Protelos (strontium ranelate)

Bone is not a static structure. It is continually shaped, reformed and rebuilt by cells called osteoblasts and osteoclasts. These cells continously deposit and remove calcium and phophorous, stored in a protein network that makes up the structure of the bone. Old bone is broken down by the osteoclasts and new bone is formed by the osteoblasts.

In women at the menopause, blood levels of the female hormone oestrogen start to decrease. This results in an increase in bone breakdown by the osteoclasts, which can lead to a loss of bone density. Bone loss is particularly rapid for the first ten years after the menopause and it may lead to the development of osteoporosis - a condition in which the bones become weak and brittle and break (fracture) more easily.

Strontium ranelate is used to treat osteoporosis in women who have passed the menopause. It works by binding very tightly to the bone and preventing the calcium being removed by the osteoclasts. This stops the osteoclasts from breaking down the bone. Strontium ranelate also stimulates the formation of new bone by the osteoblasts. Both actions help to keep the bones strong and less likely to break.

In women who have passed the menopause, strontium ranelate has been shown to reduce the risk of spinal and hip fractures.

If your dietary intake of calcium and vitamin D is low, your doctor may also ask you to take supplements of these to help keep your bones strong. If so, do not take any calcium supplements at the same time of day as this medicine. (See below for more details.)

What is it used for?

- Osteoporosis in women who have passed the menopause.

Warning!

- Protelos granules should be mixed in a glass of water before taking. The suspension should be taken on an empty stomach, preferably at bedtime at least two hours after food, milk, milk products or calcium supplements. You should not eat for at least two hours after taking the granules. This is because food, milk, milk products and calcium can interfere with the absorption of the medicine from the gut and hence make it less effective.
- People with kidney problems should have their kidney function monitored regularly while taking this medicine.
- If you are due to have surgery or be immobile for a long period of time, you should talk to your doctor about continuing to take this medicine, as it may increase the risk of blood clots in the veins (eg deep vein thrombosis).
- Stop taking this medicine and inform your doctor immediately if you experience any of the following symptoms while taking this medicine: stabbing pains or swelling in one leg; pain on breathing or coughing; breathlessness; or coughing up blood.
- This medicine may rarely cause serious allergic reactions. For this reason, if you develop a skin rash, fever, swollen glands, swelling of the face, tongue or throat, or difficulty breathing or swallowing during treatment, you should stop taking this medicine and consult your doctor immediately.

Use with caution in

- Decreased kidney function.
- History of blood clots in the veins (venous thromboembolism, eg deep vein thrombosis or pulmonary embolism).
- Blood disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, factor V Leiden.
- An inherited disorder of protein metabolism called phenylketonuria. (Protelos granules contain aspartame, which is a source of phenylalanine.)

Not to be used in

- Children.
- Pregnancy.
- Breastfeeding.
- This medicine is not recommended for people with severely decreased kidney function.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

- The safety of this medicine during pregnancy has not been established. It should not be used by pregnant women.
- This medicine passes into breast milk. It should not be used by women who are breastfeeding.

Label warnings

- Dissolve or mix with water before taking.
- Do not take indigestion remedies at the same time as this medicine.

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