RISEDRONATO 35 mg Film-Coated Tablets

2. What you need to know before taking Risedronate Weekly STADA

DO NOT take Risedronate Weekly STADA

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risedronate Weekly STADA

• If you cannot be in an upright position (either sitting or standing) for at least 30 minutes.

• If you have bone or mineral metabolism disorders (e.g., vitamin D deficiency, parathyroid hormone disorders, which can both lead to low calcium levels in the blood).

• If you have or have had problems with your esophagus (the tube that connects the mouth to the stomach). For example, you may have or have had pain or difficulty swallowing food or have been previously informed that you have Barrett's esophagus (a condition associated with changes in the cells lining the distal esophagus)
• • If your doctor has informed you that you have intolerance to some sugars (such as lactose).
  • If you have had or have pain, swelling, or numbness in the jaw, or if you notice heavy or lost teeth.
  • If you are undergoing dental treatment or are going to undergo dental surgery, inform your dentist that you are being treated with Risedronate Weekly STADA

Your doctor will advise you what to do if you take Risedronate Weekly STADA and have any of the above problems.

Children and adolescents

The use of sodium risedronate is not recommended in children (under 18 years) because there is not enough data on its safety and efficacy.

Other medications and Risedronate Weekly STADA

Medications that contain any of the following substances reduce the effect of Risedronate Weekly STADA if taken at the same time:

• calcium
• magnesium
• aluminum (e.g., some medication for indigestion)
• iron

Take these medications at least 30 minutes after taking the Risedronate Weekly STADA tablet.

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Taking Risedronate Weekly STADA with food and drinks

It is very important that you DO NOT take your Risedronate Weekly STADA tablet with food or drinks (other than plain water) for it to work properly. In particular, do not take this medication at the same time as dairy products (such as milk), as they contain calcium (see section 2 "Taking Risedronate Weekly STADA with other medications").

Take food and drinks (other than plain water) at least 30 minutes after taking the Risedronate Weekly STADA tablet.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

DO NOT take Risedronate Weekly STADA if you may be pregnant, are pregnant, or plan to become pregnant (see section 2 "DO NOT take Risedronate Weekly STADA"). The potential risk associated with the use of sodium risedronate (the active ingredient of Risedronate Weekly STADA) in pregnant women is unknown.

DO NOT take Risedronate Weekly STADA if you are breastfeeding (see section 2 "DO NOT take Risedronate Weekly STADA").

Risedronate Weekly STADA should only be used to treat postmenopausal women and men.

Driving and using machines

It is not known if Risedronate Weekly STADA affects the ability to drive and use machines

Risedronate Weekly STADA contains lactose and sodium

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

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Risedronate Weekly STADA

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Recommended dose:

Take ONE Risedronate Weekly STADA 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 Weekly STADA tablet on the chosen day.

For your convenience, to take your tablet on the correct day each week, there is an indication included on the Risedronate Weekly STADA packaging:

There are boxes/spaces on the back of the packaging. Mark the day of the week you have chosen to take the Risedronate Weekly STADA tablet. Also, write down the dates on which you will take the tablet.

WHEN to take the Risedronate Weekly STADA tablets

Take your Risedronate Weekly STADA tablet at least 30 minutes before the first meal, drink (other than plain water), or other medications of the day.

HOW to take the Risedronate Weekly STADA tablet

• Take the tablet while in an upright position (you can be sitting or standing), to avoid heartburn.
• Swallow the tablet with at least one glass (120 ml) of plain water.
• Swallow it whole. Do not chew or suck it.
• Do not lie down during the 30 minutes after taking your tablet.

Your doctor will tell you if you need to take calcium and vitamin supplements if you are not getting enough in your diet.

If you take more Risedronate Weekly STADA than you should

If you or someone else has accidentally taken more Risedronate Weekly STADA tablets than prescribed, drink a full glass of milk and consult a doctor. In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Risedronate Weekly STADA

If you have forgotten to take your tablet on the chosen day, take it on the day you remember. Go back to taking one tablet once a week, on the day you normally take the tablet. DO NOT take two tablets in one day to make up for the missed tablet.

If you interrupt treatment with Risedronate Weekly STADA

If you interrupt treatment, you may start to lose bone mass. Please consult your doctor before deciding to interrupt treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can have side effects, although not everyone gets them.

Stop taking Risedronate Weekly STADA and consult a doctor immediatelyif you experience any of the following symptoms:

• Symptoms of a severe allergic reaction, such as:

• Swelling of the face, tongue, or throat
• Difficulty swallowing
• Hives and difficulty breathing.

• Severe skin reactions that can include the appearance of blisters on the skin.

Tell your doctor promptlyif you experience the following side effects:

• Inflammation of the eyes, usually with pain, redness, and sensitivity to light.
• Jaw bone necrosis (osteonecrosis) associated with delayed healing and infection, often after a tooth extraction (see section 2, "Warnings and precautions").
• Symptoms related to the esophagus, such as pain when swallowing, difficulty swallowing, chest pain, and appearance or worsening of heartburn.

Fractures of the thigh bone can occur rarely, 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 these may be early symptoms of a possible fracture of the thigh bone.

However, in clinical studies, the side effects that were observed were generally mild and did not cause the patient to interrupt treatment.

Common side effects(may affect up to 1 in 10 people)

• Indigestion, nausea, stomach pain, discomfort, or cramps in the stomach, constipation, feeling of fullness, abdominal distension, diarrhea.
• Bone, muscle, or joint pain.
• Headache.

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

• Inflammation or ulcers of the esophagus (the tube that connects the mouth to the stomach) that cause difficulty and pain when swallowing (see section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (intestine that drains the stomach).
• Inflammation of the colored part of the eye (iris) (red, painful eyes with possible changes in vision).

Rare side effects(may affect up to 1 in 1,000 people)

Inflammation of the tongue (red, swollen, possibly painful), narrowing of the esophagus (the tube that connects the mouth to the stomach). Abnormalities in liver function tests have been reported. This can only be diagnosed with a blood test.

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

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

During post-marketing experience, the following side effects have been reported (frequency not known (cannot be estimated from the available data)):

• Hair loss
• Liver disorders, in some cases severe.

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.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them through the Spanish Medicines Monitoring System: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Risedronate Weekly STADA

Keep this medication out of the sight and reach of children.

This medication does not require special storage precautions.

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Risedronate Weekly STADA

• 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:

Core of the tablet: Pregelatinized corn starch; microcrystalline cellulose; crospovidone; magnesium stearate.

Film coating: Hypromellose, lactose monohydrate, titanium dioxide (E171), Macrogol 4000.

Appearance of the product and package contents

Risedronate Weekly STADA film-coated tablets are white, round, biconvex, 11.2 mm in diameter, 5.0 mm in thickness, and have a "35" engraved on one side. They are available in blister packs containing 4 or 12 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratory STADA S.L

Frederic Mompou, 5

08960 Sant Just Desvern

Spain

[email protected]

Manufacturer

STADA Arzneimittel

Stadastrasse 2-18,

61118 Bad Vilbel

Germany

or

Pharmathen S.A

6, Dervenakion str. 15351, Pallini Athens

Greece

or

Pharmathen International S.A.

Sapes Industrial Park, Block 5

69300 Rodopi

Greece

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

Austria Risedronate STADA once weekly 35 mg film-coated tablets

Bulgaria ZILAR 35 mg ????????? ????????

Denmark Risostad

Spain Risedronate Weekly STADA 35 mg film-coated tablets EFG

Portugal Risedronate sodium Ciclum

Date of the last revision of this leaflet: November 2020

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/