RISEDRONATE SODIUM 5 MG FILM-COATED TABLETS
Active substance: RISEDRONATE SODIUM HEMIPENTAHYDRATE
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Risedronate Sodium 5mg film-coated tablets
Read all of this leaflet carefully before you start taking this medicine.
Risedronate sodium - 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. if you have been told by your doctor that you have an intolerance to some sugars (such as lactose). if you have had or have pain, swelling or numbness of the jaw or a heavy jaw feeling or loosening of a tooth. If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Risedronate. Your doctor will advise you on what to do when taking Risedronate if you have any of the above. Children Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.
PACKAGE LEAFLET: INFORMATION FOR THE USER
In this leaflet:
1. 2. 3. 4. 5. 6.
1. WHAT RISEDRONATE IS AND WHAT IT IS USED FOR
Risedronate belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. It works directly on your bones to make them stronger and therefore less likely to break. Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone. Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain. Osteoporosis is more likely to occur in women who have reached the menopause early and also in patients treated long-term with steroids. The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis-related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it. The treatment of osteoporosis in postmenopausal women The prevention of osteoporosis in women with an increased risk of osteoporosis (including low bone mass, early menopause or a family history of osteoporosis). in postmenopausal women who have been on high doses of steroid drugs for a long time. It maintains or increases bone mass.
What Risedronate is and what it is used for Before you take Risedronate How to take Risedronate Possible side effects How to store Risedronate Further information
Taking other medicines
What Risedronate is
Medicines containing one of the following lessen the effect of Risedronate if taken at the same time: calcium magnesium aluminium (for example some indigestion mixtures) iron Take these medicines at least 30 minutes after taking Risedronate. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is very important that you do NOT take your Risedronate tablet with food or drinks (other than plain water) so that it can work properly. In particular do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, Taking other medicines). Take food and drinks (other than plain water) at least 30 minutes after your Risedronate tablet. Ask your doctor or pharmacist for advice before taking any medicine. Do NOT take Risedronate if you may be pregnant, are pregnant or are planning to become pregnant (see section 2 Do not take Risedronate). The potential risk associated with the use of risedronate sodium (active substance in Risedronate) in pregnant women is unknown. Do NOT take Risedronate if you are breast-feeding (see section 2 Do not take Risedronate).
Taking Risedronate with food and drink
Pregnancy and breast-feeding
What Risedronate is used for
Driving and using machines
2. BEFORE YOU TAKE RISEDRONATE
Do not take Risedronate
Risedronate is not known to affect your ability to drive and use machines.
Take special care and talk to your doctor BEFORE you start taking Risedronate
- if you are allergic (hypersensitive) to risedronate sodium or any of the other ingredients of Risedronate (see section 6 What Risedronate contains). - if your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level). - if you may be pregnant, are pregnant or are planning to become pregnant. - if you are breast-feeding. - if you have severe kidney problems. if you are unable to stay in an upright position (sitting or standing) for at least 30 minutes. if you have abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level). if you have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have had pain or difficulty in swallowing food.
Important information about some of the ingredients of Risedronate
Risedronate contains a small amount of lactose. If you have been told by your doctor that you have an intolorance to some sugars, contact your doctor before taking this medicinal product (see section 2, Take special care and talk to your doctor before you start taking Risedronate).
3. HOW TO TAKE RISEDRONATE
Dosage
Always take Risedronate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Usual dose Take ONE Risedronate (5mg risedronate sodium) once a day. IT IS BEST to take your tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day. If in particular instance you are unable to take your Risedronate tablet at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways:
When to take your Risedronate tablet:
EITHER: Between meals: at least 2 hours after your last food, drink (other than plain water) or other medicine. Do not eat or drink (other than plain water) for 2 hours after taking the tablet. OR: In the evening: at least 2 hours after your last food, drink (other than plain water) or other medicine of the day. Risedronate should be taken at least 30 minutes before going to bed. Take the tablet whilst you are in an upright position (you may sit or stand) to avoid heartburn. Swallow it with at least one glass (120ml) of plain water. Swallow it whole. Do not suck or chew the tablet. Do not lie down for 30 minutes after taking the tablet. Your doctor will tell you if you need calcium and vitamin supplements, if you are not taking enough from your diet.
How to take your Risedronate tablet:
If you take more Risedronate than you should If you forget to take Risedronate
If you or somebody else has accidentally taken more Risedronate tablets than prescribed, drink one full glass of milk and seek medical attention. If you have forgotten to take your tablet at your regular time, you can take it at the next possible time according to the instruction above (i.e. before breakfast, between meals, or in the evening). Do not take two tablets in one day to make up for the tablet you missed.
Abnormal liver tests have been reported. These can only be diagnosed from a blood test. 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. During post-marketing experience, the following have been reported (unknown frequency); Allergic reactions of the skin such as urticaria (hives), skin rash, swelling of the face, lips, tongue and/or neck, difficulty in swallowing or breathing. Severe skin reactions including vesiculation (blistering) under the skin; inflammation of small blood vessels, characterised by palpable red spots on the skin (leukocytoclastic vasculitis); a serious illness called Stevens Johnson syndrome (SJS) with blistering of the skin, mouth, eyes and other moist body surfaces (genitals); a severe illness called toxic epidermal necrolysis (TEN) which causes a red rash over many parts of the body and/or loss of the outer layer of skin. Hair loss. Allergic reactions (hypersensitivity). Serious liver disorders, mainly if you are treated with other medicinal products known to cause liver problems. Inflammation of the eye which causes pain and redness. Rarely, at the beginning of treatment, a patients blood calcium and phosphate levels may fall. These changes are usually small and cause no symptoms. 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. Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions. Do not use Risedronate after the expiry date which is stated on the carton. 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.
If you stop taking Risedronate
5. HOW TO STORE RISEDRONATE
If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment. Like all medicines, Risedronate can cause side effects, although not everybody gets them. Stop taking Risedronate and contact a doctor immediately if you experience any of the following: Symptoms of a severe allergic reaction such as: Swelling of the face, tongue or throat Difficulties in swallowing Hives and difficulties in breathing Severe skin reactions that can include blistering of the skin. Tell your doctor promptly if you experience the following side effects: Eye inflammation, usually with pain, redness and light sensitivity. Bone necrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, Take special care and talk to your doctor before you start taking Risedronate). Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new/worsened heartburn. However in clinical studies the other side effects that were observed were usually mild and did not cause the patient to stop taking their tablets. Common side effects (affects 1 to 10 users in 100): Indigestion, feeling sick, stomach ache, stomach cramps or discomfort, constipation, feelings of fullness, bloating, diarrhoea. Pain in your bones, muscles or joints. Headache. Uncommon side effects (affects 1 to 10 users in 1,000): Inflammation or ulcer of the oesophagus (the tube that connects your mouth with your stomach) causing difficulty and pain in swallowing (see also section 2, Take special care and talk to your doctor before you start taking Risedronate), inflammation of the stomach and duodenum (bowel draining the stomach). Inflammation of the coloured part of the eye (iris) (red painful eyes with a possible change in vision). Rare side effects (affects 1 to 10 users in 10,000): Inflammation of the tongue (red swollen, possibly painful), narrowing of the oesophagus (the tube that connects your mouth with your stomach).
4. POSSIBLE SIDE EFFECTS
6. FURTHER INFORMATION
What Risedronate contains
- The active substance is Risedronate sodium. Each tablet contains 5mg risedronate sodium, equivalent to 4.64mg risedronic acid. - The other ingredients are: Tablet core: starch, pregelatinised (maize); cellulose, microcrystalline; crospovidone; magnesium stearate. Film coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000.
What Risedronate looks like and contents of the pack
Risedronate are white round biconvex film-coated tablets with diameter of 6.1mm and 2.6mm in thickness. They are supplied in blister packs containing 14, 28, 84 and 98 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder & Manufacturer
Pharmathen SA 6 Dervenakion str. 15351 Pallini, Attiki Greece
This leaflet was last approved in 09/2011. 1010050-P4.1
Aspire Pharma Limited Antrobus House Business Centre 18 College Street, Petersfield Hampshire, GU31 4AD United Kingdom
Distributor:
Read all of this leaflet carefully before you start taking this medicine.
Risedronate sodium - 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. if you have been told by your doctor that you have an intolerance to some sugars (such as lactose). if you have had or have pain, swelling or numbness of the jaw or a heavy jaw feeling or loosening of a tooth. If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Risedronate. Your doctor will advise you on what to do when taking Risedronate if you have any of the above. Children Risedronate sodium is not recommended for use in children below age 18 due to insufficient data on safety and efficacy.
PACKAGE LEAFLET: INFORMATION FOR THE USER
In this leaflet:
1. 2. 3. 4. 5. 6.
1. WHAT RISEDRONATE IS AND WHAT IT IS USED FOR
Risedronate belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat bone diseases. It works directly on your bones to make them stronger and therefore less likely to break. Bone is a living tissue. Old bone is constantly removed from your skeleton and replaced with new bone. Postmenopausal osteoporosis is a condition occurring in women after the menopause where the bones become weaker, more fragile and more likely to break after a fall or strain. Osteoporosis is more likely to occur in women who have reached the menopause early and also in patients treated long-term with steroids. The spine, hip and wrist are the most likely bones to break, although this can happen to any bone in your body. Osteoporosis-related fractures can also cause back pain, height loss and a curved back. Many patients with osteoporosis have no symptoms and you may not even have known that you had it. The treatment of osteoporosis in postmenopausal women The prevention of osteoporosis in women with an increased risk of osteoporosis (including low bone mass, early menopause or a family history of osteoporosis). in postmenopausal women who have been on high doses of steroid drugs for a long time. It maintains or increases bone mass.
What Risedronate is and what it is used for Before you take Risedronate How to take Risedronate Possible side effects How to store Risedronate Further information
Taking other medicines
What Risedronate is
Medicines containing one of the following lessen the effect of Risedronate if taken at the same time: calcium magnesium aluminium (for example some indigestion mixtures) iron Take these medicines at least 30 minutes after taking Risedronate. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is very important that you do NOT take your Risedronate tablet with food or drinks (other than plain water) so that it can work properly. In particular do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, Taking other medicines). Take food and drinks (other than plain water) at least 30 minutes after your Risedronate tablet. Ask your doctor or pharmacist for advice before taking any medicine. Do NOT take Risedronate if you may be pregnant, are pregnant or are planning to become pregnant (see section 2 Do not take Risedronate). The potential risk associated with the use of risedronate sodium (active substance in Risedronate) in pregnant women is unknown. Do NOT take Risedronate if you are breast-feeding (see section 2 Do not take Risedronate).
Taking Risedronate with food and drink
Pregnancy and breast-feeding
What Risedronate is used for
Driving and using machines
2. BEFORE YOU TAKE RISEDRONATE
Do not take Risedronate
Risedronate is not known to affect your ability to drive and use machines.
Take special care and talk to your doctor BEFORE you start taking Risedronate
- if you are allergic (hypersensitive) to risedronate sodium or any of the other ingredients of Risedronate (see section 6 What Risedronate contains). - if your doctor has told you that you have a condition called hypocalcaemia (a low blood calcium level). - if you may be pregnant, are pregnant or are planning to become pregnant. - if you are breast-feeding. - if you have severe kidney problems. if you are unable to stay in an upright position (sitting or standing) for at least 30 minutes. if you have abnormal bone and mineral metabolism (for example lack of vitamin D, parathyroid hormone abnormalities, both leading to a low blood calcium level). if you have had problems in the past with your oesophagus (the tube that connects your mouth with your stomach). For instance you may have had pain or difficulty in swallowing food.
Important information about some of the ingredients of Risedronate
Risedronate contains a small amount of lactose. If you have been told by your doctor that you have an intolorance to some sugars, contact your doctor before taking this medicinal product (see section 2, Take special care and talk to your doctor before you start taking Risedronate).
3. HOW TO TAKE RISEDRONATE
Dosage
Always take Risedronate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Usual dose Take ONE Risedronate (5mg risedronate sodium) once a day. IT IS BEST to take your tablet at least 30 minutes before the first food, drink (other than plain water) or other medicine of the day. If in particular instance you are unable to take your Risedronate tablet at this time, you may take it on an empty stomach, at the same time every day, in one of the following ways:
When to take your Risedronate tablet:
EITHER: Between meals: at least 2 hours after your last food, drink (other than plain water) or other medicine. Do not eat or drink (other than plain water) for 2 hours after taking the tablet. OR: In the evening: at least 2 hours after your last food, drink (other than plain water) or other medicine of the day. Risedronate should be taken at least 30 minutes before going to bed. Take the tablet whilst you are in an upright position (you may sit or stand) to avoid heartburn. Swallow it with at least one glass (120ml) of plain water. Swallow it whole. Do not suck or chew the tablet. Do not lie down for 30 minutes after taking the tablet. Your doctor will tell you if you need calcium and vitamin supplements, if you are not taking enough from your diet.
How to take your Risedronate tablet:
If you take more Risedronate than you should If you forget to take Risedronate
If you or somebody else has accidentally taken more Risedronate tablets than prescribed, drink one full glass of milk and seek medical attention. If you have forgotten to take your tablet at your regular time, you can take it at the next possible time according to the instruction above (i.e. before breakfast, between meals, or in the evening). Do not take two tablets in one day to make up for the tablet you missed.
Abnormal liver tests have been reported. These can only be diagnosed from a blood test. 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. During post-marketing experience, the following have been reported (unknown frequency); Allergic reactions of the skin such as urticaria (hives), skin rash, swelling of the face, lips, tongue and/or neck, difficulty in swallowing or breathing. Severe skin reactions including vesiculation (blistering) under the skin; inflammation of small blood vessels, characterised by palpable red spots on the skin (leukocytoclastic vasculitis); a serious illness called Stevens Johnson syndrome (SJS) with blistering of the skin, mouth, eyes and other moist body surfaces (genitals); a severe illness called toxic epidermal necrolysis (TEN) which causes a red rash over many parts of the body and/or loss of the outer layer of skin. Hair loss. Allergic reactions (hypersensitivity). Serious liver disorders, mainly if you are treated with other medicinal products known to cause liver problems. Inflammation of the eye which causes pain and redness. Rarely, at the beginning of treatment, a patients blood calcium and phosphate levels may fall. These changes are usually small and cause no symptoms. 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. Keep out of the reach and sight of children. This medicinal product does not require any special storage conditions. Do not use Risedronate after the expiry date which is stated on the carton. 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.
If you stop taking Risedronate
5. HOW TO STORE RISEDRONATE
If you stop treatment you may begin to lose bone mass. Please talk to your doctor before you consider stopping treatment. Like all medicines, Risedronate can cause side effects, although not everybody gets them. Stop taking Risedronate and contact a doctor immediately if you experience any of the following: Symptoms of a severe allergic reaction such as: Swelling of the face, tongue or throat Difficulties in swallowing Hives and difficulties in breathing Severe skin reactions that can include blistering of the skin. Tell your doctor promptly if you experience the following side effects: Eye inflammation, usually with pain, redness and light sensitivity. Bone necrosis of the jaw (osteonecrosis) associated with delayed healing and infection, often following tooth extraction (see section 2, Take special care and talk to your doctor before you start taking Risedronate). Symptoms from oesophagus such as pain when you swallow, difficulties in swallowing, chest pain or new/worsened heartburn. However in clinical studies the other side effects that were observed were usually mild and did not cause the patient to stop taking their tablets. Common side effects (affects 1 to 10 users in 100): Indigestion, feeling sick, stomach ache, stomach cramps or discomfort, constipation, feelings of fullness, bloating, diarrhoea. Pain in your bones, muscles or joints. Headache. Uncommon side effects (affects 1 to 10 users in 1,000): Inflammation or ulcer of the oesophagus (the tube that connects your mouth with your stomach) causing difficulty and pain in swallowing (see also section 2, Take special care and talk to your doctor before you start taking Risedronate), inflammation of the stomach and duodenum (bowel draining the stomach). Inflammation of the coloured part of the eye (iris) (red painful eyes with a possible change in vision). Rare side effects (affects 1 to 10 users in 10,000): Inflammation of the tongue (red swollen, possibly painful), narrowing of the oesophagus (the tube that connects your mouth with your stomach).
4. POSSIBLE SIDE EFFECTS
6. FURTHER INFORMATION
What Risedronate contains
- The active substance is Risedronate sodium. Each tablet contains 5mg risedronate sodium, equivalent to 4.64mg risedronic acid. - The other ingredients are: Tablet core: starch, pregelatinised (maize); cellulose, microcrystalline; crospovidone; magnesium stearate. Film coating: hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000.
What Risedronate looks like and contents of the pack
Risedronate are white round biconvex film-coated tablets with diameter of 6.1mm and 2.6mm in thickness. They are supplied in blister packs containing 14, 28, 84 and 98 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder & Manufacturer
Pharmathen SA 6 Dervenakion str. 15351 Pallini, Attiki Greece
This leaflet was last approved in 09/2011. 1010050-P4.1
Aspire Pharma Limited Antrobus House Business Centre 18 College Street, Petersfield Hampshire, GU31 4AD United Kingdom
Distributor:
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
