32 micrograms/dose nasal spray
budesonide
What Livicort is and what it is used for
Livicort is a cortisone preparation that reduces inflammation and allergic reactions in the nose.
Livicort is used to relieve runny nose, nasal congestion, sneezing, and/or itching in the nose caused by allergies to, for example, pollen (so-called hay fever).
What you need to know before using Livicort
Do not use Livicort
if you are allergic to budesonide or any of the other ingredients of Livicort (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Livicort if you:
- get heavy or frequent nosebleeds .
- recently had sores in the nose, nose surgery or an injury to the nose that has not healed properly.
- have a fungal or viral infection (eg herpes ) in the respiratory tract.
- have pulmonary tuberculosis .
- have glaucoma (increased pressure inside the eye) or there is a history of glaucoma in the family.
- have liver problems .
Talk to your doctor if you experience any of the following while using Livicort:
- blurred vision or other visual disturbances.
When treated with high doses for a long time, Livicort can affect the normal production of steroid hormones in the body. This may cause side effects such as adrenal insufficiency (see section 4 “Possible side effects”).
Children and young people
Treatment with cortisone-containing drugs may lead to slower length growth. The long-term effects of cortisone nasal spray on children have not been established. It is recommended that the duration of children and adolescents receiving long-term corticosteroid treatment be monitored regularly. In case of suspicion that the length of growth slows down, the treatment should be evaluated with a view to the benefit of the treatment to the risk of growth inhibition.
Other medicines and Livicort
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.
Tell your doctor or pharmacist in particular if you:
- using other drugs containing cortisone (including cream against eczema , asthma inhaler, tablets, injection s, nasal spray, eye or nose drops).
- take medicines to treat fungal infections (such as itraconazole or ketoconazole ).
- taking antibiotics (such as clarithromycin or telithromycin ).
- taking anti- HIV medicines (such as saquvinavir, atazanavir, indinavir, nelfinavir, ritonavir or cobicistat- containing medicines ).
- have just stopped taking cortisone tablets such as prednisolone or cortisone injections .
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.
Experience with use during pregnancy does not indicate an increased risk of malformations. However, talk to your doctor about more than the temporary use of Livicort during pregnancy.
Budesonide passes into breast milk. However, at therapeutic doses of Livicort, the risk of effects on breast-fed infants is considered unlikely. Livicort can be used during breastfeeding.
Driving and using machines
Livicort does not affect the ability to drive or use machines.
Livicort contains potassium sorbate
Potassium sorbate may cause local skin reactions (eg contact dermatitis).
How to use Livicort
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults and children from 6 years: The recommended starting dose is 8 sprays per day. 2 sprays in each nostril morning and evening or 4 sprays in each nostril in the morning.
If you have hay fever, you should start treatment with Livicort a few days before the start of the allergy season. You usually get full effect within a few days, but you can feel some relief already after a few hours.
Once you have had the full effect, the dosage can be reduced to the minimum amount needed to control your allergic nose problems. Start by reducing the dose one by half by taking 2 sprays in each nostril only in the morning. Further dose reduction can be tried. 1 spray in each nostril in the morning may be sufficient.
Feel free to try to end the treatment if you think that the pollen season for you is over or if there are very low levels of pollen in the air.
If you get no effect within 14 days – contact a doctor.
Do not use Livicort for more than 3 months without consulting a doctor.
If you have been prescribed Livicort, your doctor will decide on a dose to suit you. Follow your doctor’s prescription carefully.
If you have a stuffy nose, you can use decongestant nasal drops during the first 2-3 days of treatment.
If the allergy symptoms from your eyes bother you, your doctor or pharmacist may recommend other medicines to relieve the symptoms.
Children under 12 years of age should only use this medicine under the supervision of an adult to ensure that dose one is administered correctly.
User manual
Before using a new bottle of Livicort nasal spray, charge the pump by shaking the bottle and spraying it in the air (5 to 10 times) until there is an even shower.
If you do not use the nasal spray daily, the pump must be recharged in the same way, but it is now sufficient to spray once in the air.
1. Sniff out the nose.
Shake the bottle.
Remove the plastic cap.
2. Hold the spray bottle as shown in the pictures.
Insert the tip into one nostril, facing the side of the nose and away from the center of the nose (nasal septum). Spray the required number of doses. Do the same in the other nostril. Note: You do not need to inhale while spraying.
4. Clean the applicator with a clean handkerchief and put the plastic cap back on.
Do not exceed the dosage!
Avoid contact with Livicort with the eyes. Rinse immediately with water if you get it in your eyes.
Cleaning:
It is advisable to clean the upper plastic parts at some point. Remove the plastic cap. Liftoff the applicator. Rinse the plastic cap and applicator in lukewarm water. Allow the parts to air dry and put them back in place.
Do not attempt to clean the applicator by inserting a needle or other sharp object.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Livicort and contact a doctor immediately if you get any of the following symptoms:
- swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing ( angioedema ), this is a less common side effect (may affect up to 1 in 100 people).
- fever, rash, swelling and sometimes a drop in blood pressure (severe allergic reaction ), this is a rare side effect (may affect up to 1 in 1,000 people).
Other side effects ar
Common (may affect up to 1 in 10 people ): Irritation of the nose, nosebleeds.
Uncommon (may affect up to 1 in 100 people ): Immediate or delayed hypersensitivity reactions such as rash, itchy skin, hives, inflammation of the skin, muscle spasms.
Rare (may affect up to 1 in 1,000 people ): Nasal ulcers, holes in the wall that separate the nostrils (nasal septum), altered voice (hoarseness), bruising, adrenal insufficiency (may cause symptoms such as loss of appetite, abdominal pain, weight loss, nausea, headache or vomiting) or blurred vision.
Has been reported (occurs in an unknown number of users): cataract ( cataract ), glaucoma ( glaucoma ), or redness.
Rare side effects in children and adolescents
Slown length growth has been reported in children receiving corticosteroid therapy through the nose. Your doctor should regularly check the length growth of children and adolescents receiving long-term treatment with corticosteroids.
How to store Livicort
Keep this medicine out of the sight and reach of children.
Do not store above 30 ° C. Do not freeze.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
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.
As drug residues can remain in the empty packages, they should not be thrown in the rubbish but the empty packages should also be returned to pharmacies.
Contents of the pack and other information
Content declaration
- The active substance is budesonide 32 micrograms / dose.
- The other ingredients are microcrystalline cellulose, carmellose sodium, anhydrous glucose , polysorbate 80, disodium edetate, preservative potassium sorbate
(E 202) 0.06 mg, hydrochloric acid for pH adjustment and water.
Other ingredients are included to give the nasal spray the right properties.
What the medicine looks like and contents of the pack
Brown glass bottles are equipped with a spray pump and nasal applicator.
Pack size:
120 dose s and 3×120 dose s
As it can be difficult to empty the bottle, it is overfilled. In this way, it is ensured that the specified amount is obtained, ie 120 doses.