Public Assessment Report Decentralised Procedure …

1 Public Assessment Report Decentralised Procedure BINOSTO 70 mg effervescent tablets (alendronate sodium) UK/H/3515/001/DC UK licence no: PL 42786/0001 EFFRX PHARMA GMBH PAR Binosto 70 mg effervescent tablets UK/H/3515/001/DC 2 LAY SUMMARY Binosto 70 mg effervescent tablets (alendronate sodium trihydrate ( alendronic acid ), effervescent tablets , 70 mg) This is a summary of the Public Assessment Report (PAR) for Binosto 70 mg effervescent tablets . It explains how Binosto 70 mg effervescent tablets was assessed and its authorisation recommended, as well as its conditions of use. It is not intended to provide practical advice on how to use Binosto 70 mg effervescent tablets .

2 For practical information about using Binosto 70 mg effervescent tablets , patients should read the package leaflet or contact their doctor or pharmacist. What are Binosto 70 mg effervescent tablets and what are they used for? The application for Binosto 70 mg effervescent tablets was submitted as a hybrid application. This means that it is similar to a reference medicine containing the same active substance, but but it is administered as a buffered oral solution whereas the reference product is administered as a tablet. The Company has provided additional own data to demonstrate the safety and efficacy of Binosto 70 mg effervescent tablets regarding this difference from the reference medicine.

3 Assessment of the application concluded that the effervescent tablets are similar to the reference medicine containing the same active substance ( alendronic acid ) but it is administered as a buffered oral solution whereas the reference product is administered as a tablet. The Company provided data to demonstrate the safety and efficacy of Binosto 70 mg effervescent tablets . The reference medicine for Binosto 70 mg effervescent tablets is Fosamax 70 mg tablets (Merck Sharp & Dohme). Binosto 70 mg effervescent tablets are used to treat osteoporosis and to reduce the risk of spine and hip fractures. What is osteoporosis? Osteoporosis is a thinning and weakening of the bones.

4 It is common in women after the menopause. At the menopause, the ovaries stop producing the female hormone, oestrogen, which helps to keep a woman s skeleton healthy. As a result, bone loss occurs and bones become weaker. The earlier a woman reaches the menopause, the greater the risk of osteoporosis. Early on, osteoporosis usually has no symptoms. If left untreated, however, it can result in broken bones. Although these usually hurt, breaks in the bones of the spine may go unnoticed until they cause height loss. Broken bones can happen during normal, everyday activity, such as lifting, or from minor injury that would not generally break normal bone.

5 Broken bones usually occur at the hip, spine, or wrist and can lead not only to pain but also to considerable problems like stooped posture ( dowager s hump ) and loss of mobility. PAR Binosto 70 mg effervescent tablets UK/H/3515/001/DC 3 How do Binosto 70 mg effervescent tablets , work? The active ingredient ( alendronic acid ) in this medicine belongs to a group of non-hormonal medicines called bisphosphonates. alendronic acid prevents the loss of bone that occurs in women after they have been through the menopause, and helps build bone. It reduces the risk of spine and hip fractures. How are Binosto 70 mg effervescent tablets , used?

6 The pharmaceutical form of Binosto 70 mg effervescent tablets is an effervescent tablet and is administered as an oral solution. Binosto 70 mg effervescent tablets must be dissolved in half a glass of plain water before taking. Do not chew or swallow the tablet whole. Take one Binosto 70 mg effervescent tablet once a week, as an oral solution. Please read section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration, and the duration of treatment. How long should Binosto 70 mg effervescent tablets be taken for? It is important that the patient continues to take Binosto 70 mg effervescent tablets for as long as their doctor prescribes the medicine.

7 Binosto 70 mg effervescent tablets can treat the patient s osteoporosis only if the patient continues to take the effervescent tablets . If the patient has any further questions on the use of this product, the patient should ask their doctor or pharmacist. Binosto 70 mg effervescent tablets can only be obtained with a prescription. What benefits of Binosto 70 mg effervescent tablets have been shown in studies? Because Binosto 70 mg effervescent tablets is a hybrid application referring to Fosamax 70 mg tablets (Merck Sharp & Dohme), a clinical safety study has been provided for Binosto 70 mg effervescent tablets to evaluate the advantages and determine the differences between Binosto 70 mg effervescent tablets which is administered as a buffered oral solution and the reference product Fosamax 70 mg tablets (Merck Sharp & Dohme) which is administered as a tablet.

8 A bioequivalence study has also been provided which successfully demonstrates that the test product Binosto 70 mg effervescent tablets is bioequivalent to the reference medicine Fosamax 70 mg tablets . Two medicines are bioequivalent when they produce the same levels of active substance in the body. What are the possible side effects of Binosto 70 mg effervescent tablets ? The most common side effects with Binosto 70 mg effervescent tablets (which may affect more than 1 in 10 people) are bone, muscle and/or joint pain which is sometimes severe. Common side effects with Binosto 70 mg effervescent tablets (which may affect 1 to 10 people in 100) are: heartburn; difficulty swallowing; pain upon swallowing; ulceration of the gullet (oesophagus the tube that connects the mouth with the stomach) which can cause chest pain, heartburn or difficulty or pain upon swallowing joint swelling PAR Binosto 70 mg effervescent tablets UK/H/3515/001/DC 4 abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence hair loss; itching headache; dizziness tiredness.

9 Swelling in the hands or legs For the full list of all side effects reported with Binosto 70 mg effervescent tablets see section 4 of the package leaflet available on the MHRA website. Why are Binosto 70 mg effervescent tablets , approved? The MHRA decided that the benefits of Binosto 70 mg effervescent tablets are greater than its risks and recommended that it be approved for use. What measures are being taken to ensure the safe and effective use of Binosto 70 mg effervescent tablets ? Safety information has been included in the Summary of Product Characteristics and the package leaflet for Binosto 70 mg effervescent tablets including the appropriate precautions to be followed by healthcare professionals and patients.

10 Known side effects are continuously monitored. Furthermore new safety signals reported by patients/healthcare professionals will be monitored/reviewed continuously. Other information about Binosto 70 mg effervescent tablets . Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Germany, Denmark, Estonia, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Latvia, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Slovak Republic, Spain, Sweden and the UK agreed to grant a Marketing Authorisation for Steovess 70mg effervescent tablets to Takeda GmbH (PL 31752/0027; UK/H/3515/001/DC) on 18 December 2011.