Realen: detailed information

Package leaflet: Information for the user

REALEN 70 mg film-coated tablets

Alendronic acid as sodium alendronate trihydrate
Equivalent medicine
Please read all of this leaflet carefully before you start 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 others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What REALEN is and what it is used for

What is REALEN?
REALEN contains the active substance alendronic acid, which belongs to a group of non-hormonal medicines called bisphosphonates that act on the structure and density of bone.
REALEN prevents the loss of bone tissue that occurs in women after menopause (osteoporosis) and promotes bone rebuilding. It reduces the risk of vertebral and hip fractures.

What is REALEN used for?
Your doctor has prescribed REALEN for the treatment of osteoporosis. It reduces the risk of vertebral and hip fractures.
REALEN 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 usually causes no symptoms. However, if left untreated, fractures may occur. Although fractures are typically painful, fractures of the bones in the spine 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 cause fractures in normal bone.

Fractures usually occur in the hip, spine or wrist and can be not only painful but 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 REALEN, your doctor may suggest lifestyle changes to improve your condition, such as:
Stop 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).

Talk to your doctor if you do not feel better or if you feel worse.

2. What you should know before taking REALEN

Do not take REALEN

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), such as narrowing or difficulty swallowing.
If you cannot stand or sit upright for at least 30 minutes.
If 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 REALEN.
Before taking REALEN, it is important that you inform your doctor if:

You have kidney problems,
You have allergies,
You have or have recently had difficulty swallowing or gastrointestinal disorders,
You have been told you have a problem absorbing minerals from your stomach or intestine (malabsorption syndrome),
You have low levels of calcium in your blood (hypocalcaemia). There have been rare reports of symptomatic hypocalcaemia, occasionally severe and often occurring in patients with predisposing conditions (e.g.: hypoparathyroidism (reduced function of the parathyroid glands, which regulate calcium metabolism), vitamin D deficiency, and calcium malabsorption), particularly in patients taking corticosteroids or similar drugs, which reduce calcium absorption,
You suffer from a condition involving changes in the cells lining the lower part of the oesophagus (Barrett’s oesophagus) (a pathological transformation of the mucosa in the lower oesophagus),
You have poor dental hygiene, suffer from gum disease, are about to undergo dental surgery or tooth extraction, or do not regularly receive dental care,
You have undergone invasive dental procedures or have poorly fitting dental prostheses,
You have cancer,
You are undergoing chemotherapy or radiotherapy,
You are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment,
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 should consider having a dental examination before starting treatment with REALEN.
During treatment with bisphosphonates, you must maintain good oral hygiene, undergo regular dental check-ups, and report any oral symptoms such as tooth mobility, pain, or swelling.
Irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach) may occur, often accompanied by symptoms such as chest pain, burning sensation in the upper stomach, difficulty or pain when swallowing, especially if you do not drink a full glass of water and/or lie down within the first 30 minutes after taking REALEN. These side effects may worsen if you continue taking REALEN after experiencing such symptoms.
Children and adolescents
REALEN must not be administered to children and adolescents under 18 years of age.
Other medicines and REALEN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Calcium supplements, antacids (used to reduce stomach acidity), and certain oral medicines may interfere with the absorption of REALEN if taken at the same time.
Therefore, it is important to follow the instructions provided in section 3 “How to take REALEN”.
Some medicines used for rheumatism or long-term pain, called NSAIDs (non-steroidal anti-inflammatory drugs), such as aspirin or ibuprofen, may cause gastrointestinal problems. Therefore, you should exercise caution when taking these medicines together with REALEN.
REALEN with food and drink
Food and drinks (including mineral water) may reduce the effectiveness of REALEN if taken at the same time. Therefore, it is important to follow the instructions provided in section 3 “How to take REALEN”.
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.
REALEN is indicated only for the treatment of postmenopausal women. Do not take REALEN if you are pregnant or think you might be pregnant, or if you are breastfeeding.
Driving and using machines
With REALEN, some side effects have been reported that may affect your ability to drive or operate machinery (e.g. blurred vision, dizziness, and severe bone, muscle, or joint pain).
REALEN contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take REALEN

Take this medicine exactly as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Take one REALEN tablet once a week.
To obtain benefit from treatment with REALEN, it is essential to follow the instructions below.

Choose the day of the week that best fits your routine. Take one tablet of REALEN once a week on your chosen day.
It is very important to follow instructions 2), 3), 4), and 5) to help ensure the tablet reaches 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 medicines, swallow the REALEN tablet with a full glass of plain water only, preferably tap water (not mineral water) (at least 200 ml).
Do not take with mineral water (still or sparkling).
Do not take with coffee or tea.
Do not take with fruit juices or milk.
Do not crush, chew, or allow the tablet to dissolve in the mouth, as this may cause ulcers in the mouth.
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.
Do not take REALEN at bedtime or before getting up in the morning.
If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking REALEN and contact your doctor immediately.
After swallowing the REALEN tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids (used to reduce stomach acidity), calcium supplements, or vitamins. REALEN is effective only when taken on an empty stomach.

If you take more REALEN 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 REALEN
If you forget to take your tablet, simply take one REALEN tablet the following morning. DO NOT take two tablets on the same day. After that, resume taking the tablet on your chosen day of the week.

If you stop taking REALEN
It is important to continue taking REALEN for as long as prescribed by your doctor. REALEN is effective in treating osteoporosis only if you continue taking the tablets regularly. You should periodically check with your doctor whether you still need to continue treatment with this medicine to determine if REALEN remains the appropriate therapy for you.

If you have any questions 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.
The possible side effects are listed below by frequency:
Seek immediate medical advice 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) causing chest pain, burning sensation, 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 including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Mouth pain, and/or problems with the jaw or mandible, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw/mandible, or tooth loss. These may be signs of damage to the jaw/mandible bone (osteonecrosis), usually associated with delayed healing and infection, often following tooth extraction. Contact your doctor or dentist if these symptoms occur.
Rarely, an unusual fracture of the femur may 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 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)
Pain in bones, muscles, or joints, sometimes severe.
Common (may affect up to 1 in 10 people)

Headache, dizziness.
Vertigo.
Abdominal pain; unpleasant sensation in the stomach or belching after meals; constipation; feeling of fullness or bloating in the stomach; diarrhoea, flatulence (passing gas from the intestine).
Alopecia (hair loss), itching.
Swelling of joints.
Fatigue, peripheral oedema (swelling of hands or legs).

Uncommon (may affect up to 1 in 100 people)

Dysgeusia (altered taste).
Blurred vision, eye inflammation, eye pain or redness. Inflammation of the eye (uveitis, scleritis, episcleritis).
Nausea, vomiting; irritation or inflammation of the oesophagus (the tube connecting the mouth to the stomach) or stomach; black or dark stools.
Skin rash, redness of the skin.
Transient flu-like symptoms, such as muscle aches, general feeling of malaise, and rarely fever, usually at the beginning of treatment.

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.
Narrowing of the oesophagus (the tube connecting the mouth to the stomach); mouth ulcers when tablets are chewed or sucked; stomach or peptic ulcers (in the upper part of the intestine) (sometimes severe or with bleeding).
Skin rash worsened by exposure 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 events could be signs of bone damage in the ear.

It may help to keep a record of any symptoms you experience, including when they started and how long they lasted.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at 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 REALEN

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.
Do not remove the tablets from the blister pack before it is time to take 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. Pack contents and other information

What REALEN contains
The active substance is alendronate sodium trihydrate. Each tablet contains the equivalent of
alendronic acid 70 mg, as alendronate sodium trihydrate.
The other components are:
Tablet core: microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, sodium stearyl fumarate;
Tablet coating: hypromellose, talc.
Description of the appearance of REALEN and pack contents
Film-coated tablets: pack containing 4 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
S.F. Group S.r.l. – Via Tiburtina, 1143 – 00156 Rome, 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
SPECIAL PRODUCT’S LINE S.P.A
Via Fratta Rotonda Vado Largo, 1
03012 Anagni (FR), Italy