Risedronate weekly Tecnigen 35 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risedronato Semanal TecniGen 35 mg film-coated tablets EFG

Sodium risedronate

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as 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 and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Risedronato Semanal TecniGen is and what it is used for

2. Before you take Risedronato Semanal TecniGen

3. How to take Risedronato Semanal TecniGen

4. Possible side effects

5. How to store Risedronato Semanal TecniGen

6. Further information

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

What Risedronate Semanal TecniGen is
Risedronate Semanal 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 thereby reducing 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 bone begins to weaken, becoming more fragile and more prone to fractures following 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 common bone fractures occur in the vertebrae, hip, and wrist, although they can occur in any bone of the body. Fractures associated with osteopor游戏副本

2. Before taking Risedronate Weekly TecniGen

Do not take Risedronate Weekly TecniGen:

• if you are allergic (hypersensitive) to sodium risedronate or to any of the other ingredients of this medicine (see section 6),
• if your doctor has told you that you have a condition called hypocalcemia (low levels of calcium 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 speak with your doctor before taking Risedronate Weekly TecniGen

• if you cannot remain sitting or standing upright for at least 30 minutes,
• if you have bone or mineral metabolism disorders (for example, vitamin D deficiency, parathyroid hormone abnormalities) that may cause low calcium levels in your blood,
• if you have previously had esophageal problems (the tube connecting the mouth to the stomach). For example, you may have experienced pain or difficulty swallowing food, or have been diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the 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 currently have jaw pain, swelling or numbness, jaw discomfort, or tooth loss,
• if you are undergoing dental treatment or are scheduled for dental surgery, inform your dentist that you are being treated with sodium risedronate.

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

Using other medicines

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

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

Medicines containing 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 may be used concomitantly with estrogen supplements (in women).

Taking Risedronate Weekly TecniGen with 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).

Food, drinks (except water), and other medicines should not be consumed 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 may only be used in postmenopausal women.

Driving and using machines

Risedronate Weekly TecniGen 35 mg does not affect the ability to drive or operate machinery.

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

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

3. How to take Risedronate TecniGen Weekly

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

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

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

To help you take 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 TecniGen Weekly tablet. Also, write down the dates on which you will take the tablet.

Elderly

No dose adjustment is required.

Patients with kidney problems

No dose adjustment is required if you have mild to moderate kidney impairment. If you have severe kidney impairment, you must not use Risedronate TecniGen Weekly 35 mg.

Children The use of Risedronate TecniGen Weekly 35 mg is not recommended in children and adolescents.

When to take your Risedronate TecniGen Weekly 35 mg tablet:

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

How to take your Risedronate TecniGen Weekly 35 mg tablet:

• Take the tablet while in an upright position (either sitting or standing). This helps prevent 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 Risedronate TecniGen Weekly 35 mg is NOT taken with food or beverages (except if the beverage is plain water), so that it can work properly.
• Swallow the tablet whole. Do not suck or chew the tablet.
• Do not lie down for at least 30 minutes after taking the tablet.

Your doctor will advise you whether you should take calcium and vitamin D supplements. This may be necessary if the amount you consume in your diet is insufficient.

If you take more Risedronate TecniGen Weekly than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you or another person has accidentally taken a large number of tablets, drink a glass of milk and seek medical attention. Symptoms of overdose include decreased calcium levels in the body, which may cause muscle or abdominal cramps.

If you forget to take Risedronate TecniGen Weekly

If you forget to take your tablet, simply take it the day you remember. Then take your next tablet the following week on your usual tablet-taking day. Do not take two tablets on the same day to make up for a missed dose (if you have forgotten to take a tablet for one week or more).

If you stop taking Risedronate TecniGen Weekly

Treatment for osteoporosis is usually required for long periods. Speak with your doctor before stopping treatment. If you stop taking the medication, you will no longer obtain its benefits and you may begin to lose bone mass again.

4. Possible adverse effects

Like all medicines, Risedronate Semanal TecniGen can cause adverse effects, although not everyone experiences them.

Inform your doctor immediately if you experience symptoms affecting the oesophagus, such as pain or difficulty swallowing, chest pain, or new or worsening heartburn.

The adverse effects observed were generally mild and did not cause patients to discontinue treatment.

Common adverse effects (affects between 1 and 10 out of every 100 patients)

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

Uncommon adverse effects (affects between 1 and 10 out of every 1,000 patients)

Inflammation or ulceration of the oesophagus (the tube connecting the mouth to the stomach), causing difficulty and pain when swallowing. Inflammation or ulceration of the stomach and/or duodenum (the intestine into which the stomach empties).

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

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

Rare adverse effects (affects between 1 and 10 out of every 10,000 patients)

Inflammation of the tongue (swollen, red, possibly painful). Narrowing of the oesophagus (the tube connecting the mouth to the stomach). Abnormal liver function tests have been reported, which can only be diagnosed by a blood test.

Very rare adverse effects (affects fewer than 1 out of every 10,000 treated patients, including isolated cases)

Contact 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 neck, difficulty swallowing or breathing. Severe skin reactions, including blisters (formation of bullae) under the skin.

• Consult your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of bone damage in the ear.

Frequency not known

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

Osteonecrosis (death of bone tissue) of the jaw.

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

Atypical femoral fractures (thigh bone) which may occur rarely, particularly in patients on long-term osteoporosis treatment. Inform your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as these may be early signs indicating a possible femoral fracture.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Risedronato Semanl TecniGen

Keep out of the sight and reach of children.

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date stated on the blister and packaging. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure how to dispose of medicines and containers you no longer need, please consult your pharmacist. This will help protect the environment.

6. Additional information

Composition of Risedronate Semanal TecniGen 35 mg

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

• The other components are:

Tablet core: Monohydrate lactose, microcrystalline cellulose, crospovidone, magnesium stearate.

Tablet coating: hypromellose, glycerol triacetate (E422), titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

Appearance of the medicinal product and contents of the pack

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

Risedronate Semanal TecniGen 35 mg is available in blisters 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 reviewed in February 2016

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/