Alendronate acid Zentiva

Package leaflet: Information for the patient

ACIDO ALENDRONICO ZENTIVA 70 mg tablets

Equivalent 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, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 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

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

Acido Alendronico Zentiva contains the active substance sodium alendronate 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 bones that occurs in women after menopause (postmenopausal osteoporosis) and reduces the risk of spinal and hip fractures.
In addition to treatment with Acido Alendronico Zentiva, your doctor may suggest certain lifestyle changes to help relieve your condition, 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 bone strength and health. Before starting an exercise programme, consult your doctor.
• Balanced diet: Your doctor can give you dietary advice or confirm whether you need to take nutritional supplements (especially calcium and vitamin D).

2. What you need to know before taking Alendronate Acid Zentiva

Do not take Alendronate Acid Zentiva

• if you are allergic to sodium alendronate trihydrate 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 (stenosis), difficulty swallowing, or regurgitation of food (achalasia);
• if you have difficulty standing or sitting upright for at least 30 minutes;
• if you have low levels of calcium in your blood (hypocalcaemia);
• if you have severe renal impairment.

Warnings and precautions
Talk to your doctor or pharmacist before taking Alendronate Acid Zentiva.
Take this medicine with caution and inform your doctor if any of the following apply to you:

• if you have kidney problems (impaired renal function);
• if you have difficulty swallowing (dysphagia);
• if you currently have or have previously had problems with your oesophagus or digestive system (oesophageal disease, gastritis, duodenitis, ulcers, peptic ulcer, or active gastrointestinal bleeding), or if you have recently undergone surgery on your oesophagus or stomach;
• if you have a specific oesophageal condition known as Barrett’s oesophagus (a disease associated with changes in the cells lining the lower part of the oesophagus);
• if you have cancer and are receiving chemotherapy or radiotherapy;
• if you are taking corticosteroid anti-inflammatory medicines 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), or if you need to undergo dental procedures (invasive dental procedures);
• if you have poor oral hygiene or poorly fitting dentures;
• if you have low levels of calcium in your blood (hypocalcaemia) or low levels of vitamin D;
• if you have thyroid problems (hypoparathyroidism).

During treatment with alendronate, jaw problems (affecting the maxilla or mandible) may occur, usually in patients with cancer, often following 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 Alendronate Acid Zentiva, have a dental check-up. It is important to maintain good oral hygiene during treatment with Alendronate Acid Zentiva. 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 loose teeth, pain, or swelling.
Stop taking the medicine and contact your doctor if, during treatment, you develop irritation, inflammation, or ulceration of the oesophagus (i.e. the tube connecting the mouth to the stomach), often accompanied by symptoms such as chest pain or difficulty or pain when swallowing, especially if you do not drink a full glass of water and/or lie down within 30 minutes after taking the medicine. These side effects may worsen if patients continue taking Alendronate Acid Zentiva after these symptoms appear.
Be cautious if you are taking this medicine, as femoral fractures may occur. If you experience any pain in your thigh, hip, or groin, contact your doctor immediately, as this may be due to an incomplete femoral fracture.

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

Other medicines and Alendronate Acid Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Before taking any other medicine together with Alendronate Acid Zentiva, it is important to read section 3 “How to take Alendronate Acid Zentiva”.
Wait at least 30 minutes after taking Alendronate Acid Zentiva before taking any other medicine.
Take this medicine with caution and inform your doctor if you are taking:

• calcium supplements and medicines for stomach acidity (antacids);
• corticosteroid anti-inflammatory medicines used to relieve pain and allergies (corticosteroids);
• medicines used to treat inflammation and pain known as non-steroidal anti-inflammatory drugs (NSAIDs).

Pregnancy and breastfeeding
Alendronate Acid Zentiva is intended for use only in postmenopausal women.
Do not take Alendronate Acid Zentiva if you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding.

Driving and using machines
This medicine may affect your ability to drive or operate machinery. Avoid driving if you experience any of the following side effects: blurred vision, dizziness, or severe bone, muscle, or joint pain.

Alendronate Acid 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 or her before taking this medicine.

3. How to take Alendronic Acid Zentiva

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Your doctor will determine the dose and duration of treatment based on your health condition.
The recommended dose is 1 tablet of 70 mg once a week.
Instructions for use
Follow the instructions below to reduce the risk of irritation of the oesophagus (the tube connecting the mouth to the
stomach).

• Choose a day of the week that best fits your routine. Take one tablet of Alendronic Acid Zentiva once a week, always on the chosen day.
• Swallow the tablet whole with a full glass (not less than 200 ml) of tap water (not mineral water) in the morning after getting up 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, chew, or allow the tablet to dissolve in the mouth.
• After taking the tablet, do not lie down; 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 Alendronic Acid Zentiva immediately before going to bed or before getting up in the morning.
• After swallowing the tablet, wait at least 30 minutes before eating, drinking, or taking any other medicines, including antacids, calcium supplements, or vitamins. Alendronic Acid Zentiva is effective only when taken on an empty stomach.

It is important to continue taking Alendronic Acid Zentiva for as long as prescribed by your doctor. Alendronic
Acid Zentiva is effective in treating osteoporosis only if the tablets are taken regularly as directed.
If you take more Alendronic Acid Zentiva than you should
If you accidentally take too much of this medicine, contact your doctor or the nearest hospital immediately.
Drink a full glass of milk or take antacids that bind to alendronate sodium trihydrate, thereby blocking its activity. Due to the risk of oesophageal irritation, do not induce vomiting and remain in a fully upright position.
In case of overdose, the following symptoms may occur: decreased levels of calcium and phosphate in the blood, stomach problems, heartburn, inflammation of the upper digestive tract (oesophagitis), inflammation of the stomach lining with pain, nausea, vomiting, loss of appetite, belching or bloating (gastritis), or an open sore developing in the internal mucosa of the gastrointestinal tract, possibly leading to vomiting of blood and/or blood in the stools (ulcer).
If you forget to take Alendronic Acid Zentiva
If you forget to take a tablet, take it the following morning.
Do not take a double dose to make up for the missed tablet. Instead, return to your usual weekly dosing schedule on your pre-established day.
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.
The following side effects may also occur:

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

• pain in muscles, bones or joints.

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

• headache, dizziness;
• vertigo;
• stomach pain (abdominal pain), constipation;
• diarrhoea, gas in the stomach (bloating and flatulence);
• digestive problems (dyspepsia/heartburn);
• oesophageal problems and difficulty swallowing (oesophageal ulcer and dysphagia);
• abdominal distension, acid regurgitation;
• hair loss (alopecia);
• itching (pruritus);
• joint swelling;
• muscle weakness (asthenia);
• swelling of the hands and feet due to fluid retention (peripheral oedema).

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

• disturbance of taste sensation (dysgeusia);
• blurred vision, inflammation and redness of the eyes (uveitis, scleritis, episcleritis);
• nausea and vomiting;
• irritation or inflammation of the oesophagus and stomach (gastritis, oesophagitis, oesophageal erosions);
• dark or black stools due to 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 may cause breathing and swallowing difficulties (angioedema);
• decreased levels of calcium in the blood (hypocalcaemia) and related disorders such as muscle cramps, spasms and tingling sensations 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 and intestinal ulcers (sometimes with perforation or bleeding);
• skin irritation worsened by exposure to sunlight, severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis;
• mouth, jaw or chin pain, swelling or sores inside the mouth, tooth loss. These may be signs of damage to the jawbone (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 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 femoral fracture.

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

• Consult your doctor if you experience ear pain, ear drainage, and/or ear infection. These events could be signs of bone damage in the ear.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via 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 stated on the carton and blister after “EXP.”.
The expiry date refers to the last day of that month.
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 Acido Alendronico Zentiva contains

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

Description of the appearance of Acido Alendronico Zentiva and contents of the pack
The tablets are oblong, white or almost white in colour.
Each pack contains 4 tablets in a blister pack.
Marketing Authorization Holder
Zentiva Italia S.r.l. – Viale L. Bodio n. 37/b, 20158 Milan
Manufacturer
Doppel Farmaceutici S.r.l - Via Volturno 48, Quinto de Stampi (Rozzano) - Milan