RESINCOLESTIRAMINE 4 g POWDER FOR ORAL SUSPENSION

2. What you need to know before taking Resincolestiramina

Do not take Resincolestiramina

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Resincolestiramina.

Resincolestiramina should never be taken as dry powder, as it can cause a spasm in the esophagus and choking or acute respiratory failure.

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

While taking this medicine, 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 medicine can cause constipation or worsen it if you already have it. Follow your doctor's instructions carefully if you have hemorrhoids or if you have a heart condition, as the dose of the medicine may need to be adjusted or decreased and fluid and dietary fiber intake increased.

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

Other medicines and Resincolestiramina

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

If you are taking other oral medicines, it is essential to take them at a different time than Resincolestiramina. Any medicine should be taken at least 1 hour before or 4-6 hours after taking Resincolestiramina, as it may alter the effects of other medicines or prevent other medicines from being absorbed by 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, 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 for the treatment of high cholesterol and triglyceride levels in the blood (statins) such as fluvastatin, pravastatin.
• Medicines for the treatment of diarrhea (antidiarrheal) 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.

Pregnancy,breastfeedingand fertility

Do not take Resincolestiramina 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

Resincolestiramina does not affect the ability to drive vehicles or operate machines.

Resincolestiramina contains propylene glycol and sodium

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

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

3. How to take Resincolestiramina

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

This medicine is administered orally. Resincolestiramina should never be taken as dry powder, as it can cause a spasm in the esophagus and choking or acute respiratory failure. The prescribed dose of the medicine should be added to 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, which should be administered at least 1 hour before or 4 to 6 hours after taking colestiramina (see section 2 "Other medicines and Resincolestiramina").

For the treatment of hypercholesterolemia and pruritus associated with partial biliary obstruction or primary biliary cirrhosis, the recommended dose in adults is 4g of colestiramina (one sachet) 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 sachet) 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 within 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 sachet) 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 of age.

If, after starting treatment for diarrhea due to bile acid 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 emergency service of the nearest hospital and take the medicine with you. You can also call the Toxicology Information Service Telephone 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Resincolestiramina

Take the missed dose as soon as you remember, unless the time for your next dose is near. In that case, do not take the missed dose and continue taking the medicine as indicated.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

Gastrointestinal reactions are the most frequent. The most frequently observed adverse reaction is constipation. Constipation can favor the appearance of fecaloma (hardened feces) and may worsen the symptoms of pre-existing hemorrhoids.

Side effects can occur with certain frequencies, which are 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
• Heartburn
• Abdominal pain
• Diarrhea
• Itching (pruritus) on the tongue
• Itching (pruritus) in the anus
• At high doses, it can cause the appearance of fat in the feces (steatorrhea)

Rare(may affect up to 1 in 1000 people)

• Fecaloma (hardened feces)

Frequency not known(cannot be estimated from available data)

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

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Conservation of Resincolestiramina

This medicine does not require special storage conditions

Keep this medicine out of sight and reach of children.

Do not use this medicine 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the package and additional information

Composition of Resincolestiramina

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

Appearance of the product and contents of the package

Resincolestiramina is presented in packages 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 last revision of thisleaflet: February 2023

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