Patient Information

Alendronic Acid Weekly Almus 70 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you are unsure about anything, ask your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have similar symptoms, as it may harm them.
• If you think you have suffered a side effect, you can report it directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
• 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 medicine.

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. Further information

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 to rebuild bone. Alendronic Acid Weekly Almus reduces the risk of fractures of the spine and hip.

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 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.

Usually, osteoporosis does not have symptoms before menopause. However, if left untreated, it can result in broken bones. Although these usually hurt, fractures of the bones of the spine can go unnoticed until they cause loss of height. 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, spine, or wrist and can cause not only pain but also significant problems such as a hunched posture (widow's hump) and loss of mobility.

How can osteoporosis be treated?

Osteoporosis can be treated and it is never too late to start treatment. Alendronic Acid Weekly Almus 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 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:

Stopping smokingIt appears that smoking increases the rate at which you lose bone and, therefore, may increase your risk of broken bones.

ExerciseAs 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).

Do not take AcidAlendrónico Semanal Almus

- If you are allergic (hypersensitive) to alendronate sodium trihydrate or to any of the other components of Acid Alendrónico Semanal Almus

- If you have certain changes in your throat (esophagus - the tube that connects your mouth to your stomach) such as narrowing or difficulty swallowing

- If you cannot stay upright or seated 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.

Be especially careful with AcidAlendrónico Semanal Almus

It is important to tell your doctor before taking Acid Alendrónico Semanal 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 cover the lower part of the esophagus)
• You have low blood calcium levels
• You have gum disease
• You are scheduled to have a tooth extraction

• 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 scheduled 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 have a planned dental procedure, inform your doctor that you are taking Acid Alendrónico Semanal Almus.

It may cause irritation, inflammation, or esophageal ulcers (the tube that connects your mouth to your stomach), 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 before 30 minutes after taking Acid Alendrónico Semanal Almus. These adverse effects may worsen if patients continue taking Acid Alendrónico Semanal Almus after developing these symptoms.

Use of other medications

It is likely that calcium supplements, antacids, and other oral medications will interfere with the absorption of Acid Alendrónico Semanal Almus, if used at the same time. Therefore, it is essential to follow the advice given in section 3. How to take Acid Alendrónico Semanal Almus 70 mg tablets.

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

Use of Acid Alendrónico Semanal Almus with food and beverages

It is likely that food and beverages (including mineral water) will make Acid Alendrónico Semanal Almus less effective if used at the same time. Therefore, it is essential to follow the advice given in section 3. How to take Acid Alendrónico Semanal Almus 70 mg tablets.

Children and adolescents

Acid Alendrónico Semanal Almus should not be administered to children or adolescents.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

This medication does not affect the ability to drive or operate machinery.

Acid Alendrónico Semanal Almus contains sodium

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

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

Take one Alendronate Weekly 70 mg tabletAlmusonce a week.

1. Choose the day of the week that best suits your routine. Take one Alendronate Weekly 70 mg tablet Almus on the day you have chosen.

It is very important to follow instructions 2, 3, 4, and 5 to ensure that the Alendronate Weekly 70 mg tablet Almus reaches your stomach quickly and helps reduce possible esophagus irritation (the tube that connects the mouth with the stomach).

2.After waking up in the morning and before taking the first meal, drink, or other medication, swallow the Alendronate Weekly 70 mg tablet Almus only with a full glass ofwater(not less than 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 Alendronate tablet or let it dissolve in your 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 Weekly 70 mg Almus at bedtime or before waking up in the morning.

5.If you experience difficulty or pain swallowing, chest pain, or new or worsening heartburn, stop taking Alendronate Weekly 70 mg Almus and inform your doctor.

6.After swallowing an Alendronate Weekly 70 mg tablet Almus, wait at least 30 minutes before consuming the first meal, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Alendronate Weekly 70 mg Almus is only effective if taken on an empty stomach.

If you take more Alendronate Weekly 70 mg Almus than you should

If you accidentally take too many tablets, drink a full glass of milk and immediately consult your doctor. Do not induce vomiting and do not lie down. In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: (91) 562-0420.

If you forget to take Alendronate Weekly 70 mg Almus

If you forget a dose, wait until the next morning to take Alendronate Weekly 70 mg Almus.Do not take two tablets on the same day.Then, resume taking one tablet once a week, on the originally chosen day.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Alendronate Weekly 70 mg Almus

It is essential to continue taking Alendronate Weekly 70 mg Almus for as long as your doctor prescribes the medication. Alendronate Weekly 70 mg Almus may only treat your osteoporosis if you continue taking the tablets.

Like all medicines, Alendronate Sodium Weekly Almusmay cause side effects, although not everyone will experience them.

The side effects are usually mild, but some patients may experience gastrointestinal disturbances that can be severe. These include esophageal irritation or ulcers (the tube that connects the mouth to the stomach), which can cause chest pain, burning, difficulty or pain swallowing and/or scars that lead to esophageal narrowing. These reactions can occur especially if patients do not drink a full glass of water with Alendronate Sodium Weekly Almusand/or if they lie down or take their first meal of the day before 30 minutes have passed after taking Alendronate Sodium Weekly Almus. Esophageal reactions can worsen if patients continue taking Alendronate Sodium Weekly Almusafter developing symptoms indicating esophageal irritation.

Other side effects are:

Frequent (in at least 1 in 100 patients)

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

Musculoskeletal: bone, muscle, or joint pain.

Neurological: headache.

Rare (in at least 1 in 1,000 patients)

Gastrointestinal: nausea, vomiting, black stools.

Systemic: skin rash, itching.

Very rare (affecting fewer than 1 in 10,000 patients):

Gastrointestinal: stomach or peptic ulcers, some were severe and some bled, mouth ulcers (if they chew and crush the tablets).

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

Systemic: allergic reactions such as urticaria, facial swelling, lips, and/or throat that can cause difficulty breathing or swallowing, skin rash worsened by sunlight.

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

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) generally 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 symptoms and indicative of a possible femoral fracture.

Very rare (affecting fewer than 1 in 10,000 patients):

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

Consult your doctor if you have ear pain, the ear is draining or you have an ear infection. These may be symptoms of damage to the bones of the ear.

During post-marketing experience, the following adverse effects have been reported (frequency unknown): dizziness, joint inflammation, redness, hair loss, hand or foot inflammation.

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

Keep out of reach and sight of children.

No special storage conditions are required.

Expiration Date:

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

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

Composition of Alendronic Acid Weekly Almus 70 mg Tablets:

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

The other components (excipients) are:Microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearate fumarate, hydroxypropylmethylcellulose 2910, and talc.

Appearance of the product and contents of the package

Alendronic Acid Weekly Almus 70 mg is presented in the form offilm-coated, oblong, white or off-white tablets.

Each package contains 4 tablets.

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone:93 739 71 80

Email:[email protected]

Responsible for manufacturing:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira

2710-089 Sintra

Portugal

Last review date of this leaflet:February 2021

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