Package leaflet: Information for the user

GLAMOR 70 mg film-coated tablets

Alendronic acid as sodium alendronate trihydrate
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because 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 pass it on to others, 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 GLAMOR is and what it is used for
What you need to know before taking GLAMOR
How to take GLAMOR
Possible side effects
How to store GLAMOR
Contents of the pack and other information

1. What GLAMOR is and what it is used for

GLAMOR contains the active substance alendronic acid (in the form of sodium alendronate trihydrate) and belongs to a group of non-hormonal medicines called bisphosphonates.
GLAMOR prevents bone tissue loss that occurs in women after menopause (postmenopausal osteoporosis) and promotes bone rebuilding. It reduces the risk of vertebral and hip fractures.
GLAMOR is used for the treatment of osteoporosis and bone diseases.

What is osteoporosis?
Osteoporosis is a condition that causes bones to become thin and weak.
It is common in women after menopause. During menopause, the ovaries stop producing female hormones (estrogens) that help maintain a woman's skeletal health. 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 does not cause symptoms. However, if not treated appropriately, fractures may occur easily. Fractures are usually painful, but those affecting the bones of the spinal column may go unnoticed until, over time, they lead to a reduction in height.
Fractures may occur during normal daily activities such as lifting heavy objects, or following minor injuries that would not cause fractures in normal bone.
Fractures typically occur in the hip, spine, or wrist and may lead to movement limitations and deformities, such as curvature of the back (kyphosis).

How can osteoporosis be treated?
It is important to remember that osteoporosis can be treated and it is never too late to start. GLAMOR not only prevents bone tissue loss but also helps rebuild bone, reducing the risk of vertebral and hip fractures.
Along with treatment with GLAMOR to improve the condition, your doctor may suggest:
to stop smoking
Smoking appears to increase the rate at which bone tissue is lost and therefore may increase the risk of fractures.
to exercise regularly
Just like muscles, bones need exercise to stay strong and healthy. Consult your doctor before starting any exercise program.
to follow a balanced diet
Your doctor can provide information on appropriate dietary choices or the possible need for dietary supplements (especially calcium and vitamin D).

Contact your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking GLAMOR

Do not take GLAMOR

if you are allergic to sodium alendronate trihydrate or to any of the other ingredients of this medicine (listed in section 6);
if you have certain diseases of the esophagus, the tube connecting your mouth to your stomach, such as narrowing (stenosis) or difficulty swallowing food (esophageal achalasia);
if you are unable to stand or sit upright for at least 30 minutes;
if you have low levels of calcium in your blood (hypocalcemia).

Warnings and precautions
Talk to your doctor or pharmacist before taking GLAMOR.
Before taking GLAMOR, it is important that you inform your doctor if:

you have kidney problems;
you have allergies;
you have difficulty swallowing or gastrointestinal disorders;
you have low levels of calcium in your blood;
you have poor dental health, gum disorders, are scheduled for a tooth extraction, or do not regularly receive dental care;
you have Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus);
- you smoke or have previously smoked (as this may increase the risk of dental problems);
- you have cancer;
- you are undergoing chemotherapy or radiotherapy;
- you are taking steroids.

You may be advised to undergo a dental examination before starting treatment with GLAMOR, especially if any of the above conditions apply to you.
During treatment with GLAMOR, appropriate preventive dental procedures should be followed as recommended by your dentist.
It is important to maintain good oral hygiene during treatment with GLAMOR. You should have regular dental check-ups throughout treatment and contact your doctor or dentist if you experience any mouth or dental problems such as tooth loss, pain, or swelling.
Irritation, inflammation, or ulceration of the esophagus may occur, often accompanied by symptoms such as chest pain, burning in the upper stomach, or difficulty or pain when swallowing, especially if you do not take the medicine correctly (see section 3).
These side effects may worsen if you continue taking GLAMOR after experiencing such symptoms.

Children and adolescents
Alendronate should not be taken by children under 18 years of age due to insufficient safety and efficacy data in conditions associated with pediatric osteoporosis.

Other medicines and GLAMOR
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Calcium supplements, antacids, and certain oral medications may interfere with the absorption of GLAMOR if taken at the same time. It is therefore important to follow the instructions provided in section 3 “How to take GLAMOR”.
Since the use of NSAIDs is associated with gastrointestinal irritation, caution should be exercised when using them concomitantly with GLAMOR.

GLAMOR with food and drinks
Food and beverages (including mineral water) may reduce the effectiveness of GLAMOR if taken at the same time. It is therefore important to follow the instructions provided in section 3 “How to take GLAMOR”.

Pregnancy and breastfeeding
GLAMOR is intended only for the treatment of postmenopausal women. Do not take GLAMOR if you are pregnant, think you may be pregnant, or are breastfeeding.
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Side effects have been reported with GLAMOR that may affect your ability to drive or operate machinery. Individual responses to GLAMOR may vary (see section 4 “Possible side effects”).

3. How to take GLAMOR

Take this medicine exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is 1 GLAMOR tablet once a week.
To obtain the benefits of GLAMOR treatment and reduce the risk of adverse events and esophageal irritation (see section "Warnings and precautions"), it is essential to follow all the instructions described below.

Choose the day of the week that best fits your routine. Take GLAMOR once a week on the chosen day.
It is very important to follow instructions 2), 3), 4), and 5).
After getting up in the morning and before taking any food, drink, or other medicines, take the GLAMOR tablet with a full glass of water, preferably tap water (not less than 200 ml).
Do not take the GLAMOR tablet with mineral water (still or sparkling), coffee, tea, juices, or milk.
Do not crush, chew, or dissolve the GLAMOR tablet in the mouth.
Do not lie down; keep your body in an upright position (sitting, standing, or walking) for at least 30 minutes after taking the tablet.
Do not take GLAMOR at bedtime or just before getting up in the morning.
If you experience difficulty or pain when swallowing the tablet, or if you develop chest pain or new or worsening heartburn, stop taking GLAMOR and contact your doctor.
After swallowing the GLAMOR tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines of the day, including antacids (used to reduce stomach acidity), calcium supplements, and vitamins.
GLAMOR is effective only when taken on an empty stomach.

If you take more GLAMOR than you should
If you accidentally take too many GLAMOR tablets, drink a full glass of milk and contact your doctor immediately.
Do not induce vomiting and maintain an upright position; do not lie down.

If you forget to take GLAMOR
If you forget to take your tablet, simply take one GLAMOR tablet the morning after the day you missed it.
DO NOT take two tablets on the same day to make up for the missed dose.
Resume taking the GLAMOR tablet once a week on your chosen day, as originally scheduled.

If you stop taking GLAMOR
GLAMOR is effective in the treatment of osteoporosis only if the tablets are taken continuously. It is therefore important to continue taking GLAMOR tablets as prescribed by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The possible side effects are listed below by frequency:
Very common (may affect more than 1 in 10 people)
muscle, bone, and/or joint pain, which in some cases may be severe.
Common (may affect up to 1 in 10 people)

headache, dizziness;
vertigo;
abdominal pain and swelling; stomach discomfort, indigestion (dyspepsia), or burping after meals; constipation and difficulty passing stools (stipsis); feeling of fullness, bloating, or burning in the stomach; diarrhoea, flatulence (passing gas from the intestine); difficulty, with burning or pain, in swallowing (dysphagia); oesophageal ulcer causing chest pain; acid regurgitation, a condition in which the contents of the stomach rise involuntarily into the mouth.
alopecia (hair loss), itching.
swelling of the joints.
feeling of tiredness (asthenia), swelling of the hands or legs (peripheral oedema).

Uncommon (may affect up to 1 in 100 people)

dysgeusia (altered taste).
eye inflammation, blurred vision, inflammation, pain, or redness of the eyes (uveitis, scleritis, episcleritis).
nausea, vomiting; irritation or inflammation of the oesophagus or stomach; black or dark and foul-smelling stools.
skin rash, redness of the skin (erythema).
transient flu-like symptoms such as muscle pain, general malaise, and sometimes fever; symptoms usually occurring at the beginning of treatment.

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

allergic reactions such as urticaria; swelling of the skin, face, lips, tongue, and/or throat with difficulty breathing or swallowing.
symptoms due to low calcium levels in the blood (hypocalcaemia), including muscle cramps or spasms and/or tingling in the fingers or around the mouth; symptoms often present in cases of hypoparathyroidism (a condition characterised by reduced or absent secretion by the parathyroid glands of parathyroid hormone, leading to hypocalcaemia), vitamin D deficiency, and impaired calcium absorption (particularly in patients taking glucocorticoids).
narrowing of the oesophagus (oesophageal stricture); mouth ulcers when tablets are chewed; stomach or peptic ulcers (in the upper intestine), sometimes severe or with bleeding.
skin rash worsened by exposure to sunlight, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
mouth pain and/or problems with the jaw or mandible.

An unusual femoral fracture related to the use of bisphosphonates, such as alendronic acid (the active ingredient in GLAMOR), may rarely occur, particularly in patients undergoing long-term osteoporosis treatment. Contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin, as this could be an early sign of a possible femoral fracture.
Very rare
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.
It may help to keep a record of the symptoms you experience, including when they started and how long they lasted.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. 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 GLAMOR

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label.
This medicine does not require any special storage conditions.
Remove the tablets from the blister pack only just before taking them.
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 GLAMOR contains
The active substance is alendronic acid (as sodium alendronate trihydrate). Each tablet contains 70 mg of alendronic acid as sodium alendronate trihydrate.
The other components are:
microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, sodium stearate fumarate in the tablet core; hypromellose and talc in the tablet coating.

Description of the appearance of GLAMOR and package contents
The GLAMOR carton package contains a blister strip with 4 film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
AGIPS FARMACEUTICI S.r.l. - Via Amendola n. 4 – 16035 Rapallo (GE), Italy

Manufacturer
West Pharma - Produções de Especialidades Farmacêuticas S.A., Rua João de Deus, 11 - Venda Nova - 2700-486 Amadora, Portugal