Hodernal 800 mg/ml oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hodernal 800 mg/ml oral solution

liquid paraffin

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

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

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

Contents of the leaflet

1. What Hodernal is and what it is used for
2. What you need to know before taking Hodernal
3. How to take Hodernal
4. Possible adverse effects
5. Storage of Hodernal
6. Contents of the pack and other information

1. What Hodernal is and what it is used for

Hodernal belongs to a group of medicines called stool softeners.

These medicines work by coating the stools with a layer that keeps them soft and lubricated, thus facilitating their passage 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 within 72 hours after taking the maximum daily dose, or if symptoms worsen or do not improve after 6 days.

2. What you need to know before taking Hodernal

Do not take Hodernal

• If you are allergic to liquid paraffin or to any of the other components of this medicine (listed in section 6).
• If you have intestinal obstruction, paralytic ileus (a type of intestinal obstruction in which intestinal movements stop), fecal impaction, or in any condition where gastrointestinal transit is impaired or blocked.
• Inflammatory bowel diseases.
• If you have abdominal pain of unknown origin.
• If you have medical conditions where increasing intestinal peristalsis (propulsive movements) is dangerous, 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 in which an end of the colon –colostomy– or of the ileum –ileostomy– is brought 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, clinical reassessment is required. Long-term treatments may lead to tolerance to the laxative effect (a condition in which the body becomes accustomed to a medicine, requiring higher doses to achieve the same effect) and dependence to achieve bowel evacuation.

Bedridden patients, elderly individuals, patients with mental disorders, or disabled individuals should consult their doctor before taking this medicine due to the risk of aspiration of oil droplets, which could lead to lipid pneumonia (lung inflammation caused by aspiration of exogenous lipids).

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

Before starting treatment, you should be adequately hydrated, as prolonged use of laxatives may cause electrolyte imbalance (minerals present in the blood) and hypokalemia (potassium deficiency).

If you are scheduled for blood tests, inform your doctor that you are taking this medicine, as blood glucose levels may increase following prolonged administration of laxatives.

Use this medicine 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.

Use with caution in children aged 6 to 12 years due to the risk of aspiration.

Other medicines and Hodernal

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

This medicine should not be taken within 2 hours before or after taking any other medicine.

This medicine must not be taken concomitantly with:

• oral anticoagulants (medicines that delay blood clotting) derived from coumarin or indandione
• digitalis glycosides (a group of medicines used to treat heart failure)
• estrogens (a type of female hormone)
• oral contraceptives
• sodium docusate (a medicine used for constipation)
• fat-soluble vitamins (vitamins A, D, E, and K), calcium, phosphorus, and potassium or potassium supplements

Taking Hodernal with food and drink

Do not take this medicine within 2 hours before or after meals.

During treatment, drink plenty of fluids (up to two liters daily) to help soften 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 medicine.

Driving and using machines

No effects on driving or machine use have been reported.

3. How to take Hodernal

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose for adults and children over 12 years of age is 15 ml of oral solution or one tablespoon (12 g of liquid paraffin) once daily, taken before going to bed. 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 two hours after breakfast.

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

Use in children

The recommended dose for children aged 6 to 12 years is 5 ml of oral solution or one teaspoon (4 g of liquid paraffin) once daily, taken before going to bed. If necessary, repeat the dose of 5 ml of oral solution or one teaspoon (4 g of liquid paraffin) in the morning, on an empty stomach or two hours after breakfast.

Do not exceed 10 ml of oral solution or two teaspoons (8 g of liquid paraffin) per day.

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

Hodernal is administered orally.

It is recommended to dilute the liquid paraffin in a glass of water and to take it while in an upright position to avoid droplets of oil entering the respiratory tract. Do not take while lying down.

During treatment, drink plenty of fluids (up to two liters daily) to help soften the stools.

If symptoms worsen, if no bowel movement occurs within 72 hours after taking the maximum daily dose, 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, anal leakage of paraffin may occur, resulting in loss of electrolytes, cramps, colicky pain, and muscle weakness.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 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 missed doses.

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 produce adverse effects, although not everyone will experience them.

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

The following is a list of adverse effects according to their 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 (pulmonary inflammation), mineral oil discharge 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 of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hodernal

Keep this medicine out of sight and reach of children.

Special storage conditions are not required.

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the package and other information

Composition of Hodernal

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

Description of the medicinal product and contents of the container

Hodernal is supplied in transparent PET bottles with an EPE/PE aluminium cap and polyester lining, containing 300 ml of a clear, colourless solution with a slight lemon odour.

Marketing Authorisation 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

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the most recent review of this leaflet: March 2023

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