Risedronate weekly Qualigen 35 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Risedronato Semanal Qualigen 35 mg film-coated tablets EFG

Sodium risedronate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

• 1. What Risedronato Semanal Qualigen 35 mg tablets are and what they are used for
• 2. What you need to know before starting to take Risedronato Semanal Qualigen 35 mg tablets
• 3. How to take Risedronato Semanal Qualigen 35 mg tablets
• 4. Possible adverse effects
• 5. How to store Risedronato Semanal Qualigen 35 mg tablets
• 6. Contents of the pack and other information

1. What is Risedronate Semanal Qualigen 35 mg tablets and what is it used for

What is Risedronate Semanal Qualigen 35 mg

Risedronate Semanal Qualigen 35 mg belongs to a group of non-hormonal medicinal products 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 bone begins to weaken, becomes more fragile, and fractures are more likely to occur following a fall or twist.

Osteoporosis may 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 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 Qualigen 35 mg 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. What you need to know before starting to take Risedronate Semanal Qualigen 35 mg tablets

Do not take Risedronate Semanal Qualigen 35 mg

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Risedronate Semanal Qualigen 35 mg.

• If you are unable to sit or stand 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 blood calcium levels.
• If you have previously had esophageal problems (the tube connecting your mouth to your stomach). At some point, you may have experienced pain or difficulty swallowing food, or if you have previously been diagnosed with Barrett's esophagus (a condition associated with changes in the cells of the lower 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 pain, 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 mentioned above, inform your doctor BEFORE taking this medicine.

Taking Risedronate Semanal Qualigen 35 mg with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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,
• aluminium,
• 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 Semanal Qualigen 35 mg with food, drinks and alcohol

It is very important that you do NOT take Risedronate Semanal Qualigen 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 Semanal Qualigen 35 mg.

Pregnancy, breastfeeding and fertility

Consult your doctor or pharmacist before using any medicine.

Do not take sodium risedronate if you could 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

Risedronate Semanal Qualigen 35 mg does not affect the ability to drive or use machines.

This medicine contains lactose

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

3. How to take Risedronate Weekly Qualigen 35 mg tablets

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

The usual dose is one Risedronate Weekly Qualigen 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 Weekly Qualigen 35 mg tablet on the chosen day.

To help you take the tablet on the same day each week, there are boxes on the carton. Mark the day of the week you have chosen to take the Risedronate Weekly Qualigen 35 mg 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 impairment of kidney function. If you have severe impairment of kidney function, you must not take Risedronate Weekly Qualigen 35 mg.

Children and adolescents

The use of Risedronate Weekly Qualigen 35 mg is not recommended in children under 18 years of age and adolescents.

When to take your Risedronate Weekly Qualigen 35 mg tablet

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

How to take your Risedronate Weekly Qualigen 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 Weekly Qualigen 35 mg is not taken with food or other beverages (except if that beverage 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 get from your diet is insufficient.

If you take more Risedronate Weekly Qualigen 35 mg than you should

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

If you or another person have 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, whose symptoms may include muscle or abdominal cramps.

If you forget to take Risedronate Weekly Qualigen 35 mg

If you forget to take your tablet, simply take it on the day you remember. Then take the next tablet on 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 Weekly Qualigen 35 mg

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, this medicine can have adverse effects, although not everyone will experience 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 (may affect up to 1 in 10 people)

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

Uncommon adverse effects (may affect up to 1 in 100 people)

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 (may affect up to 1 in 1,000 people)

Inflammation of the tongue (swollen, red, possibly painful). Narrowing of the oesophagus (the tube connecting the mouth to the stomach). Abnormal liver test results have been reported, which can only be diagnosed by a blood test. Atypical femoral fractures (thigh bone), which may rarely occur, particularly in patients on long-term treatment for osteoporosis. Inform your doctor if you notice pain, weakness, or discomfort in your thigh, hip, or groin, as these may be early signs indicating a potential femoral fracture.

Very rare adverse effects (may affect up to 1 in 10,000 people)

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. Serious skin reactions, including blistering (formation of blisters) under the skin.

Contact your doctor if you have ear pain, discharge from the ear, or an ear infection. These could be symptoms of damage to the bones of 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.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report adverse effects via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Weekly Qualigen 35 mg Tablets

Keep out of sight and reach 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 carton. 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 empty containers and unused medicines at the SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of Risedronate Weekly Qualigen 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: pregelatinized corn starch, microcrystalline cellulose (E-460i), crospovidone, magnesium stearate (E-572).

Tablet coating: hypromellose (E-464), monohydrate lactose, titanium dioxide (E171), Macrogol 4000 (E-1521).

Appearance of the product and contents of the container

Risedronate Weekly Qualigen 35 mg are film-coated tablets, biconvex, round, white, with a diameter of 11.2 mm, 5.0 mm thick, and marked with "35" on one side.

Risedronate Weekly Qualigen 35 mg is supplied in blisters containing 4 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970- Sant Joan Despí

Barcelona- Spain

Manufacturer

Pharmathen S.A.

Dervenakion 6, Pallini

153 51, Attiki

Greece

or

Pharmathen International S.A.

Sapes Industrial Park

Block 5

69300 Rodopi

Greece

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Denmark Ellidronat

Spain Risedronate Weekly Qualigen 35 mg film-coated tablets EFG

Date of the most recent review of this leaflet: April 2021

Detailed 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/)