Risedronate weekly Kern Pharma 35 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risedronato Semanal Kern Pharma 35 mg film-coated tablets EFG

Sodium risedronate

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

• 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 personally and you must not give it to other people, 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, please inform your doctor or pharmacist.

Contents of the leaflet

1. What Risedronato Semanal Kern Pharma is and what it is used for
2. Before you take Risedronato Semanal Kern Pharma
3. How to take Risedronato Semanal Kern Pharma
4. Possible side effects
5. How to store Risedronato Semanal Kern Pharma
6. Further information

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

What is Risedronate Semanal 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 thereby 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 bones begin to weaken, become more fragile, and fractures are more likely to occur 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 affect any bone in the body. Fractures associated with osteoporosis may also cause back pain, loss of height, and a curved spine. Some patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Risedronate Semanal Kern Pharma is used for

Risedronate is used for the treatment of osteoporosis in postmenopausal women and reduces the risk of fractures.

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

2. Before taking Risedronate Weekly Kern Pharma

Do not take Risedronate Weekly Kern Pharma

• if you are allergic (hypersensitive) to sodium risedronate or to any of the other components 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 if you are planning to become pregnant,
• if you are breastfeeding,
• if you have severe kidney disease.

Take special care with Risedronate Weekly Kern Pharma

• 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 disorders) that may cause low calcium levels in your blood,
• if you have previously had esophageal problems (the tube connecting the mouth to the stomach). At some point, you may have experienced 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 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 previously had problems with your esophagus (the tube connecting the mouth to the stomach). For example, you may have experienced pain or difficulty swallowing food, or you were previously diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).

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

Use of 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.

The following medicines 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 together with estrogen supplements (in women).

Taking Risedronate Weekly Kern Pharma with food and drink

It is very important NOT to 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 are planning 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

Sodium risedronate does not affect the ability to drive or operate machinery.

Important information about some of the components of Risedronate Weekly Kern Pharma

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

3. How to take Risedronate Weekly Kern Pharma

Follow exactly the dosing instructions for Risedronate given by your doctor. Consult your doctor or pharmacist if you have any doubts.

The usual dose is one Risedronate 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 tablet on the chosen day.

To help you remember to take the tablet on the same day every week, there are boxes on the package. Mark the day of the week you have chosen for taking the Risedronate tablet. Also, write down the dates on which you will take the tablet.

Elderly

Dose adjustment is not required.

Patients with kidney problems

Dose adjustment is not required if you have mild to moderate impairment of kidney function. If you have severe impairment of kidney function, you must not take 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 if that drink is plain water), or other medication of the day.

How to take your Risedronate 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 must not be taken with food or drinks (except if that drink is plain water), so that it can work properly.
• Swallow the tablet whole. Do not suck or chew the tablet.
• You must 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 Weekly Kern Pharma 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 someone else has accidentally taken a large number of tablets, drink a glass of milk and seek medical advice immediately. Symptoms of overdose include a decrease in calcium levels in the body, which may cause muscle cramps or abdominal pain.

If you forget to take Risedronate Weekly Kern Pharma

If you forget to take your tablet, simply take it on the day you remember. Then take your next tablet one week later on your usual tablet 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 Weekly Kern Pharma

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

4. Possible adverse effects

Like all medicines, Risedronate may 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 with possible 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 in 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 throat, difficulty swallowing or breathing. Serious skin reactions, including blistering (formation of blisters) under the skin.

Contact your doctor if you have ear pain, ear discharge, 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 slight decrease in blood phosphate and calcium levels has been observed in some patients. These changes are usually minor and do not cause symptoms.

Atypical femoral fractures (thigh bone) which may occur rarely, particularly in patients on long-term treatment for osteoporosis. 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 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 expiry date stated on the blister pack and outer packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of Risedronate Weekly Kern Pharma

• 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: 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), anhydrous colloidal silica, titanium dioxide (E-171), macrogol 400, macrogol 8000.

Appearance of the medicinal product and content of the container

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

Risedronate Weekly Kern Pharma is supplied in blisters containing 4 tablets.

Only certain 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 reviewed in April 2016

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