Package Leaflet: Information for the User

Alendronic Acid Weekly pensa 70 mg Film-Coated 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 give it to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult 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. How to take Alendronic Acid Weekly pensa, before taking this medicine.

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

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

3.How to take Alendronic Acid Weekly pensa

4.Possible side effects

5.Storage of Alendronic Acid Weekly pensa

6.Contents of the pack and additional information

What is alendronate acid?

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

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

What is alendronate acid used for?

Your doctor has prescribed alendronate acid to treat your osteoporosis.Alendronate acid reduces the risk of fractures of the spine and hip.

Alendronate acid is a weekly treatment.

What is osteoporosis?

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

Osteoporosis usually does not have symptoms at first. However, if left untreated, it can result in broken bones. Although these usually hurt, fractures of the bones of the spinal column can go unnoticed until they cause loss of height. The bones can break during normal daily activities, such as getting up, or from minor injuries that would not normally break a normal bone. Fractures of bones usually occur in the hip, spinal column, or wrist and can cause not only pain but also significant problems such as a hunched back (widow's hump) and loss of mobility.

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

Along with your treatment with alendronate acid, your doctor may suggest that you make lifestyle changes to help your condition, such as:

Quitting smoking.It appears that smoking increases 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).

Do not takeWeekly Alendronic Acid think

• If you are allergic to alendronate sodium trihydrate or any of the other components of this medication (listed in section 6).
• If you have certain throat (esophagus - the tube that connects your mouth to your stomach) alterations, such as narrowing or difficulty swallowing
• If you cannot remain standing or sitting 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 before starting to take Weekly Alendronic Acid.

It is essential to inform your doctor, before taking Weekly Alendronic Acid, if:

• You have kidney alterations,
• You have 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),
• Your doctor has told you 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 corticosteroids (such as prednisone or dexamethasone),
• You are being treated withangiogenesis 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 check-up before starting treatment with alendronic acid.

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.

Irritation, inflammation, or esophagus ulcer (the tube that connects your mouth to your stomach) may occur, 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. These adverse effects may worsen if patients continue taking alendronic acid after developing these symptoms.

Children and adolescents

Alendronic acid should not be administered to children or adolescents.

Other medications andWeekly Alendronic Acid

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

It is likely that calcium supplements, antacids, and other oral medications will interfere with the absorption of alendronic acid if taken at the same time. Therefore, it is essential to follow the advice given in the section

Certain medications 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.

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

TakingWeekly Alendronic Acidwith food, drinks, and alcohol

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. “How to take Weekly Alendronic Acid”.

Pregnancy, breastfeeding, and fertility

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

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

Driving and operating machinery

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

Weekly Alendronic Acid contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

Take one tablet ofalendronateonce a week.

Follow exactly the administration instructions ofthis medicationindicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

Follow these instructions carefully to ensure that you benefit from alendronate.

1)Choose the day of the week that best fits your routine. Take one tablet of alendronate every week on the day you have chosen.

It is very important to follow instructions 2, 3, 4, and 5 to ensure that the alendronate tablet reaches the stomach quickly and helps reduce possible irritation of the esophagus (the tube that connects the mouth with the stomach).

2)After getting up in the morning and before taking the first meal, drink, or other medication, swallow the entire alendronate tablet with a full glass of water (not mineral water) (not less than 200 ml).

• 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, and do not let it dissolve in the mouth.

3)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 the first meal of the day.

4)Do not take alendronate at bedtime or before getting up in the morning.

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

6)After swallowing an alendronate 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 is only effective if taken on an empty stomach.

If you take more Alendronate Weekly than you should

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 take too many tablets by mistake, drink a full glass of milk and go to the doctor immediately. Do not induce vomiting and do not lie down.

If you forget to take Alendronate Weekly

If you forget a dose, wait until the next morning to take alendronate. Do not take two tablets on the same day. Then, go back to taking 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

It is essential to continue taking alendronate for as long as your doctor prescribes the medication. Alendronate can only treat your osteoporosis if you continue taking the tablets.

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

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

The following terms are used to describe how often side 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; esophageal ulcer (the tube that connects your mouth to your stomach) that can cause chest pain, heartburn, or difficulty or pain when swallowing,
• swelling of the joints,
• abdominal pain; uncomfortable sensation in the stomach or belching after eating; constipation; feeling of fullness or bloating in the stomach; diarrhea; 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 esophagus (the tube that connects your mouth to your stomach) or stomach,
• black stools or stools similar to 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):

• allergic reactions such as urticaria; swelling of the face, lips, tongue, and/or throat, which can cause difficulty breathing or swallowing,
• 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),
• narrowing of the esophagus (the tube that connects your mouth to your stomach),
• skin rash that worsens with sunlight; 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) usually associated with delayed healing and infection, often after a dental extraction. Contact your doctor and dentist if you experience these symptoms,
• atypical femoral 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 signs and indicative of a possible femoral 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, the ear is discharging, or you have an ear infection. These may be signs of damage to the bones in the ear.

Laboratory findings:

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

Pediatric patients:

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

Inform your doctor or pharmacist immediately about these or any other symptoms.

It will help if you take note of what you experienced, when it started, and how long it lasted.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, 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 Pharmacovigilance of Medicines for Human Usehttp://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.

Do not use this medication after the expiration date that appears on the packaging and in the blister pack after CAD. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition ofWeekly Alendronic Acid

• The active ingredient is alendronate sodium trihydrate.

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

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

The coating contains Opadry composed of talc and hydroxypropylmethylcellulose.

Appearance of the product and contents of the packaging

Weekly Alendronic Acid pensa is presented in the form of coated tablets with a film coating, white or almost white, round, biconvex, approximately 9.7 mm in diameter.

The tablets are presented in cases with PVC-PVdC/aluminum blisters containing 4 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Laboratorios Alter S.A

C/ Mateo Inurria, 30

28036 Madrid-Spain

Date of the last review of this leaflet:May 2022

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