Properties
- Form
- kafsula
- Dosage mg
- 50მკგ+500
- Pack
- 1
What is it?
For inhalation use. Composition: • Active substance: Each capsule for inhalation contains 50mcg Salmeterol and 500mcg Fluticasone Propionate. • Excipients: Lactose. Read the instructions carefully before using this medication, as it contains important information for you: • Keep the instructions, you may need to read them again • Consult your doctor or pharmacist for any additional questions • This medication has been prescribed for you. Do not give it to others • If you are seeing a doctor or going to the hospital, inform your doctor that you are taking this medication • Follow the instructions provided. Do not use a dose higher or lower than recommended. From these instructions, you will learn: 1. What Fixflow is and what it is used for 2. What you should know before starting Fixflow 3. How to use Fixflow 4. What are the possible side effects 5. How to store Fixflow 1. What Fixflow is and what it is used for • Fixflow contains Salmeterol and Fluticasone as active substances. • Salmeterol belongs to the group of bronchodilators (bronchus dilating agents). It widens the airways by relaxing the smooth muscles of the bronchi. • Fluticasone belongs to the group of corticosteroids and, due to its anti-inflammatory properties, reduces swelling and inflammation of the airways, thereby reducing breathing difficulties in patients with bronchial asthma and COPD. Fixflow is presented in a package containing 60 inhalation capsules equivalent to 50mcg Salmeterol as Salmeterol Xinafoate and 100mcg Fluticasone Propionate, and one inhalation device - "Qhalyer" (a monodose inhaler). Fixflow is used for the following conditions: • Improvement and control of bronchial asthma; prescribed from step 3 of stepwise treatment • Reduction of symptoms and frequency of exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD). 2. What you should know before starting Fixflow Do not use Fixflow in the following conditions: • If you are allergic or hypersensitive to the components of Fixflow - Salmeterol, Fluticasone, or Lactose. Use Fixflow with caution in the following conditions: • Do not use Fixflow to relieve acute symptoms of asthma; always carry medication with you for these conditions. • Inform your doctor if you need to use short-acting bronchodilators more frequently to relieve acute symptoms; this indicates worsening of asthma control. • Inform your doctor in case of sudden and progressive worsening of bronchial asthma. • Do not stop treatment without consulting your doctor. Treatment with Fixflow should be discontinued gradually under medical supervision. • In patients with COPD treated with Fixflow, the risk of developing pneumonia increases. • Inform your doctor if you have an active or inactive form of pulmonary tuberculosis, as they may change your prescription. • Inform your doctor if you have thyrotoxicosis, as they may change your prescription. • Using Fixflow at doses higher than therapeutic doses may increase blood pressure and heart rate; inform your doctor if you have any cardiovascular disease, as they may change your prescription. • Fixflow, when used at doses higher than therapeutic doses, may reduce potassium levels in the blood; inform your doctor if you have low potassium levels or a predisposition to this condition, as they may change your prescription. • With high doses and prolonged use of Fixflow, due to its corticosteroid content, systemic side effects may develop, such as: Cushing's syndrome (fat deposition on the back resembling a hump, moon face, excessive hair growth, and decreased bone density, especially in the lumbar vertebrae and pelvic bones), Cushing's syndrome-like signs, adrenal suppression, growth retardation in children and adolescents, decreased bone density, cataracts, and glaucoma (increased intraocular pressure). • Fixflow may cause growth retardation in children and adolescents, so regular height monitoring is necessary in patients receiving the drug for long periods. • Some patients are more sensitive to inhaled corticosteroids, so maintain close contact with your doctor when switching from oral corticosteroids to inhaled corticosteroids. • Fixflow may increase blood glucose levels, so inform your doctor if you have diabetes, as they may change your prescription. • Inform your doctor if you are using Ritonavir (antiviral medication), as it may change your prescription. Use of Fixflow with food and drink: Simultaneous use of food and drink does not affect the efficacy of Fixflow. Pregnancy • If you are pregnant or plan to become pregnant, inform your doctor before starting the medication. • If you discover you are pregnant during treatment, please consult your doctor or pharmacist immediately for advice. Lactation • Before starting the medication, inform your doctor or pharmacist that you are breastfeeding. • There is insufficient data on the excretion of fluticasone and salmeterol in breast milk, so use the medication during breastfeeding only if your doctor considers the drug necessary for you. Driving and operating machinery: Fixflow does not affect driving and operating machinery. Important information about some ingredients of Fixflow: Fixflow contains lactose, but since the preparation is only for inhalation, no precautions are necessary. Taking with other medications: Inform your doctor if you are taking medications such as selective or non-selective beta-blockers (medications for heart disease), ritonavir, ketoconazole (medication for fungal infections), and inhibitors of the liver P450 3A4 isoenzyme system (similar to ketoconazole), as they may change your prescription. 3. How to use Fixflow Recommendations for adequate use and dosage/frequency of administration: Bronchial Asthma Adults and adolescents over 12 years of age: • One inhalation of 50mcg Salmeterol and 100mcg Fluticasone Propionate twice daily, or • One inhalation of 50mcg Salmeterol and 250mcg Fluticasone Propionate twice daily, or • One inhalation of 50mcg Salmeterol and 500mcg Fluticasone Propionate twice daily. Children over 4 years of age: • One inhalation of 50mcg Salmeterol and 100mcg Fluticasone Propionate twice daily. Adults: In adult patients, doubling the dose of all forms of Fixflow (2 inhalations twice daily) for a short period, up to 14 days, has a similar tolerability and safety profile to the standard dosing regimen (1 inhalation twice daily) and is considered in international guidelines for asthma treatment for patients requiring an additional short course (up to 14 days) of inhaled steroid therapy. Chronic Obstructive Pulmonary Disease (COPD): Adults: • One inhalation of 50/250mcg or 50/500mcg Salmeterol/Fluticasone Propionate twice daily. Route and method of administration: Fixflow is for inhalation use only. Inhale the preparation into the lungs through the mouth. If Fixflow is prescribed for a child, the preparation should only be used under the supervision of an adult who can follow the instructions correctly. Regular use of Fixflow is necessary to achieve full benefit. Do not stop treatment arbitrarily, even if you feel better. Do not change the dosage of the medication without consulting your doctor. Instructions for using the "Qhalyer" inhalation device: 1) Remove the cap from the "Qhalyer". 2) Hold the base of the "Qhalyer" with one hand and twist the mouthpiece in the direction of the arrow with the other hand. 3) Remove the capsule from the blister immediately before use and place it in the "Qhalyer" chamber. 4) Twist the mouthpiece in the direction of the arrow and close the device tightly. 5) Hold the device with the mouthpiece pointing upwards; press the buttons on both sides of the inhaler fully with your fingers only once, then release; as a result, the capsule will be punctured on both sides. Small, gelatinous particles of the capsule may enter your mouth during inhalation. Gelatinous particles are absolutely safe and are fully digested if swallowed. The risk of gelatinous particle formation is reduced by immediate use of the capsule after removal from the blister and pressing the buttons only once. 6) Exhale deeply. 7) Place the mouthpiece in your mouth and tilt your head back slightly. Seal your lips tightly around the mouthpiece and inhale as quickly and deeply as possible. 8) Remove the "Qhalyer" from your mouth and hold your breath for as long as you can; then breathe normally. Open the device again and check if any powder remains in the capsule; if the capsule is not completely empty, repeat steps 6, 7, and 8. 9) After the procedure, rinse your mouth with water and spit it out. 10) Dispose of the capsule after use and close the device. Do not forget! • Keep your "Qhalyer" dry. • Store closed. • Never inhale into the device. • Activate the device only when you are ready to use the medication. • Do not take a higher dose than recommended. Different age groups: Use in children: There is no data on the use of Fixflow in children under 4 years of age. Use in elderly patients: No dose adjustment is required in elderly patients. Special conditions: Renal/hepatic insufficiency: No dose adjustment is required in renal/hepatic insufficiency. If you feel that the effect of Fixflow is too strong or too weak, please inform your doctor. If you have used more Fixflow than you should: If you have taken more Fixflow than you should, consult your doctor or pharmacist immediately. If you forget to use Fixflow: If you forget to use Fixflow, inhale the next dose of the medication as usual, according to the dosing schedule. Do not double the dose to compensate for a missed dose. Possible effects of stopping Fixflow therapy: Sudden discontinuation of Fixflow therapy may lead to exacerbation of bronchial asthma. Treatment with Fixflow should be discontinued gradually under medical supervision. Sudden discontinuation of the drug may worsen respiratory symptoms. In patients with COPD, sudden discontinuation of treatment may lead to symptomatic decompensation (pulmonary insufficiency); treatment should be discontinued under medical supervision. 4. What are the possible side effects Very common (occurred in more than 1 in 10 patients): • Headache – decreases during treatment. • Increased incidence of common colds in patients with COPD. Common (occurred in less than 1 in 10 patients): • Thrush (painful, reddish-yellow, raised patches) in the mouth and throat. Also glossitis, hoarseness, and throat irritation. Rinsing your mouth with water after each inhalation reduces the risk of these side effects. Your doctor may prescribe an antifungal medication to treat thrush. • Sensation of rapid and irregular heartbeat (palpitations) – generally a harmless side effect that decreases with treatment. • Muscle cramps. The following side effects have been observed in patients with chronic obstructive pulmonary disease (COPD): • Pneumonia and bronchitis (lung infections). Inform your doctor if you notice the following symptoms: increased sputum production, change in sputum color, fever, chills, increased cough, worsening breathing problems. • Bruising and fractures. • Inflammation of the sinuses (sinusitis). • Reduced potassium levels in the blood (you may experience irregular heartbeat, muscle weakness, and cramps). Uncommon (occurred in less than 1 in 100 patients): • Rash. • Tachycardia (very rapid heartbeat). Rare (occurred in less than 1 in 1000 patients): • Allergic reactions: If you notice that your breathing has worsened after using Fixflow – you have uncontrollable cough and noisy breathing, itching and swelling of parts of the body (especially the face, tongue, or throat), stop taking Fixflow and seek immediate medical attention from your doctor or the nearest hospital. • With particularly high doses and prolonged use of Fixflow, the body's production of steroid hormones may decrease, which may lead to the following side effects: — Growth retardation in children and adolescents — Weakening of bones — Cataracts and glaucoma — Weight gain — Moon face (Cushing's syndrome) — Your doctor will regularly check you for any of these side effects and ensure that you are treated with the minimum dose of Fixflow necessary to control your asthma symptoms. • Arrhythmia (sensation of irregular or extra heartbeats). Inform your doctor, but do not stop using Fixflow on your own. • Increased blood glucose levels. If you have diabetes, you may need more frequent monitoring of blood glucose levels and adjustment of treatment. • Behavioral changes, such as unusual activity and irritability (more common in children). • Joint pain and swelling, muscle pain. 5. How to store Fixflow Store Fixflow in its original packaging and out of reach of children. Store in a dry place at room temperature, below 25°C. Use the preparation according to the indicated expiry date. Do not use the preparation after the expiry date indicated on the packaging. Expiry date: 2 years Dispensing category: Pharmaceutical product group II – for use by prescription only. Manufacturer: Abdi İbrahim İlaç San. ve Tic. A.Ş. Sanayi Mahallesi, Tunç Caddesi, No: 3; Esenyurt / İstanbul / Turkey Tel: (0212) 622 66 00 Fax: (0212) 623 19 52 Registration holder: Abdi İbrahim İlaç San. ve Tic. A.Ş. Reşitpaşa Mahallesi, Eski Büyükdere Caddesi No:4, 34467; Maslak, Sarıyer - Istanbul / Turkey