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|Alendronic Acid Genoptim
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
The preparation contains the substance:Sodium alendronate
The drug is available on prescription
What is Alendronic Acid Genoptim?
A drug from the bisphosphonate group affecting bone mineralization, used in the treatment of osteoporosis and other bone tissue diseases.
What does Alendronic Acid Genoptim contain and how does it work?
The active substance of the preparation is alendronic acid (exactly the alendronic acid sodium salt), an organic compound from the bisphosphonate group. Bisphosphonates are a group of medicines that prevent the loss of bone mass used in the treatment and prevention of bone diseases. Bisphosphonates include alendronate, etidronate, clodronate, ibandronic acid, zoledronic acid, pamidronate and risedronate.
Bone tissue is composed of cells and protein fibers and minerals of Calcium
and phosphorus, forming compounds called hydroxyapatites. Bones are subject to constant remodeling thanks to the action of osteoclasts and osteoblasts. Osteoclasts (osteoclastic cells) located in the bone marrow cause dissolution and resorption of bone tissue. In turn, osteoblasts (osteogenic cells) produce an organic part of the bone and are responsible for bone growth and remodeling. In healthy people, the activity of both these cell types is in equilibrium. In the case of some diseases, bone resorption processes may, however, prevail over the process of their construction, which results reduction of bone mass and an increased risk of fractures. Bisphosphonates, by joining with bone hydroxyapatites, build into the bone tissue, stabilize inorganic compounds contained in the bones and inhibit the activity of osteoclasts and accelerate the process of their cell death (apoptosis). This leads to a slower process of bone resorption and inhibition of bone mass loss and bone strength. In studies on the use of bisphosphonates in humans, it has been shown that they reduce the risk of bone fractures in patients with osteoporosis.
After oral administration, the bioavailability of alendronate is approximately 0.6% and is significantly reduced if the preparation is taken immediately before, during or up to 2 hours after a meal. It is distributed to the bone, where it binds to hydroxyapatites. It is not metabolised, excreted unchanged in urine. In the case of renal failure, the rate of excretion can be significantly reduced and more alendronation in the bones can be expected.
When should I use Alendronic Acid Genoptim?
The preparation is indicated for the treatment of osteoporosis in postmenopausal women, in order to reduce the risk of vertebral and hip fractures.
When not to use this preparation?
Unfortunately, even if there are indications to use the preparation, it can not always be used.You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients.
Do not use in people:
· Which can not stand or sit upright for 30 minutes
· With structural abnormalities or diseases of the esophagus that may delay its emptying, such as stenosis or achalasia (a disease associated with excessive contraction of the lower esophageal sphincter)
· With hypocalcemia.
Do not use in pregnant women or breast-feeding women.
Do not use in children (due to lack of appropriate tests).
Take special care with Alendronic Acid Genoptim?
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
The preparation may cause side effects on the esophagus, such as local irritation of the mucous membrane of the esophagus, inflammation, ulcerations, erosions, rarely leading to narrowing of the esophagus. Sometimes these symptoms may be severe and cause hospitalization. To reduce the risk of side effects from the upper gastrointestinal tract, the recommendations for taking bisphosphonate medicines should be strictly followed (see recommendations in the dosage section).
Caution should be exercised when there are active diseases of the upper gastrointestinal tract, such as difficulty in swallowing (dysphagia), gastritis or duodenitis, gastric or duodenal ulcer, active Gastrointestinal bleeding
over the past year, surgical procedures within upper part of the gastrointestinal tract with the exception of pyloric plasticity. In patients diagnosed with Baretta's esophagus, the doctor, after considering the benefits and possible risks, will in each case individually determine whether the preparation is appropriate.
If you have any symptoms that may indicate side effects from the esophagus, you should immediately consult a doctor. These symptoms may include, in particular: irritation of the esophagus, difficulty swallowing, pain during swallowing, retrosternal pain, onset or worsening of indigestion (heartburn). Continued use of the preparation in this situation may lead to serious side effects, including those requiring hospitalization and / or complications.
The instructions for taking the product should be strictly followed. Failure to follow the instructions significantly increases the risk of side effects from the upper gastrointestinal tract.
The use of the preparation may be associated with the risk of osteonecrosis of the jaw. The risk depends on:
· Potency, dose and route of administration of the bisphosphonate group
· The occurrence of neoplastic disease, the use of radiotherapy, Chemotherapy
, and taking corticosteroid
· Smoking tobacco
· Oral and dental diseases, poor oral hygiene, invasive dental procedures, ill-fitting dentures, periodontal diseases.
Patients with poor dental condition before using the product should consult a dentist.
If possible, invasive dental procedures should be avoided during treatment. Before the dental treatment or the necessary surgery of the maxillary surgery, the dentist should be informed about the use of a bisphosphonate drug. If there is osteonecrosis of the jaw, a dental procedure may worsen the existing condition.
During the period of treatment, care should be taken to ensure proper oral hygiene and to regularly attend dental check-ups and examinations. All symptoms of the oral cavity, such as a moving tooth, pain, numbness or swelling of the gums or jaws, should be reported to your doctor immediately.
During the treatment period, bone, joint and / or muscle pain may occur at different times after its start, rarely severe, which may prevent movement. These symptoms usually disappear after discontinuation of the preparation but may recur after resuming treatment.
People with bisphosphonates may have atypical femoral fractures (short, oblique) that occur after a minor injury or even without previous injury.Fractures often occur bilaterally and may be preceded by changes visible in imaging studies. Patients who use bisphosphonates who have a femur fracture should have their thigh bones examined in the other limb. Your doctor may decide to stop using alendronate. Any pain, thigh or groin should be reported to the doctor; these symptoms may directly precede the occurrence of a fracture.
In case of any skin symptoms of hypersensitivity, please consult your doctor; there is a risk of severe skin reactions such as Stevens and Johnson syndrome and toxic epidermal necrolysis.
If the dose is omitted by forgetting, take the tablet the next morning after realizing this fact. Do not take a double dose, but continue with the fixed dose (1 tablet once a week).
In patients with impaired renal function, if the creatinine clearance is less than 35 ml / min, the preparation is not recommended.
Before starting treatment, all calcium and mineral metabolism disorders should be corr
ected (including vitamin D3 deficiency and hypoparathyroidism). In patients with these disorders, it is recommended to monitor the level of calcium in the blood.
During the period of application, a symptomatic or asymptomatic decrease in blood calcium and phosphate levels may occur, especially in patients receiving glucocorticoids. In predisposed patients (eg with vitamin D deficiency, malabsorption syndrome, hypoparathyroidism) symptomatic hypocalcaemia may be severe. During the period of application, an adequate supply of calcium and vitamin D should be ensured, especially in patients using glucocorticoids.
Does this preparation affect the ability to drive vehicles?
There are no studies on the effect of the preparation on the ability to drive and use machines / machines. However, in some people the preparation may cause side effects that may impair psychophysical fitness and ability to drive vehicles and operate equipment / machines. Care should be taken until the individual reaction to the preparation is recognized.
Dosage of Alendronic Acid Genoptim
The preparation is in the form of tablets. It is intended for oral use. Do not exceed the recommended doses, because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts about the use of the preparation, consult your doctor.
Adults: 1 tablet of 70 mg 1 once a week.
Treatment is long-lasting. Your doctor will periodically evaluate the desirability of continuing treatment.
In order to ensure the best absorption of the drug, it is very important to:
· Take the preparation 30 minutes before the first meal, drink or other medication, with a glass, i.e. not less than 200 ml of boiled water (do not use mineral water, milk, tea, coffee, fruit juices or other beverages, because they reduce the absorption of alendronate ).
Please observe the following recommendations:
· Take the medicine in the morning, immediately after getting out of bed, on an empty stomach
· Drink with a full glass of boiled water (at least 200 ml)
· Swallow the tablet whole only; do not chew, chew it, do not allow the tablet to dissolve in the mouth (risk of mouth ulceration)
· Do not eat, drink or take any other medicines at least for 30 minutes after taking the medicine
· Do not lie down for at least 30 minutes after swallowing the tablet (keep sitting or standing position)
· Do not take tablets in the evening or in the morning before getting out of bed
· Adequate calcium and vitamin D3 supply should be provided during treatment.
If you do not take your medicine in the morning, do not take it in later hours, but wait until the next day to accept it as described above.
The use of the preparation in the elderly (after the age of 65) and in patients with mild or moderate degree of renal insufficiency (glomerular filtration rate greater than 35 ml / min) does not require dose adjustment. If the glomerular filtration rate (GFR) is less than 35 ml / min, the preparation is not recommended.
In children and adolescents up to 18.The use of the preparation is not recommended, due to the lack of data on the safety and efficacy of its use in this age group.
Can I use Alendronic Acid Genoptim during pregnancy and breastfeeding?
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or planning to become pregnant, please inform your prescribing physician about this medicine.
It should not be used in pregnant women or in women who are breast-feeding.
Can I use other preparations in parallel?
Tell your doctor about all medicines you have recently taken, including those that are over the counter. In particular, inform your doctor if you are using any of the following medicines:
Preparations containing calcium, magnesium, aluminum or iron, including antacids may reduce the absorption of oral bisphosphonates and negatively affect the effectiveness of treatment; you must strictly follow the rules for taking medicines in this group described above. After taking the preparation, wait at least 30 minutes before taking another medicine orally.
There were no clinically significant interactions of alendronate and estrogen.
Caution should be exercised if non-steroidal anti-inflammatory drugs are used in parallel, which, like alendronate, exert an irritating effect on the mucous membrane of the gastrointestinal tract.
What side effects can occur?
Like all medicines, also Alendronic Acid Genoptim can cause side effects, although they will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Very common: bone, muscle and joint pains, sometimes severe. Common or uncommon: headache, dizziness, abdominal pain, indigestion, constipation, diarrhea, gas discharge, ulceration of the esophagus, dysphagia, bloating, accumulation of gastric contents into the esophagus, nausea, vomiting, gastritis, oesophagitis, erosions esophagitis, tarry stools, taste disorders, inflammation of eye structures (uveitis, scrotum, episcleritis), swelling of the joints, peripheral edema, weakness, transient flu-like symptoms usually associated with the onset of treatment (such as muscle pain, malaise, fever), alopecia, pruritus, rash and erythema. Rare: hypersensitivity reactions (including urticaria and angioneurotic edema
), decreased calcium (hypocalcaemia) with associated symptoms, esophageal stricture, mouth and throat mucosa, gastrointestinal perforation, gastric and / or duodenal ulcer disease and bleeding with upper gastrointestinal tract, osteonecrosis of the jaw, atypical femur fracture, hypersensitivity rash, severe skin reactions such as Stevens and Johnson syndrome, toxic epidermal necrolysis.
Other preparations on the Polish market containing sodium alendronate
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Alendronat Bluefish (tablets)
Alendronate Arrow (coated tablets)
Alendronat-ratiopharm 70 (tablets)
Fosamax 70 (tablets)
Ostemax 70 comfort (tablets)
Ostenil 70 (tablets)
Ostolek (coated tablets)
Sedron (coated tablets)