ALENDRONIC 70 mg Tablets

Contents of the leaflet

1. LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER
2. Alendronic Acid Genoptim, 70 mg, tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
3. WHAT IS ALENDRONIC ACID GENOPTIM AND WHAT IS IT USED FOR
   2. What is Alendronic Acid Genoptim
   3. What is Alendronic Acid Genoptim used for
   4. What is osteoporosis
   5. How can osteoporosis be treated
4. IMPORTANT INFORMATION BEFORE TAKING ALENDRONIC ACID GENOPTIM
   2. When not to take Alendronic Acid Genoptim
   3. Warnings and precautions
   4. Children and adolescents
   5. Alendronic Acid Genoptim and other medicines
   6. Alendronic Acid Genoptim with food and drink:
   7. Pregnancy and breastfeeding:
   8. Driving and using machines:
   9. Alendronic Acid Genoptim contains sodium.
5. HOW TO TAKE ALENDRONIC ACID GENOPTIM
   1. Recommended dose
   2. Instructions for taking Alendronic Acid Genoptim
   3. Taking more than the recommended dose of Alendronic Acid Genoptim
   4. Missing a dose of Alendronic Acid Genoptim
   5. Stopping treatment with Alendronic Acid Genoptim
6. POSSIBLE SIDE EFFECTS
   1. Reporting side effects
7. HOW TO STORE ALENDRONIC ACID GENOPTIM
8. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
   1. What Alendronic Acid Genoptim contains
   2. What Alendronic Acid Genoptim looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Date of last revision of the leaflet: 12/2020

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR THE USER

Alendronic Acid Genoptim, 70 mg, tablets

Alendronic acid

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a 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 the symptoms of their illness 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 Alendronic Acid Genoptim and what is it used for
• 2. Important information before taking Alendronic Acid Genoptim
• 3. How to take Alendronic Acid Genoptim
• 4. Possible side effects
• 5. How to store Alendronic Acid Genoptim
• 6. Contents of the package and other information

1. WHAT IS ALENDRONIC ACID GENOPTIM AND WHAT IS IT USED FOR

What is Alendronic Acid Genoptim

Alendronic Acid Genoptim contains the active substance alendronate. It belongs to a group of medicines called "bisphosphonates". The action of Alendronic Acid Genoptim is to prevent bone mass loss in postmenopausal women.
It has also been shown to have a beneficial effect on bone rebuilding and reducing the risk of spinal and hip fractures in postmenopausal women with osteoporosis.

What is Alendronic Acid Genoptim used for

The doctor has prescribed Alendronic Acid Genoptim if the patient has osteoporosis or is at increased risk of developing the disease.

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 a woman enters menopause, the higher the risk of osteoporosis.
Osteoporosis starts without symptoms, and if left untreated, it can lead to bone fractures. Although fractures usually cause severe pain, they may not cause pain in the case of spinal fractures, which can lead to a decrease in the patient's height being noticed only when it happens. Fractures can occur during daily activities, as a result of lifting or minor trauma, which would not affect a healthy bone. 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

It should be remembered that osteoporosis can be treated, and it's never too late to start treatment.
Alendronic Acid Genoptim not only prevents bone loss but also helps rebuild lost bone and reduces the risk of spinal and hip fractures.
During treatment with Alendronic Acid Genoptim, the doctor may recommend lifestyle changes that are beneficial for the patient's condition, such as:

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

2. IMPORTANT INFORMATION BEFORE TAKING ALENDRONIC ACID GENOPTIM

When not to take Alendronic Acid Genoptim

• If the patient has been diagnosed with an allergy (hypersensitivity) to sodium alendronate trihydrate or any of the other ingredients of Alendronic Acid Genoptim (listed in section 6).
• If the patient has a disease of the esophagus (the tube connecting the mouth to the stomach), such as esophageal narrowing or difficulty swallowing.
• If the patient cannot stand or sit upright for at least 30 minutes.
• If the doctor has found that the patient has low calcium levels in the blood.

If any of the above symptoms occur in the patient, before taking the medicine, they should consult a doctor or pharmacist.

Warnings and precautions

Before starting to take Alendronic Acid Genoptim, you should discuss it with your doctor or pharmacist:

• if the patient has kidney problems,
• if the patient has swallowing or digestive problems,
• if the doctor has diagnosed Barrett's esophagus (a disease related to changes in the cells lining the lower part of the esophagus) in the patient,
• if the doctor has found that the patient has low calcium levels in the blood,
• if the patient has poor oral health, gum disease, a planned tooth extraction, or if the patient is not under constant dental care,
• if the patient has cancer,
• if the patient is undergoing chemotherapy or radiotherapy,
• if the patient is taking corticosteroids (such as prednisone or dexamethasone),
• if the patient smokes or has smoked tobacco (as smoking can increase the risk of dental problems),
• if the patient has been advised to undergo dental examination before starting treatment with Alendronic Acid Genoptim.

It is essential to maintain good oral hygiene during treatment with Alendronic Acid Genoptim. During treatment, the patient should undergo routine dental check-ups, and in case of oral or dental problems, such as a loose tooth, pain, or swelling, the patient should contact their doctor or dentist. Irritation, inflammation, or ulceration of the esophagus may occur, often with symptoms of chest pain, heartburn, difficulty swallowing, or pain during swallowing, especially in patients who do not drink a full glass of water and (or) if they lie down for less than 30 minutes after taking Alendronic Acid Genoptim. These symptoms may worsen if the patient continues to take Alendronic Acid Genoptim after they appear.

Children and adolescents

Alendronic Acid Genoptim should not be used in children and adolescents.

Alendronic Acid Genoptim and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Calcium supplements, antacids, and some oral medicines may reduce the absorption of Alendronic Acid Genoptim if taken at the same time. Therefore, it is essential to follow the instructions given in section 3 "How to take Alendronic Acid Genoptim".
Certain medicines used to treat rheumatic diseases or chronic pain, called non-steroidal anti-inflammatory drugs (NSAIDs) (including aspirin or ibuprofen), may cause gastrointestinal problems.
Therefore, caution should be exercised when these medicines are taken with Alendronic Acid Genoptim.

Alendronic Acid Genoptim with food and drink:

Alendronic Acid Genoptim may interact with food and drinks (including mineral water), so the patient should follow the instructions for taking the medicine given in section 3.

Pregnancy and breastfeeding:

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Alendronic Acid Genoptim is intended for use in postmenopausal women.
Alendronic Acid Genoptim should not be used during pregnancy or breastfeeding.

Driving and using machines:

There have been reports of side effects (including blurred vision, dizziness, bone, muscle, or joint pain) after taking Alendronic Acid Genoptim, which may affect the ability to drive and use machines. Individual reactions to Alendronic Acid Genoptim may vary. (See section 4. Possible side effects).

Alendronic Acid Genoptim contains sodium.

Alendronic Acid Genoptim contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. HOW TO TAKE ALENDRONIC ACID GENOPTIM

This medicine should always be taken according to the doctor's instructions. If you have any doubts, you should consult your doctor.

Recommended dose

One tablet once a week,always taken on the same day of the week. Choose a day of the week that suits you best.

Instructions for taking Alendronic Acid Genoptim

The patient should follow points 1-5 to make it easier for the tablet to reach the stomach and reduce the risk of local esophageal irritation and side effects.

• 1. After getting up from bed and before the first meal, drink, or other medicines, the patient should swallow the Alendronic Acid Genoptim tablet whole, with a full glass of tap water (at least 200 ml). The patient should not drink:
• mineral water,
• coffee or tea,
• fruit juices or milk. The tablets should not be chewed, crushed, or sucked to dissolve in the mouth.
• 2. After swallowing the tablet, the patient should not lie down; they should remain upright (standing, sitting, or walking) for at least 30 minutes and not lie down until after their first meal.
• 3. The patient should not take Alendronic Acid Genoptim while lying down before going to bed or after getting up from bed.
• 4. If the patient experiences difficulty or pain while swallowing, chest pain, heartburn, or difficulty swallowing, they should stop taking Alendronic Acid Genoptim and contact their doctor.
• 5. The patient should not take their first meal of the day until at least 30 minutes after taking the Alendronic Acid Genoptim tablet. This also applies to drinks and other medicines, including antacids, calcium, and vitamin supplements. Alendronic Acid Genoptim only works if taken on an empty stomach.

It is crucial to take Alendronic Acid Genoptim as prescribed by the doctor and for the recommended duration.

Taking more than the recommended dose of Alendronic Acid Genoptim

If the patient takes too much Alendronic Acid Genoptim, they should immediately drink a full glass of milk and contact their doctor. The patient should not induce vomiting or lie down.

Missing a dose of Alendronic Acid Genoptim

• If the patient misses a dose, they should skip the missed dose.
• The patient should take the next tablet on the next scheduled day.
• The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Alendronic Acid Genoptim

It is crucial to take Alendronic Acid Genoptim as prescribed by the doctor and for the recommended duration.
Treatment of osteoporosis with Alendronic Acid Genoptim may only be effective if the patient continues treatment.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Alendronic Acid Genoptim can cause side effects, although not everybody gets them.
If the patient experiences any of the following symptoms, they should stop taking the tablets and immediately inform their doctor or go to the emergency department at the nearest hospital:

• allergic reaction (angioedema): swelling of the face, lips, tongue, or throat, or difficulty breathing or swallowing.

This is a very serious but rare side effect (occurring in 1 in 1000 patients). The patient may require urgent medical attention or hospitalization.
Other side effects
Very common (occurring in more than 1 in 10 patients):

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

Common (occurring in 1 in 10 patients):

• heartburn; difficulty swallowing; pain during swallowing; esophageal ulceration, which can cause chest pain, heartburn, difficulty swallowing, or pain during swallowing,
• joint swelling,
• abdominal pain, discomfort in the stomach, or regurgitation after eating; constipation, feeling full, and bloating, diarrhea, bloating,
• hair loss, itching,
• headache, dizziness,
• fatigue, swelling of the hands or feet.

Uncommon (occurring in 1 in 100 patients):

• nausea, vomiting,
• irritation or inflammation of the esophagus (the tube connecting the mouth to the stomach) or stomach,
• black or tarry stools,
• blurred vision, eye pain, or inflammation, or redness of the eye,
• rash, skin redness, itching,
• flu-like symptoms, such as muscle pain, general feeling of being unwell, and sometimes, usually at the beginning of treatment, fever,
• taste disturbances.

Rare (occurring in 1 in 1000 patients):

• allergic reaction, including hives, swelling of the face, lips, tongue, and (or) throat, which may cause difficulty breathing or swallowing. If such symptoms occur, the patient should stop taking the medicine and contact their doctor.
• symptoms of low calcium levels in the blood, including muscle cramps or spasms and (or) tingling sensation in the fingers and around the mouth,
• stomach ulcers and other gastrointestinal ulcers (some with bleeding),
• esophageal narrowing (the tube connecting the mouth to the stomach),
• rash (sometimes exacerbated by sunlight),
• severe skin reactions, including mucous membranes of the mouth, nose, eyes, and genitals. If such symptoms occur, the patient should stop taking the medicine and contact their doctor:
• mouth or jaw pain, swelling, or irritation, numbness or heaviness of the jaw or loosening of a tooth. These may be signs of jawbone damage (osteonecrosis) associated mainly with prolonged healing and infection, often after tooth extraction. If such symptoms occur, the patient should contact their doctor or dentist.
• rarely, atypical fracture of the thigh bone may occur, especially in patients who have been treated for osteoporosis for a long time. If the patient experiences pain, weakness, or discomfort in the thigh, hip, or groin, they should contact their doctor, as these may be early signs of a possible fracture of the thigh bone.
• mouth ulcers in case of chewing or sucking tablets.

Very rare (occurring in 1 in 10,000 patients):

• If the patient experiences ear pain, ear discharge, or ear infection, they should tell their doctor. These may be symptoms of bone damage in the ear.

If the patient experiences any of the above symptoms, they should inform their doctor or pharmacist.
It may be helpful to note the symptoms, the date they occurred, and how long they lasted.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 309, 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, more information can be collected on the safety of the medicine.

5. HOW TO STORE ALENDRONIC ACID GENOPTIM

The medicine should be stored out of sight and reach of children.
Do not use Alendronic Acid Genoptim after the expiry date stated on the package. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.
There are no special precautions for storage.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Alendronic Acid Genoptim contains

• The active substance is sodium alendronate trihydrate, and each tablet contains 70 mg of alendronic acid in the form of sodium alendronate trihydrate.
• The other ingredients are microcrystalline cellulose, crospovidone (Type A), and magnesium stearate.

What Alendronic Acid Genoptim looks like and what the package contains

Each tablet is white, oval, flat, marked with the symbol "70" on one side.
Alendronic Acid Genoptim is available in aluminum/aluminum blisters containing 4 tablets in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Manufacturer:
Teva Pharma S.L.U
Poligono Industrial Malpica
Calle C, Number 4
50016 Zaragoza
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland: Alendronic Acid Genoptim

Date of last revision of the leaflet: 12/2020