Package Leaflet: Information for the User

Soludronate Weekly 70 mg Oral Solution

Alendronic Acid

Read this leaflet carefully before you start taking this medicine because it contains important information for you.because it contains important information for you.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. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4

1. What Soludronate Weekly 70 mg Oral Solution is and what it is used for

2.What you need to know before you take Soludronate Weekly 70 mg Oral Solution

3. How to take Soludronate Weekly 70 mg Oral Solution

4. Possible side effects

5. Storage of Soludronate Weekly 70 mg Oral Solution

6.Contents of the pack and additional information

Soludronate Weekly 70 mg Oral Solution will be referred to as Soludronate Weekly in this leaflet.

Weekly Soludronate belongs to a group of non-hormonal medications called bisphosphonates. Weekly Soludronate is used for:

• Preventing bone loss (osteoporosis) that occurs in women after menopause and helping to rebuild bone.
• Reducing the risk of fractures of the spinal column and hip.

Your doctor has prescribed Weekly Soludronate to treat your osteoporosis and reduce the risk of fractures of the spinal column and hip.

What is osteoporosis?

Osteoporosis is a thinning and weakening of the bones. It is common in women after menopause. During menopause, the ovaries stop producing the female hormone, estrogen, which helps maintain the health of the woman's skeleton. As a result of this, bone loss occurs and the bones weaken. The sooner a woman reaches menopause, the greater the risk of osteoporosis.

At first, osteoporosis usually does not cause symptoms. However, if it is not treated, it can cause bone fractures. Although these fractures usually hurt, those that occur in the spine may go unnoticed until a decrease in height is observed. Bones can break during normal daily activities, such as lifting objects, or by a minor trauma that would not normally break a normal bone. Fractures usually occur in the head, spine, or wrist and can cause not only pain, but also significant problems, such as a hunched posture (kyphosis) and loss of mobility.

How can osteoporosis be treated?

Osteoporosis can be treated and it is never too late to start treatment. Alendronic acid not only prevents bone loss but also helps to rebuild bone after it has been lost and reduces the risk of osteoporotic fractures in the spine and hip.

In addition to your treatment with Weekly Soludronate, your doctor may recommend lifestyle modifications to improve your process, such as:

Quitting smoking:Smoking appears to increase the rate of bone loss, thereby increasing the risk of fractures.

Exercise:Just like muscles, bones need to be exercised to stay strong and healthy. Consult your doctor before starting any exercise program.

Following a balanced diet:Your doctor may advise you on your diet or on the need to take dietary supplements (especially calcium and vitamin D).

Do not take Soludronate Weekly

• if you are allergic (hypersensitive) to alendronate acid or to any of the other components of Soludronate Weekly listed in section 6
• if you have some problems in the esophagus (the tube that connects the mouth with the stomach), such as narrowing or difficulty swallowing liquids
• if your doctor has told you that you have low calcium in your blood
• if you cannot remain standing or sitting upright for at least 30 minutes

If you think any of this applies to you, do not take the solution. Talk to your doctor first and follow their advice.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeSoludronate Weekly if:

• you have kidney problems
• you have allergies
• you have problems swallowing or digestive problems
• your doctor has told you that you have Barrett's esophagus (a disorder associated with alterations of the cells that line the lower part of the esophagus)
• you have low blood calcium levels
• you have poor dental hygiene
• you are planning to have a tooth extraction
• you have cancer
• you are receiving chemotherapy or radiation therapy
• you are receiving steroids
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide)
• you do not receive regular dental care
• you have gum disease
• you are orhave been a smoker (as this may increase the risk of dental problems)

You may be advised to have a dental check-up before starting treatment with Soludronate Weekly.During treatment, you will need to have adequate preventive dental care, as recommended by your dentist.You should contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or inflammation.

Irritation, inflammation, or ulceration of the esophagus (the tube that connects the mouth with the stomach) may occur, often with symptoms of chest pain, burning, or difficulty or pain swallowing, especially if patients lie down after taking Soludronate Weekly. These side effects may worsen if patients continue taking Soludronate Weekly after experiencing these symptoms.

Children and adolescents

Soludronate Weekly should not be administered to children or adolescents under 18 years of age due to insufficient data on its safety and efficacy.

Use ofSoludronate Weekly withother medicines

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

It is likely that calcium supplements, antacids, and some oral medications will interfere with the absorption of Soludronate Weekly if taken at the same time. Therefore, it is essential to follow the advice in section 3. How to take Soludronate Weekly.

Certain medications for rheumatism or for long-term pain called NSAIDs (such as aspirin or ibuprofen) may cause digestive problems. Therefore, caution should be exercised if taken at the same time as Soludronate Weekly.

Taking Soludronate Weekly with food, drinksand alcohol

It is likely that food and drinks (such as mineral water) will reduce the effectiveness of Soludronate Weekly if taken at the same time. Therefore, it is essential to follow the advice in section 3. How to take Soludronate Weekly.

Pregnancy and breastfeeding

The use of Soludronate Weekly is only intended for postmenopausal women.

You should not take Soludronate Weekly if you are pregnant or think you may be pregnant, or are breastfeeding.

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

Adverse effects (such as blurred vision, dizziness, and intense bone, muscle, or joint pain) with alendronate acid have been reported that may affect your ability to drive or operate machinery. Individual responses to alendronate acid may vary (see section 4. Possible side effects).

Soludronate Weekly contains

This medicine contains yellow-orange (E110) and parahydroxybenzoate of methyl and propyl (E218, E216), which may cause allergic reactions (possibly delayed). Allergy is more frequent if you are allergic to aspirin. Consult your doctor or pharmacist if you have doubts.

This medicine contains a volume of 0.15% ethanol (alcohol), i.e., up to 115 mg per dose, which is equivalent to 3 ml of beer or 1.3 ml of wine per dose, so it may be harmful to patients with alcoholism. It is also necessary to take this into account in high-risk groups, such as patients with liver disease or epilepsy.

Follow exactly the administration instructions for Soludronate Weekly as indicated by your doctor or pharmacist. In case of doubts, consult your doctor or pharmacist again.

The recommended dosage is a single dose of 70 mg (100 ml)once a week.

Follow these instructions carefully to ensure that you benefit from Soludronate Weekly.

Choose the day of the week that best fits your routine. Each week, take Soludronate Weekly on the day you have chosen.

It is very important that you follow these instructions so that SoludronateWeeklyreaches your stomach quickly and helps reduce the possibility of esophagus irritation (the tube that connects the mouth with the stomach).

• After getting up in the morning and before taking any food or drink or other medication, take Soludronate Weekly.
• Drink the entire bottle of solution and then at least 30 ml (one-sixth of a glass) of tap water. You can take more water (tap).
• Do not take mineral water (still or carbonated), coffee, tea, juice, or milk.
• Do not lie down for at least 30 minutes after taking the solution, stay completely upright (sitting, standing, or walking).Do not lie down until after your first meal of the day.
• Do not take Soludronate Weekly at bedtime or before getting up in the morning.
• If you experience difficulty or pain swallowing, chest pain, or new or worsening stomach burning, consult your doctor.
• After taking Soludronate Weekly, wait at least 30 minutes before taking your first meal, drink, or other medication of the day, such as antacids, calcium supplements, and vitamins. Soludronate Weekly is only effective if taken on an empty stomach.

If you take more Soludronate Weekly than you should

If you accidentally take too much solution, drink a full glass of milk.

In case of overdose or accidental ingestion, consult your doctor or pharmacistor call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. Do not induce vomiting or lie down.

If you forget to take Soludronate Weekly

If you forget a dose, take the morning dose after you remember.Do not take two doses on the same day. Resume taking a dose once a week, as originally planned on your chosen day.

If you interrupt treatment with Soludronate Weekly

It is essential that you continue taking Soludronate Weekly for as long as your doctor prescribes the medication. Soludronate Weekly can only treat your osteoporosis if you continue taking it.

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

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

Contact your doctor immediatelyif you notice any of the following side effects, as they may be serious and require urgent medical treatment:

Common:may affect up to 1 in 10 patients

• burning sensation, difficulty swallowing, pain when swallowing, esophageal ulceration (the tube that connects the mouth to the stomach), which may cause chest pain, burning, difficulty, or pain when swallowing

Rare:may affect up to 1 in 1,000 patients:

• allergic reactions such as urticaria, facial swelling, lip, tongue, or throat swelling, possibly with difficulty breathing or swallowing and severe skin reactions
• mouth and/or jaw pain, swelling, or sores in the mouth, numbness, or a feeling of heaviness in the jaw or tooth loss. These may be symptoms of mandibular bone damage (osteonecrosis) in general associated with delayed healing and infection, often after a dental extraction or if you are receiving cancer treatment
• atypical femur fractures that may occur in rare cases, especially in patients undergoing prolonged treatment for osteoporosis. Contact your doctor if you notice pain, weakness, or discomfort in the thigh, hip, or groin, as they may be early symptoms and indicative of a possible femur fracture

Other side effects:

Very common:may affect more than 1 in 10 people

• bone, muscle, or joint pain, sometimes severe

Common:may affect up to 1 in 10 people

• abdominal pain, uncomfortable sensation in the stomach, or belching after eating, indigestion, constipation, feeling full or bloated in the stomach, diarrhea, flatulence
• headache, dizziness
• swelling of the joints
• itching
• alopecia (hair loss)
• fatigue
• swelling of the hands or legs
• vertigo associated with dizziness

Uncommon:may affect up to 1 in 100 people

• nausea, vomiting
• irritation or inflammation of the esophagus (the tube that connects the mouth to the stomach) or stomach
• black stools or similar to tar
• blurred vision; eye pain or redness
• skin rash, redness of the skin
• transient symptoms similar to the flu, such as muscle pain, general feeling of discomfort, and sometimes fever that usually appear at the beginning of treatment
• alteration of taste

Rare:may affect up to 1 in 1,000 people

• symptoms of low blood calcium levels, such as muscle cramps or spasms or a tingling sensation in the fingers or around the mouth
• gastric or peptic ulcers (sometimes severe or with bleeding)
• esophageal stricture (the tube that connects the mouth to the stomach)
• exacerbation of skin rash with sunlight
• Atypical femur fractures that 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 they may be early symptoms and indicative of a possible femur fracture

Very rare:may affect up to 1 in 10,000 people

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

Inform your doctor or pharmacist immediately about these symptoms or any other unusual symptoms. It is helpful to note what you experienced, when it started, and how long it lasted.

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 leaflet. You can also report them directly 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.

Keepthis medicationout ofsight and reach ofchildren.

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

Store below 25 °C.

Do not dispose of medications through drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Soludronate Weekly

Active ingredient:

The active ingredient is alendronate sodium trihydrate. Each 100 ml of solution contains 70 mg of alendronic acid as alendronate sodium trihydrate.

Other components are:

Xanthan gum (E415), sodium cyclamate (E952), sucralose (E955), yellow-orange FCF (E110), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), orange flavor with ethanol and butylhydroxyanisole (E320) and, purified water.

Appearance of the product and contents of the container

Soludronate Weekly is an orange-colored solution. It is available in transparent polyethylene terephthalate (PET) bottles with a safety cap and a low-density polyethylene coating in container sizes of 1, 2, 4, and 12 bottles. Each bottle contains 100 ml of solution and is for single use only.

Some container sizes may be marketed exclusively.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Laboratorios Rubió, S.A.

C/ Industria, 29. Pol. Ind. Comte de Sert

08755 Castellbisbal (Barcelona)

Spain

Manufacturer responsible:

PINEWOOD LABORATORIES LTD

Ballymacarbry

Clonmel

County Tipperary

Ireland

or

Chanelle Medical

Dublin Road

Loughrea

Co. Galway

Ireland

This medicine is authorized in the EEA member states with the following names:

Bonasol: Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Portugal, Romania, Slovak Republic.

Alenat: Sweden

Alendron: Germany

Alendronic Acid Oral solution: United Kingdom

Soludronate: Spain

Last review date of this leaflet:October 2021.

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/