Alendronic acid Semanal Mabo 70 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alendronic Acid MABO Weekly 70 mg tablets EFG

Read the entire 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Alendronic Acid MABO Weekly is and what it is used for
2. What you need to know before taking Alendronic Acid MABO Weekly
3. How to take Alendronic Acid MABO Weekly
4. Possible side effects
5. How to store Alendronic Acid MABO Weekly

Contents of the pack and other information

1. What Acido Alendrónico Semanal MABO is and what it is used for

What is Acido Alendrónico Semanal MABO?

Acido Alendrónico Semanal MABO is a tablet containing the active substance ácido alendrónico (commonly known as alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Acido Alendrónico Semanal MABO prevents bone loss that occurs in women after menopause and helps rebuild bone. Acido Alendrónico Semanal MABO reduces the risk of spine and hip fractures.

What is Acido Alendrónico Semanal MABO used for?

Your doctor has prescribed Acido Alendrónico Semanal MABO to treat your osteoporosis. It reduces the risk of spine and hip fractures.

Acido Alendrónico Semanal MABO is a weekly treatment.

What is osteoporosis?

Osteoporosis is the thinning and weakening of 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 bones become weaker. The earlier a woman reaches menopause, the greater her risk of developing osteoporosis.

For a long time, osteoporosis usually has no symptoms. However, if left untreated, it can lead to broken bones. Although fractures are often painful, spinal bone fractures may go unnoticed until they cause loss of height. Bones may break during normal daily activities, such as getting up from a chair, or from minor injuries that would not normally break a healthy bone. Bone fractures typically occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as stooped posture (commonly known as "dowager's hump") and loss of mobility.

How can osteoporosis be treated?

In addition to your treatment with Acido Alendrónico Semanal MABO, your doctor may suggest lifestyle changes to help manage your condition, such as:

• Stopping smoking: Smoking appears to increase the rate at which you lose bone and therefore may increase your risk of broken bones.
• Exercise: Like muscles, bones 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 dietary supplements (especially calcium and vitamin D).

2. What you need to know before starting to take Alendronic Acid Weekly MABO

Do not take Alendronic Acid MABO Weekly

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

• If you have certain abnormalities in your throat (esophagus – the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing

• If you cannot remain upright (standing or sitting) for at least 30 minutes

• If your doctor has told you that you have low blood calcium levels

Warnings and precautions

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

Consult your doctor or pharmacist before starting this medicine if:

• You have kidney problems
• You have or have recently had digestive problems or difficulty swallowing
• Your doctor has diagnosed you with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus)
• You have been diagnosed with malabsorption syndrome (problems absorbing minerals in your stomach or intestines)
• You have been told you have low blood calcium levels
• You have poor dental hygiene, gum disease, an upcoming dental extraction, or do not receive regular dental care
• You have cancer
• You are receiving chemotherapy or radiotherapy
• You are being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment
• You are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions like asthma, rheumatoid arthritis, or 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 examination before starting treatment with this medicine.

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

Irritation, inflammation, or ulceration of the throat (esophagus – the tube connecting your mouth to your stomach) may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or lie down within 30 minutes after taking this medicine. These adverse effects may worsen if patients continue taking this medicine after developing such symptoms.

Children and adolescents

This medicine must not be given to children.

Other medicines and Alendronic Acid MABO Weekly

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

If antacids, calcium and other supplements, vitamins, or other medicines are taken at the same time as this medicine, the effectiveness of this medicine may be reduced. (See section 3, "How to take Alendronic Acid MABO Weekly".)

Taking Alendronic Acid MABO Weekly with food and drinks

Food and drinks (including mineral water) are likely to make this medicine less effective if taken at the same time. Therefore, it is important to follow the instructions provided in section 3, "How to take Alendronic Acid MABO Weekly".

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must not take this medicine if you are pregnant or think you may be pregnant.

Breastfeeding

You must not take this medicine if you are breastfeeding.

Driving and use of machines

This medicine may cause adverse effects (including blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery. Individual responses to this medicine may vary (see section 4, "Possible side effects").

Alendronic Acid MABO Weekly contains sodium

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

3. How to take Alendronic Acid Weekly MABO

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Take one tablet of Alendronic Acid Weekly MABO once a week.

Follow these instructions carefully.

1. Choose the day of the week that best fits your routine. Each week, take one tablet of Alendronic Acid Weekly MABO on the day you have chosen.

It is very important that you follow steps 2, 3, 4, and 5 to help ensure the tablet of Alendronic Acid Weekly MABO reaches your stomach quickly and to help reduce the possible irritation of the oesophagus (the tube connecting the mouth to the stomach).

1. After getting up in the morning and before taking your first food, drink, or other medication, swallow the Alendronic Acid Weekly MABO tablet whole with a full glass of water (not mineral water) (at least 200 ml), so that Alendronic Acid Weekly MABO is properly absorbed.

• do not take it with mineral water (still or sparkling).
• do not take it with coffee or tea.
• do not take it with fruit juices or milk.

Do not crush or chew the tablet, and do not allow it to dissolve in your mouth, due to the risk of developing mouth ulcers.

1. 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 your first meal of the day.

2. Do not take Alendronic Acid Weekly MABO 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 Alendronic Acid Weekly MABO and inform your doctor.

4. After swallowing one tablet of Alendronic Acid Weekly MABO, wait at least 30 minutes before taking your first food, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronic Acid Weekly MABO is only effective if taken on an empty stomach.

If you take more Alendronic Acid Weekly MABO 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone (91) 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Alendronic Acid Weekly MABO:

If you miss a dose, wait until the following morning to take this medicine. Do not take two tablets on the same day.

Afterwards, return to taking one tablet once a week on the originally chosen day.

Do not take a double dose to make up for missed doses.

If you stop treatment with Alendronic Acid Weekly MABO

It is important that you take Alendronic Acid Weekly MABO for as long as your doctor prescribes it. Since it is not known how long Alendronic Acid Weekly MABO should be taken, you should periodically discuss with your doctor whether continuing treatment with this medicine is still appropriate for you.

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

4. Possible adverse effects

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

Seek medical help immediately if you notice any of the following adverse effects, which may be serious and may require urgent medical treatment:

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

• heartburn; difficulty swallowing; pain when swallowing; ulcer in the throat (esophagus – the tube connecting your mouth to your stomach) that may 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 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 sensation of heaviness in the jaw, or tooth loss. These may be signs of bone damage in the jaw (osteonecrosis), usually associated with delayed healing and infection, often following a tooth extraction. Inform your doctor and dentist if you experience these symptoms,
• atypical femoral fractures (thigh bone) which may occur rarely, especially in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early signs indicating a possible femoral fracture,
• severe bone, muscle, and/or joint pain.

Other adverse effects include:

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

• pain, sometimes severe, in bones, muscles, and/or joints.

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

• joint swelling,
• abdominal pain; stomach discomfort or burping after eating; constipation; feeling of fullness or bloating in the stomach; diarrhoea; flatulence,
• hair loss; itching,
• headache; dizziness,
• fatigue; swelling of the hands or legs.

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

• nausea; vomiting,
• irritation or inflammation of the throat (esophagus – the tube connecting your mouth to your stomach) or stomach,
• black or tar-like stools,
• blurred vision; eye pain or redness,
• skin rash; redness of the skin,
• transient flu-like symptoms such as muscle pain, general malaise, and sometimes fever, which usually occur at the beginning of treatment,
• altered 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 sensation in the fingers or around the mouth,
• stomach ulcers or peptic ulcers (sometimes severe or with bleeding),
• narrowing of the throat (esophagus – the tube connecting 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 ear bones.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alendronic Acid MABO Weekly

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

Store below 30°C.

Keep in the original packaging.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Alendronic Acid Weekly Mabo

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

The other components (excipients) are: crospovidone, maltose, and calcium stearate.

Appearance of the medicine and contents of the pack

Alendronic Acid Weekly Mabo is supplied in a pack containing a blister with 4 tablets.

Marketing Authorization Holder

MABO-FARMA S.A.

Calle Vía de los Poblados, 3, Edificio 6

28033 Madrid,

Spain

Manufacturer

One Pharma S.A

60th km N.N.R Athinon-Lamias

320 09 Sximatari, Voiotias

Greece

Date of the most recent review of this leaflet: October 2020

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