Ostolek

PATIENT INFORMATION LEAFLET

OSTOLEK, 70 mg, coated tablets

Leaflet accompanying the packaging: information for the patient

Ostolek, 70 mg, coated tablets

(Alendronic acid)
[logo of the responsible entity]

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Ostolek and what is it used for
• 2. Important information before taking Ostolek
• 3. How to take Ostolek
• 4. Possible side effects
• 5. How to store Ostolek
• 6. Contents of the packaging and other information

1. What is Ostolek and what is it used for

What is Ostolek

Ostolek is a coated tablet containing the active substance alendronic acid (commonly called alendronate), which belongs to a group of non-hormonal medicines called bisphosphonates. It prevents bone mass loss in postmenopausal women and helps rebuild bones.

What is Ostolek used for

Ostolek is used to treat osteoporosis in adult postmenopausal women to reduce the risk of vertebral and hip fractures.
Ostolek reduces the risk of vertebral and hip fractures in women and vertebral fractures in men.

What is osteoporosis

Osteoporosis is a disease characterized by bone weakening: bones become thinner. It is common in postmenopausal women. During menopause, the ovaries reduce the production of the female hormone - estrogen, which helps maintain a healthy bone system. As a result, bone density decreases, and bones weaken. The earlier menopause occurs in a woman, the higher the risk of osteoporosis.
Osteoporosis begins without symptoms, and if left untreated, it can lead to fractures. Although fractures usually cause severe pain, they may not cause pain in the case of vertebral fractures, which can lead to a decrease in the patient's height. Fractures usually occur in the hip, spine, or wrist and can cause not only pain but also lead to problems such as a hunched figure, hump, and loss of mobility.

How can osteoporosis be treated

During treatment with Ostolek, your doctor may recommend lifestyle changes that are beneficial for your condition, such as:

• - Quitting smoking:smoking can contribute to increased bone mass loss and thus increase the risk of fractures.
• - Exercise:bones, like muscles, need proper exercise to be strong and healthy. Before starting exercise, consult your doctor.
• - Proper diet:your doctor may advise on nutrition and possible need for dietary supplements (especially calcium and vitamin D).

2. Important information before taking Ostolek

When not to take Ostolek

• if the patient is allergic (hypersensitive) to alendronic acid or any of the other ingredients of this medicine (listed in section 6),
• if the patient has esophageal disease (such as esophageal narrowing, difficulty swallowing),
• if the patient is unable to stand or sit upright for at least 30 minutes,
• if the patient has low calcium levels in the blood.

Consult your doctor, even if the following warnings apply to past situations.

Warnings and precautions

Before taking Ostolek, discuss it with your doctor or pharmacist.
It is essential to inform your doctor before taking Ostolek if:

• you have or have had kidney problems,
• you have indigestion,
• you have been diagnosed with Barrett's esophagus (a disease related to changes in the cells lining the lower part of the esophagus),
• you have been diagnosed with cancer,
• you have been informed that you have low calcium levels in the blood,
• you are undergoing chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide),
• you are taking glucocorticosteroids,
• you have poor dental health, gum disease, planned tooth extraction, or do not receive routine dental care,
• you smoke or have smoked (as this may increase the risk of dental problems).

Before starting treatment with Ostolek, it is recommended to visit a dentist.
During treatment with Ostolek, it is essential to maintain good oral hygiene. During treatment, you should regularly visit a dentist. You should also consult your doctor or dentist if you notice any problems with your mouth or teeth, such as pain, swelling, or loose teeth.
Irritation, inflammation, or esophageal ulcers (esophagus) may occur, often accompanied by symptoms such as chest pain, heartburn, swallowing problems, or pain when swallowing, especially if you do not drink a full glass of water and (or) lie down within 30 minutes of taking Ostolek. These side effects may worsen if you continue taking Ostolek after experiencing these symptoms.

Children and adolescents

Ostolek should not be used in children and adolescents under 18 years of age.

Ostolek and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Calcium supplements, antacids, and some oral medicines may reduce the absorption of Ostolek if taken at the same time. Therefore, it is essential to follow the instructions in section 3, "How to take Ostolek".
Some medicines used to treat rheumatic diseases or chronic pain, called non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid or ibuprofen, may cause gastrointestinal problems. Therefore, caution should be exercised when taking these medicines with Ostolek.

Ostolek with food and drink

Food and drinks (including mineral water) taken at the same time may reduce the effectiveness of Ostolek. Therefore, follow the instructions in section 3, "How to take Ostolek" carefully.

Pregnancy and breastfeeding

Consult your doctor before taking any medicine.
Ostolek should not be used in pregnant women.
Ostolek should not be used in breastfeeding women.

Driving and using machines

Ostolek is unlikely to affect your ability to drive or use machines.
However, some of the side effects reported with Ostolek may affect your ability to drive or use machines. Individual reactions to Ostolek may vary (see section 4).

Important information about some ingredients of Ostolek

Alendronate has a strong local irritant effect and may damage the mucous membrane of the upper gastrointestinal tract. To reduce the risk of such complications, Ostolek has a special protective coating. This coating prevents direct contact between the active substance and the mucous membrane of the mouth, throat, and esophagus. At the same time, the protective coating dissolves quickly in the stomach - it does not delay the breakdown of the tablet and the release of the active substance.

Ostolek contains lactose. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking Ostolek.

3. How to take Ostolek

Always take this medicine exactly as your doctor has told you. If you are not sure, consult your doctor or pharmacist.

Take one coated tablet of 70 mg once a week.

To fully utilize the therapeutic effect of Ostolek, follow the instructions below carefully.

It is crucial to follow the instructions in points 2), 3), 4), and 5). These guidelines will help Ostolek quickly reach the stomach and reduce the risk of esophageal irritation.

Instructions for taking Ostolek

• 1) Choose one day of the week that suits you best. On that day, take one Ostolek tablet every week.
• 2) After getting up in the morning and before eating, drinking, or taking other medicines, swallow Ostolek, drinking a full glass of water(at least 200 ml). Do not drink:
• mineral water (still or sparkling);
• coffee or tea;
• fruit juices or milk.

Do not chew, crush, or suck Ostolek tablets, as this may cause them to dissolve in your mouth.

• 3) Do not lie down - stay upright (sitting, standing, or walking) for at least 30 minutesafter swallowing the tablet. Do not lie down until you have eaten your first meal of the day.
• 4) Do not take Ostolek while lying down; before going to bed or getting up from bed.
• 5) If you experience difficulty or pain when swallowing, chest pain, heartburn, or worsening of heartburn, stop taking Ostolek and consult your doctor.
• 6) After taking Ostolek, wait at least 30 minutesbefore eating your first meal, drinking, or taking other medicines, including antacids, calcium supplements, and vitamins. Ostolek works only on an empty stomach.

Overdose of Ostolek

If you accidentally take more tablets, drink a full glass of milk and immediately consult your doctor. Do not induce vomiting, do not lie down.

Missed dose of Ostolek

If you miss a dose, take one tablet the next morning. Do not take two tablets on the same day. Return to taking one tablet once a week, following your previously established dosing schedule.

Stopping treatment with Ostolek

It is crucial to take Ostolek for the period prescribed by your doctor. It is not known how long treatment with Ostolek should last, so you should periodically discuss with your doctor the need for continued treatment to determine if it is still necessary.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ostolek can cause side effects, although not everybody gets them.
Consult your doctor immediatelyif you experience any of the following side effects, which may be serious and require immediate medical attention:

• Frequent (may occur in up to 1 in 10 people):
• heartburn; difficulty swallowing; pain when swallowing; esophageal ulcers, which cause chest pain.
• Rare (may occur in up to 1 in 1000 people):
• allergic reactions such as hives; swelling of the face, lips, tongue, and (or) throat, possibly with difficulty breathing and swallowing; severe skin reactions.
• jaw problems associated with prolonged healing and local infection, usually after tooth extraction.
• atypical fractures of the thigh bone, especially in patients treated for osteoporosis for a long time. Consult your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin area, as this may indicate a possible fracture of the thigh bone.
• severe bone, muscle, and (or) joint pain.

Other side effects

Very common (may occur in more than 1 in 10 people):

• severe bone, muscle, and (or) joint pain.

Common (may occur in up to 1 in 10 people) :

• joint swelling,
• abdominal pain, discomfort in the stomach, or bloating after eating; constipation; gas; feeling of fullness and bloating after eating; diarrhea,
• hair loss, itching,
• headache, dizziness,
• weakness, swelling of the upper or lower limbs.

Uncommon (may occur in up to 1 in 100 people) :

• nausea, vomiting;
• irritation or inflammation of the esophagus or stomach,
• black or tarry stools,
• vision disturbances, eye pain, and redness,
• rash, skin redness,
• transient flu-like symptoms, such as muscle pain, general malaise, sometimes with accompanying fever at the start of treatment,
• taste disturbances.

Rare (may occur in up to 1 in 1000 people):

• symptoms of low calcium levels in the blood, including muscle cramps and (or) tingling in fingers or around the mouth,
• stomach or duodenal ulcers (sometimes severe or with bleeding),
• esophageal narrowing,
• photosensitivity reactions,
• mouth ulcers, in case of chewing or crushing tablets.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Ostolek

Store in a temperature below 25°C.
Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Ostolek contains

The active substance of Ostolek is alendronic acid trihydrate. Each tablet contains 70 mg of alendronic acid in the form of alendronic acid trihydrate.
Other ingredients are:
Tablet core:microcrystalline cellulose, lactose monohydrate, magnesium stearate, crospovidone, sodium bicarbonate,
Coating:talc, polyvinyl alcohol, macrogol 3000, titanium dioxide, indigo carmine lake, yellow quinoline lake.

What Ostolek looks like and what the pack contains

Ostolek is available in the form of blue, oval-shaped, coated tablets without any defects.
Tablets are packaged in PVC/PVDC/Aluminum or OPA/Aluminum/PVC/Aluminum blisters, which are placed in a cardboard box. The single pack contains 4 or 12 coated tablets.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
tel. (+48) (22) 785 27 60
fax. (+48) (22) 785 27 60 ext. 106

Date of last revision of the leaflet: