Package Leaflet: Information for the Patient

Alendronic Acid Weekly Normon 70 mg Tablets EFG

Read the entire package leaflet carefully before starting to takethismedicine, because it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given 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 package leaflet. See section 4.
• It is particularly important that you understand the information in section 3 before taking this medicine.

What is Alendronic Acid weekly Normon?

Alendronic Acid weekly Normon is a tablet that contains the active ingredient alendronic acid (commonly known as alendronate) andbelongs to a group of non-hormonal medications called bisphosphonates.Alendronic Acid weekly Normon preventsbone loss that occurs in women after menopause and helps to rebuild bone. This medication reduces the risk of fractures of the spine and hip.

What is Alendronic Acid weekly Normon used for?

Your doctor has prescribed alendronic acid for you to treat your osteoporosis. It reduces the risk of fractures of the spine and hip.

Alendronic Acid weekly Normon is a weekly treatment.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause. In menopause, the ovaries stop producing the female hormone estrogen, which helps to maintain a woman's healthy skeleton. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater her risk of osteoporosis.

Osteoporosis usually does not have symptoms at first. However, if left untreated, it can result in broken bones. Although these usually hurt, fractures of the bones of the spine can go unnoticed until they cause loss of height. The bones can break during normal daily activity, such as getting up, or from minor injuries that would normally not break a normal bone. Fractures of bones usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (widow's hump) and loss of mobility.

How can osteoporosis be treated?

As well as your treatment with this medication, your doctor may suggest that you make lifestyle changes to help your condition, such as:

Stopping smokingIt seems that smoking increases the rate at which you lose bone and, therefore, may increase your risk of broken bones.

ExerciseAs muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program.

Eating a balanced dietYour doctor may advise you on your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

Do not take alendronate sodium weekly normon

If you think any of these cases apply to you, do not take the tablets. Talk to your doctor first and follow their advice.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Alendronate Sodium Weekly Normon if:

You may be advised to have a dental check-up before starting treatment with Alendronate Sodium Weekly Normon.

It is essential to maintain good oral hygiene while taking Alendronate Sodium Weekly Normon. You should have regular dental check-ups during your treatment and contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or inflammation.

There may be irritation, inflammation, or esophageal ulceration (esophagus - the tube that connects your mouth to your stomach), often with symptoms of chest pain, burning, difficulty, or pain swallowing, especially if patients do not drink a full glass of water and/or if they lie down before 30 minutes after takingAlendronate Sodium Weekly Normon. These adverse effects may worsen if patients continue takingAlendronate Sodium Weekly Normonafter developing these symptoms.

Children and adolescents

Alendronate Sodium Weekly Normon should not be administered to children or adolescents under 18 years of age

Other medicines and alendronate sodium weekly normon

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

It is likely that calcium supplements, antacids, and other oral medicines will interfere with the absorption of Alendronate Sodium Weekly Normon, if taken at the same time. Therefore, it is essential to follow the advice given in section 3.

Certain medicines for rheumatism or long-term pain called NSAIDs (such as aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised if taken at the same time as Alendronate Sodium Weekly Normon.

Alendronate sodium weekly normon with food and drinks

It is likely that foods and drinks (including mineral water) will make Alendronate Sodium Weekly Normon less effective, if taken at the same time. Therefore, it is essential to follow the advice given in section 3.

Pregnancy and breastfeeding

Alendronate Sodium Weekly Normon is only intended for use in postmenopausal women. Do not take Alendronate Sodium Weekly Normon if you are pregnant or think you may be pregnant, or during breastfeeding.

Driving and operating machines

Adverse effects with Alendronate Sodium Weekly Normon (such as blurred vision, dizziness, and intense bone, muscle, or joint pain) may affect your ability to drive or operate machines (see section 4).

Alendronate sodium weekly normon contains lactose

If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medicine.

Alendronate sodium weekly normon contains sodium

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

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

Take one Alendronate Sodium Normon tablet weeklyonce a week.

Follow these instructions carefully.

1. Choose the day of the week that best suits your routine. Take one tablet of this medication each week on the day you have chosen.

It is very important to follow instructions 2, 3, 4, and 5 to help the Alendronate Sodium Normon tablet reach your stomach quickly and reduce possible irritation of the esophagus (the tube that connects the mouth with the stomach).

2. After getting up in the morning and before taking the first meal, drink, or other medication, swallow the entire Alendronate Sodium Normon tablet with a full glass ofwater(not mineral water) (not less than 200 ml), so that the alendronate sodium is absorbed properly.

- do not take it with mineral water (with gas or without gas).

- do not take it with coffee or tea.

- do not take it with juices or milk.

Do not crush or chew the tablet, or allow it to dissolve in your mouth, due to the possibility of mouth ulcers appearing.

3. Do not lie down - remain upright (sitting, standing, or walking) - for at least 30 minutes after swallowing the tablet. Do not lie down until after the first meal of the day.

4. Do not take this medication at bedtime or before getting up in the morning.

5. If you have difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking this medication and inform your doctor.

6. After swallowing an Alendronate Sodium Normon tablet, wait at least 30 minutes before consuming the first meal, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. This medication is only effective if taken on an empty stomach.

?If you take more Alendronate Sodium Normon than you should

If you accidentally take too many tablets, drink a full glass of milk and immediately consult your doctor. Do not induce vomiting and do not lie down.

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 Alendronate Sodium Normon

If you forget a dose, wait until the next morning to take this medication. Do nottake two tablets on the same day.Then, take one tablet once a week, on the originally chosen day.

If you interrupt treatment with Alendronate Sodium Normon

It is essential to take Alendronate Sodium Normon for as long as your doctor prescribes the medication. As it is unknown how long you should take Alendronate Sodium Normon, you should discuss periodically with your doctor the need to continue treatment with this medication to determine if Alendronate Sodium Normon is still suitable for you.

The package of this medication includes a Instructions Card. It contains important information to remind you how to take Alendronate Sodium Normon correctly.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

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

Seek medical attention immediatelyif you notice any of the following side effects, which can be serious, and for which you may need urgent medical treatment:

Frequent (can affect up to 1 in 10 people):

• burning sensation; difficulty swallowing; pain when swallowing; esophageal ulcer (the tube that connects your mouth to your stomach) that can cause chest pain, burning, or difficulty or pain when swallowing.

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

• allergic reactions such as urticaria; swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing; severe skin reactions,
• toothache and/or jaw pain, swelling, or sores inside the mouth, numbness, or a feeling of heaviness in the jaw, or tooth loss. These may be signs of jaw bone damage (osteonecrosis) usually associated with delayed healing and infection, often after a dental extraction. Inform your doctor and dentist if you experience these symptoms,
• atypical femur fractures that can occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as they may be early symptoms and indicative of a possible femur fracture,

• intense bone, muscle, and/or joint pain.

Orother side effects include

Very frequent (can affect more than 1 in 10 people):

Frequent (can affect up to 1 in 10 people):

Infrequent (can affect up to 1 in 100 people):

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

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

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 leaflet. 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 medicine.

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Keep out of the sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition ofWeekly Alendronic AcidNormon:

The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.

The other components (excipients) are: Microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, and magnesium stearate.

AppearanceofWeekly Alendronic AcidNormonand contents of the packaging

White or almost white, elongated, biconvex tablets, printed with A70 on one side.

Each package contains 4 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorios Normon, S.A.

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

Date of the last review of thisleaflet:October 2024

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