Risk Minimisation Materials

Checklist for the prescription, supply or recommendation of Lariam® (mefloquine) for malaria chemoprophylaxis

This educational material is provided by CHEPLAPHARM Arzneimittel GmbH and is mandatory as a condition of the Marketing Authorisation in order to further minimise important selected risks.

For Healthcare Professionals

Lariam (mefloquine) Guide for Healthcare Professionals

This educational material is provided by CHEPLAPHARM Arzneimittel GmbH and is mandatory as a condition of the Marketing Authorisation in order to further minimise important selected risks.

For Healthcare Professionals

Lariam (mefloquine) Patient Alert Card

This educational material is provided by CHEPLAPHARM Arzneimittel GmbH and is mandatory as a condition of the Marketing Authorisation in order to further minimise important selected risks.

Leflunomide medac - RMP Patient Leaflet

Risk Management Educational Material

Leflunomide medac - RMP Physician Leaflet

In addition to the Summary of Product Characteristics, this leaflet was developed by the marketing authorisation holder to inform you about all delicate issues potentially arising from Leflunomide medac therapy. Counselling patients on important risks associated with Leflunomide medac therapy and appropriate precautions when using the medicine is required.

For Healthcare Professionals

Leflunomide Physician Leaflet

This leaflet is to highlight the most important risks associated with Leflunomide and to emphasize the need for counselling patients about those important risks

For Healthcare Professionals

Lemtrada (alemtuzumab) – Direct Healthcare Professional Communication – Restriction of use due to serious safety concerns

EMA is reviewing the benefits and risks of Lemtrada (alemtuzumab) for the treatment of multiple sclerosis. For hard copies please contact our medical information department at 0845 372 7101 or email [email protected]

For Healthcare Professionals

Lemtrada (alemtuzumab) - Healthcare Professional (HCP) Guide - Risk Minimisation Information for Healthcare Professionals

This guide has been developed for prescribers and healthcare professionals (HCPs) involved in the care of patients treated with Lemtrada (alemtuzumab), to provide further information about the potential serious risks associated with the use of this medicine.

For Healthcare Professionals

Lemtrada (alemtuzumab) – Healthcare Professional Letter- Risk Minimisation Information for Healthcare Professionals

The Prescriber Information Pack contains important educational materials which have been approved by both the HPRA and MHRA, and are designed to support the use of alemtuzumab. Please consult these educational materials before starting a patient on Lemtrada therapy, and ensure that the patient recieves the accompanying patient card that is provided in the Prescriber Information Pack. For hard copies please contact our medical information department at 0845 372 7101 or email [email protected]

For Healthcare Professionals

Lemtrada (alemtuzumab) - Patient Alert Card - Risk Minimisation Information for Patients

The card should be provided to patients prior to treatment by the prescribing physician and is designed to alert other HCPs that the patient has been prescribed Lemtrada (alemtuzumab) and includes details on the associated risks of treatment and contact details of the prescriber.

Lemtrada (alemtuzumab) - Patient Guide - Risk Minimisation Information for Patients

The guide should be provided to patients prior to treatment by the prescribing physician and includes a description of the risks of treatment, guidance on what to do in the event of risks occurring including your doctors contact details and an overview of treatment monitoring.

Lemtrada (alemtuzumab) – Prescriber check list - Risk Minimisation Information for Healthcare Professionals

Describes required initial screening tests, pre-treatment vaccination course, premedication, general health, and pregnancy and contraception checks immediately before treatment and the subsequent monitoring activities.

For Healthcare Professionals

Dear HCP: Risk of medication errors associated with overdose

The Dear Healthcare Professional letter covers the following safety concern: Levetiracetam containing products 100 mg/mL oral solution presentations: Risk of medication errors associated with overdose “Levetiracetam overdose can lead to serious adverse events, like depressed level of consciousness, respiratory depression and coma. In the cases where the cause of the reported accidental overdosing could be retrieved, it was either due to the use of an inappropriate syringe or the misunderstanding of the caregiver about how to properly measure the dose. Physicians should prescribe the recommended presentation of Levetiracetam oral solution with the appropriate syringe according to the age/bodyweight of the patient.”

For Healthcare Professionals

Dear HCP: Risk of medication errors associated with overdose

The Dear Healthcare Professional letter covers the following safety concern: Levetiracetam containing products 100mg/mL oral solution presentations: Risk of medication errors associated with overdose “Levetiracetam overdose can lead to serious adverse events, like depressed level of consciousness, respiratory depression and coma. In the cases where the cause of the reported accidental overdosing could be retrieved, it was either due to the use of an inappropriate syringe or the misunderstanding of the caregiver about how to properly measure the dose. Physicians should prescribe the recommended presentation of Levetiracetam oral solution with the appropriate syringe according to the age / body weight of the patient.”

For Healthcare Professionals

Levetiracetam oral solution - Risk of medication errors associated with overdose

Levetiracetam overdose can lead to serious adverse event. With every prescription, physicians and pharmacists should advise the patient and/or caregiver on how to measure the prescribed dose

For Healthcare Professionals

Direct HCP Communication: Systemic and inhaled fluoroquinolones: risk of aortic aneruysm and dissection

Direct HCP Communication: Systemic and inhaled fluoroquinolones: risk of aortic aneruysm and dissection

For Healthcare Professionals

Levonorgestrel 1500 mcg DHPC

Direct Healthcare professional communication, levonorgestrel-containing emergency hormonal contraception:new advice for users of hepatic-enzyme inducers

For Healthcare Professionals

Levonorgestrel Patient Sheet

Levonorgestrel emergency contraception: important information for women taking other medicines

Advice for women taking Levonorgestrel tablets

Advice for women taking Levonorgestrel tablets Levonorgestrel 1.5mg Tabletsl PL35507-0126

Checklist for Pharmacists

Checklist for Pharmacists Levonorgestrel 1.5mg Tablets PL 35507-0126

Levonorgestrel DHPC

Direct Healthcare Professional Communication, Levonorgestrel-containing emergency hormonal contraception: new advice for users of hepatic-enzyme inducers

Levonorgestrel Patient Sheet

Levonorgestrel emergency contraception: important information for women taking other medicines. Some medicines or herbal remedies that contain the ingredient St. John's wort, might reduce how well levonorgestrel emergency contraception works. Tell the doctor, pharmacist or nurse if you are currently taking a medicine to treat any of the following, or if you have used one in the past 4 weeks: epilepsy, tuberculosis, HIV, a fungal infection, or if you have taken any herbal remedies that contain the ingredient St. John's wort.

Educational material for Pharmacists & Patients

Checklist for Pharmacists and Patients

Levonorgestrel 1500mcg DHPC

Direct Healthcare professional communication, levonorgestrel-containing emergency hormonal contraception: new advice for users of hepatic-enzyme inducers.

Levonorgestrel Patient Sheet

Levonogestrel emergency contraception: important information for women taking other medicines.

Levosert Patient Card

Levosert Patient Card

For Healthcare Professionals

Lixiana (edoxaban) Patient Alert Card

Every patient prescribed Lixiana will receive a Patient Alert Card in the medication pack. This will inform doctors, dentists, pharmacists and other healthcare professionals about the patient’s anticoagulation treatment, along with emergency contact details. Encourage patients to have this card with them at all times and to show it to healthcare professionals prior to any consultation or procedure. Patients should be reminded of the importance of compliance to their treatment regimen, the need to watch for signs and symptoms of bleeding and when to seek medical advice. Patient Alert Cards are available from [email protected] or by calling 08000285122.

Lixiana (edoxaban) Prescriber Guide

This risk minimisation material has been developed for Lixiana for all indications. Please ensure that you are familiar with this material as it contains important safety information. In particular, it is aimed at increasing awareness about the potential risk of bleeding during treatment with Lixiana and providing guidance on how to manage that risk.

For Healthcare Professionals

CHCs ANNEX 1_Direct HCP Communication

Direct Healthcare Professional Communication, to inform of the results of a Europe-wide review and the latest evidence on the risk of thromboembolism in association with certain combined hormonal contraceptives (CHCs).

For Healthcare Professionals

CHCs ANNEX 2_Checklist for Prescribers

Combined Hormonal Contraceptives - checklist for prescribers.

For Healthcare Professionals

CHCs ANNEX 3_Risk of Blood Clots with CHCs

Important Information for women about risk of blood clots with combined hormonal contraceptives.

CHCs ANNEX 4_CHCs Important Info for Women

Combined hormonal contraceptives: important information for women.

Lojuxta (lomitapide) Healthcare Professional Guide

Healthcare professional guide contains information on the serious risks associated with Lojuxta and how to help mitigate these risks.

For Healthcare Professionals

Lojuxta Alert Card

The purpose of the patient alert card is to inform health care professionals of potential drug-drug interactions before any additional medicinal product is taken. Patients will be instructed to carry this card and show it to all doctors and pharmacists involved in their treatment.

Lojuxta Patient Care Guide

Patient care guide containing important safety information for patients treated with Lojuxta (lomitapide).

Direct HCP Communication: Hydrochlorothiazide, risk of non‐melanoma skin cancer

Direct Healthcare Professional Communication Hydrochlorothiazide: Risk of non‐melanoma skin cancer

For Healthcare Professionals

Losartan/HCTZ- HCP letter- Hydrochlorothiazide and the risk of non-melanoma skin cancer

The prescriber should inform the patients taking hydrochlorothiazide (HCTZ) containing medicines of the risk of non-melanoma skin cancer. Patients should be advised to limit the exposure to sunlight and UV rays and use adequate protection when exposed to sunlight and UV rays to minimise the risk of skin cancer

For Healthcare Professionals

Lucentis (ranibizumab) - Patient information booklet - for patients

A booklet containing important safety information for patients treated with Lucentis (ranibizumab). An audio version is available upon request.

Lynparza Dear Healthcare Professional Communication

To reduce the risk of medication errors with the new tablet pharmaceutical form.

For Healthcare Professionals