JORVEZA 1 mg Orodispersible Tablet

Зміст інструкції

1. Jorveza 0.5 mg orodispersible tablets, 1 mg orodispersible tablets
   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. How to store Jorveza
   6. Contents of the pack and other information

Jorveza 0.5 mg orodispersible tablets, 1 mg orodispersible tablets

budesonide

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Jorveza and what is it used for?

Jorveza contains the active ingredient budesonide, a corticosteroid medicine that reduces
inflammation.
It is used to treat eosinophilic esophagitis in adults (over 18 years of age), which is an inflammatory disease
of the esophagus that causes problems 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
Talk to your doctor or pharmacist before taking Jorveza if you suffer from:

• tuberculosis
• high blood pressure
• diabetes, or if someone in your family has diabetes
• weakening of the bones (osteoporosis)
• stomach or duodenal ulcers (peptic ulcer)
• increased pressure in the eye (which can 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 mentioned above, you may be at greater risk of
experiencing undesirable effects. The doctor will decide on the appropriate measures and whether it is still appropriate for you to
take this medicine.
Stop treatment with Jorveza and contact your doctor immediately if you develop swelling of the face, in
particular 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
section 4).
Jorveza can cause the typical undesirable 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:

• Tell your doctor if you develop fungal infections in the mouth, throat and esophagus or if you think you have any infection during treatment with this medicine. Symptoms of fungal infections can include white patches in the mouth and throat and difficulty swallowing. The symptoms of some infections may be unusual or more difficult to notice.
• Stay away from people with chickenpox or shingles (herpes zoster), if you have not had these infections. The effects of these diseases can be much more serious during treatment with this medicine. Contact your doctor immediately if you come into contact with people with chickenpox or shingles. Also tell your doctor about your vaccination status.
• Tell your doctor if you have never had measles and/or when you last received the vaccination for this disease.
• Consult your doctor before having a vaccination.
• Tell your doctor that you are taking Jorveza before undergoing surgery.

Jorveza may affect the results of adrenal function tests (ACTH stimulation tests) prescribed by your doctor or in hospital. Before undergoing any tests, tell doctors
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
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. Some of these medicines can increase the effects of Jorveza and the
doctor may want to monitor you closely if you are taking these medicines.
In particular:

• ketoconazole or itraconazole (for the treatment of fungal infections)
• clarithromycin, an antibiotic used to treat infections
• ritonavir and cobicistat (for the treatment of HIV infections)
• estrogens (used for hormone replacement therapy or for 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 when taking this medicine, as it may worsen its side effects
effects.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine during pregnancy without first consulting your doctor.
Do not take this medicine if you are breastfeeding, unless you have consulted your doctor. The
budesonide passes in small amounts into breast milk. The doctor will help you decide whether to
continue treatment and not breastfeed or stop treatment for the period when your
child is breastfed.

Driving and using machines
Jorveza should not affect your ability to drive or operate machinery.

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

3. How to take Jorveza

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
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 orodispersible tablet in the evening.
The recommended dose for the prevention of future 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 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 your tongue and close your mouth. Gently press it
against the palate with your tongue until it has completely disintegrated (usually after
a time ranging from a minimum of 2 minutes to a maximum of 20 minutes). Swallow the disintegrated material
little by little with saliva, as the orodispersible tablet breaks down.
DO NOT take liquids with the orodispersible tablet.
Do not chew or swallow the orodispersible tablet before it has 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 administering the orodispersible tablet. These precautions
allow the medicine to work correctly.

Kidney and liver problems
If you have a kidney or liver problem, consult your doctor. If you have a kidney problem, your doctor will decide
whether Jorveza is suitable for you. If your kidney problems are serious, you should not take Jorveza. If you have
any liver disease, you should not take Jorveza.

Duration of treatment
The 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 your response to therapy.

If you take more Jorveza than you should
If you have taken more orodispersible tablets than you should, take the next dose as
prescribed. Do not take a smaller amount. If in doubt, contact your doctor or pharmacist.

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

If you stop taking Jorveza
If you want to stop or prematurely end treatment, contact your doctor. It is important that
you do not stop 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 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.
Stop taking Jorveza and contact your doctor immediately if you experience any of the following
symptoms:

• swelling of the face, particularly of the eyelids, lips, tongue or throat (angioedema), which may be a symptom 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 of the esophagus (which can cause pain or difficulty 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
• altered taste, burning of the tongue
• upper abdominal pain (stomach)
• tiredness
• reduced amount of cortisol hormone in the blood
• dry eyes
• difficulty sleeping
• problems with the tongue
• cold sores.

Uncommon: may affect up to 1 in 100 people

• anxiety, agitation
• dizziness
• dry eyes
• high blood pressure
• cough, dry throat, sore throat, common cold
• abdominal pain (stomach), abdominal distension (bloating)
• difficulty swallowing
• inflammation of the stomach, gastric ulcers
• lip swelling
• skin rash, itchy skin rash
• foreign body sensation
• pain in the mouth or throat
• gum pain
• reduced level 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 not known at present:

• increased risk of infections
• Cushing's syndrome, which is associated with taking too many corticosteroids and causes a rounded face, weight gain, increased blood glucose, fluid retention in tissues (e.g. swollen legs), reduced levels of potassium in the blood (hypokalaemia), irregular menstruation in women, unwanted hair growth 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, aggressiveness
• increased pressure in the brain, with possibly increased pressure in the eye (papilledema) 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 of the small intestine
• inflammation of the pancreas, which causes severe pain in the abdomen and back
• skin rashes, red spots from bleeding in 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), damage to the bones due to poor blood circulation (osteonecrosis)
• feeling generally unwell.

Reporting of side effects
If you get 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 through 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 take this medicine after the expiry date which is stated on the package and on the blister
after “Exp”. The expiry date refers to the last day of that month.
Do not store at a temperature above 25 °C. Store in the original packaging to
protect the medicine from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Jorveza contains
Jorveza 0.5 mg orodispersible tablets

• The active ingredient is budesonide. Each orodispersible tablet contains 0.5 mg of budesonide.
• The other ingredients are disodium hydrogen citrate, sodium docusate, macrogol (6000), magnesium stearate, mannitol (E 421), anhydrous monosodium citrate, povidone (K25), sodium hydrogen carbonate and sucralose (see also section 2, “Jorveza contains sodium”).

Jorveza 1 mg orodispersible tablets

• The active ingredient is budesonide. Each orodispersible tablet contains 1 mg of budesonide.
• The other ingredients are disodium hydrogen citrate, sodium docusate, macrogol (6000), magnesium stearate, mannitol (E 421), anhydrous monosodium citrate, povidone (K25), sodium hydrogen carbonate and sucralose (see also section 2, “Jorveza contains sodium”).

Description of the appearance of Jorveza and contents of the pack
Jorveza 0.5 mg orodispersible tablet
Jorveza 0.5 mg orodispersible tablets are white, round, biconvex. They are marked
with “0.5” on one side. They are sold in blisters, in packs of 20, 60, 90, 100 or 200 orodispersible
tablets.
Jorveza 1 mg orodispersible tablet
Jorveza 1 mg orodispersible tablets are white, round, biconvex. They are sold in blisters,
in packs 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 on this medicinal product, 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
[email protected]

Lietuva
UAB Morfėjus
Tel: +370 5 2796328
[email protected]

България
Dr. Falk Pharma GmbH
Тел: +49 761 1514 0
[email protected]

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

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
[email protected]

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
[email protected]

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
Τηλ: +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]

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]

United Kingdom (Northern Ireland)
Dr. Falk Pharma GmbH
Tel: +49 761 1514 0
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu .