Jorveza 0.5 mg and 1 mg Orodispersible Budesonide Tablets
What Jorveza Is And What It Is Used For
Jorveza contains the active substance budesonide, a corticosteroid that reduces inflammation.
It is used in adults (over 18 years) to treat eosinophilic esophagitis, which is an inflammatory condition of the esophagus (esophagus) that makes it difficult to swallow food.
What You Need To Know Before Taking 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 Cautions
Talk to your doctor or pharmacist before using Jorveza if you have:
- Tuberculosis
- High blood pressure
- Diabetes, or if someone in the family has diabetes
- Bone loss ( osteoporosis )
- Ulcers in the stomach or first part of the small intestine (peptic ulcer )
- Increased pressure in the eyes (which can cause glaucoma ) or eye problems such as cloudiness of the lens ( cataract ) or if someone in the family has glaucoma
- Liver disease
If you have any of the above conditions, you may have an increased risk of side effects. Your doctor will determine the appropriate steps to take and whether it is still appropriate for you to take this medicine.
Jorveza can cause side effects typical of corticosteroids and can affect all parts of the body, especially if you take this medicine in high doses and for a long time (see section 4).
Additional precautions for treatment with Jorveza
- Contact a doctor if you get 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 get fungal infections in your mouth, throat or esophagus or if you think you may have an infection during treatment with this medicine. Symptoms of a fungal infection may include white spots in the mouth and throat and difficulty swallowing. The symptoms of certain infections may deviate from the normal or be more difficult to detect.
- Stay away from people who have chickenpox or herpes zoster ( shingles ) if you have not had these infections . The effects of these diseases may become more severe during treatment with this medicine. If you come in contact with someone who has chickenpox or shingles, contact your doctor immediately. Also inform your doctor about your vaccination status.
- Tell your doctor if you have not had measles and / or if and when you received your last vaccination against this disease.
- If you need to be vaccinated, talk to your doctor first.
- If you have any surgery, tell your doctor that you are taking Jorveza.
Jorveza can affect the results of adrenal function tests (ACTH stimulation tests) ordered by your doctor or hospital. Tell your doctor that you are taking Jorveza before any test.
Children And Young People
Jorveza should not be used by 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
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 and your doctor may want to monitor you closely if you are taking these medicines.
Particularly:
- ketoconazole or itraconazole (to treat fungal infections)
- clarithromycin, an antibiotic to treat the infection your
- kobicistat ritonavir (to treat HIV – infection s)
- estrogen er (used as hormone replacement therapy or as a contraceptive)
- cardiac glycosides such as digoxin (drug used to treat heart disease)
- diuretics (to remove excess fluid from the body).
Jorveza With Food And Drink
You should not drink grapefruit juice when you are being treated with this medicine as it may aggravate the side effects.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, 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 first checking with your doctor.
Do not take this medicine if you are breastfeeding unless you have consulted your doctor. Budesonide passes into breast milk in small amounts. Your doctor will help you decide if you should continue treatment and not breastfeed or if you should stop treatment while you are breastfeeding your baby.
Driving And Using Machines
Jorveza is not expected to affect your ability to drive or use machines.
Jorveza Contains Sodium
This medicine contains 52 mg of sodium (the main ingredient in table salt/table salt) per daily dose. This corresponds to 2.6% of the maximum recommended daily sodium intake for adults.
How To Take Jorveza
- Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- The recommended Jorveza dose for the treatment of acute episodes is two 1 mg orodispersible tablets (2 mg budesonide) daily. Take 1 mg orodispersible tablet in the morning and 1 mg orodispersible tablet in the evening.
- The recommended Jorveza dose to prevent further episodes is two 0.5 mg orodispersible tablets (1 mg budesonide) daily or two 1 mg orodispersible tablets (2 mg budesonide) daily, depending on how your body responds to the 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 your tongue and close your mouth. Gently press it against the palate with the tongue until it has completely dissolved (this takes at least two minutes but can take up to 20 minutes). Swallow the dissolved material a little at a time with saliva as the orodispersible tablet is broken up.
- DO NOT drink any liquid with the orodispersible tablet.
- The undissolved orodispersible tablet should not be chewed or swallowed.
- Wait at least 30 minutes after taking Jorveza before eating, drinking, brushing your teeth, or rinsing your mouth. Mouthwashes, sprays, or chewable tablets may be taken at least 30 minutes before or after taking Jorveza. This makes the medicine work properly.
Kidney and liver problems
- If you have any problems with your kidneys or liver, talk to your doctor. If you have kidney problems, your doctor will decide if Jorveza is right for you. If your kidney problems are serious, do not take Jorveza. If you have any liver disease, you should not take Jorveza.
Duration of treatment
- Initially, your treatment should last for about 6 to 12 weeks.
- After treatment of the acute episode, your doctor will decide how long and at what dose to 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 one time, take the next Jorveza dose as prescribed. Do not take less. Contact your doctor if you are unsure. If possible, bring the box and this information.
If You Forget To Take Jorveza
If you miss a dose, just continue the treatment with the prescribed dose. Do not take a double dose to make up for a forgotten dose.
If You Stop Taking Jorveza
Talk to your doctor if you want to stop or stop treatment earlier. It is important that you do not stop taking the medicine without talking to your doctor. Keep taking this medicine until your doctor tells you to stop, even if you feel better.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Jorveza Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported with Jorveza:
Very common: may affect more than 1 user in 10
- Jorveza weight gain and Fungal infections of the esophagus (which can cause pain or discomfort when swallowing)
Common Jorveza side effects: may affect up to 1 in 10 users
- Headache
- Fungal infections of the mouth and throat (symptoms may be white dots)
- Heartburn
- Indigestion
- Nausea
- Tingling or numbness in the mouth
- Fatigue
- Decreased amount of hormone et cortisol in the blood
Uncommon: may affect up to 1 in 100 people
- Difficulty sleeping
- Anxiety
- Dizziness
- Taste disorders
- Dry eyes
- High blood pressure
- Cough
- Dry throat
- Abdominal pain
- Pain in the upper abdomen
- Difficulty swallowing
- Inflammation of the stomach
- Ulcers of the stomach
- Stinging tongue, swelling of lips, dry mouth
- Skin rash
- Itchy skin rash
- Foreign body-feeling
- Pain in mouth or throat
The following side effects have been reported and are typical with medicines similar 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, which is associated with too much corticosteroid in the body and causes
- Rounded face
- Weight gain
- High blood sugar
- Accumulation of fluid in the body eg
- Swollen bones
- Decreased potassium levels in the blood
- Hypokalemia
- Irregular menstruation in women
- Unwanted body hair in women
- Impotence
- Red streaks on the skin
- Stretch marks
- Acne
- Stunted growth in children
- Mood swings, e.g
- Depression
- Irritation
- Euphoria
- Restlessness with increased physical activity
- Aggression
- Increased pressure in the brain
- Possibly with increased pressure in the eyes (swelling of the optic nerve papilla) in adolescents
- Dimsyn
- Increased risk of blood clots, inflammation of the blood vessels (which can occur when the drug stops being taken after prolonged use)
- Constipation
- Ulcers in the small intestine
- Inflammation of the pancreas which causes severe pain in the abdomen and back
- Rash
- Red spots caused by bleeding in the skin
- Delayed wound healing
- Skin reactions, e.g. contact dermatitis
- Bruising
- Muscle and joint pain
- Muscle weakness
- Muscle twitching
- Osteoporosis ( osteoporosis )
- Bone injury caused by poor circulation ( osteonecrosis )
- General malaise
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information. You can also report side effects directly to the Medical Products Agency,
How To Store 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 blister after EXP. The expiration date is the last day of the specified month.
- Do not store above 25 ° C. Store in the original packaging. Sensitive to light. Moisture sensitive.
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 to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
Jorveza 0.5 mg orodispersible tablet
- The active substance is budesonide. Each orodispersible tablet contains 0.5 mg budesonide.
- The other ingredients are
- Disodium hydrogen citrate
- Docusate sodium
- Macrogol (6000)
- Magnesium stearate
- Mannitol (E 421)
- Anhydrous sodium citrate
- Povidone (K25)
- Sodium bicarbonate 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 budesonide.
- The other ingredients are
- Disodium hydrogen citrate
- Docusate sodium
- Macrogol (6000)
- Magnesium stearate
- Mannitol (E 421)
- Anhydrous sodium citrate
- Povidone (K25)
- Sodium bicarbonate and sucralose (see also section 2 “Jorveza contains sodium”).
What The Medicine Looks Like And Contents Of The Pack
- Jorveza 0.5 mg orodispersible tablets
- Jorveza 0.5 mg orodispersible tablets are white, round, flat on both sides. They are marked with “0.5” on one side. They come in blisters in packs of 20, 60, 90, 100, or 200 orodispersible tablets.
- Jorveza 1 mg orodispersible tablets
- Jorveza 1 mg orodispersible tablets are white, round, flat on both sides. They come in blisters in packs of 20, 30, 60, 90, 100, or 200 orodispersible tablets.
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Dr. Falk Pharma GmbH
Leinenweberstr. 5
79108 Freiburg
Germany
Vifor Pharma Nordiska AB, Tel: +46 8 5580 6600, info.nordic@viforpharma.com