Kefort

Leaflet accompanying the packaging: patient information

Kefort

150 mg, coated tablets

Ibandronic acid

Read the 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, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Kefort and what is it used for

Kefort belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. Kefort can reverse bone loss by inhibiting bone loss and increasing bone mass in most women who take this medicine, even if they do not notice or feel the difference. Kefort may help reduce the risk of bone fractures. A reduction in the number of fractures has been shown in the case of vertebral fractures, but not in the case of hip fractures.

Kefort has been prescribed to treat postmenopausal osteoporosis due to the increased risk of fractures in this disease.

Osteoporosis is a disease characterized by a decrease in bone density and weakening of bones and often occurs in women after menopause.During menopause, the ovaries stop producing the female hormone - estrogen, which allows for the maintenance of normal bone structure. The earlier menopause occurs in a woman, the higher the risk of osteoporotic fractures. Other factors that may increase the risk of fractures include:

• insufficient calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• insufficient walking or other intense exercise
• family history of osteoporosis

A healthy lifestyle will also help to achieve the greatest benefits from treatment.This means following a balanced diet rich in calcium and vitamin D, walking or other intense exercise, not smoking, and limiting excessive alcohol consumption.

2. Important information before taking Kefort

Do not take Kefort

• If you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• If you have problems with the esophagus / food pipe, such as narrowing or difficulty swallowing.
• If you are unable to stand or sit upright for at least 1 hour (60 minutes).
• If you have or have had low calcium levels in your blood.You should consult your doctor.

Warnings and precautions

A side effect called jaw bone necrosis (damage to the jaw bone) has been very rarely reported in patients taking Kefort for osteoporosis. Jaw bone necrosis may also occur after treatment has stopped. It is essential to take steps to prevent the development of jaw bone necrosis, as it can be a painful and difficult condition to treat. To reduce the risk of jaw bone necrosis, you should:

• tell your doctor / nurse (healthcare professional) if you have any oral or dental problems, such as poor dental condition, gum disease, or planned tooth extraction
• tell your doctor / nurse (healthcare professional) if you do not receive regular dental care or have not had dental check-ups for a long time
• tell your doctor / nurse (healthcare professional) if you smoke (this may increase the risk of dental problems)
• tell your doctor / nurse (healthcare professional) if you have been treated with bisphosphonates (used to treat or prevent bone diseases) before
• tell your doctor / nurse (healthcare professional) if you are taking corticosteroids (e.g., prednisolone or dexamethasone)
• tell your doctor / nurse (healthcare professional) if you have been diagnosed with cancer

Your doctor may recommend that you have a dental check-up before starting Kefort. During treatment, you should maintain good oral hygiene (including regular tooth brushing) and have regular dental check-ups. If you wear dentures, you should ensure they fit properly. Patients undergoing dental treatment or dental procedures (e.g., tooth extraction) should inform their doctor and tell their dentist that they are taking Kefort. If you experience any oral or dental problems, such as loose teeth, pain, or swelling, non-healing ulcers, or discharge, you should contact your doctor and dentist immediately, as these may be symptoms of jaw bone necrosis.

• If you have any disorders of mineral metabolism (such as vitamin D deficiency).
• If your kidneys do not work properly / you have kidney disease.
• If you have any problems with swallowing or digestion.

Irritation, inflammation, or ulceration of the esophagus / food pipe, often with symptoms of severe chest pain after swallowing food or drink, severe nausea, or vomiting, may occur, especially if you do not drink a full glass of water or lie down after taking Kefort. If such symptoms occur, you should stop taking Kefort and consult your doctor immediately (see section 3).

Children and adolescents

Do not take Kefort in children and adolescents under 18 years old.

Other medicines and Kefort

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

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the efficacy of Kefort.
• Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, diclofenac sodium, naproxen) may irritate the stomach and intestines. Kefort may also have a similar effect. You should be careful when taking painkillers or anti-inflammatory drugs while being treated with Kefort.

After swallowing the monthly tablet of Kefort, you should wait 1 hour before taking any other medicines, including antacids or calcium or vitamin supplements.

Kefort with food and drink

Do not take Kefort with food.Kefort taken with food is less effective.

You can drink water, but do not drink any other beverages

After taking Kefort, you should wait 1 hour before taking any food or other beverages (see section 3: How to take Kefort).

Pregnancy and breastfeeding

Kefort should only be taken during menopause and should not be taken by women who may still become pregnant. Do not take Kefort during pregnancy or breastfeeding. Consult your doctor or pharmacist before taking this medicine.

Driving and using machines

You can drive and use machines, as Kefort has no or negligible influence on the ability to drive and use machines. Kefort contains lactose and sodium.If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking Kefort. The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially sodium-free.

• 3.

How to take Kefort

This medicine should always be taken exactly as your doctor has instructed. If you are not sure, ask your doctor or pharmacist.

The usual dose of Kefort is one tablet once a month.

Taking the tablet once a month

It is essential to carefully follow the instructions below. These instructions have been designed to help the Kefort tablet get into the stomach quickly, reducing the risk of irritation.

• Peel off the foil carefully.
• Take one 150 mg Kefort tablet once a month.
• Choose a specific day of the monththat is easy to remember. You can choose the same date (e.g., the first day of each month) or the same day (e.g., the first Sunday of each month). Choose a time that best suits your habits.
• Kefort should be taken at least 6 hours after eating any food or drinking any beverages, except water
• The Kefort tablet should be taken
• in the morning after getting upand
• before eating or drinking anything("on an empty stomach")
• Swallow the tablet with a full glass of water(at least 180 ml).

Do notdrink water with high calcium content, fruit juice, or any other beverage with the tablet. If you are concerned that the tap water has high calcium levels (hard water), you should use water with low mineral content.

• Swallow the tablet whole- do not chew, crush, or let it dissolve in your mouth.
• For the next hour (60 minutes)after taking the tablet
• do not lie down; if you do not stay upright (standing or sitting), part of the medicine may flow back into the esophagus

• do not eat anything
• do not drink anything(except water, if needed)
• do not take any other medicines

• After 1 hour, you can take your first food and drink of the day. After eating, you can lie down and take other medicines if needed.

Continuing treatment with Kefort

It is essential to take Kefort every month, as long as your doctor recommends. After 5 years of taking Kefort, you should consult your doctor to determine if you should continue taking Kefort.

Taking more Kefort than prescribed

If you accidentally take more than one tablet, you should drink a full glass of milk andcontact your doctor immediately.Do not induce vomiting and do not lie down- this may cause irritation of the esophagus by Kefort.

Missing a dose of Kefort

If you forget to take a tablet on the scheduled day, do not take it later in the same day. Check when the next scheduled dose is due:

If you forget to take a tablet on the scheduled day, and the next scheduled dose is due in 1 to 7 days…

Never take two Kefort tablets in the same week.

Wait until the next scheduled dose and take the tablet according to the established schedule, then continue taking one tablet per month on the scheduled days marked in your calendar.

If you forget to take a tablet on the scheduled day, and the next scheduled dose is due in more than 7 days…

Take one tablet the next morning after the day you remembered the missed dose, and then continue taking one tablet per month on the scheduled days marked in your calendar.

4. Possible side effects

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

You should immediately inform your nurse or doctor if you experience any of the following serious side effects, as you may need urgent medical attention:

Uncommon(may affect up to 1 in 100 people)

• severe chest pain, severe pain after swallowing food or drink, severe nausea, or vomiting, difficulty swallowing. Severe inflammation of the esophagus / food pipe, as well as ulcers or narrowing of the esophagus, may occur.
• symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and (or) tingling in the fingers or around the mouth.

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

• itching, swelling of the face, lips, tongue, and throat, with difficulty breathing.
• chronic eye pain and inflammation
• new pain, weakness, or discomfort in the thigh, hip, or groin. These may be early signs of atypical fractures of the thigh bone.

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

• mouth or jaw pain, or swelling. These may be early signs of serious jaw problems (necrosis (dead bone tissue) of the jaw).
• if you experience ear pain, discharge from the ear, and (or) ear infection, you should tell your doctor. These may be symptoms of bone damage in the ear.
• serious, potentially life-threatening allergic reactions.
• severe skin reactions.

Other possible side effects

Common(may affect up to 1 in 10 people)

• headache
• heartburn, discomfort when swallowing, stomach or abdominal pain (may be related to gastritis), nausea, diarrhea (loose stools)
• muscle cramps, joint stiffness, and limb pain
• flu-like symptoms, including fever, chills, and shivering, discomfort, fatigue, bone pain, and muscle and joint pain. You should talk to your nurse or doctor if any of these symptoms become troublesome or last more than a few days
• rash

Uncommon(may affect up to 1 in 100 people)

• dizziness
• bloating with gas (feeling bloated)
• back pain
• feeling tired and weak
• asthma attacks

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

• inflammation of the duodenum (the first part of the small intestine), causing stomach pain
• hives

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Medicinal Product Monitoring, 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. 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 Kefort

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date, which is stated on the carton after the words "EXP". The expiry date refers to the last day of that month. There are no special storage instructions. 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 Kefort contains

• The active substance is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as sodium ibandronate monohydrate).
• Other ingredients are: tablet core:lactose monohydrate, microcrystalline cellulose, sodium carmellose, magnesium stearate, colloidal anhydrous silica
• tablet coating:hydroxypropylcellulose, titanium dioxide (E171), macrogol 6000

What Kefort looks like and contents of the pack

Kefort 150 mg coated tablets are white, oblong, and marked with "LC" on one side. Kefort is available in packs containing 1 or 3 tablets. The tablets are packaged in aluminum/aluminum blisters containing 1 or 3 tablets. Not all pack sizes may be marketed.

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Manufacturer

Laboratorios LICONSA S.A., Avda. Miralcampo, No 7, Polígono Industrial Miralcampo, 19200 Azuqueca de Henares (Guadalajara), Spain

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

Austria: Kefort 150 mg Filmtabletten, Norway: Kefort 150 mg Tablett, filmdrasjert, Poland: Kefort, United Kingdom: Kefort 150 mg Film-coated tablets, Date of revision of the leaflet:February 2023