85229419

® Bonefos 800 mg tablets

sodium clodronate

Package leaflet: Information for the user

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

r Keep this leaflet. You may need to read it again. r If you have any further questions, ask your doctor or pharmacist.

r This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

r If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1    What Bonefos tablets are and what they are used for

2    What you need to know before you take Bonefos tablets

3    How to take Bonefos tablets

4    Possible side effects

5    How to store Bonefos tablets

6    Contents of the pack and other information

1.    What Bonefos tablets are and what they are used for

Bonefos tablets contain sodium clodronate which belongs to a group of medicines called bisphosphonates. These medicines help prevent the loss of calcium from bones.

Bonefos tablets are used to help manage bone diseases, particularly those associated with cancer. Bonefos tablets also help maintain normal levels of calcium in your blood.

2.    What you need to know before you take Bonefos tablets

Do not take Bonefos tablets if: r you have very poor kidney function r you are allergic to sodium clodronate, or to any of the other ingredients of this medicine (listed in section 6).

r you are already taking another similar medicine.

B Tell your doctor if any of these apply to you and do not take Bonefos.

■Your doctor will take special care if:

■ r you have problems with your kidneys J R you have (or have had) pain, swelling or

numbness of the jaw or a "heavy jaw feeling” or loosening of a tooth.

B Tell your doctor before you take Bonefos tablets, if any of these apply to you.

If you are having dental treatment or will undergo dental surgery, tell your dentist that you are being treated with a bisphosphonate. Certain types of dental treatment are not recommended while taking bisphosphonates.

Other medicines and Bonefos tablets

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Bonefos tablets with food and drink

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

Bonefos tablets are not normally given to people during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not breastfeed while you are taking Bonefos tablets.

Driving and using machines

Bonefos tablets have no known effect on your ability to drive or use machines.

3. How to take Bonefos tablets

You need to take plenty of fluids (such as water) before, during and after your treatment.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The tablets should be swallowed with plain water. 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 before you take them. Never take them with milk because it reduces the amount of drug that your body can absorb.

The daily dosage of Bonefos tablets varies. In most cases the dose is between 1600mg (2 tablets) and 3200mg (4 tablets) per day. If you have problems with your kidneys then the daily dosage may be reduced.

If you have been prescribed a single daily dose of Bonefos tablets, it should be taken (preferably in the morning) on an empty stomach with a glass of plain water. After using Bonefos 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 take more Bonefos tablets than you should

B 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 and liver are working.

If you forget to take Bonefos tablets

Do not take the missed dose, just take your next dose at the usual time.

Tell your doctor if you are taking: r non-steroidal anti-inflammatory drugs to relieve pain (e.g. ibuprofen or diclofenac) r antibiotics

r antacids or mineral supplements

r a drug called estramustine which is used to treat cancer.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed during treatment with Bonefos tablets.

If you experience any of these serious side effects, seek immediate medical attention: r difficulty breathing

r allergic skin reactions such as a rash, redness or itching

r 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

r kidney problems which can be experienced as feeling generally unwell, a reduced appetite and you may observe foamy urine

r 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 Bonefos tablets

r pain, swelling or numbness of the jaw, a "heavy jaw feeling” or loosening of a tooth, especially if you who have been treated in the past with bisphosphonates such as zoledronate and pamidronate

r severe bone, joint and/or muscle pain that can start days to several months after starting treatment with Bonefos tablets

r 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 (osteonecrosis of the external auditory canal) which could occur very rarely.

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.

The following side effects are presented by how often they may occur:

Common side effects (may affect up to 1 in 10 people)

r 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

r diarrhoea

r feeling sick or being sick

Rare side effects (may affect up to 1 in 1,000 people)

r low calcium levels in the blood with symptoms (symptomatic hypocalcaemia) which may include 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, less frequently, fits

r increased blood levels of a hormone (parathyroid hormone) or certain enzymes (alkaline phosphatase) which can be detected by blood tests

r allergic skin reaction such as a rash, redness or itching

r breathing difficulties (bronchospasm) - if you have any difficulties breathing seek immediate medical attention.

r Unusual fracture of the thigh bone (particularly in patients on long-term treatment for osteoporosis) - contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin

Other side effects (frequency unknown)

r breathing problems in patients with a condition called aspirin-sensitive asthma

r allergic reaction causing difficulty breathing - if you have any difficulty breathing seek immediate medical attention

r kidney problems which may include severe kidney damage and in rare cases fatal kidney failure have been reported. These problems are more common when taking some types of antiinflammatory drug (most often diclofenac) at the same time as Bonefos tablets

r dead tissue in the jaw bone (osteonecrosis of the jaw) which is mainly seen in patients who have been treated in the past with bisphosphonates such as zoledronate and pamidronate. Symptoms include pain, swelling or numbness of the jaw, a "heavy jaw feeling” or loosening of a tooth

r severe bone, joint and/or muscle pain that can start days to several months after starting treatment with Bonefos tablets. However, these symptoms may also be linked to the reason you are taking Bonefos tablets.

r Swelling and irritation of the uvea (the middle layer of the eye) has been observed with Bonefos. Swelling or infection of the conjunctiva (the membrane lining of the eyelids) has been reported in one patient who received Bonefos and another biphosphonate at the same time. To date, swelling and irritation of the episclera (a thin layer of tissue covering the sclera, the white outer wall of the eye) and the sclera, which has been reported with other biphosphonates, have not been reported with Bonefos.

B Tell your doctor if any side effect gets serious, or if you get any effects not listed in this leaflet.

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 via the Yellow Card Scheme at www.mhra.gov.uk/ yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5.    How to store Bonefos tablets

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on both the carton and on each blister strip of tablets after EXP. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.    Contents of the pack and other information

What Bonefos tablets contain

The active substance is sodium clodronate.

Each tablet contains 800mg sodium clodronate.

The other ingredients are croscarmellose sodium, magnesium stearate, silicified microcrystalline cellulose and stearic acid. Opadry II white (containing Macrogol (PEG) 3350, Polyvinyl alcohol (partially hydrolysed), Purified water, Talc, and Titanium dioxide (E171)).

What Benefos tablets look like and contents of the pack

Pale white, oval-shaped, film-coated tablets Bonefos Tablets are available in packs of 60 tablets

Marketing authorisation holder:

Bayer plc Bayer House Strawberry Hill Newbury

Berkshire RG14 1JA

Manufacturer:

Bayer Oy Pansiontie 47 20210 Turku Finland

This leaflet was last revised in:

March 2016

Product licence number:

PL00010/0522

301428 85229419 Liite Bonefos tabl 800 mg GB.indd 2 17.3.2016 12.48