IBANDRONIC ACID NORMON 150 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Ibandronic Acid Normon 150 mg Film-Coated Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Ibandronic Acid Normon 150 mg is and what it is used for
2. What you need to know before you 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 other information

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

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

Ibandronic acid can reverse bone loss because 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 risk of bone fractures. This reduction has been shown in spinal fractures but not in hip fractures.

You have been prescribed ibandronic acid to treat your postmenopausal osteoporosis because you are at high risk of fractures. Osteoporosis is a condition where your bones become thin and weak, which is common in women after the menopause. During the menopause, the ovaries stop producing the female hormone, estrogen, which helps to keep your bones healthy.

The earlier a woman reaches the menopause, the higher her risk of fractures due to osteoporosis. Other factors that increase the risk of fractures are:

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

Healthy lifestyle habitsalso help the beneficial effects of treatment. These include:

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

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

Do not take Ibandronic Acid Normon 150 mg

• if you are allergic to ibandronic acid or any of the other ingredients 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 stand or sit upright for at least one hour (60 minutes),
• if you have or have had low blood calcium levels. Please consult your doctor.

Warnings and precautions

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

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

Atypical fractures of long bones, such as the forearm (ulna) and shin (tibia), have also been reported in patients receiving long-term treatment with ibandronate. These fractures occur after minimal or no trauma, and some patients experience pain in the fracture area before a complete fracture occurs.

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

• you have dental problems or planned dental 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 been previously 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 Normon 150 mg.

While on treatment, you must maintain good oral hygiene (including regular toothbrushing) and undergo routine dental check-ups. If you wear dentures, ensure they fit properly. 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 Ibandronic Acid Normon 150 mg.

Contact your doctor and dentist immediately if you experience any problems with your mouth or teeth, such as tooth loss, pain, or swelling, or difficulty 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 Ibandronic Acid 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 the throat/food pipe (esophagus) may occur, often with symptoms of severe chest pain, severe pain after swallowing food and/or drink, severe nausea, or vomiting, especially if patients do not drink a glass of water and/or lie down before one hour after taking ibandronic acid. If you develop these symptoms, stop taking Ibandronic Acid Normon and inform your doctor immediately (see section 3).

Children and adolescents

Do not give ibandronic acid to children or adolescents under 18 years of age.

Other medicines and Ibandronic Acid Normon 150 mg

Inform your doctor or pharmacist if you are using or have recently used or might use any other medicines. Especially:

• Supplements containing calcium, magnesium, iron, or aluminum, as they may affect the action of ibandronic acid.

• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs)(such as ibuprofen, diclofenac sodium, and naproxen) may irritate the stomach and intestines, as does ibandronic acid. Therefore, be careful when taking painkillers or anti-inflammatory drugs at the same time as Ibandronic Acid Normon.

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

Ibandronic Acid Normon 150 mg with food and drinks

Do not take Ibandronic Acid Normon with food. Ibandronic Acid Normon loses its effect if taken with food.

You can drink water, but not other liquids.

After taking Ibandronic Acid Normon, wait 1 hour before taking your first meal and other drinks (see section 3 How to take Ibandronic Acid Normon 150 mg).

Pregnancy and breastfeeding

Ibandronic Acid Normon is for use in postmenopausal women only and should not be taken by women of childbearing age.

Do not take Ibandronic Acid Normon if you are pregnant or breastfeeding.

Consult your doctor or pharmacist before using this medicine.

Driving and using machines

You can drive and use machines, as ibandronic acid is not expected to affect your ability to drive or use machines.

Ibandronic Acid Normon 150 mg contains lactose and sodium

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

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

3. How to take Ibandronic Acid Normon 150 mg

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist.

The usual 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 help Ibandronic Acid Normon reach the stomach quickly and cause less irritation.

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

• Take the Ibandronic Acid Normon tablet:
• as soon as you get up, and
• before breakfast or drinking(on an empty stomach)

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

Do nottake the tablet with water that has a high concentration of calcium, fruit juice, or other drinks. If you are unsure about the potentially high calcium levels in your tap water (hard water), it is recommended to use bottled water with low mineral content.

• Swallow the tablet whole-do not chew, crush, or dissolve it in your mouth.

• During 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 medicine may come back up into the esophagus
• 

• do not eat anything

• do not drink anything(except tap water if needed)
• do not take any other medicine

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

Continuation of treatment with Ibandronic 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 Normon 150 mg than you should

If you accidentally take too many tablets, drink a full glass of milk and contact your doctor immediately.

Do not induce vomiting and do not lie down-this may cause ibandronic acid to irritate your esophagus.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service: telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Ibandronic Acid Normon 150 mg

• If you forget to take the tablet on 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...

Never take two ibandronic acid tablets within the same week. Wait until your next scheduled dose and take it as usual; then, continue taking one tablet per 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 more than 7 days away...

Take a tablet the next morning after the day you remember you missed the dose; then, continue taking one tablet per month according to the days marked on your calendar.

4. Possible side effects

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

Tell your doctor or nurse 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)

• severe chest pain, severe pain after swallowing food or drink, severe nausea, or vomiting.
• difficulty swallowing. You may have severe inflammation, possibly with a feeling of pain or constriction, in the throat/food pipe.
• symptoms of low blood calcium levels (hypocalcemia), including muscle cramps or spasms and/or a feeling of tingling in the fingers or around the mouth.

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 a possible unusual fracture of the thigh bone.

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

• pain or discomfort in the mouth or jaw. These may be early symptoms of serious 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 could be symptoms of damage to the bones of the ear.
• severe allergic reaction that can be life-threatening.
• severe skin reaction.

Other possible side effects

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

• headache.
• heartburn, difficulty swallowing, stomach pain or discomfort (due to stomach inflammation), indigestion, nausea, diarrhea (intestinal losses).
• muscle cramps, joint stiffness, and limb pain.
• flu-like symptoms, including fever, chills, and sweating, feeling unwell, bone, muscle, 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)

• dizziness.
• flatulence (bloating, feeling bloated).
• back pain.
• feeling tired and weak.
• asthma attacks.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibandronic Acid Normon 150 mg

Keep out of the reach and sight of children.

Do not use this medicine after the expiry date stated on the pack after EXP. The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and any unused medicines. This will help protect the environment.

6. Container Content and Additional Information

Composition of Ácido Ibandrónico Normon 150 mg

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

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

Appearance of the Product and Container Content

Film-coated tablets, white or almost white in color, oblong in shape, marked with the inscription “19BE” on one side and “150” on the other.

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

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

LABORATORIOS NORMON, S.A.

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

Manufacturer

Synthon BV

Microweg 22,

6545CM Nijmegen (Holland)

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)

Date of the Last Revision of this Prospectus: June 2025

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