35 mg film-coated tablet
risedronate sodium
What Risedronate Actavis is and what it is used for
What Risedronate Actavis is
Risedronate Actavis belongs to a group of non-hormone-based medicines called bisphosphonates, which are used to treat skeletal diseases. It acts directly on the bone tissue and makes the bones stronger, which reduces the risk of bone fractures.
Bone is a living tissue. Old bone is continuously removed from the skeleton and replaced with new bone.
Postmenopausal osteoporosis (osteoporosis) is a condition that affects women who have undergone menopause. This leads to the skeleton becoming weaker, more fragile, and more easily affected by fractures in connection with a fall or when it is exposed to stress. Osteoporosis can also occur in men and can be caused by, for example, aging and/or low levels of the male sex hormone testosterone.
The vertebrae, hip bone, and wrists are the bones that most often suffer from fractures, but they can affect any bone in the body. Bone fractures related to osteoporosis can also cause back pain, length loss, and a crooked back. Many patients with osteoporosis have no symptoms and you may not have known you had it.
What Risedronate Actavis is used for
Treatment of osteoporosis in
- women who have undergone menopause. Although they have severe osteoporosis, the drug reduces the risk of vertebral and hip fractures.
- men.
Risedronate sodium contained in Risedronate Actavis may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Risedronate Actavis
Do not use Risedronate Actavis
- if you are allergic to risedronate sodium or any of the other ingredients of this medicine (listed in section 6).
- if your doctor has told you that you have hypocalcemia (a condition with low levels of calcium in your blood).
- if you may be pregnant, pregnant, or planning to become pregnant.
- if you are breastfeeding.
- if you have severe kidney problems.
Warnings and cautions
Talk to your doctor or pharmacist before taking Risedronate Actavis
- if you can not stand or sit upright for at least 30 minutes.
- if you have an abnormal bone or mineral metabolism (for example, vitamin D deficiency, or abnormal levels of parathyroid hormones, both of which can cause low levels of calcium in the blood).
- 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 your doctor has told you that you are intolerant to certain sugars (such as lactose ).
- if you have or have previously had pain, swelling or numbness in the jaw, heaviness in the jaw, or tooth loss.
- If you are receiving dental care or will undergo dental surgery, tell your dentist that you are being treated with Risedronate Actavis.
Your doctor will advise you on what to do when you take Risedronate Actavis if any of the above apply to you.
Children and young people
Risedronate Actavis is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Other medicines and Risedronate Actavis
Medicines containing any of the following reduce the effects of Risedronate Actavis if taken at the same time:
- calcium.
- magnesium.
- aluminum (found in eg preparations for digestive problems).
- iron.
Take these medicines at least 30 minutes after taking the Risedronate Actavis tablet.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Risedronate Actavis with food and drink
Risedronate Actavis tablets mustn’t be taken with food or drink (plain water is allowed). Otherwise, the medicine will lose its effect. This is especially true for dairy products as they contain calcium (see section 2 “Other medicines and Risedronate Actavis”).
Food and drink (other than regular water) should only be taken when at least 30 minutes have passed since you took a Risedronate Actavis tablet.
Pregnancy and breastfeeding
Do not take Risedronate Actavis if you may be pregnant, pregnant, or planning to become pregnant (see section 2 “Do not take Risedronate Actavis”). The risk of using risedronate sodium (the active substance in Risedronate Actavis) in pregnant women is unknown.
Do not take Risedronate Actavis if you are breastfeeding (see section 2 “Do not take Risedronate Actavis”).
Risedronate Actavis should only be used to treat menopausal women and men.
Driving and using machines
Risedronate Actavis has no known effect on 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 attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. 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 Actavis contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to use Risedronate Actavis
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Recommended dose
Take one tablet of Risedronate Actavis (35 mg risedronate sodium) once a week. Choose the day of the week that suits you best. Take the Risedronate Actavis tablet every week on the day of your choice.
To make it easier for you to take the tablet on the same day every week, boxes/spaces are printed on the box. Use them to mark the day of the week you have chosen to take your tablet on.
When to take Risedronate Actavis tablet
Take a Risedronate Actavis tablet at least 30 minutes before your first food, drink (other than regular water), or other medicines.
How to take Risedronate Actavis tablet
- Take the tablet while sitting or standing to avoid heartburn.
- Swallow it with at least one glass (120 ml) of plain water.
- Swallow it 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 and if you are not getting enough in your diet.
If you use more Risedronate Actavis 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 use Risedronate Actavis
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 a double dose to make up for a forgotten tablet.
If you stop using Risedronate Actavis
If you stop the treatment, your bone mass may start to decrease. Consult 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, Risedronate Actavis can cause side effects, although not everybody gets them.
Stop taking Risedronate Actavis and contact your doctor immediately if you experience any of the following:
- symptoms of a severe allergic reaction, eg:
- swelling of the face, tongue, and throat
- difficulty swallowing
- hives and difficulty breathing
- severe skin reactions such as blisters under the skin.
Contact your doctor immediately if you experience any of the following side effects:
- eye inflammation, usually with pain, redness, and photosensitivity.
- tissue loss in the jawbone ( osteonecrosis ) associated with delayed healing and infection, often after tooth extraction (see section 2 “Warnings and Precautions”)
- pain when swallowing and difficulty swallowing chest pain, new or worsening heartburn.
However, in clinical trials, the other side effects observed were usually mild and did not require patients to stop taking their tablets.
The side effects are listed according to how common they are. The following convention has been used:
| very common: | affects more than 1 in 10 users |
|---|---|
| usual: | affects 1 to 10 users in 100 |
| less common: | affects 1 to 10 users in 1,000 |
| rare: | affects 1 to 10 users in 10,000 |
| very rare: | affects less than 1 in 10,000 users |
| no known frequency: | can not be calculated from available data |
Common side effects are
- digestive problems, nausea, abdominal pain, cramps or discomfort in the stomach, constipation, feeling that the stomach is full, gas problems, diarrhea
- pain in the skeleton, muscles, or joints
- headache
Uncommon side effects are
- inflammation or ulcers of the esophagus with difficulty swallowing and pain when swallowing (see also section 2, “Warnings and precautions”), 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 possible visual disturbances)
Rare side effects
- inflammation of the tongue (with swelling and possible pain), narrowing of the esophagus
- Abnormal results in liver function tests have been reported. These can only be diagnosed using blood tests.
From the period after the market introduction, the following side effects have been reported:
- Very rare: 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.
- No known frequency
- hair loss
- liver effects, which in some cases were severe
- inflammation of the small blood vessels which mainly affects the skin (leukocytoclastic vasculitis ).
At the beginning of treatment, in rare cases, the patient may experience decreased levels of calcium and phosphate in the blood. These changes are usually mild and do not cause any 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, or discomfort in the thigh, hip, or groin as this may be an early sign of a possible femoral fracture.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information
How to store Risedronate Actavis
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 label, carton, and blister after EXP: The expiration date is the last day of the specified month.
No special storage instructions.
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 ( amorphous ). One film-coated tablet contains 35 mg of risedronate sodium, equivalent to 32.48 mg of risedronic acid.
- The other ingredients are magnesium stearate, crospovidone, lactose monohydrate, microcrystalline cellulose, hypromellose (E464), colloidal anhydrous silica, hydroxypropylcellulose (E463), macrogol 400, macrogol 8000, titanium dioxide (E171), yellow iron oxide (E172) (red oxide).
What the medicine looks like and the contents of the pack
Film-coated tablet.
Orange, 9.0 mm round, biconvex film-coated tablet.
Pack sizes
Blisters: 2, 4, 8, and 12 film-coated tablets.
Tablet jars: 40 and 50 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Actavis Group PTC EHF.
Reykjavikurvegur 76-78
IS-220 Hafnarfjordur
Iceland
Manufacturer
Actavis hf.
Reykjavíkurvegur 76-78
IS-220 Hafnarfjörður
Iceland