Baxogar

Package Leaflet: Information for the User

BAXOGAR

150 mg film-coated tablets
ibandronic acid
Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Baxogar is and what it is used for

Baxogar belongs to a group of medicines called bisphosphonates. It contains the active substance ibandronic acid.
Baxogar can reverse bone loss by preventing further bone loss and increasing bone mass in many women who take it, although they may not see or feel any difference. Baxogar can help reduce the likelihood of bone breaks (fractures).
This reduction in fractures has been demonstrated for the spine but not for the hip.
Baxogar has been prescribed to treat your postmenopausal osteoporosis because you have a high risk of fractures. Osteoporosis involves thinning and weakening of the bones, a condition common in women after menopause. At menopause, a woman's ovaries stop producing a female hormone, estrogen, which helps maintain a healthy skeleton. The earlier a woman reaches menopause, the greater her risk of fractures due to osteoporosis. Other factors that may increase the risk of fractures include:

• inadequate intake of calcium and vitamin D through diet;
• smoking or excessive alcohol consumption;
• lack of physical activity (such as walking or other weight-bearing exercises);
• family history of osteoporosis.

A healthy lifestyle will also help you get the maximum benefit from your treatment. This includes:

• following a balanced diet rich in calcium and vitamin D;
• walking or engaging in other weight-bearing activities;
• not smoking and avoiding excessive alcohol consumption.

2. What you need to know before taking Baxogar

Do not take Baxogar

• if you are allergic to ibandronic acid or to any of the other ingredients of this medicine (listed in section 6);
• if you have certain problems with your throat/food passage (oesophagus), such as narrowing or difficulty swallowing;
• if you are unable to remain in an upright position (standing or sitting) for at least one hour (60 minutes) continuously;
• if you have, or have previously had, low levels of calcium in your blood. In this case, consult your doctor.

Warnings and precautions
Talk to your doctor or pharmacist before taking Baxogar.
Very rarely, in post-marketing experience, an adverse reaction called osteonecrosis of the jaw/mandible has been reported in patients treated with ibandronic acid for osteoporosis.
Osteonecrosis of the jaw/mandible may also occur after discontinuation of treatment.
It is important to try to prevent the development of osteonecrosis of the jaw/mandible, as it is a painful condition that may be difficult to treat. To reduce the risk of developing osteonecrosis of the jaw/mandible, you must take certain precautions.
Before starting treatment, inform your doctor/nurse (healthcare professional) if:

• you have problems with your mouth or teeth, such as poor dental health, gum disease, or if you are scheduled for a tooth extraction;
• you do not have regular dental check-ups and have not had a dental examination for a long time;
• you are a smoker (as this may increase the risk of dental problems);
• you have previously been treated with bisphosphonates (used to treat or prevent bone problems);
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone);
• you have cancer.

Your doctor may ask you to have a dental examination before starting treatment with Baxogar.
During treatment, you must maintain good oral hygiene (including regular tooth cleaning) and undergo routine dental check-ups. If you wear dentures, make sure they fit properly in your mouth. If you undergo dental procedures or need dental surgery (e.g. tooth extraction), inform your doctor about your dental treatment and inform your dentist that you are being treated with Baxogar.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as tooth loss, pain or swelling, or failure of sores to heal or discharge, as these could be signs of osteonecrosis of the jaw/mandibola.
Some people need to take particular care when taking Baxogar. Talk to your doctor before taking Baxogar:

• if you have any mineral metabolism disorders (such as vitamin D deficiency);
• if your kidneys are not functioning normally;
• if you have swallowing or digestive problems.

Irritation, inflammation or ulceration of the throat/food passage (oesophagus) may occur, often with symptoms such as severe chest pain, severe pain after eating food and/or drinking, severe nausea, or vomiting, especially if you do not drink a full glass of water and/or if you lie down within one hour after taking Baxogar. If you develop these symptoms, stop taking Baxogar and inform your doctor immediately (see section 3).
Children and adolescents
Do not give Baxogar to children or adolescents under 18 years of age.
Other medicines and Baxogar
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Especially:

• Calcium, magnesium, iron or aluminium-containing supplements, as they may affect the effects of Baxogar.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac and naproxen) which can irritate the stomach and intestines. Baxogar may have a similar effect. Be especially careful if you take painkillers or anti-inflammatory medicines at the same time as Baxogar.

After taking the monthly Baxogar tablet, wait 1 hour before taking any other medicine, including antacids, calcium supplements or vitamins.
Baxogar with food and drinks
Do not take Baxogar with food. Baxogar is less effective if taken with food.
You may drink water but no other drinks.
After taking Baxogar, wait 1 hour before consuming food and other drinks (see section 3 "How to take Baxogar").
Pregnancy and breastfeeding
Baxogar may only be used by post-menopausal women and must not be taken by women who are still able to have children.
Do not take Baxogar if you are pregnant or breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may drive and use machines, as Baxogar is expected to have no or negligible effect on the ability to drive and use machines.
Baxogar contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Baxogar contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Baxogar

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Baxogar is one tablet per month.
Taking your monthly tablet
It is important to follow the instructions below carefully. They are designed to help the Baxogar tablet reach the stomach quickly, reducing the likelihood of irritation.

• Take one 150 mg Baxogar tablet once a month.
• Choose a day of the month that is easy to remember. For taking the Baxogar tablet, you may select a specific date (e.g., the 1st of each month) or a particular day of the week (e.g., the first Sunday of each month), depending on what best fits your routine.
• Take the Baxogar tablet at least 6 hours after eating or drinking anything other than water.
• Take the Baxogar tablet
• immediately after getting up in the morning and
• before eating or drinking anything (on an empty stomach).
• Swallow the tablet with a full glass of plain water (at least 180 ml). Do not take the tablet with water high in calcium, fruit juice, or any other beverage. It is recommended to use bottled water with low mineral content if there is a concern about potentially high calcium levels in tap water (hard water).
• Swallow the tablet whole – do not chew, crush, or dissolve it in the mouth.
• During the hour following (60 minutes) tablet intake:
• Do not lie down – if you do not remain upright (standing or sitting), part of the medicine may reflux into the oesophagus.

• Do not eat anything

• Do not drink anything (except water if needed)
• Do not take any other medicines.
• After waiting one hour, you may eat and drink for your morning meal. After eating, you may lie down if desired and take other medicines as needed.

Continuing Baxogar treatment
It is important to continue taking Baxogar every month for as long as your doctor prescribes it. After taking Baxogar for 5 years, consult your doctor to determine whether you should continue the treatment.
If you take more Baxogar than you should
If you have taken more than one tablet by mistake, drink a full glass of milk and contact your doctor immediately.
Do not induce vomiting and do not lie down – this could cause Baxogar to irritate your oesophagus.
If you forget to take Baxogar

• If you forget to take the tablet in the morning on your scheduled day, do not take it later during the day. Instead, check your calendar to see when your next scheduled dose is due:
• If you forgot to take the tablet on your chosen day and only 1 to 7 days remain until your next scheduled dose, never take two Baxogar tablets within the same week. Wait until the next scheduled dose and take the tablet as usual. Then continue taking one tablet once a month on the dates marked on your calendar.
• If you forgot to take the tablet on your chosen day and more than 7 days remain until your next scheduled dose, take a tablet the morning after you remember; then continue taking one tablet once a month on the scheduled dates marked on your calendar.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Contact a nurse or doctor immediately if you notice any of the following serious side effects – you may need urgent medical treatment:
Uncommon (occur in up to 1 in 100 people):

• severe chest pain, intense pain after eating or drinking, severe nausea or vomiting, difficulty swallowing. A severe inflammation of the throat/food passage may occur, sometimes with sores or narrowing of the throat/food passage.

Rare (occur in up to 1 in 1,000 people):

• itching, swelling of the face, lips, tongue and throat, with breathing difficulties
• persistent eye pain and inflammation
• new pain, weakness or discomfort in the thigh, hip or groin. These may be early signs of an unusual fracture of the femur.

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

• pain or sores in the mouth or pain in the jaw. Early signs of serious jaw problems (necrosis, i.e. death of the jawbone tissue) may occur
• contact your doctor if you experience ear pain, ear discharge and/or ear infection. These may be signs of bone damage in the ear
• severe allergic reaction, potentially life-threatening
• severe skin reactions. You may develop a skin rash which may blister and appear as small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (signs of erythema multiforme), a widespread rash with blistering and peeling skin, particularly around the mouth, nose, eyes and genitals (signs of Stevens-Johnson syndrome), or blistering skin (signs of bullous dermatitis).

Other possible side effects
Common (occur in up to 1 in 10 people):

• headache
• heartburn, difficulty swallowing, stomach or abdominal pain (possibly due to stomach inflammation), indigestion, nausea, diarrhoea
• muscle cramps, joint and limb stiffness
• flu-like symptoms, including fever, trembling and chills, feeling unwell, bone, muscle and joint pain. Talk to a nurse or doctor if any of these effects become bothersome or last more than a few days
• skin rash

Uncommon (occur in up to 1 in 100 people):

• dizziness
• flatulence (intestinal gas, bloating sensation)
• back pain
• feeling tired and exhausted
• asthma attacks

Rare (occur in up to 1 in 1,000 people):

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

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Baxogar

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 and on the blister after
"Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Baxogar contains

• The active substance is ibandronic acid. Each film-coated tablet contains 150 mg of ibandronic acid (as sodium monohydrate).
• The other components are:

Tablet core: povidone, microcrystalline cellulose, pregelatinized maize starch,
crospovidone, anhydrous colloidal silica, glycerol dibehenate.
Tablet coating: Opadry OY-LS-28908 (White II) containing: hypromellose, lactose
monohydrate, titanium dioxide (E171), macrogol 4000.
Description of the appearance of Baxogar and package contents
Baxogar 150 mg film-coated tablets are white, round and biconvex.
Baxogar 150 mg film-coated tablets are packaged in cardboard boxes containing an appropriate number of blisters made of PA/Aluminium/PVC-Aluminium (alu-alu blisters), each containing 1 or 3 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmacare Srl
Via Marghera, 29
20149 Milano
Italy
Manufacturers:
Pharmathen S.A.
6 Dervenakion Str.
153 51 Pallini, Attiki
Greece
Pharmathen International S.A.
Sapes Industrial Park, Block 5
693 00 Rodopi
Greece
This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Baxogar 150 mg filmovertrukne tabletter
Estonia Baxogar
Italy Baxogar
Latvia Baxogar
Lithuania Baxogar 150 mg plėvele dengtos tabletės
Netherlands Baxogar 150 mg filmomhulde tabletten
Portugal Baxogar
Spain Ácido Ibandrónico Aristo 150 mg
comprimidos recubiertos con película EFG
United Kingdom Baxogar 150mg film-coated tablets