Leaflet: information for the user

Ibandronic Acid Normon 150 mg film-coated tablets

Read this leaflet carefully before you start taking the 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.

1.What is Ibandronic Acid Normon 150 mg and what it is used for

2.What you need to know before starting to take Ibandronic Acid Normon 150 mg

3.How to take Ibandronic Acid Normon 150 mg

4.Possible side effects

5.Storage of Ibandronic Acid Normon 150 mg

6.Contents of the pack and additional information

Ibandronic acid belongs to a group of medicines known asbisphosphonates.It contains the active ingredient ibandronic acid.

Ibandronic acid can 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 may help reduce the number of bone fractures (fractures). This reduction has been demonstrated in vertebral fractures but not in hip fractures.

You have been prescribed ibandronic acid to treat your post-menopausal osteoporosis because you have a high risk of suffering fractures.Osteoporosis is a condition characterized by a thinning and weakening of the bones, a common occurrence in women aftermenopause. Duringmenopause, 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:

- inadequate intake of calcium and vitamin D in the diet,

- smoking or excessive alcohol consumption,

- lack of weight-bearing exercise,

- family history of osteoporosis

A healthy lifestyle also facilitates the favorable effects of treatment. These include:

• a balanced diet rich in calcium and vitamin D;
• weight-bearing exercise;
• not smoking and moderate alcohol consumption.

Do not take Ácido Ibandrónico Normon 150 mg

• if you areallergic to ibandronic acid or to any of the other components of this medicine (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 upright, both standing and sitting, for at least one hour (60 minutes) at a time,
• if you have or have hadlow levels of calcium in the blood. Please consult your doctor.

Warnings and precautions

A very rare adverse reaction called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in patients treated with ibandronic acid for osteoporosis during post-marketing experience. 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.

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
• 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 corticosteroid medications (such as prednisolone or dexamethasone)
• if you have cancer

Your doctor may ask you to undergo a dental examination before starting treatment with Ácido Ibandrónico Normon 150 mg.

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 fixed. 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 Ácido Ibandrónico Normon 150 mg.

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 discharge, as these may be signs of osteonecrosis of the jaw.

Some people require special care during treatment with ibandronic acid. Consult your doctor before taking Ácido Ibandrónico Normon:

• if you have any mineral metabolism disorder (such as vitamin D deficiency),
• if you have any kidney problems,
• if you have any swallowing or digestive problems,

Irritation, inflammation, or ulceration of thethroat/food pipe (esophagus) may occur, often with severe chest pain, severe pain after swallowing food and/or drink, intense nausea, or vomiting, especially if patients do not drink a glass of water and/or if they lie down before an hour has passed after taking ibandronic acid. If you develop these symptoms, stop taking Ácido Ibandrónico Normon and inform your doctor immediately (see section 3).

Children and adolescents

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

Other medicines and Ácido Ibandrónico Normon 150 mg

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medicine. Especially:

• Calcium, magnesium, iron, or aluminum supplements,as they may influence the effects of ibandronic acid.

• Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen) that may irritate the stomach and intestines; like ibandronic acid. Be careful when takinganalgesics or anti-inflammatoryat the same time as Ácido Ibandrónico Normon.

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

Ácido Ibandrónico Normon 150 mg with food and drinks

Do not take Ácido Ibandrónico Normon with food.Ibandrónico acidNormonloses its effectiveness if taken with food.

You may drink water but not other liquids.

After taking Ácido Ibandrónico Normon, wait 1 hour before taking your first meal and other drinks (see section 3).

Pregnancy and breastfeeding

Ácido IbandrónicoNormon is only for use in postmenopausal women, and they should not take it if they are fertile.

Do not takeÁcido IbandrónicoNormon if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and operating machines

You may drive and operate machines as ibandronic acid is expected to have no effect or a negligible effect on your ability to drive and operate machines.

Ácido Ibandrónico Normon 150 mg contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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

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

The normal dose of Ibandronic Acid Normon is one tablet per month.

How to take the monthly tablet

It is essential to follow these instructions carefully. They are designed to ensure that Ibandronic Acid Normon reaches the stomach quickly and causes less irritation.

• Take one Ibandronic Acid Normon 150 mg tablet once a month.
• Choose the day of the month that is easiest for you to remember.You can choose the same date (such as the first day of each month) or always the same day (such as the first Sunday of each month). Choose what best fits your routine.
• Take the Ibandronic Acid Normon tablet after a minimum of 6 hours from the last meal or drinkexcept water.

• Take the Ibandronic Acid Normon tablet:
• nothing more than upon waking, and
• before breakfast or consuming liquids(with an empty stomach)

• Swallow the tabletwith a 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 doubt about the potential high calcium levels of tap water (hard water), it is recommended to use bottled water with low mineral content.

• Swallow the tablet wholedo not chew, crush, or dissolve it in your mouth.

• For the next hour (60 minutes)after taking 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

• do not drink anything(except tap 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 any other medications you need.

Continuation of treatment withIbandronic Acid Normon 150 mg

It is essential to take Ibandronic Acid Normon every month until your doctor tells you to stop.

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

If you take more Ibandronic Acid Normon150 mg 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- this can cause the ibandronic acid to irritate your esophagus.

In case of overdose or accidental ingestion,consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Ibandronic Acid Normon150 mg

• If you forget to take the tablet in the morning of the day you have chosen,do not take the tablet later. Instead, check your calendar to see when your next dose is due:

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

You should never take two ibandronic acid tablets within the same week. Wait until it is time to take your 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 andyour next dose is more than 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 medications, this medication may cause side effects, although not everyone will experience them.

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

Rare(may affect up to 1 in 100 people)

• Severe chest pain, strong pain after eating or drinking, intense nausea or vomiting.
• Difficulty swallowing. You may have intense inflammation, possibly with a sensation of pain or constriction, in the throat/ tube through which food passes.
• Symptoms of low blood calcium levels (hypocalcemia), including muscle cramps or spasms and/or a tingling sensation in the fingers or around the mouth.

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

• Itching, swelling of the face, lips, and mouth, with difficulty breathing.
• Persistent eye pain and inflammation.

• New pain, weakness, or discomfort in the thigh, hip, or groin. These may be early symptoms of an unusual fracture of the thigh bone.

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

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

Other possible side effects

Common(may affect up to 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.
• Symptoms of pseudo-gripal, 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.

Rare(may affect up to 1 in 100 people)

• Dizziness.
• Flatulence (gas, feeling bloated).
• Back pain.
• Sensation of fatigue and exhaustion.
• Asthma attacks.

Very 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 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 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 medication.

Keep out of the reach and sight of children.

Do not usethis medicationafter the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or inthe trash. Disposeof the packaging and medicines that you no longer need at the SIGREcollection pointof the pharmacy. Askyour pharmacist how to dispose of the packaging and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Ibandronic Acid Normon 150 mg

• The active ingredient is ibandronic acid. One tablet contains 150 mg of ibandronic acid (as ibandronate sodium monohydrate).

• The other components (excipients) are: lactose monohydrate, crospovidone (E-1202), microcrystalline cellulose (E-460), anhydrous colloidal silica (E-551), sodium stearate fumarate (core of the tablet); polyvinyl alcohol, macrogol/PEG 3350, talc (E-553b) and titanium dioxide (E-171) (coating).

Appearance of the product and contents of the packaging

Coated tablets with a white or off-white film, oblong shape, marked with the inscription “19BE” on one face and “ 150” on the other.

They are presented in blister packs of 1, 3, 7 or 14 tablets.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Responsible manufacturer

Synthon BV

Microweg 22,

6545CM Nijmegen (Netherlands)

Synthon Hispania SL

Castelló 1, Polígono Las Salinas,

08830 Sant Boi de Llobregat (Spain)

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Last review date of this leaflet: August 2022

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