Risedronate Bluefish - Risedronate sodium uses, dose and side effects

Risedronate Bluefish belongs to a group of non-hormonal medicines called bisphosphonates which are used to treat skeletal diseases. The drug has a direct effect on the skeleton by making it stronger and thereby reducing the likelihood that you will suffer a bone fracture.

Bone is living tissue. Old bone disappears continuously from your skeleton and is replaced with new bone.

Postmenopausal osteoporosis (osteoporosis) is a condition that affects women after menopause (menopause) when the skeleton becomes weaker and more fragile and bone fractures are more likely in connection with falls or stress. Osteoporosis can also affect men for several reasons including aging and/or low levels of the male sex hormone testosterone.

The vertebrae, hips, and wrists are the bones that are usually broken, although it can happen to any bone in your body. Fractures due to osteoporosis can also cause back pain, shorten body length and give a curved back. Many patients with osteoporosis do not experience any symptoms and you may not even know you have the disease.

What Risedronate Bluefish is used for

Risedronate Bluefish is used to treat osteoporosis (osteoporosis) in postmenopausal women. It reduces the risk of bone fractures in the spine and hip.

Risedronate Bluefish is used to treat osteoporosis in men at high risk of bone fractures.

Risedronate sodium contained in Risedronate Bluefish may also be approved for the treatment of other conditions not mentioned in this product information. 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 take Risedronate Bluefish

Do not take Risedronate Bluefish

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 something called hypocalcemia (low blood calcium levels)
if you think you are pregnant, pregnant, or planning to become pregnant
if you are breast-feeding
if you have severe renal impairment.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before taking Risedronate Bluefish

if you can not sit or stand upright for at least 30 minutes.
if you have abnormal bone and mineral metabolism (eg vitamin D deficiency, abnormal parathyroid hormone levels) which can lead to low levels of calcium in the blood.
if you have previously had problems with your esophagus. You can e.g. have had pain or difficulty swallowing food or have previously been diagnosed with Barrett’s esophagus (a condition associated with cell changes in the lower esophagus).
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 or swelling in the gums and/or jaw, numb jaw, if the jaw feels heavy, or if you have lost a tooth.
if you are undergoing dental treatment or are about to undergo dental surgery. Tell your dentist that you are being treated with Risedronate Bluefish.

Your doctor will advise you on what to do if any of the above apply to you and you are being treated with Risedronate Bluefish.

Children and young people

Risedronate sodium is not recommended for use in children under 18 years of age due to insufficient data on safety and efficacy.

Other medicines and Risedronate Bluefish

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Medicines containing one of the following substances reduce the effect of Risedronate Bluefish if taken at the same time:

calcium
magnesium
aluminum
iron

Take these medicines at least 30 minutes after taking Risedronate Bluefish.

Risedronate Bluefish 35 mg can be taken with estrogen supplements (in women).

Risedronate Bluefish with food, drink, and alcohol

Risedronate Bluefish mustn’t be taken with food or drink (except plain water). It is especially important not to take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2, “Taking other medicines”).

Food and drink (except plain water) should be taken at least 30 minutes after taking Risedronate Bluefish.

Pregnancy, breastfeeding, and fertility

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Risedronate Bluefish if there is a possibility that you are pregnant, pregnant, or planning to become pregnant (see section 2, “Do not take Risedronate Bluefish”). The risk of using risedronate sodium (the active substance in Risedronate Bluefish) in pregnant women is unknown.

Do not take Risedronate Bluefish if you are breastfeeding (see section 2, “Do not take Risedronate Bluefish”).

Risedronate Bluefish should only be used to treat postmenopausal women.

Driving and using machines

Risedronate Bluefish has no known effect on the ability to drive or use machines.

Risedronate Bluefish 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.

Risedronate Bluefish contains sodium

Risedronate Bluefish contains less than 1 mmol (23 mg) sodium per 35 mg tablet, ie essentially ‘sodium-free’.

How to take Risedronate Bluefish

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose is one tablet of Risedronate Bluefish (35 mg risedronate sodium) once a week. Choose the day of the week that suits you best.

Take one tablet of Risedronate Bluefish weekly on this day of the week.

There is space/boxes on the box. Mark on the box which day you have chosen to take your tablet on. Also, write down the dates you should take your tablet.

When to take your Risedronate Bluefish tablet:

Take your tablet at least 30 minutes before the first meal of the day, and drink (except plain water) or other medicines.

How to take your Risedronate Bluefish tablet:

Take the tablet sitting or standing to avoid heartburn.
Swallow the tablet with at least one glass (120 ml) of plain water. You mustn’t take Risedronate Bluefish with food or drink (except plain water) so that the tablet has the right effect.
Swallow the tablet whole. Do not suck or chew on the tablet.
Do not lie down for the next 30 minutes after taking your tablet.

Your doctor will tell you if you need calcium or vitamin D supplements if you are not getting enough food.

If you take more Risedronate Bluefish than you should

If you or anyone else accidentally takes more tablets of Risedronate Bluefish than prescribed, drink a full glass of milk and contact your doctor or hospital for an assessment of risk as well as advice. Overdose causes a decrease in the calcium levels in your body, symptoms can be sudden, painful, involuntary muscle contractions and then, especially in the abdominal muscles.

If you forget to take Risedronate Bluefish

If you forget to take your tablet on the chosen day of the week, take the tablet the same day you remember that you forgot a tablet. Then continue to take one tablet a week on the day of the week that the tablet is normally taken. Do not take a double dose to make up for a forgotten tablet (if you forgot to take the tablet for a week or more).

If you stop taking Risedronate Bluefish

Osteoporosis treatment often lasts for long periods. Talk to your doctor before considering stopping treatment. If you stop the treatment, you may start to lose bone mass.

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

Possible side effects

Like all medicines, Risedronate Bluefish can cause side effects, although not everybody gets them.

Stop taking Risedronate Bluefish and contact your doctor immediately if you experience any of the following:

Symptoms of severe allergic reaction such as:
- Swelling of the face, tongue, or throat
- Difficulty swallowing
- Hives and difficulty breathing
Severe skin reactions involving blisters under the skin.

Tell your doctor immediately if you experience the following side effects:

Eye inflammation, usually with pain, red eyes, and hypersensitivity to light.
Bone tissue death in the jaw ( osteonecrosis ) is associated with delayed healing and infection, often associated with tooth extraction (see section 2 “Take special care with Risedronate Bluefish”).
Symptoms of the esophagus such as pain when swallowing, difficulty swallowing, chest pain, or new or worsening heartburn.

Other side effects observed were usually mild and did not result in the patient having to discontinue treatment:

Common side effects ( less than 1 in 10 patients but more than 1 in 100 patients):

Indigestion, nausea ( dyspepsia ), constipation, abdominal pain, stomach cramps or discomfort, flatulence.
Pain in bones, muscles, or joints.
Headache.

Uncommon side effects ( less than 1 in 100 patients but more than 1 in 1,000 patients):

Inflammation or ulcer in the esophagus (the connection between the mouth and the stomach) that causes pain and difficulty swallowing. Inflammation or ulcers in the stomach and duodenum (the intestine in which the stomach empties).
Inflammation of the iris (red, painful eyes, possibly with vision changes).

Rare side effects ( less than 1 in 1,000 patients):

Inflammation of the tongue (red, swollen, possibly painful), narrowing of the esophagus (the connection between the mouth and the stomach).
Abnormal liver values have been reported. These can only be detected with a blood test.

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.

Very rare (less than 1 in 10,000 patients):

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.

Unknown frequency:

Osteonecrosis (bone tissue death) in the jaw. Allergic reactions such as hives (rash), swelling of the face, lips, tongue, and/or neck, and difficulty swallowing or breathing. Severe skin reactions may include blisters under the skin. Eye inflammation.

Following the market introduction, the following have been reported (unknown frequency):

Hair loss
Liver disease, in some cases severe
Inflammation and destruction of small blood vessels

In rare cases, the patient’s calcium and phosphate levels in the blood may drop during the start of treatment. These changes are usually small and do not cause any 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.

How to store Risedronate Bluefish

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the carton after “EXP”. The expiration date is the last day of the specified 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.

Contents of the pack and other information

Content declaration

The active substance is risedronate sodium. Each tablet contains 35 mg of risedronate sodium, equivalent to 32.5 mg of risedronic acid.
Other ingredients are Tablet core: pregelatinized maize starch, microcrystalline cellulose, crospovidone, and magnesium stearate. Film coating: Hypromellose, lactose monohydrate, titanium dioxide (E171), macrogol 4000.

What the medicine looks like and the contents of the pack

Risedronate Bluefish is a white, round, biconvex, film-coated tablet with a diameter of 11.2 mm, a thickness of 5.0 mm, and marked with “35” on one side.

Risedronate Bluefish is available in transparent PVC / PE / PVDC / Aluminum blisters containing 4 or 12 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Manufacturer

Bluefish Pharmaceuticals AB

Gävlegatan 22

113 30 Stockholm

Sweden

Pharmathen SA

Dervenakion 6, Pallini Attiki, 15351,

Greece

Pharmathen International SA

Sales Rodopi Prefecture Industrial Park,

Block No 5, Rodopi, 693 00,