2. What you need to know before you take Protelos
Do not take PROTELOS:
- if you are allergic to strontium ranelate or any of the other ingredients of PROTELOS (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.
Warnings and precautions:
Talk to your doctor or pharmacist before taking PROTELOS:
- if you have severe kidney disease.
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 PROTELOS and seek medical advice.
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis and severe hyper-sensitivity reactions (DRESS)) have been reported with the use of PROTELOS.
Stevens-Johnson syndrome and toxic epidermal necrolysis appear initially as reddish target-like spots or circular
patches often with central blisters on the trunk. Additional signs to look for 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.
DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature,
increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and
enlarged lymph nodes.
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 have developed Stevens-Johnson syndrome or toxic epidermal necrolysis or DRESS with the use of PROTELOS, you must not be re-started on PROTELOS at any time.
If you develop a rash or these skin symptoms, stop taking PROTELOS, seek urgent advice from a doctor and tell him
that you are taking this medicine.
If you are of Asian origin, talk to your doctor before taking PROTELOS as you may be at higher risk of skin reactions.
Children and adolescents
PROTELOS is not intended for use in children and adolescents (below the age of 18).
Other medicines and PROTELOS:
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
- You should stop taking PROTELOS if you have to take oral tetracyclines or quinolones (two types of antibiotics). You can take PROTELOS 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 PROTELOS.
- If you take antacids (medicines to relieve heartburn) you should take them at least 2 hours after PROTELOS. If this is not possible, it is acceptable to take the two medicines at the same time.
PROTELOS with food and drink:
Food, milk and milk products reduce the absorption of strontium ranelate. It is recommended that you take PROTELOS 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 PROTELOS 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:
Protelos is unlikely to affect your ability to drive or use machines.
PROTELOS contains aspartame:
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 Protelos
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
PROTELOS is for oral use.
The recommended dose is one 2g sachet a day.
It is recommended that you take PROTELOS at bedtime, preferably at least 2 hours after dinner. You may lie down
immediately after taking PROTELOS if you wish.
Take the granules contained in the sachets as a suspension in a glass of water (see instructions below). PROTELOS can
interact with milk and milk products, so it is important that you mix PROTELOS only with water to be sure it works
properly.
Empty the granules from the sachet into a glass;
Add water;
Stir until the granules are evenly dispersed in the water.
Drink straight away. You should not leave it 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 PROTELOS. Do not take calcium
supplements at bedtime, at the same time as PROTELOS.
Your doctor will tell you how long you should continue to take PROTELOS. Osteoporosis-therapy is usually required
for a long period. It is important that you continue taking PROTELOS for as long as your doctor prescribes the
medicine.
If you take more PROTELOS than you should:
If you take too many sachets of PROTELOS, 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 PROTELOS:
Do not take a double dose to make up for forgotten individual doses. Just carry on with the next dose at the normal time.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of possible side effects listed below is defined using the following convention:
very common: may affect more than 1 in 10 people
common: may affect up to 1 in 10 people
uncommon: may affect up to 1 in 100 people
rare: may affect up to 1 in 1,000 people
very rare: may affect up to 1 in 10,000 people
not known: frequency cannot be estimated from the available data
Common:
Blood clots. Signs of a blood clot include painful swelling in your leg, sudden chest pain or difficulty breathing. See a doctor straight away if you experience any of these symptoms. Nausea, diarrhoea, headache, skin irritation, memory
troubles, fainting fit. 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:
Seizures.
Rare:
Severe hypersensitivity reactions (DRESS: see section 2)
Very rare:
Potentially life-threatening skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported
(see section 2).
Not known:
Vomiting, abdominal pain, reflux, indigestion, constipation, flatulence, dry mouth, pins and needles, dizziness, vertigo, difficulty in sleeping, inflammation of the liver (hepatitis), oral irritation (such as mouth ulcers and gum inflammation), bone, muscle and/or joint pain, muscle cramps, hair loss, reduction in production of blood cells in the bone marrow, itching, hives, blistering, angioedema (such as swollen face, tongue or throat, difficulty in breathing or swallowing), swelling in limbs, feeling unwell, feeling confused, bronchial hyperreactivity (symptoms include wheezing, shortness of breath and cough).
If you have stopped treatment due to hypersensitivity reactions, do not take PROTELOS again
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5. How to store Protelos
Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.
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.
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.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
