Package Insert: Information for the User

Hodernal 800 mg/ml Oral Solution

Paraffin Liquid

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

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 6 days.

Hodernal belongs to a group of medications called stool softeners,

These medications work by coating the stool with a layer that makes it stay soft and lubricated, thus facilitating its passage through the intestine and subsequent evacuation.

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

You should consult a doctor if no bowel movement is produced after 72 hours following the maximum daily dose or if it worsens or does not improve after 6 days.

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 in which the movements of the intestine stop), fecal impaction, and in all situations in which the gastrointestinal transit is difficult or impeded.
• Inflammatory intestinal diseases.
• If you have unknown abdominal pain.
• If you have conditions in which 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.
• Dysentery, dysphagia (difficulty swallowing).
• Undiagnosed intestinal or rectal bleeding.
• Colostomy and ileostomy (surgical procedures in which an end of the colon - colostomy - or the ileum - ileostomy - is removed through the abdominal wall).
• Children under 6 years old.

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 in which the body becomes accustomed to a medication, requiring a larger amount to achieve the desired effect) and dependence on evacuation.

Patients who are bedridden, elderly, mentally ill, or disabled should consult their doctor before taking this medication due to the risk of aspiration of oil droplets, which could lead to lipoid pneumonia (inflammation of the lungs caused by the aspiration of exogenous lipids).

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

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

If you are to undergo blood tests, inform your doctor that you are taking this medication, as blood glucose concentration 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 old.

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

Other medications and Hodernal

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

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

This medication should not be taken concurrently 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

-sodium docusate (a medication used for constipation)

-liposoluble vitamins (vitamins A, D, E, and K), calcium, phosphorus, and potassium or potassium supplements

Taking Hodernal with food and drinks

This medication should not be taken within 2 hours before or after meals.

During treatment, you should drink an abundant amount of liquid (up to 2 liters per day) to facilitate the softening of feces.

Pregnancy, lactation, and fertility

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

Driving and operating machinery

No effects on driving and operating machinery have been described.

Follow exactly the administration instructions of the medication contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose in adults and children over 12 years is 15 ml of oral solution or one tablespoon (12 g of liquid paraffin) once a day, 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 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 from 6 to 12 years is 5 ml of oral solution or one teaspoon (4 g of liquid paraffin) once a day, 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 take more than 10 ml of oral solution or two teaspoons (8 g of liquid paraffin) per day.

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

Hodernal is administered orally.

It is recommended to dilute the liquid paraffin in a glass with water and take it in an upright position to avoid the passage of oil droplets to the respiratory system. Do not take in a lying position.

During treatment, it is necessary to take an abundant amount of liquid (up to two liters per day) to facilitate the softening of the stools.

If symptoms worsen, if no stool is produced after 72 hours after 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, it may cause anal elimination of paraffin with loss of electrolytes, cramps, nausea, and muscle weakness.

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

If you forgot to take Hodernal

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

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.

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

The following adverse effects are listed by their frequency:

-Infrequent (may affect up to 1 in 100 people): anal itching, anal irritation.

-Rare (may affect up to 1 in 1000 people): deficiency of fat-soluble vitamins (A, D, E, and K).

-Very rare (may affect up to 1 in 10,000 people): hypersensitivity reactions.

-Unknown frequency(cannot be estimated from available data): lipoid pneumonia and pneumonitis (inflammatory lung condition), elimination of mineral oil by the rectum, anal incontinence, watery stools, abdominal pain, worsening of constipation, granulomatous reactions (type of inflammatory response caused by paraffin oil), dehydration.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://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.

No special storage conditions are required.

Do not use this medication after the expiration date that appears 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 drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Hodernal

- The active ingredient isliquid paraffin. Each ml contains 800 mg of liquid paraffin.

- The other components arelemon essential oil, sorbitan trioleate.

Appearance of the product and contents of the packaging

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

Marketing Authorization Holder

Meda Pharma SL

C/General Aranaz, 86

28027 Madrid

Spain

Manufacturer Responsible

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.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet:March 2023

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es