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# Bonefos Capsules

sodium clodronate

Package leaflet - information for the user Read all of this leaflet carefully before you start taking this medicine.

r Keep this leaflet. You may need to read it again.

r If you have more questions, ask your doctor or pharmacist.

r This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. r If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1    What Bonefos Capsules are and what they are used for

2    Before you take Bonefos Capsules

3    How you take Bonefos Capsules

4    Possible side effects

5    How to store Bonefos Capsules

6    Further information

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

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

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

2.    Before you take Bonefos Capsules

Do not take Bonefos Capsules if:

r you have very poor kidney function r you are allergic to the active ingredient (sodium clodronate), or to any of the other ingredients. The ingredients are 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.

The doctor will take special care if: r you have problems with your kidneys

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 Capsules, 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 Capsules

Tell your doctor about any other medicines that you are taking, or have recently taken. This includes any products you bought without a prescription.

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.

Do not take any other medicines by mouth for

2 hours before and 1 hour after each dose of Bonefos Capsules.

Food and drink with Bonefos Capsules

It is important that you take your capsules 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 Capsules 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 Bonefos Capsules.

Do not breastfeed while you are taking Bonefos Capsules.

Driving and using machines

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

3.    How you take Bonefos Capsules

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

You should take Bonefos Capsules exactly as prescribed by your doctor.

The capsules should be swallowed whole with plain water. Never take them with milk because it reduces the amount of Bonefos Capsules that your body can absorb.

The daily dosage of Bonefos Capsules varies.

In most cases the dose is between 1600mg (4 capsules) and 3200mg (8 capsules) 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 Capsules, it should be taken (preferably in the morning) on an empty stomach with a glass of plain water. After using Bonefos Capsules, 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 too many capsules r Get medical help immediately and drink plenty of water. If possible, take your capsules 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 the capsules

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

4.    Possible side effects

Like all medicines, Bonefos Capsules can cause side effects, although not everybody gets them.

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

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

Please turn over B

►    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 Capsules

►    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 Bonefos Capsules.

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

(These may affect up to 1 in 10 people)

►    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

►    diarrhoea

►    feeling sick or being sick Rare side effects

(These may affect up to 1 in 1,000 people)

►    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

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

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

►    breathing difficulties (bronchospasm) - if you have any difficulty breathing seek immediate medical attention

►    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)

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

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

►    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 Capsules

►    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

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

► 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

UK

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

Malta

ADR Reporting 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 Bonefos Capsules

Keep out of the reach and sight of children.

Do not use after the expiry date which is marked on the carton and each blister strip of capsules. Store below 25 °C.

Do not dispose of medicines in waste water or household rubbish. Any unused capsules should be returned to a pharmacist (chemist) who will dispose of them properly. This helps protect the environment.

6.    Further Information

What Bonefos Capsules contain

The active substance is sodium clodronate.

Each capsule contains 400mg sodium clodronate. The capsules also contain calcium stearate, colloidal silica, lactose and talc.

The capsule shell contains gelatine, titanium dioxide (E171), yellow iron oxide (E172) and red iron oxide (E172).

What's in the pack

Bonefos Capsules are available in packs of 120

Marketing authorisation holder:

Bayer plc, Bayer House, Strawberry Hill Newbury, Berkshire, RG14 1JA

Manufacturer:

Bayer Oy

Pansiontie 47, 20210 Turku, Finland The leaflet was last revised: June 2014 Product licence number: PL 00010/0521