Ibandronate Teva

Package leaflet: Information for the patient

Ibandronic Acid Teva 50 mg film-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. 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 other people, even if their symptoms are the same as yours, as it may 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 Ibandronic Acid Teva is and what it is used for
2. What you need to know before taking Ibandronic Acid Teva
3. How to take Ibandronic Acid Teva
4. Possible side effects
5. How to store Ibandronic Acid Teva
6. Contents of the pack and other information

1. What Acido Ibandronico Teva is and what it is used for

Acido Ibandronico Teva contains the active substance acidum ibandronicum. This belongs to a group
of medicines known as bisphosphonates.
Acido Ibandronico Teva is used in adults and is prescribed to you if you have breast cancer
that has spread to the bones (bone metastases).

• It helps prevent bone fractures.
• It helps prevent other bone problems that might require surgery or radiotherapy.

Acido Ibandronico Teva works by reducing calcium loss from the bones. This helps stop the weakening of bones.

2. What you need to know before taking Ibandronic Acid Teva

Do not take Ibandronic Acid Teva

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

Do not take this medicine if any of these conditions apply to you. If you are unsure, consult your doctor or pharmacist before taking Ibandronic Acid Teva.
Warnings and precautions
A side effect called osteonecrosis of the jaw/mandible (severe deterioration of the jaw/mandible bone tissue) has been reported very rarely after marketing in patients taking Ibandronic Acid Teva for the treatment of cancer-related conditions.
Osteonecrosis of the jaw/mandible may also occur after treatment has ended.
It is important to try to prevent the development of osteonecrosis of the jaw/mandible, as this is a painful condition that may be difficult to treat. Several precautions should be taken to reduce the risk of developing osteonecrosis of the jaw/mandible.
Before starting treatment, inform your doctor or nurse (healthcare professional) if:

• you have any 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 receive routine dental care or have not had a dental check-up for a long time
• you are a smoker (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 will require you to undergo a dental examination before starting treatment with Ibandronic Acid Teva.
During treatment with Ibandronic Acid Teva, you must maintain good oral hygiene (including regular tooth cleaning) and have routine dental check-ups. If you wear dentures, ensure they fit properly in your mouth. If you are undergoing dental treatment or need dental surgery (e.g., tooth extractions), inform your doctor about your dental treatment and tell your dentist that you are being treated with Ibandronic Acid Teva.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as tooth loss, pain or swelling, or non-healing sores or discharge, as these could be signs of osteonecrosis of the jaw/mandible.
Atypical fractures of long bones, such as the ulna and tibia, have also been reported in patients receiving long-term ibandronate treatment.
These fractures occur after minimal or no trauma, and some patients experience pain in the area of the fracture before a complete fracture occurs.
Consult your doctor or pharmacist before taking Ibandronic Acid Teva:

• if you are allergic to any other bisphosphonate
• if you have problems with swallowing or digestive issues
• if you have high or low levels of vitamin D or any other mineral in your blood
• if you have kidney problems

Irritation, inflammation, or ulceration of the oesophagus, often associated with symptoms such as severe chest pain, intense pain when swallowing food and/or drinks, severe nausea or vomiting, may occur, especially if you do not drink a full glass of water after taking Ibandronic Acid Teva and/or lie down during the first hour after taking Ibandronic Acid Teva. If you develop these symptoms, stop treatment with Ibandronic Acid Teva and inform your doctor immediately (see sections 3 and 4).
Children and adolescents
Ibandronic Acid Teva must not be used in children and adolescents under 18 years of age.
Other medicines and Ibandronic Acid Teva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is because Ibandronic Acid Teva may affect the action of other medicines. In addition, other medicines may affect the action of Ibandronic Acid Teva.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

• supplements containing calcium, magnesium, iron, or aluminium
• acetylsalicylic acid and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen or naproxen, as both NSAIDs and Ibandronic Acid Teva may cause irritation of the stomach and intestines
• a type of injectable antibiotic called “aminoglycoside” such as gentamicin, as both aminoglycosides and Ibandronic Acid Teva may reduce the amount of calcium in the blood.

Medicines that reduce stomach acidity, such as cimetidine and ranitidine, may slightly increase the effects of Ibandronic Acid Teva.
Ibandronic Acid Teva with food and drink
Do not take Ibandronic Acid Teva with food or any other drink except water, as Ibandronic Acid Teva is less effective when taken with food or drinks (see section 3).
Take Ibandronic Acid Teva at least 6 hours after eating, drinking, or taking other medicines or supplements (e.g., products containing calcium (milk), aluminium, magnesium, or iron), except water. After swallowing the tablet, wait at least 30 minutes. You may then consume food and drinks and take other medicines or supplements (see section 3).
Pregnancy and breastfeeding
Do not take Ibandronic Acid Teva if you are pregnant, planning to become pregnant, or breastfeeding.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You may drive and operate machinery, as Ibandronic Acid Teva is not expected to have any effect or to have a negligible effect on the ability to drive and operate machinery. However, consult your doctor before driving, using machinery, or equipment.
Ibandronic Acid Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e., it is essentially ‘sodium-free’.

3. How to take Ibandronic Acid Teva

Take this medicine exactly as your doctor has told you. If you have any doubts, consult your doctor or pharmacist.
Take the tablet at least 6 hours after eating, drinking, or taking any other medicines or supplements, except water. Water with a high calcium concentration must not be used.
It is recommended to use bottled water with a low mineral content if you suspect that tap water may have potentially high levels of calcium (hard water).
Your doctor may carry out periodic blood tests during treatment with Ibandronic Acid Teva to ensure that the correct dose of this medicine is being administered.

Taking the medicine
It is important that you take Ibandronic Acid Teva at the correct time and in the correct way, as it may cause irritation, inflammation, or ulcers in the food passage (oesophagus).
To prevent this from happening, follow the instructions below:

• Take the tablet as soon as you get up in the morning, before taking any food, drinks, or other medicines or supplements.
• Take the tablet with a full glass of water (approximately 200 mL). Do not take the tablet with any other beverage except water.
• Swallow the tablet whole. Do not chew, suck, or crush it. Do not allow the tablet to dissolve in the mouth.
• After taking the tablet, wait at least 30 minutes before taking any food or drink, other medicines, or supplements.
• Remain in an upright position (sitting or standing) when taking the tablet and for at least one hour (60 minutes) afterwards; otherwise, part of the medicine may reflux into the food passage (oesophagus).

How much medicine to take
The usual dose of Ibandronic Acid Teva is one tablet daily. If you have mild kidney problems, your doctor may reduce the dose to one tablet taken on alternate days. If you have severe kidney problems, your doctor may reduce the dose to one tablet per week.

If you take more Ibandronic Acid Teva than you should
If you take more tablets than prescribed, contact your doctor immediately or go to hospital straight away. Before going, drink a full glass of milk. Do not induce vomiting and do not lie down.

If you forget to take Ibandronic Acid Teva
Do not take a double dose to make up for the forgotten dose. If you take one tablet daily, simply skip the missed dose and take the next dose as usual the following day. If you take the tablet on alternate days or once a week, consult your doctor or pharmacist for advice.

If you stop taking Ibandronic Acid Teva
Continue taking Ibandronic Acid Teva for as long as your doctor tells you to, because this medicine is effective only if taken continuously for the prescribed duration.

Continuing treatment with Ibandronic Acid Teva
It is important to continue receiving Ibandronic Acid Teva every month for as long as your doctor prescribes it. After receiving Ibandronic Acid Teva for 3–5 years, consult your doctor to determine whether you should continue treatment.

If you have any questions about how to use this medicine, ask 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:
Common (affects up to 1 in 10 people):

• nausea, heartburn and difficulty swallowing (inflammation of the throat/food passage).

Uncommon (affects less than 1 in 100 people):

• severe stomach pain. This could be a sign of a bleeding ulcer in the first part of the intestine (duodenum), or that your stomach is inflamed (gastritis).

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

• persistent eye pain and inflammation
• new pain, weakness or discomfort in the thigh, hip or groin. These could be early signs of a possible fracture of the femur.

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

• pain or sores in the mouth or jaw. These could be early signs of serious jaw problems (osteonecrosis, i.e. severe degeneration and death of jawbone tissue)
• contact your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes could be signs of bone damage in the ear
• itching, swelling of the face, lips, tongue and throat, with breathing difficulties. You may be experiencing a severe allergic reaction that could be life-threatening
• serious skin reactions

Not known (frequency cannot be estimated from the available data):

• asthma attack

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

• stomach pain, indigestion
• low calcium levels in the blood
• weakness

Uncommon (affects up to 1 in 100 people):

• chest pain
• itching or tingling of the skin (paraesthesia)
• flu-like symptoms, general feeling of being unwell or pain
• dry mouth, strange taste in the mouth or difficulty swallowing
• anaemia (low blood count)
• high levels of urea or high levels of parathyroid hormone in the blood.

Reporting of side effects
If you get any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ibandronic Acid Teva

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton 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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Acido Ibandronico Teva contains
The active substance is ibandronic acid.

• Each film-coated tablet contains 50 mg of ibandronic acid (as sodium monohydrate). The other components are:
• tablet core: microcrystalline cellulose, povidone K-30, crospovidone (type A), anhydrous colloidal silica, stearic acid;
• tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80.

Description of the appearance of Acido Ibandronico Teva and package contents

• The film-coated tablets of Acido Ibandronico Teva are white, biconvex, capsule-shaped, with "50" engraved on one side and smooth on the other side.
• Acido Ibandronico Teva is available in blisters (PVC/Aclar/PVC - Aluminium) in packages containing 28 or 84 tablets.

Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands
Manufacturer:
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen
Hungary
Pharmachemie B.V.
Swensweg 5,
2031 GA Haarlem
The Netherlands
Teva Czech Industries s.r.o
Ostravska 29/305,
747 70 Opava-Komarov
Czech Republic
Teva Operations Poland Sp.z.o.o
ul. Mogilska 80
31-546 Krakow
Poland
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203
България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373
Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400
Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 Ireland
Tel: +44 2075407117
Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400
Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590
Ελλάδα Österreich
TEVA HELLAS A.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070
España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300
France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550
Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524
Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390
Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911
Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900
Κύπρος Sverige
TEVA HELLAS A.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000
Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.

Patient information leaflet: information for the patient

Ibandronic Acid Teva 150 mg film-coated tablets

ibandronic acid
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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Acido Ibandronico Teva is and what it is used for

Acido Ibandronico Teva belongs to a group of medicines called bisphosphonates. It contains the active
substance ibandronic acid. Acido Ibandronico Teva 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. Acido Ibandronico Teva can help reduce the likelihood of bone breaks (fractures).
This reduction in fractures has been demonstrated for the spine, but not for the hip.
Acido Ibandronico Teva has been prescribed to you for the treatment of postmenopausal
osteoporosis because you have a high risk of fractures. Osteoporosis involves thinning and weakening
of the bones, a common condition in women after menopause. At menopause, a woman's ovaries
stop producing the female hormone oestrogen, 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 exercise)
• 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 Acido Ibandronico Teva

Do not take Acido Ibandronico Teva

• 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 the food passage tube (esophagus), 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 the blood. Consult your doctor.

Warnings and precautions
A side effect called osteonecrosis of the jaw/mandible (severe deterioration of the bone tissue of the jaw and maxilla) has been reported very rarely after marketing in patients taking Acido Ibandronico Teva 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, several precautions should be taken.
Atypical fractures of long bones, such as the ulna and tibia, have also been reported in patients receiving long-term treatment with ibandronate. These fractures occur after minimal or no trauma, and some patients experience pain in the area of the fracture before a complete fracture occurs.
Before starting treatment, inform your doctor or nurse (healthcare professional) if:

• you have any problems with your mouth or teeth, such as poor dental health, gum disease, or if you are planning a dental extraction
• you do not receive routine dental care or have not had a dental check-up for a long time
• you are a smoker (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 Acido Ibandronico Teva.
During treatment with Acido Ibandronico Teva, you must maintain good oral hygiene (including regular tooth cleaning) and have routine dental check-ups. If you wear dentures, ensure they fit properly in your mouth. If you are undergoing or need to undergo dental procedures or oral surgery (e.g., tooth extractions), inform your doctor about your dental treatment and inform your dentist that you are being treated with Acido Ibandronico Teva.
Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as tooth loss, pain or swelling, or non-healing lesions or discharge, as these could be signs of osteonecrosis of the jaw/mandible.
Some people need to take special care when taking Acido Ibandronico Teva. Consult your doctor before taking Acido Ibandronico Teva:

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

Irritation, inflammation, or ulceration of the throat/food passage tube (esophagus) may occur, often with symptoms such as severe chest pain, severe pain after eating 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 Acido Ibandronico Teva. If you develop these symptoms, stop taking Acido Ibandronico Teva and inform your doctor immediately (see section 3).
Children and adolescents
Do not administer Acido Ibandronico Teva to children or adolescents under 18 years of age.
Other medicines and Acido Ibandronico Teva
Inform 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 Acido Ibandronico Teva.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including ibuprofen, sodium diclofenac, and naproxen), which can irritate the stomach and intestines. Acido Ibandronico Teva may have a similar effect. Exercise particular caution if you are taking painkillers or anti-inflammatory drugs together with Acido Ibandronico Teva.

After taking the monthly tablet of Acido Ibandronico Teva, wait 1 hour before taking any other medicine, including antacids, calcium supplements, or vitamins.
Acido Ibandronico Teva with food and drinks
Do not take Acido Ibandronico Teva with food. Acido Ibandronico Teva is less effective when taken with food.
You may drink water but no other beverages
After taking Acido Ibandronico Teva, wait 1 hour before consuming food and other beverages (see section 3 “How to take Acido Ibandronico Teva”).
Pregnancy and breastfeeding
Acido Ibandronico Teva may only be used by postmenopausal women and must not be taken by women who are still able to have children.
Do not take Acido Ibandronico Teva 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 machinery, as Acido Ibandronico Teva is not expected to have any or has a negligible influence on the ability to drive and operate machinery.
Acido Ibandronico Teva contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially ‘sodium-free’.

3. How to take Acido Ibandronico Teva

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
The usual dose of Acido Ibandronico Teva is one tablet per month.
Taking your monthly tablet
It is important to follow the instructions below carefully. They are designed to help the Acido Ibandronico Teva tablet reach your stomach quickly, reducing the likelihood of irritation.

• Take one 150 mg Acido Ibandronico Teva tablet once a month.
• Choose a day of the month that is easy to remember. For taking the Acido Ibandronico Teva tablet, you may choose a specific day of the month (e.g. the 1st of each month) or a specific day of the week (e.g. the first Sunday of each month), whichever best fits your routine.
• Take the Acido Ibandronico Teva tablet at least 6 hours after eating or drinking anything other than water.
• Take the Acido Ibandronico Teva 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 water (at least 180 mL).

Do not take your tablet with highly calcium-rich water, fruit juice, or any other beverage. It is recommended to use bottled water with a low mineral content if you suspect that tap water may have high calcium levels (hard water).

• Swallow the tablet whole – do not chew, crush, or let it dissolve in your mouth.
• During the hour (60 minutes) after taking the tablet
• 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 plain 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 treatment with Acido Ibandronico Teva
It is important to continue taking Acido Ibandronico Teva every month for as long as your doctor prescribes it. After taking Acido Ibandronico Teva for 3–5 years, consult your doctor to determine whether you should continue treatment.
If you take more Acido Ibandronico Teva 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 Acido Ibandronico Teva to irritate your oesophagus.
If you forget to take Acido Ibandronico Teva

• If you forget to take the tablet in the morning on your chosen 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 there are only 1 to 7 days left until your next scheduled dose,
  do not take two Acido Ibandronico Teva tablets within the same week. Wait until the next scheduled dose day and take the tablet as usual; then continue taking one tablet once a month on the scheduled dates marked on your calendar.

• If you forgot to take the tablet on your chosen day and there are more than 7 days until your next scheduled dose,
  take one tablet the morning after the day you remember; then continue taking one tablet once a month on the scheduled dates marked on your calendar.

4. Possible side effects

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

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

Rare (affects 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. This could be early signs of an atypical femoral fracture

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

• pain or sores in the mouth or jaw. These could be early signs of serious jaw problems (osteonecrosis, i.e. severe deterioration and death of jaw bone tissue)
• contact your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes could be signs of bone damage in the ear
• severe allergic reaction, potentially life-threatening
• severe skin reactions

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

• headache
• heartburn, difficulty swallowing, stomach or abdominal pain (could be due to stomach inflammation), indigestion, nausea, diarrhoea (loose stools), muscle cramps, joint and limb stiffness
• flu-like symptoms, including fever, trembling and chills, feeling unwell, bone pain and muscle and joint pain. Talk to a nurse or doctor if any side effect becomes bothersome or lasts more than a few days
• skin rash

Uncommon (affects up to 1 in 100 people):

• dizziness
• flatulence (intestinal gas, bloating sensation)
• back pain
• feeling of tiredness and exhaustion
• asthma attacks
• symptoms of low calcium levels in the blood (hypocalcaemia), including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth

Rare (affects 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, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Acido Ibandronico Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton 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 medicines via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Acido Ibandronico Teva contains

• The active substance is ibandronic acid. Each film-coated tablet contains 150 mg of ibandronic acid (as monosodium monohydrate).
• The other components are:
• Tablet core: microcrystalline cellulose, povidone K-30, crospovidone (type A), anhydrous colloidal silica, stearic acid

Tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400,
polysorbate 80.
Description of the appearance of Acido Ibandronico Teva and pack sizes
Acido Ibandronico Teva tablets are white, biconvex, capsule-shaped, with "I150" engraved on one side and smooth on the other.
Acido Ibandronico Teva is available in blisters (PVC/Aclar/PVC – Aluminium) in packs containing 1 or 3
tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder:
Teva B.V.
Swensweg 5
2031 GA Haarlem,
The Netherlands
Manufacturer:
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen
Hungary
Pharmachemie B.V.
Swensweg 5,
2031 GA Haarlem
The Netherlands
Teva Czech Industries s.r.o
Ostravska 29/305,
747 70 Opava-Komarov
Czech Republic
Teva Operations Poland Sp.z o.o
ul. Mogilska 80
31-546 Krakow
Poland
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
België/Belgique/Belgien Lietuva
Teva Pharma Belgium N.V./S.A./AG UAB Teva Baltics
Tél/Tel: +32 38207373 Tel: +370 52660203
България Luxembourg/Luxemburg
Тева Фарма ЕАД Teva Pharma Belgium N.V./S.A./AG
Teл.: +359 24899585 Belgique/Belgien
Tél/Tel: +32 38207373
Česká republika Magyarország
Teva Pharmaceuticals CR, s.r.o. Teva Gyógyszergyár Zrt.
Tel: +420 251007111 Tel.: +36 12886400
Danmark Malta
Teva Denmark A/S Teva Pharmaceuticals Ireland
Tlf.: +45 44985511 L-Irlanda
Tel: +44 2075407117
Deutschland Nederland
TEVA GmbH Teva Nederland B.V.
Tel: +49 73140208 Tel: +31 8000228400
Eesti Norge
UAB Teva Baltics Eesti filiaal Teva Norway AS
Tel: +372 6610801 Tlf: +47 66775590
Ελλάδα Österreich
TEVA HELLAS A.E. ratiopharm Arzneimittel Vertriebs-GmbH
Τηλ: +30 2118805000 Tel: +43 1970070
España Polska
Teva Pharma, S.L.U. Teva Pharmaceuticals Polska Sp. z o.o.
Tel: +34 913873280 Tel.: +48 223459300
France Portugal
Teva Santé Teva Pharma - Produtos Farmacêuticos, Lda.
Tél: +33 155917800 Tel: +351 214767550
Hrvatska România
Pliva Hrvatska d.o.o. Teva Pharmaceuticals S.R.L.
Tel: +385 13720000 Tel: +40 212306524
Ireland Slovenija
Teva Pharmaceuticals Ireland Pliva Ljubljana d.o.o.
Tel: +44 2075407117 Tel: +386 15890390
Ísland Slovenská republika
Teva Pharma Iceland ehf. TEVA Pharmaceuticals Slovakia s.r.o.
Sími: +354 5503300 Tel: +421 257267911
Italia Suomi/Finland
Teva Italia S.r.l. Teva Finland Oy
Tel: +39 028917981 Puh/Tel: +358 201805900
Κύπρος Sverige
TEVA HELLAS A.E. Teva Sweden AB
Ελλάδα Tel: +46 42121100
Τηλ: +30 2118805000
Latvija United Kingdom (Northern Ireland)
UAB Teva Baltics filiāle Latvijā Teva Pharmaceuticals Ireland
Tel: +371 67323666 Ireland
Tel: +44 2075407117
This leaflet was last updated on {MM/YYYY}
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu/.