Package Leaflet: Information for the User

Alendronic Acid Weekly Ababor 70 mg Tablets

Read this leaflet carefully before you start taking this 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 pass it on to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• It is particularly important that you understand the information in section 3 before taking this medicine.

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

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

3. How to take Alendronic Acid Weekly Ababor

4. Possible side effects

5. Storage of Alendronic Acid Weekly Ababor

6. Contents of the pack and additional information

Alendronic acid belongs to a group of non-hormonal medications called bisphosphonates.

Alendronic acid is indicated for the treatment of postmenopausal osteoporosis. Alendronic acid reduces the risk of fractures of the spine and hip.

Do not take Alendronic Acid Weekly Ababor

- if you are allergic to alendronic acid or any of the other ingredients in this medicine (listed in section 6)

- if you have certain throat problems (esophagus - the tube that connects your mouth to your stomach) such as narrowing or difficulty swallowing

- if you cannot stand or sit for at least 30 minutes

- if your doctor has told you that you have low blood calcium

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 Alendronic Acid Weekly Ababor if:

- you have kidney problems

- you have or have had recent digestive problems or difficulty swallowing

- your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that cover 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,

- you have poor dental hygiene, gum disease, a planned tooth extraction or do not receive regular dental care,

- you have cancer,

- you are undergoing chemotherapy or radiation therapy,

- you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,

- you are taking corticosteroids (such as prednisone or dexamethasone) used in the treatment of diseases such as 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 Ababor.

It is essential to maintain good oral hygiene while taking alendronic acid. 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 within 30 minutes of taking Alendronic Acid Weekly Ababor. These adverse effects may worsen if patients continue taking alendronic acid after developing these symptoms

Children and adolescents

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

Other medicines and Alendronic Acid Weekly Ababor

Inform your doctor or pharmacist if you are using, or 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 Alendronic Acid Weekly Ababor 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 Alendronic Acid Weekly Ababor.

Taking Alendronic Acid Weekly Ababor with food and drinks

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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

Adverse effects with alendronic acid (such as blurred vision, dizziness, and intense bone, muscle, or joint pain) may affect your ability to drive or operate machinery (see section 4).

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

Remember to take your medication.

Take Alendronate Weekly Ababor once a week as prescribed.

You may have been prescribed 10 mg alendronate tablets to be taken once a day on other occasions.

Alendronate Weekly Ababor is takenonce a week.

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

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

2. After getting up in the morning and before taking the first meal, drink the Alendronate Weekly Ababor tablet with a full glass of tap water (not less than 200 ml).

- do not take it with mineral water

- do not take it with coffee or tea

- do not take it with juices.

Do not crush or chew the alendronate tablet or let it dissolve in the mouth due to the possibility of mouth ulcers appearing.

3. Do not lie down after taking the alendronate tablet: stay upright (sitting, standing, or walking) for at least 30 minutes and do not lie down until after the first meal of the day.

4. Do not take Alendronate Weekly Ababor at bedtime or before getting up in the morning.

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

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

7. If you forget a dose, wait until the next morning to take Alendronate Weekly Ababor.Do not take two tablets on the same day.Then, take one tablet once a week on the originally chosen day.

8. It is essential to continue taking Alendronate Weekly Ababor for the entire time your doctor indicates. Alendronate Weekly Ababor can only treat osteoporosis if you continue taking the tablets.

If you take more Alendronate Weekly Ababor than you should

If you accidentally take too many tablets, drink a full glass of milk and immediately see 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 forgot to take Alendronate Weekly Ababor

If you forget a dose, wait until the next morning to take alendronate weekly. Do not take two tablets on the same day. Then, take one tablet once a week on the originally chosen day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Alendronate Weekly Ababor

It is essential to take alendronate weekly for as long as your doctor prescribes the medication.

Since it is unknown how long you should take alendronate weekly, you should discuss periodically with your doctor the need to continue treatment with this medication to determine if Alendronate Weekly Ababor is still suitable for you.

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

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

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

Frequent (may 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 may cause chest pain, burning, or difficulty or pain when swallowing.

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

• allergic reactions such as urticaria; swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions,
• pain in the mouth and/or jaw, 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) generally 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 may 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 possible femur fractures,
• intense bone, muscle, and/or joint pain.

Other side effects include

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; uncomfortable sensation in the stomach or belching after eating; constipation; feeling of a full or bloated stomach; diarrhea; flatulence,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

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

nausea; vomiting,

• irritation or inflammation of the throat (esophagus - the tube that connects your mouth to your stomach) or stomach,
• black stools or stools resembling tar,
• blurred vision; eye pain or redness,
• skin rash; skin redness,
• transient symptoms similar to the flu, such as muscle pain, general feeling of discomfort, and, sometimes, fever that usually appear at the beginning of treatment,
• alteration of taste.

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

• symptoms of low calcium levels in the blood, including muscle cramps or spasms and/or tingling in the fingers or around the mouth,
• stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
• esophageal stricture,
• 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, your ear is discharging, or you have an ear infection.

These may be signs of damage to the bones of the ear.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 the Vigilance of Medicines for Human Use: http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store at a temperature below 30°C.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash. Deposit empty containers and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Alendronic Acid Weekly Ababor

• The active ingredient is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.
• The other components (excipients) are: maltose, crospovidone, and calcium stearate.

Appearance of the product and content of the packaging

Alendronic Acid Weekly Ababor is presented in the form of biconvex, round, white to off-white tablets.

Each package contains 4 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

ABABOR PHARMACEUTICALS, S.L.

Chile, 4. Building 1 – Office 1. Las Matas

28290 Las Rozas – Madrid

Spain

Responsible for manufacturing

ONE PHARMA, S.A.

National Highway Athens Lamia, Km 60

Sximatari, CP: GR-32009

Greece

Last review date of this leaflet: August 2021

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