Osseor - patient leaflet, side effects, dosage

A. MANUFACTURER(S)RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

Les Laboratoires Servier Industrie

905, route de Saran

45520 Gidy

France

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in ule 1.8.2 of the Marketing Authorisation and any agreed subsequent updates

An updated RMP should be submitted:

• At the request of the European Medicines Agency;
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

Additional risk minimisation measures

In each Member State where OSSEOR is marketed, the Marketing Authorisation Holder (MAH) shall agree the final educational programme with the National Competent Authority.

The MAH shall ensure that, following discussion and agreement with the National Competent Authority in each Member State where OSSEOR is marketed, all physicians who are expected to prescribe OSSEOR are provided with the following educational package:

• SmPC
• Package leaflet
• Prescriber guide and checklist
• Patient alert card

The prescriber guide and checklist shall contain the following key messages:

• OSSEOR is only indicated for use in patients with severe osteoporosis at high risk of fracture, for whom treatment with other medicinal products approved for the treatment of osteoporosis is not possible due to, for example, contraindications or intolerance.
• The initiation of treatment with OSSEOR should be based on an assessment of the

individual patient’s overall risk.

All patients should be fully informed that cardiovascular risks should be monitored on a regular basis generally every 6–12 months.

The patient alert card should be given to every patient.

OSSEOR is contraindicated and must not be used in patients with :

o Established, current or past history of ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

o Uncontrolled hypertension.

o Current or previous venous thromboembolic events (VTE), including deep

vein thrombosis and pulmonary embolism.

Temporary or permanent immobilisation due to e.g. post-surgical recovery or prolonged bed rest.

Hypersensitivity to the active substance (strontium ranelate) or any of the excipients.

OSSEOR should only be used with caution in:

o Patients with significant risk factors for cardiovascular events such as

hypertension, hyperlipidaemia, diabetes mellitus or smoking.

o Patients at risk of VTE. When treating patients over 80 years at risk of VTE, the need for continued treatment with OSSEOR should be re-evaluated.

• The treatment should be either discontinued or stopped in the following situations:

o If the patient develops ischaemic heart disease, peripheral arterial disease, cerebrovascular disease or if hypertension is uncontrolled, the treatment should be stopped.

o As soon as possible in the event of an illness or a condition leading to immobilization, the treatment should be discontinued.

o If symptoms or signs of Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN) or Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) (e.g. rash, fever, eosinophilia and systemic involvement, e.g. adenopathy, hepatitis, interstitial nephropathy, interstitial lung disease) are present, OSSEOR treatment should be discontinued immediately. If the patient has developed SJS, TEN or DRESS with the use of OSSEOR, OSSEOR must not be re-started.

• Within the prescriber guide there will be a check-list to remind prescribers of the contraindications, warnings and precautions prior to prescribing and to support the regular monitoring of cardiovascular ris­k.

The patient alert card shall contain the following key messages:

• Importance of showing the patient alert card to any Health Care Professional involved in their treatment.
• The contraindications to the treatment with OSSEOR.
• Key signs and symptoms of myocardial infarction, VTE and serious skin reactions.

1. NAME OF THE MEDICINAL PRODUCT

OSSEOR 2 g granules for oral suspension Strontium ranelate

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

EU/1/04/287/001

• 13. BATCH NU MBER

Batch

• 14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

OSSEOR 2 g

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

1. NAME OF THE MEDICINAL PRODUCT

OSSEOR 2 g granules for oral suspension Strontium ranelate

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

EU/1/04/287/002

• 13. BATCH NU MBER

Batch

• 14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

2D barcode carrying the unique identifier included.

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

SN:

NN:

1. NAME OF THE MEDICINAL PRODUCT

OSSEOR 2 g granules for oral suspension Strontium ranelate

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

EU/1/04/287/003

• 13. BATCH NU MBER

Batch

• 14. GENERAL CLASSIFICATION FOR SUPPLY

Medicinal product subject to medical prescription.

• 15. INSTRUCTIONS ON USE

• 16. INFORMATION IN BRAILLE

  2D barcode carrying the unique identifier included.

  
  

  18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

  
  

  PC:

  SN:

  NN:

  
  
  
  

• 1. NAME OF THE MEDICINAL PRODUCT

OSSEOR 2 g granules for oral suspension Strontium ranelate

• 2. STATEMENT OF ACTIVE SUBSTANCE(S)

Each sachet contains 2 g strontium ranelate.

Also contains aspartame (E 951).

• 4. PHARMACEUTI­CAL FORM AND CONTENTS

Granules for oral suspension.

56 sachets

84 sachets

100 sachets

• 5. METHOD AND ROUTE(S) OF ADMINISTRATION

  For oral use

  Read the package leaflet be

  
  
  
  

• 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

If not used immediately after reconstitution, the preparation should be consumed within 24 hours.

• 9. SPECIAL STORAGE CONDITIONS

• 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

OSSEOR 2 g

• 17. UNIQUE IDENTIFIER – 2D BARCODE 2D barcode carrying the unique identifier included.

• 18. UNIQUE IDENTIFIER – HUMAN READABLE DATA

PC:

Sachet

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

OSSEOR 2 g granules for oral suspension.

Strontium ranelate.

For oral use.

Package leaflet: Information for the patient

OSSEOR 2 g granules for oral suspension

Strontium ranelate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or your pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm

them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side

effects not listed in this leaflet. See section 4.

What is in this leaflet:

• 1. What OSSEOR is and what it is used for

• 2. What you need to know before you take OSSEOR

• 3. How to take OSSEOR

• 4. Possible side effects

• 5. How to store OSSEOR

  6.

  
  

  1.

  
  

Contents of the pack and other information

What OSSEOR is and what it is used for

OSSEOR is a medicine used to treat severe osteoporosis: – in postmenopausal wo­men,

• – in adult men, at high risk of fracture, for whom other alternative treatments are not possible. In postmenopausal women, strontium ranelate reduces the risk of fracture at the spine and at the hip.

About osteoporosis

Your body is constantly breaking down old bone and making new bone tissue. If you have osteoporosis, your body breaks down more bone than it forms so that gradually bone loss occurs and your bones become thinner and fragile. This is especially common in women after the menopause. Many people with osteoporosis have no symptoms and you may not even know that you have it. However, osteoporosis makes you more likely to have fractures (break bones), especially in your spine, hips and wrists.

OSSEOR, which contains the substance strontium ranelate, belongs to a group of medicines used to treat bone diseases.

OSSEOR works by reducing bone breakdown and stimulating rebuilding of bone and therefore reduces the risk of fracture. The newly formed bone is of normal quality.

2. What you need to know before you take OSSEOR

Do not take OSSEOR:

• – if you are allergic to strontium ranelate or any of the other ingredients of OSSEOR (listed in section 6).

• – if you have or have had a blood clot (for example, in the blood vessels in your legs or lungs).

• – if you are immobilised permanently or for some time such as being wheel-chair bound, or

confined to bed or if you are to undergo an operation or recovering from an operation. The risk of vein thrombosis (blood clots in the leg or lungs) may be increased in the event of lengthy immobilisation.

if you have established ischaemic heart disease, or cerebrovascular disease, e.g. you have been diagnosed with a heart attack, stroke, or transient ischaemic attack (temporary reduction of blood flow to the brain; also known as “mini-stroke”), angina, or blockages of blood vessels to the heart or brain.

if you have or have had problems with your blood circulation (peripheral arterial disease) or if you have had surgery on the arteries of your legs.

if you have high blood pressure not controlled by treatment.

Warnings and precautions:

Talk to your doctor or pharmacist before taking OSSEOR:

• – if you are at risk of heart disease, this includes high blood pressure, high cholesterol, diabetes, smoking.

• – if you are at risk of blood clots.

• – if you have severe kidney disease.

Your doctor will evaluate the conditions of your heart and blood vessels regularly, generally every 6 to 12 months for as long you are taking OSSEOR.

During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must immediately stop taking OSSEOR and seek medical advice (see section 4).

Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hypersensitivity reactions (DRESS)) have been reported with the use of OSSEOR.

The highest risk of occurrence of serious skin reactions is within the first weeks of treatment for Stevens-Johnson syndrome and toxic epidermal necrolysis and usually around 3–6 weeks for DRESS.

If you develop a rash or serious skin symptoms (see section 4), stop taking OSSEOR, seek urgent advice from a doctor and tell him that you are taking this medicine.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of OSSEOR, you must not be re-started on OSSEOR at any time

If you are of Asian origin, you may be at higher risk of skin reactions.

The risk of these skin reactions in patients of Asian origin, particularly Han Chinese, may be predicted. Patients who have the HLA-A*33:03 and/or the HLA-B*58:01 genes are more likely to develop a serious skin reaction than those who do not have the genes.

Your doctor should be able to advise if a blood test is necessary before taking OSSEOR.

Other medicines and OSSEOR:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

You should stop taking OSSEOR if you have to take oral tetracyclines such as doxycycline or quinolones such as ciprofloxacin (two types of antibiotics). You can take OSSEOR again when you have finished taking these antibiotics. If you are unsure about this ask your doctor or pharmacist. If you are taking medicines containing calcium, you should leave at least 2 hours before you take OSSEOR.

If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after OSSEOR. If this is not possible, it is acceptable to take the two medicines at the same time.

If you need to have blood or urine tests to check your level of calcium, you should tell the laboratory that you are taking OSSEOR as it may interfere with some testing methods.

OSSEOR with food and drink:

Food, milk and milk products reduce the absorption of strontium ranelate. It is recommended that you take OSSEOR in-between meals, preferably at bedtime at least two hours after food, milk or milk products or calcium supplements.

Pregnancy and breast-feeding:

Do not take OSSEOR during pregnancy or when you are breastfeeding. If you take it by accident during pregnancy or breastfeeding, stop taking it straight away and talk to your doctor.

Driving and using machines:

Osseor is unlikely to affect your ability to drive or use machines.

OSSEOR contains aspartame (E951):

If you suffer from phenylketonuria (a rare, hereditary disorder of the metabolism) talk to your doctor before you start to take this medicine.

3. How to take OSSEOR

The treatment should only be started by a doctor with experience in treating osteoporosis.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

OSSEOR is for oral use.

The recommended dose is one 2g sachet a day.

It is recommended that you take OSSEOR at bedtime, preferably at least 2 hours after dinner. You may lie down immediately after taking OSSEOR if you wish.

Take the granules contained in the sachets as a suspension in a glass containing a minimum of 30 ml (approximately one third of a standard glass) of water. See instructions below. OSSEOR can interact with milk and milk products, so it is important that you mix OSSEOR only with water to be sure it works properly.

Empty the granules from the sachet into a glass;

Stir until the granules are evenly dispersed in the water.

Drink straight away. You should not leave more than 24 hours before you drink it. If for some reason you cannot drink the medicine straight away, make sure you stir it again before drinking.

Your doctor may advise you to take calcium and vitamin D supplements in addition to OSSEOR. Do not take calcium supplements at bedtime, at the same time as OSSEOR.

Your doctor will tell you how long you should continue to take OSSEOR. Osteoporosis-therapy is usually required for a long period. It is important that you continue taking OSSEOR for as long as your doctor prescribes the medicine.

If you take more OSSEOR than you should:

If you take more sachets of OSSEOR than recommended by your doctor, tell your doctor or pharmacist. They may advise you to drink milk or take antacids to reduce the absorption of the active ingredient.

If you forget to take OSSEOR:

Do not take a double dose to make up for forgotten individual doses. Just carry on with the next dose at the normal time.

If you stop taking OSSEOR:

It is important that you continue taking OSSEOR for as long as your doctor prescribes the m OSSEOR can treat your severe osteoporosis only if you continue to take it.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the following happens to you, stop using OSSEOR and talk to your doctor immediately:

.0^

Common (may affect up to 1 in 10 people):

Heart attack: sudden crushing pains in your chest which may reach your left arm, jaw, stomach, back and/or shoulders. Other symptoms may be nausea/vomiting, sweating, shortness of breath, palpitations, (extreme) tiredness and/or dizziness. Heart attack may occur commonly in patients at high risk for heart disease. Your doctor will not prescribe OSSEOR for you if you are at particular risk.

Blood clots in veins: pain, redness, s g in your leg, sudden chest pain or difficulty breathing.

Rare (may affect up to 1 in 1000 peopl

Signs of severe hypersensitivity reactions (DRESS): initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature (uncommon ), increased levels of liver enzymes seen in blood tests (uncommon ) an increase in a type of white blood cell (eosinophilia) (rare ) and enlarged lymph nodes (uncommon ).

Very rare (may affect up to 1 in 10,000 people):

• – Signs of potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal

necrolysis): initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs may include ulcers in the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These potentially life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to widespread blistering or peeling of the skin.

Other possible side effects

Very Common (may affect more than 1 in 10 people):

Itching, hives, skin rash, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), bone, limb, muscle and/or joint pain, muscle cramps.

Common:

Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, difficulty in sleeping, inflammation of the liver (hepatitis), swelling in limbs, bronchial hyperreactivity (symptoms include wheezing and shortness of breath and cough), increased level of a muscle enzyme (Creatine phosphokinase), increased levels of cholesterol.

Nausea, diarrhoea, headache, eczema, memory trouble, fainting fit, pins and needles, dizziness, vertigo. However, these effects were mild and short-lived and usually did not cause the patients to stop taking their treatment. Talk to your doctor if any effects become troublesome or persist.

Uncommon (may affect up to 1 in 100 people):

Seizures, oral irritation (such as mouth ulcers and gum inflammation), hair loss, feeling confused, feeling unwell, dry mouth, skin irritation.

Rare:

Reduction in production of blood cells in the bone marrow.

If you have stopped treatment due to hypersensitivity reactions, do not take OSSEOR a

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any pos sible side effects not listed in this leaflet. You can also report side effects directly via the nationa1 re porting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store OSSEOR

Keep this medicine out of the sight and reach of children

Do not use this medicine after the expiry date which is stated on the box and the sachet after EXP.

The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Once reconstituted in water, the suspension is stable for 24 hours. However, it is recommended to drink the suspension immediately after preparation (see section 3).

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What OSSEOR contains

• – The active substance is strontium ranelate. Each sachet contains 2 g of strontium ranelate.

• – The other ingredients are aspartame (E 951), maltodextrin, mannitol (E 421).

What OSSEOR looks like and contents of the pack

OSSEOR is available in sachets containing yellow granules for oral suspension.OSSEOR is supplied in boxes of 7, 14, 28, 56, 84 or 100 sachets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Les Laboratoires Servier

50, rue Carnot

92284 Suresnes cedex

France

Manufacturer

Les Laboratoires Servier Industrie

905, route de Saran

45520 Gidy

France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.

Slovenska republika

Servier Slovensko spol. s r.o.

Tel.:+421 (0) 2 5920 41 11

Suomi/Finland

Servier Finland Oy

P./Tel: +358 (0)9 279 80 80

Knnpog

C.A. Papaellinas Ltd.Tql: +357 22741741

Latvija

SIA Servier Latvia

Tel. +371 67502039

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

Scientific conclusions

Taking into account the PRAC Assessment Report for the non-interventional imposed PASS final study report for the medicinal product mentioned above, the scientific conclusions of CHMP are as follows:

The PASS final study report submitted by the MAH complies with their obligation to perform a PASS to evaluate risk of serious cardiac disorders as imposed during the Article 20 procedure EMA/112925/2014.

Therefore, in view of available data regarding the PASS final study report, the PRAC considered that changes to the conditions of the marketing authorization were warranted.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisati

On the basis of the scientific conclusions for the results of the study for the medicinal product mentioned above, the CHMP is of the opinion that the benefit-risk balance of this medicinal product is unchanged, subject to the proposed changes to the product information.

authorisation of the medicinal

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