Alendronate Almus 70 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Alendronic Acid Weekly Almus 70 mg Film-coated Tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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; do not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, 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 medicine.

Leaflet Contents:

1. What Alendronic Acid Weekly Almus 70 mg Tablets are and what they are used for
2. Before you take Alendronic Acid Weekly Almus 70 mg Tablets
3. How to take Alendronic Acid Weekly Almus 70 mg Tablets
4. Possible side effects
5. How to store Alendronic Acid Weekly Almus 70 mg Tablets
6. Further information

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

What is Alendronic Acid Almus Weekly?

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

What is Alendronic Acid Almus Weekly used for?

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

Alendronic Acid Almus Weekly 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.

Long before menopause, osteoporosis usually has no symptoms. 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 everyday activities, such as standing up, 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.

How can osteoporosis be treated?

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

In addition to your treatment with Alendronic Acid Almus Weekly, 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, thereby increasing 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. Before taking Alendronic Acid Weekly Almus 70 mg tablets

Do not take Alendronic Acid Weekly Almus

• If you are allergic (hypersensitive) to sodium alendronate trihydrate or to any of the other ingredients of Alendronic Acid Weekly Almus
• 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 cannot 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 apply to you, do not take the tablets. Speak to your doctor first and follow the advice given.

Take special care with Alendronic Acid Weekly Almus

It is important to inform 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 condition associated with changes in the cells lining the lower part of the esophagus)

• you have low levels of calcium in your blood

• you have gum disease

• you are scheduled for a dental extraction

• if you are taking corticosteroids (such as prednisone or dexamethasone)

• if you have cancer

• if you are undergoing chemotherapy or radiotherapy

• if you have poor dental hygiene, gum disease, a planned dental 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 dental procedure planned, inform your doctor that you are taking Alendronic Acid Weekly Almus.

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 Weekly Almus. These adverse effects may worsen if patients continue taking Alendronic Acid Weekly Almus after developing these symptoms.

Use of other medicines

Calcium supplements, antacids, and other oral medications may interfere with the absorption of Alendronic Acid Weekly Almus if taken at the same time. Therefore, it is important to follow the advice provided in section 3. How to take Alendronic Acid Weekly Almus 70 mg tablets.

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

Use of Alendronic Acid Weekly Almus with food and drinks

Food and beverages (including mineral water) may reduce the effectiveness of Alendronic Acid Weekly Almus if taken simultaneously. Therefore, it is important to follow the advice provided in section 3. How to take Alendronic Acid Weekly Almus 70 mg tablets.

Children and adolescents

Alendronic Acid Weekly Almus must not be given 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 breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Alendronic Acid Weekly Almus contains sodium

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

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

Follow exactly the instructions given by your doctor for taking this medicine. Consult your doctor or pharmacist if you have any doubts.

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

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

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

2. After getting up in the morning and before taking any food, drink, or other medication, swallow the Alendronic Acid Weekly Almus tablet with a full glass of plain water (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 fruit juices or milk.

Do not chew the alendronic acid tablet or allow it to 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 your first meal of the day.

4. Do not take Alendronic Acid Weekly Almus at bedtime or before getting up in the morning.

5. If you have difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronic Acid Weekly Almus and contact your doctor.

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

If you take more Alendronic Acid Weekly Almus than you should

If you accidentally take too many tablets, 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 the Toxicology Information Service. Telephone: (91) 562-0420.

If you forget to take Alendronic Acid Weekly Almus

If you miss a dose, wait until the following morning to take Alendronic Acid Weekly Almus. Do not take two tablets on the same day. Then resume 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 Almus

It is important that you continue taking Alendronic Acid Weekly Almus for as long as your doctor has prescribed it. Alendronic Acid Weekly Almus can treat your osteoporosis only if you continue taking the tablets.

4. Possible adverse effects

Like all medicines, Alendronic Acid Almus Weekly may have adverse effects, although not everyone experiences them.

The adverse effects are usually mild, but some patients might experience gastrointestinal disturbances that could be serious. These include irritation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), which may cause chest pain, heartburn, difficulty or pain when swallowing, and/or scarring leading to narrowing of the oesophagus. These reactions may occur especially if patients do not take a full glass of water with Alendronic Acid Almus Weekly and/or lie down or eat their first meal of the day within 30 minutes after taking Alendronic Acid Almus Weekly. Oesophageal reactions may worsen if patients continue taking Alendronic Acid Almus Weekly after developing symptoms indicating oesophageal irritation.

Other adverse effects are:

Common (affects at least 1 in 100 patients)

Gastrointestinal: abdominal pain, indigestion-related discomfort, constipation, diarrhoea, difficulty swallowing, flatulence, feeling of fullness, or bloating sensation.

Musculoskeletal: bone, muscle or joint pain.

Neurological: headache.

Uncommon (affects at least 1 in 1,000 patients)

Gastrointestinal: nausea, vomiting, black stools.

Systemic: skin rash, itching.

Rare (affects at least 1 in 10,000 patients)

Gastrointestinal: stomach or peptic ulcers, some of which were severe and some with bleeding; mouth ulcers (if tablets are chewed or sucked).

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

Systemic: allergic reactions such as urticaria, swelling of the face, lips and/or throat, which may cause difficulty breathing or swallowing, skin rash worsened by sunlight.

Tell 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 jaw bone damage (osteonecrosis), usually associated with delayed healing and infection, often following a dental extraction. Contact your doctor and dentist if you experience these symptoms.

Atypical femoral 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 the thigh, hip or groin, as these may be early signs indicating a possible femoral fracture.

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

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

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

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, 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.

Expiry:

Do not use Alendronic Acid Weekly Almus after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

6. Additional Information

Composition of Alendronic Acid Weekly Almus 70 mg Tablets:

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

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

Appearance of the medicinal product and contents of the container

Alendronic Acid Weekly Almus 70 mg is presented as white or almost white, film-coated, oval tablets.

Each pack 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]

Manufacturing Responsible Party:

Atlantic Pharma - Produções Farmacêuticas, S.A.

Rua da Tapada Grande, n.º 2, Abrunheira

2710-089 Sintra

Portugal

Date of the most recent review of this leaflet: February 2021

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