Alendran 70

Package Leaflet: Information for the Patient

Alendran 70, 70 mg, Tablets

(Alendronic Acid)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.
• It is very important to read the information in section 3 before taking this medicine.

Table of Contents of the Leaflet:

• 1. What is Alendran 70 and what is it used for
• 2. Important information before taking Alendran 70
• 3. How to take Alendran 70
• 4. Possible side effects
• 5. How to store Alendran 70
• 6. Contents of the pack and other information

1. What is Alendran 70 and what is it used for

What is Alendran 70?

Alendran 70 is a tablet containing the active substance alendronic acid (also known as alendronate), which belongs to a group of non-hormonal medicines called bisphosphonates. Alendran 70 prevents bone loss in postmenopausal women and helps to rebuild bone. It reduces the risk of vertebral and hip fractures.

What is Alendran 70 used for?

Alendran 70 is used to treat osteoporosis. Alendran 70 reduces the risk of vertebral and hip fractures.

Alendran 70 is taken once a week.

What is osteoporosis?

Osteoporosis is a disease in which bones become thinner and weaker. It is common in postmenopausal women. During menopause, the ovaries stop producing the hormone estrogen, which helps to maintain bone strength. As a result, bone mass decreases and bones weaken. The earlier a woman has menopause, the greater the risk of osteoporosis. Osteoporosis usually starts without symptoms. If left untreated, it can lead to bone fractures. Although fractures can be painful, they may not cause pain in the case of vertebral fractures, which can only be noticed when the patient's height decreases. Fractures can occur during daily activities, as a result of lifting or minor injuries that would not affect a healthy bone. Fractures usually occur in the hip, spine, or wrist and can cause not only pain but also significant discomfort, such as a hunched back ("dowager's hump") and loss of mobility.

How can osteoporosis be treated?

During treatment with Alendran 70, your doctor may recommend lifestyle changes that are beneficial for your condition, such as:
quitting smoking:
smoking can contribute to increased bone loss and thus increase the risk of fractures.
exercises:
bones, like muscles, need proper exercise to stay strong and healthy. Before starting exercises, you should consult with your doctor.
proper diet:
your doctor may recommend changing your diet and possibly supplementing it with appropriate preparations (especially calcium and vitamin D supplements).

2. Important information before taking Alendran 70

When not to take Alendran 70:

If any of the above conditions apply to you, do not take the tablets. You should first talk to your doctor and follow their advice.

Warnings and precautions

Before taking Alendran 70, talk to your doctor or pharmacist if:

• you have kidney disease,
• you have had difficulty swallowing or esophageal problems,
• your doctor has diagnosed you with Barrett's esophagus (a disease related to changes in the cells lining the lower part of the esophagus),
• your doctor has informed you that your body has difficulty absorbing minerals in the intestines (malabsorption syndrome),
• you have low calcium levels in your blood,
• you have oral health problems, gum disease, a planned tooth extraction, or you do not follow proper oral hygiene instructions,
• you have cancer,
• you are undergoing chemotherapy or radiotherapy,
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used to treat cancer,
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat asthma, rheumatoid arthritis, and severe allergic reactions,
• you smoke or have smoked (this may increase the risk of dental problems).

A dental examination is recommended before starting treatment with Alendran 70. It is essential to maintain good oral hygiene during treatment with Alendran 70. You should have regular dental check-ups during treatment and contact your doctor or dentist if you experience any oral or dental problems, such as loose teeth, pain, or swelling.

Children and adolescents

Alendran 70 should not be used in children and adolescents under 18 years of age.

Alendran 70 and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take. It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption of Alendran 70 when taken at the same time. Therefore, it is essential to follow the instructions in section 3 "HOW TO TAKE ALENDRAN 70". Some medicines used to treat rheumatic diseases or chronic pain, called non-steroidal anti-inflammatory drugs (e.g., acetylsalicylic acid or ibuprofen), may cause gastrointestinal problems. Therefore, caution should be exercised when taking these medicines with Alendran 70.

Taking Alendran 70 with food and drink

It is likely that food and drinks (including mineral water) will reduce the effectiveness of alendronate if taken at the same time. Therefore, it is essential to follow the instructions in section 3 "HOW TO TAKE ALENDRAN 70".

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Alendran 70 is only intended for postmenopausal women. You should not take Alendran 70 if you are or think you may be pregnant or are breastfeeding.

Driving and using machines

Alendran 70 has been reported to cause side effects (such as vision disturbances, dizziness, and severe bone, muscle, or joint pain) that may affect your ability to drive or use machines (see section 4).

Alendran 70 contains sodium

This medicine contains 25.2 mg of sodium (the main component of common salt) per tablet, which is 1.26% of the maximum recommended daily intake of sodium for adults.

3. How to take Alendran 70

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Take one tablet once a week.

Read the following instructions carefully.

• 1) Choose a day of the week that best fits your schedule. Take one Alendran 70 tablet on the same day every week.

To help the tablet reach your stomach quickly and to reduce the risk of esophageal irritation (the tube that connects your mouth to your stomach), it is very important to follow these instructions:

• 2) After getting up in the morning of your designated day, before eating, drinking, or taking any other medicine, swallow your Alendran 70 tablet with a full glass of plain water (not less than 200 ml) to help the tablet reach your stomach quickly.
• Do not drink mineral water (still or sparkling).
• Do not drink coffee or tea.
• Do not drink fruit juices or milk.

Do not crush, chew, or allow the tablet to dissolve in your mouth, as this may cause mouth ulcers.

• 3) After swallowing the tablet, do not lie down – stay upright (sitting, standing, or walking) for at least 30 minutes. Do not lie down until after your first food of the day.
• 4) Do not take Alendran 70 at bedtime or before getting up in the morning.
• 5) If you experience difficulty or pain when swallowing, chest pain, or new or worsening heartburn, stop taking the medicine and contact your doctor immediately.
• 6) After taking the Alendran 70 tablet, wait at least 30 minutes before eating, drinking, or taking any other medicine, including antacids, calcium, and vitamin supplements. Alendran 70 is only effective when taken on an empty stomach.

Taking more than the recommended dose of Alendran 70

If you accidentally take too many tablets, drink a full glass of milk and contact your doctor immediately. Do not induce vomiting or lie down.

Missing a dose of Alendran 70

If you miss a dose, take one tablet the next morning after you remember. Do not take two tablets on the same day. Return to your original schedule of taking one tablet once a week on the day you chose.

Stopping treatment with Alendran 70

It is essential to take Alendran 70 for as long as your doctor prescribes it. Since it is not known how long you should take Alendran 70, you should discuss the need to continue taking this medicine with your doctor periodically to ensure it is still right for you. A card with instructions is included with the Alendran 70 package. It contains important information on how to take Alendran 70 properly. If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Alendran 70 can cause side effects, although not everybody gets them. You should contact your doctor immediatelyif you experience any of the following side effects, which may be serious and require urgent medical attention:

• frequent (may affect up to 1 in 10 people): heartburn; difficulty swallowing; pain when swallowing; esophageal ulcers, which may cause chest pain, heartburn, difficulty swallowing, or pain when swallowing.

rare (may affect up to 1 in 1000 people):

• allergic reactions such as hives; swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing; severe skin reactions.
• pain in the mouth, jaw pain, swelling, or ulcers in the mouth, feeling of numbness or heaviness in the jaw or mouth, or loosening of teeth. These may be symptoms of jawbone damage (necrosis) usually associated with delayed healing and infection, often after tooth extraction. If you experience any of these symptoms, contact your doctor and dentist.
• atypical fractures of the thigh bone, especially in patients treated for osteoporosis for a long time. You should contact your doctor if you experience pain, weakness, or discomfort in the thigh, hip, or groin area, as this may be an early sign of a possible fracture of the thigh bone.
• severe bone, muscle, and/or joint pain.

Other side effects include

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

• bone, muscle, and/or joint pain, sometimes severe.

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

• joint swelling,
• stomach pain, discomfort in the stomach, or bloating after eating; constipation; gas; feeling full after eating; diarrhea, bloating,
• hair loss, itching,
• headache, dizziness,
• weakness, swelling of the arms or legs.

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

• nausea, vomiting,
• irritation or inflammation of the esophagus or stomach,
• black or tarry stools,
• vision disturbances, eye pain, and redness,
• rash, skin redness,
• flu-like symptoms, such as muscle pain, general feeling of being unwell, sometimes with fever at the start of treatment,
• taste disturbances.

rare (may affect up to 1 in 1000 people):

• symptoms of low calcium levels in the blood, including muscle cramps and/or tingling in the fingers or around the mouth,
• stomach or duodenal ulcers (sometimes severe or with bleeding),
• esophageal narrowing,
• skin rash that worsens with sunlight,
• mouth ulcers.

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Poland, tel.: 22 49 21 301, fax: 22 49 21 309, e-mail: [email protected]. You can also report side effects to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Alendran 70

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month. Store in the original package. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Alendran 70 contains

The active substance is alendronic acid. One film-coated tablet contains 70 mg of alendronic acid (equivalent to 76.188 mg of anhydrous sodium alendronate). The other ingredients are mannitol, croscarmellose sodium type A, magnesium stearate, talc, and anhydrous colloidal silica.

What Alendran 70 looks like and contents of the pack

The tablets are white to almost white, round, and marked with the letter "A" on one side and the number "4" on the other side. They are packaged in blisters of 4, 8, and 12 tablets. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o., ul. Kubickiego 11, 02-954 Warsaw, Poland

Manufacturer

Alkaloida Chemical Company Zrt., Kabay János u. 29, H-4440 Tiszavasvári, Hungary; Sun Pharmaceutical Industries Europe B.V., Polarisavenue 87, 2132 JH, Hoofddorp, Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium: Alendromono 70mg tabletten; Germany: Alendronsäure Basics einmal wöchentlich 70 mg Tabletten; Italy: Alendronato SUN 70 mg compresse; Spain: Ácido Alendrónico Semanal SUN 70mg comprimidos EFG

Date of last revision of the leaflet:09.04.2020