Package leaflet: Information for the patient

Strontium ranelate 2 g granules for oral suspension

Strontium ranelate

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get See the end of section 4 for how to report side effects.

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 Strontium ranelate tablets is and what it is used for

2.    What you need to know before you take Strontium ranelate tablets

3.    How to take Strontium ranelate tablets

4.    Possible side effects

5.    How to store Strontium ranelate tablets

6.    Contents of the pack and other information

1.    WHAT STRONTIUM RANELATE TABLETS IS AND WHAT IT IS USED FOR

The full name of your medicine is "Strontium ranelate 2 g granules for oral suspension". It is referred to as " Strontium ranelate tablets" in the rest of the leaflet.

Strontium ranelate tablets 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.

How Strontium ranelate tablets works

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

Strontium ranelate tablets 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 STRONTIUM RANELATE TABLETS

Do not take Strontium ranelate tablets:

if you are allergic to strontium ranelate or any of the other ingredients of Strontium ranelate tablets (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.

Warning and precautions:

Talk to your doctor or pharmacist before taking Strontium ranelate tablets:

-    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 Strontium ranelate tablets

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 Strontium ranelate tablets 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 Strontium ranelate tablets.

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 Strontium ranelate tablets, 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 Strontium ranelate tablets, you must not be re-started on Strontium ranelate tablets at any time

If you are of Asian origin, talk to your doctor before taking Strontium ranelate tablets as you may be at higher risk of skin reactions.

Children and adolescents

Strontium ranelate tablets is not intended for use in children and adolescents (below the age of 18).

Other medicines and Strontium ranelate tablets:

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

You should stop taking Strontium ranelate tablets if you have to take oral tetracyclines such as doxycycline or quinolones such as ciprofloxacin (two types of antibiotics). You can take Strontium ranelate tablets 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 Strontium ranelate tablets.

If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after Strontium ranelate tablets. 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 Strontium ranelate tablets as it may interfere with some testing methods.

Strontium ranelate tablets with food and drink:

Food, milk and milk products reduce the absorption of strontium ranelate. It is recommended that you take Strontium ranelate tablets 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 Strontium ranelate tablets 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:

Strontium ranelate tablets is unlikely to affect your ability to drive or use machines.

Strontium ranelate tablets 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 STRONTIUM RANELATE TABLETS

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.

Strontium ranelate tablets is for oral use.

The recommended dose is one 2 g sachet a day.

It is recommended that you take Strontium ranelate tablets at bedtime, preferably at least 2 hours after dinner. You may he down immediately after taking Strontium ranelate tablets 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. Strontium ranelate tablets can interact with milk and milk products, so it is important that you mix Strontium ranelate tablets only with water to be sure it works properly.

37
W 1		0 2		®3

Empty the granules    Add water;

from the sachet into a glass;

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 Strontium ranelate tablets. Do not take calcium supplements at bedtime, at the same time as Strontium ranelate tablets.

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

If you take more Strontium ranelate tablets than you should:

If you take more sachets of Strontium ranelate tablets 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 Strontium ranelate tablets:

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 Strontium ranelate tablets:

It is important that you continue taking Strontium ranelate tablets for as long as your doctor prescribes the medicine. Strontium ranelate tablets 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 Strontium ranelate tablets and talk to your doctor immediately:

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 nausca/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 Strontium ranelate tablets for you if you are at particular risk.

Blood clots in veins: pain, redness, swelling in your leg, sudden chest pain or difficulty breathing

Rare (may affect up to 1 in 1000people):

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 Ever 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 10,000people):

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 10people):

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 Ever (hepatitis), swelling in Embs, 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, feinting fit, pins and needles, dizziness, vertigo. However, these effects were mild and short-Eved and usuaUy 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, feeEng confused, feeEng unweU, 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 Strontium ranelate tablets again.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not Ested in this leaflet You can also report side effects directly via the Yellow Card Scheme at wwwmhra.gov.uk/yeUowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    HOW TO STORE STRONTIUM RANELATE TABLETS

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 Strontium ranelate tablets 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 Strontium ranelate tablets looks Eke and contents of the pack

Strontium ranelate tablets is available in sachets containing white to sEghtly yellow granules for oral suspension. Strontium ranelate tablets is supplied in boxes of 28 sachets.

Marketing Authorisation Holder

Rivopharm UK Ltd 30th Floor 40 Bank Street Canary Wharf London, E14 5NR United Kingdom

Manufacturer

Atlantic Pharma - Produces Farmaceuticas, S.A.

Rua da Tapada Grande, n.° 2, Abrunheira, 2710-089 Sintra, Portugal

This leaflet was last revised in 09/2016

3 Rivopharm

R/MA/0060/PIL/001