Patient Information Leaflet: Information for the Patient

Teva Ibuprofen 150 mg Film-Coated Tablets

ibuprofen

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as 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 they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Teva Ibandronic Acid belongs to a group of medicines known as bisphosphonates and contains ibandronic acid. Teva Ibandronic Acid may reverse bone loss as it prevents further bone loss and increases bone mass in most women who take it, even if they cannot see or appreciate the difference. Teva Ibandronic Acid may help reduce the likelihood of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribed Teva Ibandronic Acid to treat your postmenopausal osteoporosis because you have a high risk of suffering fractures. Osteoporosis consists of a thinning and weakening of the bones, a common condition among women after menopause. During menopause, the ovaries stop producing the female hormone —estrogens— that helps maintain bone health.

The earlier a woman reaches menopause, the greater her risk of suffering fractures due to osteoporosis.

Other factors that increase the risk of suffering fractures include:

• insufficient intake of calcium and vitamin D in the diet

• smoking or excessive alcohol consumption
• limited walks or other weight-bearing exercises
• family history of osteoporosis

Healthy lifestyle habits also facilitate the favorable effects of treatment. These include a balanced diet rich in calcium and vitamin D, walks or any other weight-bearing exercise, not smoking, and not drinking too much alcohol.

Do not take Teva Ibandronate

• If you are allergic to ibandronate or any of the other ingredients of this medicine (listed in section 6)
• If you have certain problems with your esophagus/throat such as narrowing or difficulty swallowing
• If you cannot remain standing or sitting upright for at least one hour (60 minutes)
• If you have or have had low calcium levels in your blood. Consult your doctor.

Warnings and precautions

There have been very rare reports of a side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) during post-marketing experience in patients treated with Teva Ibandronate for osteoporosis. ONJ may also appear after stopping treatment.

It is essential to try to prevent the development of ONJ as it is a painful condition that can be difficult to treat. In order to reduce the risk of developing osteonecrosis of the jaw, certain precautions should be taken.

There have also been reports of atypical fractures of long bones, such as the forearm (radius) and shin (tibia), in patients receiving long-term treatment with ibandronate. These fractures occur after minor trauma or no trauma at all, and some patients experience pain in the area of the fracture before presenting a complete fracture.

Before receiving treatment, inform your doctor/nurse (healthcare professional) if:

• You have problems in the mouth or teeth, such as poor dental health, gum disease, or a planned tooth extraction,
• If you do not receive regular dental care or if you have not had a dental check-up for a long time,
• If you are a smoker (as this may increase the risk of dental problems),
• If you have been previously treated with a bisphosphonate (used to treat or prevent bone disorders),
• If you are taking medications called corticosteroids (such as prednisolone or dexamethasone),
• If you have cancer

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

While on treatment, you should maintain good oral hygiene (including regular brushing of your teeth) and undergo routine dental check-ups. If you wear dentures, ensure they are properly secured. If you are undergoing dental treatment or are about to undergo dental surgery (e.g., tooth extraction), inform your doctor about your dental treatment and inform your dentist that you are being treated with Teva Ibandronate.

Contact your doctor and dentist immediately if you experience any problems in the mouth or teeth, such as tooth loss, pain, or swelling, difficulty in healing of ulcers or secretion, as these may be signs of osteonecrosis of the jaw.

Some people require special care during treatment with Teva Ibandronate. Talk to your doctor before taking Teva Ibandronate:

• If you have any mineral metabolism disorder (e.g., vitamin D deficiency).
• If your kidneys do not function normally.
• If you have any swallowing problems or digestive problems.

You may experience irritation, inflammation, or ulceration of the esophagus/throat sometimes with symptoms of severe chest pain after swallowing food and/or drink, nausea, or vomiting, especially if you have not drunk a full glass of water and/or if you have lain down before an hour after taking Teva Ibandronate. If you develop these symptoms, stop taking Teva Ibandronate and inform your doctor immediately (see section 3).

Children and adolescents:

Teva Ibandronate should not be used in children or adolescents under 18 years.

Other medicines and Teva Ibandronate

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Especially:

• Supplements containing calcium, magnesium, iron, or aluminum as they may influence the effects of Teva Ibandronate.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac sodium, and naproxen) which may irritate the stomach and intestine; just like Teva Ibandronate. Therefore, be careful when taking analgesics or anti-inflammatory medications at the same time as Teva Ibandronate.

After taking the monthly Teva Ibandronate tablet, wait 1 hour before taking any other medicine, including antacids, calcium supplements, or vitamins.

Teva Ibandronate with food and drinks

Do not take Teva Ibandronate with food. Teva Ibandronate loses effectiveness if taken with food.

You may drink water but not other liquids.

After taking Teva Ibandronate, wait 1 hour before taking your first meal and other foods (see "How to take Teva Ibandronate").

Pregnancy and breastfeeding

Teva Ibandronate is only for use in postmenopausal women, and should not be taken by women of childbearing age.

Do not take Teva Ibandronate if you are pregnant or breastfeeding. If you are breastfeeding, you may need to stop it to take Teva Ibandronate.

Consult your doctor or pharmacist before using this medicine.

Driving and operating machines

Teva Ibandronate is expected to have no or negligible effect on the ability to drive and operate machines.

Teva Ibandronate contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per coated tablet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

How to take the monthly tablet

It is essential to follow these instructions carefully. They are designed to facilitate the immediate arrival of Teva Ibandronic Acid in the stomach and cause less irritation.

• Take one Teva Ibandronic Acid 150 mg tablet once a month.
• Choose the day of the monththat is easiest for you to remember. You can choose the same date (either the first day of each month) or always the same day (such as the first Sunday of each month) to take your Teva Ibandronic Acid tablet. Choose what best suits your routine.
• Take the Teva Ibandronic Acid tabletafter a minimum of 6 hours from the last meal or drink, except water.

• Take the Teva Ibandronic Acid tablet
• • as soon as you get up, and
  • before taking any food or drink(with an empty stomach)

• Swallow the tablet with a full glass of water(at least 180 ml)ml).

Do nottake the tablet with water high in calcium, fruit juice, or other beverages. If you consider high levels of calcium in tap water, it is recommended to use bottled water with low mineral content.

• Swallow the tablet whole. Do not chew, crush, or leave it to dissolve in the mouth.

• During the hour following (60 minutes)after having ingested the tablet

-do not lie down;if you do not remain upright (standing or sitting), part of the medication could return to the esophagus

-do not eat anything

• After waiting 1 hour, you can take breakfast and the first drink of the day. Once you have eaten, you can, if you wish, lie down and take the other medications you need.

Continuation of treatment with Teva Ibandronic Acid

It is essential to take Teva Ibandronic Acid every month, for the time your doctor prescribes.

After 3-5 years of taking Teva Ibandronic Acid, consult your doctor to see if you should continue taking Teva Ibandronic Acid.

If you take more Teva Ibandronic Acid than you should

If, by mistake, you take too many tablets, drink a full glass of milk and immediately contact your doctor. Do not induce vomiting and do not lie down because Teva Ibandronic Acid could irritate your esophagus

If you forget to take Teva Ibandronic Acid

If you forget to take the tablet in the morning of the day you have chosen,do not take the tablet later.

Instead, consult your calendar to see when your next dose is due.

• If you forget to take the tablet on your chosen day and your next dose is within 1 to 7 days

You should never take two Teva Ibandronic Acid tablets within the same week. Wait until it is time to take the next dose and take it as usual, then go back to taking one tablet a month according to the days marked on your calendar.

• If you forget to take the tablet on your chosen day and your next dose is within 1 to 7 days

Take a tablet the next morning after the day you remember forgetting the dose, then go back to taking one tablet a month according to the days marked on your calendar.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Inform your doctor or nurse immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

Rare (may affect fewer than 1 in 100 people)

• Severe chest pain, severe pain after swallowing food or liquids, intense nausea or vomiting, difficulty swallowing. You may have a severe inflammation with sores or constriction in the tube that connects your mouth to your stomach (esophagus/throat)

Uncommon (may affect fewer than 1 in 1,000 people)

• Itching, swelling of the face, lips, tongue, and throat, with difficulty breathing

• Difficulty breathing

• Persistent eye pain and inflammation.
• New pain, weakness, or discomfort in the thigh, hip, or groin. It may be the first sign of an unusual bone fracture in the thigh.

Very rare (may affect fewer than 1 in 10,000 people)

• Pain or sore in the mouth or jaw. You may have the first signs of severe jaw problems (necrosis [tissue death] in the jawbone)
• Consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These may be symptoms of bone damage in the ear.
• Severe allergic reaction, potentially fatal.

• Severe adverse reactions in the skin.

Other possible side effects

Common(may affect fewer than 1 in 10 people)

• Headache
• Heartburn, discomfort when swallowing, stomach pain or cramps (due to stomach inflammation), indigestion, nausea, diarrhea (intestinal losses)
• Muscle cramps, joint stiffness and extremities
• Flu-like symptoms, including fever, chills, and shivering, feeling unwell, bone and muscle pain, and joint pain. Consult your nurse or doctor if any effect becomes bothersome or lasts more than a couple of days.
• Skin rash.

Uncommon(may affect fewer than 1 in 100 people)

• Dizziness
• Flatulence (gas, feeling bloated)
• Back pain
• Sensation of fatigue and exhaustion
• Asthma attacks
• Symptoms of low calcium levels in the blood (hypocalcemia), including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth

Rare(may affect fewer than 1 in 1,000 people)

• Inflammation of the duodenum (first portion of the intestine) causing stomach pain.
• Urticaria

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the carton box after “EXP”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This will help protect the environment.

Composition of Ibandronate Teva

• The active ingredient is ibandronate.

Each film-coated tablet contains 150 mg of ibandronate (as the sodium monohydrate salt)

• The other components are:

Tablet core: microcrystalline cellulose, povidone K-30), colloidal anhydrous silica, and stearic acid;

Tablet coating:titanium dioxide (E171), hypromellose, macrogol 400, and polysorbate 80.

Appearance of the product and contents of the package

Ibandronate Teva film-coated tablets are white, biconvex, capsule-shaped, and have "I150" engraved on one side and are smooth on the other.

Ibandronate Teva is available in blister packs (PVC/Aclar/PVC – Aluminum) in packs of 1 and 3 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder and responsible manufacturer

Teva B.V.

Swensweg 5

Holland

Responsible manufacturer:

Teva Pharmaceutical Works Private Limited Company

Pallagi ut 13

4042 Debrecen

Hungary

Pharmachemie B.V.

Swensweg 5,

2031 GA Haarlem

Holland

Teva Czech Industries s.r.o

Ostravka 29/305

747 70 Opava-Komarov

Czech Republic

Teva Operations Poland Sp.z o.o

ul.Mogilska 80

31-546 Krakow

Poland

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet: {MM/YYYY}

For more detailed information about this medicine, please visit the European Medicines Agency websitehttp://www.ema.europa.eu.