed with budesonide and concomitant intake of low-dose combination oral contraceptives.

Cardiac glycosides

The action of glycoside can be potentiated by potassium deficiency which is a potential and known adverse reaction of glucocorticoids.

Saluretics

Concommitant use of glucocorticoids may result in enhanced potassium excretion and aggravated hypokalaemia.

4.6. Fertility, pregnancy and lactation

Pregnancy

Administration during pregnancy should be avoided unless there are compelling reasons for therapy with Jorveza. There are few data of pregnancy outcomes after oral administration of budesonide in humans. Although data on the use of inhaled budesonide in a large number of exposed pregnancies indicate no adverse effect, the maximal concentration of budesonide in plasma has to be expected to be higher in the treatment with Jorveza compared to inhaled budesonide. In pregnant animals, budesonide, like other glucocorticosteroids, has been shown to cause abnormalities of fetal development (see section 5.3). The relevance of this to man has not been established.

Breast-feeding

Budesonide is excreted in human milk (data on excretion after inhalative use is available). However, only minor effects on the breast-fed child are anticipated after oral use of Jorveza within the therapeutic range. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Jorveza therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility

There are no data on the effect of budesonide on human fertility. Fertility was unaffected following budesonide treatment in animal studies (see section 5.3).

4.7. Effects on ability to drive and use machines

Jorveza has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile

Fungal infections in the mouth, pharynx and the oesophagus were the most frequently observed adverse reactions in clinical studies with Jorveza. In the clinical studies BUL-1/EEA and BUL-2/EER, a total of 44 out of 268 patients (16.4%) exposed to Jorveza experienced cases of suspected fungal infections associated with clinical symptoms, which were all of mild or moderate intensity. The total number of infections (including those diagnosed by endoscopy and histology without symptoms) was 92, occurring in 72 out of 268 patients (26.9%). Long-term treatment with Jorveza of up to 3 years (48-weeks in the BUL-2/EER followed by 96-week openlabel treatment) did not increase the rate of side effects including local candidiasis.

Tabulated list of adverse reactions

Adverse reactions observed in clinical studies with Jorveza are listed in the table below, by MedDRA system organ class and frequency. 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), very rare (< 1/10,000) or not known (cannot be estimated from the available data).

MedDRA system organ class

Very common

Common

Uncommon

Infections and infestations

Esophageal candidiasis, oral and/or oropharyngeal candidiasis

Nasopharyngitis, pharyngitis

Immune system disorders

Angioedema

Psychiatric disorders

Sleep disorder

anxiety, agitation

Nervous system disorders

Headache, dysgeusia

Dizziness

Eye disorders

Dry eyes

Vascular disorders

Hypertension

Respiratory, thoracic and mediastinal disorders

Cough, dry throat, oropharyngeal pain

Gastrointestinal disorders

Gastroesophageal reflux disease, nausea, oral paraesthesia, dyspepsia, upper abdominal pain, dry mouth, glossodynia tongue disorder, oral herpes

Abdominal pain, abdominal distension, dysphagia, erosive gastritis, gastric ulcer, lip edema, gingival pain,

Skin and subcutaneous tissue disorders

Rash, urticaria

General disorders and administration site conditions

Fatigue

Sensation of foreign body

Investigations

Blood cortisol decreased

Osteocalcin decreased, weight increased

The following known adverse reactions of the therapeutic class (corticosteroids, budesonide) could also occur with Jorveza (frequency = not known).

MedDRA system organ class

Adverse reactions

Immune system disorders

Increased risk of infection

Endocrine disorders

Cushing's syndrome, adrenal suppression, growth retardation in children

Metabolism and nutrition disorders

Hypokalaemia, hyperglycaemia

Psychiatric disorders

Depression, irritability, euphoria, psychomotor hyperactivity, aggression

Nervous system disorders

Pseudotumor cerebri including papilloedema in adolescents

Eye disorders

Glaucoma, cataract (including subcapsular cataract), blurred vision, central serous chorioretinopathy (CSCR) (see also section 4.4)

Vascular disorders

Increased risk of thrombosis, vasculitis (withdrawal syndrome after long-term therapy)

Gastrointestinal disorders

Duodenal ulcers, pancreatitis, constipation

Skin and subcutaneous tissue disorders

Allergic exanthema, petechiae, delayed wound healing, contact dermatitis, ecchymosis

Musculoskeletal and connective tissue disorders

Muscle and joint pain, muscle weakness and twitching, osteoporosis, osteonecrosis

General disorders and administration site conditions

Malaise

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

4.9. Overdose

In case of short-term overdose no emergency medical treatment is required. There is no specific antidote. Subsequent treatment should be symptomatic and supportive.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • CORTIMENT 9 mg prescriptionBUDESONIDUM · taken by mouth
  • BUDENOFALK UNO 9 mg prescriptionBUDESONIDUM · taken by mouth
  • BUDENOFALK 3 mg prescriptionBUDESONIDUM · taken by mouth
  • KINPEYGO 4 mg prescriptionBUDESONIDUM · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • Cortiment MMXBudesonidum · taken by mouth
  • JorvezaBudesonidum · taken by mouth

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

💬 Ask about this leaflet

Ask anything about Jorveza 1mg orodispersible 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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