JORVEZA 0.5 mg ORALLY DISINTEGRATING TABLETS

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. You may need to read it again.

• Keep this leaflet, as 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.

Contents of the pack

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

1. What is Jorveza and what is it used for

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

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

2. What you need to know before you take 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

Tell your doctor or pharmacist before you start taking Jorveza if you have:

• tuberculosis;
• high blood pressure;
• diabetes or if a member of your family has diabetes;
• weakening of the bones (osteoporosis);
• ulcers in the stomach or the first part of the small intestine (peptic ulcer);
• increased pressure in the eye (which can cause glaucoma) or eye problems such as cataracts or if a member of your family has glaucoma;
• liver disease.

If you have any of the above conditions, you may have a higher risk of side effects. Your doctor will decide what measures to take and whether it is 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:

• Tell your doctor if you have fungal infections in the mouth, throat, and oesophagus or if you think you have an infection during treatment with this medicine. Symptoms of fungal infections can be white patches in the mouth and throat and difficulty swallowing. Symptoms of some infections can be unusual or less noticeable.
• Stay away from people who have chickenpox or shingles (herpes zoster) if you have not had these infections. The effects of these diseases can be much more severe during treatment with this medicine. If you come into contact with chickenpox or shingles, see your doctor immediately. Also, tell your doctor about your vaccination status.
• Tell your doctor if you have not had measles and/or if and when you received your last vaccine for this disease.
• If you need to receive any vaccine during treatment with this medicine, tell your doctor beforehand.
• Tell 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. Tell 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 been studied yet.

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, so your doctor will monitor you closely if you are taking these medicines.

In particular:

• ketoconazole or itraconazole (to treat fungal infections);
• clarithromycin, an antibiotic 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 (medicines used to treat excess fluid in your body).

Taking Jorveza with food and drinks

Do not drink grapefruit juice during treatment with this medicine, as it may 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 consulting your doctor first.

Do not take this medicine if you are breast-feeding unless you have discussed it with your doctor. Budesonide passes into breast milk in small amounts. Your doctor will help you decide whether to continue treatment and stop breast-feeding or to stop treatment during the period you are breast-feeding your baby.

Driving and using machines

Jorveza is unlikely to affect your ability to drive or use machines.

Jorveza contains sodium

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

3. How to take Jorveza

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, ask 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 another 1 mg orodispersible 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 another orodispersible tablet in the evening.

Method of administration

Take the orodispersible tablet immediately after removal 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. Press it gently with your tongue against the palate until it has dissolved completely (this usually takes at least two minutes, but may take up to 20 minutes). Swallow the dissolved material slowly with saliva as the orodispersible tablet disintegrates.

DO NOT take any liquid with the orodispersible tablet.

Do not chew or swallow the orodispersible tablet without dissolving.

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 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.

Kidney and liver problems

If you have any kidney or liver problems, tell your doctor. If you have kidney problems, your doctor will decide whether Jorveza is suitable for you. If 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 approximately 6 to 12 weeks.

After treatment of the acute episode, your doctor will decide 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 orodispersible tablets at once, just take the prescribed dose when it is time for your next dose. Do not take a lower dose. If you are unsure, contact your doctor. If possible, take the pack and this 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 forgotten doses.

If you stop taking Jorveza

Talk to your doctor if you want to stop or conclude your treatment early. It is important that you do not stop taking your medicine without talking to your doctor. Continue 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.

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 oesophagus (which can cause pain or difficulty swallowing).

Common: may affect up to 1 in 10 people

• Headache.
• • Fungal infections in the mouth and throat (which can cause white patches).
  • Heartburn.
  • Indigestion.
  • Feeling sick (nausea).
  • Numbness or tingling of the mouth.
  • Fatigue.
  • Decreased amount of cortisol hormone in the blood.

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, pain in the upper abdomen.
• Difficulty swallowing.
• Inflammation of the stomach, stomach ulcers.
• Tongue burning, lip swelling, dry mouth.
• Rash, itchy rash.
• Feeling of a foreign body.
• Pain in the mouth or throat.

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

• Increased risk of infection.
• Cushing's syndrome, which is associated with excessive corticosteroid use and causes roundness of the face (moon face), weight gain, increased blood sugar, fluid accumulation in tissues (e.g. swollen legs), decreased potassium levels in the blood (hypokalemia), irregular menstrual periods in women, unwanted hair growth in women, impotence, stretch marks on the skin, acne.
• Growth retardation in children.
• Mood changes, such as depression, irritation, or euphoria.
• Restlessness with increased physical activity, anxiety, aggression.
• Increased intracranial pressure, possibly with increased eye pressure (inflammation of the optic disc) in adolescents.
• Blurred vision.
• Increased risk of blood clots, inflammation of blood vessels (which can occur when the medicine is stopped after long-term use).
• Constipation, ulcers in the small intestine.
• Pancreatitis, which causes severe abdominal and back pain.
• Rash, red spots due to bleeding in 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 discomfort.

Reporting of side effects

If you experience 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 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. Storage of 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 the month shown.

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package Contents and Additional Information

Jorveza Composition

Jorveza 0.5 mg orodispersible tablet

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

• The other ingredients are disodium 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 ingredient is budesonide. Each orodispersible tablet contains 1 mg of budesonide.

• The other ingredients are disodium 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").

Product Appearance and Package Contents

Jorveza 0.5 mg orodispersible tablet

Jorveza 0.5 mg orodispersible tablets are white, round, and biplanar. They are engraved 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 biplanar. They are available in blisters of 20, 30, 60, 90, 100, or 200 orodispersible tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Dr. Falk Pharma GmbH

Leinenweberstr. 5

79108 Freiburg

Germany

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:{MM/AAAA}.

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