Clasteon 800mg Film-Coated Tablets
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CLASTEON 800MG FILM-COATED TABLETS (Sodium clodronate)
Please read this leaflet carefully before taking Clasteon tablets.
Keep the leaflet in case you need to refer to it again. If you want to know more about Clasteon tablets or have any questions, you should ask your doctor or pharmacist.
What is in this leaflet
1. What Clasteon tablets are used for
2. What you need to know before taking Clasteon tablets
3. How to take Clasteon tablets
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1. What Clasteon Tablets are used for
Clasteon tablets contain sodium clodronate, which is one of a group of medicines known as bisphosphonates. These medicines help prevent loss of calcium from bones.
Clasteon tablets are used to manage bone diseases, particularly those associated with cancer. They also help to maintain normal levels of calcium in your blood.
2. What you need to know before taking Clasteon Tablets
You must NOT take Clasteon tablets and should talk to your doctor if:
• you are allergic to sodium clodronate, similar medicines or any of the ingredients (listed in section 6)
• you have very poor kidney function
• you are pregnant or breast feeding
• you are already taking a similar medicine (containing bisphosphonates).
Tell your doctor if:
• you have ever had/have pain, numbness or swelling of your jaw or a heavy jaw feeling or loosening of a tooth
• you are having dental treatment or will undergo dental surgery, tell your dentist that you are being treated with a bisphosphonate (sodium clodronate). Certain types of dental treatment are not recommended while taking bisphosphonates
• you have problems with your kidneys.
Other medicines and Clasteon
Tell your doctor or pharmacist if you are taking or have recently taken any other medicine including those obtained without a prescription.
This is particularly important if you are taking any of the following:
• antibiotics
• non-steroidal anti-inflammatory medicines such as ibuprofen or diclofenac
• antacid indigestion tablets
• mineral supplements
• estamustine, used to treat prostate cancer.
Do not take any other medicines by mouth for 2 hours before and 1 hour after each dose of Clasteon Tablets.
Food and drink with Clasteon Tablets
It is important that you take your tablets on an empty stomach (otherwise your body will not absorb the drug properly). Except for plain water, do not eat or drink for 2 hours before and 1 hour after each dose. It is particularly important to avoid drinking milk in this period. You can drink water whenever you like.
Pregnancy and breastfeeding
Clasteon Tablets are not normally given to people during pregnancy. If you think you might be pregnant or if you are planning a family, tell your doctor before taking Clasteon Tablets.
Do not breastfeed while you are taking Clasteon Tablets.
Driving and using machines
Clasteon Tablets have no known effect on your ability to drive or use machines.
Important information about some of the ingredients of this medicine
This medicinal product contains 128.24 mg sodium per tablet. To be taken into consideration by patients on a controlled sodium diet.
3. How to take Clasteon Tablets
Always take the tablets exactly as your doctor tells you to.
Clasteon tablets are for use in adults only.
You need to take plenty of fluids (such as water) before, during and after your treatment.
The daily dosage varies. In most cases the dose is between 1600 mg (2 tablets) and 3200 mg (4 tablets) per day. If you have problems with your kidneys then the dose may be reduced.
• Swallow the tablets with plain water. The tablets may be divided into two halves to help with swallowing, but the two halves must be taken at the same time
• Do not crush or dissolve the tablets and never take them with milk because this reduces the amount of drug that your body can absorb.
• Take the tablets at least 2 hours before or 1 hour after food (and avoid milk during this period).
• Take the tablets even if you are not eating at present.
If you have been prescribed a single daily dose of Clasteon Tablets, it should be taken (preferably in the morning) on an empty stomach with a glass of plain water. After using Clasteon Tablets, you should not eat, drink (other than plain water) or take any other medicines by mouth for 1 hour.
If you have been prescribed a twice daily dose, the first dose should be taken as recommended above. The second dose should be taken between meals, more than 2 hours after and 1 hour before eating, drinking (other than plain water), or taking any other medicines by mouth.
If you forget a dose take it as soon as possible. However, if it is nearly time for your next dose, skip the missed dose and carry on as before. Do not take a double dose.
If you take too many Clasteon tablets or
someone else accidentally takes your medicine, get medical help immediately and drink plenty of water. If possible, take your tablets with you to show the doctor. Your doctor may want to check the amount of calcium in your blood and how well your kidneys are working.
Symptoms of an overdose may be a feeling of sickness, or being sick (nausea or vomiting).
Your doctor has prescribed this medicine for you. Never give it to others as it may harm them, even if their symptoms are the same as yours.
4. Possible side effects
As with all medicines Clasteon tablets may cause side effects in some patients.
Stop taking the tablets and contact your doctor if any of the following occur:
• wheezing or difficulty in breathing
• swelling of face, tongue or throat
• itching, rash.
These may be symptoms of an allergic (hypersensitivity) reaction.
if you experience any of the following serious side effects, seek immediate medical attention:
• numbness and tingling sensations around the mouth and/or in the fingers and toes, muscle cramps or spasms (in the back, hands and/or feet) or fits
• kidney problems which can be experienced as feeling generally unwell, a reduced appetite and you may observe foamy urine
• severe kidney damage which may include symptoms such as weakness or tiredness, change in frequency of urination and swelling of the face, arms, legs and abdomen. These problems are more common when taking some types of anti-inflammatory drug (most often diclofenac) at the same time as Clasteon Tablets
• pain, swelling or numbness of the jaw, a "heavy jaw feeling" or loosening of a tooth, especially if you have been treated in the past with bisphosphonates such as zoledronate and pamidronate
• severe bone, joint and/or muscle pain that can start days to several months after starting treatment with Clasteon Tablets
Common side effects (occur in less than 1 in 10 patients):
• low calcium levels in the blood without any symptoms (asymptomatic hypocalcaemia) or small increases in the levels of liver enzymes, which can be detected by blood tests
• being sick, feeling sick (nausea) or diarrhoea. If this happens it may help if you take half the number of tablets in the morning and the rest in the evening.
Rare side effects (occur in less than 1 in 1,000 patients)
• skin reactions
• difficulty breathing
• Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the thigh bone.
• low calcium levels in the blood with symptoms (symptomatic hypocalcaemia) or small increases in levels of liver enzymes or some hormones
Other side effects (frequency unknown)
• Breathing problems - aspirin sensitive asthma or allergic reactions
• Kidney problems which may include severe kidney damage and has been fatal, this is more common in patients also taking diclofenac
• Dead tissue in the jaw bone (osteonecrosis) seen mainly in patients treated in the past with zoledronate or pamidronate
• Severe bone, joint and/or muscle pain
• Inflammation of part of the eye, conjunctivitis.
Your doctor may test your blood from time to time, to check that Clasteon tablets are working correctly.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
UK: Yellow Card Scheme at:
Ireland: Tel: +353 1 6764971 Website: www.imb.ie
e-mail: imbpharmacovigilance@imb.ie
Malta: The Medicines Authority, Post-Licensing
Directorate, 203 level 3 Rue D'Argens, GZR-1368
Gzira
Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store this medicine
Keep this medicine out of the reach and sight of children.
Do not use Clasteon after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What is in this medicine:
Each tablet contains 800mg of the active ingredient sodium clodronate (as the tetrahydrate).
The other ingredients are starch pregelatinised, microcrystalline cellulose, colloidal silicon dioxide, sodium starch glycolate (type A) and magnesium stearate. The tablet coating contains: hypromellose, titanium dioxide (E171) and macrogol 400.
What this medicine looks like and contents of the pack:
Clasteon tablets are white oval convex film-coated tablets with a breakline, the breakline is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Available in packs of 10,
30 or 60 tablets. Not all pack sizes may be marketed.
The product is called Clasteon 800mg film-coated Tablets in the UK, Ireland and Malta.
Marketing authorisation holder: Beacon Pharmaceuticals Ltd. Tunbridge Wells, Kent TN1 1YG, UK.
Manufacturer: Abiogen Pharma S.p.A., via Meucci 36, Ospedaletto - Pisa - Italy.
Date of last revision: 05/2014
& Beacon
PHARMACEUTICALS
Beacon Pharmaceuticals Ltd, 85 High Street, Tunbridge Wells.TN1 1YG. UK