OSTENIL 70 mg Tablets

Contents of the leaflet

1. WHAT IS OSTENIL 70 AND WHAT IS IT USED FOR
2. IMPORTANT INFORMATION BEFORE TAKING OSTENIL 70
   1. When not to take Ostenil 70
   2. Warnings and precautions
   3. Ostenil 70 and other medicines
   4. Taking Ostenil 70 with food and drink
   5. Taking Ostenil 70 in patients with renal impairment
   6. Children and adolescents
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Important information about some ingredients of Ostenil 70
3. HOW TO TAKE OSTENIL 70
   1. Taking more Ostenil 70 than prescribed
   2. Missing a dose of Ostenil 70
4. POSSIBLE SIDE EFFECTS
   1. If any of the following side effects occur, the patient should stop taking Ostenil 70 and consult their doctor as soon as possible:
   2. Very common
   3. Common
   4. Uncommon
   5. Rare
   6. Very rare
5. HOW TO STORE OSTENIL 70
6. CONTENTS OF THE PACK AND OTHER INFORMATION
   1. What Ostenil 70 contains
   2. What Ostenil 70 looks like and what the pack contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer

1. WHAT IS OSTENIL 70 AND WHAT IS IT USED FOR

Ostenil 70 tablets contain the active substance alendronic acid, 70 mg.
Alendronic acid is a bisphosphonate, which strongly inhibits the process of bone tissue absorption by osteoclasts (bone-resorbing cells). The effect of the action is a gradual increase in bone mass and a reduction in the risk of bone fractures.
The indication for the use of alendronate is the treatment of osteoporosis in postmenopausal women, in order to reduce the risk of vertebral and hip fractures, as well as the treatment of men with osteoporosis, in order to reduce the risk of vertebral and hip fractures.

2. IMPORTANT INFORMATION BEFORE TAKING OSTENIL 70

When not to take Ostenil 70

• if the patient is hypersensitive (allergic) to the active substance or to any of the other ingredients of Ostenil 70
• if the patient has changes in the esophagus that delay its emptying, such as narrowings, ulcers, or spasms of the esophageal sphincter
• in patients who are unable to stand or sit upright for at least 30 minutes
• in patients with decreased calcium levels in the blood.

Warnings and precautions

Before starting treatment with Ostenil 70, the patient should discuss it with their doctor or pharmacist.
Alendronate may cause local irritation of the mucous membrane of the upper gastrointestinal tract. If patients experience difficulty swallowing, esophageal disease, gastritis, or duodenal ulcers, or if they have had severe gastrointestinal diseases in the last year, such as gastric or duodenal ulcers, active gastrointestinal bleeding, or surgical procedures in the upper gastrointestinal tract other than pyloroplasty, caution should be exercised when taking the medicine, as it may exacerbate side effects.
In patients taking alendronate, esophageal side effects have been reported, such as inflammation, ulcers, and erosions, rarely esophageal narrowing. Some of these side effects were severe and required hospitalization. Therefore, the doctor should carefully monitor the patient for possible esophageal side effects. If symptoms of esophageal irritation occur, such as dysphagia (swallowing difficulties), pain when swallowing, or chest pain, the patient should consult a doctor, who will decide whether to discontinue the medicine. Not following the doctor's instructions may increase the risk of esophageal disorders.
It is essential to inform the doctor before taking this medicine if the patient has been diagnosed with Barrett's esophagus (a disease associated with changes in the cells lining the lower part of the esophagus).
In patients with advanced renal failure (creatinine clearance <35 ml min), the medicine should not be administered.
Before starting treatment, calcium and vitamin D metabolism disorders should be corrected.
During treatment with this medicine for osteoporosis in postmenopausal women, it is recommended to perform bone density measurements every 1-2 years to assess the effectiveness of treatment and to determine calcium levels in the blood every 6-12 months (this value should increase during treatment).
A slight, asymptomatic decrease in calcium and phosphate levels in the blood may occur, especially in patients taking glucocorticosteroids, in whom calcium absorption may be impaired.
Ensuring adequate intake of calcium and vitamin D is particularly important in patients taking glucocorticosteroids.
The medicine should not be given to children due to the lack of data on the use of alendronate sodium in children.
Bone, joint, and/or muscle pain have been observed in patients taking bisphosphonates.
The first symptoms may occur on the first day of treatment and/or after many months of treatment. In most patients, the symptoms disappeared after discontinuation of treatment. Recurrence of symptoms may occur after re-administration of the same medicine or after taking another bisphosphonate.
After the medicine was introduced to the market, rare cases of severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported.
Osteonecrosis of the jaw, usually associated with tooth extraction and/or local infection (including osteomyelitis), has been reported in patients with cancer, receiving a treatment regimen mainly consisting of intravenous bisphosphonates. Many of these patients also received chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis taking oral bisphosphonates.
In patients with risk factors (e.g., cancer, chemotherapy, radiotherapy, corticosteroid treatment, poor oral hygiene) before bisphosphonate treatment, the doctor should consider performing dental examinations with appropriate dental prophylaxis.
If possible, these patients should avoid invasive dental procedures during treatment. The doctor's clinical assessment should be based on a treatment plan estimated based on the risk-benefit ratio for each patient.

Ostenil 70 and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, including those that are available without a prescription.
Antacids reduce the absorption and effectiveness of alendronate. Therefore, after taking alendronate, the patient should not take another oral medicine for at least 30 minutes.
Alendronate has a high affinity for calcium and other divalent and trivalent cations

• binding to them reduces the absorption and effectiveness of the medicine. Concomitant use of alendronate with acetylsalicylic acid and other salicylates (including mesalazine and benorylate) increases the risk of upper gastrointestinal tract damage, especially the occurrence of gastric ulcers. When hormonal replacement therapy (estrogen or estrogen-progesterone combination) and alendronate are used concomitantly, a significant increase in bone mass and a decrease in bone metabolic turnover have been observed compared to monotherapy with both treatments. It has also been found that the safety and tolerability of concomitant use of these therapies are comparable to monotherapy. Based on the assessment of the effect of alendronate sodium on protein binding, renal excretion, and metabolism of other medicines, no other interactions of clinical significance are expected.

Since the use of NSAIDs is associated with irritation of the gastrointestinal tract mucosa, caution should be exercised when taking Ostenil 70 concomitantly.

Taking Ostenil 70 with food and drink

Food and drinks (including mineral water, especially caffeinated beverages) reduce the absorption and effectiveness of alendronate.

Taking Ostenil 70 in patients with renal impairment

In patients with advanced renal failure (creatinine clearance <35 ml min), the medicine should not be administered.< p>

Children and adolescents

Ostenil 70 should not be given to children and adolescents.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking the medicine.
Pregnancy
Ostenil 70 should not be given to pregnant women.
Breastfeeding
Ostenil 70 should not be used in women who are breastfeeding.

Driving and using machines

Some side effects caused by Ostenil 70 (including blurred vision, dizziness, bone, muscle, or joint pain) may affect the patient's ability to drive or operate machinery. The individual patient's reaction to Ostenil 70 may vary (see section 4 Possible side effects).

Important information about some ingredients of Ostenil 70

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. HOW TO TAKE OSTENIL 70

Ostenil 70 should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor or pharmacist again.
In postmenopausal osteoporosis, the recommended dose is 70 mg (1 tablet) once a week. The patient should choose one day a week and always take the medicine on that day of the week.
Ostenil 70 should be taken orally, 30 minutes before the first meal, drink, or other medicines, with a full glass of boiled water. Other drinks (including mineral water), food, and medicines may reduce the absorption of the medicine.
To facilitate the passage of the tablet into the stomach and reduce the possibility of local irritation in the esophagus and other side effects, the patient should:

• take Ostenil 70 in the morning, after getting up, and drink a full glass of boiled water (at least 200 ml). Do not use mineral water, coffee, or tea.
• take the tablet before the first meal
• swallow the tablet whole. Do not chew, crush, or let it dissolve in the mouth, as this may cause oral ulcers
• after swallowing the tablet, the patient should not lie down until they have eaten their first meal, which should be consumed no earlier than 30 minutes after swallowing the tablet
• the patient should not lie down for at least 30 minutes after taking the medicine
• the patient should not take Ostenil 70 before going to bed or before getting up in the morning
• after swallowing, the patient should not lie down for at least 30 minutes.

Patients with osteoporosis should have an adequate intake of calcium and vitamin D in their diet.
In elderly patients (over 65 years), patients with mild and moderate renal impairment (creatinine clearance 35-60 ml/min), and patients with liver function disorders, no dose adjustment is necessary.
Patients should be informed that if they miss a dose, they should take it the next morning. They should not take a double dose of the medicine on the same day to make up for the missed dose. They should return to the Ostenil 70 dosing schedule and take only one dose of the medicine.
No studies have been conducted on the use of the medicine in patients with osteoporosis caused by glucocorticosteroid use.

Taking more Ostenil 70 than prescribed

Overdose may cause a decrease in calcium levels in the blood, a decrease in phosphate levels in the blood, and disorders in the upper gastrointestinal tract (esophagitis, gastritis, or ulcers with accompanying burning pains, nausea, vomiting, and a feeling of fullness in the upper abdomen).
The patient should be given milk or antacids containing calcium compounds to bind alendronate. Due to the risk of esophageal irritation, vomiting should not be induced, and the patient should remain upright.

Missing a dose of Ostenil 70

If a dose of Ostenil 70 is missed, the missed tablet should be taken the next morning, and then the patient should return to the established dosing schedule of taking one tablet once a week on the previously chosen day. The patient should not take a double dose to make up for the missed dose.
In case of doubts about taking the medicine, the patient should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ostenil 70 can cause side effects, although not everybody gets them.
In clinical trials, the medicine was well tolerated. Side effects were usually mild and did not require discontinuation of treatment.
Frequency of side effects:

• very common- more than 1 in 10 patients
• common- 1 to 10 patients in 100 patients
• uncommon- 1 to 10 patients in 1000 patients
• rare- 1 to 10 patients in 10,000 patients
• very rare- less than 1 in 10,000 patients
• not known- frequency cannot be estimated from the available data

If any of the following side effects occur, the patient should stop taking Ostenil 70 and consult their doctor as soon as possible:

• difficulty or pain when swallowing
• appearance or worsening of heartburn
• chest pain

Very common

• muscle, bone, or joint pain, sometimes severe

Common

• stomach pain or discomfort, nausea, constipation, diarrhea, bloating with gas, esophagitis, difficulty swallowing, feeling of fullness or bloating in the stomach
• headache, dizziness
• joint swelling, swelling of hands and feet
• itching, hair loss
• fatigue.

Uncommon

• esophageal irritation and ulcers, nausea or vomiting, black or bloody stools
• skin rash, skin reactions, itching and redness of the skin
• changes in taste
• eye inflammation (usually painful)
• transient symptoms (muscle pain, malaise, and rarely fever) at the beginning of treatment.

Rare

• allergic reactions, which may include (red, itchy swellings on the skin, also known as hives or rash; swelling of the face, lips, tongue, or throat, which may cause difficulty swallowing or breathing
• skin rash, which worsens under the influence of sunlight, hair loss
• transient flu-like symptoms (muscle weakness, malaise, and rarely fever), usually occurring at the beginning of treatment
• esophageal narrowing, symptoms similar to stomach ulcers, sometimes severe, including bleeding
• ulcers of the oral mucosa and/or throat occurred when the tablets were chewed or sucked.
• osteonecrosis of the jaw (bone necrosis)
• severe bone, muscle, or joint pain

Very rare

• severe skin reactions, known as Stevens-Johnson syndrome and toxic epidermal necrolysis. These are severe conditions characterized by the formation of blisters on the skin, lips, oral mucosa, eyes, and genital and anal areas.

After the medicine was introduced to the market, the following side effects have occurred with an unknown frequency:

• nervous system: dizziness, changes in taste
• muscles and bones: joint swelling,
• general disorders: fatigue, swelling of hands and feet

In rare cases, atypical fractures of the thigh bone may occur, especially in patients who have been treated for osteoporosis for a long time. The patient should consult their doctor if they experience pain, weakness, or discomfort in the thigh, hip, or groin area, as this may already indicate a possible fracture of the thigh bone.
Ostenil 70 may affect calcium and phosphate levels in the blood. To monitor them, the doctor may recommend regular blood tests during treatment.
In rare cases, atypical fractures of the thigh bone may occur, especially in patients who have been treated for osteoporosis for a long time. The patient should consult their doctor if they experience pain, weakness, or discomfort in the thigh, hip, or groin area, as this may already indicate a possible fracture of the thigh bone.
If any of the side effects worsen or if any side effects not mentioned in the leaflet occur, the patient should tell their doctor or pharmacist.
Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. HOW TO STORE OSTENIL 70

Store in a temperature below 25°C.
Store in a place inaccessible and invisible to children.
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer need. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Ostenil 70 contains

• The active substance of the medicine is alendronic acid.
• The other ingredients are microcrystalline cellulose, lactose monohydrate, colloidal silicon dioxide, magnesium stearate.

What Ostenil 70 looks like and what the pack contains

Tablets.
1 blister pack of 4 tablets (4 tablets) in a cardboard box;
1 blister pack of 6 tablets (6 tablets) in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Poland
Phone: (022) 345 93 00

Manufacturer

Teva Operations Poland Sp. z o.o.
ul. Mogilska 80
31-546 Krakow
Poland
Date of last revision of the leaflet:April 2022