Properties
What is it?
DEXARIS (0.2028+0.5) mg/ml nasal spray, suspension Dexamethasone isonicotinate + Oxymetazoline hydrochloride Read this entire leaflet carefully before you start using this medicine, as it contains important information for you. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What DEXARIS is and what it is used for 2. What you need to know before using DEXARIS 3. How to use DEXARIS 4. Possible side effects 5. How to store DEXARIS 6. Contents of the pack and other information 1. What DEXARIS is and what it is used for DEXARIS is a special medicine that has a strong effect when used locally in cases of persistent and severe nasal congestion. It contains two active substances, oxymetazoline hydrochloride and dexamethasone-21-isonicotinate. Oxymetazoline hydrochloride is a sympathomimetic drug that narrows the blood vessels in the nose by opening up congestion in the nasal mucosa, providing rapid and long-lasting relief from nasal congestion. It helps to open the nasal passages and allows patients with a blocked ("stuffy") nose to breathe better. Dexamethasone belongs to a group of drugs called corticosteroids (cortisone type), which are used to reduce and prevent inflammation. Dexamethasone has anti-inflammatory and anti-allergic properties, and when used nasally, it reduces and prevents inflammation or swelling of the nasal mucosa. DEXARIS is indicated in children over 7 years of age and adults in the following cases: allergic rhinitis (hay fever), vasomotor rhinitis, acute rhinitis and nasopharyngitis, sinusitis, and nasal polyps. 2. What you need to know before using DEXARIS Do not use DEXARIS - if you are allergic to oxymetazoline hydrochloride, dexamethasone isonicotinate or any of the other ingredients of this medicine (listed in section 6). - if you suffer from: · untreated infections of the nose, mouth, eye, and upper respiratory tract (e.g., herpes, cowpox, chickenpox, fungal infection of the nose, etc.) · tuberculosis · dry rhinitis · glaucoma (including angle-closure glaucoma) (high intraocular pressure) - after surgical operation on the skull through the nasal cavity - if you are simultaneously taking monoamine oxidase inhibitors (MAO inhibitors, tricyclic antidepressants used to treat depression), bromocriptine (used to treat Parkinson's disease, male and female infertility, male hyperprolactinemia, suppression of lactation, and pituitary adenomas) and other drugs that may potentially increase blood pressure (risk of hypertensive crisis). - if you suffer from atrophic and vasomotor rhinitis, or rhinitis caused by dryness of the mucosa. - after trans-sphenoidal hypophysectomy (surgical removal of the pituitary gland through the nose) or after surgery of the nose and oral cavity involving the dura mater, and as with all other vasoconstrictors. DEXARIS is not suitable and should not be prescribed for children under 7 years of age. In addition, the product should not be used during pregnancy and breastfeeding. Warnings and precautions Talk to your doctor or pharmacist before using DEXARIS. Talk to your doctor or pharmacist before using DEXARIS, especially in the following cases: - if you suffer from cardiovascular diseases, such as coronary artery disease or hypertension (high blood pressure) - if you suffer from metabolic disorders, such as hyperthyroidism (overactive thyroid gland), diabetes mellitus (high blood sugar levels), congenital porphyria (a rare, usually hereditary disease characterized by high levels of porphyrin in the stool and urine) or osteoporosis - if you suffer from prostate hypertrophy (enlarged prostate) or pheochromocytoma (adrenal gland tumor). If any of the above applies to you, do not use DEXARIS before consulting your doctor or pharmacist. DEXARIS should not be used for more than 7 days. If symptoms persist, consult your doctor. Prolonged or excessive use may cause nasal mucosal congestion (rebound phenomenon) and lead to medicamentous rhinitis or atrophy of the nasal mucosa. In particular, prolonged or excessive use of nasal decongestants may reduce their effectiveness. Caution is also required in the elderly and children, as they may be more sensitive to the side effects of this medicine. Do not use this medicine for a prolonged period and do not exceed the recommended dose. Each container should be used by only one patient, and the sprayer should be cleaned after each use to reduce the risk of transmitting viral or bacterial infections. Prolonged use of corticosteroids at doses higher than recommended may cause hypercorticism and adrenal insufficiency. Treatment with nasal corticosteroids at doses higher than recommended may cause clinically significant suppression of the adrenal glands. If there is evidence of use at doses higher than recommended, then protection with additional systemic corticosteroids during stress or elective surgery should be considered. Caution is required when spraying the medicine to avoid contact of DEXARIS with the eyes, as this may cause irritation, as well as increased eye pressure and, in exceptional cases, clouding of the lens of the eye (cataract). In this case, you should consult a doctor. When switching from oral to topical steroids, your adrenal function may be impaired, and any existing allergies may be exacerbated. In this case, you should consult your doctor. Due to the corticosteroid component of DEXARIS, the risk of infection (e.g., tuberculosis, specific viral infections such as herpes zoster, herpes simplex, cowpox) or even opportunistic infections may increase. If you have an infection, contact your doctor. Systemic effects of nasal corticosteroids may develop, especially when high doses are prescribed for a prolonged period. The development of these effects is much less likely than with oral corticosteroids and may vary between individual patients and different corticosteroid preparations, and this is particularly important in children and patients treated with ritonavir or cobicistat. Effects such as Cushing's syndrome, cushingoid signs (you may develop swelling and weight gain in the trunk and face, as these are usually the first signs of Cushing's syndrome), adrenal suppression (this can occur after stopping long-term or intensive treatment with DEXARIS. Therefore, you should not stop treatment arbitrarily, but should consult your doctor first), growth retardation in children and adolescents, cataracts, glaucoma, and, more rarely, a range of psychological and behavioral effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children) may develop. In this case, you should consult your doctor. Growth retardation has also been observed in children who received nasal corticosteroids at recommended doses. For this reason, the doctor will regularly monitor your child's height when treated with nasal corticosteroids for a prolonged period. If growth slows down, therapy should be reviewed to reduce the dose of the nasal corticosteroid, if possible, to the lowest dose at which effective symptom control is maintained. In addition, you may need advice from a specialist pediatrician. You should inform your doctor if you suffer from hematological malignancy, if you have symptoms of tumor lysis syndrome, such as muscle cramps, muscle weakness, confusion, vision loss, or breathing difficulties and shortness of breath. Children DEXARIS is not suitable for children under 7 years of age. It is recommended to use DEXARIS in children aged 7 to 12 years under adult supervision. It is recommended that the growth of children undergoing prolonged treatment with nasal corticosteroids be regularly monitored (see section "Warnings and precautions" above). Other medicines and DEXARIS Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. You should not use DEXARIS if you are taking the following medicines: • Monoamine oxidase inhibitors (MAO inhibitors): if you are currently taking monoamine oxidase inhibitors (MAOIs) or have taken MAOIs within the last 2 weeks • Tricyclic antidepressants • Bromocriptine • Vasoconstrictor drugs • Other drugs that may increase blood pressure • Thyroxine • Antihypertensive agents, especially those whose action involves the sympathetic nervous system • β2-sympathomimetic drugs • Cytochrome CYP3A4 inhibitors (e.g.: ketoconazole, itraconazole, clotrimazole, ritonavir or cobicistat, cyclosporine, ethinylestradiol, troleandomycin, clarithromycin, cimetidine, diltiazem, indinavir), as they can increase the level of dexamethasone in the blood. • Cytochrome CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbital, rifampicin) If you are taking any of the above medicines, do not use DEXARIS before consulting your doctor or pharmacist. Pregnancy, breastfeeding and fertility 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. DEXARIS should not be used during pregnancy and breastfeeding. Driving and operating machinery Studies on the effect on the ability to drive and operate machinery have not been conducted. However, during treatment with DEXARIS, you may experience side effects such as hallucinations, drowsiness, sedation, dizziness, and fatigue, or other side effects affecting the nervous or cardiovascular system. In this case, you should not drive or operate machinery and, in general, avoid potentially dangerous activities. DEXARIS contains benzalkonium chloride and benzyl alcohol DEXARIS contains benzalkonium chloride as a preservative, which may cause irritation or swelling inside the nose, especially with prolonged use. It also contains benzyl alcohol as a preservative, which may cause mild local irritation. 3. How to use DEXARIS Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist. Recommended dose: Adults and children over 7 years of age 300 dose pack Unless otherwise prescribed, 2-3 sprays (50 µl each) in each nostril 1-3 times a day are sufficient. In children, the use can be repeated 2 times in 24 hours. The duration of treatment is determined by the treating physician individually (see section 2). Each course of treatment should not exceed 7 days, unless otherwise prescribed by the treating physician. Do not use this medicine for a long time and do not exceed the recommended dose (see section "Warnings and precautions"). If the doctor recommends long-term treatment, the nasal mucosa should be checked regularly. Use in children and adolescents DEXARIS is intended for adults and children over 7 years of age only. It is recommended to use DEXARIS in children aged 7 to 12 years under adult supervision. Method of administration For topical nasal use. Instructions for use: 1. Shake the container well. 2. Remove the protective cap from the spray tip. Before using DEXARIS nasal spray for the first time, the spray pump must be prepared so that the product works properly. To do this, hold the bottle, place your thumb on the bottom of the bottle, and your index and middle fingers around the ring of the sprayer. Make sure the bottle is in a vertical position away from your eyes. Press firmly and quickly on the bottom of the bottle with your thumb 3 times. The pump is now prepared and ready for use. If you do not use the product for more than 24 hours, the pump should also be prepared until a fine spray is ejected. 3. If necessary, blow your nose to clear the nostrils. 4. Hold the container in a vertical position. Use your finger to close the nostril on the side where you are not administering the medicine. Tilt your head slightly forward, insert the spray tip into the other nostril, and press firmly and quickly on the bottom of the bottle with your thumb, holding the "sides" between your index and middle fingers, while simultaneously inhaling gently through your nose. 5. Repeat step 4 in the other nostril. 6. Do not blow your nose immediately after spraying. 7. The spray tip should be cleaned regularly with warm water. 8. Replace the protective cap. The bottle should be used by only one person, otherwise there is a risk of transmitting viral or bacterial infections. If you have used more DEXARIS than you should How to act if you have used more product than necessary: It is important to take the dose as described in the package leaflet or as directed by your doctor. You should use the amount prescribed by your doctor: using more or less product may worsen your symptoms. Oxymetazoline hydrochloride DEXARIS is intended for local use in the nose only and, at recommended doses, the amount of oxymetazoline that enters the systemic circulation is negligible. Excessive local use of oxymetazoline or accidental ingestion may cause the following effects: hypertension (increased blood pressure), tachycardia (increased heart rate), palpitations, cardiac arrhythmias (irregular heartbeat), cardiac arrest, sweating (excessive sweating), anxiety, agitation, convulsions, mydriasis (dilated pupils), nausea, vomiting, cyanosis (pale skin), fever, circulatory shock, pulmonary edema, respiratory disorders, including respiratory failure, mental disorders, lethargy, drowsiness, miosis (constricted pupils), hypothermia, bradycardia (slowed heart rate), sudden hypotension (drop in blood pressure), respiratory depression (shallow breathing), respiratory arrest, and coma. Young children are more sensitive to toxicity than adults. Overdose of oxymetazoline in children can cause: convulsions, bradycardia, coma or respiratory depression, hypertension, which may be followed by hypotension. If you suspect an overdose or accidental ingestion, seek medical attention or a poison control center immediately. Dexamethasone Chronic misuse and overdose of dexamethasone can cause suppression of the hypothalamic-pituitary-adrenal axis and growth retardation in children. Symptomatic treatment may be considered appropriate. If you forget to use DEXARIS If you need to take the medicine regularly and you miss a dose, take the missed dose as soon as possible. However, if your next dose is approaching, skip the missed dose and continue with your schedule. Do not take a double dose to make up for a missed dose. If you have any further questions on 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. Prolonged use of corticosteroids at doses higher than recommended may cause systemic symptoms. Hormonal problems: excessive hair growth on the body (especially in women), muscle weakness and wasting, purple stretch marks on the skin, increased blood pressure, irregular or missed periods, changes in protein and calcium levels in the body, swelling and weight gain in the body and face (so-called "Cushing's syndrome") (see section 2, "Warnings and precautions"). Growth retardation has been reported in children receiving intranasal steroids. The following side effects caused by the use of the active ingredients have also been observed: - Hypersensitivity (development of reactions such as angioedema or skin reactions), masked infection (signs of masked local infection of the ear, nose, and throat) - High cortisol levels (indicating hypercortisolemia) - Hallucinations, insomnia, restlessness (mainly in children) - Headache, drowsiness, sedation, dizziness, dysgeusia - Increased intraocular pressure, cataracts (clouding of the lens of the eye), visual disturbances, vision loss. - Pathological heart rhythm (arrhythmias), palpitations, rapid heartbeat (tachycardia) - Perforation and ulceration of the nasal septum, nosebleeds, nasal swelling, nasal discomfort, burning and dryness sensation in the nasal or cheek mucosa, runny nose, sneezing, throat irritation. - Convulsions (especially in children) - Nausea - Rash, itching, hives, increased sweat secretion (hyperhidrosis) - Fatigue - Increased blood pressure (hypertension) Prolonged or excessive use may cause nasal mucosal congestion (rebound phenomenon), chronic swelling of the nasal mucosa, and may lead to medicamentous rhinitis or atrophy of the nasal mucosa (see section "Warnings and precautions"). 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. By reporting side effects, you can help provide more information about the safety of this medicine. 5. How to store DEXARIS Store below 25°C. Keep this medicine out of the reach and sight of children. Do not use this medicine after the expiry date which is stated after EXP on the carton. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6. Contents of the pack and other information What DEXARIS contains - The active substances are dexamethasone isonicotinate (0.2028 mg/ml) and oxymetazoline hydrochloride (0.5 mg/ml). - Other ingredients (excipients) are: benzalkonium chloride, benzyl alcohol, disodium phosphate, sodium dihydrogen phosphate dihydrate, sodium carboxymethylcellulose, polysorbate 80, sodium hydroxide/hydrochloric acid, distilled water. What DEXARIS looks like and contents of the pack A 15 ml amber glass bottle equipped with a dosing pump that delivers 50 µl 300 doses. Dispensing category: Pharmaceutical product group III, available without prescription.