Efensol 3 g powder for oral suspension
SpainTable of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Efensol 3 g powder for oral suspension
Cholestyramine
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
Contents of the leaflet
- What Efensol is and what it is used for
- What you need to know before taking Efensol
- How to take Efensol
- Possible side effects
- How to store Efensol
- Contents of the pack and other information
1. What Efensol is and what it is used for
Efensol belongs to a group of medicines called ion-exchange resins, which bind to bile acids.
Efensol is used to reduce cholesterol levels (a type of fat) in your body that may lead to heart problems. The medicine works in the intestine by binding to bile acids containing cholesterol, thereby preventing their absorption and eliminating them through the faeces.
It may 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 to any of the components of this medicine (listed in section 6).
- If you have a disease causing complete blockage of 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 starting to take Efensol.
Efensol must never be taken as a dry powder without dissolving it in liquid, as it may cause esophageal spasm and choking.
While taking this medicine, your doctor may prescribe vitamin supplements containing vitamins A, D, E, and K or folic acid. Follow your doctor's instructions carefully.
During treatment with this medicine, blood triglyceride levels may not decrease or may even increase, usually temporarily.
This medicine may cause constipation or worsen existing constipation. Follow your doctor's instructions carefully if you have hemorrhoids or heart disease (coronary heart disease), as in these cases the dose of the medicine may need to be adjusted or reduced, and intake of fluids and dietary fiber should be increased.
If you currently have or have previously had a stomach ulcer, take this medicine with caution, as a relapse may occur.
Taking Efensol with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, homeopathic remedies, herbal medicines, 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 may alter the effects of other medicines, preventing them from working properly. Additionally, Efensol may remain in the digestive system and may interfere with the absorption of other medicines into the body.
Consult your doctor if you are taking:
- Medicines for heart rhythm disorders (antiarrhythmics) such as amiodarone.
- Medicines for 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 depression (antidepressants) such as doxepin and imipramine.
- Medicines for diabetes (antidiabetics) such as glipizide, acarbose.
- Medicines for malaria and other parasitic infections such as chloroquine and metronidazole.
- Medicines for certain heart conditions known as beta-blockers such as propranolol.
- Medicines for heart failure (cardiotonics) such as digoxin.
- Corticosteroids such as hydrocortisone.
- Medicines to increase urine volume (diuretics) such as furosemide, hydrochlorothiazide.
- Hormones such as estrogens, progesterone.
- Thyroid hormones such as levothyroxine, liothyronine.
- Medicines to treat high blood cholesterol and triglyceride levels (statins) such as fluvastatin, pravastatin.
- Medicines for diarrhea (antidiarrheals) such as loperamide.
- Antibiotics such as tetracyclines.
- Medicines to prevent transplant rejection (immunosuppressants), such as mycophenolate mofetil.
- Medicines for prevention of osteoporosis such as raloxifene.
- Medicines for epilepsy such as valproic acid, barbiturates.
Taking Efensol with food and drinks
It is recommended that your alcohol intake does not exceed the amount permitted by your doctor, as alcohol may 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
Consult your doctor or pharmacist before using 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine. Taking medicines during pregnancy may be harmful to 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 or operate machinery.
Efensol contains aspartame (E-951) and sorbitol (E-420)
This medicine may be harmful for people with phenylketonuria because it contains aspartame, a source of phenylalanine.
This medicine contains sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine. It may have a mild laxative effect because it contains 3.46 g of sorbitol per sachet. Calorific value: 2.6 kcal/g of sorbitol.
3. How to take Efensol
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
This medicine is administered orally.
Adults: The usual dose ranges from 1 to 4 or 5 sachets per day, preferably taken before meals. If considered appropriate, the entire daily dose may be taken as a single dose in the early morning.
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 may cause spasms in the esophagus.
To reconstitute the sachets, pour the contents into a glass of water or fruit juice (approximately 150 ml), shake vigorously until a uniform suspension is obtained, and take immediately.
Continue taking this medicine for as long as your doctor has instructed. You will have periodic check-ups while taking this medicine.
If you take more Efensol than you should
In case of accidental ingestion, contact your doctor or pharmacist immediately, or go to the nearest hospital emergency department, and take the medicine with you. You may also call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount ingested.
If you forget to take Efensol
Take the missed dose as soon as you remember, unless it is almost time for 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 a missed dose.
4. Possible adverse effects
Like all medicines, Efensol may cause adverse effects, although not everyone gets them.
Gastrointestinal disorders.
Gastrointestinal reactions are the most commonly observed.
The most frequently reported adverse reaction is constipation. Constipation may lead to fecal impaction (fecaloma) and may worsen symptoms of pre-existing haemorrhoids.
Other observed adverse reactions include: haemorrhoids, burning and acid reflux (dyspepsia), abdominal pain, flatulence, nausea, vomiting, diarrhoea.
Occasionally reported: pruritus (itching sensation) of the tongue, anal pruritus.
Efensol may cause steatorrhoea (fat in the stools), especially when administered at high doses.
Metabolic and nutritional disorders.
Hyperchloraemic acidosis (increased acid levels in body fluids).
Blood and lymphatic system disorders.
Risk of bleeding due to decreased protamine, a substance necessary for blood coagulation.
Chronic use of Efensol may be associated with an increased tendency to bleeding due to hypoprothrombinemia secondary to vitamin K deficiency caused by reduced absorption (see section 4.4 Warnings and precautions).
Musculoskeletal and connective tissue disorders.
Osteoporosis (loss of bone mass with increased risk of fractures).
Skin and subcutaneous tissue disorders.
Erythema (skin rash).
To minimize these effects, you will start taking Efensol at a low dose, which will be gradually increased. These adverse effects usually disappear with time.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.
5. Storage of Efensol
Keep out of the sight and reach of children.
Do not use Efensol after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.
6. Package contents and other information
Composition of Efensol
- The active substance is cholestyramine. Each sachet contains 3 g of cholestyramine.
- The other components (excipients) are: aspartame (E-951), sorbitol (E-420), citric acid, sodium carboxymethylcellulose, guar gum, and banana flavouring.
Presentation of the product and contents of the pack
Efensol is available in packs containing 40 single-dose sachets.
Marketing Authorization Holder
LAZLO INTERNACIONAL, S.A.
Cristalia Business Park
Vía de los Poblados 3, Building 2, 2nd floor, left side
28033 Madrid, Spain
Manufacturer
FAES FARMA, S.A.
Maximo Aguirre, 14
48940 Lamiaco-Lejona (Vizcaya), Spain
Date of the most recent revision of this leaflet: March-2013
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./