Leaflet: information for the user

RICINO REIG JOFRE CASTOR OIL 1g/ml oral liquid

Read this leaflet carefully before you start taking this medicine because it contains important information for you

Follow exactly the administration instructions of the medicine contained in this leaflet or those indicated by your doctor.

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

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

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

You should consult a doctor if your condition worsens or does not improve after taking the medicine.

1. What isRICINO REIG JOFRE CASTOR OILand what it is used for

2. What you need to know before starting to takeRICINO REIG JOFRE CASTOR OIL

3. How to takeRICINO REIG JOFRE CASTOR OIL

4. Possible side effects

5. Storage ofRICINO REIG JOFRE CASTOR OIL

6. Contents of the pack and additional information

It belongs to a group of medicines called contact laxatives

ORRAVAN CASTOR OIL is a purgative laxative whose active ingredient, castor oil, is indicated to facilitate intestinal emptying.

You should consult a doctor if it worsens or does not improve after taking the medication.

Do not take REIG JOFRE CASTOR OIL:

- If you are hypersensitive (allergic) to castor oil

- Do not administer this medication to children under 12 years old.

- If you are pregnant or breastfeeding.

- If you have inflammatory bowel diseases (ulcerative colitis, Crohn's disease, etc.)

- If you have unknown abdominal pain, as it may mask a more serious clinical condition.

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

- If you have nausea, vomiting, cramps, and abdominal pain, as they may be symptoms of appendicitis.

- If you have a clinical condition 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. REIG JOFRE CASTOR OIL is a strong laxative-purgative that can cause dehydration, electrolyte imbalance, and hypokalemia,

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

- This medication is indicated to be taken once, despite the abuse of laxatives, it may damage intestinal function, and typical symptoms may appear, such as abdominal pain, weakness, fatigue, thirst, vomiting, bone pain (due to osteomalacia), fluid and electrolyte imbalance, and diarrhea. Moreover, intestinal transit may accelerate, leading to a reduction in nutrient absorption. Although the intestine is not permanently damaged

it may take several months to adapt the intestine to normalcy.

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

- Laxatives should be used with caution in the elderly, as they may exacerbate states of weakness, hypotension, and psychomotor incoordination.

- It is not recommended to use the medication in children under 12 years old, as there are no adequate studies to establish the safety and efficacy of the treatment.

If symptoms persist or worsen during the use of the medication, consult a doctor or pharmacist.

Use of REIG JOFRE CASTOR OIL 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 the time of intestinal transit,the simultaneous use of other drugs with this laxative may decrease their absorption.

- Do not use REIG JOFRE CASTOR OIL simultaneously with:

Antiarrhythmics such as sotalol, amiodarone.

- Diuretics, adrenocorticoids, or preparations of licorice root, as it may potentiate potassium loss.

- Digitalis (medications that increase the heart's contraction rate) due to the risk of causing hypokalemia, which may exacerbate the toxic effects of these medications.

Pregnancy, lactation, and fertility

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

Pregnancy

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

Lactation

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

Driving and operating machinery:

No studies have been conducted on the effects on the ability to drive and operate machinery.

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

The recommended dose is

Adults25 ml in a single dose

Ricino Reig Jofre Oil 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 oil.

Do not take the medication late in the day or before bedtime.

Use in children and adolescents

Do not use in children under 12 years old.

Seniors

Laxatives should generally be used with caution in seniors as they may exacerbate states of weakness, hypotension, and psychomotor incoordination.

If you take more Ricino Reig Jofre Oil

It may cause an aggravation of the described adverse 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 in case of significant fluid loss.

If you forget to take Ricino Reig Jofre Oil

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

If you interrupt treatment with Ricino Reig Jofre Oil

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

Like all medications, this medication may produce adverse effects

although not all people may experience them.

Severe nausea, vomiting, abdominal pain, and severe diarrhea may occur. The frequency of these effects is unknown.

If these or other adverse reactions not mentioned previously occur, you should consult your doctor or pharmacist.

Reporting Adverse Effects

If you experience any of these adverse effects, consult your doctor or pharmacist,

even if they are not listed in this prospectus. You can also report them directly to the Spanish System for Pharmacovigilance of Medicinal Products for Human Use, Website:www.notificaram.es

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

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

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

Do not use CASTOR OIL REIG JOFRE after the expiration date that appears on

the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist

how to dispose of the packaging and unused medications. By doing so, you will help

protect the environment.

Composition ofCastor Oil Reig Jofre 1g/ml oral liquid

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

Appearance of the product and content of the container

This medication is presented in a transparent bottle with a screw cap containing 25 ml of

castor oil

Holder of the marketing authorization and responsible for manufacturing:

LABORATORIO REIG JOFRÉ, S.A.

C/ Gran Capitán 10,

08970 Sant Joan Despí Barcelona

Spain

Date of the last review of this leaflet:November 2023

The detailed and updated information of this medication is available on the webpage

of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.es/