Package Insert: Information for the Patient

Jorveza 0.5 mg Buccal Tablets

Jorveza 1 mg Buccal Tablets

budesonide

Read this entire package insert carefully before starting to take this medication, because

it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1. What is Jorveza and how is it used

2. What you need to know before starting to take Jorveza

3. How to take Jorveza

4. Possible adverse effects

5. Storage of Jorveza

6. Contents of the package and additional information

Jorveza contains the active ingredient budesonide, a corticosteroid medication that reduces inflammation.

It is used in adults (over 18 years old) to treat eosinophilic esophagitis, an inflammatory disorder of the esophagus that causes problems swallowing food.

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

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;
• bone weakening (osteoporosis);
• ulcers in the stomach or 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 mentioned above, you may be at a higher risk of experiencing side 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 side effects of corticosteroid medicines and may affect all parts of the body, particularly 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 have other vision problems.

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

• Inform your doctor if you experience fungal infections in the mouth, throat, and oesophagus or if you think you have an infection during treatment with this medicine. The symptoms of fungal infections may be white patches in the mouth and throat and difficulty swallowing. The symptoms of some infections may be unusual or less noticeable.
• Avoid 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 if and when you received the last vaccine for this disease.
• Inform your doctor before receiving any vaccine during treatment with this medicine.
• Inform your doctor that you are taking Jorveza in case of surgery.

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

Children and adolescents

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

Other medicines and Jorveza

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

Particularly:

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

Taking Jorveza with food and drink

You should not take grapefruit juice during your treatment with this medicine, as it may worsen its side effects.

Pregnancy and breastfeeding

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

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

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

Driving and operating machines

It is not expected that Jorveza will affect your ability to drive or operate machines.

Jorveza contains sodium

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose for the treatment of acute episodes is two buccal tablets of 1 mg (2 mg of budesonide) per day. Take one buccal tablet of 1 mg in the morning and another buccal tablet of 1 mg at night.

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

Administration Form

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

Take the buccal tablet after a meal.

Place the buccal tablet at the tip of your tongue and close your mouth. Press it gently with your tongue against the palate 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 buccal tablet disintegrates.

DO NOT take any liquid with the buccal tablet.

Do not chew or swallow the buccal tablet without dissolving it.

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

Renal and Hepatic Problems

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

Treatment Duration

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

After the 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 response to treatment.

If you take more Jorveza than you should

If you have taken too many buccal tablets at once, stick to the prescribed dose when it's time for your next dose. Do not take a lower dose. If you have any doubts, contact your doctor. If possible, bring the box and the leaflet with you.

If you forgot to take Jorveza

If you forgot to take a dose, take the next dose at the usual time. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Jorveza

Talk to your doctor if you want to interrupt or conclude your treatment. It is essential that you do not stop taking your medication without talking to your doctor. Continue taking your medication until your doctor tells you to, even if you feel better.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Very common: may affect more than 1 in 10 people

Common: may affect up to 1 in 10 people

• Headache.
• • Mouth and throat fungal infections (whose symptoms may be white patches).
  • Heartburn.
  • Indigestion.
  • Nausea (urge to vomit).
  • Tingling or numbness of the mouth.
  • Fatigue.
  • Decreased cortisol hormone levels in the blood.

Uncommon: may affect up to 1 in 100 people

The following side effects have been reported, which are typical with similar medicines to Jorveza (corticosteroids), so they may also occur with this medicine. The frequency of these events is currently unknown:

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not take this medication after the expiration date that appears on the box and on the blister pack after “CAD”. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment..

Composition of Jorveza

Jorveza 0.5 mg buccal tablet

• The active ingredient is budesonide. Each buccal tablet contains 0.5 mg of budesonide.

• The other components are dibasic sodium 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 buccal tablet

• The active ingredient is budesonide. Each buccal tablet contains 1 mg of budesonide.

• The other components are dibasic sodium 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").

Appearance of the product and contents of the pack

Jorveza 0.5 mg buccal tablet

Jorveza 0.5 mg buccal tablets are white, round, and biplanar tablets. They are engraved with "0.5" on one side. They are available in blisters of 20, 60, 90, 100, or 200 buccal tablets.

Jorveza 1 mg buccal tablet

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

Only some pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Dr. Falk Pharma GmbH

Leinenweberstr.5

79108 Freiburg

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of the summary of product characteristics:{MM/YYYY}.

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.