Kefort

Package leaflet: Information for the patient

Kefort
150 mg, coated tablets
Ibandronic acid
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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

Kefort belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid. Kefort can reverse bone tissue loss by inhibiting bone loss and increasing bone mass in most women taking this medicine, even if they are not able to notice or feel this difference. Kefort may help reduce the likelihood of bone fractures. Reduction in fracture incidence has been demonstrated for vertebral fractures, but not for fractures of the femoral neck.
Kefort has been prescribed for the treatment of postmenopausal osteoporosis, due to the increased
risk of bone fractures associated with this condition. Osteoporosis is a disease characterized by reduced bone density and weakened bones, and it commonly occurs in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps maintain normal bone structure.
The earlier menopause occurs in a woman, the greater her risk of osteoporosis-related fractures.
Other factors that may increase the risk of fractures include:

• insufficient intake of calcium and vitamin D in the diet
• smoking or excessive alcohol consumption
• lack of walking or other weight-bearing exercises
• family history of osteoporosis

A healthy lifestyle will also help you achieve the best benefits from treatment. This means following a balanced diet rich in calcium and vitamin D, walking or doing other weight-bearing exercises, not smoking, and limiting excessive alcohol consumption.

2. Important information before using Kefort

Do not use Kefort

• If the patient is allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6).
• If the patient has problems with the oesophagus (the tube through which food passes), such as narrowing or difficulty swallowing.
• If the patient is unable to remain upright (standing or sitting) continuously for at least one hour (60 minutes).
• If the patient has low calcium levels in the blood or has had them in the past. Consult a doctor.

Warnings and precautions
A side effect called osteonecrosis of the jaw and (or) mandible (damage to the jaw and (or) mandible bone) has been very rarely reported after marketing of Kefort in patients treated with this medicine for osteoporosis. Osteonecrosis of the jaw and (or) mandible may also occur after stopping treatment.
It is important to take preventive measures to reduce the risk of developing osteonecrosis of the jaw and (or) mandible, as it may be a painful condition and difficult to treat. To reduce the risk of osteonecrosis of the jaw and (or) mandible, appropriate precautions should be taken.
Before starting treatment, the patient should inform the doctor/nurse (healthcare professional):

• if she has any oral or dental conditions, such as poor dental health, gum disease, or planned tooth extraction
• if she does not receive routine dental care or has not had regular dental check-ups for a long time
• if she smokes tobacco (this may increase the risk of dental problems)
• if she has previously been treated with a bisphosphonate (used in the treatment or prevention of bone diseases)
• if she is taking corticosteroids (e.g. prednisolone or dexamethasone)
• if she has a cancer diagnosis

The doctor may recommend that the patient undergo a dental examination before starting treatment with Kefort.
During treatment, proper oral hygiene (including regular tooth brushing) should be maintained and routine dental check-ups should be attended. If the patient wears dentures, they should be properly fitted. Patients undergoing dental treatment or prior to dental procedures (e.g. tooth extraction) should inform their doctor and inform the dentist that they are taking Kefort.
If the patient experiences any symptoms in the mouth or teeth, such as loose teeth, pain or swelling, non-healing ulcers or presence of discharge, she should immediately contact her doctor and dentist, as these may be symptoms of osteonecrosis of the jaw and (or) mandible.
Special caution should be taken in certain individuals when using Kefort. Therefore, before taking Kefort, consult your doctor:

• If there are any disturbances in mineral metabolism (e.g. vitamin D deficiency).
• If the kidneys are not functioning properly / if there are kidney diseases.
• If there are any problems with swallowing or digestion.

Irritation, inflammation or ulceration of the oesophagus (the tube through which food passes), often with symptoms of acute chest pain after swallowing food or drink, acute nausea or vomiting, may occur, particularly if the patient did not drink a full glass of water and (or) lies down after taking Kefort. If such symptoms develop, stop taking Kefort and contact a doctor immediately (see section 3).
Children and adolescents
Do not use Kefort in children and adolescents under 18 years of age.
Other medicines and Kefort
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken or plan to take, especially:

• Calcium, magnesium, iron or aluminium-containing supplements, as they may affect the effectiveness of Kefort.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac, naproxen) which may irritate the stomach and intestines. Kefort may also have similar effects. Therefore, special caution should be taken when using painkillers or anti-inflammatory drugs during treatment with Kefort.

After swallowing the monthly tablet of Kefort, do not take any other medicines for 1 hour, including antacids, calcium supplements or vitamins.
Kefort with food and drink
Do not take Kefort with food. Kefort taken with food is less effective.
You may drink water, but do not drink any other beverages
After taking Kefort, wait 1 hour before consuming any food or other drinks (see section 3: How to take Kefort).
Pregnancy and breastfeeding
Kefort should only be taken during menopause and must not be taken by women who may still become pregnant.
Do not take Kefort during pregnancy or breastfeeding.
Before using this medicine, consult a doctor or pharmacist.
Driving and using machines
You may drive and operate machinery, as Kefort has no effect or negligible effect on the ability to drive and operate machinery.
Kefort contains lactose and sodium.
If the patient has previously been diagnosed with intolerance to certain sugars, she should consult her doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Kefort

This medicine should always be taken as directed by the doctor. If in doubt, consult your doctor or pharmacist.
The usual dose of Kefort is one tablet once a month.
Taking the tablet once a month
It is important to carefully follow the instructions below. These instructions are designed to ensure that the Kefort tablet reaches the stomach quickly, thereby reducing the risk of irritation.

• Tear open and carefully peel back the foil cover.
• Take one 150 mg Kefort tablet once a month.
• Choose a specific day of the month that will be easy to remember. You may choose the same date (e.g. the first of each month) or the same day (e.g. the first Sunday of each month). Choose a date that best fits your routine.
• Kefort should be taken at least 6 hours after consuming any food or drink, except water
• The Kefort tablet should be taken
• in the morning after getting up from bed and
• before eating or drinking anything ("on an empty stomach")
• Swallow the tablet with a full glass of water (at least 180 ml).

Do not take the tablet with water high in calcium, fruit juice, or any other beverage. If there is concern that tap water has high calcium content (so-called hard water), low-mineral water is recommended.

• Swallow the tablet whole – do not chew, crush, or allow it to dissolve in the mouth.
• For the next hour (60 minutes) after taking the tablet
• do not lie down; if you do not remain upright (standing or sitting), some of the medicine may flow back into the oesophagus

• do not eat anything

• do not drink anything (except water, if needed)
• do not take any other medicines
• After one hour, you may take your first meal and drink of the day. After eating, you may lie down and take other medicines, if necessary.

Continuation of Kefort treatment
It is important to take Kefort every month for as long as your doctor recommends.
After 5 years of taking Kefort, consult your doctor to determine whether continued treatment with Kefort is necessary.
Taking more Kefort than prescribed
If you accidentally take more than one tablet, drink a full glass of milk and contact your doctor immediately.
Do not induce vomiting or lie down – this may cause irritation of the oesophagus by Kefort.
Missed dose of Kefort
If the patient forgets to take the tablet on the scheduled day, she should not take it later on the same day. In this case, check when the next scheduled dose is due:

• If the patient forgets to take the tablet on the scheduled day, and the next scheduled dose is only 1 to 7 days away…

Never take two Kefort tablets within 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 previously planned dates marked in the calendar.

• If the patient forgets to take the tablet on the scheduled day, and the next scheduled dose is more than 7 days away… Take one tablet in the morning of the next day after remembering the missed dose, then continue taking one tablet per month on the previously planned dates marked in the calendar.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone gets them.
You should immediately inform your nurse or doctor if any of the following serious adverse
reactions occur, as immediate medical help may be required:

Uncommon (may affect up to 1 in 100 people)

• severe chest pain, severe pain when swallowing food or drink, severe nausea or vomiting, difficulty swallowing. A serious inflammation of the oesophagus (the tube through which food passes) may occur, as well as ulceration or narrowing of the oesophagus.
• symptoms of low blood calcium levels (hypocalcaemia), including muscle cramps or spasms and (or) tingling sensations 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 groin, hip or thigh area. These may be early signs indicating a possible risk of atypical fractures of the femur.

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

• pain or ulceration of the mouth or jaw. Early signs of serious jaw problems may occur (osteonecrosis (dead bone tissue) of the jaw).
• if the patient experiences ear pain, ear discharge and (or) ear infection, this should be reported to the doctor. These may be symptoms of bone tissue damage in the ear.
• serious, potentially life-threatening allergic reactions.
• severe skin reactions.

Other possible adverse reactions
Common (may affect up to 1 in 10 people)

• headache
• heartburn, discomfort during swallowing, stomach or abdominal pain (may be associated with stomach inflammation), indigestion, nausea, diarrhoea (loose stools)
• muscle cramps, joint and limb stiffness
• flu-like symptoms including fever, chills and shivering, discomfort, fatigue, bone pain and muscle and joint aches. You should talk to your nurse or doctor if any of these symptoms become bothersome or last longer than a few days
• rash

Uncommon (may affect up to 1 in 100 people)

• dizziness
• bloating with gas (feeling of bloating)
• back pain
• feeling of fatigue and exhaustion
• asthma attacks

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

• duodenitis (inflammation of the first part of the small intestine), causing abdominal pain
• urticaria

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Kefort

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP". The expiry date refers to the last day of the specified month.
No special storage instructions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures 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 ibandronate sodium monohydrate).
• Other ingredients are: tablet core: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, colloidal anhydrous silica
• film coating: hydroxypropylcellulose, titanium dioxide (E171), macrogol 6000

What Kefort looks like and contents of the pack
Kefort 150 mg film-coated tablets are white, oblong-shaped tablets, marked "LC" on one side.
Kefort 150 mg film-coated tablets are supplied in packs containing 1 or 3 tablets. Tablets are provided in aluminium/aluminium blisters containing 1 or 3 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in 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