CASTOR OIL REIG JOFRE 1g/ml ORAL LIQUID

2. What you need to know before taking CASTOR OIL REIG JOFRE 1g/ml oral liquid

Do not take CASTOR OIL REIG JOFRE:

• If you are hypersensitive (allergic) to castor oil
• Do not administer this medication to children under 12 years of age.
• If you are pregnant or breastfeeding.
• If you have inflammatory bowel diseases (ulcerative rectocolitis, Crohn's disease...)
• If you have abdominal pain of unknown origin, as it could mask a more serious clinical condition

more severe.

• In situations where intestinal transit is difficult or impeded, such as intestinal obstruction or occlusion, digestive tract stenosis, paralytic ileus, spastic ileus, fecal impaction.

if you have nausea, vomiting, cramps, and abdominal pain, as they could be symptoms of appendicitis.

• If you present a clinical situation of dehydration with loss of fluids and electrolytes.

nausea or vomiting.

Warnings and precautions

Before starting treatment, the patient must be properly hydrated and have normal electrolyte levels. CASTOR OIL REIG JOFRE is a strong laxative-purgative that can cause dehydration, hydrolytic imbalance, and hypokalemia,

• The prolonged use of laxatives should be avoided. If you need to use laxatives regularly, the cause of constipation should be evaluated.

If you need to use laxatives regularly, the cause of constipation should be evaluated.

• This medication is indicated for single use; however, the abuse of laxatives can damage intestinal function, leading to symptoms such as abdominal pain, weakness, fatigue, thirst, vomiting, bone pain (due to osteomalacia), fluid and electrolyte imbalance, and diarrhea. Additionally, intestinal transit is accelerated, which can lead to reduced nutrient absorption. Although the intestine is not permanently damaged, it may take several months to readapt the intestine to normal function.

the intestine to normal function.

• Castor oil should only be used when normal intestinal function cannot be achieved through changes in dietary habits or bulk-forming laxatives, such as plantago.

such as plantago.

• Laxatives should generally be used with caution in the elderly, as they can exacerbate weakness, hypotension, and psychomotor incoordination.

and psychomotor incoordination.

• The use of this medication is not recommended in children under 12 years of age, as there are no adequate studies to establish the safety and efficacy of the treatment.

the safety and efficacy of the treatment.

If symptoms persist or worsen during the use of the medication, you should consult your doctor or pharmacist.

Using CASTOR OIL REIG JOFRE with other medications:

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

Due to the fact that this type of laxative decreases intestinal transit time, thesimultaneous use of other medications with this laxative may decrease the absorption of these medications.

• The simultaneous use of castor oil with the following is not recommended: Antiarrhythmics such as sotalol, amiodarone.

amiodarone.

• Diuretics, adrenocorticoids, or licorice root preparations, as they may potentiate potassium loss.

potassium loss.

• Digitalis (medications that increase heart contraction speed) due to the risk of inducing hypokalemia, which favors the toxic effects of these medications.

these medications.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The stimulant effects of castor oil can cause uterine contractions in pregnant women. CASTOR OIL REIG JOFRE should not be used during pregnancy.

Breastfeeding

There is not enough information available regarding the excretion of castor oil in breast milk. It is recommended not to use this medication during breastfeeding.

Driving and using machines:

No studies have been conducted on the effects on the ability to drive and use machines.

3. How to take CASTOR OIL REIG JOFRE

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

The recommended dose is

Adults: 25 ml in a single dose

CASTOR OIL REIG JOFRE is administered on an empty stomach in the morning.

It can be taken mixed with milk, fruit juice, or chilled carbonated beverages, which improves tolerance.

Evacuation occurs between 2 and 6 hours after taking the castor oil. It is not recommended to take the medication late in the day or before bedtime.

Use in children and adolescents

Do not use in children under 12 years of age.

Elderly

Laxatives should generally be used with caution in the elderly, as they can exacerbate weakness, hypotension, and psychomotor incoordination.

If you take more CASTOR OIL REIG JOFRE

There may be an aggravation of the described side effects, gastrointestinal irritation, diarrhea, and loss of fluids and electrolytes. In these cases, symptomatic treatment will be performed, with rehydration and restoration of fluids and electrolytes if there is significant fluid loss.

If you forget to take CASTOR OIL REIG JOFRE

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

If you interrupt treatment with CASTOR OIL REIG JOFRE

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Nausea, vomiting, colic pain, abdominal pain, and severe diarrhea may occur. The frequency of these effects is unknown. If these or other adverse reactions occur, consult your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use, Website: www.notificaram.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of CASTOR OIL REIG JOFRE

Keep this medication out of sight and reach of children.

Store the bottle in the outer packaging to protect it from light and moisture.

Do not use CASTOR OIL REIG JOFRE after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of CASTOR OIL REIG JOFRE 1g/ml oral liquid

Each ml of oral liquid contains 1 g of castor oil from the seeds of Ricinus communisL.

Appearance of the product and package contents

This medication is presented in a transparent screw-top bottle containing 25 ml of castor oil.

Marketing authorization holder and manufacturer:

LABORATORIO REIG JOFRÉ, S.A.

C/ Gran Capitán 10,

08970 Sant Joan Despí Barcelona

Spain

Date of the last revision of this package leaflet:November 2023

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.es/