Ibandronic acid Normon 150 mg film-coated tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It could harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if the adverse reactions are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Ibandronic Acid Normon 150 mg is and what it is used for
2. What you need to know before taking Ibandronic Acid Normon 150 mg
3. How to take Ibandronic Acid Normon 150 mg
4. Possible side effects
5. How to store Ibandronic Acid Normon 150 mg
6. Contents of the pack and other information

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

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

Ibandronic acid can reverse bone loss by preventing further bone loss and increasing bone mass in most women who take it, even if they are unable to see or feel the difference. Ibandronic acid can help reduce the occurrence of bone fractures. This reduction has been demonstrated for vertebral fractures, but not for hip fractures.

You have been prescribed ibandronic acid to treat your post-menopausal osteoporosis because you are at high risk of fractures. Osteoporosis is a condition characterized by thinning and weakening of the bones, which is common in women after menopause. During menopause, the ovaries stop producing the female hormone estrogen, which helps maintain skeletal health.

The earlier a woman reaches menopause, the higher her risk of osteoporotic fractures. Other factors that increase the risk of fractures include:

• inadequate dietary intake of calcium and vitamin D,
• smoking or excessive alcohol consumption,
• lack of walking or other weight-bearing exercises,
• family history of osteoporosis.

Healthy lifestyle habits also support 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 taking 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 (oesophagus), such as narrowing or difficulty swallowing,
• if you cannot remain upright, either standing or sitting, for at least one continuous hour (60 minutes),
• if you have or have had low levels of calcium in the blood. Please consult your doctor.

Warnings and precautions

Very rarely, an 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 may also occur after stopping treatment.

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

Atypical fractures of long bones, such as the forearm bone (ulna) and shin bone (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 area of the fracture before a complete fracture occurs.

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

• you have mouth or dental problems, such as poor dental health, gum disease, or planned tooth 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 previously been 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 have a dental examination before starting treatment with

Ibandronic Acid Normon 150 mg.

While on treatment, you should maintain good oral hygiene (including regular tooth brushing) and undergo routine dental check-ups. If you wear dentures, ensure they are properly fitted. If you are undergoing dental treatment or are scheduled for 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 mouth or dental problems, such as tooth loss, pain or swelling, or difficulty healing of 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 disorders (such as vitamin D deficiency),
• if you have any kidney problems,
• if you have any difficulty swallowing or digestive problems.

Irritation, inflammation, or ulceration of the throat/food pipe (oesophagus) may occur, often with symptoms such as severe chest pain, severe pain after swallowing food and/or drink, severe nausea or vomiting, especially if patients do not drink a full glass of water and/or lie down before one hour has passed 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

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines. Especially:

• Supplements containing calcium, magnesium, iron, or aluminium, as they may interfere with the effects of ibandronic acid.

• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (such as ibuprofen, sodium diclofenac, and naproxen), which can irritate the stomach and intestine, just like ibandronic acid. Therefore, take great care when taking painkillers or anti-inflammatory drugs at the same time as Ibandronic Acid Normon.

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

Ibandronic Acid Normon 150 mg with food and drink

Do not take Ibandronic Acid Normon with food. Ibandronic Acid Normon becomes less effective if taken with food.

You may drink water, but no other liquids.

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

Pregnancy and breastfeeding

Ibandronic Acid Normon is intended for use only in postmenopausal women and must not be taken by women of childbearing potential.

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 may drive and operate machinery, as ibandronic acid is not expected to have any effect or its effect is negligible on your ability to drive and use machines.

Ibandronic Acid Normon 150 mg contains lactose and sodium

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

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

3. How to take Ibandronic Acid NORMON 150 mg

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, 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 important that you follow these instructions carefully. They are designed to ensure that Ibandronic Acid Normon reaches the stomach quickly and causes less irritation.

• Take one tablet of Ibandronic Acid Normon 150 mg once a month.

• Choose the day of the month that is easiest for you to remember. You may 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 whichever best fits your routine.

• Take the Ibandronic Acid Normon tablet after at least 6 hours without food or drink, except water.

• Take the Ibandronic Acid Normon tablet:

• immediately upon waking up, and

• before breakfast or drinking any liquids (on an empty stomach)

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

Do not take the tablet with water that has a high calcium concentration, fruit juice, or other beverages. If you are unsure about potentially high calcium levels 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 dissolve it in the mouth.

• During the following hour (60 minutes) after taking the tablet:

• do not lie down – if you do not remain upright (standing or sitting), part of the medicine could flow back into the esophagus

• do not eat anything

  

• do not drink anything (except tap water, if needed)

• do not take any other medication

• After waiting 1 hour, you may eat breakfast and drink your first beverage of the day. Once you have eaten, you may lie down and take any other medications you require, if desired.

Continuation of treatment with Ibandronic Acid Normon 150 mg

It is important that you take Ibandronic Acid Normon every month, as directed by your doctor.

After 5 years of taking Ibandronic Acid Normon, consult your doctor to determine whether you should continue treatment.

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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ibandronic Acid Normon 150 mg

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

• If you forget to take the tablet on your chosen day and your next dose is due in 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 dates marked on your calendar.

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

Take one tablet on the morning after the day you remember missing the dose; then continue taking one tablet per month according to the dates marked on your calendar.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

Uncommon (may affect up to 1 in 100 people)

• severe chest pain, strong pain after taking food or liquids, severe nausea or vomiting.
• difficulty swallowing. You may have severe swelling, possibly with pain or tightness, in the throat/food pipe.
• 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 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 signs of an unusual femur bone fracture.

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

• pain or discomfort in the mouth or jaw. These may be early signs of serious jaw problems [osteonecrosis (bone tissue death) of the jaw bone].
• consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be signs of damage to the ear bones.
• severe allergic reaction that may be life-threatening.
• severe skin adverse reaction.

Other possible adverse effects

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

• headache.
• heartburn, discomfort when swallowing, stomach or abdominal pain (due to stomach inflammation), indigestion, nausea, diarrhea (loose bowel movements).
• muscle cramps, stiffness in joints and limbs.
• flu-like symptoms, including fever, chills and shivering, feeling unwell, bone, muscle and joint pain. Consult your nurse or doctor if any of these effects become bothersome or last more than a few days.
• skin rash.

Uncommon (may affect up to 1 in 100 people)

• dizziness.
• flatulence (gas, bloated feeling).
• back pain.
• feeling of fatigue and exhaustion.
• asthma attacks.

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

• inflammation of the duodenum (first part of the intestine) causing stomach pain.
• hives.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 packaging after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point located at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibandronic Acid Normon 150 mg

• The active substance 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), colloidal anhydrous 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 contents of the pack

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Manufacturer

Synthon BV
Microweg 22,
6545CM Nijmegen (The 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)

Date of the most recent revision of this leaflet: June 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es