Ibandronic Acid Teva 150 mg film-coated tablets

Ibandronic Acid Teva belongs to a group of medicines called bisphosphonates. It contains ibandronic acid. It does not contain hormones.
Ibandronic Acid Teva may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they will not be able to see or feel a difference. Ibandronic Acid Teva may help lower the chances of breaking bones (fractures). This reduction in fractures was shown for the spine but not for the hip.

Ibandronic Acid Teva 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.

Ibandronic Acid Teva prevents loss of bone from osteoporosis, and helps to rebuild bone. Therefore Ibandronic Acid Teva 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.

Do not take Ibandronic Acid Teva

• if you are allergic (hypersensitive) to ibandronic acid or any of the other ingredients of Ibandronic Acid Teva.
• 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 if any of the above apply.

Do not give Ibandronic Acid Teva to children or adolescents.

Take special care with Ibandronic Acid Teva

Some people need to be especially careful while they?re taking Ibandronic Acid Teva. 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 Ibandronic Acid Teva.

Irritation, inflammation or ulceration of the oesophagus (the tube that connects 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 Ibandronic Acid Teva. If you develop these symptoms, stop taking Ibandronic Acid Teva 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 a prescription. Especially:

• supplements containing calcium, magnesium, iron or aluminium, as they could possibly influence the effects of Ibandronic Acid Teva;
• aspirin and other non-steroidal anti-inflammatory medicines (NSAIDs) ( including ibuprofen, diclofenac sodium and naproxen) may irritate the stomach and intestine. Bisphosphonates (like Ibandronic Acid Teva) may also do so. So be especially careful if you take painkillers or anti-inflammatories while you?re taking Ibandronic Acid Teva.

After swallowing your monthly Ibandronic Acid Teva tablet, wait for 1 hour before taking any other medication, including indigestion tablets, calcium supplements, or vitamins.

Taking Ibandronic Acid Teva with food and drink

Do not take Ibandronic Acid Teva with food or milk. Ibandronic Acid Teva is less effective if it?s taken with food.
You can drink plain water but no other drinks (see section 3. How to take Ibandronic Acid Teva).

Pregnancy and breast-feeding

Do not take Ibandronic Acid Teva if you?re pregnant or breast feeding. If you?re breast feeding, you may need to stop in order to take Ibandronic Acid Teva.

Driving and using machines

You can drive and use machines as it?s very unlikely that Ibandronic Acid Teva will affect your ability to drive and use machines.

Always take Ibandronic Acid Teva exactly as your doctor has told you. If you?re not sure about anything, ask your doctor or pharmacist.

The usual dose of Ibandronic Acid Teva is one tablet once a month.

Taking your monthly tablet

It?s important to follow these instructions carefully. They are designed to help your Ibandronic Acid Teva tablet reach your stomach quickly, so it?s less likely to cause irritation.

• Take one Ibandronic Acid Teva 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 Ibandronic Acid Teva tablet. Choose the date that best fits your routine.
• Take your Ibandronic Acid Teva tablet at least 6 hours after you last had anything to eat or drink except plain water.
• Take your Ibandronic Acid Teva 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, milk, fruit juice or any other drinks.
• Swallow your tablet whole ? do not chew it, crush it, suck it or let it dissolve in your mouth.
• For the next hour (60 minutes) after you?ve taken your tablet
• do not lie down; if you do not stay upright (standing or sitting), some of the medicine could leak back 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 (other than water). 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.

If you take more Ibandronic Acid Teva than you should

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 Ibandronic Acid Teva to irritate your oesophagus.

If you forget to take Ibandronic Acid Teva
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 Ibandronic Acid Teva tablets within the same week.

If you stop taking Ibandronic Acid Teva

It?s important to keep taking Ibandronic Acid Teva every month, as long as your doctor prescribes it for you.
Ibandronic Acid Teva can treat osteoporosis only as long as you keep taking it.

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

Like all medicines, Ibandronic Acid Teva can cause side effects, although not everybody gets them.

The following terms are used to describe how often side effects have been reported:

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:
• heartburn,
• indigestion,
• diarrhoea,
• stomach ache,
• nausea.

Ibandronic Acid Teva 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 straight away.

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 Ibandronic Acid Teva. Talk to your doctor if any effects become troublesome or last a long time.

• Uncommon:
• dizziness,
• back pain,
• flatulence.
• Rare:
• swelling and itching of the face, lips and mouth.
• Not known:
• jaw problems associated with delayed healing and infection, often following tooth extraction

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.

Keep out of the reach and sight of children.

This medicinal product does not require any special storage conditions.

Do not use Ibandronic Acid Teva 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.

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.

What Ibandronic Acid Teva contains

• The active substance is ibandronic acid.Each film-coated tablet contains 150 mg ibandronic acid (as ibandronate 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 (E171), 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 ?I150? on one side and plain on the other.
• Ibandronic Acid Teva comes in blisters (PVC/Aclar/PVC ? Aluminium) in cartons of 1 or 3 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Teva Pharma B.V.,
Computerweg 10,
3542 DR Utrecht,
The Netherlands

Manufacturer:

Teva Pharmaceutical Works Private Limited Company
Pallagi út 13,
4042 Debrecen
Hungary

Teva Pharmaceutical Works Private Limited Company

Táncsics Mihály út 82,

H-2100 Gödöll-

Hungary

Teva UK Ltd

Brampton Road, Hampden Park, Eastbourne,

East Sussex, BN22 9AG

United Kingdom

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

The Netherlands

Teva Santé SA

Rue Bellocier,

89107 Sens

France

Teva Czech Industries s.r.o

Ostravska 29/305,

747 70 Opava-Komarov

Czech Republic

PLIVA Krakow Zaklady Farmaceutyczne SA

ul. Mogilska 80

31-546 Krakow

Poland

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

BelgiëBelgiqueBelgien Teva Pharma Belgium N.V.S.A. TélTel 32 3 820 73 73 Te. 359 2 489 95 82 eská republika Teva Pharmaceuticals CR, s.r.o. Tel 420 251 007 111 Danmark Teva Denmark AS Tlf 45 44 98 55 11 Deutschland Teva GmbH Tel 49 7661 98 45 04 LuxembourgLuxemburg Teva Pharma Belgium S.A . TélTel 32 3 820 73 73 Magyarország Teva Magyarország Zrt Tel. 36 1 288 64 00 Malta Teva .. Tel 302107279099 Nederland Teva Nederland B.V. Tel 31 0 800 0228400 Norge Teva Sweden AB Tlf 46 42 12 11 00

Österreich Teva GmbH Tel 49 351 834 0 Polska Teva Pharmaceuticals Polska Sp. z o.o Tel. 48 22 345 93 00 Portugal Teva Pharma - Produtos Farmacêuticos Lda Tel 351 214 235 910 România Teva Pharmaceuticals S.R.L Tel 4021 2306524 Slovenija Pliva Ljubljana d.o.o. Tel 386 1 58 90 390 Slovenská republika Teva Pharmaceuticals Slovakia s.r.o. Tel 421 2 5726 7911 SuomiFinland Teva Sweden AB PuhTel 46 42 12 11 00 Sverige Teva Sweden AB Tel 46 42 12 11 00 United Kingdom Teva UK Limited Tel 44 1323 501 111 Eesti Teva Eesti esindus UAB Sicor Biotech Eesti filiaal Tel 372 611 2409 Teva .. 30 210 72 79 099 España Teva Pharma, S.L.U. Tel 34 91 387 32 80 France Teva Santé Tél 33 1 55 91 7800 Ireland Teva Pharmaceuticals Ireland Tel 353 042 9395 892 Ísland Teva UK Limited Sími 44 1323 501 111 Italia Teva Italia S.r.l. Tel 39 0289179805 Teva .. 30 210 72 79 099 Latvija UAB Sicor Biotech filile Latvij Tel 371 67 784 980 Lietuva UAB Sicor Biotech Tel 370 5 266 02 03

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