Leaflet: information for the user

Aurovitas Ibuprofen 150 mg film-coated tablets

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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.

1. What isAurovitas Ibuprofenand what it is used for

2. What you need to know before starting to takeAurovitas Ibuprofen

3. How to takeAurovitas Ibuprofen

4. Possible side effects

5. Storage ofAurovitas Ibuprofen

6. Contents of the pack and additional information

Ibandronic Acid Aurovitasbelongs to a group of medications known as bisphosphonates. It contains the active ingredient ibandronic acid.

Ibandronic Acid Aurovitasmay 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.Ibandronic Acid Aurovitasmay help reduce the likelihood of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribedibandronic acidto treat your postmenopausal osteoporosis because you have a high risk of suffering fractures. Osteoporosis is characterized by a thinning and weakening of the bones, a common condition among women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which 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 fractures include:

• insufficient intake of calcium and vitamin D in the diet,
• smoking or excessive alcohol consumption,
• limited walking or other weight-bearing exercise,
• family history of osteoporosis.

Healthy lifestyle habitsalso facilitate the favorable effects of treatment. These include:

• 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 takeIbandronate Aurovitas:

• If you are allergic to Ibandronate or any of the components of this medication (listed in section 6).
• If you have certain problems with your throat/food pipe (esophagus), such as narrowing or difficulty swallowing.
• If you cannot remain standing or upright for at least one hour (60 minutes) at a time.
• If you have or have had low levels of calcium in your blood. Please consult your doctor.

Warnings and precautions

A very rare adverse reaction called osteonecrosis of the jaw (ONJ) (death of bone in the jaw) has been reported during post-marketing experience in patients treated with Ibandronate for osteoporosis. ONJ may also appear after stopping treatment.

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

Also, atypical fractures of long bones, such as the forearm (radius) and shin (tibia), have been reported 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 a complete fracture occurs.

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

• You have problems in your mouth or teeth, such as poor dental health, gum disease, or a planned tooth extraction.
• You do not receive regular 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 been previously treated with a bisphosphonate (used to treat or prevent bone disorders).
• You are taking corticosteroid medications (such as prednisolone or dexamethasone).
• You have cancer.

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

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

Some people require special care during treatment with Ibandronate. Consult your doctor before starting to take 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 or digestive problems.

Esophageal irritation, inflammation, or ulceration may occur, often with intense pain in the chest, intense pain after swallowing food and/or drink, and/or intense nausea or vomiting, especially if patients do not drink a full glass of water and/or if they lie down before an hour has passed after taking Ibandronate. If you develop these symptoms, stop taking Ibandronate and inform your doctor immediately (see section 3).

Children and adolescents

Do not administer Ibandronate to children or adolescents under 18 years old.

Taking Ibandronate Aurovitas with other medications

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

• Supplements containing calcium, magnesium, iron, or aluminummay possibly influence the effects of Ibandronate.
• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, diclofenac, and naproxen) may irritate the stomach and intestines, just like Ibandronate Aurovitas. Therefore, be especially careful when taking analgesics or anti-inflammatory medications at the same time as Ibandronate.

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

Taking Ibandronate Aurovitas with food, drinks, and alcohol

Do not take Ibandronate with food.Ibandronate Aurovitas is less effective if taken with food.

You may drink water but not other liquids.

After taking Ibandronate, please wait 1 hour before taking your first meal and other drinks (see section 3. How to take Ibandronate Aurovitas).

Pregnancy, breastfeeding, and fertility

Ibandronate is only for use in postmenopausal women and should not be taken by women of childbearing age. Do not take Ibandronate if you are pregnant or breastfeeding.

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

You may drive and use machines as it is expected that Ibandronate will not affect your ability to drive and use machines or this will be negligible.

Ibandronate Aurovitas contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

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

The recommended dose is one tablet per month.

How to take the monthly tablet

It is essential to follow these instructions carefully. These instructions are designed to facilitate the rapid arrival of ibandronate acid in the stomach and cause less irritation.

• Take one tablet of Ibandronic Acid Aurovitas 150 mg once a month.
• Choose the day of the month that 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 ibandronate acid tablet. Choose the date that best suits your routine.
• Take the tablet ofibandronate acidafter a minimum of 6 hours after the last meal or drink,except for water.

• Take the tablet ofibandronate acid:
• nothing more than waking up, and
• before breakfast or before consuming liquids(with an empty stomach).

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

Do not take the tablet with water with a high concentration of calcium, fruit juice, or other beverages.If you have any doubts about the potential high levels of calcium in tap water (hard 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 may return to the stomach.

• Do not eat anything.

• Do not drink anything(except water, if you need it).
• Do not take any other medication.

• 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 rest of the medications you need.

Continuation of treatment withIbandronic Acid Aurovitas

It is essential to takeibandronate acidevery month, for the time prescribed by your doctor. After 3-5 years of takingibandronate acid, please consult your doctor if you should continue takingIbandronic Acid Aurovitas.

If you take moreIbandronic Acid Aurovitasthan you should

If you have taken, by mistake, any tablet ofmedication,drink a full glass of milk and inform your doctor immediately.

Do not induce vomiting or lie downbecause you may irritate your stomach.

If you forgot to takeIbandronic Acid Aurovitas

• If you forget to take the tablet on the day you have chosen,do not ingest the tablet later..

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

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

You should never take two tablets of ibandronate acid within the same week. Wait until it is time to take the next dose and take it as usual, then take another tablet once a month on the marked days in your calendar.

• If you forgot to take the tablet on your chosen day and your next dose is more than 7 days...

Take a tablet the next day after the day you remember forgetting the dose, then take another tablet once a month on the marked days in your calendar.

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

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

Uncommon(may affect up to 1 in 100 people):

• Intense chest pain, intense pain when swallowing food or drink, nausea, vomiting, difficulty swallowing. You may have intense inflammation in the throat/food pipe, possibly with a sensation of pain or constriction.

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

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

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

• Pain or sensation of pain in the mouth or jaw. These may be early signs of serious jaw problems [jaw bone necrosis (death of bone tissue)].
• Consult your doctor if you have ear pain, the ear is discharging and/or you have an ear infection. These may be signs of damage to the ear bones.
• Severe allergic reaction that may pose a life-threatening risk.
• Severe adverse reactions in the skin.

Frequency not known(cannot be estimated from available data):

• Unusual fractures in long bones other than the femur.

Other possible side effects

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

• Headache.
• Heartburn, difficulty swallowing, stomach pain or stomach cramps (due to stomach inflammation), indigestion, nausea, diarrhea (intestinal losses).
• Muscle cramps, joint stiffness and extremities.
• Symptoms similar to the flu, 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 up to 1 in 100 people):

• Coughing.
• 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 a sensation of tingling in the fingers or around the mouth.

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

• Inflammation of the duodenum (first section of the intestine) that causes stomach pain.
• Urticaria.

Reporting of 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 Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. 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.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofIbandronic Acid Aurovitas

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

Tablet core: microcrystalline cellulose, povidone (K-25), anhydrous colloidal silica, crospovidone (Type-B), sodium stearyl fumarate.

Tablet coating: hypromellose 2910, triacetin, talc, titanium dioxide (E171).

Appearance of the product and content of the container

Ibandronic Acid Aurovitas are film-coated tablets, white or off-white, oblong, biconvex, marked with “X” on one face of the tablet and “78” on the other.

The tablets of Ibandronic Acid Aurovitas are available in PVC/PE/PVdC/aluminum foil blisters.

Container sizes:1, 3, and 50 film-coated tablets.

Only some container sizes may be marketed.

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

Spain:Ibandronic Acid Aurovitas 150 mg film-coated tablets EFG

Netherlands:Ibandroninezuur Aurobindo 150 mg, filmomhulde tabletten

Poland: Ibandronic Acid Aurovitas

Date of the last review of this leaflet:August 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es)