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It is important to emphasise that if you (or a family member) are being treated with a Napp product and you have a question or concern about your treatment, it is recommended that you speak to your Healthcare Professional in the first instance, as they will be best-placed to assist you.

Reporting of Side Effects

Patients, their family members, or carers

If you get any side-effects, talk to your doctor, nurse or pharmacist. You can report side effect directly to Napp via email or to the Medicines and Healthcare  Regulatory Agency (MHRA) via their Yellow card reporting scheme at . By reporting side-effects you can help provide more information on the safety of medicines.

Please provide as much information as you can:

  • About the person who experienced the adverse event: initials, gender, age or date or birth
  • About the person contacting us for this report: your name, contact details and confirmation that we can contact you to request additional information
  • About the adverse event: the symptom(s) experienced, when it started, when it stopped or if it is still ongoing
  • About the Napp medicinal product involved: product name, dose being taken, Lot or Batch Number, and date treatment was started and/or stopped.

Napp, Mundipharma and companies within the Mundipharma global network of independent associated companies are required by law to collect certain minimum information relating to persons who have suffered an adverse event to the company’s medicinal product in order to monitor the safety of its medicinal products. This includes reviewing safety data from clinical studies and collecting reports of adverse events. Drug safety staff may contact you if additional information is required to fully document the adverse event report.

All the information and personal data you share with us will be protected and kept confidential in line with our Data Privacy Policy and local regulations and guidance. Your information will be used for the purpose of drug safety surveillance and to enable us to deal with your enquiry appropriately.

The information that you share may be shared with health authorities and other third parties who are also responsible for drug safety surveillance. If you are a patient, you can ask someone else (e.g., your doctor or pharmacist) to send the report if you do not wish to give us your name.

The medicines are listed by alphabetical order of the active ingredient. Patient Information Leaflets (PILs) are the most suitable information for patients and public, however you may also review the Summary of Product Characteristics (SmPC) and/or regulatory Assessment Report (AR) if you wish, although both of the document types are primarily intended for Healthcare Professionals.

Due to the UK’s recent exit from the European Union, some medicines now have separate information available for Northern Ireland (NI) and Great Britain (GB), whereas the information for some products is still applicable across the United Kingdom (UK). Please ensure you select the link corresponding to the part of the UK where you are resident.

Medicines marked with an exclamation mark (!) are in the process of being discontinued and may have limited availability. Please speak to your Healthcare Professional if you have any concerns.

Active IngredientBrand NamePatient Information LeafletSummary of Product CharacteristicsRegulatory Assessment Report
BuprenorphineBuTrans® patchesUK: BuTrans 5 mcg/hr PIL, BuTrans 10 mcg/hr PIL, BuTrans 15 mcg/hrPIL, BuTrans 20 mcg/hr PILUK: BuTrans 5 mcg/hr SmPC BuTrans 10 mcg/hr SmPC BuTrans 15 mcg/hr SmPC BuTrans 20 mcg/hr SmPCNot available
Diltiazem hydrochlorideAdizem-SR® capsulesUK: Adizem-SR 90mg PIL, Adizem-SR 120mg PIL, Adizem-SR 180mg PIL,UK: Adizem-SR 90mg SmPC, Adizem-SR 120mg SmPC, Adizem-SR 180mg SmPCNot available
Diltiazem hydrochlorideAdizem-XL® capsulesUK: Adizem-XL 120mg PIL, Adizem-XL 180mg PIL, Adizem-XL 200mg PIL, Adizem-XL 240mg PIL Adizem-XL 300mg PIL,UK: Adizem-XL 120mg SmPC, Adizem-XL 180mg SmPC, Adizem-XL 200mg SmPC Adizem-XL 240mg SmPC Adizem-XL 300mg SmPCNot available
Fluticasone propionate, formoterol fumarate dihydrateflutiform® inhalerUK: Flutiform 50/5mg PIL, Flutiform 125/5mg PIL, Flutiform 250/10mg PIL,UK: Flutiform 50/5mg SmPC, Flutiform 125/5mg SmPC, Flutiform 250/10mg SmPC,UK: AR
Hydromorphone hydrochloridePalladone® injectionUK: Palladone injection 2 mg/ml PIL UK: Palladone Injection 10mg/ml PILUK: Palladone injection 2mg/ml SmPC UK: Palladone injection 10mg/ml SmPCUK: AR
Hydromorphone hydrochloridePalladone® capsulesUK: Palladone capsules 1.3 mg PIL UK: Palladone capsules 2.6 mg PILUK: Palladone capsules 1.3mg SmPC UK: Palladone capsules 2.6 mg/ml SmPCNot available
Hydromorphone hydrochloridePalladone® SR capsulesUK: Palladone SR capsules 2 mg PIL, Palladone SR capsules 4 mg PIL, Palladone SR capsules 8 mg PIL, Palladone SR capsules 16 mg PIL, Palladone SR capsules 24 mg PILUK: Palladone SR capsules 2 mg SmPC, Palladone SR capsules 4 mg SmPC, Palladone SR capsules 8 mg SmPC, Palladone SR capsules 16 mg SmPC, Palladone SR capsules 24 mg SmPCNot available
Morphine sulfateMST® Continus® tabletsUK: MST Continus 5mg PIL MST Continus 10mg PIL MST Continus 15mg PIL MST Continus 30mg PIL MST Continus 60mg PIL MST Continus 100mg PIL MST Continus 200mg PILUK: MST Continus 5mg SmPC MST Continus 10mg SmPC MST Continus 15mg SmPC MST Continus 30mg SmPC MST Continus 60mg SmPC MST Continus 100mg SmPC MST Continus 200mg SmPCNot available
Morphine sulfateMXL® capsulesUK: MXL Capsules 30 mg PIL, MXL Capsules 60 mg PIL, MXL Capsules 90 mg PIL, MXL Capsules 120 mg PIL, MXL Capsules 150 mg PIL, MXL Capsules 200mg PIL UK: MXL Capsules 30 mg SmPC, MXL Capsules 60 mg SmPC, MXL Capsules 90 mg SmPC, MXL Capsules 120 mg SmPC, MXL Capsules 150 mg SmPC, MXL Capsules 200mg SmPCNot available
Morphine sulfateSevredol® tabletsUK: Sevredol® tablets 10 mg PIL, Sevredol® tablets 20 mg PIL, Sevredol® tablets 50 mg PILUK: Sevredol® tablets 10 mg SmPC, Sevredol® tablets 20 mg SmPC, Sevredol® tablets 50 mg SmPCNot available
Naloxone hydrochloride dihydrateNyxoid® nasal sprayUK: Training Card; Patient Information Card; Training Video NI: SmPC & PILGB: SmPC UK: Healthcare Professional Guidance Document NI: SmPC & PILEU : AR
Oxycodone hydrochlorideOxyContin® tabletsUK: OxyContin® tablets 5 mg PIL, OxyContin® tablets 10 mg PIL, OxyContin® tablets 15 mg PIL, OxyContin® tablets 20 mg PIL, OxyContin® tablets 30 mg PIL, OxyContin® tablets 40 mg PIL, OxyContin® tablets 60 mg PIL, OxyContin® tablets 80 mg PIL OxyContin® tablets 120 mg PILUK: OxyContin® tablets 5 mg SmPC, OxyContin® tablets 10 mg SmPC, OxyContin® tablets 15 mg SmPC, OxyContin® tablets 20 mg SmPC, OxyContin® tablets 30 mg SmPC, OxyContin® tablets 40 mg SmPC, OxyContin® tablets 60 mg SmPC, OxyContin® tablets 80 mg SmPC OxyContin® tablets 120 mg SmPC UK: AR
Oxycodone hydrochlorideOxyNorm® capsulesUK: OxyNorm® capsules 5 mg PIL, OxyNorm® capsules 10 mg PIL, OxyNorm® capsules 20 mg PIL,UK: OxyNorm® capsules 5 mg SmPC, OxyNorm® capsules 10 mg SmPC, OxyNorm® capsules 20 mg SmPC,Not available
Oxycodone hydrochlorideOxyNorm® injectionUK: OxyNorm® Injection 10mg/ml PIL, UK: OxyNorm® Injection 50mg/ml PILUK: OxyNorm® Injection 10mg/ml SmPC, OxyNorm® Injection 50mg/ml SmPC10 mg/ml - Not available 50 mg/ml - UK: AR
Oxycodone hydrochlorideOxyNorm® liquid and OxyNorm® concentrateUK: OxyNorm® oral concentrate 10mg/ml PIL UK: OxyNorm® oral liquid 1mg/ml PILUK: OxyNorm® oral concentrate 10mg/ml SmPC UK: OxyNorm® oral liquid 1mg/ml SmPCNot available
Oxycodone hydrochloride / naloxone hydrochloride dihydrateTarginact® tabletsUK: Targinact® tablets 5 mg/2.5mg PIL, Targinact® tablets 10 mg/5mg PIL, Targinact® tablets 20 mg/10mg PIL, Targinact® tablets 40 mg/20mg PILUK: Targinact® tablets 5 mg/2.5mg SmPC, Targinact® tablets 10 mg/5mg SmPC, Targinact® tablets 20 mg/10mg SmPC, Targinact® tablets 40 mg/20mg SmPCNot available
Pegfilgrastim▼Pelmeg® injectionGB: PIL NI: SmPC & PILGB: SmPC NI: SmPC & PILEU: AR
Rezafungin acetate▼Rezzayo® powder for concentrate for solution for infusionGB: PIL NI: SmPC & PILGB: SmPC NI: SmPC & PILEU: AR

Opioid Charter

For Mundipharma’s Charter on the responsible medical use of opioid analgesics in pain management click here.

Opioid Safety Statement

“Attention should be given as the use of opioids has a risk of addiction, misuse and abuse. Therefore, appropriate assessment and monitoring is a requirement at initiation, maintenance and tapering down of opioid therapy.”