35 mg film-coated tablet
risedronate sodium
What Risedronate Sandoz is and what it is used for
Risedronate Sandoz is used for treating osteoporosis in
- menopausal women, even if they have severe osteoporosis (osteoporosis). The preparation reduces the risk of spine and hip fractures.
- men at high risk for fracture er.
The active substance in Risedronate Sandoz, risedronate, belongs to the group of medicines bisphosphonates. It acts directly on the bone tissue and makes the bones stronger, which reduces the risk of bone fractures.
Risedronate sodium contained in Risedronate Sandoz may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist,t or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Risedronate Sandoz
Do not take Risedronate Sandoz again
- you are allergic to risedronate sodium or any of the other ingredients of this medicine (listed in section 6).
- The calcium level in your blood is abnormally low
- there is a possibility that you are pregnant, are pregnant,t or planning to become pregnant
- you breastfeed
- you have a severe kidney problem.
Warnings and cautions
Talk to your doctor before using Risedronate Sandoz if any of the following apply to you:
- if you can not stand or sit upright for at least 30 minutes
- if you have abnormal bone or mineral turnover, for example:
- vitamin D deficiency
- abnormal content of parathyroid hormones
Both conditions can cause an abnormally low calcium content in the body.
- if you have previously had problems with the esophagus, for example, had pain or difficulty swallowing food, or have previously been diagnosed with Barrett’s esophagus (a condition associated with cell changes in the lower part of the esophagus)
- if you have or have previously had pain, swelling,g or numbness in the jaw, feeling of heaviness in the jaw,w or tooth loss
- if you are receiving dental care or will undergo dental surgery tell your dentist that you are being treated with Risedronate Sandoz.
- if you have been told by your doctor that you have an intolerance to some sugars (such as lactose ).
Children and young people
Risedronate Sandoz is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.
Other medicines and Risedronate Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, n, or might take any other medicines.
Medicines containing any of the following reduce the effects of Risedronate Sandoz if taken at the same time:
- calcium
- magnesium
- aluminum, which is found in, for example, preparations for heartburn
- iron
Take these medicines at least 30 minutes after taking your Risedronate Sandoz tablet.
Risedronate Sandoz with food and drink
Risedronate Sandoz tablets must not be taken with food or drink (plain water is allowed). Otherwise,e the medicine will lose its effect. This is especially true of dairy products (such as milk) as they contain calcium.
Food and drink (other than regular water) should only be taken when at least 30 minutes have passed since you took a Risedronate Sandoz tablet.
Pregnancy and breastfeeding
Do not take Risedronate Sandoz if there is a possibility that you are pregnant, pregnant, or planning to become pregnant.
The risk of using risedronate sodium in pregnant women is unknown.
Do not take Risedronate Sandoz if you are breastfeeding.
Risedronate Sandoz should only be used to treat postmenopausal women and men.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
As far as is known, Risedronate Sandozdoes not affect the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle
or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effect. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Risedronate Sandoz contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
How to use Risedronate Sandoz
Dosage
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is 1 tablet once a week.
Choose the day of the week that suits you best. Take one tablet of Risedronate Sandoz weekly on this weekday.
Method of use
The tablet should be taken whole:
- in the morning at least 30 minutes before the first intake of food, drink, or other drugs
- while sitting or standing, to avoid heartburn
- with at least one glass (120 ml) of plain water.
- Swallow the tablet whole. Do not suck or chew on the tablet.
Do not go to bed until at least 30 minutes have passed after taking the tablet.
Your doctor will tell you if you need calcium or vitamin supplements.
Duration of treatment
Talk to your doctor before considering stopping treatment. Your doctor will decide this.
If you take more Risedronate Sandoz than you should
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
Drink a glass of milk and contact your doctor or hospital immediately if you have taken more tablets than you should.
If you forget to take Risedronate Sandoz
If you forget to take the tablet on the day of the week you have chosen, take it the same day you remember it. Then continue to take one tablet a week on the usual day of the week.
Do not take two tablets on the same day to make up for a forgotten tablet.
If you stop taking Risedronate Sandoz
If you stop the treatment, your bone mass may start to decrease. Discuss the matter with your doctor before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Risedronate Sandoz and contact your doctor immediately if you experience any of the following:
- symptoms of severe allergic reaction such as:
- swelling of the face, lips, tongue, throat, and/or throat
- difficulty swallowing
- difficulty breathing
- hives and skin rashes
- severe skin reaction, such as:
- blistering of the skin, mouth, eye,s and other mucous membranes (eg genitals) (Stevens-Johnson’s south)
- palpable red spots on the skin caused by inflammation in small blood vessels (leukocytoclastic vasculitis )
- red rash over many parts of the body and/or with flaking of the outer layer of the skin ( toxic epidermal necrolysis ).
Contact your doctor immediately if you have:
- eye inflammation, usually with pain, redness, and photosensitivity.
- Tissue loss in the jawbone is associated with delayed healing and infection, often after tooth extraction
- pain when swallowing and difficulty swallowing chest pain, new or worsening heartburn.
Common side effects may affect less than 1 in 10 people
- digestive problems, nausea, abdominal pain, cramps or discomfort in the stomach, constipation, feeling that the stomach is full, gas problems, diarrhea
- pain in the legs, muscles, or joints
- headache
Uncommon side effects may affect less than 1 in 100 people
- inflammation or ulcers in the esophagus that cause difficulty swallowing and pain when swallowing
- inflammation of the stomach and duodenum (the intestine in which the stomach empties).
- inflammation of the iris with redness and pain in the eyes and visual disturbances
Rare side effects may affect less than 1 in 1,000 people
- inflammation of the tongue with swelling and possible pain
- constrictions in the esophagus
- abnormal results in liver function tests
- decreased levels of calcium or phosphate in the blood (these changes are usually mild, occur at the beginning of treatment, and give no symptoms).
- Unusual femoral fractures, especially in patients receiving long-term treatment for osteoporosis, may occur in rare cases. Contact your doctor if you experience pain, weakness,s or discomfort in the thigh, high,p, or groin as this may be an early sign of a possible femoral fracture.
Very rare side effects may affect less than 1 in 10,000 people
- Talk to a doctor if you have ear pain, discharge from the ear, and/or an ear infection. This may be a sign of a bone injury in the ear.
Following the launch of the drug, the following side effects (with unknown frequency) have been reported:
- Hair loss
- Liver disease, in some cases severe.
How to store Risedronate Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister, label, or carton after “EXP”. or “EXP”. The expiration date is the last day of the specified month.
No special storage instructions.
Shelf life after first opening:
Jars: 6 months
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.
Contents of the pack and other information
Content declaration
- The active substance is risedronate sodium. Each film-coated tablet contains 35 mg of risedronate sodium, equivalent to 32.5 mg of risedronic acid.
- The other ingredients are in the tablet core microcrystalline cellulose, crospovidone, lactose monohydrate, magnesium sstearatee, and in the film coating hypromellose, macrogol 400, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).
What the medicine looks like and the contents of the pack
Oval, orange, round on both sides and bears the marking “35” on one side.
The film-coated tablets are packaged in PVC / Alu-blister packs and inserted in a carton or packed in HDPE cans with polyethylene closures.
Pack sizes:
Blisters: 1, 2, 4, 10, 12, 16, 28, 84 film-coated tablets.
Cans: 1, 2, 4, 10, 12, 16, 28, 84 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer:
LEK Pharmaceuticals dd,Trimline 2D, 9220 Lendava, Slovenia