Properties
What is it?
DENSON DENSON for oral use, each film-coated tablet contains: Active ingredients: 10 mg Montelukast (as 10.4mg Montelukast Sodium). Fillers: Hydroxypropylcellulose, Microcrystalline Cellulose pH 102, Lactose Monohydrate, Croscarmellose Sodium, Aerosil 200, Magnesium Stearate, Opadry 85F34274 Yellow, Ethanol, Distilled Water. This leaflet 1. What is DENSON and what is it used for 2. Before you take DENSON 3. How to take DENSON 4. Possible side effects 5. How to store DENSON Sections are presented 1. What is DENSON and what is it used for? DENSON is a leukotriene receptor antagonist (antagonistic action) that blocks leukotrienes. It relieves asthma symptoms and allergic rhinitis by suppressing leukotrienes. DENSON is not a steroid (an organic compound with a fatty structure related to cholesterol). Studies have shown that montelukast does not affect the growth rate of children (information on asthma and allergic rhinitis is provided in the following sections). DENSON is prescribed for the relief of chronic asthma, symptoms of allergic rhinitis, and chronic idiopathic urticaria of unknown origin. Asthma: DENSON should be used for the treatment of chronic asthma in children and adults aged 15 years and older. DENSON should not be used for short-term improvement of asthma attacks. In case of an asthma attack, follow your doctor's instructions. During an asthma attack, you should do what your doctor recommends for an asthma attack. Allergic rhinitis: DENSON is used to manage symptoms of allergic rhinitis (sneezing, nasal congestion, runny nose, and itching). DENSON film-coated tablets are used for the symptomatic treatment of seasonal allergic rhinitis and year-round allergic rhinitis in patients aged 15 years and older. DENSON comes in a pack of 28 tablets. Each tablet contains 10mg of the active ingredient (montelukast). What is asthma? Asthma is a persistent (chronic) inflammation of the bronchial tubes through which air is supplied to the body and lungs. Symptoms of asthma include: • Cough • Sneezing • Chest tightness • Shortness of breath What is allergic rhinitis? Seasonal allergic rhinitis, also known as hay fever, is caused by outdoor allergens such as tree, grass, and weed pollen. Perennial (year-round) allergic rhinitis can occur throughout the year and is usually caused by indoor allergens such as dust mites, pet dander, and/or mold spores. Symptoms of allergic rhinitis may include: - Nasal congestion, discharge, and/or itching - Sneezing Chronic idiopathic urticaria: DENSON can be used to relieve symptoms such as itching, pustules, and redness of the skin that develop during an allergic skin disease (chronic idiopathic urticaria) in patients aged 15 years and older. 2. Before taking DENSON Do not take DENSON if: You are allergic (hypersensitive) to montelukast or any of the other ingredients of the medicine. Take special care with DENSON If your asthma or breathing worsens, inform your doctor immediately. Oral DENSON is not intended for the treatment of acute asthma attacks. In case of an attack, follow your doctor's instructions. Always carry a fast-acting inhaler for asthma attacks. It is important that you and your child take all asthma medications exactly as prescribed by your doctor. Do not change DENSON, prescribed by your doctor, with other asthma medications. All patients taking asthma medications should be warned to consult a doctor if they experience flu-like symptoms, numbness or tingling in the hands or feet, worsening of lung symptoms, and/or rash. If you have asthma that worsens when taking acetylsalicylic acid (aspirin), you should try to avoid taking similar drugs such as aspirin or non-steroidal anti-inflammatory drugs while using DENSON. Mood changes (including agitation, aggressive behavior or hatred, anxiety, depression, disorientation (confusion of time and place), abnormal sleep, nightmares, hallucinations, difficulty falling asleep, restlessness, hyperactivity, sleepwalking, suicidal thoughts and behavior (including suicide attempts), tremor) have been described with the use of DENSON. Patients should be warned to consult a doctor if such changes occur. If any of these apply to you or have applied to you in the past, consult your doctor. Taking DENSON with food and drink DENSON 10mg can be taken with or without food. Pregnancy: Ask your doctor or pharmacist for advice before taking any medicine. If you are pregnant or planning to become pregnant, consult your doctor before taking DENSON. Your doctor will assess your condition and decide if you can take DENSON. If you discover you are pregnant during treatment, inform your doctor or pharmacist immediately. Breastfeeding: Ask your doctor or pharmacist for advice before taking any medicine. It is unknown whether DENSON is excreted in breast milk. Therefore, if you are breastfeeding or planning to breastfeed, you should consult your doctor before taking DENSON. Driving and using machinery The effect of DENSON on the ability to drive and operate machinery is not expected. However, individuals may react differently to medications. Some side effects (dizziness and drowsiness), which are very rarely reported by patients, may affect the ability to drive and operate machinery. Important information about some ingredients of DENSON DENSON contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before using this medicinal product. Use with other medicines Some medicines may alter the mechanism of action of DENSON or vice versa. If you are taking the following medicines, please inform your doctor before starting DENSON: • Phenobarbital (used to treat epilepsy) • Phenytoin (used to treat epilepsy) • Rifampicin (used to treat tuberculosis and some other infections) • Gemfibrozil (used to treat high levels of lipids, which are present in blood fluid in larger quantities than in other cells). If you are taking or have recently taken any medicine, prescription or over-the-counter, tell your doctor or pharmacist. 3. How to take DENSON? Instructions for proper use and dosage/frequency Adolescent and adult patients with asthma (15 years and older) Take DENSON 10mg film-coated tablets once a day, at night (see method of use). You should take DENSON every day, as prescribed by your doctor, even if you do not have asthma symptoms. If asthma symptoms worsen or if you need to use an emergency inhaler for asthma attacks, consult your doctor immediately. Do not use DENSON to quickly relieve an asthma attack. In case of an asthma attack, act exactly as prescribed by your doctor. Always carry an emergency inhaler for asthma attacks. Do not stop taking asthma medications or reduce the dose without your doctor's prescription. Adults and adolescents (15 years and older) with seasonal and year-round rhinitis Take DENSON once a day, usually at the same time. Take DENSON once a day, as prescribed by your doctor. Method of use DENSON is for oral use only. You can take the medicine with or without food. Take one tablet with a sufficient amount of water (e.g., with a glass of water, without chewing). During the use of DENSON, make sure you are not taking other medications containing montelukast. Chronic idiopathic urticaria The duration of treatment for allergic skin disease (chronic idiopathic urticaria) may vary between patients, so you should follow your doctor's instructions. Different age groups: Use in children: DENSON 4mg chewable tablets for children aged 2 and 5 years DENSON 5mg chewable tablets for children aged 6 and 14 years. Use in the elderly: Dose adjustment is not necessary based on age. Special populations Renal/hepatic insufficiency: Dose adjustment is not necessary in patients with renal insufficiency and mild to moderate hepatic insufficiency. There is no data in patients with severe hepatic insufficiency. If you have the impression that the effect of DENSON is too strong or too weak, consult your doctor or pharmacist. If you take more DENSON than you should In most cases of overdose, side effects were not described. In case of overdose in adults and children, the most common symptoms noted included abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity. If you take more DENSON than you should, consult your doctor or pharmacist. If you forget to take DENSON Try to take the medicine as prescribed. If you miss a dose, do not take it and continue with the old regimen. Do not take a double dose to compensate for the missed dose. If you stop taking DENSON If you continue to take DENSON, it will only treat asthma. It is important to take medications for the duration prescribed by your doctor. DENSON will help you control your asthma. If you have any further questions about the use of the product, consult your doctor or pharmacist. 4. Possible side effects Like all medicines, DENSON may cause side effects in people sensitive to its ingredients. The following side effects were most common and described in clinical trials of film-coated tablets containing 10mg montelukast (reported in at least 1 patient out of 100 and less than 1 in 10 cases): - Abdominal pain - Headache Side effects of DENSON are usually mild and occur more frequently with the use of montelukast film-coated tablets compared to placebo (tablets that do not contain an active ingredient). Side effects categorized are shown below: Very common: reported in at least 1 in 10 patients Common: reported in less than 1 in 10, but more than 1 in 100 patients Uncommon: reported in less than 1 in 100, but more than 1 in 1000 patients Rare: reported in less than 1 in 1000, but more than 1 in 10000 patients Very rare: reported in less than 1 in 10000 patients Unknown: may occur in such small numbers that they cannot be identified with existing data. If any of the following events occur, stop taking DENSON and seek immediate medical attention or go to the nearest hospital emergency department: - Allergic reactions [swelling of the face, lips, tongue and/or throat (may cause difficulty swallowing or breathing)] These are serious side effects. If any of them occur, you have a serious allergy to DENSON. You may require emergency medical intervention or hospitalization. Very serious side effects occur rarely. Additionally, the following events have been described during marketing of the product: Very common: - Upper respiratory tract infection Common: - Diarrhea, nausea, vomiting - Rash - Fever - Increased liver enzymes Uncommon: - Behavioral and mood-related changes, sleep disturbances, including nightmares, hallucinations, difficulty falling asleep, sleepwalking, nervousness or hyperreactivity, anxiety, restlessness, agitation, including aggressive behavior and hatred, depression). - Dizziness, drowsiness, tingling/numbness, seizures [convulsions (involuntary muscle contractions) or crisis] - Nosebleeds - Dry mouth, indigestion - Bruising, itching and rash - Joint or muscle pain, muscle cramps - Fatigue, worsening of self-perception, swelling Rare - Increased tendency to bleed - Palpitations - Attention disturbance - Memory impairment Very rare: - Hallucinations (seeing things that are not there) - Disorientation (loss of perception of time-space) - Suicidal thoughts and behavior (including suicide) - Hepatitis (inflammation of the liver) - Red blisters under the skin, most commonly in the shin area (erythema nodosum); severe skin reactions that develop suddenly without symptoms (erythema multiforme). - Pulmonary edema (inflammation) In patients treated with montelukast, a combination of flu-like illness, tingling and numbness of the hands and feet, worsening of lung symptoms, and/or rash (Churg-Strauss syndrome) has been described. If any of these symptoms occur, you should consult your doctor. If you notice any side effects not listed in this leaflet, consult your doctor or pharmacist. Reporting of side effects Tell your doctor or pharmacist about any side effects that are listed or not listed in the leaflet. You can also report additional side effects by clicking on the "Reporting Side Effects of Medicines" logo or by calling 0 800 314 00 08 (Turkish Pharmacovigilance Center) (TÜFAM). By reporting side effects, you will help to obtain more information about the side effects of the medicine. 5. How to store DENSON Keep out of reach and sight of children, in the original packaging. Store at a temperature not exceeding 25°C. Store in a place protected from light and moisture. DENSON is a product and trademark of "NOVATOR PHARMA" LLP (UK). Do not discard expired or unused medicines. Hand them over to the collection system determined by the Ministry of Environment and Urbanization. Use according to the expiry date. Do not use DENSON after the expiry date indicated on the packaging. Do not use DENSON if you notice any defect in the product and/or packaging. Dispensing rule: Pharmaceutical product group II, dispensed with prescription N3. Commercial license holder: Recordati İlaç San. ve Tic. A.Ş. Ç.O.S.B. Karaağaç Mah. Atatürk Cad.No:36 Kapaklı / TEKIRDAĞ, Turkey Tel: 0 282 999 16 00 Place of manufacture: Recordati İlaç San. ve Tic. A.Ş. Ç.O.S.B. Karaağaç Mah. Atatürk Cad. No:36 Kapaklı / TEKIRDAĞ, Turkey
