RISEDRONATE SEMANAL KERN PHARMA 35 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Risedronate Weekly Kern Pharma 35 mg film-coated tabletsEFG

Sodium risedronate

Read all of this leaflet carefully before you start takingthismedicine.

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

Contents of the pack

1. What Risedronate Weekly Kern Pharma is and what it is used for
2. Before taking Risedronate Weekly Kern Pharma
3. How to take Risedronate Weekly Kern Pharma
4. Possible side effects
5. Storing Risedronate Weekly Kern Pharma
6. Further information

1. What Risedronate Weekly Kern Pharma is and what it is used for

What isRisedronate Weekly Kern Pharma

Risedronate 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, becoming more fragile and prone to fractures 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. Osteoporosis-related fractures can also cause back pain, loss of height, and a curved back. Some patients with osteoporosis may not have symptoms and may not even know they have it.

What Risedronate Weekly Kern Pharma is 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 Kern Pharma

Do not takeRisedronate Weekly Kern Pharma

• 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 withRisedronate Weekly Kern Pharma

• if you cannot sit or stand up for at least 30 minutes,
• if you have bone 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 esophageal problems (the tube that connects the mouth to the stomach) in the past. You may have had pain or difficulty swallowing food,
• 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 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 had esophageal problems (the tube that connects the mouth to the stomach) in the past. For example, you may have had pain or difficulty swallowing food, or you may have been told that you have Barrett's esophagus (a disease associated with changes in the cells that line the lower part of the esophagus).

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 any other medicines, including those obtained without a prescription.

There are few medicines that 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 Kern Pharmawith food and drinks

It is very important that you DO NOT take Risedronate 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.

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 does not affect the ability to drive or use machines.

Important information about some of the ingredients ofRisedronate Weekly Kern Pharma

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 Kern Pharma

Follow the instructions for administration of Risedronate indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

The normal dose is one Risedronate 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 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 tablet. Also, write the dates on which 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.

Children

The use of Risedronate is not recommended in children and adolescents.

When to take your Risedronate tablet:

Take the Risedronate tablet at least 30 minutes before the first meal, drink of the day (except in the case of plain water) or other medicine of the day.

How to take your Risedronate 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 with food or drinks (except 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 Kern Pharmathan 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, 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 Kern Pharma

If you have forgotten to take your tablet, simply take the tablet on the day you remember. Go back to taking the 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 missed dose (if you have forgotten to take a tablet for a week or more).

If you stop takingRisedronate Weekly Kern Pharma

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 can have side effects, although not everyone gets them.

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

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

Common side effects(affect 1 to 10 in every 100 patients)

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

Uncommon side effects(affect 1 to 10 in every 1,000 patients)

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(affect 1 to 10 in every 10,000 patients)

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(affect less than 1 in every 10,000 patients treated, 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 (formation of bubbles) 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 on long-term treatment for osteoporosis. Tell 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 experiencing is serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. Storing Risedronate Weekly Kern Pharma

Keep out of the reach and sight 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. Further information

Composition ofRisedronate Weekly Kern Pharma

• 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:

Tablet core: lactose monohydrate, microcrystalline cellulose (E-460i), crospovidone, and magnesium stearate (E-470b).

Tablet coating: yellow iron oxide (E-172), red iron oxide (E-172), hypromellose (E-464), hydroxypropylcellulose (E-463), colloidal anhydrous silica, titanium dioxide (E-171), macrogol 400, macrogol 8000.

Appearance of the product and pack contents

Risedronate Weekly Kern Pharma are film-coated tablets, round, biconvex, pale orange in color.

Risedronate Weekly Kern Pharma is available in blister packs containing 4 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

or

ADAMED PHARMA S.A.

ul. Szkolna, 33

95-054 Ksawerów

Poland

This leaflet was last revised in April 2016

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