RISEDRONATE SEMANAL TECNIGEN 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Risedronate Weekly TecniGen 35 mg film-coated tabletsEFG

Sodium risedronate

Read all of this leaflet carefully before you start taking this medicine.

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack:

1. What is Risedronate Weekly TecniGen and what is it used for
2. Before taking Risedronate Weekly TecniGen
3. How to take Risedronate Weekly TecniGen
4. Possible side effects
5. Storage of Risedronate Weekly TecniGen

1. Additional information

1. What is Risedronate Weekly TecniGen and what is it used for

What is Risedronate Weekly TecniGenRisedronate Weekly TecniGen 35 mg belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It acts directly on the bones, strengthening them, and thus reduces the likelihood of fractures.

Bone is a living tissue. Old bone in the skeleton is constantly being renewed and replaced by new bone.

Postmenopausal osteoporosis occurs in women after menopause when the bone begins to weaken, becomes more fragile, and fractures are more likely after a fall or twist.

Osteoporosis can also affect men due to various causes, including aging and/or low levels of the male hormone, testosterone.

The most likely bone fractures are those of the vertebrae, hip, and wrist, although they can occur in any bone in the body. Fractures associated with osteoporosis can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

What is Risedronate Weekly TecniGen used for

Risedronate is used to treat osteoporosis in postmenopausal women and reduces the risk of fractures.

It is also used to treat osteoporosis in men with a high risk of fracture.

2. Before taking Risedronate Weekly TecniGen

Do not takeRisedronate Weekly TecniGen:

• if you are allergic (hypersensitive) to sodium risedronate or any of the other ingredients of this medicine (see section 6),
• if your doctor has told you that you have a disease called hypocalcemia (you have low calcium levels in your blood),
• if you may be pregnant or plan to become pregnant,
• if you are breastfeeding,
• if you have severe kidney disease.

Take special care and talk to your doctor before taking Risedronate Weekly TecniGen

• if you cannot sit or stand for at least 30 minutes,
• if you have bone problems or mineral metabolism problems (e.g., vitamin D deficiency, parathyroid hormone disorders) that may cause low calcium levels in your blood,

• if you have had problems in your esophagus (the tube that connects your mouth to your stomach) in the past. For example, you may have had pain or difficulty swallowing food, or you have been told that you have Barrett's esophagus (a disease associated with changes in the cells that line the lower part of your esophagus).
• if you have gastritis
• if your doctor has told you that you have an intolerance to certain sugars (such as lactose),
• if you have had or have pain, inflammation, or numbness of the jaw, jaw pain, or tooth loss,
• if you are undergoing dental treatment or are going to have dental surgery, inform your dentist that you are being treated with sodium risedronate.

If you have any of the above problems, inform your doctor BEFORE taking this medicine.

Using other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.

Few medicines are known to interfere with the effects of sodium risedronate.

Medicines that contain any of the following substances reduce the effect of sodium risedronate when taken at the same time:

• calcium
• magnesium
• aluminum
• iron

Take these medicines at least 30 minutes after taking sodium risedronate.

Sodium risedronate can be used in conjunction with estrogen supplements (in women).

TakingRisedronate Weekly TecniGenwith food and drinks

It is very important that you DO NOT take Risedronate Weekly TecniGen 35 mg with food or drinks (other than water). In particular, do not take this medicine at the same time as dairy products (such as milk) as they contain calcium (see section 2).

DO NOT consume food, drinks (except water), or other medicines for at least 30 minutes after taking Risedronate Weekly TecniGen.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Do not take sodium risedronate if you may be pregnant or plan to become pregnant (see section 2).

Do not take sodium risedronate if you are breastfeeding (see section 2).

Sodium risedronate can only be used in postmenopausal women.

Driving and using machines

Risedronate Weekly TecniGen 35 mg does not affect your ability to drive or use machines.

Important information about some of the ingredients ofRisedronate Weekly TecniGen 35 mg

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Risedronate Weekly TecniGen

Follow the instructions for taking Risedronate Weekly TecniGen exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose is one Risedronate Weekly TecniGen 35 mg tablet (35 mg of sodium risedronate) once a week.

Choose the day of the week that best suits your schedule. Each week, take the Risedronate Weekly TecniGen 35 mg tablet on the chosen day.

To facilitate taking the tablet on the same day each week, there are boxes on the package. Mark the day of the week you have chosen to take the Risedronate Weekly TecniGen tablet. Also, write down the dates you will take the tablet.

Elderly

No dose adjustments are required.

Patients with kidney problems

No dose adjustments are required if you have mild to moderate kidney function impairment. If you have severe kidney function impairment, you should not use Risedronate Weekly TecniGen 35 mg.

ChildrenDo not recommend the use of Risedronate Weekly TecniGen 35 mg in children and adolescents.

When to take your Risedronate Weekly TecniGen 35 mg tablet:

Take the risedronate tablet at least 30 minutes before the first meal, drink of the day (except if this drink is plain water) or other medicine of the day.

How to take your Risedronate Weekly TecniGen 35 mg tablet:

• Take the tablet while standing or sitting upright. This prevents heartburn (a burning sensation in the throat).
• Swallow the tablet with at least one glass (120 ml) of plain water. It is very important that you DO NOT take Risedronate Weekly TecniGen 35 mg with food or drinks (except if this drink is plain water), so it can work properly.
• Swallow the tablet whole. Do not chew or suck the tablet.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will tell you if you should take calcium and vitamin D supplements. It may be necessary if the amount you take in your diet is not sufficient.

If you take moreRisedronate Weekly TecniGenthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

If you or someone else has taken a large number of tablets accidentally, drink a glass of milk and go to the doctor. The symptoms of overdose include a decrease in the amount of calcium in the body, whose symptoms include muscle cramps or abdominal cramps.

If you forget to takeRisedronate Weekly TecniGen

If you have forgotten to take your tablet, simply take the tablet on the day you remember. Take the next tablet the following week, on the day you normally take the tablet. Do not take two tablets on the same day to make up for the forgotten dose (if you have forgotten to take a tablet for a week or more).

If you stop takingRisedronate Weekly

Treatment of osteoporosis is usually necessary for long periods. Talk to your doctor before stopping treatment. If you stop taking the treatment, you will no longer get the benefits of it and may start losing bone mass again.

4. Possible side effects

Like all medicines, Risedronate Weekly TecniGen can cause side effects, although not everybody gets them.

Tell your doctor immediately if you experience symptoms in the esophagus, such as pain or difficulty swallowing, chest pain, or heartburn that is new or worsening.

The side effects that were observed were generally mild and did not cause the patient to stop treatment.

Common side effects(affects 1 to 10 users in 100)

Constipation, upset stomach (dyspepsia), indigestion, nausea, stomach pain, diarrhea. Bone or muscle pain. Headache.

Uncommon side effects(affects 1 to 10 users in 1,000)

Inflammation or ulceration of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain when swallowing. Inflammation or ulceration of the stomach and/or duodenum (intestine where the stomach empties).

Consult your doctor immediately if you experience any of the following side effects:

Inflammation of the colored part of the eye (red, painful eyes with possible changes in vision).

Rare side effects(affects 1 to 10 users in 10,000)

Inflammation of the tongue (swollen, red, possibly painful). Narrowing of the esophagus (the tube that connects the mouth to the stomach). Abnormal liver tests have been reported, which can only be diagnosed with a blood test.

Very rare side effects(affects less than 1 user in 10,000, including isolated cases)

Consult your doctor immediately if you experience any of the following side effects:

Allergic reactions such as hives (skin rash), swelling of the face, lips, tongue, and/or throat, difficulty swallowing or breathing. Severe skin reactions, including blisters (blisters) under the skin.

• Consult your doctor if you have ear pain, your ear is draining, or you have an ear infection. These could be symptoms of damage to the bones of the ear.

Frequency not known

Consult your doctor immediately if you experience any of the following side effects:

Dead jawbone (necrosis of the jawbone).

Rarely, at the start of treatment, a slight decrease in phosphate and calcium levels in the blood has been observed in some patients. These changes are usually small and do not cause symptoms.

Atypical fractures of the thigh bone (femur) can occur rarely, especially in patients undergoing prolonged treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early symptoms of a possible fracture of the femur.

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

5. Storage of Risedronate Weekly TecniGen

Keep out of sight and reach of children.

This medicine does not require special storage conditions.

Do not use this medicine after the expiration date that appears on the blister pack and carton. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Additional information

Composition ofRisedronate Weekly TecniGen 35 mg

• The active ingredient is sodium risedronate. Each tablet contains 35 mg of sodium risedronate, equivalent to 32.5 mg of risedronic acid.

• The other ingredients are:

Core of the tablet: Lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate

Coating of the tablet: Hypromellose, glycerol triacetate (E422), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the product and package contents

Risedronate Weekly TecniGen 35 mg are film-coated tablets, biconvex, pink-salmon in color, with a diameter of approximately 9.7 mm.

Risedronate Weekly TecniGen 35 mg is available in blister packs containing 4 tablets.

Only certain pack sizes may be marketed.Marketing authorization holder and manufacturer

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid). SPAIN

Manufacturer

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

This leaflet was last revised in February 2016

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/