Muconazal Plus Nasal Spray x10 ml

MUCONASAL PLUS / MUCONASAL PLUS SPRAY indications:
For the relief of swelling of the nasal mucosa, e.g. in inflammation of the respiratory tract and hay fever. The active ingredient of Muconasal® Plus Spray, tramazoline hydrochloride, is an alpha-sympathomimetic that has a vasoconstrictor effect and immediately reduces swelling of the nasal mucosa. This leads to an immediate and long-lasting reduction in swelling and nasal secretion. After intranasal administration of Muconasal® Plus Spray, usually after 5 minutes, local vasoconstriction occurs, which lasts from 8 to 10 hours.
MUCONASAL PLUS / MUCONASAL PLUS SPRAY dosage and application:
Spray into each nostril up to 4 times daily. Should not be continued for more than 5-7 days without medical advice.
MUCONASAL PLUS SPRAY composition:
1 ml of solution contains 1.18 mg tramazoline hydrochloride (0.118 %).ExcipientsCitric acid monohydrate, sodium hydroxide, benzalkonium chloride, hypromellose, povidone, glycerol 85%, magnesium sulfate heptahydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium hydrogen carbonate, sodium chloride, cineole, levomenthol, grape camphor, purified water.
MUCONASAL PLUS 0.118 % nasal spray MUCONASAL® PLUS 0.118 % nasal spray, solution Tramazoline hydrochloride Read this leaflet carefully because it contains important information for you This medicine is available without a prescription. However, it is necessary to use MUCONASAL PLUS with caution in order to achieve the best results from the treatment. – Keep this leaflet. You may need to read it again. – Ask your pharmacist if you need more information or advice. – If your symptoms worsen, contact a doctor immediately. – If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist. In this leaflet you will find: 1. What MUCONASAL PLUS is and what it is used for 2. Before using MUCONASAL PLUS 3. How to use MUCONASAL PLUS 4. Possible side effects 5. How to store MUCONASAL PLUS 6. Further information 1. WHAT MUCONASAL PLUS IS AND WHAT IT IS USED FOR The active ingredient of MUCONASAL PLUS, tramazoline hydrochloride, constricts blood vessels, thereby reducing swelling of the nasal mucosa. This leads to a long-term reduction in nasal secretions. After intranasal administration of MUCONASAL PLUS, local vasoconstriction usually occurs within 5 minutes, which lasts from 8 to 10 hours. MUCONASAL PLUS is indicated for the relief of swelling of the nasal mucosa, for example in inflammation of the upper respiratory tract and hay fever, as well as for facilitating secretion in inflammation of the sinuses and middle ear infection (otitis media), as prescribed by a doctor. 2. BEFORE USING MUCONASAL PLUS Do not use MUCONASAL PLUS - if you are allergic (hypersensitive) to tramazoline hydrochloride or any of the other ingredients of MUCONASAL PLUS - if you have narrow-angle glaucoma or dry nose (rhinitis sicca) - if you have ever undergone surgery on the skull (head) through the nasal cavity - MUCONASAL PLUS is not suitable for children under 6 years of age. Pay special attention when using MUCONASAL PLUS - if after seven days of use of MUCONASAL PLUS the symptoms have not disappeared, please consult your doctor whether the treatment needs to be continued. Prolonged use of intranasal sprays can lead to chronic inflammation (and, thus, nasal congestion) and the inability of the active ingredient to penetrate the nasal mucosa. -if you have any of the following diseases: - high blood pressure - heart disease - overactive thyroid gland (hyperthyroidism) - enlarged prostate (prostatic hypertrophy) - pheochromocytoma (a type of adrenal gland tumor) - porphyria (a rare disorder in the formation of the blood component heme) you should take MUCONASAL PLUS only on prescription if you are taking any of the following medicines at the same time as MUCONASAL PLUS: - MAO inhibitors (for the treatment of depression) or tricyclic antidepressants - vasopressors (for the treatment of low blood pressure) - medicines for the treatment of high blood pressure, please see the section "Taking other medicines" After the drug effect has decreased, a distinct swelling of the nasal mucosa may occur. Be careful not to let MUCONASAL PLUS get into the eyes to avoid eye irritation. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. If certain medicines for the treatment of depression (MAO inhibitors or tricyclic antidepressants) or vasopressors (for the treatment of low blood pressure) are taken together with MUCONASAL PLUS, the effect on the cardiovascular system may lead to an increase in blood pressure. Concomitant use with tricyclic antidepressants may also lead to irregular heartbeat. Interactions with medicines for the treatment of high blood pressure can be complex and manifest themselves in the form of various cardiovascular reactions. Pregnancy and breast-feeding Ask your doctor or pharmacist before using any medicine. The use of MUCONASAL PLUS is not recommended during the first trimester of pregnancy. During the rest of pregnancy, as well as during breast-feeding, this medicinal product should only be used on medical advice. Driving and using machines No studies have been conducted on the effect of the medicinal product on the ability to drive and use machines. However, during treatment with MUCONASAL PLUS, side effects such as hallucinations, drowsiness, sedation, dizziness and fatigue may occur. Therefore, caution is recommended when driving and using machines. If you experience any of the side effects mentioned above, you should avoid potentially dangerous activities such as driving or using machines. Important information about some of the ingredients of MUCONASAL PLUS MUCONASAL PLUS contains the preservative benzalkonium chloride, which may cause irritation of the nasal mucosa. 3. HOW TO USE MUCONASAL PLUS Always use MUCONASAL PLUS exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist. The usual dose is: Spray up to 4 times a day in each nostril, as needed. Without a prescription from your doctor, use MUCONASAL PLUS for no more than 5-7 days. MUCONASAL PLUS is only suitable for adults and children over 6 years of age. Instructions for use of the dosing device. Please follow the following instructions before each use: 1. Remove the protective cap. 2. Before using the dosing device for the first time, activate it several times until a spray is released. 3. When using it again, the dosing device is already ready for use. Before using MUCONASAL PLUS, clean your nose thoroughly. 4. Place the applicator in your nostril and activate the dosing device once. Repeat this in the other nostril. When a spray is released, inhale gently through your nose. 5. After use, replace the protective cap. Clean the spray applicator after use. If you use more MUCONASAL PLUS than necessary If you use more MUCONASAL PLUS than necessary, consult your doctor or pharmacist. The increase in blood pressure and heart rate may, especially in children, be followed by a sharp decrease in blood pressure, shock, slow heart rate and subnormal temperatures. Intoxication with MUCONASAL PLUS may alternate between phases of stimulation and phases of depression of the central nervous and cardiovascular systems. Especially in children, intoxication occurs with effects on the central nervous system, including seizures and loss of consciousness (coma), slow heart rate and respiratory depression. Symptoms of central nervous system depression are anxiety, agitation, hallucinations and seizures, central nervous system depression is a decrease in body temperature, drowsiness and loss of consciousness (coma). Additionally, the following symptoms may occur: dilation and constriction of the pupils, sweating, fever, pallor, bluish lips, cardiovascular disorders, including cardiac arrest, respiratory disorders, including pulmonary failure and respiratory arrest, psychological changes. If you forget to use MUCONASAL PLUS If you miss a dose, do so as soon as you remember, but do not take a double dose to make up for the missed one. Then take the next dose as usual. If you stop using MUCONASAL PLUS MUCONASAL PLUS should only be used when necessary and should be discontinued after the symptoms have subsided. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, MUCONASAL PLUS can cause side effects, although not everybody gets them. The following classification has been used for the frequencies of occurrence: very common: more than 1 in 10 patients; common: more than 1 in 100 but less than 1 in 10 patients; uncommon: more than 1 in 1,000 but less than 1 in 100 patients; rare: more than 1 in 10,000 but less than 1 in 1,000 patients; very rare: less than 1 in 10,000 patients with unknown frequency: cannot be estimated from the available data Immune system disorders with unknown frequency: hypersensitivity Psychiatric disorders uncommon: anxiety with unknown frequency: hallucinations, drowsiness Nervous system disorders uncommon: headache rare: dizziness, altered taste with unknown frequency: drowsiness, sedative effect Cardiac disorders uncommon: sensation of a strong or irregular heartbeat (palpitations) with unknown frequency: irregular heartbeat, rapid heartbeat Respiratory, thoracic and mediastinal disorders common: nasal discomfort uncommon: nasal edema, dry nose, nasal discharge and cough rare: epistaxis Gastrointestinal disorders: uncommon: nausea Skin and subcutaneous tissue disorders with unknown frequency: rash*, pruritus*, skin edema* General disorders and administration site conditions with unknown frequency frequency: mucosal swelling*, fatigue Investigations Frequency unknown: increase in blood pressure * these side effects may be signs of hypersensitivity If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please contact your doctor or pharmacist. 5. HOW TO STORE MUCONASAL PLUS No special storage conditions. Keep out of the reach of children. Do not use MUCONASAL PLUS after the date stated on the packaging after „EXP“. 6. FURTHER INFORMATION What MUCONASAL PLUS contains – The active ingredient is: tramazoline hydrochloride (1.18 mg/ml) – The other ingredients are: benzalkonium chloride, cineole, levomenthol, camphor, racemic, glycerol, citric acid, sodium hydroxide, hypromellose, povidone, magnesium sulfate, magnesium chloride, calcium chloride, sodium hydrogen carbonate, sodium chloride, purified water What MUCONASAL PLUS looks like and contents of the pack 10 ml glass vial with dosing pump and nasal applicator. Marketing authorisation holder and manufacturer Marketing authorisation holder Boehringer Ingelheim International Binger Srasse 173 D-55216 Ingelheim am Rhein Germany Manufacturer Istituto De Angeli Srl Localita i Prulli No. 103/c 1-50066 Regello (FI) Italy Detailed information about this medicinal product can be found on the website of the Bulgarian Medicines Agency (BDA) www.bda.bg.