Alendrogen

Leaflet attached to the packaging: patient information

Alendrogen, 70 mg, tablets

Alendronic acid

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

1. What is Alendrogen and what is it used for

Alendrogen contains the active substance alendronate sodium.
Alendrogen belongs to a group of medicines called bisphosphonates. Bisphosphonates are used to treat bone diseases such as osteoporosis.
Osteoporosis is a disease characterized by a decrease in bone density and weakening of bones. Alendrogen can be used to treat postmenopausal women. Alendrogen reduces the risk of vertebral fractures and hip fractures.

2. Important information before taking Alendrogen

When not to take Alendrogen:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• if the patient has esophageal diseases that make swallowing difficult or cause food to get stuck,
• 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 (hypocalcemia).

Warnings and precautions

Before starting treatment with Alendrogen, consult your doctor or pharmacist:

• if the patient has kidney disease,
• if the patient has difficulty swallowing, digestive problems, or intestinal problems,
• if the patient has had stomach ulcers, stomach bleeding, or stomach surgery in the last year,
• if the patient has pain when swallowing,
• if the doctor has diagnosed the patient with Barrett's esophagus (a disease related to changes in the cells lining the lower part of the esophagus),
• if the patient has been informed that they have low calcium levels in the blood or if they have a vitamin D deficiency or hypoparathyroidism (which can affect calcium levels in the blood). These conditions should be treated before starting treatment with Alendrogen.

There may be irritation, inflammation, or ulcers, which are often accompanied by symptoms such as chest pain, heartburn, swallowing problems, or pain when swallowing, especially if the patient does not drink a full glass of water and (or) lies down within 30 minutes of taking Alendrogen. These side effects may worsen if the patient continues to take Alendrogen after experiencing these symptoms. See the section "How to take Alendrogen" later in the leaflet. In case of doubts, consult your doctor or pharmacist.

Mouth and jaw diseases

Alendrogen may cause damage (including necrosis or loss) to the jawbone. The risk increases:

• if the patient has poor dental health, gum disease, poorly fitting dental prostheses, or if a tooth extraction is planned, or if the patient does not receive routine dental care,
• if the patient has cancer,
• if the patient is undergoing chemotherapy or radiotherapy,
• if the patient is taking glucocorticoids (such as prednisone or dexamethasone),
• if the patient is taking angiogenesis inhibitors (drugs used to treat cancer, preventing the formation of new blood vessels, such as bevacizumab or thalidomide),
• if the patient currently smokes or has smoked in the past.

Before starting treatment with Alendrogen, the patient may be referred for a dental check-up.
During treatment with Alendrogen, it is very important to maintain good oral hygiene and attend routine dental check-ups. You should also consult your doctor or dentist if you experience any problems with your teeth or mouth, such as a loose tooth, pain, or swelling.

Alendrogen and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take, including those that are available without a prescription, and:

• calcium supplements,
• antacids used to treat heartburn,
• glucocorticoids, such as prednisone or dexamethasone, used to treat inflammatory conditions; a well-balanced diet rich in calcium and vitamin D is also important (a risk factor for oral and jaw diseases - see "Mouth and jaw diseases")
• certain medicines used to treat rheumatic diseases or long-term pain, belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin or ibuprofen), may cause gastrointestinal disorders. Therefore, caution should be exercised when taking these medicines with alendronic acid.

Wait at least 30 minutes after taking Alendrogen before taking any other oral medicines.

Alendrogen with food and drink

Food and drink can reduce the absorption of Alendrogen into the blood. Therefore, take Alendrogen with a glass of plain water (not mineral water) on an empty stomach, at least 30 minutes before eating or drinking.

Pregnancy and breastfeeding

Alendrogen is intended for use only in postmenopausal women. Do not take Alendrogen during pregnancy or breastfeeding, or if you suspect you are pregnant, or if you plan to become pregnant - consult your doctor or pharmacist before taking this medicine.

Driving and using machines

There have been reports of side effects (such as blurred vision, dizziness, and severe bone, muscle, or joint pain) after taking alendronate, which may affect the ability to drive or operate machinery. Do not drive or operate machinery until you are sure that the medicine does not affect you.
Alendrogen contains lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medicine.
Alendrogen contains less than 1 mmol(23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Alendrogen

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
Adults and the elderly:
The recommended dose is 70 mg once a week.

Use in patients with kidney disease:

It is not recommended to take Alendrogen in patients with severe kidney disease.

Use in children and adolescents:

Do not take alendronate in children and adolescents under 18 years of age.

Method of administration:

• take the tablet on an empty stomach immediately after getting up from bed beforeeating or drinking anything,
• swallow the tablet whole while standing or sitting upright, with a full glass (at least 200 ml) of plain water (not mineral water), and do not drink mineral water (still or sparkling) or coffee or tea or juice or milk
• do not chew, crush, or dissolve the tablets in the mouth,
• do nottake the medicine at bedtime. After taking Alendrogen, do not lie down until you have eaten your first meal of the day.
• However, wait at least 30 minutes after swallowing the medicine before eating, drinking, or taking any other medicines.

Stop taking Alendrogen and consult your doctor if:

• you experience pain or difficulty swallowing,
• you experience chest pain,
• you experience new or worsening heartburn,
• you experience ulcers in the mouth and throat.

Do not take Alendrogen in patients with severe kidney disease.

Taking more than the recommended dose of Alendrogen:

Drink a full glass of milk and contact your doctor or the nearest emergency department immediately. Take the packaging of the taken medicine with you.
Do not inducevomiting and do notlie down. In case of overdose, stomach upset, heartburn, esophagitis, stomach pain, nausea, vomiting, bloody vomiting, blood in the stool (gastritis), or ulcers may occur. Changes in blood test results (e.g., low calcium or phosphorus levels in the blood) may also occur.

Missing a dose of Alendrogen:

Take the tablet the next morning. Do not take two tablets on the same day, but return to taking one tablet once a week.

Stopping treatment with Alendrogen:

Do not stop treatment suddenly without consulting your doctor.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking the medicine and tell your doctor immediately if you experience any of the following symptoms:

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

• Pain in the mouth, throat, chest, or stomach, which may be related to eating. Bloating, nausea, vomiting, loss of appetite, or weight loss. These may be symptoms of inflammation or ulcers of the digestive tract. If you experience vomiting with coffee grounds-like particles or black, tarry stools.
• New or worsening heartburn or indigestion, chest pain, or pain when swallowing. If you experience these symptoms, consult your doctor as soon as possible.

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

• Irritation or pain in the eye or eyes. You may experience eye redness, vision problems, tearing, sensitivity to light, or floaters (spots in your vision).

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

• Allergic reactions such as hives; swelling of the face, lips, tongue, and/or throat, causing difficulty breathing or swallowing (angioedema).
• Skin reactions, appearing as widespread blisters and bleeding from the mouth, eyes, nose, and genitals (Stevens-Johnson syndrome) or severe skin reactions, which start with painful red areas, then large blisters, and finally peeling of the skin. This is accompanied by fever and chills, muscle pain, and general malaise (toxic epidermal necrolysis).
• Pain in the mouth and/or jaw, swelling, or ulcers in the mouth, numbness, or a feeling of heaviness in the jaw or a loose tooth. These may be symptoms of bone damage (necrosis), usually associated with prolonged healing and the presence of infection, often after tooth extraction. If you experience these symptoms, consult your doctor.
• Unusual fractures of the thigh bone, mainly in patients treated for osteoporosis, are rare. Consult your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms of a thigh bone fracture.

if you experience ear pain, ear discharge, and/or ear infection, tell your doctor. These may be symptoms of bone damage in the ear.

Other possible side effects:

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):

• Joint swelling, swelling of the hands or feet.
• Stomach pain, discomfort, or bloating in the stomach or belching after eating, constipation, diarrhea, gas.
• Hair loss, skin itching.
• Headache, dizziness, loss of balance, or a feeling of spinning (dizziness), weakness.

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

• Nausea, vomiting.
• Rash, skin redness.
• Short-term flu-like symptoms, such as muscle pain, general malaise, sometimes with accompanying fever. These symptoms usually occur at the start of treatment.
• Changes in taste.

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

• Symptoms of low calcium levels in the blood, including muscle cramps and/or a feeling of tingling in the fingers or around the mouth.
• Narrowing of the esophagus.
• Photosensitive rash.

Tell your doctor immediately if you experience any of these side effects or any other unusual symptoms.
It will be helpful to keep a record of any side effects you have observed, when they occurred, and how long they lasted.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, consult your doctor or pharmacist.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +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, you can help provide more information on the safety of this medicine.

5. How to store Alendrogen

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: "EXP". The expiry date refers to the last day of that month.
There are no special precautions for storage.
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 pack and other information

What Alendrogen contains:

The active substance of the medicine is 70 mg of alendronic acid in the form of alendronate sodium.
The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, povidone, sodium croscarmellose, magnesium stearate.

What Alendrogen looks like and contents of the pack

White, biconvex tablets with "AD70" engraved on one side and "G" on the other side.
One pack contains 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Manufacturer
Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary
To obtain more detailed information on the medicine and its names in the Member States of the European Economic Area, contact the local representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: +48 22 546 64 00
Date of last revision of the leaflet:October 2024