Soludronate Semanal 70 mg oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Soludronate Weekly 70 mg oral solution

alendronic acid

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

It is especially important to understand the information in section 3. How to take Soludronate Weekly before taking this medicine.

Contents of the leaflet:

1. What Soludronate Weekly is and what it is used for
2. What you need to know before taking Soludronate Weekly
3. How to take Soludronate Weekly
4. Possible side effects
5. How to store Soludronate Weekly
6. Contents of the pack and other information

Soludronate Weekly 70 mg oral solution will be referred to as Soludronate Weekly throughout this leaflet.

1. What Soludronate Weekly is and what it is used for

Soludronate Weekly contains the active substance alendronic acid and belongs to a group of non-hormonal medicines called bisphosphonates. Soludronate Weekly is used to:

• Prevent bone loss (osteoporosis) that occurs in women after menopause and help rebuild bone.
• Reduce the risk of spinal and hip fractures.

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

Soludronate Weekly is a treatment taken once a week.

What is osteoporosis?

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

In its early stages, osteoporosis usually does not cause symptoms. However, if left untreated, it can lead to bone fractures. Although these fractures are often painful, those occurring in the spine may go unnoticed until a decrease in height is observed. Bones may break during normal daily activities, such as lifting objects, or from minor trauma that would not normally break a healthy bone. Fractures commonly occur in the spine, hip, or wrist and may cause not only pain but also significant problems, such as stooped 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 rebuild bone after it has been lost and reduces the risk of spinal and hip fractures.

In addition to your treatment with Soludronate Weekly, your doctor may recommend lifestyle changes to improve your condition, 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 exercise 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).

2. What you need to know before starting Soludronate Weekly

Do not take Soludronate Weekly

• if you are allergic (hypersensitive) to alendronic acid or to any of the other ingredients of Soludronate Weekly listed in section 6
• if you have certain problems with your oesophagus (the tube connecting your mouth to your stomach), such as narrowing or difficulty swallowing liquids
• if you are at risk of aspiration (liquid entering the airways) due to difficulty swallowing liquids
• if your doctor has told you that you have low blood calcium levels
• if you cannot remain upright or sitting fully upright for at least 30 minutes

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Soludronate Weekly if:

• you have kidney problems
• you currently have or have recently had difficulty swallowing or digestive problems
• your doctor has told you that you have Barrett’s oesophagus (a condition associated with changes in the cells lining the lower part of the oesophagus)
• you have problems absorbing minerals in your stomach or intestines (malabsorption syndrome)
• you have poor dental hygiene, gum disease, a planned tooth extraction, or do not receive routine dental care
• you have cancer
• you are receiving chemotherapy or radiotherapy
• you are taking angiogenesis inhibitors (such as bevacizumab or thalidomide) used in the treatment of cancer
• you are taking corticosteroids (such as prednisone or dexamethasone) used to treat conditions such as asthma, rheumatoid arthritis, and severe allergies
• you are or have been a smoker (as this may increase the risk of dental problems)

You may be advised to have a dental examination before starting treatment with Soludronate Weekly. Adequate preventive dental care, as recommended by your dentist, is necessary during treatment. Contact your doctor or dentist if you experience any problems in your mouth or teeth, such as tooth loss, pain, or swelling.

Irritation, inflammation, or ulceration of the oesophagus (the tube connecting the mouth to the stomach) may occur, often with symptoms such as chest pain, heartburn, or difficulty or pain when 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 must not be given to children or adolescents under 18 years of age, as there is insufficient data on its safety and efficacy.

Use of Soludronate Weekly with other medicines

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

Calcium supplements, antacids, and certain oral medications may interfere with the absorption of Soludronate Semanal if taken at the same time. Therefore, it is important that you follow the instructions in section 3. How to take Soludronate Semanal.

Certain long-term rheumatism or pain medications called NSAIDs (e.g., acetylsalicylic acid (aspirin) or ibuprofen) may cause gastrointestinal problems. Therefore, caution should be exercised when taking these medications concurrently with Soludronate Weekly.

Taking Soludronate Weekly with food, drinks, and alcohol

Food and beverages (such as mineral water) may reduce the effectiveness of Soludronate Weekly if taken at the same time. Therefore, it is important that you follow the instructions in section 3. How to take Soludronate Weekly.

Pregnancy and breastfeeding

Soludronate Weekly is intended for use only in postmenopausal women.

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

Driving and use of machines

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

Soludronate Weekly contains

This medicine contains orange yellow (E110) and methyl and propyl parahydroxybenzoate (E218, E216), which may cause allergic reactions (possibly delayed).

This medicine contains 0.15% v/v ethanol (alcohol), i.e., up to 115 mg per dose, equivalent to 3 ml of beer or 1.3 ml of wine per dose. The small amount of alcohol in this medicine will not have noticeable effects.

3. How to take Soludronate Weekly

Follow exactly the administration instructions for Soludronate Weekly as given by your doctor or pharmacist. If you have any doubts, please consult your doctor or pharmacist again.

The recommended dose is one single dose of 70 mg (100 ml) once weekly.

Carefully follow these instructions to ensure 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 Soludronate Weekly reaches your stomach quickly and helps reduce the possibility of irritation of the esophagus (the tube connecting the mouth to the stomach).

• Take Soludronate Weekly after getting up in the morning and before eating any food or drink or taking any other medication.
• Drink the entire bottle of solution, followed by at least 30 ml (one-sixth of a glass) of plain tap water. You may drink more water (tap water).
• Do not drink mineral water (still or sparkling), coffee, tea, juice, or milk.
• Do not lie down for at least 30 minutes after taking the solution; remain fully 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 when swallowing, chest pain, or new or worsening heartburn, stop taking Soludronate Weekly and consult your doctor.
• After taking Soludronate Weekly, wait at least 30 minutes before taking your first meal, drink, or other medication of the day, including antacids, calcium supplements, and vitamins. Soludronate Weekly is effective only 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, contact your doctor or pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. Do not induce vomiting and do not lie down.

If you forget to take Soludronate Weekly

If you miss a dose, take the dose the morning you remember. Do not take two doses on the same day. Resume your once-weekly dosing schedule as originally planned on your chosen day.

If you stop taking Soludronate Weekly

It is important to continue taking Soludronate Weekly for as long as your doctor has prescribed it. Soludronate Weekly can treat your osteoporosis only if you continue taking it.

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.

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

Common: may affect up to 1 in 10 people

• heartburn, difficulty swallowing, pain when swallowing, oesophageal ulceration (the tube connecting the mouth to the stomach), which may cause chest pain, heartburn, difficulty or pain when swallowing

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

• allergic reactions such as hives, swelling of the face, lips, tongue or throat, possibly with difficulty breathing or swallowing, and severe skin reactions
• pain in the mouth and/or jaw, swelling or sores in the mouth, numbness or a feeling of heaviness in the jaw, or tooth loss. These could be symptoms of jaw bone damage (osteonecrosis), generally associated with delayed healing and infection, often following dental extraction or if you are receiving cancer treatment
• atypical femoral fractures (thigh bone), which may rarely occur, particularly in patients on long-term treatment for osteoporosis. Contact 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

Frequency not known (cannot be estimated from available data):

• atypical fractures occurring at sites other than the femur (thigh bone)

Other adverse effects:

Very common: may affect more than 1 in 10 people

• bone, muscle or joint pain, sometimes severe

Frequent: may affect up to 1 in 10 people

• abdominal pain, uncomfortable feeling in the stomach or burping after eating, indigestion, constipation, feeling of fullness or bloating in the stomach, diarrhea, flatulence
• headache, dizziness
• joint swelling
• itching
• alopecia (hair loss)
• fatigue
• swelling of the hands or legs
• sensation of spinning associated with dizziness (vertigo)

Uncommon: may affect up to 1 in 100 people

• nausea, vomiting
• irritation or inflammation of the esophagus (the tube connecting the mouth to the stomach) or stomach
• black or tar-like stools
• blurred vision; eye pain or redness
• skin rash, redness of the skin
• transient flu-like symptoms, such as muscle pain, general malaise, and sometimes fever, which usually occur at the beginning of treatment
• altered 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)
• narrowing of the esophagus (the tube connecting the mouth to the stomach)
• worsening of skin rash upon exposure to sunlight

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

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

Promptly inform your doctor or pharmacist about these symptoms or any other unusual symptoms. It is helpful to keep a record of what you experienced, when it started, and how long it lasted.

Reporting of adverse reactions

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

5. Storage of Soludronate Weekly

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and bottle. The expiry date is the last day of the month indicated.

Store below 25 °C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Soludronate Weekly

Active substance:

The active substance is sodium alendronate trihydrate. Each single dose of 100 ml of solution contains sodium alendronate trihydrate equivalent to 70 mg of alendronic acid.

Other components:

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

Appearance of the product and contents of the container

Soludronate Semanal is an orange-coloured solution. It is available in transparent polyethylene terephthalate (PET) bottles with a tamper-evident seal and a low-density polyethylene lining, in pack sizes of 1, 2, 4 and 12 bottles. Each bottle contains 100 ml of solution and is intended for single use only.

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Laboratorios Rubió, S.A.

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

08755 Castellbisbal (Barcelona)

Spain

Manufacturer:

PINEWOOD LABORATORIES LTD

Ballymacarbry

Clonmel

County Tipperary

Ireland

or

Chanelle Medical

Dublin Road

Loughrea

Co. Galway

Ireland

This medicinal product is authorised in EEA Member States under the following names:

Bonasol: France, Ireland, Italy, Netherlands, Portugal

Alensol: Denmark, Finland, Norway, Sweden

AlendroDrink: Germany

Elanosta: Hungary

Alendronic Acid: United Kingdom

Soludronate: Spain

Date of the most recent review of this leaflet: February 2026

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