HODERNAL 800 mg/ml ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Hodernal 800 mg/ml Oral Solution

liquid paraffin

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 6 days.

Contents of the Package Leaflet

1. What is Hodernal and what is it used for
2. What you need to know before taking Hodernal
3. How to take Hodernal
4. Possible side effects
5. Storage of Hodernal
6. Package Contents and Additional Information

1. What is Hodernal and what is it used for

Hodernal belongs to a group of medications called stool softeners,

These medications work by coating the stool with a layer that keeps it soft and lubricated, making it easier to pass through the intestine and subsequent evacuation.

Hodernal is indicated for the symptomatic relief of occasional constipation in adults and children over 6 years of age.

You should consult a doctor if no bowel movement occurs after 72 hours following the maximum daily administration or if symptoms worsen or do not improve after 6 days.

2. What you need to know before taking Hodernal

Do not takeHodernal

• If you are allergic to liquid paraffin or any of the other components of this medication (listed in section 6).
• If you have intestinal obstruction, paralytic ileus (a type of intestinal obstruction where intestinal movements stop), fecal impaction, and in all situations where gastrointestinal transit is difficult or impaired.
• Inflammatory bowel diseases.
• If you have abdominal pain of unknown origin.
• If you have pathologies where it is dangerous to increase intestinal peristalsis (propulsive movements), such as appendicitis or its symptoms (nausea, vomiting, stomach pain or lower abdominal pain, abdominal cramps) or intestinal perforation.
• Diarrhea, dysphagia (difficulty swallowing).
• Undiagnosed intestinal or rectal bleeding.
• Colostomy and ileostomy (surgical procedures where one end of the colon - colostomy - or ileum - ileostomy - is removed through the abdominal wall).
• Children under 6 years of age.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Hodernal.

If symptoms worsen or persist for more than 6 days, the clinical situation should be evaluated. Long-term treatments can produce tolerance to the laxative effect (a situation where the body gets used to a medication, so a larger amount of it is needed) and dependence to achieve evacuation.

Bedridden, elderly, mentally ill, or disabled patients should consult their doctor before taking this medication due to the risk of aspirating oil droplets, which could lead to lipoid pneumonia (lung inflammation caused by aspirating exogenous lipids).

This medication should not be taken while lying down, especially in small children and bedridden patients.

Before starting treatment, you should be properly hydrated, as prolonged use of laxatives can cause electrolyte imbalance and hypokalemia (potassium deficiency).

If you are going to have blood tests, inform your doctor that you are taking this medication, as blood glucose levels may increase after prolonged administration of laxatives.

You should use this medication with caution if you experience sudden changes in bowel habits that persist for more than 2 weeks.

Children and Adolescents

Do not administer to children under 6 years of age.

It should be administered with caution to children between 6 and 12 years of age due to the risk of aspiration.

Other Medications and Hodernal

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

It should not be administered within 2 hours before or after taking another medication.

This medication should not be administered in combination with:

- oral anticoagulants (medications that make blood take longer to clot) derived from coumarin or indandione

- digitalis glycosides (a group of medications used to treat heart failure)

- estrogens (a type of female hormone)

- oral contraceptives

- docusate sodium (a medication used for constipation)

- fat-soluble vitamins (vitamin A, D, E, and K), calcium, phosphorus, and potassium or potassium supplements

Taking Hodernal with Food and Drinks

It should not be administered within 2 hours before or after meals.

During treatment, you should drink plenty of fluids (up to 2 liters daily) to facilitate softening of the stool.

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.

Driving and Using Machines

No effects on driving or using machines have been described.

3. How to Take Hodernal

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. If in doubt, ask your doctor or pharmacist.

The recommended dose in adults and children over 12 years of age is 15 ml of oral solution or one tablespoon (12 g of liquid paraffin) once a day, before bedtime. If necessary, repeat the dose of 15 ml of oral solution or one tablespoon (12 g of liquid paraffin) in the morning, on an empty stomach or 2 hours after breakfast.

Do not take more than 30 ml of oral solution or two tablespoons (24 g of liquid paraffin) per day.

Use in Children

The recommended dose in children between 6 and 12 years of age is 5 ml of oral solution or one coffee teaspoon (4 g of liquid paraffin) once a day, before bedtime. If necessary, repeat the dose of 5 ml of oral solution or one coffee teaspoon (4 g of liquid paraffin) in the morning, on an empty stomach or 2 hours after breakfast.

Do not take more than 10 ml of oral solution or two coffee teaspoons (8 g of liquid paraffin) per day.

Hodernal should not be administered to children under 6 years of age due to the lack of safety and efficacy data.

Hodernal is administered orally.

It is recommended to dilute the liquid paraffin in a glass of water and take it in an upright position to avoid oil droplets passing into the respiratory system. It should not be taken while lying down.

During treatment, you should drink plenty of fluids (up to 2 liters daily) to facilitate softening of the stool.

If symptoms worsen, if no bowel movement occurs after 72 hours following the maximum daily administration, or if symptoms persist after 6 days of treatment, inform your doctor or pharmacist.

If You Take More Hodernal Than You Should

If you take more Hodernal than recommended, it may cause anal elimination of paraffin with loss of electrolytes, cramps, abdominal spasms, and muscle weakness.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 62 04 20, indicating the medication and the amount ingested.

If You Forget to Take Hodernal

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

If you have any other doubts 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 experiences them.

The side effects of liquid paraffin are generally mild and transient.

The following side effects are listed by frequency:

• Uncommon (may affect up to 1 in 100 people): anal pruritus (itching), anal irritation.
• Rare (may affect up to 1 in 1,000 people): deficiency of fat-soluble vitamins (A, D, E, and K).
• Very rare (may affect up to 1 in 10,000 people): hypersensitivity reactions.
• Frequency not known (cannot be estimated from available data): lipoid pneumonia and lipoid pneumonitis (lung inflammation), elimination of mineral oil through the rectum, anal incontinence, watery stools, abdominal pain, worsening of constipation, granulomatous reactions (a type of inflammatory response caused by paraffin oil), dehydration.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hodernal

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging after CAD or EXP. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE Point in your pharmacy. If in doubt, 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

Hodernal Composition

• The active ingredient is liquid paraffin. Each ml contains 800 mg of liquid paraffin.
• The other ingredients are lemon essential oil, sorbitan trioleate.

Product Appearance and Package Contents

Hodernal is presented in transparent PET bottles with an aluminum EPE/PE cap and a polyester coating, containing 300 ml of a clear, colorless solution with a slight lemon scent.

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

ALCALÁ FARMA SL

Avenida de Madrid 82.

28802 Alcalá de Henares (Madrid)

Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the Last Revision of this Package Leaflet:March 2023

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