64 micrograms/dose of nasal spray
budesonide
What Rhinocort Aqua is and what it is used for
Rhinocort Aqua is a cortisone preparation that reduces inflammation and allergic reactions in the nose.
Rhinocort Aqua is used to relieve runny nose, nasal congestion, sneezing, and/or itching in the nose caused by allergies and also against so-called vasomotor runny nose where the cause can be, for example, smoke or perfume.
Rhinocort Aqua is also used for polyps in the nose and after surgery of polyps to reduce the risks of regeneration of new polyps.
What you need to know before using Rhinocort Aqua
Do not use Rhinocort Aqua
- if you are allergic to budesonide or any of the other ingredients of Rhinocort Aqua (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Rhinocort Aqua 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 (such as 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 Rhinocort Aqua:
- blurred vision or other visual disturbances.
When treated with high doses for a long time, Rhinocort Aqua 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. If there is a suspicion that the length of growth is slowing down, the treatment must be evaluated with a view to the benefit of the treatment about the risk of growth inhibition.
Other medicines and Rhinocort Aqua
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.
In particular, tell your doctor or pharmacist if you:
- use other medicines containing cortisone (including cream for eczema, asthma inhaler, tablets, injections, nasal sprays, 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 saquinavir, 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 Rhinocort Aqua during pregnancy.
Budesonide passes into breast milk. However, at therapeutic doses of Rhinocort Aqua, the risk of effects on breast-fed infants is considered unlikely. Rhinocort Aqua can be used during breastfeeding.
Driving and using machines
Rhinocort Aqua does not affect your ability to drive or use machines.
Rhinocort Aqua contains potassium sorbate
Potassium sorbate may cause local skin reactions (eg contact dermatitis).
How to use Rhinocort Aqua
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Allergic nose problems
Adults and children from 6 years: The recommended starting dose is 4 sprays (256 micrograms) per day. 1 spray in each nostril morning and evening or 2 sprays in each nostril in the morning.
Once you have had a full effect, the dosage can be reduced to the minimum amount needed to control your allergic nose problems.
If you have seasonal allergic rhinitis (hay fever), you should try to start treatment with Rhinocort Aqua a few days before the allergy season begins. You usually get full effect within a few days, but you can feel some relief already after a few hours.
If you have a stuffy nose, you can use decongestant nasal drops during the first 2-to 3 days of treatment.
If the allergy symptoms from your eyes bother you, your doctor may give you supplements or other medicines to relieve the symptoms.
Nasal polyps
The recommended starting dose is 4 sprays (256 micrograms) per day. 1 spray in each nostril morning and evening or 2 sprays in each nostril in the morning.
Once you have had a full effect, the dosage can be reduced to the minimum amount needed to control your symptoms.
Children
The use of Rhinocort Aqua in children should be supervised by an adult so that the spraying is carried out correctly and the dosage is by the doctor’s prescription.
User manual
Before using a new bottle of Rhinocort Aqua nasal spray, charge the pump by shaking the bottle and spraying 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 Rhinocort Aqua 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. Lift off 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.
If you use more Rhinocort Aqua than you should
If you use too much Rhinocort Aqua on a single occasion, you should not get any unpleasant effects. If you have any questions about ingesting an overdose of medicines, always contact a doctor or hospital for risk assessment and advice.
You must take a dose as stated on the package label or as your doctor advised. Use only the amount prescribed by your doctor. Using too little or too much can aggravate your symptoms.
If you forget to take Rhinocort Aqua
If you forget to take a dose of Rhinocort Aqua, take it as soon as you remember. If it is time to take your next dose, do not take the missed dose. Do not take a double dose to make up for a forgotten dose.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Rhinocort Aqua and contact your 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, and 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): Cataracts ( cataracts ), glaucoma ( glaucoma ), or reddening of the skin.
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 of growth of children and adolescents receiving long-term treatment with corticosteroids.
How to store Rhinocort Aqua
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 64 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 the contents of the pack
Brown glass bottles are equipped with a spray pump and nasal applicator.
Pack size:
60 doses are, 120 doses are respectively 3×120 doses are
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 60 doses or 120 doses.
Not all pack sizes may be marketed.