Montelukast Sandoz

Montelukast Sandoz Adverse Reactions

montelukast

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Agencia Lei Va Hong
Full Prescribing Info
Adverse Reactions
Chewable Tablet 4- and 5-mg: Like all medicines, Montelukast Sandoz Chewable Tablet can cause side effects, although not everybody gets them.
In clinical studies with Montelukast Sandoz Chewable Tablet 4 mg, the most commonly reported side effects (occurring in 1 to 10 out of 100 patients) thought to be related to montelukast were abdominal pain and thirst.
In clinical studies with Montelukast Sandoz Chewable Tablet 5 mg, the most commonly reported side effects (affects 1 to 10 users in 100) thought to be related to montelukast was headache.
These were usually mild and occurred at a greater frequency in patients treated with montelukast than placebo (a tablet containing no medication).
Additionally, while the medicine has been on the market, the following have been reported: Increased bleeding tendency; 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 [dream abnormalities, including nightmares, hallucinations, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, tremor, depression, trouble sleeping, sleep walking, suicidal thoughts and actions (in very rare cases)]; dizziness, drowsiness, pins and needles/numbness, epileptic seizure; palpitations (rapid, pounding heartbeat); nosebleed; diarrhoea, dry mouth, indigestion, nausea, vomiting; inflammation of the liver; bruising, itching, hives, tender red lumps under the skin most commonly on your shins (erythema nodosum); joint or muscle pain, muscle cramps; tiredness, feeling unwell, swelling, fever.
In asthmatic patients treated with montelukast, very rare cases (in less than 1 out of 10,000 patients) of a 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) have been reported. Tell the physician right away if the child gets one or more of these symptoms.
Ask the physician or pharmacist for more information about side effects. If any of the side effects gets serious, or if any side effects is noticed, tell the child’s doctor or pharmacist.
Film-Coated Tablet 10-mg: Montelukast has been evaluated in clinical studies as follows: 10-mg film-coated tablet in approximately 4,000 adult asthmatic patients ≥15 years.
10-mg film-coated tablet in approximately 400 adult asthmatic patients with seasonal allergic rhinitis ≥15 years.
5-mg chewable tablet in approximately 1,750 pediatric asthmatic patients 6-14 years.
The following drug-related adverse reactions in clinical studies were reported commonly (≥1/100 to <1/10) in asthmatic patients treated with montelukast and at a greater incidence than in patients treated with placebo. (See Table 1.)

Click on icon to see table/diagram/image

With prolonged treatment in clinical trials with a limited number of patients for up to 2 years for adults, and up to 12 months for paediatric patients 6-14 years, the safety profile did not change.
Post-Marketing Experience: Adverse reactions reported in post-marketing use are listed by system organ class and specific adverse experience term as follows (see Table 2). Frequency categories were estimated based on relevant clinical trials.

Click on icon to see table/diagram/image

Oral Granules: Montelukast Sandoz Oral Granules can cause side effects, although not everybody gets them. In clinical studies with montelukast, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to montelukast were diarrhoea, hyperactivity, asthma, scaly and itchy skin and rash.
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $768 a year.
Sign up for free
Already a member? Sign in