PROSPECTO: INFORMATION FOR THE USER

Efensol 3 g powder for oral suspension

Colestiramina

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to other people, 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.

Contents of theprospectus

1.What Efensol is and for what it is used

2.What you need to know before starting to take Efensol

3.How to take Efensol

4.Possible adverse effects

5.Storage of Efensol

6.Contents of the package and additional information

Efensol belongs to a group of medications known as ion exchange resins, which bind to bile acids.

Efensol is used to reduce levels of cholesterol (a type of fat) in your body that can cause heart problems. The medication acts in the intestine by binding to bile acids containing cholesterol, preventing its absorption and eliminating it through feces.

It may also be used to treat a specific type of itching.

Do not take Efensol:

• If you are allergic to the active ingredient or any of the components of this medication (listed in section 6).
• If you have a disease that completely blocks your bile ducts..
• If you have severe constipation.
• If you are pregnant or plan to become pregnant while taking this medication.
• If you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Efensol.

Efensol should never be taken as dry powder without dissolving it in a liquid, as it may cause a spasm in the esophagus and choking.

While taking this medication, your doctor may order you to take supplements of vitamins A, D, E, and K or folic acid.Follow your doctor's instructions carefully.

During treatment with this medication, your triglycerides in the blood may not decrease or may even increase, usually temporarily.

This medication may cause constipation or worsen it if you have it. Follow your doctor's instructions carefully if you have hemorrhoids or a heart disease (coronary disease), as in those cases, the medication dose should be adjusted or reduced and fluid and dietary fiber intake should be increased.

If you have or have had a stomach ulcer, take this medication with caution, as you may have a relapse.

Taking Efensol with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription, homeopathic, herbal, and other health-related products.

If you are taking other oral medications, it is essential to take them at a different time than Efensol. Any medication should be taken at least 1 hour before or 4-6 hours after taking Efensol. This is because Efensol may alter the effects of other medications, preventing them from working properly. Additionally, Efensol may remain in the digestive system and prevent other medications from being absorbed by the body.

Consult your doctor if you are taking:

• Medications for the treatment of heart rhythm disorders (antiarrhythmics) such as amiodarone.
• Medications for the treatment of pain and/or fever (analgesics and anti-inflammatory drugs) such as paracetamol, diclofenac, phenylbutazone, ibuprofen, meloxicam, piroxicam, tenoxicam, sulindac.
• Medications to prevent blood clots (anticoagulants) such as warfarin.
• Medications for the treatment of depression (antidepressants) such as doxepin and imipramine.
• Medications for the treatment of diabetes (antidiabetics) such as glipizide, acarbose.
• Medications for the treatment of malaria and other parasitic infections such as chloroquine and metronidazole.
• Medications to treat some heart diseases called beta-blockers such as propranolol.
• Medications for the treatment of heart failure (cardiotonics) such as digoxin.
• Corticosteroids such as hydrocortisone.
• Medications to increase urine volume (diuretics) such as furosemide, hydrochlorothiazide.
• Hormones such as estrogens, progesterone.
• Hormones such as levothyroxine, liothyronine.
• Medications to treat high levels of cholesterol and triglycerides in the blood (statins) such as fluvastatin, pravastatin.
• Medications to treat diarrhea (antidiarrheals) such as loperamide.
• Antibiotics such as tetracyclines.
• Medications to prevent transplant rejection (immunosuppressants), such as mycophenolate mofetil.
• Medications for the prevention of osteoporosis such as raloxifene.
• Medications for the treatment of epilepsy such as valproic acid, barbiturates.

Taking Efensol with food and drinks

It is recommended that you do not exceed the amount of alcohol allowed by your doctor, as alcohol may increase cholesterol levels.

If you have been prescribed a medication to lower cholesterol levels, it is recommended that you follow a low-fat diet as advised by your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

Do not take this medication if you are pregnant or plan to become pregnant.

IMPORTANT FOR WOMEN:

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.The consumption of medications during pregnancy can be hazardous to the embryo or fetus and should be monitored by your doctor.

Breastfeeding

Do not take Efensol while breastfeeding your child.

Driving and operating machinery

Efensol does not affect your ability to drive vehicles or operate machinery.

Efensol contains aspartame (E-951) and sorbitol (E-420)

This medication may be hazardous for individuals with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

This medication contains sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause a mild laxative effect due to the presence of 3.46 g of sorbitol per tablet. Caloric value: 2.6 kcal/g of sorbitol.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medication is administered orally.

Adults:The usual doses are from 1 to 4 or 5 sachets per day taken preferably before meals. If considered advisable, a single dose may be taken at the first hours of the morning with the entire daily dose recommended.

Children:Efensol is not recommended for use in children.

Do not take this medication without mixing it with water or another liquid, as it may cause a spasm in the esophagus.

To reconstitute the sachets, pour their contents and shake vigorously in a glass of water or fruit juice (approximately 150 ml) until a uniform suspension is obtained, and proceed to take it immediately.

Take this medication until your doctor tells you to stop. You will have regular check-ups while taking this medication.

If you take more Efensol than you should

In case of accidental ingestion, consult your doctor or pharmacist immediately or contact the emergency service at the nearest hospital and bring the medication with you. You can also call theToxicological Information Service Telephone 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Efensol

Take the missed dose as soon as you remember, except if the time of your next dose is near. In that case, do not take the missed dose and continue taking the medication as instructed.

Do not take a double dose to compensate for the missed doses.

Like all medications, Efensol may produce adverse effects, although not all people will experience them.

Gastrointestinal disorders.

Gastrointestinal reactions are the most frequent.

The most frequently observed adverse reaction is constipation. Constipation may favor the occurrence of fecal impaction (fecaloma), and may exacerbate the symptoms of pre-existing hemorrhoids.

Other observed adverse reactions include: hemorrhoids, heartburn and acid reflux (dyspepsia), abdominal pain, flatulence, nausea, vomiting, diarrhea.

Occasionally, the following have occurred: pruritus (itching sensation) on the tongue, pruritus (itching sensation) anal.

Efensol may cause the appearance of steatorrhea (fatty stools), especially when administered at high doses.

Metabolic and nutritional disorders.

Hyperchloremic acidosis (increase of acid in the body's fluids).

Blood and lymphatic system disorders

Risk of bleeding, due to decreased prothrombin, a substance necessary for blood to clot.

The chronic use of Efensol may be associated with a greater tendency to the occurrence of hemorrhage due to secondary hypoprothrombinemia secondary to a vitamin K deficiency due to a decrease in its absorption (see section 4.4. Warnings and precautions).

Musculoskeletal and connective tissue disorders

Osteoporosis (bone mass loss with greater propensity to fractures).

Skin and subcutaneous tissue disorders

Erythema (skin eruption).

To minimize these effects, you will start taking Efensol with a low dose that will be gradually increased. These adverse effects usually disappear over time.

If you experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Keep out of sight and reach of children.

Do not use Efensol after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medicines at the SIGRE collection point at the pharmacy.If in doubtask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Efensol

• The active ingredient is colestiramine. Each packet contains 3 g of colestiramine.
• The other components (excipients) are:aspartame (E-951), sorbitol (E-420), citric acid, sodium carboxymethylcellulose, guar gum and banana essence.

Appearance of the product and contents of the packaging

Efensol is presented in packaging containing 40 single-dose packets.

Holder of the marketing authorization

LAZLO INTERNACIONAL, S.A.

Cristalia Business Park

Vía de los Poblados 3, Edif. 2, 2nd left.

28033 Madrid

Responsible for manufacturing

FAES FARMA, S.A.

Maximo Aguirre, 14.

48940Lamiaco-Lejona (Biscay), Spain

Date of the last review of this leaflet: March-2013

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