Label:Information for the User

Colestiramine 4 g Powder for Oral Suspension

Colestiramine

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult yourdoctor or pharmacist.
• This medication has been prescribedonlyto you, and you should not give it to other people even if they havethe same symptomsas you, as it may harm them.
• If you experience any adverse effects,consult your doctor or pharmacist, evenif they are not listed in this label. See section 4.

1.What is Colestiramine and how is it used

2.What you need to knowbeforestarting totake Colestiramine

3.How to take Colestiramine

4.Possible adverse effects

5Storage of Colestiramine

6. Contents of the package and additional information

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

• Resincolestiraminais used to decrease 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.
• Resincolestiramina is used to treat diarrhea caused by an excess of bile acids in the intestine due to poor absorption of the same. This situation can occur in cases of Crohn's disease, intestinal resection (removal of a part of the intestine), vagotomy (surgery of the vagus nerve) or other situations that cause an excess of bile acids in the intestine.
• Resincolestiramina may also be used to treat a specific type of itching caused by bile retention (biliary stasis).

Do not take Resincolestiramina

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• if you have a condition where your bile ducts are completely blocked.
• if you have severe constipation.
• if you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Resincolestiramina.

Resincolestiramina should never be taken as dry powder, due to the risk of causing a spasm in the esophagus and choking or acute respiratory insufficiency.

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

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

This medication may cause constipation or worsen it if you already have it. Follow your doctor's instructions carefully if you have hemorrhoids or a heart disease, as in those cases the medication dose may need to be adjusted or decreased and your liquid and fiber intake increased.

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

Other medications and Resincolestiramina

Inform your doctor or pharmacist if you arecurrently taking, have recently taken, or may need to take any other medication.

If you are taking other oral medications, it is essential to take them at a different time than Resincolestiramina. Any medication should be taken at least 1 hour before or 4-6 hours after taking Resincolestiramina, as it may alter the effects of other medications or 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 conditions 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.

- Thyroid hormones such as levothyroxine, liothyronine.

- Medications to treat high 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.

Pregnancy, lactation, and fertility

Do not take Resincolestiramina during pregnancy or lactation.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

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

Resincolestiramina contains propylene glycol and sodium

This medication contains 22.74 mg of propylene glycol (E 1520) (as alginates) in each sachet. If the baby is under 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

This medication contains less than 1 mmol of sodium (23 mg) per sachet; it is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

This medication is administered orally.Resincolestiramina should never be taken as dry powder, due to the risk of causing a spasm in the esophagus and choking or acute respiratory insufficiency.The prescribed medication dose should be added to half a glass of water, milk, or fruit juice, and should be taken orally before meals.It should be shaken before administration.Resincolestiramina may interact with other medications, for which it is recommended to administer them at least 1 hour before or 4 to 6 hours after taking colestiramina (see section 2 “Other medications and resincolestiramina”)

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

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

Use in children and adolescents

For the treatment of decreased cholesterol levels and itching caused by bile retention,the recommended dose is 2g of colestiramina (half a packet) 2 to 4 times a day (equivalent to 4 – 8g of colestiramina per day), although it is preferable to administer the total daily dose in only 2 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 indicated by your doctor, based on the child's weight.For children over 12 years, the recommended dosage is the same as for adults.

The efficacy and safety have not been established in children under 6 years.

If, after starting treatment for diarrhea due to malabsorption, 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 service and bring the medication with you.You can also call the Toxicological Information Service Telephone 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Resincolestiramina

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 indicated.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

Gastrointestinal side effects are the most common.The most frequently observed adverse reaction is constipation. Constipation may favor the appearance of fecaloma (hard stools) and may exacerbate the symptoms of pre-existing hemorrhoids.

Side effects may occur with certain frequencies, which are defined as follows:

Frequent(may affect up to 1 in 10 people)

• Constipation
• Indigestion
• Flatulence
• Nausea
• Vomiting

Infrequent(may affect up to 1 in 100 people)

• Decreased appetite
• Acid reflux
• Abdominal pain
• Diarrhea
• Itching in the tongue
• Itching in the anus
• At high doses, it may cause the appearance of fat in the stool (steatorrhea)

Rare(may affect up to 1 in 1000 people)

• Fecaloma (hard stools)

Unknown frequency(cannot be estimated from available data)

• Hypoprothrombinemia (decreased prothrombin, a substance necessary for blood coagulation)
• Hyperchloremic acidosis (increase of acid in the body's fluids)
• Osteoporosis (secondary to decreased calcium and vitamin D absorption)
• Bleeding (chronic use of Resincolestiramina may be associated with an increased tendency to bleeding due to hypoprothrombinemia secondary to decreased vitamin K absorption)
• Hemorrhoids
• Erythema (skin eruption)

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

This medication does not require special storage conditions

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

Do not use this medication after the expiration date that appears 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.Deposit the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Resincolestiramina

• The active ingredient is cholestyramine. Each packet contains4 gof cholestyramine.
• The other components (excipients) are: carboxymethylcellulose, propylene glycol alginate, colloidal silica, sodium saccharin, and strawberry flavor (containing modified tapioca starch).

Appearance of the product and contents of the packaging

Resincolestiramina is presented in packaging containing 50 packets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Rubió, S. A.

C/ Industria, 29

Polígono Industrial Comte de Sert

08755 Castellbisbal – Barcelona

Spain

Last review date of thisleaflet: February 2023

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