This site is intended for US Consumers
When you visit or register on galen.co.uk you may be asked to provide certain information about yourself including your name and contact. We may also collect information about your usage of our website as well as information about you from e-mails or letters you send to us.
You agree and warrant that the processing, including the transfer itself, of Personal Data has been and will continue to be carried out in accordance with the relevant provisions of the applicable data protection law, including but not limited to, the European Data Protection Directive 95/46/EC and the applicable national laws of the country where you are established (“Data Protection Law”) (and, where applicable, has been notified to the relevant authorities of the country where you are established) and does not violate the relevant provisions of the Data Protection Law. “Personal Data” means any information or set of information that identifies or can reasonably be used to identify an individual. Personal Data does not include information that is encoded or anonymous, or publicly available information that has not been combined with non-public information.
Your information will enable us to provide you with access to all parts of our site and to supply the goods or services you have requested. We will also use and analyse the information we collect so that we can administer, support, improve and develop our business and meet our Regulatory obligations. In particular, we may use your information to contact you for your views on our services and to notify you occasionally about important changes or developments to the site or our services. Further, where you have consented, we might also use your information to let you know about other products and services which we offer which may be of interest to you and we may contact you by post, telephone or fax, as well as by e-mail. If you change your mind about being contacted in the future, please let us know.
When processing Personal Data, Galen Limited shall comply with all relevant applicable law relating to data protection, including for the avoidance of doubt, the European Data Protection Directive 95/46/EC and the Data Protection Act 1998.
The information you provide to us will be held on our computers in the US and may be accessed by or given to our staff working outside the UK and third parties including companies within Almac Group Limited some of whom are located in the US who act for us for the purposes set out in this policy or for other purposes approved by you. Where you have consented when providing us with your details, we may also allow carefully selected third parties, including other companies in our group, to contact you occasionally about products and services which may be of interest to you including. They may contact you by post, telephone or fax, as well as by e-mail. If you change your mind about being contacted by these companies in the future, please let us know. Finally, if our business enters into a joint venture with or is sold to or merged with another business entity, your information may be disclosed to our new business partners or owners. Countries outside the European Economic Area do not always have strong data protection laws. However, we will always take steps to ensure that your information is used by third parties in accordance with this policy. Unless required to do so by law, we will not otherwise share, sell or distribute any of the information you provide to us without your consent.
We employ security measures to protect your information from access by unauthorised persons and against unlawful processing, accidental loss, destruction and damage. We will retain your information for a reasonable period or as long as the law requires.
You are entitled to see the information held about you and you may ask us to make any necessary changes to ensure that it is accurate and kept up to date. If you wish to do this, please contact us. We are entitled by law to charge a fee of £40 to meet our costs in providing you with details of the information we hold about you.
Please contact us if you have any comments, queries and requests relating to our use of your information.
In clinical studies involving 1,449 subjects treated with SYNERA®, the most common local reactions were redness of the skin (71%), pale skin (12%) and swelling (12%); these reactions were generally mild and resolved on their own soon after patch removal. There were no treatment related serious adverse events.1
SYNERA® (lidocaine and tetracaine) Topical Patch is indicated for use on unbroken skin to help prevent the pain of needle sticks into superficial veins (apply for 20-30 mins) and some superficial skin procedures (apply for 30 mins).
SYNERA® is not to be used in patients with a known history of sensitivity to lidocaine, tetracaine, numbing medications of the amide or ester type, or any other component of the product and in patients with para-aminobenzoic acid (PABA) hypersensitivity. Keeping a patch on longer than recommended or applying multiple patches at the same time or one right after the other could result in absorption of sufficient amounts of drug to result in serious adverse effects. Patients should not use SYNERA® if they have a history of methemoglobinemia.
Used SYNERA® patches contain a large amount of lidocaine and tetracaine (at least 90% of the initial amount). Chewing or swallowing a new or used SYNERA® patch may result in serious adverse effects. Store and dispose of SYNERA® out of the reach of children and pets.
SYNERA® should be used with caution in patients who may be more sensitive to the general effects on the body of lidocaine and tetracaine, particularly those who are seriously ill or weakened by illness, and those with reduced liver function. Patients with severe liver disease or missing adequate blood plasma enzymes are at greater risk of developing toxic plasma concentrations.
Do not use on body passages such as inside the nose or mouth or on areas with unhealthy, broken skin.
Application to broken or inflamed skin may result in toxic blood concentrations of lidocaine and tetracaine.
Allergic or extreme sensitivity (skin rash, swelling or hives, narrowing of airways, and shock) to the active or inactive components of SYNERA® can occur and should be managed by a medical professional. Seek immediate emergency help if any of these occur.
Avoid contact of SYNERA® with the eyes due to potential irritation or abrasion. If contact occurs, immediately wash out the eye with water or saline, and protect it until sensation returns.
The application of more than two SYNERA® patches at the same time or one right after another to children is not recommended as it has not been fully studied. Safety and effectiveness of SYNERA® have been established in patients 3 years of age and older.
Lidocaine, one of the numbing medications in SYNERA®, has been shown to prevent the growth of viruses and bacteria. The effect of SYNERA® on needle sticks into the skin for certain vaccines has not been determined.
The heating component contains iron powder, and the patch must be removed before some diagnostic procedures, including magnetic resonance imaging (MRI).
SYNERA® may lead to little or no feeling in the area of the skin where it is applied; therefore, patients should avoid trauma (rubbing, scratching, or exposure to heat or cold) before complete feeling returns.
SYNERA® should be used with caution in patients receiving certain heart medications and/or other local pain-preventing medications, because there may be additional toxic effects with lidocaine and tetracaine.
SYNERA® should be applied immediately after opening the pouch. Do not cut or remove the top cover of the patch as this could result in a burn injury.
If skin irritation or a burning sensation occurs during application, remove the patch and inform your doctor or nurse immediately.
Please see Full Prescribing Information including Instructions For Use before using SYNERA®.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.