Ostemax 70 comfort

Package Leaflet: Information for the Patient

Ostemax 70 comfort, 70 mg, tablets

Alendronic acid

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Ostemax 70 comfort and what is it used for
• 2. Important information before taking Ostemax 70 comfort
• 3. How to take Ostemax 70 comfort
• 4. Possible side effects
• 5. How to store Ostemax 70 comfort
• 6. Contents of the pack and other information

1. What is Ostemax 70 comfort and what is it used for

Ostemax 70 comfort, whose active substance is alendronic acid (alendronate), is a medicine from the group of bisphosphonates, used in the treatment and prevention of osteoporosis.
Osteoporosis is characterized by a progressive decrease in the mass of normal bone tissue, which leads to a weakening of the skeleton's strength. The most common complications of osteoporosis are bone fractures, usually in the hip, spine, or wrist.
Alendronate is localized in areas of progressive bone loss. As a result of its action, there is a gradual increase in bone mass.
Indications for use of the medicine are:
Treatment of osteoporosis in postmenopausal women to reduce the risk of fractures, including vertebral and hip fractures.
Treatment of osteoporosis in men to prevent vertebral and hip fractures.

2. Important information before taking Ostemax 70 comfort

When not to take Ostemax 70 comfort

• if you are allergic to alendronate or any of the other ingredients of this medicine (listed in section 6).
• if you have abnormalities of the esophagus and esophageal diseases that cause delayed emptying, such as narrowing or achalasia (contraction of the lower part of the esophagus).
• if you cannot stay upright or sitting for at least 30 minutes.
• if you have low calcium levels in the blood.
• if you are pregnant or breastfeeding.

If any of these situations occur, do not take the medicine. First, consult a doctor and then follow the received recommendations.

Warnings and precautions

Before starting to take Ostemax 70 comfort, discuss it with your doctor:

• if you have kidney problems
• if you have any type of allergy
• if your doctor has diagnosed you with Barrett's esophagus (a disease related to changes in the cells lining the lower part of the esophagus).
• if you have swallowing or digestion problems
• if you have gum problems
• if a tooth extraction is planned
• if you have disturbances in calcium metabolism and other mineral metabolism disorders (e.g., vitamin D deficiency, calcium malabsorption syndrome, hypoparathyroidism). The doctor should completely correct these disorders before starting treatment and monitor blood calcium levels and symptoms of hypocalcemia during treatment. During treatment with Ostemax 70 comfort (especially important in patients taking glucocorticosteroids), it is necessary to ensure an adequate amount of calcium and vitamin D.
• if you smoke or have ever smoked.

You should consult a dentist before starting to take Ostemax 70 comfort or if you are being treated for any of the following reasons:

• if you have been diagnosed with cancer
• if you are receiving chemotherapy or radiation therapy
• if you are taking corticosteroids (e.g., cortisone or hormones)
• if you do not undergo regular dental check-ups
• if you have gum problems.

During treatment, follow the dentist's recommendations for using appropriate dental prophylaxis.
Stop taking Ostemax 70 comfort and contact your doctor if you experience: irritation, inflammation, or ulceration of the esophagus, often in combination with chest pain, heartburn, or difficulty and pain when swallowing.
The above side effects may worsen if you continue to take Ostemax 70 comfort despite their worsening. The risk of these side effects increases if you do not follow the recommendations contained in section 3. "How to take Ostemax 70 comfort".
Stop taking Ostemax 70 comfort and contact your doctor immediately if you experience the following symptoms (angioedema):

• swelling of the face, tongue, and throat
• difficulty swallowing
• hives and difficulty breathing.

Children and adolescents

Alendronate is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety and efficacy of osteoporosis treatment in children and adolescents.

Ostemax 70 comfort and other medicines

The information contained in this leaflet may also apply to medicines used in the past or those that will be used in the future.
Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take, especially about the use of:

• non-steroidal anti-inflammatory drugs (due to their irritating effect on the digestive tract).

There is a possibility that taking medicines containing calcium (or mineral water), antacids, and oral administration of some medicines may interfere with the absorption of Ostemax 70 comfort. Therefore, after taking Ostemax 70 comfort, wait at least 30 minutes before taking another medicine orally.

Ostemax 70 comfort with food and drink

Food and drinks (including mineral water) taken with Ostemax 70 comfort may reduce its effectiveness. Therefore, it is essential to strictly follow the recommendations given in section 3. "How to take Ostemax 70 comfort".

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Ostemax 70 comfort should not be used during pregnancy or breastfeeding.

Driving and using machines

Certain side effects (e.g., vision disturbances, dizziness, and severe bone, muscle, or joint pain) may impair your ability to drive or operate machines in some patients. Therefore, it is recommended to check your individual reaction to the medicine before driving a vehicle or operating machines.

Ostemax 70 comfort contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, consult your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Ostemax 70 comfort

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

Use in children and adolescents

Alendronate is not recommended for use in children and adolescents under 18 years of age due to insufficient data on safety and efficacy of osteoporosis treatment in children and adolescents.

Use in adults

Take one Ostemax 70 comfort tablet once a week. To fully utilize the therapeutic effect of Ostemax 70 comfort, you must strictly follow the following recommendations

It is very important to follow the recommendations from point 2 to 6 so that Ostemax 70 comfort quickly reaches the stomach and reduces the risk of esophageal irritation.

• 1. Choose a day– Choose the most convenient day of the week. Take the Ostemax 70 comfort tablet on the chosen day every week.
• 2. Do not eat or drink- After getting up in the morning and before eating, drinking anything, or taking other medicines, swallow the Ostemax 70 comfort tablet witha full glass (at least 200 ml) of water (but not mineral water).
• Do not drink mineral water (still or sparkling).
• Do not drink coffee or tea.
• Do not drink juice or milk.

The tablet should be swallowed whole. Do not chew the tablet or allow it to dissolve in your mouth.

• 3. Do not lie down- Stay upright (sitting, standing, or walking) – for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten your first meal of the day.
• 4. Do not take Ostemax 70 comfort in the evening before going to bed or in the morning before getting up.

5. If you experience difficulty or pain when swallowing, chest pain, heartburn, or worsening of heartburn, stop taking Ostemax 70 comfort and contact your doctor

Ostemax 70 comfort

• 6. At least 30 minutes must passbetween taking Ostemax 70 comfort and eating your first meal, drinking your first liquid, or taking other medicines, including antacids, calcium preparations, and vitamins. Ostemax 70 comfort works only on an empty stomach.

During treatment, consume an adequate amount of calcium, and if the intake is insufficient in your diet, take additional calcium and vitamin D preparations.

Overdose of Ostemax 70 comfort

In case of overdose, consult your doctor immediately.
Overdose may cause hypocalcemia (decreased calcium levels in the blood), hypophosphatemia (decreased phosphate levels in the blood), and side effects related to the upper gastrointestinal tract, such as nausea, heartburn, esophagitis, and gastritis.
Treatment: Administer milk or antacids to bind alendronate.
Due to the risk of esophageal irritation, do not induce vomiting, and the patient should remain upright or standing.

Missed dose of Ostemax 70 comfort

If you miss a dose, take it the next morning. Do not take a double dose to make up for the missed dose. Then, return to the established schedule of taking the medicine.

Stopping Ostemax 70 comfort

Ostemax 70 comfort should be taken for as long as your doctor has prescribed. This medicine is effective in treating osteoporosis only if you take the tablets all the time.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ostemax 70 comfort can cause side effects, although not everybody gets them.
The following side effects have been reported:
Very common(may affect more than 1 in 10 people):

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

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

• heartburn, difficulty swallowing, pain when swallowing, esophagitis, which causes chest pain, heartburn, difficulty, or pain when swallowing;
• joint swelling;
• abdominal pain, discomfort in the stomach or regurgitation after eating, constipation, feeling of fullness and bloating of the stomach, diarrhea, bloating with gas;
• hair loss, itching;
• headache, dizziness;
• fatigue, swelling of the hands or feet.

Uncommon(may affect 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;
• flu-like symptoms, such as muscle pain, general malaise, sometimes with accompanying fever at the start of treatment;
• taste disturbance.

Rare(may affect up to 1 in 1,000 people):

• allergic reactions such as hives, swelling of the face, lips, tongue, and (or) throat, possible difficulty breathing and swallowing;
• symptoms of low calcium levels in the blood, including muscle cramps and (or) tingling sensation in the fingers or around the mouth;
• gastric ulcer or gastrointestinal ulcers (sometimes severe or with bleeding);
• esophageal narrowing (esophagus is the tube connecting the mouth to the stomach);
• photosensitivity rash; severe skin reactions;
• mouth pain and (or) jaw pain, swelling or pain in the mouth, feeling of pressure or numbness of the jaw, or a loose tooth. These may be symptoms of jawbone damage (necrosis), usually associated with prolonged healing and the presence of infection, often after tooth extraction. If you experience such symptoms, contact your doctor and dentist;
• atypical fractures of the thigh bone, mainly in patients treated for osteoporosis for a long time, are rare. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin area, as these may be early symptoms of a thigh bone fracture;
• mouth ulcers if the tablets are chewed or crushed.

Very rare(may affect up to 1 in 10,000 people):

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Ostemax 70 comfort

Keep the medicine out of the sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot/LOT means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Ostemax 70 comfort contains

• The active substance of the medicine is alendronic acid. Each tablet contains 70 mg of alendronic acid, which corresponds to 91.36 mg of alendronate sodium trihydrate.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, anhydrous colloidal silica.

What Ostemax 70 comfort looks like and what the pack contains

Ostemax 70 comfort is a white, biconvex, elongated tablet.
The pack contains 4 tablets.

Marketing authorization holder and manufacturer

Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of the last update of the leaflet: