Kefort 150mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Kefort
150 mg film-coated tablets Ibandronic acid
Read all of this leaflet carefully before you start taking this medicine.
- 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Kefort is and what it is used for
2. Before you take Kefort
3. How to take Kefort
4. Possible side effects
5. How to store Kefort
6. Further information
1. WHAT KEFORT IS AND WHAT IT IS USED FOR
Kefort belongs to a group of medicines called bisphosphonates. It contains ibandronic acid. It does not contain hormones.
Kefort may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they won’t be able to see or feel a difference. Kefort may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.
Kefort is prescribed to you to treat osteoporosis because you have an increased risk of fractures. Osteoporosis is a thinning and weakening of the bones, which is common in women after the menopause. At the menopause, a woman’s ovaries stop producing the female hormone, oestrogen, which helps to keep her skeleton healthy.
The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis. Other things that can increase the risk of fractures include:
- not enough calcium and vitamin D in the diet
- smoking, or drinking too much alcohol
- not enough walking or other weight-bearing exercise
- a family history of osteoporosis
Many people with osteoporosis have no symptoms. If you have no symptoms you may not know if you have the condition. However, osteoporosis makes you more likely to break bones if you fall or hurt yourself. A broken bone after the age of 50 may be a sign of osteoporosis. Osteoporosis can also cause back pain, height loss and a curved back.
Kefort prevents loss of bone from osteoporosis, and helps to rebuild bone. Therefore Kefort makes bone less likely to break.
A healthy lifestyle will also help you to get the most benefit from your treatment. This includes eating a balanced diet rich in calcium and vitamin D; walking or any other weight-bearing exercise; not smoking; and not drinking too much alcohol.
2. BEFORE YOU TAKE KEFORT
Do not take Kefort
- If you are allergic (hypersensitive) to ibandronic acid, or to any of the other ingredients of Kefort.
- If you have certain problems with your oesophagus (the tube connecting your mouth with your stomach) such as narrowing or difficulty swallowing.
- If you can’t stand or sit upright for at least one hour (60 minutes) at a time.
- If you have, or had in the past low blood calcium. Please consult your doctor.
Do not give Kefort to children or adolescents.
Take special care with Kefort
Some people need to be especially careful while they’re taking Kefort. Check with your doctor:
- If you have any disturbances of mineral metabolism (such as vitamin D deficiency).
- If your kidneys are not functioning normally.
- If you have any swallowing or digestive problems.
- If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Kefort.
Irritation, inflammation or ulceration of the oesophagus (the tube connecting your mouth with your stomach) often with symptoms of severe pain in the chest, severe pain after swallowing food and/or drink, severe nausea, or vomiting may occur, especially if you do not drink a full glass of plain water and/or if you lie down within an hour of taking Kefort. If you develop these symptoms, stop taking Kefort and tell your doctor straight away.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken any other medicines, including medicines obtained without prescription. Especially:
- Supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Kefort.
- Aspirin and other non-steroidal anti-inflammatory medicines (NSAIDs) (including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine. Bisphosphonates (like Kefort) may also do so. So be especially careful if you
take painkillers or anti-inflammatories while you’re taking Kefort.
After swallowing your monthly Kefort tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.
Taking Kefort with food and drink:
Do not take Kefort with food. Kefort is less effective if it’s taken with food.
You can drink plain water but no other drinks (see 3. HOW TO TAKE KEFORT).
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
There are no adequate data from the use of Kefort in pregnant women. Studies in animals have shown that Kefort could be toxic to reproduction. Kefort should therefore not be used during pregnancy.
It is not known if the medicine is excreted in human milk. Studies in animals have shown low levels of the active substance in milk. Kefort should therefore not be used during breast feeding.
Driving and using machines
You can drive and use machines as it’s very unlikely that Kefort will affect your ability to drive and use machines.
Important information about some of the ingredients of Kefort
Kefort contains an ingredient called lactose. If you have been told by your doctor that
you have an intolerance to some sugars, contact your doctor before taking this medicinal
product.
3. HOW TO TAKE KEFORT
Always take Kefort exactly as your doctor has told you. If you’re not sure about anything, ask your doctor or pharmacist.
The usual dose of Kefort is one tablet once a month.
Taking your monthly tablet
It’s important to follow these instructions carefully. They are designed to help your Kefort tablet reach your stomach quickly, so it’s less likely to cause irritation.
- Take one Kefort 150 mg tablet once a month.
- Choose one day of the month that will be easy to remember. You can choose either the same date (such as the 1st of each month) or the same day (such as the first Sunday of each month) to take your Kefort tablet. Choose the date that best fits your routine.
- Take your Kefort tablet at least 6 hours after you last had anything to eat or
drink except plain water.
- Take your Kefort tablet
- after you first get up for the day, and
- before you have anything to eat or drink (on an empty stomach)
- Swallow your tablet with a full glass of plain water (at least 180 ml). Do not take your tablet with mineral water, fruit juice or any other drinks.
- Swallow your tablet whole — do not chew it, crush it or let it dissolve in your mouth.
- For the next hour (60 minutes) after you’ve taken your tablet
could leak
- do not lie down; if you do not stay upright (standing or sitting), some of the medicine into your oesophagus
- do not eat anything
- do not drink anything (except plain water if you need it)
- do not take any other medicines
- After you’ve waited for an hour, you can have your first food and drink of the day. Once you’ve eaten, it’s OK to lie down if you wish, and to take any other medication you need.
Do not take your tablet at bedtime or before you get up for the day.
Continuing to take Kefort
It’s important to keep taking Kefort every month, as long as your doctor prescribes it for you.
Kefort can treat osteoporosis only as long as you keep taking it.
If you take too much Kefort
If you’ve taken more than one tablet by mistake, drink a full glass of milk and talk to your doctor straight away.
Do not make yourself vomit, and do not lie down — this could cause Kefort to irritate your oesophagus.
If you forget a dose
If you forget to take your tablet on the morning of your chosen day, do not take a tablet later in the day. Instead, consult your calendar and find out when your next scheduled dose is:
If your next scheduled dose is only 1 to 7 days away...
You should wait until the next scheduled dose is due and take it as normal; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendar.
If your next scheduled dose is more than 7 days away.
You should take one tablet the next morning after the day you remember; then, continue taking one tablet once a month on the scheduled days you’ve marked on your calendar.
Never take two Kefort tablets within the same week.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Kefort can cause side effects, although not everybody gets them.
These side effects may occur with certain frequencies, which are defined as follows:
- very common: affects more than 1 user in 10
- common: affects 1 to 10 users in 100
- uncommon: affects 1 to 10 users in 1,000
- rare: affects 1 to 10 users in 10,000
- very rare: affects less than 1 user in 10,000
- not known: frequency cannot be estimated from the available data.
Common side effects are heartburn, indigestion, diarrhoea, stomach ache, and nausea. Kefort can also irritate the oesophagus, although you can usually avoid this by taking your dose as described in this leaflet. If you develop symptoms such as severe pain in the chest, severe pain after swallowing food or drink, severe nausea, or vomiting, tell your doctor straightaway.
Other common side effects include rash, cramps in the muscles, pain in the muscles and joints, and headache.
It also includes flu-like symptoms (aches and pains, feeling of discomfort, fatigue) which are usually mild, are short-lasting and disappear soon after you have taken the first dose. So you should be able to carry on taking Kefort. Talk to your doctor if any effects become troublesome or last a long time.
Uncommon side effects are dizziness, back pain and flatulence.
Rare side effects are swelling and itching of the face, lips and mouth.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE KEFORT
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the carton after “EXP”.
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. These measures will help to protect the environment.
6. FURTHER INFORMATION What Kefort contains
- The active substance is ibandronic acid. One tablet contains 150 mg ibandronic acid (as ibandronate sodium hydrate).
- The other ingredients are:
tablet core: lactose monohydrate, cellulose microcrystalline, croscarmellose sodium, magnesium stearate, silica colloidal anhydrous
tablet coat: hydroxypropylcellulose, titanium dioxide (E171), macrogol 6000 What Kefort looks like and contents of the pack
Kefort 150 mg film-coated tablets are white film-coated tablets of oblong shape and scored “LC” on one side.
Kefort 150 mg film-coated tablets is available in pack sizes of 1 and 3 film-coated tablets. The tablets are supplied in blisters containing 1 or 3 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Crescent Pharma Limited
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hants RG25 3ED United Kingdom
Manufacturer:
Laboratories LICONSA, S.A.
Avda. Miralcampo, N° 7, Poligono Industrial Miralcampo 19200 Azuqueca de Henares (Guadalajara),
SPAIN
This medicinal product is authorised in the Member States of the EEA under the following names:
[NO/H/160/001/DC]:
Austria: Kefort 150 mg Filmtabletten
Bulgary: Kefort 150 mg OuuMHpaHa TadueTKa
Czech Republic: Kefort 150 mg potahovane tablety
Estonia: Kefort 150 mg
France: Kefort 150 mg Comprimes pellicules
Germany: Kefort 150 mg Filmtabletten
Greece: Kefort 150 mg Emrakuppevo ps ksrno upevio SiaKo
Ireland: Kefort 150 mg Film-coated tablets
Italy: Kefort 150 mg Compressa rivestita con film
Latvia: Kefort 150 mg Apvalkotas tabletes
Lithuania: Kefort 150 mg Plevele dengtos tabletes
Norway: Kefort 150 mg Tablett, filmdrasjert
Poland: Kefort Portugal: Kefort 150 mg
Slovenia: Kefort 150 mg Filmsko oblozene tablete
Slovak Republic: Kefort 150 mg
United Kingdom: Kefort 150 mg Film-coated tablets
This leaflet was last approved in: September 2010