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RESTOFOS 10mg Tablet 10's
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INTRODUCTION
RESTOFOS 10MG contains Alendronate which belongs to a group of non-hormonal medicines called bisphosphonates. It is used in the treatment of osteoporosis in men and in post-menopausal women. Osteoporosis is a condition in which the bones become fragile and brittle due to loss of tissue, typically as a result of hormonal changes, or deficiency of calcium or vitamin D. If left untreated, it can cause thinning and weakening of bones in the skeleton which further leads to fractures, usually of the hip, backbone and wrists.
Alendronate prevents the loss of bone that occurs in men and in women after they have been through the menopause and helps to rebuild bone. It reduces the risk of hip and spine fractures. Along with treatment, your doctor may suggest you make changes to your lifestyle to help your condition, such as stop smoking, eat a balanced diet and perform regular exercise. The most common side effects of taking this medicine are jaw swelling and pain, muscle pain, joint pain, stomach pain, bloating and headache.
Do not take this medicine, if you have certain disorders of the esophagus or low calcium levels in your blood. Before taking this medicine, inform your doctor if you have any stomach problems, kidney problem, cancer or low levels of vitamin D. This medicine should be taken on an empty stomach, because food and drink can greatly reduce the effectiveness of the medicine. Do not take this medicine if you are pregnant, think you may be pregnant or are breast-feeding. Consult your doctor for advice. This medicine is strictly not recommended for use in children and adolescents.
USES OF RESTOFOS 10MG
- Used in the treatment of osteoporosis in men and in post-menopausal women
HOW RESTOFOS 10MG WORKS
Alendronate bind to a bone component called hydroxyapatite. It targets the skeleton, and primarily act by inhibiting osteoclastic bone resorption. Generally, bone resorption causes release of alendronic acid, which is that taken up osteoclasts where they induce apoptosis (programmed cell death). Inhibition of osteoclasts, results in a decreased bone resorption, prevents bone loss and helps to rebuild bone.
DIRECTIONS FOR USE
Take this medicine only on an empty stomach. It should only be taken with a full glass of plain water (not less than 200ml) and should be taken at least 30 minutes before any other food, drink or medicine. Do not take this medicine with tea, coffee, mineral water or juice. Swallow the medicine as a whole. Do not crush or chew the medicine. Do not lie down after taking this medicine. You must stay upright (sitting, standing or walking) for at least 30 minutes after you have swallowed the tablet.
SIDE EFFECTS OF RESTOFOS 10MG
SERIOUS
- allergic reactions (such as rash, itching, swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing)
- pain in mouth, and/or jaw
- swelling or sores inside mouth
- loosening of a tooth
- pain behind breastbone
- fracture of thigh bone
- bone, muscle or joint pain
COMMON
- joint swelling
- abdominal pain
- constipation, bloating, diarrhea
- hair loss or itching
- headache
- dizziness
- swelling in hands or legs
- nausea or vomiting
- irritation or inflammation of gullet or stomach
- black or tar-like stools
- blurred vision
- taste disturbance
RARE
- stomach or peptic ulcers
- Mouth and/or throat ulcers
- Skin rash with sensitivity to light
- Low calcium levels which may cause muscle cramps or spasms and tingling sensation in the fingers or around the mouth
- Pain and/or inflammation of the jaw (this is more common in people who have had a tooth taken out and/or a mouth infection)
HOW TO MANAGE SIDE EFFECTS
Feeling sick (nausea):
Try taking this medicine with, or just after, a meal and stick to simple meals. Do not eat rich or spicy food.
Bloating or wind:
Eat smaller and frequent meals. Eat and drink slowly, and exercise regularly. If the symptoms get worse, contact your doctor straight away.
Constipation:
Eat fibre rich foods like fresh fruit, vegetables and cereals. Drink plenty of water. Exercise more regularly.
Diarrhea:
Drink lots of fluids to avoid dehydration. Do not take any other medicines without speaking to a doctor.
Stomach pain:
Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.
WARNING & PRECAUTIONS
PREGNANCY
RESTOFOS 10MG is not recommended for use in pregnant women unless necessary. Discuss the risks and benefits with your doctor.
BREASTFEEDING
RESTOFOS 10MG is not recommended for use in breastfeeding women unless necessary. Discuss the risks and benefits with your doctor.
DRIVING AND USING MACHINES
Do not drive or operate any machines if your ability is affected by this medicine.
ALCOHOL
Avoid consumption of alcohol while taking this medicine.
KIDNEY
RESTOFOS 10MG should be taken with caution in patients with severe kidney disease. Consult your doctor for advice.
ALLERGY
Do not take this medicine if you are allergic to alendronate.
OTHERS
Do not take this medicine, if you have:
- inflammation of esophagus or low levels of calcium in blood
- stomach ulcer, low levels of vitamin D, hypoparathyroidism, pain, swelling or numbness of jaw, loosening of a tooth or cancer
INTERACTIONS
Talk to your doctor, if you are taking:
- non-steroidal anti-inflammatory drug (NSAID) such as acetylsalicylic acid or ibuprofen
- calcium supplements
- antacids (used to reduce stomach acid)
SYNOPSIS
| Drug | : | Alendronate |
| Pharmacological Category | : | Bisphosphonate Derivative |
| Therapeutic Indication | : | Osteoporosis |
| Dosage Forms | : | Tablet |
MORE INFORMATION
Store below 20-25°C and keep out of reach of children.
FAQs ABOUT RESTOFOS 10MG
Can RESTOFOS 10MG be used in pregnancy?
No. This medicine is contraindicated for use during pregnancy. Do not take this medicine if you are pregnant, think you may be pregnant or are breast-feeding.
Can RESTOFOS 10MG be used in chronic kidney failure patients?
It should be taken with caution in patients with chronic kidney failure. Consult your doctor for advice.
REFERENCES
1. KD. Tripathi. Drugs affecting calcium balance. Essentials of medical pharmacology. Seventh edition. 2013. Page – 343-346.
2. Gerald G. Briggs and Roger K. Freeman. A. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 125-127.
3. Peter A. Friedman. Agents affecting mineral ion hemostasis and bone turnover. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1294-1296 & 1298-1299.
4. Amgen. A Randomized, Double-Blind Study to Compare the Efficacy of Treatment with Denosumab Versus Alendronate Sodium in Postmenopausal Women with Low Bone Mineral Density. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on January 2011] [Accessed 24th November 2020] https://clinicaltrials.gov/ct2/show/NCT00330460
5. Aasis Unnanuntana, Atthakorn Jarusriwanna and Panupan Songcharoen. Randomized clinical trial comparing efficacy and safety of brand versus generic alendronate (Bonmax®) for osteoporosis treatment. NCBI; PMC US National Library of Medicine, National Institute of Health. July 2017. [Accessed 24th November 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5498028/
6. Actavis Ltd. Electronic Medicines Compendium (EMC); [Revised on November 2015] [Accessed 24th November 2020] https://www.medicines.org.uk/emc/files/pil.5431.pdf
7. Actavis Ltd. Electronic Medicines Compendium (EMC); [Revised on November 2015] [Accessed 24th November 2020] https://www.medicines.org.uk/emc/files/pil.5697.pdf
8. Merck Sharp & Dohme Limited. Electronic Medicines Compendium (EMC); [Revised on May 2020] [Accessed 24th November 2020] https://www.medicines.org.uk/emc/files/pil.1281.pdf
9. Merck & Co. Inc. U.S. Food & Drug Administration. [Revised on 2000] [Accessed 24th November 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20560slr030,21575slr002_fosamax_lbl.pdf
USEFUL DIAGNOSTIC TESTS
- Calcium test
PRODUCT DETAILS
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