NOFRATTIL 70 mg Film-Coated Tablets

Зміст інструкції

1. NOFRATTIL 70 mg film-coated tablets
   1. WHAT NOFRATTIL IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE TAKING NOFRATTIL
   3. HOW TO TAKE NOFRATTIL
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE NOFRATTIL
   6. PACKAGE CONTENTS AND OTHER INFORMATION

NOFRATTIL 70 mg film-coated tablets

Alendronic acid
Generic Medicine

Read 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. It may be harmful to people even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT NOFRATTIL IS AND WHAT IT IS USED FOR

What is NOFRATTIL?
NOFRATTIL contains the active ingredient Alendronic acid which belongs to a group of medicines
called bisphosphonates.
NOFRATTIL prevents the loss of bone tissue (osteoporosis) that occurs in women after the
menopause and promotes bone reconstruction. It reduces the risk of vertebral and hip fractures.

What is NOFRATTIL used for?
NOFRATTIL is used for the treatment of osteoporosis that occurs in women after the meno-
pause and reduces the risk of vertebral and hip fractures.

NOFRATTIL is a treatment that must be taken once a week.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women after the
menopause because the ovaries stop producing female hormones, estrogens, which contribute to
maintaining a woman's healthy skeleton.
Consequently, 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 normally does not cause symptoms. However, if left untreated, fractures
can occur.
Although usually painful, fractures of the vertebral bones may not be felt until they lead to a decrease
in height.
Fractures can occur during daily activities such as lifting weights, or due to minor
trauma that would not be able to cause fractures in a normal bone. Fractures usually occur in the hip of
the spine or wrist and can be not only painful but can lead to significant deformity and disability.

How can osteoporosis be treated?
It is important to remember that osteoporosis can be treated and that it is never too late to begin.
NOFRATTIL not only prevents the loss of bone tissue but helps to rebuild bone
that may have been lost and reduces the risk of vertebral and hip fractures.
Along with treatment with NOFRATTIL, your doctor may suggest changing your lifestyle to im-
prove the condition of the disease, such as:

Stop smokingsmoking appears to increase the rate at which bone tissue is lost
and, therefore, may increase the risk of fractures.

Physical exerciselike muscles, bones need exercise to stay strong and
healthy. Consult your doctor before starting any exercise program.

Balanced dietyour doctor can provide information on diet or the possible need to
take dietary supplements (especially calcium and vitamin D)

2. WHAT YOU NEED TO KNOW BEFORE TAKING NOFRATTIL

Do not take NOFRATTIL

• If you are allergic to alendronic acid trihydrate or any of the other ingredients of this medicine.
• If you have problems with your esophagus (the tube connecting your mouth to your stomach) such as narrowing and difficulty swallowing
• If you cannot 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.

Warnings and precautions
Talk to your doctor or pharmacist before taking Nofrattil if:

• You have kidney problems
• You suffer from or have suffered from difficulty swallowing or problems affecting the digestive tract (esophageal stricture, gastritis, duodenitis, ulcers, active gastrointestinal bleeding) or if you have recently undergone surgery on the esophagus or stomach.
• You suffer from Barrett's esophagus, a condition associated with changes in the cells lining the lower portion of the esophagus.
• You have been told you have a problem with the absorption of minerals in the stomach or intestine (malabsorption syndrome).
• You have low levels of calcium in your blood, and/or low levels of vitamin D.
• You are undergoing therapy with glucocorticoids.
• You have thyroid problems (hypoparathyroidism).
• You have poor dental health, have dental problems or gum problems, are planning to have a tooth extracted or do not have regular dental check-ups.
• You have undergone invasive dental procedures.
• You are planning dental surgery.
• You have poorly fitting dentures.
• You have cancer or are undergoing chemotherapy and radiotherapy.
• You are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) which are used in the treatment of cancer
• You are taking corticosteroids (such as prednisone or dexamethasone).
• You are a smoker or have been in the past.

Problems with the jaw or jawbone may occur during the use of alendronate, generally in patients with cancer, often after dental extractions and/or local infection. Many of these patients were undergoing chemotherapy or corticosteroids and were smokers.
Consider having a dental examination before starting treatment with NOFRATTIL. It is important to maintain good oral hygiene and have regular dental check-ups during treatment with bisphosphonates.
Tell your doctor about any type of oral symptoms such as tooth mobility, pain or swelling.
Irritation, inflammation or ulceration of the esophagus may occur, often with symptoms of chest pain, heartburn, difficulty or pain swallowing, especially if patients do not drink a full glass of water and/or lie down within the first 30 minutes after taking NOFRATTIL. These side effects may worsen if patients continue to take NOFRATTIL after experiencing these symptoms. If you notice the appearance of any of the side effects described above, stop taking the medicine and see your doctor.
Fractures of the femur have been reported in patients treated with alendronate for long periods, with or without a minor injury (stress fractures).
If you experience pain, weakness or discomfort in the leg, hip or groin tell your doctor immediatelyas this may be an early indication of a possible femur fracture (see section 4). Your doctor will decide whether it is necessary to stop treatment with NOFRATTIL.
Cases of bone, joint and/or muscle pain have occurred in patients treated with bisphosphonates, including alendronate, which in rare cases have been severe and caused disability. The onset of symptoms has varied from one day to several months after the start of treatment. In most patients, discontinuation of treatment led to relief of symptoms.

Other medicines and NOFRATTIL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Some medicines are likely to interfere with the absorption of NOFRATTIL if taken at the same time. It is therefore important to follow the instructions given in section 3. HOW TO TAKE NOFRATTIL.
Take this medicine with cautionand tell your doctor in particular if you are taking:

• Calcium supplements and antacids may alter the effect of alendronate if taken with alendronic acid.
• NSAIDs (ibuprofen, aspirin) may cause digestive problems if taken with alendronic acid.

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

• 3.

Children and adolescents
NOFRATTIL should not be given to children and adolescents under 18 years of age.

Fertility, pregnancy and breastfeeding
NOFRATTIL is only for women after menopause. Do not take NOFRATTIL if you are pregnant or think you might be, if you are planning a pregnancy or if you are breastfeeding.

Driving and using machines
Side effects (such as blurred vision, dizziness and severe bone, muscle or joint pain) have been reported with NOFRATTIL which may affect your ability to drive vehicles or use machines (see section 4).

NOFRATTIL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially “sodium-free”.

3. HOW TO TAKE NOFRATTIL

Take this medicine following the doctor's instructions at all times. If you have any doubts, consult your doctor
or pharmacist.

The recommended dose is one NOFRATTIL tablet once a week.
To obtain benefits from treatment with NOFRATTIL, it is necessary to act as described here below.
It is very important to follow the instructions to facilitate the quick passage of the NOFRATTIL tablet into the stomach and help reduce the possibility of irritating the esophagus (the channel that connects the mouth to the stomach).

• 1) Choose the day of the week that best suits your activities. Take NOFRATTIL once a week on the chosen day.
• 2) After getting out of bed to start the day, and before taking any food, drink or other medication of the day, swallow the entire NOFRATTIL tablet with a large glass of tap 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 juices or milk.

The NOFRATTIL tablet must only be swallowed whole. Do not crush, chew or let the tablet dissolve in your mouth.

• 3) Do not lie down, keep the torso in an upright position (whether sitting, standing, or walking) for at least 30 minutes after swallowing the tablet. Do not lie down until you have eaten something.
• 4) After swallowing the NOFRATTIL tablet, wait at least 30 minutes before eating, drinking or taking other medications of the day, including antacids, calcium supplements and vitamins. NOFRATTIL is only effective when taken on an empty stomach.
• 5) NOFRATTIL should not be taken at bedtime or before getting out of bed at the beginning of the day.
• 6) If difficulty and pain when swallowing, chest pain, or heartburn in the upper part of the stomach appears or worsens, stop taking NOFRATTIL and con-tact your doctor.

If you take more NOFRATTIL 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 NOFRATTIL
Do not take a double dose to make up for a missed dose.
If you forget to take the tablet, it is sufficient to take one NOFRATTIL tablet the next morning. Do NOT take two tablets on the same day.
Afterwards, start taking the tablet again on the chosen day of the week.

If you stop taking NOFRATTIL
It is important to continue taking NOFRATTIL for as long as prescribed by your doctor.
NOFRATTIL is only effective for the treatment of osteoporosis if you continue to take the tablets.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, NOFRATTIL can cause side effects, although not everybody gets them.
The frequency of occurrence of side effects has been defined as follows:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Not known: (frequency cannot be estimated from the available data)

Immune system disorders
Rare: allergic reactions such as hives, swelling of the face, lips, tongue and/or throat, possibly causing difficulty breathing and swallowing.

Metabolism and nutrition disorders
Rare: symptoms due to low levels of calcium in the blood, including muscle cramps or spasms and/or numbness or tingling in the fingers or around the mouth.

Nervous system disorders
Common: headache, dizziness
Uncommon: dysgeusia (altered taste)

Eye disorders
Uncommon: blurred vision, eye pain or redness. Eye inflammation
(uveitis, scleritis, episcleritis)

Ear and labyrinth disorders
Common: vertigo
Very rare: Contact your doctor if you experience ear pain, ear discharge and/or ear infection. These episodes may be signs of bone damage in the ear.

Gastrointestinal disorders
Common: abdominal pain, unpleasant sensation in the stomach or belching after meals, constipation, feeling of fullness or bloating in the stomach, diarrhea, flatulence, heartburn, difficulty swallowing, pain when swallowing, ulcers of the esophagus (the channel connecting the mouth to the stomach) causing chest pain, heartburn, or difficulty or pain when swallowing.
Uncommon: nausea, vomiting, irritation or inflammation of the esophagus (the channel connecting the mouth to the stomach) or stomach; black or tarry stools.
Rare: narrowing of the esophagus; ulcers of the mouth when the tablets are chewed or sucked; stomach or peptic ulcers (sometimes severe or with bleeding).

Skin and subcutaneous tissue disorders
Common: alopecia (hair loss), itching
Uncommon: skin rash, erythema
Rare: skin rash worsened by exposure to sunlight, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis

Musculoskeletal and connective tissue disorders
Very common: Musculoskeletal (bone, muscle or joint) pain which is sometimes severe
Common: joint swelling
Rare: pain in the mouth, and/or jaw/mandible, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw/mandible or tooth loss. These phenomena may be signs of damage to the jaw bone (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor or dentist if these phenomena occur.
Not known: Unusual fractures in locations other than the femur.
Rarely, an unusual fracture of the femur may occur, particularly in patients 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 indication of a possible femur fracture.

System disorders
Common: muscle fatigue (asthenia), swelling of the hands or legs (peripheral edema)
Uncommon: flu-like symptoms transiently, such as muscle aches, general feeling of discomfort and sometimes with fever, usually at the beginning of treatment.

Changes in diagnostic tests
Very common: mild and transient decreases in calcium and phosphate levels in the blood, generally within the normal range.
It is good to note any symptoms that may occur, from the time of their onset and their duration.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 NOFRATTIL

Keep NOFRATTIL out of the reach and sight of children
Do not use NOFRATTIL after the expiry date which is reported on the label. The expiry period
refers to the product in intact packaging, correctly stored.
Do not remove the tablets from the blister pack before the time of taking them.
Medicines should not be disposed of via drains or household waste. Ask your phar-
macist how to dispose of medicines you no longer use. This will help protect the environment

6. PACKAGE CONTENTS AND OTHER INFORMATION

What NOFRATTIL contains
Each tablet contains:

Active substance: alendronic acid 70 mg, as alendronate sodium trihydrate.
Other components :

Core: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, sodium stearyl fu-
marate.

Coating: hypromellose, talc.

Description of the appearance of NOFRATTIL and package contents
Film-coated tablets; pack of 4 and 12 tablets

Marketing Authorisation Holder
S.F. GROUP srl
Via Tiburtina, 1143 00156 Rome

Manufacturer
SPECIAL PRODUCT'S LINE SpA
Via Fratta Rotonda Vado Largo, n.1
03012 Anagni (FR)
Laboratorio Chimico Farmaceutico Salentino
S.S. 16 Adriatica - Zona Industriale
73010 Zollino (LE)