Castor oil Reig Jofre 1 g/ml oral liquid

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CASTOR OIL REIG JOFRE 1g/ml oral liquid

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow exactly the instructions for use of this medicine provided in this leaflet or those given by your doctor.

Keep this leaflet, as you may need to read it again.

If you need advice or further information, consult your pharmacist.

If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

You should consult a doctor if you worsen or do not improve after taking the medicine.

Contents of the leaflet

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

1. What ACEITE DE RICINO ORRAVAN 1g/ml oral liquid is and what it is used for

It belongs to a group of medicines called stimulant laxatives.

ACEITE DE RICINO REIG JOFRE is a purgative laxative whose active ingredient, castor oil, is indicated to facilitate bowel evacuation.

You should consult a doctor if you worsen or do not improve after taking the medicine.

2. What you need to know before taking ACEITE DE RICINO REIG JOFRE 1g/ml oral liquid

Do not take ACEITE DE RICINO REIG JOFRE:

• If you are hypersensitive (allergic) to castor oil.

• Do not administer this medicine to children under 12 years of age.

• If you are pregnant or breastfeeding.

• If you suffer from inflammatory colon conditions (e.g., ulcerative proctocolitis, Crohn's disease, etc.).

• If you have abdominal pain of unknown origin, as it could mask a more serious clinical condition.

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

• If you experience nausea, vomiting, cramps, or abdominal pain, as these may be symptoms of appendicitis.

• If you have clinical 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. ACEITE DE RICINO REIG JOFRE is a strong laxative-purgative that may cause dehydration, hydroelectrolytic imbalance, and hypokalemia.

• Prolonged use of laxatives should be avoided. If you require regular use of laxatives, the underlying cause of constipation should be evaluated.

• This medicine is intended for single-dose use. However, abuse of laxatives may damage intestinal function, leading to typical symptoms such as abdominal pain, weakness, fatigue, thirst, vomiting, bone pain (due to osteomalacia), fluid and electrolyte imbalance, and diarrhea. Also, intestinal transit is accelerated, potentially reducing nutrient absorption. Although the intestine is not permanently damaged, several months may be needed for the intestine to readapt to normal function.

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

• Laxatives should generally be used with caution in elderly patients, as they may worsen conditions of weakness, hypotension, and psychomotor incoordination.

• Use of this medicine is not recommended in children under 12 years of age, as adequate studies to establish safety and efficacy are lacking.

If symptoms persist or worsen during treatment, consult your doctor or pharmacist.

Use of ACEITE DE RICINO REIG JOFRE with other medicines:

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

Due to the fact that this type of laxative reduces intestinal transit time, concomitant use with other drugs may reduce their absorption.

• Concomitant use of castor oil is not recommended with antiarrhythmics such as sotalol or amiodarone.

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

• Digitalis (medications that increase the force of heart contractions), due to the risk of inducing hypokalemia, which enhances their toxic effects.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

The stimulant effects of castor oil may cause uterine contractions in pregnant women. ACEITE DE RICINO REIG JOFRE must not be used during pregnancy.

Breastfeeding

There is insufficient information regarding the excretion of castor oil in breast milk. Use of this medicine during breastfeeding is not recommended.

Driving and using machines:

No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery.

3. How to take ACEITE DE RICINO REIG JOFRE

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

The recommended dose is:

Adults: 25 ml as a single dose.

ACEITE DE RICINO REIG JOFRE is administered on an empty stomach in the morning.

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

Bowel movement occurs between 2 and 6 hours after taking castor oil. It is not recommended to take the medicine late in the day or before going to sleep.

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 may worsen conditions of weakness, hypotension, and psychomotor incoordination.

If you take more ACEITE DE RICINO REIG JOFRE than you should

An exacerbation of the adverse effects described may occur, including gastrointestinal irritation, diarrhea, and loss of fluids and electrolytes. In such cases, necessary symptomatic treatment should be administered, including rehydration and restoration of fluids and electrolytes if there has been significant fluid loss.

If you forget to take ACEITE DE RICINO REIG JOFRE

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

If you stop taking ACEITE DE RICINO REIG JOFRE

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Nausea, vomiting, colicky pain, abdominal pain, and severe diarrhoea may occur. The frequency of occurrence of these effects is unknown. If these or any other adverse reactions not mentioned above occur, consult your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products at Website: www.notificaram.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of CASTOR OIL REIG JOFRE

Keep this medicine out of the 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 expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

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

Each ml of oral liquid contains 1 g of oil from the seeds of Ricinus communis L.

Appearance of the product and contents of the container

This medicine comes in a transparent screw-cap 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 latest review of this leaflet: November 2023

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS):
http://www.aemps.es/