ALENDRONIC ACID WEEKLY ABABOR 70 mg TABLETS

Introduction

Package Leaflet: Information for the User

Alendronic Acid Ababor 70 mg Tablets

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.
• It is especially important that you understand the information in section 3 before you take this medicine.

Contents of the Package Leaflet

1. What is Alendronic Acid Ababor and what is it used for
2. What you need to know before you take Alendronic Acid Ababor
3. How to take Alendronic Acid Ababor
4. Possible side effects
5. Storage of Alendronic Acid Ababor
6. Contents of the pack and other information

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

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

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

2. What you need to know before you take Alendronic Acid Ababor

Do not take Alendronic Acid Ababor

• 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 oesophagus (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.

Warnings and precautions

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

• you have kidney problems
• you have or have had digestive problems or problems swallowing
• your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells that line the lower part of the oesophagus)
• 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 health, 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 the treatment of cancer
• 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 Ababor.

It is important to maintain good oral hygiene when taking alendronic acid. You should have regular dental check-ups throughout 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 ulceration of the oesophagus (the tube that connects your mouth to your stomach) may occur, often with symptoms of chest pain, burning, difficulty or pain on 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 Ababor. These side effects may worsen if patients continue taking alendronic acid after developing these symptoms.

Children and adolescents

Alendronic Acid Ababor should not be given to children and adolescents under 18 years of age.

Other medicines and Alendronic Acid Ababor

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

It is likely that calcium supplements, antacids and other oral medicines will interfere with the absorption of Alendronic Acid Ababor if taken at the same time. Therefore, it is important that you follow the advice given in section 3.

Certain medicines for rheumatism or for 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 Ababor.

Taking Alendronic Acid 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 important that you follow the advice given in section 3.

Pregnancy, breastfeeding and fertility

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

Driving and using machines

Alendronic acid has been reported to cause side effects such as blurred vision, dizziness and severe bone, muscle or joint pain that may affect your ability to drive or use machines (see section 4).

3. How to take Alendronic Acid Ababor

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

Remember to take your medicine.

Take Alendronic Acid Ababor once a week as prescribed by your doctor.

It is possible that you have been prescribed 10 mg alendronic acid tablets to be taken once daily on other occasions.

Alendronic Acid Ababor is takenonce a week.

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

1. Choose the day of the week that best fits your schedule. Every week, take one Alendronic Acid Ababor tablet on the day you have chosen.

1. After getting up in the morning and before taking your first food, drink or other medicine, swallow your Alendronic Acid Ababor tablet with a full glass of tap water (at least 200 ml).
   • do not take with mineral water
   • do not take with coffee or tea
   • do not take with juice.

Do not crush or chew the alendronic acid tablet or let it dissolve in your mouth due to the possibility of mouth ulcers.

1. Do not lie down after swallowing the alendronic acid tablet: remain upright (sitting, standing or walking) for at least 30 minutes and do not lie down until after your first food of the day.

1. Do not take Alendronic Acid Ababor at bedtime or before getting up in the morning.

1. If you have difficulty or pain swallowing, chest pain or new or worsening heartburn, stop taking Alendronic Acid Ababor and contact your doctor.

1. After swallowing an Alendronic Acid Ababor tablet, wait at least 30 minutes before consuming your first food, drink or other medicine of the day, including antacids, calcium supplements and vitamins. Alendronic Acid Ababor is only effective if taken with an empty stomach.

1. If you forget a dose, wait until the next morning to take Alendronic Acid Ababor. Do not take two tablets on the same day. After that, take one tablet once a week on the originally chosen day.

1. It is important that you continue taking Alendronic Acid Ababor for as long as your doctor prescribes it. Alendronic Acid Ababor can only treat your osteoporosis if you continue taking the tablets.

If you take more Alendronic Acid Ababor 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, telephone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid Ababor

If you forget a dose, wait until the next morning to take alendronic acid weekly. Do not take two tablets on the same day. After that, take one tablet once a week, on the originally chosen day. Do not take a double dose to make up for forgotten doses.

If you stop taking Alendronic Acid Ababor

It is important that you take alendronic acid weekly for as long as your doctor prescribes it.

As it is not known how long you should take alendronic acid weekly, you should discuss with your doctor the need to continue treatment with this medicine to determine if Alendronic Acid Ababor is still suitable for you.

If you have any further questions on 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 serious side effects, which may require urgent medical treatment:

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

• heartburn; difficulty swallowing; pain on swallowing; ulcer in the oesophagus (the tube that connects your mouth to your stomach) that may cause chest pain, heartburn or difficulty or pain on 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 may 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 may be signs of damage to the jawbone (osteonecrosis) usually associated with delayed healing and infection, often after a tooth extraction. Inform your doctor and dentist if you experience these symptoms
• atypical fractures of the thigh bone (femur) that may 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 may be early signs of a possible fracture of the femur
• severe bone, muscle and/or joint pain.

Other side effects include

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

• bone, muscle and/or joint pain, which may be severe.

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

• swelling of the joints
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; feeling of fullness or bloating; diarrhoea; 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 oesophagus (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
• flu-like symptoms, such as muscle pain, general feeling of being unwell and, sometimes, fever, which usually occur at the start of treatment
• altered sense of 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 ulcers or peptic ulcers (sometimes severe or with bleeding)
• narrowing of the oesophagus (the tube that connects your mouth to your stomach)
• skin rash that gets worse 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.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: http://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid Ababor

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

Store at a temperature below 30°C.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alendronic Acid Ababor

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

Appearance of the product and contents of the pack

Alendronic Acid Ababor is presented as biconvex, round, white to off-white tablets.

Each pack contains 4 tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

ABABOR PHARMACEUTICALS, S.L.

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

28290 Las Rozas – Madrid

Spain

Manufacturer

ONE PHARMA, S.A.

Athens-Lamia National Road, Km 60

Sximatari, PC: GR-32009

Greece

Date of last revision of this leaflet: August 2021

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