Singulair
(Montelukast Sodium)-
All Strengths
-
10mg

What is a generic medication?
Generic medications are significantly discounted copies of brand name medication that have the same active ingredients, intended use, dosage, side effects, effects, and route of administration as the original brand name medication. In other words, generic medications have the same pharmacological effects as their brand-name counterparts. Over half of all prescribed medications are for generic medications.

What Singulair is and what it is used for
What Singulair is Singulair is a leukotriene receptor antagonist that blocks substances called leukotrienes. How Singulair works Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Singulair improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis). When Singulair should be used Your doctor has prescribed Singulair to treat asthma, preventing your asthma symptoms during the day and night.
• Singulair is used for the treatment of adults and adolescents 15 years of age and older who are not adequately controlled on their medication and need additional therapy.
• Singulair also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom Singulair is indicated in asthma, Singulair can also provide symptomatic relief of seasonal allergic rhinitis. Your doctor will determine how Singulair should be used depending on the symptoms and severity of your asthma.
How to take Singulair
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• You should take only one tablet of Singulair once a day as prescribed by your doctor.
• It should be taken even when you have no symptoms or have an acute asthma attack. For adults and adolescents 15 years of age and older: The recommended dose is one 10 mg tablet to be taken daily in the evening. If you are taking Singulair, be sure that you do not take any other products that contain the same active ingredient, montelukast. This medicine is for oral use. You can take Singulair 10 mg with or without food. If you take more Singulair than you should Contact your doctor immediately for advice. There were no side effects reported in the majority of overdose reports. The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity. If you forget to take Singulair Try to take Singulair as prescribed. However, if you miss a dose, just resume the usual schedule of one tablet once daily. Do not take a double dose to make up for a forgotten dose. If you stop taking Singulair Singulair can treat your asthma only if you continue to take it. It is important to continue taking Singulair for as long as your doctor prescribes. It will help control your asthma. If you have any further questions on the use of this medicine, ask your doctor or pharmacist
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. In clinical studies with Singulair 10 mg film-coated tablets, the most commonly reported side effects (may affect up to 1 in 10 people) thought to be related to Singulair were:
• abdominal pain
• headache These were usually mild and occurred at a greater frequency in patients treated with Singulair than placebo (a pill containing no medication). Serious side effects Talk with your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment.
Uncommon: the following may affect up to 1 in 100 people
• allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
• behaviour and mood related changes: agitation including aggressive behaviour or hostility, depression
• seizure
Rare: the following may affect up to 1 in 1,000 people
• increased bleeding tendency
• tremor
• palpitations
Very rare: the following may affect up to 1 in 10,000 people
• combination of symptoms such as flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) (see Section 2)
• low blood platelet count
• behaviour and mood related changes: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may occur without warning
• inflammation of the liver (hepatitis)
Other side effects while the medicine has been on the market
Very common: the following may affect more than 1 in 10 people
• upper respiratory infection
Common: the following may affect up to 1 in 10 people
• diarrhoea, nausea, vomiting
• rash
• fever
• elevated liver enzymes
Uncommon: the following may affect up to 1 in 100 people
• behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, pins and needles/numbness
• nosebleed
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting in children
• weakness/tiredness, feeling unwell, swelling
Rare: the following may affect up to 1 in 1,000 people
• behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements
Very rare: the following may affect up to 1 in 10,000 people
• tender red lumps under the skin, most commonly on your shins (erythema nodosum)
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL
•Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: [email protected] Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal
How to Store Singulair
Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister after EXP. The first two numbers indicate the month
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