Aston

Patient Information Leaflet

ASTON 70 mg film-coated tablets

alendronic acid
Generic Medicine
Please read this leaflet carefully before 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• It is particularly important to understand the information contained in section 3 before taking this medicine.

Contents of this leaflet:

1. What ASTON is and what it is used for
2. What you need to know before taking ASTON
3. How to take ASTON
4. Possible side effects
5. How to store ASTON
6. Contents of the pack and other information

1. What ASTON is and what it is used for

What is ASTON?
ASTON is a tablet containing the active substance alendronic acid (commonly known as alendronate) and
belongs to a group of non-hormonal medicines called bisphosphonates. ASTON prevents bone tissue loss that
occurs in women after menopause and promotes bone rebuilding. It reduces the risk of vertebral and hip
fractures.
What is ASTON used for?
Your doctor has prescribed ASTON for the treatment of osteoporosis. It reduces the risk of vertebral and hip
fractures.
ASTON is a treatment to be taken once a week.
What is osteoporosis?
Osteoporosis is thinning and weakening of the bones. It is common in women after menopause. During
menopause, the ovaries stop producing female hormones, oestrogens, 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 the early stages, osteoporosis generally causes no symptoms. However, if left untreated, fractures may occur.
Although fractures are usually painful, fractures of the spinal bones may go unnoticed until they lead to a loss of
height. Fractures may occur during normal daily activities such as lifting weights, or due to minor trauma that would not cause fractures in a normal bone. Fractures typically occur in the hip, spine or wrist and can be not only painful but may also lead to significant deformities and disability, such as curvature of the back (dowager's hump) and limitations in movement.
How can osteoporosis be treated?
Along with treatment with ASTON, your doctor may recommend lifestyle changes to improve the condition, such as:
Stopping smoking: smoking appears to increase the rate at which bone tissue is lost and therefore may
increase the risk of fractures.
Physical exercise: like muscles, bones need physical activity to stay strong and healthy. Consult your
doctor before starting any exercise programme.
Balanced diet: your doctor can provide advice on diet or the possible need for dietary supplements (especially calcium and vitamin D).

2. What you should know before taking ASTON

Do not take ASTON:

• If you are allergic to alendronic acid or to any of the other ingredients of this medicine (listed in section 6);
• if you have certain problems with your oesophagus (the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing;
• if you are unable to stand or sit upright for at least 30 minutes;
• if your doctor has told you that you have low levels of calcium in your blood.

If you think any of these apply to you, do not take the tablets. Consult your doctor and follow their advice.

Warnings and precautions

Talk to your doctor or pharmacist before taking ASTON if:

• You have kidney problems;
• you currently have or have recently had difficulty swallowing or gastrointestinal disorders;
• your doctor has told you that you have Barrett's oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus);
• you have been told that you have a problem with mineral absorption in the stomach or intestine (malabsorption syndrome);
• you have been told that you have low levels of calcium in your blood;
• you have poor dental health, gum disease, are scheduled for a tooth extraction, or do not regularly visit your dentist;
• you have cancer or are undergoing chemotherapy or radiotherapy;
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer;
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions such as asthma, rheumatoid arthritis, and severe allergies;
• you are a smoker or have been a smoker in the past (as this may increase the risk of dental problems).

Problems affecting the jawbone or mandible may occur during treatment with alendronic acid, particularly in patients with cancer, often following dental extractions and/or local infection. Many of these patients were also receiving chemotherapy and corticosteroids. Consider having a dental examination before starting treatment with ASTON.

It is important, during treatment with bisphosphonates, to maintain good oral hygiene and to have regular dental check-ups. Report any oral symptoms such as loose teeth, pain, or swelling.

Irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach) may occur, often accompanied by chest pain, burning sensation in the upper stomach, difficulty or pain when swallowing, especially if patients do not drink a full glass of water and/or lie down within the first 30 minutes after taking ASTON. These side effects may worsen if patients continue taking ASTON after experiencing such symptoms. If you notice any of the side effects described above, stop taking the medicine and consult your doctor.

In patients treated with alendronic acid for long periods, femoral fractures—sometimes preceded by minor trauma (stress fractures)—have been reported. If you experience pain, weakness, or discomfort in your leg, hip, or groin, inform your doctor, as this may be an early sign of a possible femoral fracture (see section 4).

Your doctor will decide whether it is necessary to discontinue treatment with ASTON.

Inform your doctor if you develop bone, joint, and/or muscle pain, even long after starting treatment, as it may be necessary to stop taking the medicine.

Other medicines and ASTON

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Tell your doctor if you are taking:

• Calcium supplements and antacids, as they may alter the effect of alendronate;
• medicines used to treat inflammation and pain called non-steroidal anti-inflammatory drugs (NSAIDs), (e.g. ibuprofen or aspirin), as they may cause stomach or intestinal problems (gastrointestinal irritation) when taken with alendronic acid.

In general, taking other oral medicines at the same time may interfere with the absorption of ASTON. Therefore, wait at least 30 minutes after taking ASTON before taking any other medicine (see section 3).

Children and adolescents

Alendronic acid must not be given to children and adolescents under 18 years of age.

Fertility, pregnancy and breastfeeding

ASTON should only be used by postmenopausal women. Do not take ASTON if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

Driving and using machines

With ASTON, side effects have been reported (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) that may impair your ability to drive or operate machinery (see section 4).

ASTON with food and drinks

Food and drinks (including mineral water) are likely to reduce the effectiveness of ASTON if taken at the same time. It is therefore important to wait at least 30 minutes after taking ASTON before eating or drinking (see section 3).

ASTON contains sodium

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

3. How to take ASTON

Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

The recommended dose is 1 ASTON tablet once a week.

It is very important to follow these instructions to help the ASTON tablet quickly enter the stomach and help reduce the possibility of irritating the esophagus (the tube connecting the mouth to the stomach).

1. Choose the day of the week that best fits your routine. Take ASTON once a week on the chosen day.

2. After getting up in the morning and before taking any food, drink, or other medicine, swallow the ASTON tablet whole with a full glass of tap water only (not mineral water) (at least 200 ml), so that ASTON is adequately absorbed.

• Do not take ASTON with mineral water (still or sparkling).
• Do not take it with coffee or tea.
• Do not take it with juices or milk.

The ASTON tablet must be swallowed whole. Do not crush, chew, or allow the tablet to dissolve in the mouth, as this may cause mouth ulcers.

3. Remain upright (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until after you have eaten something.

4. Do not take ASTON 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 ASTON and contact your doctor.

6. After swallowing the ASTON tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, and vitamins. ASTON is effective only when taken on an empty stomach.

If you take more ASTON than you should

If you accidentally take too much of this medicine, drink a full glass of milk and contact your doctor immediately or go to the nearest hospital.

Do not induce vomiting and do not lie down.

If you forget to take ASTON

If you forget to take your tablet, simply take one ASTON tablet the following morning. Do not take two tablets on the same day. Then resume taking the tablet on your chosen day of the week.

If you stop taking ASTON

It is important to continue taking ASTON for as long as prescribed by your doctor. ASTON is effective in treating osteoporosis only if you continue taking the tablets.

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 everybody gets them.

The following side effects have been reported with the use of ASTON:

Very common (may affect at least 1 in 10 people):

• muscle, bone and/or joint pain, sometimes severe.
• mild and transient decreases in blood calcium and phosphate levels, generally within normal limits.

Common (may affect at least 1 in 100 and less than 1 in 10 people):

• headache, dizziness.
• vertigo.
• abdominal pain, stomach discomfort or burping after meals, constipation, feeling of fullness or bloating in the stomach, diarrhoea, flatulence, heartburn, difficulty swallowing, pain when swallowing, oesophageal ulcers (the tube connecting the mouth to the stomach) causing chest pain, burning sensation or difficulty or pain when swallowing.
• alopecia (hair loss), itching.
• joint swelling.
• fatigue, peripheral oedema (swelling of the hands or legs).

Uncommon (may affect at least 1 in 1,000 and less than 1 in 100 people):

• dysgeusia (taste disturbances).
• blurred vision, 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) or stomach, black or tarry stools.
• skin rash, erythema.
• transient flu-like symptoms such as muscle pain, general malaise, and sometimes fever, usually at the beginning of treatment.

Rare (may affect at least 1 in 10,000 and less than 1 in 1,000 people):

• allergic reactions such as urticaria, swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing.
• symptoms due to low blood calcium levels including muscle cramps or 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 intestinal ulcers (sometimes severe or with bleeding).
• skin rash worsened by exposure to sunlight, serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis.
• mouth pain and/or jaw pain, swelling or sores inside the mouth, numbness or 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 dental extraction. Contact your doctor or dentist if you experience these symptoms.
• muscle, bone and/or joint pain, sometimes severe.
• 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 could 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 signs of bone damage in the ear.

Not known (frequency cannot be estimated from the available data):

• unusual fractures occurring at sites other than the femur.

It is advisable to keep a note of any symptoms you may experience, including when they start and how long they last.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ASTON

Keep this medicine out of the sight and reach of children.
Do not use ASTON after the expiry date stated on the label. The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging, properly stored.
Do not remove the tablets from the blister pack before the time of taking them.
This medicine does not require any special storage conditions.
Medicines must not be disposed of 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 ASTON contains
Each tablet contains:
The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid as alendronate
sodium trihydrate.
Other components are:
Core: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fumarate.
Coating: hypromellose, talc.
Description of the appearance of ASTON and the contents of the pack
Film-coated tablets: pack sizes of 4 and 12 tablets in blisters.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SF GROUP Srl – Via Tiburtina, 1143 – 00156 Rome
Manufacturer
Special Product’s Line
Via Fratta Rotonda Vado Largo, n.1 - 03012 Anagni (FR)
Lachifarma Srl
Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica - Zona Industriale
73010 Zollino (LE)