Leaflet: information for the user

Risedronate Weekly Kern Pharma 35 mg tabletsfilm-coatedEFG

Risedronate sodium

Read this leaflet carefully before starting to take themedicine.

-Keep this leaflet, as you may need to read it again.

-If you have any questions, consult your doctor or pharmacist.

-This medicine has been prescribed for you personally and should not be given to others,even if they have the same symptoms, as it may harm them.

-If you consider that any of the side effects you are experiencing are serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

1. What is Risedronate Weekly Kern Pharma 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. Storage of Risedronate Weekly Kern Pharma

6.Information additional

What isRisedronato Semanal Kern Pharma

Risedronato belongs to a group of non-hormonal medications called bisphosphonates, which are used for the treatment of bone diseases.It acts directly on the bones strengthening them, and therefore, reduces the probability of fractures.

The bone is a living tissue.Theold boneof the skeleton is constantly being renewedand replaced by new bone.

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

Osteoporosis can also be suffered by men due to numerous 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 of the body. Fractures associated with osteoporosis can also produce back pain, height loss, and a curved back. Some patients with osteoporosis do not have symptoms and may not even know they have it.

What is it used forRisedronato Semanal Kern Pharma

Risedronato is used for the treatment of osteoporosis in women after menopause and reduces the risk of fractures.

It is also used for the treatment of osteoporosis in men with a high risk of fracture.

Do not takeRisedronate Weekly Kern Pharma

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

Be especially careful withRisedronate Weekly Kern Pharma

• if you cannot remain seated or standing for at least 30 minutes,
• if you have bone or mineral metabolism problems (for example, vitamin D deficiency, parathyroid hormone alterations) that may cause low levels of calcium in your blood,

• if in the past you have had esophageal problems (the tube that connects your mouth to your stomach). You may have hadhad pain or difficulty swallowing food,
• if you have gastritis
• if your doctor has told you that you have intolerance to certain sugars (such as lactose),
• if you have had or have jaw pain, inflammation, or numbness, maxillary 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 risedronate sodium,
• if you have had in the past esophageal problems (the tube that connects your mouth to your stomach). For example, you may have had pain or difficulty swallowing food or previously been told that you have Barrett's esophagus (a disease associated with changes in the cells that cover the lower part of the esophagus).

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

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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

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

• calcium,
• magnesium,
• aluminum,
• iron.

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

Risedronate sodium can be used in combination with estrogen supplements (in women).

Administration ofRisedronate Weekly Kern Pharmawith food and beverages

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

Do not consume food, beverages (except water) and other medications for at least 30 minutes after taking Risedronate.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

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

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

Risedronate sodium can only be used in postmenopausal women.

Driving and operating machinery

Risedronate does not affect your ability to drive or operate machinery.

Important information about some of the components ofRisedronate Weekly Kern Pharma

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

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

The usual dose is one Risedronate tablet (35 mg of risedronate sodium) 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 every week, there are boxes in the packaging.Mark the day of the week you have chosen to take the Risedronate tablet.Also, write the dates on which the tablet will be taken.

Seniors

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

Risedronate is not recommended for use 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 water) or other medication of the day.

How to take your Risedronate tablet:

• Take the tablet while standing upright (either sitting or standing). This prevents heartburn (sensation of burning in the throat).
• Swallow the tablet with at least one glass (120 ml) of water. It is very important that Risedronate should not be taken with food or drinks (except in the case of water), so that it can function 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 tell you if you need to take calcium and vitamin D supplements.You may need them if the amount you take in your diet is not enough.

If you take more Risedronate Weekly Kern Pharma than 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 medication and the amount taken.

If you or another person have accidentally taken a large number of tablets, drink a glass of milk and see a doctor.The symptoms of overdose include a decrease in the amount of calcium in the body, whose symptoms include muscle or abdominal cramps.

If you forgot to take Risedronate Weekly Kern Pharma:

If you forgot to take your tablet, simply take the tablet on the day you remember.Resume 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 interrupt treatment with Risedronate Weekly Kern Pharma:

Usual osteoporosis treatment is necessary for long periods.Talk to your doctor before stopping treatment.Stopping treatment will mean you will no longer get its benefits and you may start losing bone mass again.

Like all medications, Risedronate may have side effects, although not everyone will experience them.

Inform your doctor quickly if you experience symptoms in the esophagus, such as pain or difficulty swallowing, chest pain, or new or worsening stomach burning.

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

Frequent side effects(affects between 1 and 10 of every 100 patients)

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

Less frequent side effects(affects between 1 and 10 of every 1,000 patients)

Inflammation or ulcer of the esophagus (the tube that connects the mouth to the stomach) causing difficulty and pain swallowing.Inflammation or ulcer 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 between 1 and 10 of 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, which can only be diagnosed through blood tests.

Very rare side effects(affects fewer than 1 of 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 urticaria (skin rash), swelling of the face, lips, tongue, and/or neck, difficulty swallowing or breathing.Severe skin reactions, including vesicles (formation of blisters) under the skin.

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

Unknown frequency

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

Osteonecrosis (bone tissue death) in the jaw.

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

Atypical fractures of the femur (thigh bone) that may occur in rare cases, 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 they may be early symptoms and indicative of a possible femur fracture.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

This medication does not require special storage conditions.

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

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of packaging and unused medications.This will help protect the environment.

Composition ofRisedronate Weekly Kern Pharma

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

Product appearance and packaging contents

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

Risedronate Weekly Kern Pharma is presented in blisters containing4 tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder

Kern Pharma, S.L.

Venus, 72 – Pol. Ind. Colón II

08228 Terrassa – Barcelona

Spain

Responsible for manufacturing

Adamed Pharma S. A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

or

ADAMED PHARMA S.A.

ul. Szkolna, 33

95-054Ksawerów

Poland

This leaflet was revised in April 2016

The detailed and updated informationon this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/