Jorveza 1 mg orodispersible tablet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Jorveza 0.5 mg orodispersible tablets

Jorveza 1 mg orodispersible tablets

budesonide

Read all of this leaflet carefully before you start taking this medicine because it

contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only; do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Jorveza is and what it is used for
2. What you need to know before taking Jorveza
3. How to take Jorveza
4. Possible side effects
5. How to store Jorveza
6. Contents of the pack and other information

1. What Jorveza is and what it is used for

Jorveza contains the active substance budesonide, a corticosteroid medicine that reduces inflammation.

It is used in adults (over 18 years of age) to treat eosinophilic esophagitis, which is an inflammatory disorder of the oesophagus that causes difficulty in swallowing food.

2. What you need to know before starting Jorveza

Do not take Jorveza

• if you are allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Jorveza if you have:

• tuberculosis;
• high blood pressure;
• diabetes or if someone in your family has diabetes;
• weakened bones (osteoporosis);
• ulcers in the stomach or the first part of the small intestine (peptic ulcer);
• increased pressure in the eye (which may cause glaucoma) or eye problems such as clouding of the lens (cataracts), or if someone in your family has glaucoma;
• liver disease.

If you have any of the conditions listed above, you may be at increased risk of experiencing adverse effects. Your doctor will decide on the appropriate measures to take and whether it is still suitable for you to take this medicine.

Jorveza may cause the typical adverse effects of corticosteroid medicines and may affect all parts of the body, especially if you take this medicine at high doses and for a long time (see section 4).

Additional precautions during treatment with Jorveza

• Contact your doctor if you experience blurred vision or other vision problems.

Take the following precautions during treatment with Jorveza, as your immune system may be weakened:

• Inform your doctor if you develop fungal infections in the mouth, throat, or esophagus, or if you suspect you have an infection during treatment with this medicine. Symptoms of fungal infections may include white patches in the mouth and throat and difficulty swallowing. Symptoms of some infections may be unusual or less noticeable.
• Avoid contact with people who have chickenpox or shingles (herpes zoster) if you have not had these infections. The effects of these diseases may be much more severe during treatment with this medicine. If you come into contact with chickenpox or shingles, see your doctor immediately. Also inform your doctor about your vaccination status.
• Inform your doctor if you have not had measles and/or when you last received the measles vaccine.
• If you need to receive any vaccine during treatment with this medicine, inform your doctor beforehand.
• Inform your doctor that you are taking Jorveza if you are undergoing surgery.

Jorveza may alter the results of adrenal function tests (ACTH stimulation test) requested by your doctor or in a hospital. Inform your doctors that you are taking Jorveza before any test is performed.

Children and adolescents

Jorveza must not be used in children and adolescents under 18 years of age. The use of this medicine has not yet been studied in children under 18 years of age.

Other medicines and Jorveza

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Some of these medicines may increase the effects of Jorveza, so your doctor will monitor you closely if you are taking these medicines.

In particular:

• ketoconazole or itraconazole (used to treat fungal infections);
• clarithromycin, an antibiotic used to treat infections;
• ritonavir and cobicistat (used to treat HIV infection);
• estrogens (used for hormone replacement therapy or contraception);
• cardiac glycosides such as digoxin (medicines used to treat heart conditions);
• diuretics (medicines used to treat excess fluid in your body).

Taking Jorveza with food and drinks

You must not drink grapefruit juice during treatment with this medicine, as it may worsen its adverse effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take this medicine during pregnancy without first consulting your doctor.

Do not take this medicine while breastfeeding unless advised by your doctor. Budesonide passes into breast milk in small amounts. Your doctor will help you decide whether to continue treatment and stop breastfeeding or to interrupt treatment during the period you are breastfeeding your baby.

Driving and using machines

Jorveza is not expected to affect the ability to drive or use machines.

Jorveza contains sodium

This medicine contains 52 mg of sodium (a main component of cooking/table salt) per daily dose. This corresponds to 2.6% of the maximum daily intake of sodium recommended for an adult.

3. How to take Jorveza

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The recommended dose for the treatment of acute episodes is two 1 mg orodispersible tablets (2 mg of budesonide) per day. Take one 1 mg orodispersible tablet in the morning and one 1 mg orodispersable tablet in the evening.

The recommended dose for the prevention of new episodes is two 0.5 mg orodispersible tablets (1 mg of budesonide) per day or two 1 mg orodispersible tablets (2 mg of budesonide) per day, depending on your body's response to treatment. Take one orodispersible tablet in the morning and one orodispersible tablet in the evening.

Method of administration

Take the orodispersible tablet immediately after removing it from the blister pack.

Take the orodispersible tablet after a meal.

Place the orodispersible tablet on the tip of the tongue and close your mouth. Gently press it against the palate with your tongue until it has completely dissolved (this usually takes at least two minutes, but may take up to 20 minutes). Swallow the dissolved material gradually with saliva as the tablet disintegrates.

DO NOT take any liquid with the orodispersible tablet.

Do not chew or swallow the orodispersible tablet without allowing it to dissolve.

Do not eat, drink, brush your teeth, or rinse your mouth for at least 30 minutes after taking the orodispersible tablet. Do not use any type of oral solution, spray, or chewable tablet for at least 30 minutes before or after administration of the orodispersible tablet. This will ensure the proper functioning of the medicine.

Renal and hepatic problems

If you have any kidney or liver problems, inform your doctor. If you have a kidney problem, your doctor will decide whether Jorveza is suitable for you. If your kidney problems are severe, you must not take Jorveza. If you have any liver disease, you must not take Jorveza.

Duration of treatment

Initially, your treatment should last approximately 6 to 12 weeks.

After treatment of the acute episode, your doctor will decide for how long and at what dose you should continue treatment, depending on your condition and your response to treatment.

If you take more Jorveza than you should

If you have taken too many orodispersible tablets at once, simply take the prescribed dose at your next scheduled time. Do not take a lower dose. If you have any doubts, contact your doctor. If possible, bring the package and the leaflet with you.

If you forget to take Jorveza

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for missed doses.

If you stop taking Jorveza

Talk to your doctor if you wish to stop or end your treatment early. It is important that you do not stop taking your medicine without speaking to your doctor. Continue taking your medicine until your doctor tells you otherwise, even if you feel better.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following adverse effects have been reported during the use of Jorveza:

Very common: may affect more than 1 in 10 people

• Fungal infections in the oesophagus (which may cause pain or discomfort when swallowing).

Common: may affect up to 1 in 10 people

• Headache.
• Fungal infections in the mouth and throat (symptoms of which may include white patches).
• Heartburn.
• Indigestion.
• Nausea.
• Tingling or numbness of the mouth.
• Fatigue.
• Reduced blood levels of the hormone cortisol.

Uncommon: may affect up to 1 in 100 people

• Difficulty sleeping.
• Anxiety.
• Dizziness.
• Taste disturbance.
• Dry eyes.
• High blood pressure.
• Cough, dry throat.
• Abdominal pain, upper abdominal pain.
• Difficulty swallowing.
• Inflammation of the stomach, stomach ulcers.
• Burning of the tongue, swelling of the lips, dry mouth.
• Rash, itchy rash.
• Foreign body sensation.
• Pain in the mouth or throat.

The following adverse effects have been reported with similar medicines to Jorveza (corticosteroids) and may therefore also occur with this medicine. The frequency of these events is currently unknown:

• Increased risk of infection.
• Cushing's syndrome, associated with excessive corticosteroid use, causing facial rounding (moon face), increased body weight, elevated blood sugar, fluid accumulation in tissues (e.g., swollen legs), decreased blood potassium levels (hypokalaemia), irregular menstrual periods in women, unwanted hirsutism in women, impotence, stretch marks on the skin, acne.
• Growth retardation in children.
• Mood changes such as depression, irritability, or euphoria.
• Restlessness with increased physical activity, anxiety, aggression.
• Increased intracranial pressure, possibly with elevated ocular pressure (optic disc swelling) in adolescents.
• Blurred vision.
• Increased risk of blood clots, inflammation of blood vessels (which may occur when the medicine is stopped after long-term use).
• Constipation, ulcers in the small intestine.
• Pancreatitis, causing severe abdominal and back pain.
• Rash, red spots due to bleeding under the skin, delayed wound healing, skin reactions such as contact dermatitis, bruising.
• Muscle and joint pain, muscle weakness, muscle spasms.
• Weakening of the bones (osteoporosis), bone damage due to poor blood circulation (osteonecrosis).
• General feeling of malaise.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the blister after “EXP”. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Store in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Jorveza

Jorveza 0.5 mg orodispersible tablet

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

• The other components are disodium hydrogen citrate, sodium docusate, macrogol (6000), magnesium stearate, mannitol (E 421), anhydrous sodium 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 components are disodium hydrogen citrate, sodium docusate, macrogol (6000), magnesium stearate, mannitol (E 421), anhydrous sodium citrate, povidone (K25), sodium hydrogen carbonate and sucralosa (see also section 2, “Jorveza contains sodium”).

Appearance of the product and contents of the pack

Jorveza 0.5 mg orodispersible tablet

Jorveza 0.5 mg orodispersible tablets are white, round, and biconvex. They are marked with “0.5” on one side. They are available in blisters of 20, 60, 90, 100 or 200 orodispersible tablets.

Jorveza 1 mg orodispersible tablet

Jorveza 1 mg orodispersible tablets are white, round, and biconvex. They are available in blisters of 20, 30, 60, 90, 100 or 200 orodispersible tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Dr. Falk Pharma GmbH

Leinenweberstr. 5

79108 Freiburg

Germany

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: {MM/YYYY}.

Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.