Nofrattil
ItalyTable of Contents
PACKAGE LEAFLET: INFORMATION FOR THE USER
NOFRATTIL 70 mg film-coated tablets
Alendronic acid
Generic medicine
Read this entire 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 personally. Never give it to others. It could be harmful to other people, even if their symptoms are the same as yours.
- If any of the side effects worsen, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Contents of this leaflet:
- What NOFRATTIL is and what it is used for
- What you need to know before taking NOFRATTIL
- How to take NOFRATTIL
- Possible side effects
- How to store NOFRATTIL
- Contents of the pack and other information
1. WHAT NOFRATTIL IS AND WHAT IT IS USED FOR
What is NOFRATTIL?
NOFRATTIL contains the active substance Acidum alendronicum (alendronic acid), which belongs to a group of medicines called bisphosphonates.
NOFRATTIL prevents bone tissue loss (osteoporosis) that occurs in women after menopause and promotes bone rebuilding. It reduces the risk of vertebral and hip fractures.
What is NOFRATTIL used for?
NOFRATTIL is used for the treatment of osteoporosis occurring in women after menopause and reduces the risk of vertebral and hip fractures.
NOFRATTIL is a treatment to be taken once a week.
What is osteoporosis?
Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause because the ovaries stop producing female hormones, 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.
Spinal bone fractures may be painful but often go unnoticed until they cause a decrease in height.
Fractures can occur during everyday activities such as lifting heavy objects, or following minor injuries that would not cause fractures in a normal bone. Fractures typically occur in the spine, hip, or wrist and can not only be painful but may also lead to significant deformities and disability.
How can osteoporosis be treated?
It is important to remember that osteoporosis can be treated and it is never too late to start. NOFRATTIL not only prevents bone tissue loss but also helps rebuild bone that may have been lost and reduces the risk of vertebral and hip fractures.
Along with treatment with NOFRATTIL, 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 program.
Balanced diet – your doctor can provide information about diet or the possible need for dietary supplements (especially calcium and vitamin D).
2. WHAT YOU SHOULD KNOW BEFORE TAKING NOFRATTIL
Do not take NOFRATTIL
- If you are allergic to alendronate sodium trihydrate or any of the other ingredients of this medicine.
- If you have problems with your oesophagus (the tube connecting the mouth to the stomach), such as strictures or 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 have or have had difficulty swallowing or gastrointestinal disorders (oesophageal disease, gastritis, duodenitis, ulcers, peptic ulcer, or active gastrointestinal bleeding), or if you have recently undergone surgery on the oesophagus or stomach.
- 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 malabsorption 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 being treated with glucocorticoids.
- You have thyroid problems (hypoparathyroidism).
- You have poor dental health, dental or gum problems, are scheduled for a tooth extraction, or do not have regular dental check-ups.
- You have undergone invasive dental procedures.
- You are scheduled for dental surgery.
- You wear dentures (false teeth) that fit poorly.
- You have cancer or are undergoing chemotherapy and radiotherapy.
- You are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in cancer treatment.
- You are taking corticosteroids (such as prednisone or dexamethasone).
- You are a smoker or have smoked in the past.
During treatment with alendronate, jaw or mandible problems may occur, usually in patients with cancer, often following tooth extraction and/or local infection. Many of these patients were also receiving 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 to have regular dental check-ups during treatment with bisphosphonates.
Inform your doctor of any oral symptoms such as loose teeth, pain or swelling.
Irritation, inflammation or ulceration of the oesophagus may occur, often with symptoms such as chest pain, burning 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 NOFRATTIL. These side effects may worsen if patients continue taking NOFRATTIL after experiencing such symptoms. If you notice any of the above-mentioned side effects, stop taking the medicine and consult your doctor immediately.
In patients treated with alendronate for long periods, femoral fractures (with or without minor trauma) have been reported (stress fractures).
If you experience pain, weakness or discomfort in your leg, hip or groin, inform your doctor immediately, 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 NOFRATTIL.
In patients treated with bisphosphonates, including alendronate, cases of bone, joint and/or muscle pain have been reported, which in rare cases have been severe and disabling. The onset of symptoms has varied from one day to several months after starting treatment. In most patients, discontinuation of treatment led to symptom relief.
Other medicines and NOFRATTIL
Inform 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 provided in section 3. HOW TO TAKE NOFRATTIL.
Take this medicine with caution and inform your doctor, especially if you are taking:
- Calcium supplements and antacids may alter the effect of alendronate if taken with alendronic acid.
- NSAIDs (ibuprofen, aspirin) may cause gastrointestinal problems if taken with alendronic acid.
NOFRATTIL with food and drink
Foods and beverages (including mineral water) may reduce 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 must not be given to children and adolescents under 18 years of age.
Fertility, pregnancy and breastfeeding
NOFRATTIL is intended only for postmenopausal women. Do not take NOFRATTIL if you are pregnant or think you may be pregnant, if you are planning a pregnancy, or if you are breastfeeding.
Driving and using machines
Undesirable effects have been reported with NOFRATTIL (e.g. blurred vision, dizziness, and severe bone, muscle or joint pain) which may impair the ability to drive or operate machinery (see section 4).
NOFRATTIL contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.
3. HOW TO TAKE NOFRATTIL
Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is one tablet of NOFRATTIL once a week.
To obtain benefit from treatment with NOFRATTIL, it is necessary to follow the instructions below.
It is very important to follow these instructions to help ensure the rapid passage of the NOFRATTIL tablet into the stomach and to help reduce the possibility of irritating the oesophagus (the tube connecting the mouth to the stomach).
- Choose the day of the week that best fits your routine. Take NOFRATTIL once a week on the chosen day.
- After getting up in the morning and before taking any food, drink, or other medication, swallow the NOFRATTIL tablet whole with a full glass of tap water (not less than 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.
The NOFRATTIL tablet must be swallowed whole. Do not crush, chew, or allow the tablet to dissolve in the mouth.
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 you have eaten something.
4) After swallowing the NOFRATTIL tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines of the day, including antacids, calcium supplements, and vitamins. NOFRATTIL is effective only when taken on an empty stomach.
5) NOFRATTIL must not be taken at bedtime or before getting up in the morning.
6) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn or upper stomach pain, stop taking NOFRATTIL and contact your doctor immediately.
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 the missed dose.
If you forget to take the tablet, simply take one NOFRATTIL tablet the following morning. DO NOT take two tablets on the same day.
Afterwards, resume taking the tablet on your 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 effective in the treatment of osteoporosis only if you continue taking the tablets.
If you have any questions about how to use this medicine, ask your doctor or pharmacist.
4. POSSIBLE ADVERSE EFFECTS
Like all medicines, NOFRATTIL can cause adverse effects, although not everyone experiences them.
The frequency of occurrence of adverse effects has been defined as follows:
Very common (occur in at least 1 out of 10 treated patients)
Common (occur in at least 1 out of 100 and less than 1 out of 10 treated patients)
Uncommon (occur in at least 1 out of 1,000 and less than 1 out of 100 treated patients)
Rare (occur in at least 1 out of 10,000 and less than 1 out of 1,000 treated patients)
Very rare (occur in less than 1 out of 10,000 patients)
Not known: (frequency cannot be estimated from the available data)
Immune system disorders
Rare: allergic reactions such as urticaria, swelling of the face, lips, tongue and/or throat, possibly causing difficulty in breathing or swallowing.
Metabolism and nutrition disorders
Rare: symptoms due to low calcium levels in the blood, including muscle cramps or spasms and/or tingling sensations 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 could be signs of bone damage in the ear.
Gastrointestinal disorders
Common: abdominal pain, stomach discomfort or belching after meals, constipation, bloating or fullness in the stomach, diarrhoea, flatulence, heartburn, difficulty swallowing, pain when swallowing, oesophageal ulcers (the tube connecting the mouth to the stomach), causing chest pain, heartburn or difficulty or pain when swallowing.
Uncommon: nausea, vomiting, irritation or inflammation of the oesophagus (the tube connecting the mouth to the stomach) or stomach; black or tarry stools.
Rare: narrowing of the oesophagus; mouth ulcers when tablets are chewed or sucked; stomach or peptic ulcers (sometimes severe or with bleeding).
Skin and subcutaneous tissue disorders
Common: alopecia (hair loss), pruritus (itching)
Uncommon: 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 pain (bone, muscle or joint pain), sometimes severe
Common: joint swelling
Rare: mouth pain and/or jaw/mandible, swelling or sores inside the mouth, numbness or heaviness in the jaw/mandible, or tooth loss. These events 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 events occur.
Not known: Unusual fractures occurring at sites other than the femur.
Rarely, an unusual femur fracture may occur, particularly in patients receiving long-term treatment for osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in the thigh, hip or groin, as this may be an early sign of a possible femur fracture.
General disorders
Common: muscle fatigue (asthenia), swelling of the hands or legs (peripheral oedema)
Uncommon: transient flu-like symptoms such as muscle pain, general feeling of discomfort, and sometimes fever, usually at the beginning of treatment.
Investigations
Very common: mild and transient decreases in blood calcium and phosphate levels, generally within normal limits.
It is advisable to note any symptoms that may occur, including when they start and how long they last.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report adverse effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting adverse 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 stated on the label. The shelf life refers to the product in its original, unopened packaging, correctly stored.
Do not remove the tablets from the blister pack until the time of taking.
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. PACK 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, croscarmellose sodium, anhydrous colloidal silica, sodium stearyl fumarate.
Coating: hypromellose, talc.
Description of the appearance of NOFRATTIL and pack contents
Film-coated tablets; pack sizes of 4 and 12 tablets.
Marketing Authorization 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)