Alendronate Pharmacare

Package leaflet: Information for the patient

ALENDRONATE PHARMACARE

70 mg tablets
alendronic acid
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 give it to others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell 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 Alendronate Pharmacare is and what it is used for
2. What you need to know before taking Alendronate Pharmacare
3. How to take Alendronate Pharmacare
4. Possible side effects
5. How to store Alendronate Pharmacare
6. Contents of the pack and other information

1. What Alendronate Pharmacare is and what it is used for

What is Alendronate Pharmacare?
Alendronate Pharmacare is a tablet containing the active substance alendronic acid
(commonly referred to as alendronate) and belongs to a group of non-hormonal medicines
called bisphosphonates. Alendronate Pharmacare 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 Alendronate Pharmacare used for?
Your doctor has prescribed Alendronate Pharmacare for the treatment of osteoporosis. It
reduces the risk of vertebral and hip fractures.
Alendronate Pharmacare 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, the estrogens,
which 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 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 result in a loss of height. Fractures can occur during normal daily
activities such as lifting weights, or from minor trauma that would not cause fractures in
normal bone. Fractures typically occur in the hip, spine, or wrist and can be not only painful
but may lead to significant deformities and disabilities, such as curvature of the back (dowager's hump) and limitations in movement.
How can osteoporosis be treated?
Along with treatment with Alendronate Pharmacare, your doctor may suggest 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 program.
Balanced diet Your doctor may provide information about diet or the possible
need for dietary supplements (especially calcium and vitamin D).

2. What you need to know before taking Alendronato Pharmacare

Do not take Alendronato Pharmacare

• if you are allergic to alendronic acid or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems with your oesophagus (the tube connecting your mouth to your stomach) or other conditions delaying oesophageal emptying, such as severe narrowing of the oesophagus or failure of the oesophageal muscles to relax (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 (hypocalcaemia).

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Alendronato Pharmacare:

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

You may be advised to have a dental examination before starting treatment with
Alendronato Pharmacare.
During treatment with Alendronato Pharmacare, it is important to maintain good oral
hygiene and to have regular dental check-ups throughout treatment. Contact your doctor or
dentist if you notice any mouth or dental problems 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 with symptoms such as chest pain, burning sensation in the upper
abdomen, difficulty or pain when swallowing, especially if patients do not drink a full glass of
water and/or lie down during the first 30 minutes after taking Alendronato Pharmacare. These
side effects may worsen if patients continue taking Alendronato Pharmacare after experiencing
these symptoms.

Children and adolescents
Alendronato Pharmacare must not be given to children and adolescents under 18 years of age.

Other medicines and Alendronato Pharmacare
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Calcium supplements, antacids, and certain oral medicines are likely to interfere with the absorption of Alendronato Pharmacare if taken at the same time. It is therefore important to follow the instructions given in section 3.
Some medicines used for rheumatism or long-term pain, called NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause gastrointestinal problems; therefore, caution should be used when these medicines are taken together with Alendronato Pharmacare.

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

Pregnancy and breastfeeding
Alendronato Pharmacare is indicated only for postmenopausal women. Do not take Alendronato Pharmacare if you are pregnant or suspect you may be pregnant, or if you are breastfeeding.

Driving and using machines
Alendronato Pharmacare may cause side effects such as dizziness, vertigo, blurred vision, or bone, muscle or joint pain. As a result, reaction ability may be impaired and the ability to drive or operate machinery may be compromised (see section 4).

Alendronato Pharmacare contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.

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

3. How to take Alendronato Pharmacare

Take this medicine exactly as directed by your doctor or
pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take one tablet of Alendronato Pharmacare once a week.
Carefully follow the instructions below:

1. Choose the day of the week that best fits your routine. Take one tablet of Alendronato Pharmacare once a week on the chosen day.
   It is very important that you strictly follow the instructions 2), 3), 4) and 5) below to
   ensure rapid passage of the Alendronato Pharmacare tablet into the stomach and help
   reduce the risk of irritating the oesophagus (the tube connecting the mouth to the
   stomach).
2. After getting up in the morning and before taking any food, drink, or other medicine, swallow the Alendronato Pharmacare tablet with a full glass of tap water only (not mineral water), (at least 200 ml), to ensure adequate absorption of Alendronato Pharmacare:

• Do not take with mineral water (still or sparkling).
• Do not take with coffee or tea.
• Do not take with fruit juices or milk.
  Because of the risk of mouth and throat ulcers, the tablet must not be broken, chewed, or dissolved in the mouth.

3. Do not lie down – remain in an upright position (sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
4. Do not take the Alendronato Pharmacare tablet at bedtime or just before getting up.
5. If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alendronato Pharmacare and contact your doctor.
6. After swallowing the Alendronato Pharmacare tablet, wait 30 minutes before eating, drinking, or taking any other medicines of the day, including antacids, calcium, or vitamin supplements. Alendronato Pharmacare is effective only when taken on an empty stomach.

If you take more Alendronato Pharmacare than you should
If you have taken more tablets than prescribed, drink a full glass of milk and contact
your doctor immediately. Do not induce vomiting and do not lie down.
If you forget to take Alendronato Pharmacare
If you forget to take a tablet at the scheduled time, take it the following morning.
Then resume your regular weekly dosing schedule on your chosen day of the week. Do not take a double dose on the same day.
If you stop taking Alendronato Pharmacare
It is important to continue taking Alendronato Pharmacare for as long as prescribed by your doctor. Since it is not known how long you should continue treatment, you should periodically consult your doctor to assess whether continued therapy with this medicine is still appropriate for you.
A patient instruction card is included in the Alendronato Pharmacare package.
It contains important information reminding you how to take Alendronato Pharmacare correctly.
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.
Contact your doctor immediately if you notice any of the following side effects, which may be serious and for which you may need urgent medical treatment:

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

• heartburn; difficulty swallowing; pain when swallowing; oesophageal ulcers (the tube connecting the mouth to the stomach), which may cause chest pain, heartburn, or difficulty or pain when swallowing.

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

• allergic reactions have been reported, such as hives, swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing or swallowing; severe skin reactions,
• mouth pain, and/or jaw/mandible pain, swelling or ulcers inside the mouth, numbness or a sensation of heaviness in the jaw/mandible, or tooth loss. These could be signs of bone damage in the jaw/mandible (osteonecrosis), usually associated with delayed healing and infection, often following dental extraction. Contact your doctor and dentist if you experience these symptoms,
• unusual femoral fractures may rarely occur, particularly in patients who have been treated for a long time 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 femoral fracture,
• severe bone, muscle, and/or joint pain.

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

• Unusual fractures occurring at sites other than the femur.

Other side effects include:
Very common (may affect more than 1 in 10 people):

• bone, muscle, and/or joint pain, sometimes severe.

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

• headache, dizziness;
• abdominal pain, stomach discomfort or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhoea, intestinal gas;
• hair loss, skin itching;
• joint swelling;
• feeling of weakness, swelling of arms and legs (oedema).

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

• changes in taste sensation;
• blurred vision; eye pain or redness;
• nausea, vomiting;
• inflammation of the stomach lining, inflammation of the oesophagus (the tube connecting the mouth to the stomach);
• black and/or bloody stools;
• skin rash, redness of the skin;
• transient flu-like symptoms (muscle aches, feeling unwell, and, rarely, fever), usually at the beginning of treatment.

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

• hypersensitivity reactions (including hives and swelling of the face, lips, tongue and/or throat);
• low levels of calcium in the blood, with symptoms such as muscle cramps or spasms, tingling in the fingers or around the mouth;
• narrowing of the oesophagus (the tube connecting the mouth to the stomach);
• peptic or stomach ulcers (sometimes severe or with bleeding);
• skin rash with sensitivity to sunlight.

Very rare (may affect up to 1 in 10,000 people):

• Consult your doctor if you experience ear pain, ear discharge, and/or ear infection. These episodes could be signs of bone damage in the ear.

Reporting of side effects
If you experience any side effects, 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:
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 Alendronato Pharmacare

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not store above 25 °C.
Store in the original packaging to protect it from moisture.
Do not dispose of medicines via wastewater. 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 Pharmacare contains

• The active substance is alendronic acid. Each tablet contains 70 mg of alendronic acid (as alendronate sodium trihydrate).
• The other components are: microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, magnesium stearate (Ph.Eur.).

Description of the appearance of Alendronato Pharmacare and contents of the pack
Alendronato Pharmacare is a white to off-white tablet.
Alendronato Pharmacare is available in packs containing 2, 4, 8, 12 and 40 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pharmacare Srl
Via Marghera 29
20149 Milano
Italy
Manufacturer
Lachifarma S.R.L. Laboratorio Chimico Farmaceutico Salentino – SS16 Zona Industriale -
73010 - Zollino (LE) (Italy)
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Italy: Alendronato Pharmacare 70 mg tablets
This leaflet was last updated in March 2026