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Atelvia (Generic Risedronate)

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Why is this medication prescribed?

In women who have experienced menopause (the “change of life,” the end of monthly periods), risedronate pills and delayed-release (long-acting tablets) are used to prevent and treat osteoporosis (a disorder in which the bones become thin and fragile and break easily). For both men and women using glucocorticoids, osteoporosis is also treated with risedronate tablets (a type of corticosteroid medication that may cause osteoporosis). Additionally, Paget’s disease of the bones is managed using risedronate pills (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Risedronate belongs to the bisphosphonates class of drugs. It functions by halting bone deterioration and boosting bone density (thickness).

How should this medicine be used?

Risedronate is available as an oral tablet and a delayed-release tablet. Once a week, right after breakfast, the delayed-release pills are often taken. Depending on your health and the dosage recommended by your doctor, the tablets are typically taken on an empty stomach once daily in the morning, once weekly in the morning, once monthly in the morning, or once monthly for two mornings in a row. Take risedronate on the same day each week, each month, or the same two days consecutively each month if you take it once a week, once a month, or twice a month. Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take risedronate as prescribed by your doctor. Never take it in larger or less amounts, or for longer periods of time than your doctor has advised.

If risedronate is not taken as directed, it might not work as intended, hurt the oesophagus (the tube that connects the mouth and stomach), or result in mouth sores. If you don’t understand, don’t think you’ll remember, or are unable to follow these directions, tell your doctor right away.

  • Risedronate tablets must be taken as soon as you get out of bed in the morning and before you consume any food or liquids. Risedronate delayed-release tablets must be taken right after following breakfast. Never take risedronate right before going to sleep or right before getting out of bed for the day.
  • While seated or standing, swallow the pills with a full glass (6 to 8 ounces [180 to 240 mL]) of ordinary water. While seated or standing, ingest the delayed-release tablets with at least 4 ounces (120 mL) of ordinary water. Never take risedronate with anything other than plain water, including tea, coffee, juice, mineral water, milk, or other dairy products.
  • Pills and delayed-release tablets should be taken whole. Never eat, split, or crush them. The tablets should not be chewed or kept in the mouth for an extended period of time.
  • Do not eat, drink, or take any other drugs for at least 30 minutes after taking risedronate. For at least 30 minutes after taking risedronate, avoid lying down. Wait at least 30 minutes before sitting or standing up straight.

Despite not curing Paget’s disease of the bones or osteoporosis, risedronate manages these illnesses. Risedronate works best to treat and prevent osteoporosis when taken frequently. Risedronate should still be taken even if you feel OK. Do not discontinue taking risedronate without consulting your doctor, but occasionally discuss whether you still require risedronate with your doctor.

When you start risedronate therapy and each time you refill your prescription, your doctor or pharmacist will give you the medication guide provided by the manufacturer. If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking risedronate,

  • If you have an allergy to risedronate, any other drugs, or any of the ingredients in risedronate tablets or delayed-release tablets, tell your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about all prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products that you are now taking or intend to use. Incorporate any of the following: Aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (Advil, Ibu-Tab, Motrin, others), and naproxen (Aleve, Naprelan, Naprosyn, others), cancer chemotherapy, or oral steroids like dexamethasone, methylprednisolone (Medrol), and prednisone. Angiogenesis inhibitors like bevacizumab (Avastin (Rayos). You should let your doctor know if you are taking the delayed-release tablets along with any H2 blockers or proton pump inhibitors, such as cimetidine, famotidine (Pepcid), nizatidine (Axid), and ranitidine (Zantac), as well as esomeprazole (Nexium, in Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid (AcipHex). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Actonel and Atelvia both include risedronate, so you should be aware of it. Both of these drugs must be taken separately.
  • Take any additional oral drugs, such as antacids, vitamins, or supplements, at least 30 minutes after taking risedronate.
  • If you are unable to sit or stand erect for at least 30 minutes, as well as if you currently have or previously had a low calcium level in your blood, let your doctor know. Your doctor might advise against taking risedronate.
  • Inform your doctor if you are undergoing radiation therapy, experiencing difficulty swallowing, heartburn, ulcers, or any other stomach issues, have cancer, any type of infection, particularly in your mouth, issues with your mouth, teeth, or gums, any condition that prevents your blood from clotting normally, or have dental or kidney disease. Anemia is a condition in which the red blood cells do not bring enough oxygen to all parts of the body.
  • Inform your doctor if you are expecting or nursing a child. Additionally, let your doctor know if you intend to conceive in the future because risedronate may stay in your system for years after you stop taking it. If you find out you’re pregnant while or after taking risedronate, call your doctor right away.
  • It’s important to be aware that risedronate may induce excruciating joint, muscle, or bone discomfort. After taking risedronate for the first time, you can experience this pain days, months, or even years later. It’s critical that you and your doctor are aware that risedronate may be the source of this type of pain, even if it may start after you’ve taken the medication for a while. If you ever have significant discomfort while receiving risedronate treatment, call your doctor right once. The doctor might advise you to stop taking risedronate, and your pain might go away if you do so.
  • Risedronate may develop osteonecrosis of the jaw (ONJ), a dangerous disorder of the jaw bone, therefore you should be aware of this, especially if you receive dental care while taking the prescription. Before you begin taking risedronate, get your teeth checked by a dentist and have any necessary procedures, such as cleaning or repairing ill-fitting dentures, performed. While using risedronate, make sure to carefully brush your teeth and clean out your mouth. Before getting any dental work done while taking this medication, see your doctor.
  • Consult your doctor about further measures you might take to halt the progression of osteoporosis. Your doctor will probably advise you to quit smoking, limit your alcohol intake, and engage in regular weight-bearing activity.

What special dietary instructions should I follow?

While taking risedronate, you should consume a lot of foods that are high in calcium and vitamin D. Your doctor will advise you on the best foods to eat in order to get these nutrients as well as the recommended daily portion size. Inform your doctor if you have trouble consuming enough of these items. In that situation, your doctor may suggest or prescribe a supplement.

What should I do if I forget a dose?

Do not take the once-daily risedronate medication again if you miss a dose. Take one pill as usual the next morning and skip the missed dose.

Do not take the once-weekly risedronate dose the following day if you missed it. The morning after you recall, take one dose. Then go back to taking one dose on the day you usually do each week.

Take the missing dosage of once-monthly risedronate the morning after you realise you missed it if you remember more than 7 days before your next dose is planned. Do not take the missed dose if you remember it fewer than 7 days before your next scheduled dose. Wait until the morning of your next scheduled dose and then proceed as usual with the risedronate.

You can take the missed doses of the once-monthly, two-days in a row risedronate if you remember more than 7 days before your next scheduled dose. If you missed both doses, take the second missed dose the morning after you take the first one. Take the first missed dose as soon as you remember it. Do not take the missing dose if you remember less than 7 days before your next scheduled dose (s). Wait until the morning of your next scheduled dose and then proceed as usual with the risedronate.

Call your doctor if you forget to take your risedronate dose and are unsure what to do. Risedronate should always be taken first thing in the morning. Never take two doses in one day, and never take two doses to make up for a missing one.

What side effects can this medication cause?

Side effects from risedronate could exist. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Nausea
  • Burping
  • Mouth ache
  • Abdominal pain
  • Diarrhea
  • Constipation
  • Gas
  • Headache
  • Dizziness
  • Weakness
  • Leg twitches
  • Back ache
  • Urge to urinate frequently or immediately
  • Unpleasant urination

Some adverse effects can be very harmful. Before taking any additional risedronate, call your doctor right away if you suffer any of the following negative effects:

  • Swallowing problems or swallowing pain
  • New or escalating heartburn
  • Chest pain
  • Itching
  • Rash
  • Hives
  • Skin blisters
  • Swelling of the lower legs, hands, feet, ankles, or face, neck, tongue, lips, eyes, or mouth
  • Having trouble breathing
  • Hoarseness
  • Cramps, twitches, or spasms of the muscles
  • Tingling or numbness in the hands, feet, or mouth
  • Eyes that are swollen, red, or hurt.
  • Responsiveness to light
  • Bruised or painful gums
  • Tooth sensitivity
  • Jaw tingling or feeling heavy
  • Jaw healing is not very good
  • Hips, thighs, or groyne: dull, aching ache

Other negative effects of risedronate are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

Using a bisphosphonate drug for osteoporosis, such risedronate, may make you more likely to break your thigh bone (s). Before the bone(s) break, you may suffer discomfort in your hips, groyne, or thighs for a few weeks or months. You may also discover that one or both of your thigh bones have broken even though you haven’t fallen or been in any other kind of accident. In healthy individuals, it is uncommon for the thigh bone to break, however individuals with osteoporosis may still break this bone even if they do not take risedronate. The dangers of taking risedronate should be discussed with your doctor.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Store it away from excessive heat and moisture at room temperature (not in the bathroom).

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

In case of emergency/overdose

Give the victim a full glass of milk in the event of an overdose, and then dial 1-800-222-1222 to contact your local poison control centre. Dial 911 to reach the nearest emergency services if the sufferer has collapsed or has stopped breathing.

Overdose signs could include the following:

  • Tingling or numbness in the hands, feet, or mouth
  • Cramps, twitches, or spasms of the muscles
  • Seizures

What other information should I know?

Keep all of your appointments with your physician and the lab.

Inform your doctor and the lab staff that you are taking risedronate prior to any laboratory test or bone imaging study.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Actonel®
  • Atelvia
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