Prospecto:Information for the User

Risedronate Weekly STADA35 mg Film-Coated Tablets

Risedronate Sodium

Read this entire prospectus carefully before starting to take this medication, as it contains important information for you.

• Keep this prospectus, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What is Risedronate Weekly STADA and for what it is used

2.What you need to knowbefore starting to take Risedronate Weekly STADA

3.How to take Risedronate Weekly STADA

4.Possible adverse effects

1. Storage of Risedronate Weekly STADA

6.Contents of the package andadditional information

What is Risedronato Semanal STADA

Risedronato Semanal STADA belongs to a group of non-hormonal medications called bisphosphonates, which are used to treat bone diseases.It acts directly on the bones, making them stronger and therefore less prone to breaking.

The bone is a living tissue.The old bone in the skeleton is constantly being renewed and replaced by new bone.

Postmenopausal osteoporosis is a problem that occurs in women after menopause, in which the bones weaken, become more fragile and are more prone to breaking in a fall or excessive effort.

Osteoporosis can also occur in men due to various causes, including aging or a low level of the male hormone, testosterone.

The vertebrae, hip, and wrist are the bones most prone to breaking, although this can occur in any bone in the body. Fractures related to osteoporosis can also cause back pain, height loss, and curved deformation of the back.Many patients with osteoporosis do not have symptoms and may not even know they have it.

What is Risedronato Semanal STADA used for

Treatment of osteoporosis in postmenopausal women, even in cases of severe osteoporosis. It reduces the risk of vertebral and hip fractures.

Treatment of osteoporosis in men with a high risk of fractures.

Do not take Risedronato Semanal STADA

Warnings and precautions

Consult your doctor or pharmacist before starting to take Risedronato Semanal STADA

• 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 difficulty swallowing food or have been previously informed that you have Barrett's esophagus (a condition associated with changes in the cells that cover the distal part of the esophagus)
• • If your doctor has informed you that you have intolerance to some sugars (such as lactose).
  • If you have had or have jaw pain, swelling, or numbness, or if you notice heavy jaws or have lost a tooth.
  • If you are undergoing dental treatment or are going to undergo dental surgery, inform your dentist that you are being treated with Risedronato Semanal STADA

Your doctor will advise you what to do if you take Risedronato Semanal STADA and have any of the problems mentioned above.

Children and adolescents

Risedronate sodium is not recommended for use in children (under 18 years) as there are not enough data on its safety and efficacy.

Other medicines and Risedronato Semanal STADA

Medicines that contain any of the following substances reduce the effect of Risedronato Semanal STADA if taken at the same time:

• Calcium
• Magnesium
• Aluminum (for example, some medication for indigestion)
• Iron

Take these medicines at least 30 minutes after taking the Risedronato Semanal STADA tablet.

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

Taking Risedronato Semanal STADA with food and drinks

It is very important that you DO NOT take your Risedronato Semanal STADA tablet with food or drinks (other than plain water) so that it can work correctly.In particular, do not take this medicine at the same time as dairy products (such as milk), as they contain calcium (see section 2 “Taking Risedronato Semanal STADA with other medicines”).

Take food and drinks (other than plain water) at least 30 minutes after taking the Risedronato Semanal 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 medicine.

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

DO NOT take Risedronato Semanal STADA if you are breastfeeding (see section 2 “Do not take Risedronato Semanal STADA”).

Risedronato Semanal STADA should only be used to treat postmenopausal women and men.

Driving and operating machinery

The effect of Risedronato Semanal STADA on the ability to drive and operate machinery is unknown.

Risedronato Semanal STADA contains lactose and sodium

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

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

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

Recommended dose:

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

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

There are squares/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 the tablet will be taken.

WHEN to take Risedronate Weekly STADA tablets

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

HOW to take the Risedronate Weekly STADA tablet

• Take the tablet while standing upright (you can be seated or standing), to avoid stomach burning.
• Swallow the tablet with at least one glass (120 ml) of water.
• Swallow it whole.Do not suck or chew it.
• Do not lie down for 30 minutes after taking your tablet.

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

IF you take more Risedronate Weekly STADA than you should

If you or someone else have accidentally taken more Risedronate Weekly STADA tablets than prescribed, drink a full glass of milk and see your doctor.In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological 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.Resume taking a tablet once a week, on the day the tablet is normally taken.DO NOT take two tablets in one day to compensate 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.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Stop taking Risedronato Semanal STADA and see your doctor immediatelyif you experience any of the following symptoms:

• Severe allergic reaction symptoms, such as:

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

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

Inform your doctor quicklyif you experience the following side effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light.
• jawbone necrosis (osteonecrosis) associated with delayed healing and infection, often after a dental extraction (see section 2, "Warnings and precautions").
• Esophageal symptoms such as difficulty swallowing, chest pain, and appearance or worsening of stomach acid.

Atypical femoral fractures 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 these may be early signs and indicative of a possible femoral fracture.

However, in clinical studies, the side effects 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 full, abdominal distension, diarrhea.
• Bone, muscle, or joint pain.
• Headache.

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

• Inflammation or ulceration of the esophagus (the tube that connects the mouth to the stomach) that causes difficulty and pain swallowing (see section 2, "Warnings and precautions"), inflammation of the stomach and duodenum (the 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)

Language inflammation (red, swollen, possibly painful),esophageal narrowing (the tube that connects the mouth to the stomach).Liver function abnormalities. 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 may be symptoms of damage to the bones in the ear.

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

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of packaging and unused medications. This will help protect the environment.

Risedronate Weekly STADA Composition

• 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:Maize pregelatinized starch; microcrystalline cellulose; crospovidone; magnesium stearate.

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

Product appearance and packaging contents

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

STADA S.L

Frederic Mompou, 5

08960 Sant Just Desvern

Spain

[email protected]

Manufacturer responsible

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 medicine is authorized in the member states of the European Economic Area with the following names:

AustriaRisedronat STADA einmal wöchentlich 35 mg Filmtabletten

BulgariaZILAR 35 mg

DinamarcaRisostad

SpainRisedronate Weekly STADA 35 mg film-coated tablets

PortugalRisedronate sodium Ciclum

Last review date of this leaflet: November 2020

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