ACIDO 70 mg Коированная Таблетка

Содержание инструкции

1. ACIDO ALENDRONICO ZENTIVA 70 mg tablets
   1. What is Acido Alendronico Zentiva and what is it used for
   2. What you need to know before taking Acido Alendronico Zentiva
   3. How to take Acido Alendronico Zentiva
   4. Possible side effects
   5. How to store Acido Alendronico Zentiva
   6. Contents of the pack and other information

ACIDO ALENDRONICO ZENTIVA 70 mg tablets

Generic medicine

Read 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Acido Alendronico Zentiva and what is it used for

Acido Alendronico Zentiva contains the active ingredient alendronic acid sodium trihydrate, which belongs to a
group of medicines called bisphosphonates, used for the treatment of bone diseases that occur
in women after menopause.
This medicine prevents the weakening of the bones that occurs in women after menopause
(postmenopausal osteoporosis) and reduces the risk of vertebral and hip fractures.
In addition to treatment with Acido Alendronico Zentiva, your doctor may suggest some lifestyle changes to alleviate your symptoms, such as:

• Stop smoking:Smoking appears to increase the rate of bone loss and therefore possibly also the risk of fractures.
• Physical activity:As with muscles, exercise is also necessary for the strength and health of bones. Consult your doctor before starting an exercise program.
• Balanced diet:Your doctor can give you advice on diet or confirm whether it is necessary to take food supplements (especially calcium and vitamin D).

2. What you need to know before taking Acido Alendronico Zentiva

Do not take Acido Alendronico Zentiva

• if you are allergic to alendronic acid trihydrate sodium or to any of the other ingredients of this medicine (listed in section 6);
• if you have problems with your esophagus (the tube connecting your mouth to your stomach) such as narrowing (stenosis), difficulty swallowing and regurgitation of food (achalasia);
• if you have difficulty remaining upright or sitting and keeping your torso straight (erect) for at least 30 minutes;
• if you have low levels of calcium in your blood (hypocalcemia).
• if you suffer from severe kidney failure

Warnings and precautions
Consult your doctor or pharmacist before taking Acido Alendronico Zentiva.
Take this medicine with cautionand inform your doctor in the following cases:

• if you have kidney problems (impaired renal function);
• if you have difficulty swallowing (dysphagia);
• if you suffer from or have suffered from problems with the esophagus and digestive tract (esophageal disease, gastritis, duodenitis, ulcers, peptic ulcer or active gastrointestinal bleeding) or if you have recently undergone surgery on the esophagus or stomach;
• if you suffer from a particular disease of the esophagus known as Barrett's esophagus (a disease associated with changes in the cells that line the lower part of the esophagus);
• if you have cancer and are undergoing chemotherapy and radiotherapy;
• if you are taking anti-inflammatory corticosteroids used to relieve pain and allergies (corticosteroids);
• if you smoke or have been a smoker (as this may increase the risk of dental problems);
• if you have dental or gum problems (dental diseases, periodontal disease) and if you need to undergo dental treatment (invasive dental procedures);
• if you have poor oral hygiene or dentures with poor adhesion;
• if you have low levels of calcium in your blood (hypocalcemia) and low levels of vitamin D;
• if you suffer from thyroid problems (hypoparathyroidism).

During the use of alendronate, problems with the jaw or mandible may occur, generally
in patients affected by cancer, often after dental extractions and/or local infection. Many of these
patients were also being treated with chemotherapy and corticosteroids and were smokers.
Before starting treatment with Acido Alendronico Zentiva, have a dental check-up. It is
important to maintain good oral hygiene during treatment with Acido Alendronico Zentiva. You should
undergo regular dental check-ups throughout the entire treatment and contact your doctor or dentist
if you experience problems with your mouth or teeth, such as loose teeth, pain or swelling.

Stop taking the medicine and consult your doctorif, during treatment, you notice the appearance
of irritation, inflammation or ulceration of the esophagus (i.e. the tube connecting the mouth to the stomach),
often with symptoms such as chest pain or difficulty or pain when swallowing, especially if patients
do not drink a full glass of water and/or lie down before 30 minutes have passed after taking the
medicine. These undesirable effects may worsen if patients continue to take Acido
Alendronico Zentiva even after the appearance of these symptoms.
Be careful if you need to use this medicine because fractures of the femur may occur. If you notice
any pain in the thigh, hip or groin inform your doctor immediatelyas this may
be due to an incomplete fracture of the femur.

Children and adolescents
This medicine should not be used in children and adolescents under 18 years of age.

Other medicines and Acido Alendronico Zentiva
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.

Before taking any other medicine at the same time as Acido Alendronico Zentiva it is
important to read section 3 “How to take Acido Alendronico Zentiva”.
Wait at least 30 minutes after taking Acido Alendronico Zentiva before taking any
other medicine.
Take this medicine with cautionand inform your doctor if you are taking:

• calcium supplements and medicines to treat heartburn (antacids);
• anti-inflammatory corticosteroids used to relieve pain and allergies (corticosteroids);
• medicines used to fight inflammation and pain called non-steroidal anti-inflammatory drugs (NSAIDs).

Pregnancy and breastfeeding
Acido Alendronico Zentiva is intended for use exclusively in post-menopausal women.
Do not take Acido Alendronico Zentiva if you are pregnant, if you think you may be, if you are planning a
pregnancy or if you are breastfeeding your baby.

Driving and operating machinery
This medicine may impair your ability to drive vehicles or operate machinery. Avoid driving if you experience
blurred vision, dizziness, severe bone, muscle or joint pain.

Acido Alendronico Zentiva contains lactose
This medicine contains lactose, a type of sugar. If your doctor has diagnosed you with an intolerance to
certain sugars, contact him before taking this medicine.

3. How to take Acido Alendronico Zentiva

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The doctor will decide the dose and duration of treatment based on your health conditions.
The recommended doseis 1 tablet of 70 mg once a week.
Method of administration
Follow these instructions to reduce the risk of irritation of the esophagus (the channel that connects the mouth to the
stomach).

• Choose the day of the week that best suits your schedule. Take one tablet of Acido Alendronico Zentiva once a week, always on the chosen day.
• Take the tablet whole, with a large glass (at least 200 ml) of tap water (not mineral water), in the morning after getting out of bed and at least 30 minutes before eating, drinking, or taking any other medicine.
• Do not take it with mineral water (still or sparkling)
• Do not take it with tea or coffee
• Do not take it with fruit juices or milk
• Do not crush or chew the tablet and do not let it dissolve in your mouth.
• After you have taken the tablet DO NOT lie down, instead remain in an upright position (sitting, standing or walking) for at least 30 minutes and do not lie down until you have eaten something.
• DO NOT take Acido Alendronico Zentiva before bedtime or before getting up in the morning.
• After swallowing the tablet, wait at least 30 minutes before eating, drinking or taking other medicines of the day, including antacids, calcium supplements and vitamins. Acido Alendronico Zentiva is only effective when taken on an empty stomach.

It is important to continue taking Acido Alendronico Zentiva as long as prescribed by your doctor. Acido
Alendronico Zentiva is effective for the treatment of osteoporosis only if you continue to take the
tablets.

If you take more Acido Alendronico Zentiva than you should
In case of ingestion of an excessive amount of this medicine, immediately contact your doctor or
the nearest hospital.
Drink a full glass of milk or take antacids that bind to sodium alendronate trihydrate, blocking its
activity. Due to the risk of esophageal irritation, do not induce vomiting and remain in an
completely upright position.
In case of overdose, the following symptoms may occur: decreased levels of calcium and phosphate
in the blood, stomach disorders, heartburn, inflammation of the upper digestive tract
(esophagitis), inflammation of the stomach wall with pain, nausea, vomiting, decreased
appetite, eructation or bloating (gastritis) or an open wound that develops on the inner lining of the gastrointestinal tract with possible appearance of vomiting blood and/or blood in the stool (ulcer).

If you forget to take Acido Alendronico Zentiva
If you forget to take a tablet, take it the next morning.
Do not take a double dose to make up for the missed tablet, but return to the usual
taking of one tablet a week, on the scheduled day.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may also occur:

Very common(may affect more than 1 in 10 people):

• muscle, bone or joint pain.

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

• headache and dizziness;
• vertigo;
• stomach pain (abdominal pain), constipation;
• diarrhoea, gas in the stomach (bloating and flatulence);
• digestive problems (dyspepsia/heartburn);
• problems with the esophagus and difficulty swallowing (esophageal ulcer and dysphagia);
• abdominal distension, acid reflux;
• hair loss (alopecia);
• itching;
• swelling of the joints;
• muscle fatigue (asthenia);
• swelling of the hands and legs due to fluid retention (peripheral edema).

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

• taste disturbance (dysgeusia);
• blurred vision, inflammation and redness of the eyes (uveitis, scleritis, episcleritis);
• nausea and vomiting;
• irritation or inflammation of the esophagus and stomach (gastritis, esophagitis, esophageal erosions);
• dark or black stools due to the presence of blood (melena);
• skin inflammation (rash and erythema);
• muscle pain (myalgia), fever especially at the beginning of treatment;
• general malaise especially at the beginning of treatment.

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

• allergic reactions (hypersensitivity) including hives and swelling of the tongue, larynx and throat which can cause breathing and swallowing problems (angioedema);
• decreased levels of calcium in the blood (hypocalcemia) and disturbances such as muscle cramps, spasms and tingling in the fingers or around the mouth;
• narrowing of the esophagus (the channel connecting the mouth to the stomach);
• mouth ulcers when the tablets are chewed or sucked; ulcers of the stomach and intestines (sometimes with perforation or bleeding);
• skin irritation worsened by exposure to sunlight, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis;
• pain in the mouth, jaw or mandible, swelling or sores inside the mouth, tooth loss. These may be signs of damage to the jaw/mandible bone (osteonecrosis) generally associated with delayed healing and infection, often following tooth extraction. Contact your doctor or dentist if you experience these symptoms;
• femur fracture, 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 may be an early indication of a possible femur fracture.

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

• Contact your doctor if you have ear pain, ear discharge and/or an ear infection. These episodes may be signs of bone damage in the ear.

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 www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Acido Alendronico Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the box and blister after “EXP.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acido Alendronico Zentiva contains

• The active ingredient is alendronic acid sodium trihydrate. Each tablet contains 91.37 mg of alendronic acid sodium trihydrate equivalent to 70 mg of alendronic acid.
• The other ingredients are: microcrystalline cellulose, anhydrous lactose, sodium croscarmellose, magnesium stearate.

Description of the appearance of Acido Alendronico Zentiva and contents of the pack
The tablets are oblong in shape and white or almost white in color.
Each pack contains 4 tablets in blisters.

Marketing Authorisation Holder
Zentiva Italia S.r.l. – Viale L. Bodio n. 37/b, 20158 Milano

Manufacturer
Doppel Farmaceutici S.r.l - Via Volturno 48, Quinto de Stampi (Rozzano) - Milano