Alendronate Almus: detailed information

Patient Information Leaflet

ALENDRONATE ALMUS 70 mg film-coated tablets

Equivalent medicine
Please read this leaflet carefully before taking this medicine, as 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What ALENDRONATE ALMUS is and what it is used for
What you need to know before taking ALENDRONATE ALMUS
How to take ALENDRONATE ALMUS
Possible side effects
How to store ALENDRONATE ALMUS
Contents of the pack and other information

1. What ALENDRONATO ALMUS is and what it is used for

What ALENDRONATO ALMUS is
ALENDRONATO ALMUS contains the active substance alendronic acid, which belongs to a group of
medicines called bisphosphonates.
What ALENDRONATO ALMUS is used for
This medicine prevents bone tissue loss that occurs in women after menopause (osteoporosis) and promotes bone rebuilding. It reduces the risk of vertebral and hip fractures.
What is osteoporosis?
Osteoporosis is a disease that causes bones to become thin and weak, eventually leading to fractures. It is common in women after menopause. During menopause, the ovaries stop producing female hormones, the estrogens, which help maintain a woman's healthy skeleton. As a result, bone tissue is lost and the bone becomes weaker. The risk of osteoporosis is greater the earlier a woman reaches menopause.
In its early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are typically painful, spinal bone fractures may go unnoticed until they result in a decrease in height. Fractures can occur during everyday activities such as lifting weights, or following minor injuries that would not normally cause fractures in healthy bone. Fractures most commonly occur in the hip, spine, or wrist and can be not only painful but may also lead to significant deformities and disabilities, such as curvature of the back (dowager's hump) and movement limitations.

2. What you need to know before taking ALENDRONATE ALMUS

Do not take ALENDRONATE ALMUS

if you are allergic to alendronate or to any of the other ingredients of this medicine (listed in section 6);
if you have problems with your oesophagus (the tube connecting the mouth to the stomach), such as narrowing (stenosis) or difficulty swallowing (achalasia);
if you have difficulty remaining upright (standing or sitting) for at least 30 minutes;
if you have low levels of calcium in your blood (hypocalcaemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking ALENDRONATE ALMUS.
Take this medicine with caution and inform your doctor in the following cases:

if you have kidney problems (impaired renal function);
if you have difficulty swallowing (dysphagia), or if you have gastrointestinal disorders such as oesophageal diseases, inflammation of the stomach (gastritis), or of the first part of the intestine (duodenitis). If you have previously suffered from severe gastric or duodenal conditions such as ulcers, gastric or intestinal bleeding within the past year, or have undergone surgery on the stomach or oesophagus, since ALENDRONATE ALMUS may have irritating effects and could potentially worsen underlying gastrointestinal disease;
if you have low levels of calcium in your blood (hypocalcaemia). This condition must be corrected before starting treatment with this medicine (see section “Do not take ALENDRONATE ALMUS”). Rare cases of symptomatic hypocalcaemia, occasionally severe, have been reported, particularly in patients with predisposing conditions (e.g. hypoparathyroidism, vitamin D deficiency, and calcium malabsorption), especially in patients taking glucocorticoids, which reduce calcium absorption. It is particularly important to ensure adequate intake of calcium and vitamin D in patients receiving glucocorticoid therapy;
if you have poor dental health, gum disease, are planning a tooth extraction, or do not regularly visit your dentist;
if you are planning dental surgery;
if you have a specific oesophageal condition known as Barrett's oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus);
if you smoke or have been a smoker;
if you have cancer;
if you are undergoing chemotherapy and radiotherapy;
if you are taking corticosteroid anti-inflammatory medicines used to relieve pain and allergies (corticosteroids);
if you have undergone invasive dental procedures or have ill-fitting dentures.

During treatment with ALENDRONATE ALMUS, osteonecrosis of the jaw/mandible (severe deterioration of the bone tissue in the jaw and maxilla) may occur, generally in patients with cancer, often following tooth extraction and/or local infection. Many of these patients were receiving chemotherapy and corticosteroids.
Before starting treatment with ALENDRONATE ALMUS, you should have a dental examination. It is important to maintain good oral hygiene during treatment with ALENDRONATE ALMUS. You should have regular dental check-ups throughout the treatment period and contact your doctor or dentist if you experience any problems with your mouth or teeth, such as tooth loss, pain, or swelling.
Stop taking the medicine and consult your doctor if, during treatment, you develop difficulty swallowing (dysphagia), experience pain when swallowing (odynophagia), chest pain (retrosternal pain), or notice the onset or worsening of a burning sensation in the chest (heartburn). The risk of these adverse effects increases if patients do not drink a full glass of water and/or lie down before 30 minutes have passed after taking the medicine. These adverse effects may worsen if patients continue taking ALENDRONATE ALMUS after these symptoms appear.
Be vigilant and inform your doctor immediately if, during treatment with this medicine, you experience pain in the thigh, hip, or groin, as these may be symptoms of a femoral fracture (see section 4). Such fractures may be preceded by minor injuries (stress fractures).
Inform your doctor if you experience bone, joint, and/or muscle pain, as it may be necessary to discontinue treatment.

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.

Other medicines and ALENDRONATE ALMUS
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Take this medicine with caution and inform your doctor if you are taking:

calcium supplements and medicines used to treat stomach acidity (antacids);
medicines used to treat inflammation and pain called non-steroidal anti-inflammatory drugs (NSAIDs). In general, taking any other oral medicine may interfere with the absorption of ALENDRONATE ALMUS. Wait at least 30 minutes after taking ALENDRONATE ALMUS before taking any other medicine.

ALENDRONATE ALMUS with food and drink
Food and beverages (including mineral water) are likely to reduce the effectiveness of ALENDRONATE ALMUS if taken at the same time. It is therefore important to follow the instructions given in section 3.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
ALENDRONATE ALMUS is intended for use only in postmenopausal women. Do not take this medicine if you are pregnant or breastfeeding.

Driving and using machines
Some adverse effects reported with ALENDRONATE ALMUS may affect your ability to drive or operate machinery. Individual responses to ALENDRONATE ALMUS may vary (see section 4).

3. How to take ALENDRONATE ALMUS

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose and duration of treatment based on your health condition. It is important
that you continue taking ALENDRONATE ALMUS for as long as prescribed by your doctor. ALENDRONATE
ALMUS is effective for the treatment of osteoporosis only if you continue taking the tablets.
The recommended dose is 1 tablet of ALENDRONATE ALMUS once a week.
To obtain benefit from treatment with ALENDRONATE ALMUS, it is necessary to follow carefully the
instructions below.

Choose the day of the week that best fits your routine. Take one tablet of ALENDRONATE ALMUS once
a week on the chosen day.
It is very important to follow instructions 2), 3), 4), and 5) to help the tablet reach the stomach quickly and to
help reduce the risk of irritating the oesophagus (the tube connecting the mouth to the stomach).
After getting up in the morning and before taking any food, drink, or other medication, swallow the
ALENDRONATE ALMUS tablet whole with a full glass of tap water (not less than 200 ml).

Do not take it with mineral water (still or sparkling)
Do not take it with tea or coffee
Do not take it with fruit 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 you have eaten something.
4) ALENDRONATE ALMUS must not be taken at bedtime or before getting out of bed in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop
taking ALENDRONATE ALMUS and contact your doctor.
6) After swallowing the ALENDRONATE ALMUS tablet, wait at least 30 minutes before eating, drinking,
or taking any other medicines, including antacids, calcium supplements, or vitamins.
ALENDRONATE ALMUS is effective only when taken on an empty stomach.
Your doctor may recommend that you take dietary supplements (especially calcium and vitamin D) during
treatment with this medicine.

Children and adolescents
This medicine is not recommended for children and adolescents under 18 years of age.

If you take more ALENDRONATE ALMUS than you should
If you have taken too much of this medicine, contact your doctor or go to the nearest hospital immediately.
In case of overdose, drink a full glass of milk and contact your doctor immediately.
Due to the risk of oesophageal irritation, do not induce vomiting and remain in an upright position.

If you forget to take ALENDRONATE ALMUS
If you forget to take a tablet, take it the following morning.
Do not take a double dose to make up for the missed tablet, but return to your usual weekly schedule of one
tablet on the predetermined day.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may also occur:

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

muscle, joint and bone pain (musculoskeletal), sometimes severe.

Common (may affect up to 1 in 10 people):

headache (cephalalgia), dizziness;
vertigo;
abdominal pain, stomach discomfort or belching after meals (dyspepsia), constipation, feeling of fullness or bloating in the stomach (abdominal distension), diarrhoea, intestinal gas, difficulty or pain when swallowing, oesophageal ulcers (the tube connecting the mouth to the stomach) causing chest pain, acid regurgitation;
hair loss (alopecia), itching;
joint swelling;
muscle weakness (asthenia), swelling of the legs and ankles due to fluid retention (peripheral oedema).

Uncommon (may affect up to 1 in 100 people):

altered taste (dysgeusia);
eye pain or redness, eye inflammation (uveitis, scleritis, episcleritis);
nausea, vomiting, irritation or inflammation of the oesophagus (the tube connecting the mouth to the stomach) and of the stomach, black or dark stools due to blood (melena), damage to the oesophageal tissue (erosions);
skin rash, erythema;
transient flu-like symptoms such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment.

Rare (may affect up to 1 in 1,000 people):

allergic reactions such as hives, swelling of the face, lips, tongue and/or throat, possibly causing difficulty in breathing or swallowing (angioedema);
decreased levels of calcium in the blood (hypocalcaemia), whose symptoms include muscle cramps, spasms and/or tingling in the fingers or around the mouth;
narrowing of the oesophagus (the tube connecting the mouth to the stomach), mouth ulcers when tablets are chewed or sucked, stomach or peptic ulcers (sometimes severe, with bleeding or perforation);
skin rash worsened by exposure to sunlight, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis;
mouth, jaw or chin pain, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw/chin, or tooth loss. These may be signs of a serious deterioration of the bone tissue in the jaw and chin (osteonecrosis), generally associated with delayed healing and infection, often following dental extraction. Contact your doctor or dentist immediately if you experience these symptoms;
unusual femur fracture, particularly in patients on long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this may be an early sign of a possible femur fracture.

Very rare (may affect less than 1 in 10,000 people): Consult your doctor if you experience ear pain, ear discharge and/or ear infection. These events could be symptoms of bone damage in the ear.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ALENDRONATE ALMUS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.:".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What ALENDRONATO ALMUS contains

The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate sodium trihydrate.
The other components are: tablet core: microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, sodium stearyl fumarate; coating: hypromellose, talc.

Description of the appearance of ALENDRONATO ALMUS and package contents
Packaging containing 4 film-coated tablets.
Marketing Authorization Holder
Almus S.r.l. – Via Cesarea 11/10 – 16121 Genoa – Italy.
Manufacturers
West Pharma Produções de Especialidades Farmacêuticas S.A. – Rua João de Deus, 11 – Venda Nova –
2700-486 Amadora – Portugal.
Atlantic Pharma - Produções Farmacêuticas S.A. – Rua da Tapada Grande, 2 – Abrunheira – 2710-089 Sintra – Portugal