Alenic

Package leaflet: Information for the patient

ALENIC 70 mg tablets

Alendronic acid as sodium alendronate trihydrate
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 other people, even if their symptoms are the same as yours, because it could 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:

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

1. What Alenic is and what it is used for

What Alenic is
Alenic is a tablet containing the active substance alendronic acid (commonly known as alendronate) and belongs to a group of non-hormonal medicines called bisphosphonates. Alenic prevents the loss of bone tissue that occurs in women after menopause and promotes bone rebuilding. It reduces the risk of vertebral and hip fractures.
What Alenic is used for
Your doctor has prescribed Alenic for the treatment of osteoporosis. Alenic reduces the risk of vertebral and hip fractures.
Alenic 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 bone becomes weaker. The risk of osteoporosis is greater the earlier a woman reaches menopause.
In the early stages, osteoporosis usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are usually painful, fractures of the bones in the spine may go unnoticed until they result in a loss of height. Fractures can occur during normal daily activities such as lifting weights, or following 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 disability, such as curvature of the back (kyphosis) and limitations in movement.
How can osteoporosis be treated?
Along with treatment with Alenic, 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 programme.
Balanced diet
Your doctor can provide information about diet or the possible need for dietary supplements (especially calcium and vitamin D).

2. What you need to know before taking Alenic

Do not take Alenic:

• 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 cannot stand or sit upright with your back straight 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 Alenic if:

• you have kidney problems
• you have or have recently had difficulty swallowing or problems affecting the digestive system
• 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 have regular dental check-ups
• you have cancer
• you 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 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 Alenic.
It is important to maintain good oral hygiene during treatment with Alenic.
You should have regular dental check-ups throughout your 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 oesophagus (the tube connecting the mouth to the stomach) may occur, often with symptoms such as 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 during the first 30 minutes after taking Alenic. These side effects may worsen if patients continue taking Alenic after experiencing such symptoms.
Children and adolescents
Alenic must not be given to children and adolescents under 18 years of age.
Other medicines and Alenic
Tell 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 Alenic if taken at the same time.
Therefore, it is important to follow the instructions provided in section 3. How to take Alenic.
Some medicines used for rheumatic conditions or long-term pain, called NSAIDs (e.g. acetylsalicylic acid or ibuprofen), may cause digestive problems. Therefore, caution should be used when taking these medicines together with Alenic.
Alenic with food and drink
Food and drinks (including mineral water) may reduce the effectiveness of Alenic if taken at the same time. Therefore, it is important to follow the instructions provided in section 3. How to take Alenic.
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.
Alenic is indicated only for postmenopausal women. Do not take Alenic if you are pregnant or think you might be pregnant, or if you are breastfeeding.
Driving and using machines
With Alenic, side effects have been reported (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain) which may affect your ability to drive or operate machinery (see section 4).
Alenic contains lactose and sodium
Lactose: If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Alenic

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.
Take one Alenic tablet once a week.
Follow the instructions below carefully:

1. Choose a day of the week that best fits your routine. Take one Alenic tablet once a week on your chosen day.
   It is very important that you follow instructions 2), 3), 4), and 5) to help the Alenic tablet reach the stomach quickly 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 medicines, swallow the Alenic tablet whole with a full glass of tap water only (not mineral water), (at least 200 mL), to ensure adequate absorption of Alenic.

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

Do not crush, chew, or allow the tablet to dissolve in the mouth, as this may cause mouth ulcers.
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 you have eaten something.
4) Do not take Alenic at bedtime or before getting up in the morning.
5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking Alenic and contact your doctor.
6) After swallowing the Alenic tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines of the day, including antacids, calcium supplements, and vitamins. Alenic is effective only when taken on an empty stomach.

If you take more Alenic 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.

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

If you stop taking Alenic
It is important to continue taking Alenic for as long as your doctor has prescribed it. Since it is not known how long you should continue treatment, you should periodically check with your doctor whether you should continue therapy with this medicine and whether Alenic is still the right treatment for you.

An instruction card is included in the Alenic package. It contains important information to remind you how to take Alenic correctly.
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 gets them.
See a doctor immediately if you notice any of the following side effects, which can 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; ulcers of the oesophagus (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 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, 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 such symptoms.
• an unusual fracture of the femur 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 femur fracture.

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):

• joint swelling
• abdominal pain; stomach discomfort or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhoea, intestinal gas
• hair loss; itching
• headache; dizziness
• fatigue; swelling of the hands or legs.

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

• nausea; vomiting
• irritation or inflammation of the oesophagus (the tube connecting the mouth to the stomach) or stomach
• black or dark stools
• blurred vision; eye pain or redness
• skin rash; redness of the skin
• transient flu-like symptoms, such as muscle aches, general malaise, and sometimes fever, usually at the beginning of treatment
• taste disturbance.

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

• symptoms due to low levels of calcium in the blood including muscle cramps or spasms and/or tingling in the fingers or around the mouth
• peptic or stomach ulcers (sometimes severe or with bleeding)
• narrowing of the oesophagus (the tube connecting the mouth to the stomach)
• skin rash worsened by exposure to sunlight
• mouth ulcers.

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 get 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 Alenic

Keep this medicine out of 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.
Store below 25°C. Do not remove the tablets from the blister pack before it is time to take them.
Do not use this medicine if you notice any visible signs of deterioration.
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 Alenic contains

• The active substance is sodium alendronate trihydrate. Each tablet contains the equivalent of 70 mg alendronic acid as sodium alendronate trihydrate.
• The other components are microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, magnesium stearate.

Description of the appearance of Alenic and contents of the pack
Packs of 4 and 12 white or almost white, oval tablets in aluminium blisters.
Marketing Authorization Holder
Epifarma S.r.l. - Via San Rocco, 6 – 85033 Episcopia (PZ)
Manufacturer
Doppel Farmaceutici S.r.l. – Via Volturno, 48 – 20089 Quinto De’ Stampi (Rozzano – MI)
Vamfarma S.r.l. - Via Kennedy, 5 - 26833 – Comazzo (LO)