1. What Rhinam-M Tablet is and what it is used for
Rhinam-M Tablets is a combination of two active substances, Montelukast and Levocetirizine in one tablet. Both substances help to control seasonal allergies/allergic rhinitis.
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Levocetirizine hydrochloride is the active ingredient of Levocetirizine 5 mg film-coated tablets.
Levocetirizine is an anti-allergic medication. For the treatment of signs of illness (symptoms) associated with:
- allergic rhinitis (including persistent allergic rhinitis);
- nettle rash (urticaria).
What are seasonal allergies?
Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollens from trees, grasses and weeds.
The symptoms of seasonal allergies typically may include - stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes.
2. What you need to know before you take Rhinam-M Tablets
Do not take Rhinam-M Tablets
- If you are allergic to montelukast, levocetirizine dihydrochloride, to cetirizine, to hydroxyzine or any of the other ingredients of this medicine (listed in section 6)
- If you have a severe kidney disease requiring dialysis
Warnings and precautions
Talk to your doctor or pharmacist before taking Rhinam-M Tablets.
- If your asthma or breathing gets worse, tell your doctor immediately.
- Oral Montelukast are not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you. Always have your inhaled rescue medicine for asthma attacks with you.
- It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast should not be substituted for other asthma medications your doctor has prescribed for you.
- Any patient on anti-asthma medicines should be aware that if you develop a combination of symptoms such as a flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.
- You should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
- If you are likely to be unable to empty your bladder (with conditions such as spinal cord injury or enlarged prostate), please ask your doctor for advice.
- If you suffer from epilepsy or are at risk of convulsions, please ask your doctor for advice as use of Levocetirizine 5mg film-coated tablets may cause seizure aggravation.
- If you are scheduled for allergy testing, ask your doctor if you should stop taking Levocetirizine 5mg film-coated tablets for several days before testing. This medicine may affect your allergy test results.
Patients should be aware that various neuropsychiatric events (for example behaviour and mood-related changes) have been reported in adults, adolescents and children with montelukast (see section 4). If you develop such symptoms while taking Montelukast, you should consult your doctor.
Children and adolescents
Do not give this medicine to children. There are different form(s) of this medicine available for pediatric patients under 15 years of age based on age range.
Other medicines and Rhinam-M Tablets
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines including those obtained without a prescription. Some medicines may affect how Montelukast works, or Montelukast may affect how other medicines work.
Tell your doctor if you are taking the following medicines before starting Montelukast:
- Phenobarbital (used for treatment of epilepsy)
- Phenytoin (used for treatment of epilepsy)
- Rifampicin (used to treat tuberculosis and some other infections)
- Gemfibrozil (used for treatment of high lipid levels in plasma)
Taking Rhinam-M Tablets with food and drink
Rhinam-M Tablets may be taken with or without food.
Caution is advised if Rhinam-M Tablets is taken at the same time as alcohol or other agents acting on the brain. In sensitive patients, the concurrent administration of Levocetirizine and alcohol or other agents acting on the brain may cause additional reductions in alertness and impairment of performance.
Pregnancy and breast feeding
If you are pregnant or breast feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- Pregnancy: Your doctor will assess whether you can take Rhinam-M Tablets during this time.
- Breast-feeding: It is not known if Rhinam-M Tablets appears in breast milk. You should consult your doctor before taking Montelukast if you are breast-feeding or intend to breast feed.
Driving and using machines
Some patients being treated with Rhinam-M Tablets (Levocetirizine) may experience somnolence/drowsiness, tiredness and exhaustion. Use caution when driving or operating machinery until you know how this medicine affects you.
However, special tests have revealed no impairment of mental alertness, the ability to react or the ability to drive in healthy test persons after taking levocetirizine in the recommended dosage.
3. How to take Rhinam-M Tablets.
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 Rhinam-M 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 Rhinam-M Tablet to be taken daily in the evening.
If you are taking Rhinam-M Tablets, be sure that you do not take any other products that contain the same active ingredient, montelukast or Levocetirizine.
This medicine is for oral use.
You can take Rhinam-M Tablets with or without food.
If you take more Rhinam-M Tablets than you should
Contact your doctor immediately for advice.
If you take more Rhinam-M Tablets than you should somnolence can occur in adults. Children may initially show excitation and restlessness followed by somnolence.
If you think you have taken an overdose of Rhinam-M Tablets, please tell your doctor who will then decide what action should be taken.
The other most frequently occurring symptoms are reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
If you forget to take Rhinam-M Tablets
Try to take Montelukast 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 Rhinam-M Tablets
Rhinam-M Tablets can treat your allergic rhinitis only if you continue to take it.
It is important to continue taking Rhinam-M Tablets for as long as your doctor prescribes. It will help control your allergic rhinitis/asthma.
Stopping treatment should have no negative effects. However, rarely pruritus (intense itching) may occur if you stop taking Levocetirizine, even if those symptoms were not present before treatment initiation.
The symptoms may resolve spontaneously. In some cases, the symptoms may be intense and may require treatment to be restarted. The symptoms should resolve when the treatment is restarted.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Special dosage instructions for specific populations:
Renal and hepatic impairment
Patients with impaired kidney function may be given a lower dose according to the severity of their kidney disease and in children the dose will also be chosen based on body weight; the dose will be determined by your doctor.
Patients who have a severe kidney disease requiring dialysis must not take Rhinam-M Tablets.
Patients who only have impaired liver function should take the usual prescribed dose.
Patients who have both impaired liver and kidney function may be given a lower dose depending on the severity of the kidney disease, and in children the dose will also be chosen based on body weight; the dose will be determined by your doctor.
Elderly patients aged 65 years and above
No adaptation of the dose is necessary in elderly patients, provided their renal function is normal.
Use in Children
Rhinam-M Tablets are not recommended for children under 18 years of age.
How long should you take Rhinam-M Tablets
The duration of use depends on the type, duration and course of your complaints and is determined by your physician.
4. Possible side effects:
MONTELUKAST:
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with montelukast 10 mg film-coated tablets, the most reported side effects (may affect up to 1 in 10 people) thought to be related to montelukast were:
- Abdominal pain, Headache: These were usually mild and occurred at a greater frequency in patients treated with montelukast 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: 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: may affect up to 1 in 1,000 people
- Increased bleeding tendency, Tremor, Palpitations
Very rare: 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 (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: may affect more than 1 in 10 people
- Upper respiratory infection
Common: may affect up to 1 in 10 people
- Diarrhea, nausea, vomiting, Rash, Fever, Elevated liver enzymes
Uncommon: may affect up to 1 in 100 people
- Behavior 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: may affect up to 1 in 1,000 people
- Behavior and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements
Very rare: may affect up to 1 in 10,000 people
- Tender red lumps under the skin, most commonly on your shins (erythema nodosum)
- Behavior and mood related changes: obsessive-compulsive symptoms, stuttering
LEVOCETIRIZINE
Common: (may affect up to 1 in 10 people)
- dry mouth, headache, tiredness, somnolence/drowsiness
Uncommon: (may affect up to 1 in 100 people)
- exhaustion and abdominal pain
Reporting of side effects
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via email to: medico@zorvia.com
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Rhinam-M tablet
Store protected from light and moisture at a temperature not exceeding 30°C.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister after EXP. The expiry date refers to the last date of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Rhinam-M Tablet contains:
Qualitative and quantitative composition
Each uncoated tablet contains:
Montelukast Sodium IP
Equivalent to Montelukast ………………10 mg
Levocetirizine hydrochloride IP ………….5 mg
Excipients q.s.
Each strip of Rhinam-M tablet contains 10 Tablets
7. Marketing Authorisation Holder and Manufacturer
Zorvia Healthcare Ltd,
Suite 4, 10th floor, Centaurus, Central Avenue,
Hiranandani Estate, Ghodbandar Road, Thane West,
Maharashtra: 400607.
8. Date of revision
This leaflet was last revised in 05/2026.