EFENSOL 3 g ORAL SUSPENSION POWDER

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Efensol 3 g powder for oral suspension

Colestyramine

Read 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 symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of theleaflet

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

1. What is Efensol and what is it used for

Efensol belongs to a group of medicines called ion exchange resins, which bind to bile acids.

Efensol is used to lower cholesterol levels (a type of fat) in your body that can cause heart problems. The medicine works in the intestine by binding to bile acids that contain cholesterol, preventing their absorption and eliminating them through the feces.

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

2. What you need to know before taking Efensol

Do not take Efensol:

• If you are allergic to the active substance or any of the other ingredients of this medicine (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 planning to become pregnant while taking this medicine.
• If you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before taking Efensol.

Efensol should never be taken as dry powder without dissolving it in liquid, as it can cause esophageal spasm and choking.

While taking this medicine, your doctor may order you to take a vitamin A, D, E, and K supplement or folic acid. Follow your doctor's instructions carefully.

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

This medicine can cause constipation or worsen it if you already have it. Follow your doctor's instructions carefully if you have hemorrhoids or heart disease (coronary artery disease), as the dose of the medicine may need to be adjusted or decreased and fluid and dietary fiber intake increased.

If you have or have had a stomach ulcer, you should take this medicine with caution, as it may cause a relapse.

Taking Efensol with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription, homeopathic medicines, herbal remedies, and other health-related products.

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

Talk to your doctor if you are taking:

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

Taking Efensol with food and drinks

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

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

Pregnancy and breastfeeding

Talk to your doctor or pharmacist before taking any medicine.

Pregnancy

Do not take this medicine if you are pregnant or planning to become pregnant.

IMPORTANT FOR WOMEN:

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, talk to your doctor or pharmacist before taking this medicine. Taking medicines during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Breastfeeding

Do not take Efensol while breastfeeding your child.

Driving and using machines

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

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

This medicine may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, talk to them before taking this medicine. It can cause a mild laxative effect because it contains 3.46 g of sorbitol per sachet. Caloric value: 2.6 kcal/g of sorbitol.

3. How to take Efensol

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, talk to your doctor or pharmacist again.

This medicine is administered orally.

Adults:The usual doses are from 1 to 4 or 5 sachets per day, taken preferably before meals. If necessary, a single dose can be taken in the early morning hours with the entire daily recommended dose.

Children:The use of Efensol is not recommended in children.

Do not take this medicine without mixing it with water or another liquid, as it can cause esophageal spasm.

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

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

If you take more Efensol than you should

In case of accidental ingestion, talk to your doctor or pharmacist immediately or contact the emergency department of the nearest hospital and take the medicine with you. You can also call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount taken.

If you forget to take Efensol

Take the missed dose as soon as you remember, unless it is close to the time of your next dose. In that case, do not take the missed dose and continue taking the medicine as instructed.

Do not take a double dose to make up for missed doses.

4. Possible side effects

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

Gastrointestinal disorders.

Gastrointestinal reactions are the most frequent.

The most commonly observed adverse reaction is constipation. Constipation can favor the appearance of fecal impaction (fecaloma) and can worsen pre-existing hemorrhoid symptoms.

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

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

Efensol can cause the appearance of steatorrhea (fat in the feces), especially when administered at high doses.

Metabolic and nutritional disorders.

Hyperchloremic acidosis (increase in acid in body fluids).

Blood and lymphatic system disorders

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

Chronic use of Efensol may be associated with an increased tendency to bleeding due to hypoprothrombinemia secondary to vitamin K deficiency due to decreased absorption (see section 4.4. Warnings and precautions).

Musculoskeletal and connective tissue disorders

Osteoporosis (loss of bone mass with increased propensity for fractures).

Skin and subcutaneous tissue disorders

Erythema (skin rash).

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

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

5. Storage of Efensol

Keep out of the sight and reach of children.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Efensol

• The active substance is colestyramine. Each sachet contains 3 g of colestyramine.
• The other ingredients (excipients) are: aspartame (E-951), sorbitol (E-420), citric acid, sodium carboxymethylcellulose, guar gum, and banana flavor.

Appearance of the product and packaging contents

Efensol is presented in packs containing 40 single-dose sachets.

Marketing authorization holder

LAZLO INTERNACIONAL, S.A.

Parque empresarial Cristalia

Vía de los Poblados 3, Edif. 2, 2º izda.

28033 Madrid

Manufacturer

FAES FARMA, S.A.

Maximo Aguirre, 14.

48940 Lamiaco-Lejona (Vizcaya), Spain

Date of last revision of this leaflet: March 2013

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