ALENDRONIC ACID WEEKLY ALMUS 70 mg FILM-COATED TABLETS

Introduction

Prospect: Information for the user

Alendronic Acid Weekly Almus 70 mg film-coated tablets EFG

Read the entire prospectus carefully before starting to take the medication.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.
• It is particularly important that you understand the information in section 3. How to take Alendronic Acid Weekly Almus 70 mg Tablets, before taking this medication.

Contents of the prospectus:

1. What Alendronic Acid Weekly Almus 70 mg tablets are and what they are used for
2. Before taking Alendronic Acid Weekly Almus 70 mg tablets
3. How to take Alendronic Acid Weekly Almus 70 mg tablets
4. Possible side effects
5. Storage of Alendronic Acid Weekly Almus 70 mg tablets
6. Additional information

1. What is Alendronic Acid Weekly Almus 70 mg and what is it used for

What is Alendronic Acid Weekly Almus?

Alendronic Acid Weekly Almus belongs to a group of non-hormonal medications called bisphosphonates. It prevents bone loss that occurs in women after menopause and helps rebuild bone. Alendronic Acid Weekly Almus reduces the risk of spinal and hip fractures.

What is Alendronic Acid Weekly Almus used for?

Your doctor has prescribed Alendronic Acid Weekly Almus to treat your osteoporosis. Alendronic Acid Weekly Almus reduces the risk of hip fractures.

Alendronic Acid Weekly Almus is a weekly treatment

What is osteoporosis?

Osteoporosis is a 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 healthy skeleton. As a result, bone loss occurs and the bones become weaker. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

Long before menopause, osteoporosis usually has no symptoms. However, if left untreated, it can result in broken bones. Although these usually hurt, spinal fractures can go unnoticed until they cause loss of height. Bones can break during normal daily activity, such as when getting up or from minor injuries that would not normally break a bone. Bone fractures usually occur in the hip, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (dowager's hump) and loss of mobility.

How can osteoporosis be treated?

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

As well as your treatment with Alendronic Acid Weekly Almus, your doctor may suggest that you make lifestyle changes to help your condition, such as:

Quitting smokingSmoking seems to increase the rate at which bone is lost and, therefore, may increase your risk of broken bones.

ExerciseLike muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program.

Eating a balanced dietYour doctor may advise you on your diet or whether you should take any dietary supplements (especially calcium and vitamin D).

2. Before taking Alendronic Acid Weekly Almus 70 mg tablets

Do not take Alendronic Acid Weekly Almus

• If you are allergic (hypersensitive) to alendronate sodium trihydrate or any of the other components of Alendronic Acid Weekly Almus
• If you have certain throat problems (esophagus - the tube that connects the mouth to the 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

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

Be careful with Alendronic Acid Weekly Almus

It is important that you tell your doctor before taking Alendronic Acid Weekly Almus if:

• you have kidney problems
• you have any allergies
• you have pain or difficulty swallowing
• your doctor has told you that you have Barrett's esophagus (a disease associated with changes in the cells that line the lower part of the esophagus)
• you have low blood calcium levels
• you have gum disease
• you are scheduled to have a tooth extracted

• if you are taking corticosteroids (such as prednisone or dexamethasone).
• if you have cancer,
• if you are undergoing chemotherapy or radiation therapy,
• if you have poor dental hygiene, gum disease, a planned tooth extraction, or do not receive regular dental care
• if you suffer from periodontal disease,
• if you are or have been a smoker,
• if you are undergoing dental treatment or if you have a planned dental procedure, inform your doctor that you are taking Alendronic Acid Weekly Almus.

Irritation, inflammation, or ulceration of the throat (esophagus - the tube that connects your mouth to your stomach) may occur, often with symptoms of chest pain, burning, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or if they lie down before 30 minutes after taking Alendronic Acid Weekly Almus. These adverse effects may worsen if patients continue to take Alendronic Acid Weekly Almus after developing these symptoms.

Use of other medications

Calcium supplements, antacids, and other oral medications are likely to interfere with the absorption of Alendronic Acid Weekly Almus if used at the same time. Therefore, it is essential that you follow the advice given in section 3. How to take Alendronic Acid Weekly Almus 70 mg tablets.

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

Use of Alendronic Acid Weekly Almus with food and drinks

Food and drinks (including mineral water) are likely to make Alendronic Acid Weekly Almus less effective if used at the same time. Therefore, it is essential that you follow the advice given in section 3. How to take Alendronic Acid Weekly Almus 70 mg tablets.

Children and adolescents

Alendronic Acid Weekly Almus should not be administered to children or adolescents.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and using machines

This medication does not affect the ability to drive or use machines.

Alendronic Acid Weekly Almus contains sodium

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

3. How to take Alendronic Acid Weekly Almus 70 mg tablets

Follow the administration instructions of this medication exactly as indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

Take one Alendronic Acid Weekly Almus 70 mg tablet once a week.

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

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

1. After getting up in the morning and before taking the first meal, drink, or other medication, swallow the Alendronic Acid Weekly Almus tablet with a full glass of water (at least 200 ml).
   • do not take it with mineral water
   • do not take it with coffee or tea
   • do not take it with juices or milk.

Do not chew the Alendronic Acid Weekly Almus tablet or let it dissolve in your mouth.

1. Do not lie down - stay 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.
2. Do not take Alendronic Acid Weekly Almus 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 Almus and inform your doctor.
4. After swallowing an Alendronic Acid Weekly Almus tablet, wait at least 30 minutes before consuming the first meal, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronic Acid Weekly Almus is only effective if taken on an empty stomach.

If you take more Alendronic Acid Weekly Almus than you should

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. In case of overdose or accidental ingestion, consult the Toxicology Information Service. Telephone: (91) 562-0420.

If you forget to take Alendronic Acid Weekly Almus

If you forget a dose, wait until the next morning to take Alendronic Acid Weekly Almus. 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 make up for forgotten doses.

If you interrupt treatment with Alendronic Acid Weekly Almus

It is essential that you continue taking Alendronic Acid Weekly Almus for as long as your doctor prescribes the medication. Alendronic Acid Weekly Almus can only treat your osteoporosis if you continue taking the tablets.

4. Possible side effects

Like all medications, Alendronic Acid Weekly Almus can have side effects, although not everyone experiences them.

Side effects are usually mild, but some patients may experience gastrointestinal disorders that can be severe. These include irritation or ulceration of the esophagus (the tube that connects the mouth to the stomach), which can cause chest pain, burning, difficulty or pain when swallowing, and/or scarring that leads to narrowing of the esophagus. These reactions can occur especially if patients do not drink a full glass of water with Alendronic Acid Weekly Almus and/or if they lie down or take the first meal of the day before 30 minutes after taking Alendronic Acid Weekly Almus. Esophageal reactions can worsen if patients continue to take Alendronic Acid Weekly Almus after developing symptoms that indicate esophageal irritation.

Other side effects are:

Frequent (at least 1 in 100 patients)

Gastrointestinal: abdominal pain, digestive discomfort, constipation, diarrhea, difficulty swallowing, flatulence, feeling of fullness or bloating.

Musculoskeletal: bone, muscle, or joint pain.

Neurological: headache.

Uncommon (at least 1 in 1,000 patients)

Gastrointestinal: nausea, vomiting, black stools.

Systemic: skin rash, itching.

Rare (at least 1 in 10,000 patients)

Gastrointestinal: stomach or peptic ulcers, some were severe and some bled, mouth ulcers (if the tablets are chewed or sucked).

Eye disorders: eye pain, decreased vision or blurred vision and/or floating black spots.

Systemic: allergic reactions such as hives, swelling of the face, lips, and/or throat that can cause difficulty breathing or swallowing, worsened sun-induced skin rash.

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

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 jawbone damage (osteonecrosis) usually associated with delayed healing and infection, often after a tooth extraction. Contact your doctor and dentist if you experience these symptoms.

Atypical fractures of the femur (thigh bone) that can occur rarely, 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 these may be early symptoms of a possible femur fracture.

Very rare (affect less than 1 in 10,000 patients):

Severe skin reactions including Stevens-Johnson syndrome (an allergic reaction that can cause blisters on the skin, fever, and eye damage) and toxic epidermal necrolysis (the skin turns red, peels like a second-degree burn, often accompanied by blisters).

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.

During post-marketing experience, the following side effects have been reported (frequency unknown): dizziness, joint inflammation, redness, hair loss, swelling of hands or feet.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of Alendronic Acid Weekly Almus 70 mg tablets

Keep out of the reach and sight of children.

No special storage conditions are required.

Expiration date:

Do not use Alendronic Acid Weekly Almus after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medications in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional information

Composition of Alendronic Acid Weekly Almus 70 mg tablets:

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

The other components (excipients) are: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate, hypromellose 2910, and talc.

Appearance and packaging of the product

Alendronic Acid Weekly Almus 70 mg is presented in the form of film-coated tablets, oblong, white or almost white.

Each package contains 4 tablets.

Marketing authorization holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira

2710-089 Sintra

Portugal

Date of the last revision of this prospectus:February 2021

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