Alendronic acid Semanal Pensá 70 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Alendronic Acid Semanal pensa 70 mg film-coated tablets EFG

Read the entire 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 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. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

It is particularly important that you understand the information in section 3, How to take Alendronic Acid Semanal pensa, before taking this medicine.

Contents of the leaflet

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

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

What is alendronic acid?

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

Alendronic acid prevents bone loss that occurs in women after menopause and helps rebuild bone. Alendronic acid reduces the risk of spinal and hip fractures.

What is alendronic acid used for?

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

Alendronic acid is a weekly treatment.

What is osteoporosis?

Osteoporosis is 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 skeleton in good health.

As a result, bone loss occurs and bones become weaker. The earlier a woman reaches menopause, the greater her risk of developing osteoporosis.

Often, osteoporosis has no symptoms for a long time. However, if left untreated, it can lead to broken bones. Although fractures are usually 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 (widow's hump) and loss of mobility.

Osteoporosis can be treated, and it is never too late to start treatment. Alendronic acid not only prevents bone loss but actually helps rebuild bone that may have been lost and reduces the risk of fractures in the spine and hip.

In addition to your treatment with alendronic acid, your doctor may suggest that you make 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 about your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

2. What you need to know before taking Ácido Alendrónico Semanal pensa

Do not take Ácido Alendrónico Semanal pensa

• If you are allergic to sodium alendronate trihydrate or to any of the other ingredients of this medicine (listed in section 6).
• If you have certain disorders of your throat (esophagus – the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing
• If you are unable to remain upright (standing or sitting) for at least 30 minutes
• If your doctor has told you that you have low blood calcium levels

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

Warnings and precautions

Talk to your doctor before starting to take Ácido Alendrónico Semanal pensa.

It is important that you inform your doctor, before taking Ácido Alendrónico Semanal pensa, if:

• you have kidney problems,
• you have 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 told you have low blood calcium,
• 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 radiation therapy,
• you are taking corticosteroids (such as prednisone or dexamethasone),
• you are being treated with angiogenesis inhibitors (such as bevacizumab or thalidomide),
• 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 alendronic acid.

It is important to maintain good oral hygiene while receiving alendronic acid. You should have regular dental check-ups during treatment and contact your doctor or dentist if you experience any mouth or dental problems, 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 alendronic acid. These adverse effects may worsen if patients continue taking alendronic acid after developing these symptoms.

Children and adolescents

Ácido Alendrónico should not be given to children or adolescents.

Other medicines and Ácido Alendrónico Semanal pensa

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

Calcium supplements, antacids, and other oral medications may interfere with the absorption of alendronic acid if taken at the same time. Therefore, it is important that you follow the advice provided in section 3.

Certain medications used for rheumatism or long-term pain known as NSAIDs (for example, aspirin or ibuprofen) may cause gastrointestinal problems. Therefore, caution should be exercised if these medications are taken concurrently with alendronic acid.

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Taking Ácido Alendrónico Semanal pensa with food, drinks, and alcohol

Food and beverages (including mineral water) may reduce the effectiveness of alendronic acid if taken at the same time. Therefore, it is important that you follow the advice given in section 3, “How to take Ácido Alendrónico Semanal pensa”.

Pregnancy, breastfeeding, and fertility

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

Ácido Alendrónico is intended for use only in postmenopausal women. Do not take alendronic acid if you are pregnant or think you might be pregnant, or during breastfeeding.

Driving and using machines

Adverse effects have been reported with alendronic acid (including blurred vision, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or operate machinery. Individual responses to alendronic acid may vary. (See Possible side effects).

Ácido Alendrónico Semanal pensa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; i.e., essentially “sodium-free”.

3. How to take Alendronic Acid Weekly pensa

Take one alendronic acid tablet once a week.

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

Follow these instructions carefully to ensure you benefit from alendronic acid.

1. Choose the day of the week that best fits your routine. Each week, take one alendronic acid tablet on the day you have chosen.

It is very important that you follow steps 2, 3, 4, and 5 to help ensure the alendronic acid tablet reaches your stomach quickly and to help reduce the risk of possible irritation of the esophagus (the tube connecting the mouth to the stomach).

1. After getting up in the morning and before taking any food, drink, or other medication, swallow the alendronic acid tablet whole with a full glass of water (not mineral water) (no less than 200 ml).
   • Do not take it with mineral water (carbonated or still).
   • Do not take it with coffee or tea.
   • Do not take it with fruit juices or milk.

Do not crush, chew, or allow the tablet to dissolve in your mouth.

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 at bedtime or before getting up in the morning.

3. If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking alendronic acid and contact your doctor.

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

If you take more Alendronic Acid Weekly pensa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medication and the amount ingested.

If you have taken too many tablets by mistake, drink a full glass of milk and seek medical attention immediately. Do not induce vomiting and do not lie down.

If you forget to take Alendronic Acid Weekly pensa

If you miss a dose, wait until the following morning to take alendronic acid. Do not take two tablets on the same day. Afterwards, return to taking one tablet once a week on your originally chosen day.

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

If you stop taking Alendronic Acid Weekly pensa

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

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 can cause adverse effects, although not everyone experiences them.

The following terms are used to describe how frequently the adverse effects have been reported:

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

• bone, muscle and/or joint pain, sometimes severe.

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) which may cause chest pain, heartburn, or difficulty or pain when swallowing,
• 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):

• allergic reactions such as hives; swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing,
• 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; severe skin reactions,
• mouth pain, 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 following a tooth extraction. Contact your doctor and dentist if you experience these symptoms,
• atypical femur fractures (thigh bone) which may occur rarely, particularly 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 warning signs of a possible femur fracture,
• mouth ulcers when the tablets have been chewed or sucked.

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

• Consult your doctor if you have ear pain, ear discharge, or an ear infection. These could be symptoms of damage to the ear bones.

Laboratory findings:

Very common: mild and transient decreases in blood calcium and phosphate levels, usually within the normal range.

Paediatric patients:

Alendronate sodium has been studied in a small number of patients under 18 years of age with osteogenesis imperfecta. Results are insufficient to support the use of alendronate sodium in paediatric patients with osteogenesis imperfecta.

Promptly inform your doctor or pharmacist about these or any other symptoms.

It will be helpful if you note down what you experienced, when it started, and how long it lasted.

Reporting of adverse effects:

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

5. Storage of Alendronic Acid Weekly pensa

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

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

This medicine does not require any special storage conditions. Do not remove the tablets from the blister pack until you are ready to take the medicine.

Medicines must not be disposed of via wastewater or household waste. Dispose of packaging and unused medicines at the SIGRE point in your pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ácido Alendrónico Semanal pensa

• The active substance is sodium alendronate trihydrate.

Each tablet contains 70 mg of alendronic acid as sodium alendronate trihydrate.

• The other components are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate.

The coating contains Opadry, composed of talc and hydroxypropylmethylcellulose.

Appearance of the product and contents of the pack

Ácido Alendrónico Semanal pensa is presented as white or almost white, round, biconvex film-coated tablets, approximately 9.7 mm in diameter.

The tablets are packed in cartons with PVC-PVdC/aluminum blisters containing 4 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Alter S.A

C/ Mateo Inurria, 30

28036 Madrid - Spain

Date of the most recent revision of this leaflet: May 2022

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