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.
Side effects
Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.
Nausea.
Diarrhoea.
Headache.
Eczema.
Blood clots in the blood vessels (venous thromboembolism, eg deep vein thrombosis).
Fainting.
Memory loss.
Seizures.
Vomiting.
Sore mouth.
Abdominal pain.
Allergic reactions.
The side effects listed above may not include all of the side effects reported by the drug's manufacturer.
For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to ensure that the combination is safe.
The following medicines should not be taken in the two hours before or the two hours after taking your Protelos granules, as they may reduce the absorption of the medicine from the gut and make it less effective:
calcium supplements
multivitamins or other medicines containing calcium.
You should also avoid taking antacids (indigestion remedies) for at least two hours after taking Protelos granules. However, if this is not possible they can be taken at the same time.
This medicine may reduce the absorption of tetracycline antibiotics (eg tetracycline, minocycline, doxycycline) and quinolone antibiotics (eg ciprofloxacin, norfloxacin, nalidixic acid) from the gut and could make them less effective. If you are prescribed a course of one of these types of antibiotics the manufacturer recommends that you stop taking this medicine during the course of antibiotics.
Other medicines containing the same active ingredient
There are currently no other medicines available in the UK that contain strontium ranelate as the active ingredient.
