Ostemax 70 comfort

Package leaflet: Information for the patient

Ostemax 70 comfort, 70 mg, tablets
Acidum alendronicum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents

1. What Ostemax 70 comfort is and what it is used for
2. What you need to know 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 Ostemax 70 comfort is and what it is used for

Ostemax 70 comfort contains alendronic acid (alendronate) as the active substance and belongs to a group of medicines called bisphosphonates, used in the treatment and prevention of osteoporosis.
Osteoporosis is characterized by progressive loss of normal bone tissue, leading to weakened skeletal strength. The most common complications of osteoporosis are bone fractures, typically occurring in the hip, spine, or wrist.
Alendronate localizes in areas of active bone resorption. As a result of its action, gradual increase in bone mass occurs.
Indications for use:
Treatment of osteoporosis in postmenopausal women to reduce the risk of fractures, including vertebral compression fractures and hip fractures.
Treatment of osteoporosis in men to prevent vertebral and hip fractures.

2. Important information before using Ostemax 70 comfort

When not to use Ostemax 70 comfort

• if the patient is allergic to alendronate or any of the other ingredients of this medicine (listed in section 6).
• if the patient has structural abnormalities of the oesophagus or oesophageal disorders causing delayed emptying, such as stricture or achalasia (spasm of the lower part of the oesophagus).
• if the patient cannot maintain an upright position (standing or sitting) for at least 30 minutes.
• if the patient has low blood calcium levels.
• if the woman is pregnant or breastfeeding.

If any of the above situations apply, Ostemax 70 comfort must not be used. First consult a doctor and follow the advice given.

Warnings and precautions

Before starting treatment with Ostemax 70 comfort, discuss the following with your doctor:

• if you have kidney problems
• if you have any type of allergy
• if your doctor has diagnosed you with Barrett's oesophagus (a condition involving changes in the cells lining the lower part of the oesophagus)
• if you have problems with swallowing or digestion
• if you have gum disease
• if dental extraction is planned
• if you have calcium metabolism disorders or other mineral metabolism disorders (e.g. vitamin D deficiency, malabsorption of calcium, hypoparathyroidism). Your doctor should fully correct these disorders before starting treatment and monitor blood calcium levels and symptoms of hypocalcaemia (low blood calcium) during treatment. Adequate intake of calcium and vitamin D is essential during treatment with Ostemax 70 comfort (particularly important for patients taking glucocorticosteroids).
• if the patient smokes or has ever smoked tobacco.

You should consult a dentist before starting treatment with 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 radiotherapy
• 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 your dentist's recommendations regarding appropriate dental prophylaxis.

Stop taking Ostemax 70 comfort and contact your doctor if you experience irritation, inflammation or ulceration of the oesophagus, often associated with chest pain, heartburn, or difficulty and pain when swallowing.

The above adverse effects may worsen if the patient continues taking Ostemax 70 comfort despite worsening of these symptoms. The risk of these adverse effects increases if the instructions in section 3. "How to take Ostemax 70 comfort" are not followed.

Stop taking Ostemax 70 comfort and contact your doctor immediately if you experience any of the following symptoms (angioedema):

• swelling of the face, tongue or throat
• difficulty swallowing
• urticaria and breathing difficulties.

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 this population.

Ostemax 70 comfort and other medicines

The information contained in this leaflet may also apply to medicines previously used or those to be used in the future.

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, especially:

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

Concomitant use of calcium-containing products (or mineral water), medications that neutralize gastric acid, and oral administration of certain medicines may interfere with the absorption of Ostemax 70 comfort. Therefore, at least 30 minutes must elapse after taking Ostemax 70 comfort before taking any other oral medication.

Ostemax 70 comfort with food and drink

Food and beverages (including mineral water) taken together with Ostemax 70 comfort may reduce its effectiveness. Therefore, it is important to strictly follow the instructions provided in section 3. "How to take Ostemax 70 comfort".

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.

Ostemax 70 comfort must not be used during pregnancy or while breastfeeding.

Driving and operating machinery

Certain adverse effects (e.g. visual disturbances, dizziness, and severe bone, muscle or joint pain) may affect the ability of some patients to drive or operate machinery. Therefore, it is recommended to assess your individual response to the medicine before driving or operating machinery.

Ostemax 70 comfort contains lactose and sodium

If you have previously been diagnosed with an intolerance to certain sugars, you should consult your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) of sodium per tablet; therefore, this medicine is considered "sodium-free".

3. How to use Ostemax 70 comfort

This medicine should always be taken as prescribed by your doctor. If in doubt, consult 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 this population.

Use in adults
Take one Ostemax 70 comfort tablet once a week.
To ensure the full therapeutic effect of Ostemax 70 comfort, strictly follow the instructions below:
It is very important to follow the instructions from point 2 to 6 to ensure that Ostemax 70 comfort reaches the stomach quickly and to reduce the risk of esophageal irritation.

1. Choose a day – Select 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 any other medication, swallow the Ostemax 70 comfort tablet with a full glass (not less than 200 ml) of water (but not mineral water).

• Do not take with mineral water (still or carbonated).
• Do not take with coffee or tea.
• Do not take with juice or milk. The tablet must be swallowed whole. Do not chew the tablet or allow it to dissolve in the mouth. 3. Do not lie down – Remain in an upright position (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until after 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 out of bed.

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

6. At least 30 minutes must pass between taking the Ostemax 70 comfort tablet and eating your first meal, drinking any fluids, or taking any other medications, including antacids, calcium supplements, or vitamins. Ostemax 70 comfort works effectively only on an empty stomach.

During treatment, maintain an adequate intake of calcium. If dietary calcium intake is insufficient, additional calcium and vitamin D supplements should be taken.

Taking more Ostemax 70 comfort than prescribed
In case of overdose, seek medical advice immediately.
Overdose may cause hypocalcemia (low blood calcium levels), hypophosphatemia (low blood phosphate levels), and adverse effects in the upper gastrointestinal tract, such as indigestion, heartburn, esophagitis, gastritis, or gastric/duodenal ulceration.
Treatment: Administer milk or antacids to bind alendronate. Due to the risk of esophageal irritation, vomiting must not be induced. The patient should remain in an upright (sitting or standing) position.

Missed dose of Ostemax 70 comfort
If you miss a dose, take it the following morning. Do not take a double dose to make up for the missed dose. Resume your regular dosing schedule afterward.

Stopping Ostemax 70 comfort
Ostemax 70 comfort should be taken for as long as prescribed by your doctor. This medicine is effective in treating osteoporosis only if the tablets are taken continuously.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will get 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, oesophageal ulceration causing chest pain, heartburn, difficulty or pain when swallowing;
• joint swelling;
• abdominal pain, stomach discomfort or burping after meals, constipation, feeling of fullness and bloating, diarrhoea, flatulence;
• 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 oesophagus or stomach;
• black or tar-like stools;
• visual disturbances, eye pain and redness;
• rash, skin redness;
• transient flu-like symptoms such as muscle pain, general malaise, sometimes with accompanying fever at the beginning of treatment;
• taste disturbance.

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

• allergic reactions such as hives, facial swelling, swelling of the lips, tongue and/or throat, possibly causing difficulty in breathing and swallowing;
• symptoms of low calcium levels in the blood, including muscle spasms and/or tingling sensations in the fingers or around the mouth;
• stomach ulcer or peptic ulcers (sometimes severe or with bleeding);
• oesophageal stricture (oesophagus is the tube connecting the mouth to the stomach);
• skin rash due to photosensitivity; severe skin reactions;
• mouth pain and/or jaw pain, swelling or tenderness in the mouth, sensation of pressure or numbness in the jaw, or loose teeth. These may be symptoms indicating jaw bone damage (osteonecrosis), usually associated with delayed healing and presence of infection, often following tooth extraction. If such symptoms occur, contact your doctor and dentist;
• atypical femoral fractures, mainly in patients on long-term anti-osteoporosis treatment, occur rarely. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as these may be early signs of a femoral fracture;
• mouth ulceration if tablets are chewed or crushed.

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

• if a patient experiences ear pain, ear discharge and/or ear infection, inform the doctor. These may be symptoms of bone tissue damage in the ear.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 authorisation holder.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Ostemax 70 comfort

Keep this medicine out of the sight and reach of children.
No special storage conditions are required for this 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 indicated.
The marking on the packaging following the abbreviation EXP indicates the expiry date, and following the abbreviation Lot/LOT indicates the batch number.
Medicines must 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 package and other information

What Ostemax 70 comfort contains

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

What Ostemax 70 comfort looks like and contents of the pack
Ostemax 70 comfort is a white, elongated, biconvex tablet.
The pack contains 4 tablets.
Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Pelplińska Street 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01