ALENDRONIC ACID WEEKLY NORMON 70 mg TABLETS

1. What is Alendronic Acid Weekly Normon and what is it used for

What is Alendronic Acid Weekly Normon?

Alendronic Acid Weekly Normon is a tablet that contains the active ingredient alendronic acid (commonly called alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Alendronic Acid Weekly Normon prevents bone loss that occurs in women after menopause and helps rebuild bone. This medicine reduces the risk of vertebral and hip fractures.

What is Alendronic Acid Weekly Normon used for?

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

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What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing the female hormone, estrogen, which helps 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 the risk of osteoporosis.

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

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

Stopping smoking, as smoking appears to increase the rate at which you lose bone and may therefore increase your risk of broken bones.

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

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

2. What you need to know before taking Alendronic Acid Weekly Normon

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• if you are allergic to alendronic acid or any of the other ingredients of this medicine (listed in section 6)
• if you have certain problems with your esophagus (the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing
• if you cannot stand or sit upright for at least 30 minutes
• if your doctor has told you that you have low blood calcium levels

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

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Talk to your doctor or pharmacist before taking Alendronic Acid Weekly Normon if:

• you have kidney problems
• you have, or have had recently, digestive problems or swallowing problems
• your doctor has told you that you have Barrett's esophagus (a condition associated with changes in the cells that line the lower part of the esophagus)
• you have been told that you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome)
• you have been told that you have low blood calcium levels
• you have poor dental hygiene, gum disease, a planned dental extraction, or do not receive regular dental care
• you have cancer
• you are undergoing chemotherapy or radiotherapy
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat diseases like asthma, rheumatoid arthritis, and severe allergies
• you are or have been a smoker (as this may increase the risk of dental problems)

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

It is important to maintain good oral hygiene when taking Alendronic Acid Weekly Normon. You should have regular dental check-ups during your treatment and should contact your doctor or dentist if you experience any problems with your mouth or teeth, such as tooth loss, pain, or swelling.

Irritation, inflammation, or ulcers of the esophagus (the tube that connects your mouth to your stomach) may occur, often with symptoms of chest pain, heartburn, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or if they lie down less than 30 minutes after taking Alendronic Acid Weekly Normon. These side effects may worsen if patients continue taking Alendronic Acid Weekly Normon after developing these symptoms.

Children and Adolescents

Alendronic Acid Weekly Normon should not be given to children or adolescents under 18 years of age.

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Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Calcium supplements, antacids, and other oral medicines may interfere with the absorption of Alendronic Acid Weekly Normon if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Certain medicines for rheumatism or long-term pain, called NSAIDs (e.g., aspirin or ibuprofen), may cause stomach problems. Therefore, caution should be exercised if these medicines are taken at the same time as Alendronic Acid Weekly Normon.

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Food and beverages (including mineral water) may make Alendronic Acid Weekly Normon less effective if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

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

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Side effects with Alendronic Acid Weekly Normon (e.g., blurred vision, dizziness, and intense pain in bones, muscles, or joints) have been reported that may affect your ability to drive or use machines (see section 4).

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

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

3. How to take Alendronic Acid Weekly Normon

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

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Follow these instructions carefully.

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

It is very important that you follow instructions 2, 3, 4, and 5 to help the tablet reach your stomach quickly and reduce the possibility of irritating your esophagus (the tube that connects your mouth to your stomach).

1. After getting up in the morning and before taking your first food, drink, or other medicine, swallow the Alendronic Acid Weekly Normon tablet whole with a full glass of water (not less than 200 ml), so that the alendronic acid is absorbed properly.
• do not take it with mineral water (with 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 ulcers in the mouth.

1. Do not lie down - stay upright (sitting, standing, or walking) - for at least 30 minutes after swallowing the tablet. Do not lie down until after your first food of the day.
2. Do not take this medicine at bedtime or before getting up in the morning.
3. If you have difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking this medicine and inform your doctor.
4. After swallowing an Alendronic Acid Weekly Normon tablet, wait at least 30 minutes before consuming your first food, drink, or other medicine of the day, including antacids, calcium supplements, and vitamins. This medicine is only effective if taken on an empty stomach.

If you take more Alendronic Acid Weekly Normon than you should

If you take too many tablets by mistake, drink a full glass of milk and contact your doctor immediately. 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 Toxicology Information Service, phone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid Weekly Normon

If you forget a dose, wait until the next morning to take this medicine. Do not take two tablets on the same day.Afterward, take one tablet once a week, on the original day you chose.

If you stop treatment with Alendronic Acid Weekly Normon

It is important that you take Alendronic Acid Weekly Normon for as long as your doctor prescribes it. As it is not known how long you should take Alendronic Acid Weekly Normon, you should discuss this with your doctor periodically to determine if Alendronic Acid Weekly Normon is still suitable for you.

A Instructions Card is included in the package of this medicine. It contains important information to remind you how to take Alendronic Acid Weekly Normon correctly.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

See your doctor immediatelyif you notice any of the following side effects, which may be serious and require urgent medical treatment:

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

• heartburn; difficulty swallowing; pain when swallowing; ulcers in the esophagus (the tube that connects your mouth to your stomach) that can cause chest pain, heartburn, or difficulty or pain when swallowing.

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

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

• intense pain in bones, muscles, and/or joints.

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

• intense pain in bones, muscles, and/or joints.

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

• swelling of the joints
• abdominal pain; discomfort in the stomach or belching after eating; constipation; feeling of fullness or bloating; diarrhea; flatulence
• hair loss; itching
• headache; dizziness
• fatigue; swelling of the hands or feet.

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

• nausea; vomiting
• irritation or inflammation of the esophagus (the tube that connects your mouth to your stomach) or stomach
• black or tarry stools
• blurred vision; eye pain or redness
• skin rash; redness of the skin
• symptoms similar to flu, such as muscle pain, general feeling of being unwell, and sometimes fever, which usually appear at the beginning of treatment
• altered taste.

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

• symptoms of low blood calcium levels, including muscle cramps or spasms and/or tingling sensation in the fingers or around the mouth
• stomach or duodenal ulcers (sometimes severe or with bleeding)
• narrowing of the esophagus (the tube that connects your mouth to your stomach)
• skin rash that worsens with sunlight
• mouth ulcers.

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

• 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.

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If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Weekly Normon

Keep out of the sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Further Information

Composition of Alendronic Acid Weekly Normon:

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

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

Appearance of Alendronic Acid Weekly Normon and package contents

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

Each package contains 4 tablets.

Marketing Authorization Holder and Manufacturer:

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet:October 2024

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