Jorveza

Patient Information Leaflet

Jorveza 0.5 mg orodispersible tablets, 1 mg orodispersible tablets

budesonide
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this 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 to treat eosinophilic esophagitis in adults (aged over 18 years), a chronic inflammatory disease of the esophagus that causes difficulty swallowing food.

2. What you should know before taking 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
Talk to your doctor or pharmacist before taking Jorveza if you have:

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

If you have any of the conditions listed above, you may be at higher risk of experiencing adverse effects. Your doctor will decide on appropriate measures and whether you should continue taking this medicine.
Stop treatment with Jorveza and contact your doctor immediately if you develop swelling of the face, especially around the mouth (lips, tongue or throat), and/or difficulty breathing or swallowing. These could be signs of an allergic reaction, which may also include itching and skin rash (see also section 4).
Jorveza may cause the typical side effects of corticosteroid medicines, which can affect all parts of the body, especially if you take this medicine at high doses and for a long time (see section 4).
Other 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, because your immune system may be weakened:

• Inform your doctor if you develop fungal infections in the mouth, throat or oesophagus, or if you suspect you have any infection while taking 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 more difficult to detect.
• Avoid contact with people who have chickenpox or shingles (herpes zoster), if you have not previously had these infections. The effects of these diseases may be much more serious while you are taking this medicine. Contact your doctor immediately if you come into contact with someone who has chickenpox or shingles. Also inform your doctor about your vaccination status.
• Inform your doctor if you have not had measles and/or when you last received a measles vaccination.
• Consult your doctor before receiving any vaccination.
• Inform your doctor that you are taking Jorveza before undergoing any surgical procedure.

Jorveza may interfere with the results of adrenal function tests (ACTH stimulation tests) prescribed by your doctor or in hospital. Before undergoing any test, inform healthcare professionals that you are taking Jorveza.
Children and adolescents
Jorveza must not be used in children and adolescents under 18 years of age. The use of this medicine in children under 18 years has not yet been studied.
Other medicines and Jorveza
Inform 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 closely if you are taking them.
In particular:

• ketoconazole or itraconazole (used to treat fungal infections)
• clarithromycin, an antibiotic used to treat infections
• ritonavir and cobicistat (used to treat HIV infections)
• estrogens (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
Do not drink grapefruit juice while taking this medicine, as it may worsen its side effects.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine during pregnancy without first consulting your doctor.
Do not take this medicine while breastfeeding unless you have consulted your doctor. Budesonide passes into breast milk in small amounts. Your doctor will help you decide whether to continue treatment and stop breastfeeding, or discontinue treatment for the period during which your baby is breastfed.
Driving and using machines
Jorveza should not affect your ability to drive or use machinery.
Jorveza contains sodium
This medicine contains 52 mg of sodium (a key component of table salt) per daily dose. This corresponds to 2.6% of the maximum daily recommended dietary intake for an adult.

3. How to take Jorveza

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The recommended dose for the treatment of acute episodes is two orodispersible tablets of 1 mg
(2 mg of budesonide) daily. Take one 1 mg orodispersible tablet in the morning and one
1 mg orodispersible tablet in the evening.
The recommended dose for the prevention of future episodes is either two orodispersible tablets of
0.5 mg (1 mg of budesonide) daily or two orodispersible tablets of 1 mg (2 mg of
budesonide) daily, depending on your 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.
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 disintegrated (usually within 2 to 20 minutes).
Swallow the disintegrated material gradually with saliva as the orodispersible tablet breaks down.
DO NOT take liquids together with the orodispersible tablet.
Do not chew or swallow the orodispersible tablet before it has completely disintegrated.
Do not eat, drink, brush your teeth, or rinse your mouth for at least 30 minutes after taking the
orodispersible tablet. Do not use oral solutions, sprays, or chewable tablets for at least
30 minutes before or after administration of the orodispersible tablet. These precautions ensure
that the medicine works properly.
Problems with kidneys and liver
If you have kidney or liver problems, consult your doctor. If you have kidney problems, 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
Initial treatment usually lasts about 6–12 weeks.
After treating the acute episode, your doctor will decide how long and at what dose you should continue
treatment, depending on your health condition and response to therapy.
If you take more Jorveza than you should
If you have taken more orodispersible tablets than prescribed, take the next dose as directed. Do not take a lower amount.
If in doubt, consult your doctor or pharmacist.
If possible, bring the pack and this leaflet with you.
If you forget to take Jorveza
If you miss a dose, simply take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
If you stop taking Jorveza
If you wish to stop or discontinue treatment early, consult your doctor. It is important that you do not stop taking the medicine
without first consulting your doctor. Continue taking the medicine until your doctor tells you to stop, even if you feel better.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop treatment with Jorveza and contact your doctor immediately if you notice any of the following symptoms:

• swelling of the face, particularly of the eyelids, lips, tongue or throat (angioedema), which could be a sign 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 oesophagus (which may cause pain or discomfort when swallowing)
• fungal infections in the mouth and throat (symptoms may include white patches).

Common: may affect up to 1 in 10 people

• headache
• heartburn
• indigestion
• feeling unwell (nausea)
• tingling or numbness in the mouth, dry mouth
• taste disturbances, burning of the tongue
• upper abdominal pain (stomach pain)
• fatigue
• reduced blood levels of the hormone cortisol
• dry eyes
• difficulty sleeping
• problems with the tongue
• cold sores (herpes labialis).

Uncommon: may affect up to 1 in 100 people

• anxiety, restlessness
• dizziness
• dry eyes
• high blood pressure
• cough, dry throat, sore throat, cold
• abdominal pain (stomach pain), abdominal distension (bloating)
• difficulty swallowing
• inflammation of the stomach, gastric ulcers
• lip swelling (edema)
• skin rash, itchy rash
• sensation of a foreign body
• pain in the mouth or throat
• gum pain
• reduced levels of osteocalcin, weight gain.

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

• increased risk of infections
• Cushing's syndrome, associated with excessive corticosteroid intake, causing roundness of the face, weight gain, increased blood glucose, fluid retention in tissues (e.g. swollen legs), low potassium levels in the blood (hypokalaemia), menstrual irregularities in women, development of unwanted 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 intracranial pressure, possibly with increased ocular pressure (papilledema) in adolescents
• blurred vision
• increased risk of blood clots, inflammation of blood vessels (which may occur when the medicine is discontinued after long-term use)
• constipation, small intestine ulcers
• inflammation of the pancreas, causing severe pain in the abdomen and back
• skin rashes, red spots from bleeding under the skin, delayed wound healing, skin reactions such as contact dermatitis, bruising
• muscle and joint pain, muscle weakness, muscle cramps
• weakening of the bones (osteoporosis), bone damage due to poor blood supply (osteonecrosis)
• general feeling of malaise.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system detailed in [Annex 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 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. Keep in the original packaging to protect the medicine from light and moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Jorveza contains
Jorveza 0.5 mg orodispersible tablets

• 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 tablets

• 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 sucralose (see also section 2, “Jorveza contains sodium”).

Description of the appearance of Jorveza and pack contents
Jorveza 0.5 mg orodispersible tablet
Jorveza 0.5 mg orodispersible tablets are white, round, biconvex tablets. They are marked with “0.5” on one side. They are supplied in blisters, in pack sizes of 20, 60, 90, 100 or 200 orodispersible tablets.
Jorveza 1 mg orodispersible tablet
Jorveza 1 mg orodispersible tablets are white, round, biconvex tablets. They are supplied in blisters, in pack sizes of 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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Dr. Falk Pharma Benelux B.V. UAB Morfėjus
Tél/Tel: +32-(0)16 40 40 85 Tel: +370 5 2796328
[email protected] [email protected]

България Luxembourg/Luxemburg
Dr. Falk Pharma GmbH Dr. Falk Pharma Benelux B.V.
Teл: +49 761 1514 0 Tél/Tel: +32-(0)16 40 40 85
[email protected] [email protected]

Česká republika Magyarország
Ewopharma, spol. s r. o. Ewopharma Hungary Kft.
Tel: +420 267 311 613 Tel.: +36 1 200 4650
[email protected] [email protected]

Danmark Malta
Vifor Pharma Nordiska AB Dr. Falk Pharma GmbH
Tlf: +46 8 5580 6600 Tel: +49 761 1514 0
[email protected] [email protected]

Deutschland Nederland
Dr. Falk Pharma GmbH Dr. Falk Pharma Benelux B.V.
Tel: +49 761 1514 0 Tel: +31-(0)30 880 48 00
[email protected] [email protected]

Eesti Norge
Dr. Falk Pharma GmbH Vifor Pharma Nordiska AB
Tel: +49 761 1514 0 Tlf: +46 8 5580 6600
[email protected] [email protected]

Ελλάδα Österreich
GALENICA A.E Dr. Falk Pharma Österreich GmbH
Tηλ: +30 210 52 81 700 Tel: +43 (1) 577 3516 0
[email protected] [email protected]

España Polska
Dr. Falk Pharma España Dr. Falk Pharma GmbH
Tel: +34 91 372 95 08 Tel: +49 761 1514 0
[email protected] [email protected]

France Portugal
Dr. Falk Pharma SAS Dr. Falk Pharma Portugal, Sociedade Unipessoal Lda.
Tél: +33(0)1 78 90 02 71 Tel: +351 21 412 61 70
[email protected] [email protected]

Hrvatska România
Würth d.o.o. Dr. Falk Pharma GmbH
Tel: +385 1 4650358 Tel: +49 761 1514 0
[email protected] [email protected]

Ireland Slovenija
Dr. Falk Pharma GmbH Ewopharma d.o.o.
Tel: +49 761 1514 0 Tel: +386 (0)590 848 40
[email protected] [email protected]

Ísland Slovenská republika
Dr. Falk Pharma GmbH Dr. Falk Pharma GmbH
Sími: +49 761 1514 0 Tel: +49 761 1514 0
[email protected] [email protected]

Italia Suomi/Finland
Dr. Falk Pharma GmbH Vifor Pharma Nordiska AB
Tel: +49 761 1514 0 Puh/Tel: +46 8 5580 6600
[email protected] [email protected]

Κύπρος Sverige
THESPIS PHARMACEUTICAL Ltd Vifor Pharma Nordiska AB
Τηλ: +357 22677710 Tel: +46 8 5580 6600
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
UAB Morfėjus Dr. Falk Pharma GmbH
Tel: +370 5 2796328 Tel: +49 761 1514 0
[email protected] [email protected]

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