Jorveza – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Jorveza, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 1. What Jorveza is and what it is used for
Jorveza contains the active substance budesonide, a corticosteroid medicine that reduces inflammation.
Jorveza 0.2 mg/mL oral suspension is used in children and adolescents aged 2 to 17 years to treat eosinophilic esophagitis, which is an inflammatory condition of the gullet (food pipe) that causes problems with swallowing food.
⚠️ 2. What you need to know before you use Jorveza
Do not use Jorveza
− if your child is 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 using Jorveza if your child has: − infections − high blood pressure − diabetes, or if somebody in their family has diabetes − weakening of the bones (osteoporosis) − ulcers in the stomach or first part of the small intestine (peptic ulcer) − increased pressure in their eye (which can cause glaucoma) or eye problems such as clouding of the lens (cataracts) or if somebody in their family has glaucoma − liver disease.
If your child has any of the conditions mentioned above they may be at increased risk of side effects.
Your child’s doctor will decide on the appropriate measures and if it is still all right for your child to take this medicine.
If your child develops swelling of their face, particularly around their mouth (lips, tongue or throat) and/or difficulties to breathe or swallow, stop using Jorveza and contact your child’s doctor immediately. These may be signs of an allergic reaction, which may also include rash and itching ( see also section 4).
This medicine may cause typical side effects of corticosteroid medicines and may affect all parts of the body, particularly when your child takes this medicine at high doses and over a long time (see section 4).
Further precautions during treatment with this medicine − Contact your doctor if your child gets blurred vision or has other problems with their vision.
Take the following precautions during treatment with this medicine because your child’s immune system may be weakened: − Tell your doctor if your child gets fungal infections in their mouth, throat and food pipe or if you think your child has any infection during treatment with this medicine . Symptoms of fungal infection can be white spots in the mouth and throat and difficulty i n swallowing. The symptoms of some infections can be unusual or less noticeable. − Keep your child away from people who have chickenpox or herpes zoster (shingles) if your child has not had these infections. The effects of these illnesses can be much more severe during treatment with this medicine. If your child does come into contact with chickenpox or shingles, see their doctor straight away. Please also report your child’s vaccination status to their doctor. − Tell your child’s doctor if your child has not yet had measles and/or if and when they have received their last vaccination for this disease. − If your child needs to be vaccinated please speak to their doctor first. − If you know that your child is due to have an operation please tell their doctor that they are taking Jorveza.
The oral suspension could affect the results of adrenal function tests (ACTH stimulation test) ordered by your child’s doctor or in hospital. Tell doctors that your child is taking Jorveza before your child has any tests.
Children and adolescents
The oral suspension is not recommended for children aged under 2. The safety and effectiveness are not yet known in children under 2 years of age.
Other medicines and Jorveza
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines. Some of these medicines may increase the effects of the budesonide oral suspension and the doctor may wish to monitor your child carefully if they 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 conditio ns) − diuretics (to remove excess fluid from the body).
Jorveza with food and drink Your child should not drink grapefruit juice whilst they are taking this medicine as this can worsen its side effects.
Pregnancy and breast -feeding If the patient is pregna nt or breast -feeding, think s she may be pregnant or is planning to have a baby, ask her doctor or pharmacist for advice before taking this medicine.
A patient should not take this medicine during pregnancy without checking with her doctor first.
A patient should not take this medicine if she is breast -feeding without checking with her doctor first.
Budesonide passes into the breast milk in small amounts . The patient’s doctor will help the patient decide whether she should continue treatment and avoi d breast -feed ing or if the patient should stop treatment during the period she is breast -feeding .
Driving and using machines
This medicine is not expected to affect your child’s ability to drive, ride a bicycle or use machines.
Jorveza contains sodium, sodium benzoate (E 211) and sucrose
This medicine contains less than 1 mmol sodium (23 mg) per mL, that is to say essentially ‘sodium – free’.
This medicine contains 0.86 mg sodium benzoate in each mL.
This medicine contains 100 mg sucrose in each mL. If you have been told by your child’s doctor that they have an intolerance to some sugars, contact their doctor before taking this medicinal product. May be harmful to the teeth.
💊 3. How to use Jorveza
Always use this medicine exactly as the doctor or pharmacist has told you. Check with your child’s doctor or pharmacist if you are not sure.
Recommended dose for treatment of acute episodes (induction of remission):
Children 2 to 11 years of age The recommended daily dose is 1 mg budesonide to be administered as two separate doses per day: one oral dose of 2.5 mL suspension (corresponding to 0.5 mg budesonide) in the morning and one oral dose of 2.5 mL suspension (corresponding to 0.5 mg budesonide) in the evening.
Adolescents 12 to 17 years of age The recommended daily dose is 2 mg budesonide to be administered as two separate doses per day: one oral dose of 5 mL suspension (corresponding to 1 mg budesonide) in the morning and one oral dose of 5 mL suspension (corresponding to 1 mg budesonide) in the evening.
Recommended dose for preventi on of further episodes (maintenance therapy):
Children 2 to 11 years of age The recommended daily dose is 0.5 mg budesonide as one oral dose of 2.5 mL suspension (corresponding to 0.5 mg budesonide) in the morning.
Depending on the patient’s response to the treatment, 1 mg budesonide as one oral dose of 2.5 mL suspension (corresponding to 0.5 mg budesonide) in the morning and one oral dose of 2.5 mL suspension (corresponding to 0.5 mg budesonide) in the evening may be given.
Adolescents 12 to 17 years of age 1 mg budesonide as one oral dose of 5 mL suspension (corresponding to 1 mg budesonide) in the morning.
Depending on the patient’s response to the treatment, 2 mg budesonide as one oral dose of 5 mL suspension ( corresponding to 1 mg budesonide) in the morning and one oral dose of 5 mL suspension (corresponding to 1 mg budesonide) in the evening may be given.
Duration of treatment Initially, your child’s treatment should last about 12 to 24 weeks.
After treatment of the acute episode, your child’s doctor will decide how long the treatment should continue and at what dose depending on your child’s condition and response to the treatment.
Method of administration The oral suspension should be taken a fter a meal.
Instructions for use:
Shake the suspension well before use.
Only use the oral syringe provided as a measuring device to dose this medicine. Do not use any other measuring device .
To open the bottle, push the cap down firmly whilst turning it anti- clockwise.
Tightly i nsert the oral syringe into the bottle , while the plunger of the oral syringe is completely pushed down .
Turn the bottle upside -down and hold the oral syringe firmly whilst gently filling up the syringe to the required level .
Turn upright and gently remove the oral syringe by screwing it off the bottle .
Imme diately afterwards, p lace the tip of the syringe in the patient’s mouth. The patient should now completely swallow the suspension contained in the oral syringe.
Screw the cap back onto the bottle.
After each dose administration, remove the plunger from the barrel. Rinse both parts with cold water and allow to air dry. Insert the plunger into the barrel before next use.
Your child may not eat, drink, brush their teeth or rinse their mouth for at least 30 minutes after using the oral suspension. They may not use any oral solutions, sprays or chewable tablets for at least 30 minutes before and after taking a dose of the oral suspension . This will ensure that the medicine works properly.
Kidney and liver problems If your child has any problem with their kidneys or liver, talk to their doctor. If your child has a kidney problem, their doctor will decide if this treatment is suitable for them. In case your child’s kidney problems are severe, they should not take this medicine. If your child has any liver disease, they should not take this medicine .
If you use more Jorveza than you should
If your child has taken more oral suspension than they should, your child should take the next dose as prescribed. They should not take a smaller amount. Ask your child’s doctor or pharmacist if you are in doubt. Take the carton and this leaflet with you if possible.
If you forget to us e Jorveza If your child misses a dose, they should just take the next dose at the usual time. They should not take a double dose to make up for a forgotten dose.
If you stop using Jorveza Speak to your child’s doctor if you want to interrupt or end your child’s treatment early. It is important that a patient does not stop using the medicine without talking to their doctor. Keep using the medicine until your child’s doctor tells you to stop, even if your child feels better.
If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist .
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop using the oral suspension 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 this medicine :
Very common: may affect more than 1 in 10 people
− fungal infections in the gullet (food pipe) (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 − decreased level of osteocalcin, weight gain .
The following side effects have been reported and are typical with medicines similar to this oral suspension (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 chi ldren − 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 r child gets any side effects, talk to your child’s doctor or pharmacist . This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Jorveza
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and bottle after “EXP”.
The expiry date refers to the last day of that month.
After first opening: use within 6 weeks.
Do not store above 25 °C.
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.
📦 6. Contents of the pack and other information
What Jorveza contains
The active substance is budesonide.
Each mL of oral suspension contains 0.2 mg budesonide.
The other ingredients are sucrose, purified water, sodium benzoate (E 211), disodium edetate, citric acid, methylcellulose [1500 mPa s] and blackcurrant flavour (see also section 2, ”Jorveza contains sodium, sodium benzoate (E 211) and sucrose”).
What Jo rveza looks like and contents of the pack
Jorveza 0.2 mg/mL oral suspension is a whitish, viscous suspension .
It comes in a bottle containing 165 mL of oral suspension with one graduated oral syringe for oral administration.
Marketing Authorisation Holder and Manufacturer
Dr. Falk Pharma GmbH Leinenweberstr. 5 79108 Freiburg im Breisgau Germany For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Dr. Falk Pharma Benelux B.V.
Tél/Tel: +32 -(0)16 40 40 85 info@drfalkpharma -benelux.eu Lietuva UAB Morfėjus Tel: +370 5 2796328 [email protected] България Dr. Falk Pharma GmbH Teл: +49 761 1514 0 [email protected] Luxembourg/Luxemburg Dr. Falk Pharma Benelux B.V.
Tél/Tel: +3 2-(0)16 40 40 85 info@drfalkpharma -benelux.eu Česká republika Ewopharma, spol. s r. o.
Tel: +420 267 311 613 [email protected] Magyarország Ewopharma Hungary Kft.
Tel.: +36 1 200 4650 [email protected] Danmark Vifor Pharma Nordiska AB Tlf.: +46 8 5580 6600 info.nordic@ viforpharma.com Malta Dr. Falk Pharma GmbH Tel: +49 761 1514 0 [email protected] Deutschland Dr. Falk Pharma GmbH Tel: +49 761 1514 0 [email protected] Nederland Dr. Falk Pharma Benelux B.V.
Tel: +31 -(0)30 880 48 00 info@drfalkpharma -benelux.eu Eesti Dr. Falk Pharma GmbH Tel: +49 761 1514 0 [email protected] Norge Vifor Pharma Nordiska AB Tlf: +46 8 5580 6600 [email protected] Ελλάδα GALENICA A.E Tηλ: +30 210 52 81 700 [email protected] Österreich Dr. Falk Pharma Österreich GmbH Tel: +43 (1) 577 3516 0 [email protected] España Dr. Falk Pharma España Tel: +34 91 372 95 08 [email protected] Polska Dr. Falk Pharma GmbH Tel: +49 761 1514 0 [email protected] France Dr. Falk Pharma SAS Tél: + 33(0)1 78 90 02 71 [email protected] Portugal Dr. Falk Pharma Portugal, Sociedade Unipessoal Lda.
Tel: +351 21 412 61 70 [email protected] Hrvatska Würth d.o.o.
Tel: +385 1 4650358 [email protected] -com.hr Ireland Dr. Falk Pharma GmbH Tel: +49 761 1514 0 [email protected] România Dr. Falk Pharma GmbH Tel: +49 761 1514 0 [email protected] Slovenija Ewopharma d.o.o.
Tel: + 386 (0) 590 848 40 [email protected] Ísland Dr. Falk Pharma GmbH Sími: +49 761 1514 0 [email protected] Slovenská republika Dr. Falk Pharma GmbH Tel: +49 761 1514 0 [email protected] Italia Dr. Falk Pharma GmbH Tel: +49 761 1514 0 [email protected] Suomi/Finland Vifor Pharma Nordiska AB Puh/Tel: +46 8 5580 6600 [email protected] Κύπρος THESPIS PHARMACEUTICAL Ltd Τηλ: +357 22677710 [email protected] Sverige Vifor Pharma Nordiska AB Tel: +46 8 5580 6600 [email protected] Latvija UAB Morfėjus Tel: +370 5 2796328 [email protected] This leaflet was last revised in .
Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu .
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Jorveza (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/17/1254).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.