Resincolestiramina 4 g powder for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Resincolestiramina 4 g oral suspension powder

colestipol

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, 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. See section 4.

Contents of this leaflet:

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

1. What Resincolestiramine is and what it is used for

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

• Resincolestiramine is used to lower the levels of cholesterol (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, preventing their absorption and eliminating them through the faeces.
• Resincolestiramine is used to treat diarrhoea caused by an excess of bile acids in the intestine due to poor absorption of these acids. This condition may occur in cases of Crohn's disease, intestinal resection (removal of part of the intestine), or vagotomy (surgery of the vagus nerve), or other conditions leading to excess bile acids in the intestine.
• Resincolestiramine may also be used to treat a specific type of itching caused by bile retention (cholestasis).

2. What you need to know before taking Resincolestiramine

Do not take Resincolestiramine

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you have a disease in which your bile ducts are completely blocked.
• if you suffer from severe constipation.
• if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before taking Resincolestiramine.

Resincolestiramine must never be taken as a dry powder, due to the risk of causing esophageal spasm, choking, or acute respiratory failure.

During treatment with this medicine, blood triglyceride levels may not decrease or may even increase, usually temporarily.

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

This medicine may cause constipation or worsen existing constipation. Follow your doctor's instructions carefully if you have hemorrhoids or a heart condition, as in such cases the dose of the medicine may need to be adjusted or reduced, and your 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.

Other medicines and Resincolestiramine

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

If other oral medicines are being taken, it is important to take them at a different time than Resincolestiramine. Any other medicine should be taken at least 1 hour before or 4–6 hours after taking Resincolestiramine, as it may alter the effects of other medicines or prevent their absorption into the body.

Consult 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 and acarbose.
• Medicines for the treatment of malaria and other parasitic infections, such as chloroquine and metronidazole.
• Medicines for the treatment of certain heart conditions known as beta-blockers, such as propranolol.
• Medicines for the treatment of heart failure (cardiotonics), such as digoxin.
• Corticosteroids, such as hydrocortisone.
• Medicines to increase urine volume (diuretics), such as furosemide and hydrochlorothiazide.
• Hormones, such as estrogens and progesterone.
• Thyroid hormones, such as levothyroxine and liotrix.
• Medicines for treating high cholesterol and triglyceride levels in the blood (statins), such as fluvastatin and pravastatin.
• Medicines for treating 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 and barbiturates.

Pregnancy, breastfeeding, and fertility

Do not take Resincolestiramine during pregnancy or breastfeeding.

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.

Driving and using machines

Resincolestiramine does not affect the ability to drive or operate machinery.

Resincolestiramine contains propylene glycol and sodium

This medicine contains 22.74 mg of propylene glycol (E 1520) (as alginate) per sachet. If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medicines containing propylene glycol or alcohol.

This medicine contains less than 1 mmol of sodium (23 mg) per sachet; therefore, it is essentially “sodium-free”.

3. How to take Resincolestiramina

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

This medicine is administered orally. Resincolestiramina must never be taken as a dry powder due to the risk of causing esophageal spasm, choking, or acute respiratory failure. The prescribed dose should be mixed with half a glass of water, milk, or fruit juice and taken orally before meals. It should be shaken before administration. Resincolestiramina may interact with other medicines; therefore, it is recommended to take other medications at least 1 hour before or 4 to 6 hours after taking colestyramine (see section 2 “Other medicines and resincolestiramine”).

For the treatment of hypercholesterolemia and pruritus associated with partial biliary obstruction or primary biliary cirrhosis, the recommended dose in adults is 4 g of colestyramine (one sachet) 3 to 4 times daily (equivalent to 12–16 g of colestyramine per day).

For the treatment of diarrhea due to bile acid malabsorption, the recommended dose in adults is 4 g of colestyramine (one sachet) 3 to 6 times daily (equivalent to 12–24 g of colestyramine per day). Your doctor will determine the dose you should take. If you do not observe improvement within 3 days, consult your doctor.

Use in children and adolescents

For the treatment of reduced cholesterol levels and itching caused by bile retention, the recommended dose is 2 g of colestyramine (half a sachet) 2 to 4 times daily (equivalent to 4–8 g of colestyramine per day). However, it is preferable to administer the total daily dose in only two doses, before breakfast and dinner.

For the treatment of diarrhea due to excess bile acids in the intestine, the dose for children aged 6 to 12 years will be determined by the physician according to the child's weight. For children over 12 years of age, the recommended dosage is the same as for adults.

The efficacy and safety of this medicine have not been established in children under 6 years of age.

If, after starting treatment for bile acid malabsorption-related diarrhea, the diarrhea persists for more than 3 days, consult your doctor.

If you take more Resincolestiramina than you should

In case of accidental ingestion, consult your doctor or pharmacist immediately or contact 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, stating the name of the medicine and the amount ingested.

If you forget to take Resincolestiramina

Take the missed dose as soon as you remember, unless it is almost time for your next scheduled 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, this medicine can cause adverse effects, although not everyone will experience them.

To minimize these effects, you will start taking Resincolestiramine at a low dose, which will be gradually increased. These adverse effects usually disappear with time.

Gastrointestinal reactions are the most commonly observed. The most frequently reported adverse reaction is constipation. Constipation may promote the development of fecaloma (hardened stools) and may worsen symptoms of pre-existing haemorrhoids.

Adverse effects may occur with certain frequencies, defined as follows:

Frequent (may affect up to 1 in 10 people)

• Constipation
• Indigestion
• Flatulence
• Nausea
• Vomiting

Uncommon (may affect up to 1 in 100 people)

• Decreased appetite
• Acid reflux
• Abdominal pain
• Diarrhoea
• Pruritus (itching) of the tongue
• Anal pruritus (anal itching)
• At high doses, may cause fat in the stools (steatorrhoea)

Rare (may affect up to 1 in 1000 people)

• Fecaloma (hardened stools)

Frequency not known (cannot be estimated from available data)

• Hypoprothrombinaemia (reduced prothrombin, a substance necessary for blood clotting)
• Hyperchloraemic acidosis (increased acid levels in body fluids)
• Osteoporosis (secondary to decreased absorption of calcium and vitamin D)
• Haemorrhage (chronic use of Resincolestiramine may be associated with increased tendency to bleeding due to hypoprothrombinaemia secondary to reduced vitamin K absorption)
• Haemorrhoids
• Erythema (skin rash)

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 effects, you can help provide more information on the safety of this medicine.

5. Storage of Resincolestiramine

This medicine does not require any special storage conditions.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Resincolestiramina

• The active substance is colestyramine. Each sachet contains 4 g of colestyramine.
• The other components (excipients) are: carboxymethylcellulose, propylene glycol alginate, colloidal silicon dioxide, sodium saccharin, and strawberry flavor (containing chemically modified tapioca starch).

Appearance of the medicinal product and contents of the pack

Resincolestiramina is presented in packs containing 50 sachets.

Marketing Authorization Holder and Manufacturer

Laboratorios Rubió, S. A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal – Barcelona

Spain

Date of the most recent revision of the package leaflet: February 2023

Detailed 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