Risedronate weekly Stada 35 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Risedronato Semanal STADA 35 mg film-coated tablets EFG

Sodium risedronate

Read all of this 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 may harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Risedronato Semanal STADA is and what it is used for

2. What you need to know before taking Risedronato Semanal STADA

3. How to take Risedronato Semanal STADA

4. Possible side effects

   1. How to store Risedronato Semanal STADA

5. Contents of the pack and other information

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

What Risedronate Semanal STADA is

Risedronate Semanal STADA belongs to a group of non-hormonal medicines called bisphosphonates, which are used to treat bone diseases. It acts directly on the bones to make them stronger and therefore less likely to break.

Bone is living tissue. Old bone in the skeleton is constantly being renewed and replaced by new bone.

Postmenopausal osteoporosis is a condition that occurs in women after menopause, in which bones become weakened, more fragile, and more likely to fracture from a fall or excessive strain.

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

The spine, hip, and wrist are the bones most prone to fracture, although fractures can occur in any bone of the body. Osteoporosis-related fractures can also cause back pain, loss of height, and a curved spinal deformity. Many patients with osteoporosis have no symptoms and may not even be aware they have the condition.

What Risedronate Semanal STADA is used for

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

Treatment of osteoporosis in men at high risk of fractures.

2. What you need to know before taking Risedronato Semanal STADA

DO NOT take Risedronato Semanal STADA

• If you are allergic to sodium risedronate or 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 may be pregnant, are pregnant, or plan to become pregnant.
• If you are breastfeeding.
• If you have severe kidney problems.

Warnings and precautions

Talk to your doctor or pharmacist before taking Risedronato Semanal STADA

• If you are unable to remain in an upright position (sitting or standing) for at least 30 minutes.

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

• If you have or have previously had problems with your esophagus (the tube connecting the mouth to the stomach). For example, you may have had or currently have pain or difficulty swallowing food, or you have previously been diagnosed with Barrett's esophagus (a condition associated with changes in the cells lining the lower part of the esophagus).

  • If your doctor has told you that you have intolerance to certain sugars (such as lactose).
  • If you have had or currently have pain, swelling, or numbness in the jaw, feel heaviness in the jaw, or have lost a tooth.
  • If you are undergoing dental treatment or are scheduled to have dental surgery, inform your dentist that you are being treated with Risedronato Semanal STADA.

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

Children and adolescents

The use of sodium risedronate is not recommended in children (under 18 years of age) due to insufficient data on its safety and efficacy.

Other medicines and Risedronato Semanal STADA

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

• calcium
• magnesium
• aluminium (for example, some medicines 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 recently taken, or might need to take any other medicines.

Taking Risedronato Semanal STADA with food and drinks

It is very important NOT to take your Risedronato Semanal STADA tablet with food or drinks (other than plain water) so that it can work properly. In particular, do not take this medicine at the same time as dairy products (such as milk), because 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 might 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 sodium risedronate (the active substance in 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 using machines

It is unknown whether Risedronato Semanal STADA affects the ability to drive or use machinery.

Risedronato Semanal STADA contains lactose and sodium

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

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

3. How to take Risedronate Weekly STADA

Follow exactly the instructions given by your doctor or pharmacist for taking this medicine. 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 fits your schedule. Each week, take the Risedronate Weekly STADA tablet on the chosen day.

For your convenience, to help you take your tablet on the correct day each week, a reminder is included in the Risedronate Weekly STADA packaging:

There are boxes/spaces on the back of the package. 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 Risedronate Weekly STADA tablets

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

HOW to take the Risedronate Weekly STADA tablet

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

Your doctor will tell you if you need to take calcium and vitamin supplements, if you are not getting enough from 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 contact your doctor immediately. In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Risedronate Weekly STADA

If you forget to take your tablet on your chosen day, take it on the day you remember. Then return to taking one tablet once a week on your usual tablet-taking day. DO NOT take two tablets in one day to make up for the missed tablet.

If you stop treatment with Risedronate Weekly STADA

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

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Stop taking Risedronate Weekly STADA and see your doctor immediately if 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 may include blistering of the skin.

Tell your doctor promptly if you experience any of the following adverse effects:

• Eye inflammation, usually with pain, redness, and sensitivity to light.
• Jaw bone necrosis (osteonecrosis), associated with delayed healing and infection, often following a tooth extraction (see section 2, “Warnings and precautions”).
• Symptoms related to the oesophagus, such as pain when swallowing, difficulty swallowing, chest pain, or onset or worsening of heartburn.

Atypical femoral fractures 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 symptoms indicating a possible femoral fracture.

However, in clinical studies, the adverse effects observed were generally mild and did not lead to discontinuation of treatment.

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

• Indigestion, nausea, stomach pain, stomach discomfort or cramps, constipation, feeling of fullness, bloating, diarrhoea.
• Bone, muscle, or joint 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 (see section 2, “Warnings and precautions”), inflammation of the stomach and duodenum (the intestine that receives contents from the stomach).
• Inflammation of the coloured part of the eye (iris) (painful red eyes with possible changes in vision).

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

• Inflammation of the tongue (red, swollen, possibly painful), narrowing of the oesophagus (the tube connecting the mouth to the stomach). Abnormal liver function test results have been reported. This can only be diagnosed by a blood test.

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

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

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

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

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 effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Risedronate Weekly STADA

Keep this medicine out of sight and reach of children.

This medicine does not require special storage precautions.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Risedronate Semanal STADA

• 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 maize starch; microcrystalline cellulose; crospovidone; magnesium stearate.

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

Appearance of the medicine and contents of the pack

Risedronate Semanal STADA film-coated tablets are white, round, biconvex, 11.2 mm in diameter, 5.0 mm thick, with "35" engraved on one side. They are supplied in blister packs containing 4 or 12 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio 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 medicinal product is authorised in the European Economic Area member states under the following names:

Austria Risedronat STADA einmal wöchentlich 35 mg Filmtabletten
Bulgaria ZILAR 35 mg ????????? ????????
Denmark Risostad
Spain Risedronato Semanal STADA 35 mg film-coated tablets EFG
Portugal Risedronato de sódio Ciclum

Date of the most recent review of this leaflet: November 2020

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