Patient leaflet - Clasteon 800 mg film-coated tablets
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 problems with your kidneys (renal failure with creatinine clearance below 10 ml/min).
- you are pregnant, might become pregnant, or are breast-feeding (see the section on ‘Pregnancy and breast-feeding’).
- you have pain or discomfort in your stomach or bowel that is severe.
- you are taking any other bisphosphonate medicines. These include amongst other alendronate sodium, ibandronic and risedronate sodium.
Warnings and precautions
Talk to your doctor or pharmacist before taking Clasteon Tablets if:
Osteonecrosis (death of bone tissue) of the jaw, generally associated with pulling teeth and/or local infection (including inflammation of the bone or bone marrow (osteomyelitis), has been reported when bisphosphonates were used intravenously or orally for the treatment of cancer. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphosphonates.
If you are planning to have dental treatment or dental surgery, talk to your doctor before you start taking Clasteon Tablets. Your doctor may want you to have the dental treatment before you start taking this medicine.
If you need to have dental treatment or dental surgery while you are taking Clasteon Tablets, talk to your doctor and tell your dentist that you are taking this medicine.
- Monitoring of liver enzymes is recommended.
- Orally administered, mainly nitrogen-containing, ulcers). bisphosphonates may cause local irritation of the upper gastrointestinal mucosa. Thus, talk to your doctor if you have known gastrointestinal problems (e.g. Barrett's oesophagus, swallowing disorder, other oesophageal diseases, gastritis, duodenitis or Stop taking Clasteon Tablets and tell your doctor if you start to have difficulty or pain when swallowing, or you begin to get indigestion or heartburn, or your indigestion or heartburn gets worse.
- Clasteon Tablets should be taken with care if you have problems with your kidneys. (see section 3). During treatment with Clasteon Tablets you must drink large amounts of liquid (water). This is particularly important if you have too much calcium in the blood (hypercalcaemia) or if your kidneys do not work adequately (renal insufficiency). Before and during therapy with Clasteon Tablets regular checks should be made on kidney function with serum creatinine, serum calcium and phosphate levels.
- If you experience pain, weakness or discomfort in your thigh, hip or groin, consult your doctor, as this might be an early sign of a possible thighbone fracture.
Other medicines and Clasteon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. This includes medicines that are obtained without a prescription.
This is because Clasteon can affect the way some medicines work. Also some other medicines can affect the way Clasteon works:
Antibiotics called ‘aminoglycosides.’ These include e.g. streptomycin and gentamicin. If you have taken one of these antibiotics in the last month, you must tell your doctor or pharmacist. Aminoglycosides can enhance the
calcium-lowering effect of clodronate, even if you have stopped taking them some weeks before. As a result, the amount of calcium and magnesium in your blood may be reduced.
Medicines called ‘non-steroidal
anti-inflammatory drug’ (NSAIDs), most often diclofenac. There have been reports that clodronate may be associated with the onset of kidney disorder during concomitant taking of drugs against pain and inflammation
- Antacids (used to treat indigestion) and mineral supplements. Uptake of the active substance within the gastrointestinal tract (absorption) and hence the effect clodronate can be reduced by medicines with high levels of calcium, iron or magnesium. You should therefore allow a sufficient interval (about 2 hours) between taking such medicines and clodronate.
- Estramustine, an increase in the serum concentration of estramustine phosphate by up to 80% has been reported when estramustine phosphate and clodronate were used at the time.
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
Tell your doctor or pharmacist if you are taking any food supplements that contain calcium. You may need to stop taking these while you are taking Clasteon Capsules. Also, calcium rich foods may impair absorption. 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 medicine contains 128.24 mg sodium (main component of cooking/table salt) in each tablet. This is equivalent to 6.4% of the recommended maximum daily dietary intake of sodium for an adult.
3. HOW TO TAKE CLASTEON TABLETS
Always take this medicine exactly as your doctor or pharmacist has told you to. Check with your doctor or pharmacist if you are not sure. 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 one hour before food or 2 hours 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.
Customer: Kent Pharma UK Change: Split between MA Colour: 273 CV Size: 150 x 360mm Proof: 4 Date: 02 Oct 24
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.
- Increase of liver enzyme (transaminases) in blood, usually within normal range
Rare side effects (occur in less than 1 in 1,000 patients)
- hypersensitivity reactions manifesting as skin reactions
- allergic reaction
- increased serum parathyroid hormone associated with serum calcium decreased
- increased serum alkaline phosphatase
- Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
- transaminases increased (exceeding twice the normal range without associated other hepatic function abnormality)
- 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
- worsening kidney function
Very rare side effects (occur in less than 1 in 10,000 patients):
- Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.
- Decreased serum phosphate level
- Increased serum lactate dehydrogenase (LDH)
Breathing problems, including shortness of breath and tightness in the chest
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
- Isolated cases of severe disease of the jaw bone (osteonecrosis - damage and death of the bone), mainly in patients treated with other bisphosphonates e.g. zoledronate and pamidronate. Symptoms may include pain, swelling or numbness of the jaw
- Impairment of renal function (elevation of serum creatinine and proteinuria), severe renal damage especially after rapid intravenous infusion of high doses
- Severe bone, joint and/or muscle pain. The onset of symptoms varied from days to several months after starting treatment
Eye disorders including uveitis (inflammation of the uvea, the vascular skin of the eye), conjunctivitis (pink eye), episcleritis
(inflammation of the episclera, a thin layer of tissue covering the white part of the eye) and scleritis (inflammation of the white of the eye) 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.
Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
5. HOW TO STORE THIS MEDICINE
Keep this medicine out of the sight and reach 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: Talc, polyvinyl alcohol, titanium dioxide (E171) and macrogol (E1521).
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.
Marketing authorisation holder:
Kent Pharma UK Limited, 2nd Floor,
Connect 38, 1 Dover Place, Ashford, Kent, England, TN23 1FB.
Manufacturer: Abiogen Pharma S.p.A., via Meucci 36, Ospedaletto – Pisa - Italy.
Date of last revision:
October 2024
161175-12
ABXP225BNK