SOLUDRONATE SEMANAL 70 mg ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Soludronate Weekly 70 mg Oral Solution

Alendronic Acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

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. Storing Soludronate Weekly 70 mg Oral Solution
6. Contents of the pack and further information

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

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

Soludronate Weekly 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.

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 a woman's skeleton. As a result, bone loss occurs and the bones weaken. The earlier a woman reaches menopause, the greater the risk of osteoporosis.

At first, osteoporosis does not usually cause symptoms. However, if left untreated, it can cause bones to fracture. Although these fractures are usually painful, those that occur in the spine may go unnoticed until a loss of height is observed. Bones can break during normal daily activity, such as lifting objects, or due to minor trauma that would not normally break a healthy 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's never too late to start treatment. Alendronic acid not only prevents bone loss but also actually helps rebuild bone after it has been lost and reduces the risk of bone fractures in the spine and hip.

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: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 the need to take dietary supplements (especially calcium and vitamin D).

2. What you need to know before you take Soludronate Weekly

Do not take Soludronate Weekly

• if you are allergic (hypersensitive) to alendronic acid or any of the other ingredients of Soludronate Weekly listed in section 6
• if you have certain problems with your esophagus (the tube that connects your mouth to your stomach), such as narrowing or difficulty swallowing liquids
• if your doctor has told you that you have low calcium levels in your blood
• if you cannot stand or sit up for at least 30 minutes

If you think any of these apply to you, do not take the solution. Talk 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 have allergies
• you have swallowing or digestive problems
• your doctor has told you that you have Barrett's esophagus (a disorder associated with changes in the cells that line the lower part of the esophagus)
• you have low blood calcium levels
• you have poor dental hygiene
• you are scheduled to have a tooth extracted
• 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 or have 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, adequate preventive dental care is necessary, as recommended by your dentist. You should contact your doctor or dentist if you experience any problems with your mouth or teeth, such as tooth loss, pain, or swelling.

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

Children and adolescents

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

Using Soludronate Weekly with other medicines

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

It is likely that calcium supplements, antacids, and some oral medicines will interfere with the absorption 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.

Certain medicines for rheumatism or long-term pain called NSAIDs (such as aspirin or ibuprofen) can cause digestive problems. Therefore, caution is advised if these medicines are taken at the same time as Soludronate Weekly.

Taking Soludronate Weekly with food, drinks, and 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 important that you follow the instructions in section 3. How to take Soludronate Weekly.

Pregnancy and breastfeeding

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

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

Soludronate Weekly contains

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

3. How to take Soludronate Weekly

Follow exactly the instructions for administration of Soludronate Weekly given by your doctor or pharmacist. If you are unsure, 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 you benefit from Soludronate Weekly.

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

• After getting up in the morning and before taking any food or drink or other medicine, take Soludronate Weekly.
• Drink the entire bottle of solution and then at least 30 ml (one-sixth of a glass) of plain water. You can drink more water (plain).
• 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, 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 when swallowing, chest pain, or new or worsening heartburn, consult your doctor.
• After taking Soludronate Weekly, wait at least 30 minutes before taking your first meal, drink, or other medicine 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 take too much solution by mistake, drink a full glass of milk.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine 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 dose the next morning after you remember. Do not take two doses on the same day. Take a dose once a week, as originally scheduled on your chosen day.

If you stop taking Soludronate Weekly

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Common:may affect up to 1 in 10 people

• heartburn, difficulty swallowing, pain when swallowing, esophagus ulcers (the tube that connects the mouth to the stomach), which can 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
• mouth and/or jaw pain, swelling or ulcers in the mouth, numbness or a feeling of heaviness in the jaw or tooth loss. These could be symptoms of damage to the jawbone (osteonecrosis) often associated with delayed healing and infection, usually after a tooth extraction or if you are receiving treatment for cancer
• atypical fractures of the thigh bone (femur) that can occur rarely, especially 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 of a possible fracture of the femur

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 feeling in the stomach or belching after eating, indigestion, constipation, feeling of fullness or bloating in the stomach, diarrhea, flatulence
• headache, dizziness
• joint swelling
• itching
• hair loss (alopecia)
• fatigue
• swelling of the hands or feet
• feeling 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 that connects the mouth to the stomach) or stomach
• black or tarry stools
• blurred vision; eye pain or redness
• skin rash, redness of the skin
• symptoms similar to those of the flu, such as muscle pain, general feeling of discomfort, and sometimes fever, which 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 feeling of tingling in the fingers or around the mouth
• gastric or duodenal ulcers (sometimes severe or with bleeding)
• narrowing of the esophagus (the tube that connects the mouth to the stomach)
• worsening of skin rash with sunlight
• Atypical fractures of the thigh bone (femur) that can occur rarely, especially 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 of a possible fracture of the femur

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

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

Tell your doctor or pharmacist about these symptoms or any other unusual symptoms. It is useful to make a note of what you experienced, when it started, and how long it lasted.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Soludronate Weekly

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

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

Store below 25°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

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 ingredients are:

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

Appearance of the product and packaging contents

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

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the EEA Member States under 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

Date of the last revision of this leaflet:October 2021.

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