Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - ibandronic

Document Subject

Generated Narrative: MedicinalProductDefinition mp3b1ab70efa7458a20495ebc38b1c3fc7

identifier: http://ema.europa.eu/identifier/EU/1/10/642/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Ibandronic Acid Teva 50 mg film-coated tablets

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-3b1ab70efa7458a20495ebc38b1c3fc7

identifier: http://ema.europa.eu/identifier/EU/1/10/642/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - ibandronic

Attesters

What is in this leaflet

1. What Ibandronic Acid Teva is and what it is used for
2. What you need to know before you take 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

Ibandronic Acid Teva contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates.

Ibandronic Acid Teva is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called bone metastases ).

• It helps to prevent your bones from breaking (fractures).
• It also helps to prevent other bone problems that may need surgery or radiotherapy.

Ibandronic Acid Teva works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker.

Do not take Ibandronic Acid Teva

• 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 your food pipe/gullet (oesophagus) such as narrowing or difficulty swallowing
• if you cannot stand or sit upright for at least one hour (60 minutes) at a time
• if you have or ever had low calcium in your blood.

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Ibandronic Acid Teva.

Warnings and precautions A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post-marketing setting in patients receiving Ibandronic Acid Teva for cancer-related conditions. ONJ can also occur after stopping treatment. It is important to try and prevent ONJ developing as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, there are some precautions you should take.

Before receiving treatment, tell your doctor/nurse (health care professional) if:

• you have any problems with your mouth or teeth such as poor dental health, gum disease or a planned 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 (as this may increase the risk of dental problems).
• you have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).
• you are taking medicines called corticosteroids (such as prednisolone or dexamethasone).
• you have cancer.

Your doctor may ask you to undergo a dental examination before starting treatment with Ibandronic Acid Teva.

While being treated, you should maintain good oral hygiene (including regular teeth brushing) and receive routine dental check-ups. If you wear dentures you should make sure these fit properly. If you are under dental treatment or will undergo 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 loose teeth, pain or swelling, non-healing of sores or discharge, as these could be signs of osteonecrosis of the jaw.

Talk to your doctor or pharmacist before taking Ibandronic Acid Teva:

• if you are allergic to any other bisphosphonates
• if you have any swallowing or digestion problems
• if you have high or low blood levels of vitamin D or any other minerals
• if you have kidney problems.

Irritation, inflammation or ulceration of the gullet/food pipe (oesophagus) 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 water and/or if you lie down within an hour of taking Ibandronic Acid Teva. If you develop these symptoms, stop taking Ibandronic Acid Teva and tell your doctor straight away (see sections 3 and 4).

Children and adolescents
Ibandronic Acid Teva should not be used in children and adolescents below the age of 18 years.

Other medicines and Ibandronic Acid Teva Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Ibandronic Acid Teva can affect the way some other medicines work. Also some other medicines can affect the way Ibandronic Acid Teva works.

In particular, tell 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 medicines called NSAIDs , such as ibuprofen or naproxen. This is because NSAIDs and Ibandronic Acid Teva can both irritate your stomach and gut
• a type of antibiotic injection called aminoglycoside such as gentamicin. This is because aminoglycosides and Ibandronic Acid Teva can both lower the amount of calcium in your blood.

Taking medicines that reduce stomach acid 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 drinks except water as Ibandronic Acid Teva is less effective if it is taken with food or drink (see section 3).

Take Ibandronic Acid Teva with at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements (e.g. products containing calcium (milk), aluminium, magnesium and iron) except water. After taking your tablet, wait at least 30 minutes. Then you can have your first food and drink, and take any medicines or supplements (see section 3).

Pregnancy and breast-feeding Do not take Ibandronic Acid Teva if you are pregnant, planning to get pregnant or if you are breast-feeding. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines You can drive and use machines as it s expected that Ibandronic Acid Teva has no or negligible effect on your ability to drive and use machines. Talk to your doctor first if you want to drive, use machine or tools.

Ibandronic Acid Teva contains sodium This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, that is to say essentially sodium-free .

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Take your tablet at least 6 hours after you had last had anything to eat, drink or any other medicines or supplements except water. Water with a high concentration of calcium should not be used. If there is concern regarding potentially high levels of calcium in the tap water (hard water), it is advised to use bottled water with a low mineral content.

Your doctor may do regular blood tests while you are taking Ibandronic Acid Teva. This is to check that you are being given the right amount of medicine.

Taking this medicine It is important that you take Ibandronic Acid Teva at the right time and in the right way. This is because it can cause irritation, inflammation or ulcers in your food pipe/gullet (oesophagus).

You can help stop this happening by doing the following:

• Take your tablet as soon as you get up for the day before having your first food, drink, any medicine or supplements.

• Take your tablet with a full glass of water only (about 200 mL). Do not take your tablet with any drink other than water.

• Swallow the tablet whole. Do not chew, suck or crush the tablet. Do not let the tablet dissolve in your mouth.

• After taking your tablet, wait at least 30 minutes. Then you can have your first food and drink, and take any medicines or supplements.

• Stay upright (sitting or standing) while taking your tablet and for the next hour (60 minutes). Otherwise, some of the medicine could leak back into your food pipe/gullet (oesophagus). How much to take The usual dose of Ibandronic Acid Teva is one tablet each day. If you have moderate kidney problems, your doctor may reduce your dose to one tablet every other day. If you have severe kidney problems, your doctor may reduce your dose to one tablet each week.

If you take more Ibandronic Acid Teva than you should If you take too many tablets talk to a doctor or go to hospital straight away. Drink a full glass of milk before you go. Do not make yourself sick. Do not lie down.

If you forget to take Ibandronic Acid Teva Do not take a double dose to make up for a forgotten dose. If you are taking a tablet each day, skip the missed dose completely. Then carry on as usual the next day. If you are taking a tablet every other day or once a week, ask your doctor or pharmacist for advice.

If you stop taking Ibandronic Acid Teva Keep taking Ibandronic Acid Teva for as long as your doctor tells you. This is because the medicine will only work if it is taken all the time.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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

Talk to a nurse or a doctor straight away if you notice any of the following serious side effects, you may need urgent medical treatment:

Common (may affect up to 1 in 10 people):

• feeling sick, heartburn and discomfort in swallowing (inflammation of your gullet/food pipe)

Uncommon (may affect less than 1 in 100 people):

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

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

• persistent eye pain and inflammation
• new pain, weakness or discomfort in your thigh, hip or groin. You may have early signs of a possible unusual fracture of the thigh bone.

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

• pain or sore in your mouth or jaw. You may have early signs of severe jaw problems (necrosis [dead bone tissue] in the jaw bone).
• Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear.
• itching, swelling of your face, lips, tongue and throat, with difficulty breathing. You may be having a serious, potentially life threatening allergic reaction.
• severe adverse skin reactions.

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

• asthma attack

Other possible side effects

Common (may affect up to 1 in 10 people):

• tummy pain, indigestion
• low calcium levels in your blood
• weakness.

Uncommon (may affect less than 1 in 100 people):

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

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

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 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 throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Ibandronic Acid Teva contains

• The active substance is ibandronic acid. Each film-coated tablet contains 50 mg ibandronic acid (as sodium monohydrate). The other ingredients are:
• tablet core: cellulose microcrystalline, povidone K-30, crospovidone (type A), silica colloidal anhydrous, stearic acid;
• tablet coating: titanium dioxide (E 171), hypromellose, macrogol 400, polysorbate 80. What Ibandronic Acid Teva looks like and contents of the pack The Ibandronic Acid Teva film-coated tablets are white, biconvex, capsule-shaped, engraved 50 on one side and plain on the other.

Ibandronic Acid Teva comes in blisters (PVC/Aclar/PVC Aluminium) in cartons of 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 t 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 31-546 Krakow Poland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG T l/Tel: +32 38207Lietuva UAB Teva Baltics Tel: +370 52660

Te : +359 24899Luxembourg/Luxemburg Teva Pharma Belgium N.V./S.A./AG Belgique/Belgien T l/Tel: +32 38207 esk republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007Magyarorsz g Teva Gy gyszergy r Zrt. Tel: +36 12886Danmark Teva Denmark A/S Tlf: +45 44985Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407Deutschland TEVA GmbH Tel: +49 73140Nederland Teva Nederland B.V. Tel: +31 8000228Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610Norge Teva Norway AS Tlf: +47 66775
Specifar A.B.E.E. : +30 2118805 sterreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970Espa a Teva Pharma, S.L.U. Tel: +34 913873Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459France Teva Sant
T l: +33 155917Portugal Teva Pharma - Produtos Farmac uticos, Lda. Tel: +351 214767Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720Rom nia Teva Pharmaceuticals S.R.L. Tel: +40 212306Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890 sland Teva Pharma Iceland ehf. S mi: +354 5503Slovensk republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267Italia Teva Italia S.r.l. Tel: +39 028917Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805
Specifar A.B.E.E.

: +30 2118805Sverige Teva Sweden AB Tel: +46 42121Latvija UAB Teva Baltics fili le Latvij
Tel: +371 67323United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency web site: