Alendrogen

Package leaflet: Information for the patient

Alendrogen, 70 mg, tablets
Acidum alendronicum
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Alendrogen is and what it is 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 Alendrogen is and what it is used for

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

2. Important information before using Alendrogen

When not to use Alendrogen:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if the patient has esophageal disorders (the esophagus is the tube connecting the mouth to the stomach) that make swallowing difficult or cause food to get stuck
• if the patient is unable to remain in an upright (standing or sitting) position for at least 30 minutes
• if the patient has low calcium levels in the blood (hypocalcemia).

Warnings and precautions
Before starting Alendrogen, consult a doctor or pharmacist:

• if the patient has kidney disease,
• if the patient has difficulty swallowing, digestive problems, or intestinal disorders,
• if the patient has had gastric ulcer disease, gastrointestinal bleeding in the past year, or has undergone surgery of the stomach, esophagus, or throat,
• if the patient experiences pain when swallowing,
• if the patient has been diagnosed with Barrett's esophagus (a condition involving changes in the cells lining the lower part of the esophagus),
• if the patient has been informed of low blood calcium levels, vitamin D deficiency, or hypoparathyroidism (which may affect blood calcium levels). These conditions should be treated before starting Alendrogen.

Irritation, inflammation, or ulceration of the esophagus may occur, often accompanied by symptoms such as chest pain, heartburn, difficulty swallowing, or pain when swallowing, especially if the patient does not drink a full glass of water and (or) lies down within 30 minutes after taking Alendrogen. These adverse effects may worsen if the patient continues taking Alendrogen after such symptoms appear. See section "How to take Alendrogen" later in this leaflet. In case of doubt, consult a doctor or pharmacist.
Oral and jaw disorders
Alendrogen may cause damage (including osteonecrosis or bone loss) to the jawbone. The risk increases:

• if the patient has poor dental health, gum disease, ill-fitting dentures, planned tooth extraction, or does not receive routine dental care,
• if the patient has cancer,
• if the patient is undergoing chemotherapy or radiotherapy,
• if the patient is taking glucocorticosteroids (such as prednisone or dexamethasone),
• if the patient is taking angiogenesis inhibitors (medicines used in cancer treatment to prevent the formation of new blood vessels, e.g. bevacizumab or thalidomide),
• if the patient currently smokes or has smoked in the past.

Before starting Alendrogen, the patient may be referred for a dental examination.
During treatment with Alendrogen, it is very important to maintain proper oral hygiene and to attend regular dental check-ups. The patient should also consult their physician or dentist if any dental or oral problems occur, such as loose teeth, pain, or swelling.
Alendrogen with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as:

• calcium-containing supplements,
• antacids used to treat indigestion,
• glucocorticosteroids such as prednisone or dexamethasone, used to treat inflammatory conditions; it is also important to consume adequate dietary calcium and vitamin D (a risk factor for oral disorders - see "Oral and jaw disorders"),
• certain medicines used to treat rheumatic conditions or chronic pain, known as non-steroidal anti-inflammatory drugs (NSAIDs) (e.g. aspirin or ibuprofen), which may cause gastrointestinal disturbances. Therefore, caution should be exercised when taking these medicines together with alendronic acid.

At least 30 minutes should elapse between taking Alendrogen and taking any other oral medication.
Alendrogen with food and drink
Food and drink may reduce the absorption of Alendrogen into the blood. Therefore, Alendrogen should be taken with plain water, at least 30 minutes before eating or drinking anything else.
Pregnancy and breastfeeding
Alendrogen is intended for use only in postmenopausal women. Alendrogen should not be used during pregnancy or breastfeeding, or if pregnancy is suspected, or if the patient is planning to become pregnant. Consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Adverse effects (such as blurred vision, dizziness, and severe bone, muscle, or joint pain) have been reported after taking alendronate, which may affect the ability to drive or operate machinery. Do not drive or operate machinery until the patient is certain that the medicine does not affect them.
Alendrogen contains lactose. If the patient has been previously diagnosed with an intolerance to certain sugars, they should consult their doctor before taking this medicine.
Alendrogen contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free."

3. How to use Alendrogen

This medicine should always be taken as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.
Adults and elderly patients:
The recommended dose is 70 mg once weekly.
Use in patients with kidney disease:
Alendrogen is not recommended for patients with severe kidney disease.
Use in children and adolescents:
Alendronate should not be used in children and adolescents under 18 years of age.
Method of administration:

• The tablet should be taken on an empty stomach immediately after getting up, before eating or drinking anything.
• The whole tablet should be swallowed while remaining in an upright position (sitting, standing, or walking), with a full glass (at least 200 ml) of plain water (not mineral water).
  o Do not take with mineral water (still or sparkling).
  o Do not take with coffee or tea.
  o Do not take with juice or milk.
• Do not crush, chew, or dissolve the tablet in the mouth.
• Do not take the medicine at bedtime. After taking Alendrogen, do not lie down until after eating a meal.
• However, at least 30 minutes should elapse after swallowing the tablet before eating, drinking, or taking any other medicines.

Discontinue use of Alendrogen and contact your doctor if:

• you experience pain or difficulty swallowing,
• chest pain,
• heartburn that is new or worsening,
• ulceration of the mucous membranes of the mouth or throat.

Taking more than the recommended dose of Alendrogen:
Drink a full glass of milk and immediately contact your doctor or the nearest emergency department.
Bring the medicine packaging and any remaining tablets with you. Do not induce vomiting and do not assume a lying position.
In case of overdose, symptoms may include gastrointestinal upset, heartburn, inflammation of the oesophagus, abdominal pain, nausea, vomiting, vomiting blood, blood in stool (inflammation of the gastric mucosa), ulcers.
Changes in blood test results may also occur (e.g. low blood calcium or phosphate levels).
Missed dose of Alendrogen:
Take the tablet the next morning. Do not take two tablets on the same day, but resume taking one tablet per week as usual.
Stopping treatment with Alendrogen:
Do not stop treatment suddenly without first consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Discontinue use of the medicine and immediately contact your doctor if any of the following symptoms occur:
Common (may affect up to 1 in 10 people):

• Mouth pain, sore throat, chest pain, or stomach pain, which may be related to eating. Bloating, nausea, vomiting, loss of appetite, or weight loss. These may be symptoms of inflammation or ulceration of the gastrointestinal tract. Vomiting material resembling coffee grounds or passing black, tarry stools.
• New or worsening heartburn or indigestion, pain in the middle of the chest, or pain on swallowing. If these symptoms occur, contact your doctor as soon as possible.

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

• Irritation or pain in the eye(s). This may include redness of the eye, blurred vision, excessive tearing, light sensitivity, or floaters (shadows appearing in the visual field).

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

• Allergic reactions such as hives; swelling of the face, lips, tongue, and (or) throat, which may cause difficulty breathing or swallowing (angioedema).
• Skin reactions presenting as widespread blisters and bleeding of the lips, eyes, mouth, nose, and genital organs (Stevens-Johnson syndrome), or severe skin reactions beginning with painful red areas, followed by large blisters, and ending with peeling of skin layers. This is accompanied by fever, chills, muscle pain, and general malaise (toxic epidermal necrolysis).
• Pain in the mouth and (or) jaw, swelling or ulceration in the mouth, numbness or heaviness in the jaw, or loose teeth. These may be symptoms indicating bone tissue damage (osteonecrosis), usually associated with delayed healing and presence of infection, often following tooth extraction (removal). If such symptoms occur, contact your doctor.
• Rare atypical fractures of the femur, particularly in patients undergoing long-term osteoporosis treatment. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early signs of femoral fracture.

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

• If the patient experiences ear pain, ear discharge, and (or) ear infection, inform the doctor. These may be symptoms of bone tissue damage in the ear.

Frequency not known (frequency cannot be estimated from available data):

• Atypical fractures at sites other than the femur.

If any of these symptoms occur, consult your doctor.
Other possible adverse 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 hands or feet.
• Abdominal pain, discomfort or fullness in the stomach, or belching after eating, constipation, diarrhoea, bloating with gas.
• Hair loss, skin itching.
• Headache, dizziness, loss of balance, or sensation of spinning (vertigo), unusual tiredness.

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

• Nausea, vomiting.
• Rash, skin redness.
• Transient flu-like symptoms such as muscle pain, general malaise, sometimes accompanied by fever. These symptoms usually occur at the beginning of treatment.
• Changes in taste sensation.

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

• Symptoms of low blood calcium levels, including muscle cramps and (or) tingling sensations in the fingers or around the mouth.
• Oesophageal stricture.
• Skin rash caused by photosensitivity.

Seek immediate medical advice if any of the above adverse effects occur, or if any other unusual symptoms develop.
It may be helpful to keep notes about any adverse effects observed—when they occurred and how long they lasted.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult your doctor or pharmacist.
Adverse 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
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Alendrogen

Keep this medicine out of 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 the specified month.
No special storage conditions are required.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

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

What Alendrogen looks like and contents of the pack
White, biconvex tablets, printed with "AD70" on one side and "G" on the other side.
Each pack contains 4 or 8 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer
Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary

This medicine is authorised in the Member States of the European Economic Area under the following names:
Austria: Alendronsäure Viatris 70 mg - einmal wöchentlich - Tabletten
Belgium: Alendronate Viatris 70mg, tabletten
Czech Republic: Alendrogen 70 mg, tablety
Denmark: Alendronat Viatris 70 mg tabletter
Finland: Alendronat Viatris 70 mg tabletti
Poland: Alendrogen
Portugal: Acido Alendronico Mylan
Ireland: Fostepor Once weekly 70 mg Tablets
Italy: Alendronato Mylan Generics
Norway: Alendronat Viatris tabletter 70 mg
Slovenia: ALENAX 70 mg tablete
Sweden: Alendronat Viatris Veckotablett

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00