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STRONTIUM RANELATE

Brand Name(s) : Protelos
Warnings
Uses
Side Effects
Precautions
Interactions
Overdose

STRONTIUM RANELATE WARNINGS

Strontium ranelate should be used with caution in:

  • People with severely reduced kidney function
  • People at risk of developing a blood clot
  • People at risk of heart disease, including high blood pressure, diabetes, smoking

It should not be used in:

  • People with a hypersensitivity (allergy) to strontium ranelate or to any of the ingredients in the medication
  • People who have or have had a blood clot in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
  • People who are immobilised for a long or short period of time, such as being wheel-chair bound, being confined to bed or after an operation.
  • Children under the age of 18 years
  • People with phenylketonuria, as the medication contains aspartame - a source of phenylalanine
  • People who have established, ischaemic heart disease or cerebrovascular disease e.g. heart attack, stroke, mini stroke or angina.
  • People who have or have had problems with blood circulation (peripheral arterial disease).
  • People with high blood pressure not controlled by treatment.

Also see list of precautions and interactions

STORAGE

This medicine does not require any special storage conditions.

STRONTIUM RANELATE USES

What is it used for?

  • Strontium ranelate is used to treat severe osteoporosis in women who have gone through the menopause and who are at high risk of fracture. It is also used to treat severe osteoporosis in men who are at increased risk of fracture.
  • It is a drug affecting bone structure and mineralisation.
  • It is used to reduce the breakdown of bones and increase the formation of new bone, therefore reducing the risk of fracture. Strontium ranelate is used to treat women with severe osteoporosis after the menopause. Osteoporosis causes thinning and weakening of the bones, which is especially common in post-menopausal women. Women with this condition are more likely to get a fracture (break of the bone) from any falls.
  • In general this drug is used to increase bone strength to help reduce the risk of fractures due to severe osteoporosis after the menopause. It is also used in men with severe osteoporosis who are at increased risk of fractures.
  • Benefits of being on this drug can include a reduced risk of getting a bone fracture in the spine and hip.

Listed below are the typical uses of strontium ranelate.

  • Treatment of severe osteoporosis in postmenopausal women at high risk of fractures.
  • Treatment of severe osteoporosis in men at increased risk of fractures

On occasion your doctor may prescribe this medicine to treat a condition not on the above list.

HOW TO USE/TAKE

How often do I take it?

  • Take this medication by mouth usually one sachet once a day, without food. Add the granules in the sachet to a glass of water and stir well. Swallow the mixture straight away. The sachet should be taken at bedtime, preferably at least two hours after eating. It is important to only mix the granules with water, as milk and milk products can interact with this drug.
  • Use this medication regularly in order to get the most benefit from it.
  • Certain medical conditions may require different dosage instructions as directed by your doctor.

What dose?

  • Dosage is based on your age, gender, medical condition, response to therapy, and use of certain interacting medicines.

Do I need to avoid anything?

  • Avoid taking the medication with food, drink (other than water) or other medication.
  • Food, particularly products containing calcium such as milk, cheese, yoghurts and medicinal products containing calcium, aluminium or magnesium should be avoided for 2 hours before and 2 hours after you take strontium ranelate.

This medication is unlikely to affect driving ability or the ability to operate machinery. Consult your doctor or pharmacist for more details.

When can I stop?

  • It is important to continue taking this medication, unless your doctor tells you to stop.

STRONTIUM RANELATE SIDE EFFECTS

If you get any side effects inform your doctor or pharmacist.

Tell your doctor immediately and stop taking the medication if you develop any of the following symptoms:

  • Rash, flu-like symptoms, high temperatures, enlarged lymph nodes and increased levels of white cells and liver enzymes.
  • Any other signs of a serious allergic reaction (see below)
  • There have been reports of very serious allergic reactions affecting internal organs with this medication. If you stop taking strontium ranelate because of an allergic reaction, you must stop it permanently and not restart treatment.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

The Yellow Card Scheme allows you to report suspected side effects from any type of medicine (which includes vaccines, herbals and over the counter medicines) that you are taking. It is run by the medicines safety watchdog called the Medicines and Healthcare products Regulatory agency (MHRA). Please report any suspected side effect on the Yellow Card Scheme website.

STRONTIUM RANELATE PRECAUTIONS

Before taking strontium ranelate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist in case of:

  • Hypersensitivity (allergy) to strontium ranelate or to any of the ingredients in the medication
  • Previous or current blood clot in the legs (deep vein thrombosis) or in the lungs (pulmonary embolism).
  • Being immobilised for a long or short period of time, such as being wheel-chair bound, being confined to bed or after an operation.
  • Phenylketonuria, as the medication contains aspartame - a source of phenylalanine
  • Established, ischaemic heart disease or cerebrovascular disease e.g. heart attack, stroke, mini stroke or angina.
  • Problems with blood circulation (peripheral arterial disease).
  • high blood pressure not controlled by treatment.

Before using this medication tell your doctor or pharmacist your medical history, especially any of the following:

  • Diagnosed as being at risk of developing a blood clot
  • Severe kidney problems
  • High risk of heart disease

Before having surgery, tell your doctor or dentist that you are taking this medication.

Does alcohol intake affect this drug?

  • Alcohol intake is not known to affect strontium ranelate.

The elderly: strontium ranelate can be used in the elderly.

Pregnancy and breastfeeding - please ensure you read the detailed information below

PREGNANCY

Strontium ranelate is not safe to take if you are, or are planning to become, pregnant.

It is sensible to limit use of medication during pregnancy whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

BREAST FEEDING

Strontium ranelate is not safe to take if you are breastfeeding.

It is sensible to limit use of medication during breastfeeding whenever possible. However, your doctor may decide that the benefits outweigh the risks in individual circumstances and after a careful assessment of your specific health situation.

If you have any doubts or concerns you are advised to discuss the medicine with your doctor or pharmacist.

STRONTIUM RANELATE INTERACTIONS

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious, possibly fatal interactions may occur:

  • None known

Before using this medication, tell your doctor or pharmacist of all prescription and non-prescription/herbal products you may use, especially of:

  • Antibiotics such as tetracycline or quinolone antibiotics (e.g. ciprofloxacin) to treat bacterial infections
  • The following must be taken at least 2 hours after strontium ranelate:
    - Calcium supplements
    - Antacids used to treat indigestion
    - Any other medications containing aluminium, calcium or magnesium

This information does not contain all possible interactions. Therefore, before using strontium ranelate, tell your doctor or pharmacist of all the products you use.

STRONTIUM RANELATE OVERDOSE

People who have taken too much strontium ranelate, should tell a doctor or pharmacist. They may advise you to drink milk or take antacids to reduce how much of the medicine goes into your system.

If you think you, or someone you care for, might have accidentally taken more than the recommended dose of strontium ranelate or intentional overdose is suspected, contact your local hospital, GP or if in England call 111. In Scotland call NHS 24. In Wales, call NHS Direct Wales. In the case of medical emergencies, always dial 999.

MISSED DOSE

If you miss a dose, take the sachet the next day and then resume your usual dosing schedule. Do not double the dose to catch up.

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Source: Selected from data included with permission and copyrighted by Boots UK Limited or TicTac Communications Ltd. This copyrighted material is sourced from a licensed data provider and is not for distribution, except as may be authorised by the applicable terms of use.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgement of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse events, nor should it be construed to indicate that use of a particular medicine is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any medicine, changing any diet, or discontinuing any course of treatment.

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