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Intended for UK patients and members of the public

Montelukast Tablets

Active Ingredients

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Montelukast 10mg Film coated Tablets

PL Number:
20075/0182
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Montelukast 4mg chewable Tablets

PL Number:
20075/0180
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • To update SmPC sections 4.4, 4.8 and PIL section 2 in line with information of reference product (Singulair 10 mg film-coated tablets; DCP procedure number: FI/H/0104/001; MAH: N.V. ORGANON) for Montelukast 4 mg & 5 mg Chewable Tablets.

     

    Additionally, applicant has updated SmPC and PIL with editorial changes and PIL with the full form of European Economic Area and United Kingdom (Northern Ireland) as QRD template related changes in line with reference products.

  • To update SmPC sections 4.4, 4.8 and PIL section 2 in line with information of reference product (Singulair 10 mg film-coated tablets; DCP procedure number: FI/H/0104/001; MAH: N.V. ORGANON) for Montelukast 4 mg & 5 mg Chewable Tablets.

     

    Additionally, applicant has updated SmPC and PIL with editorial changes and PIL with the full form of European Economic Area and United Kingdom (Northern Ireland) as QRD template related changes in line with reference products.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Montelukast 5mg chewable Tablets

PL Number:
20075/0181
MA Holder:
Accord Healthcare Limited
Product Classification:
POM
Product Status:
Active

Product Documentation

  • To update SmPC sections 4.4, 4.8 and PIL section 2 in line with information of reference product (Singulair 10 mg film-coated tablets; DCP procedure number: FI/H/0104/001; MAH: N.V. ORGANON) for Montelukast 4 mg & 5 mg Chewable Tablets.

     

    Additionally, applicant has updated SmPC and PIL with editorial changes and PIL with the full form of European Economic Area and United Kingdom (Northern Ireland) as QRD template related changes in line with reference products.

  • To update SmPC sections 4.4, 4.8 and PIL section 2 in line with information of reference product (Singulair 10 mg film-coated tablets; DCP procedure number: FI/H/0104/001; MAH: N.V. ORGANON) for Montelukast 4 mg & 5 mg Chewable Tablets.

     

    Additionally, applicant has updated SmPC and PIL with editorial changes and PIL with the full form of European Economic Area and United Kingdom (Northern Ireland) as QRD template related changes in line with reference products.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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