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Didronel®PMO
CODE ARTICLE 7055228 LAIZE — mm DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 DIMENSIONS 110 x 110 mm RECTO / VERSO P. 1 306 DU NOIR Noir DU NOIR CODE LEATUS : — Recto 1 PACKAGE LEAFLET: INFORMATION FOR THE USER Didronel PMO ® (etidronate disodium, calcium carbonate) VERY IMPORTANT INFORMATION Read before taking the tablets Keep this booklet for future reference CODE ARTICLE 7055228 LAIZE — mm DIMENSIONS 110 x 110 mm RECTO / VERSO P. 2-3 DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 Verso 2 Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. -If you have any further questions, ask your doctor or pharmacist. -This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. -If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Didronel PMO is and what it is used for .................................. 5 2.Before you take Didronel PMO ........................................................................ 7 3.How to take Didronel PMO ................................................................................ 10 4.Possible side effects ................................................................................................ 12 5.How to store Didronel PMO .............................................................................. 14 6.Further information .................................................................................................... 15 trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : 306 DU NOIR Noir DU NOIR CODE LEATUS : — Recto 3 CODE ARTICLE 7055228 LAIZE — mm DIMENSIONS 110 x 110 mm RECTO / VERSO P. 4-5 DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 Verso trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : 306 DU NOIR Noir DU NOIR CODE LEATUS : — Recto 4 5 1.WHAT DIDRONEL PMO IS AND WHAT IT IS USED FOR Didronel PMO is a non-hormonal therapy used to treat existing osteoporosis (a condition where bone mass decreases and bone brittleness increases) and to prevent bone loss in postmenopausal women who are at risk of getting osteoporosis. It is also used to prevent and treat osteoporosis that has been caused by use of corticosteroid treatment. Whilst osteoporosis can affect any bone, the spine, wrist and hip are the most common bones that break. As well as broken bones, people with osteoporosis may have back pain, develop a curved back and lose height. Didronel PMO works directly on your bones to increase bone density which may reduce the risk of fractures. Didronel PMO consists of two different types of tablets: • Didronel 400mg Tablets, which contain the active ingredient etidronate disodium. These help stop the destructive process that weakens your bones when you have osteoporosis. CODE ARTICLE 7055228 LAIZE — mm DIMENSIONS 110 x 110 mm RECTO / VERSO P. 6-7 DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 Verso trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : 306 DU NOIR Noir DU NOIR CODE LEATUS : — Recto 6 • C acit 500mg Effervescent Tablets, which contain calcium carbonate as the active ingredient (when dispersed in water provide 500mg of elemental calcium in the form of calcium citrate). These provide the calcium that your body may need to harden new bone. 7 2.BEFORE YOU TAKE DIDRONEL PMO DO NOT take Didronel PMO if you: • have an allergy (hypersensitivity) to etidronate disodium or any of the other ingredients of Didronel PMO (see Section 6 on “What Didronel PMO contains”) • If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Didronel PMO. • have a high concentration of calcium in your blood (hypercalcaemia) or urine (hypercalciuria) • have severe kidney impairment • have osteomalacia (a disease in which the bones soften) • are pregnant, think you might be pregnant or are breast-feeding. Children must NOT be given Didronel PMO. Patients with an intolerance to fructose (sugar found in many foods) should not take the medicine. Take special care with Didronel PMO Consult your doctor before taking this medicine if you have: • impaired kidney function or kidney stones, now or in the past • bowel problems such as enterocolitis (inflammation of the large and small intestine) CODE ARTICLE 7055228 LAIZE — mm DIMENSIONS 110 x 110 mm RECTO / VERSO P. 8-9 DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 Verso trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : 306 DU NOIR Noir DU NOIR CODE LEATUS : — Recto 8 • p ain, swelling or numbness of the jaw or a ‘heavy jaw feeling’, or loosening of a tooth (if you are undergoing dental surgery, tell your dentist that you are being treated with Didronel). • The diagnostic utility of bone-imaging agents may be impaired by current or recent etidronate use. Taking other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription. The following should NOT be taken two hours before or after taking a Didronel tablet: • vitamins with mineral supplements, such as iron • calcium supplements • laxatives containing magnesium • antacids containing calcium or aluminium. Your doctor also needs to know if you are taking the anticoagulant ‘warfarin’ before Didronel PMO is prescribed. Seek medical advice before taking the Cacit tablets if you are taking: • vitamin D • heart medicines such as digoxin and other cardiac glycosides • tetracycline antibiotics. 9 Pregnancy and breast-feeding It is important not to become pregnant whilst taking Didronel PMO, so adequate contraceptive measures need to be taken where necessary. It is not known if etidronate disodium (the active ingredient in the white tablet) passes into breast milk. This medicine should therefore not be taken during breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines Didronel PMO is not expected to affect your ability to drive or operate machinery. Important information about some of the ingredients of Didronel PMO Sunset yellow FCF (colouring E110) - this may cause allergic reactions, including asthma. Allergy is more common in those people who are allergic to aspirin. Sorbitol - if you know you have an intolerance to some sugars, contact your doctor before taking this medicine. CODE ARTICLE 7055228 LAIZE — mm DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 DIMENSIONS 110 x 110 mm RECTO / VERSO P. 10-11 Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 Verso trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : 306 DU NOIR Noir DU NOIR CODE LEATUS : — Recto 10 3.HOW TO TAKE DIDRONEL PMO Step I) Didronel tablets Swallow one white Didronel tablet with plain water (NOT with milk or other drinks) each day for 14 days on an empty stomach. Dairy products and other foods containing calcium can stop your Didronel PMO from being absorbed properly. You should not eat or drink anything but water for at least two hours before and two hours after taking the tablet (i.e. take the tablet in the middle of a 4-hour fast). Step II) Cacit tablets Once you have finished taking the Didronel tablets for 14 consecutive days, take one Cacit tablet each day for the next 76 days – with or without food. These tablets need to be dissolved in water or milky drinks and the solution consumed immediately after the fizzing has stopped. One treatment pack contains all these tablets and will last for 90 days. Do NOT take a Didronel tablet and a Cacit tablet on the same day; the therapy is in two steps and should be followed as directed above. It will take some time for this medicine to have 11 a full effect on your bones. Stay on the therapy for as long as your doctor has prescribed it for you. Do not forget to get a prescription for another pack of Didronel PMO from your doctor’s surgery when this one is nearly finished. Didronel PMO therapy is not recommended for children. If you take more Didronel PMO than you should Do not exceed the recommended dose. If you take more than one Didronel tablet in one day, inform your doctor immediately or go to your nearest Accident & Emergency Department (take the box with you if possible). If you take more than one Cacit tablet in a day, check with your doctor before continuing treatment. If you forget to take Didronel PMO If you forget to take either a Didronel or Cacit tablet, skip that dose completely and continue on the next day as usual. Do NOT take a double dose to make up for the one you have forgotten. If you have any further questions on the use of this product, ask your doctor or pharmacist. CODE ARTICLE 7055228 LAIZE — mm DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 DIMENSIONS 110 x 110 mm RECTO / VERSO P. 12-13 Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 Verso trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : 306 DU NOIR Noir DU NOIR CODE LEATUS : — Recto 12 4.POSSIBLE SIDE EFFECTS Like all medicines, Didronel PMO can cause side effects, although not everybody gets them. You may suffer an allergic reaction, symptoms of which may include skin rash, itching, swelling of the face and tongue as well as difficulty breathing. If this happens to you, stop taking the medicine immediately and seek urgent medical help. Common side effects: • nausea (feeling sick) • diarrhoea • constipation or wind • indigestion, stomach pain or irritation • vomiting. Uncommon side effects: • hypersensitivity including fluid retention in the skin (angioedema) Rare side effects: • sensory disturbances (paresthesia) • worsening of asthma for those who suffer from it • confusion • burning of the tongue 13 • hair loss • Blood cell count abnormalities which will be seen in the results of the blood tests • red blotches which may include red spots on the skin (erythema multiforme) • headache • tingling sensation (“pins and needles”) typically in the arms or legs • joint problems such as arthritis or joint pain • mild leg cramps. Very rare side effects: • Osteonecrosis of the jaw (see section 2 “Take special care with Didronel PMO”). A few people with stomach ulcers may notice that these get worse with Didronel treatment. If you are unable to overcome an infection or experience a sore throat, fever and bruising, contact your doctor as you may need a blood test. Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact CODE ARTICLE 7055228 LAIZE — mm DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 DIMENSIONS 110 x 110 mm RECTO / VERSO P. 14-15 Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 Verso trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : 306 DU NOIR Noir DU NOIR CODE LEATUS : — Recto 14 your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone. If any of the side effects gets serious, or if your notice any side effects not listed in this leaflet, please tell your doctor. 5.HOW TO STORE DIDRONEL PMO Keep out of the reach and sight of children. Store the product in a dry place, below 30°C. The stopper on the tube of the Cacit tablets should be carefully replaced after use. Do not use Didronel PMO after the expiry date which is stated on the label after ‘Exp’. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 15 6.FURTHER INFORMATION What Didronel PMO contains • Didronel tablet – the active substance is etidronate disodium 400mg and other ingredients are pregelatinised starch (nonwheat starch), magnesium stearate and microcrystalline cellulose. • Cacit tablet – the active substance is calcium carbonate 500mg and other ingredients are citric acid, sodium saccharin, sodium cyclamate, sunset yellow (E110) and orange flavouring (containing Sorbitol E420). See section 2 on “Important information about some of the ingredients of Didronel PMO”. What Didronel PMO looks like and contents of the pack The product consists of two different types of tablets: 14 white Didronel tablets packaged in a blister pack and 76 round, and flat white/pink speckled Cacit 500mg effervescent tablets packaged in four plastic tubes. CODE ARTICLE 7055228 LAIZE — mm DIMENSIONS 110 x 110 mm RECTO / VERSO P. 16-17 DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 Verso 16 Marketing Authorisation Holder Warner Chilcott UK Limited Old Belfast Road Millbrook, Larne County Antrim BT40 2SH United Kingdom. Manufacturer Warner Chilcott France Parc d’activité de la Grande Brèche 5 rue Désir Prévost 91070 Bondoufle France. trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : 306 DU NOIR Noir DU NOIR CODE LEATUS : — Recto 17 CODE ARTICLE 7055228 LAIZE — mm DIMENSIONS 110 x 110 mm RECTO / VERSO P. 18-19 DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : 306 DU NOIR Noir DU NOIR Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 Verso CODE LEATUS : — Recto 18 19 Didronel® is a registered Trademark Marketing Authorisation Number: PL 10947/0019 The leaflet was last revised in October 2011 PL Number: Legal category: 10947/0019 POM DESCRIPTIF TECHNIQUE DE L’ARTICLE (Remplace 7054252) LIVRET (L22) DIDRONEL 400 mg PMO / Angleterre V2_2 NOV 2011 CODE ARTICLE 7055228 LAIZE — mm DIMENSIONS 110 x 110 mm RECTO / VERSO P. 20 Responsable: Mr FRANC Pascal Patheon France bp 448 38317 bourgoin-jallieu cedex tél. 0474938700 fax. 04 74938781 trames: couleur(s) pantone dans l’ordre prévu linéature: 150 lpi inclinaison : d’impression : Noir DU NOIR CODE LEATUS : — Verso 20 0407G070 / 7055228
