Patient Information Leaflet

XXXXXXXX

Loron®    l-coated Tablets

Clodronate disodium

Please read all of this leaflet

carefully before you start taking

this medicine.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    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.

•    If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Loron is and what it is used for

2.    Before you take Loron

3.    How to take Loron

4.    Possible side effects

5.    How to store Loron

6.    Further information

1. What Loron is and what it is used for

Loron contains a medicine called clodronate disodium. This medicine is a non-amino-bisphosphonate.

Loron is used to treat bone problems in people with certain types of cancer. These problems include:

•    Loss of calcium (a mineral) from the bones and bone pain.

•    High levels of calcium in the blood caused by loss of calcium from the bones.

Loron works by binding to the bones. This helps to stop the bones from losing calcium which helps to keep the bones strong.

2. Before you take Loron

Do not take Loron if:

•    You are allergic (hypersensitive) to clodronate disodium or any of the other ingredients of Loron (listed in Section 6: Further information).

•    You are taking any other bisphosphonate medicines. These include alendronate sodium, ibandronic acid and risedronate sodium. See the section on ‘Taking other medicines’.

•    You have pain or discomfort in your stomach or bowel that is severe or has been going on for a long time.

•    You have problems with your kidneys (renal failure).

•    You are pregnant, might become pregnant, or are breast-feeding (see the section on ‘Pregnancy and breast-feeding’).

Do not take Loron if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Loron.

Take special care with Loron

Check with your doctor or pharmacist before taking Loron if:

•    You have heartburn, stomach pain or discomfort, or have an ulcer. Stop taking Loron 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.

•    You have ever had pain or swelling of your jaw.

Dental treatment

•    If you are planning to have dental treatment or dental surgery, talk to your doctor before you start taking Loron. 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 Loron, talk to your doctor and tell your dentist that you are taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Loron can affect the way some medicines work. Also some other medicines can affect the way Loron works.

Do not take Loron, and tell your doctor or pharmacist, if you are taking any of the following medicines:

•    Other bisphosphonate medicines such as alendronate sodium, ibandronic acid or risedronate sodium. These are used to treat bone diseases including osteoporosis.

Tell your doctor or pharmacist if you are taking any of the following medicines:

•    Medicines called ‘non-steroidal anti-inflammatory drugs’ (NSAIDs). These include aspirin, indometacin and ibuprofen.

•    Antibiotics called ‘aminoglycosides’. These include streptomycin and gentamicin. If you have taken one of these antibiotics in the last month, you must tell your doctor or pharmacist.

•    Antacids containing calcium (used to treat indigestion).

Taking Loron with food and food supplements

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 Loron.

Pregnancy and breast-feeding

Do not take Loron if you are pregnant, might become pregnant or are breast-feeding. This is because it may affect your baby.

You should use effective contraception during treatment with Loron.

Driving and using machines

Loron is not likely to affect you being able to drive or use any tools or machines.

Important information about some of the ingredients of Loron

Loron contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

Each Loron tablet contains 3.6 mmol (or 83.4 mg) of sodium. You should

x

x

X

X

X

X

X

X

3. How to take Loron

Always take Loron exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

•    Take Loron one hour before or one hour after food.

•    Swallow each tablet with a drink (not milk).

Adults and elderly people

•    The usual dose is 2 tablets once a day.

•    Your doctor may change this to 1 tablet twice a day, if certain side effects happen.

•    If your doctor thinks it is necessary, your dose may be increased to a maximum of 4 tablets a day.

People with kidney problems

•    If you have problems with your kidneys, your doctor may want you to take 1 tablet a day.

If you take more Loron than you should

If you take more Loron than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: feeling or being sick, ‘pins and needles’ in your hands or feet, or cramps in your muscles.

If you forget to take Loron

•    If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.

•    Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If someone else takes your Loron tablets by mistake, they should talk to a doctor or go to a hospital straight away.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Loron

•    Loron 520 mg Film-coated Tablets do not need special storage conditions.

•    Keep out of the reach and sight of children.

•    Do not use Loron after the expiry date printed on the pack.

•    Do not throw away any left over tablets. Instead return them to your pharmacist so that they can be disposed of carefully. Only keep them if your doctor tells you to.

6. Further information

4. Possible side effects

Like all medicines Loron can cause

side effects, although not everyone

will get them.

The following side effects may

happen with this medicine:

•    Feeling sick or having mild diarrhoea. Tell your doctor if this happens to you. You may be given some advice to help you with these problems.

•    Changes to your blood. Your doctor may want you to have blood tests to check for this.

•    Problems with your kidneys.

•    Allergic skin rashes and itching.

•    Breathing problems, including shortness of breath and tightness in the chest.

•    Unusual fracture of the thigh bone particularly in patients on longterm 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.

•    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.

•    Very rare: Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.

What Loron contains

The active substance in Loron 520 mg Film-coated Tablets is clodronate disodium. Each tablet contains 520 mg clodronate disodium.

The other ingredients are talc, maize starch, cellulose microcrystalline, magnesium stearate, sodium starch glycolate, hypromellose, polyacrylate dispersion 30 %, macrogol 10000, lactose monohydrate, titanium dioxide (E171), polysorbate 80 and sodium citrate.

What Loron looks like and contents of the pack

Loron tablets are oblong white tablets with E9 marked on one side. They are scored with a break line on both sides, so that they can easily be broken into equal halves.

Loron tablets are supplied in blister packs containing 10 or 60 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder RIEMSER Pharma GmbH An der Wiek 7

17493 Greifswald-Insel Riems Germany

Manufacturer RIEMSER Pharma GmbH An der Wiek 7

17493 Greifswald-Insel Riems Germany

UK distributor Intrapharm Laboratories Ltd The Courtyard Barns, Choke Lane, Maidenhead, Berks, SL6 6PT United Kingdom

This leaflet was last revised in November 2015.

Patient Information Leaflet

XXXXXXXX

Loron®    l-coated Tablets

Clodronate disodium

Please read all of this leaflet

carefully before you start taking

this medicine.

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

•    If you have any further questions, ask your doctor or pharmacist.

•    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.

•    If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Loron is and what it is used for

2.    Before you take Loron

3.    How to take Loron

4.    Possible side effects

5.    How to store Loron

6.    Further information

1. What Loron is and what it is used for

Loron contains a medicine called clodronate disodium. This medicine is a non-amino-bisphosphonate.

Loron is used to treat bone problems in people with certain types of cancer. These problems include:

•    Loss of calcium (a mineral) from the bones and bone pain.

•    High levels of calcium in the blood caused by loss of calcium from the bones.

Loron works by binding to the bones. This helps to stop the bones from losing calcium which helps to keep the bones strong.

2. Before you take Loron

Do not take Loron if:

•    You are allergic (hypersensitive) to clodronate disodium or any of the other ingredients of Loron (listed in Section 6: Further information).

•    You are taking any other bisphosphonate medicines. These include alendronate sodium, ibandronic acid and risedronate sodium. See the section on ‘Taking other medicines’.

•    You have pain or discomfort in your stomach or bowel that is severe or has been going on for a long time.

•    You have problems with your kidneys (renal failure).

•    You are pregnant, might become pregnant, or are breast-feeding (see the section on ‘Pregnancy and breast-feeding’).

Do not take Loron if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Loron.

Take special care with Loron

Check with your doctor or pharmacist before taking Loron if:

•    You have heartburn, stomach pain or discomfort, or have an ulcer. Stop taking Loron 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.

•    You have ever had pain or swelling of your jaw.

Dental treatment

•    If you are planning to have dental treatment or dental surgery, talk to your doctor before you start taking Loron. 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 Loron, talk to your doctor and tell your dentist that you are taking this medicine.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Loron can affect the way some medicines work. Also some other medicines can affect the way Loron works.

Do not take Loron, and tell your doctor or pharmacist, if you are taking any of the following medicines:

•    Other bisphosphonate medicines such as alendronate sodium, ibandronic acid or risedronate sodium. These are used to treat bone diseases including osteoporosis.

Tell your doctor or pharmacist if you are taking any of the following medicines:

•    Medicines called ‘non-steroidal anti-inflammatory drugs’ (NSAIDs). These include aspirin, indometacin and ibuprofen.

•    Antibiotics called ‘aminoglycosides’. These include streptomycin and gentamicin. If you have taken one of these antibiotics in the last month, you must tell your doctor or pharmacist.

•    Antacids containing calcium (used to treat indigestion).

Taking Loron with food and food supplements

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 Loron.

Pregnancy and breast-feeding

Do not take Loron if you are pregnant, might become pregnant or are breast-feeding. This is because it may affect your baby.

You should use effective contraception during treatment with Loron.

Driving and using machines

Loron is not likely to affect you being able to drive or use any tools or machines.

Important information about some of the ingredients of Loron

Loron contains lactose, which is a type of sugar. If you have been told by your doctor that you cannot tolerate or digest some sugars (have an intolerance to some sugars), talk to your doctor before taking this medicine.

Each Loron tablet contains 3.6 mmol (or 83.4 mg) of sodium. You should

x

x

X

X

X

X

X

X

3. How to take Loron

Always take Loron exactly as your doctor has told you.

You should check with your doctor or pharmacist if you are not sure.

•    Take Loron one hour before or one hour after food.

•    Swallow each tablet with a drink (not milk).

Adults and elderly people

•    The usual dose is 2 tablets once a day.

•    Your doctor may change this to 1 tablet twice a day, if certain side effects happen.

•    If your doctor thinks it is necessary, your dose may be increased to a maximum of 4 tablets a day.

People with kidney problems

•    If you have problems with your kidneys, your doctor may want you to take 1 tablet a day.

If you take more Loron than you should

If you take more Loron than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: feeling or being sick, ‘pins and needles’ in your hands or feet, or cramps in your muscles.

If you forget to take Loron

•    If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose.

•    Do not take a double dose (two doses at the same time) to make up for a forgotten dose.

If someone else takes your Loron tablets by mistake, they should talk to a doctor or go to a hospital straight away.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. How to store Loron

•    Loron 520 mg Film-coated Tablets do not need special storage conditions.

•    Keep out of the reach and sight of children.

•    Do not use Loron after the expiry date printed on the pack.

•    Do not throw away any left over tablets. Instead return them to your pharmacist so that they can be disposed of carefully. Only keep them if your doctor tells you to.

6. Further information

4. Possible side effects

Like all medicines Loron can cause

side effects, although not everyone

will get them.

The following side effects may

happen with this medicine:

•    Feeling sick or having mild diarrhoea. Tell your doctor if this happens to you. You may be given some advice to help you with these problems.

•    Changes to your blood. Your doctor may want you to have blood tests to check for this.

•    Problems with your kidneys.

•    Allergic skin rashes and itching.

•    Breathing problems, including shortness of breath and tightness in the chest.

•    Unusual fracture of the thigh bone particularly in patients on longterm 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.

•    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.

•    Very rare: Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.

What Loron contains

The active substance in Loron 520 mg Film-coated Tablets is clodronate disodium. Each tablet contains 520 mg clodronate disodium.

The other ingredients are talc, maize starch, cellulose microcrystalline, magnesium stearate, sodium starch glycolate, hypromellose, polyacrylate dispersion 30 %, macrogol 10000, lactose monohydrate, titanium dioxide (E171), polysorbate 80 and sodium citrate.

What Loron looks like and contents of the pack

Loron tablets are oblong white tablets with E9 marked on one side. They are scored with a break line on both sides, so that they can easily be broken into equal halves.

Loron tablets are supplied in blister packs containing 10 or 60 tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder RIEMSER Pharma GmbH An der Wiek 7

17493 Greifswald-Insel Riems Germany

Manufacturer

CENEXI

52 Rue Marcel et Jacques Gaucher 94120 Fontenay sous Bois France

UK distributor Intrapharm Laboratories Ltd The Courtyard Barns, Choke Lane, Maidenhead, Berks, SL6 6PT United Kingdom

This leaflet was last revised in November 2015.