Hodernal 300 ml View larger

Hodernal jarabe 300 ml

Hodernal syrup softens and lubricates the stool for easy transit and evacuation. Relieves constipation in adults and children over 6 years old

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 1. What it is Hodernal and what it is used
This medicine works by coating the feces of a layer that keeps them soft and lubricated, thus facilitating their transit through the intestine and its evacuation.
Hodernal is indicated in adults and children aged over 6 years old for the symptomatic relief of occasional constipation.
Should consult a doctor if any deposition does not occur after 72 hours after the maximum daily administration or if it worsens or does not improve after 6 days.


 2. What you need to know before you start taking Hodernal
Check with your doctor before taking Hodernal if:
- If you are allergic to liquid paraffin or any of the other ingredients of this medicine (listed in section 6).
- If you have intestinal obstruction, paralytic ileus (type of bowel obstruction in which bowel movements stop), fecal impaction and in all those situations where gastrointestinal transit be hindered or prevented.
- Inflammatory bowel diseases.
- If you have abdominal pain of unknown origin.
- If you have pathologies that is dangerous intestinal increase peristalsis (propulsion movements), such as appendicitis or symptoms (nausea, vomiting, stomach pain or lower abdomen, abdominal cramps) or intestinal perforation.
- Diarrhoea, dysphagia (difficulty swallowing).
- Intestinal or rectal bleeding undiagnosed.
- Colostomy and ileostomy (surgical procedures in which one end of -colostomía- colon or ileum -ileostomía- through the abdominal wall is removed).
- Children under 6 years old.

Warnings and Precautions
Consult your doctor or pharmacist before you start taking Hodernal.
If symptoms worsen or remain for more than six days, the clinical situation should be assessed. Long treatments can produce tolerance laxative action (situation in which the body gets used to a medicine so that more of this is needed) and dependence for evacuation.
Patients bedridden, elderly, mentally ill or handicapped should consult their doctor before taking this medicine because of the risk of aspiration of oil droplets, which could lead to a lipid pneumonitis (lung inflammation caused by aspiration of exogenous lipids ).
This medicine should not be taken lying down, especially young children and bedridden patients.
Before starting treatment, you must be properly hydrated, since prolonged use of laxatives can cause an electrolyte imbalance (minerals present in the blood) and hypokalemia (potassium deficiency).
If you are having blood tests the doctor know you are taking this medicine, since the blood glucose concentration may increase after prolonged administration of laxatives.
You must use this medicine with caution if you have sudden changes in bowel habits that persist over 2 weeks.

Children and adolescents
Do not administer to children under 6 years old.
It should be administered with caution to children 6 to 12 years old due to risk of aspiration.

Taking with other medicines Hodernal
Tell your doctor or pharmacist if you are taking ,, has recently taken or might take any other medicines.
It should not be given within 2 hours before or after taking other medication. This medication should not be administered with:
Oral Anticoagulants (medicines that cause the blood take longer to clot) coumarin derivatives or indandione
digitalis glucosides (group of medicines used to treat heart failure).
including estrogen (a type of female hormone)
-oral contraceptives
-docusato sodium (medicine used for constipation)
-vitamins soluble vitamins (vitamin A, D, E and K), calcium, phosphorus and potassium or potassium supplements

Taking Hodernal with food and drink
It should not be given within 2 hours before or after meals.
During treatment, take plenty of fluids (up to two liters per day) to facilitate softening of the stool.

Pregnancy, lactation and fertility
If you are pregnant or breast-feeding, you think you may be pregnant or planning to become pregnant, ask your doctor or pharmacist before using this medicine.

Driving and using machines
There have been no effect on driving and using machines.

Hodernal contains sorbitol
This medicine contains sorbitol. If your doctor has told you have an intolerance to some sugars, contact your doctor before taking this medicine.


 3. How to take Hodernal
Follow exactly the instructions of medicine administration in this leaflet or as your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
The recommended dose in adults and children over 12 years dose is 15 ml of oral solution or a tablespoon (12 g of liquid paraffin) once daily before bedtime. If necessary, repeat the dose of15 ml of oral solution or a tablespoon (12 g liquid paraffin) in the morning on an empty stomach or two hours after breakfast.
No more than 30 ml of oral solution or two tablespoons (24 g of liquid paraffin day).

Use in children
The recommended dose in children 6 to 12 years old dose is 5 ml of oral solution or a teaspoon (4 g of liquid paraffin) once daily before bedtime. If necessary, repeat the dose of 5 ml of oral solution or a 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 of coffee (8 g of liquid paraffin) per day.
Hodernal solution should not be given to children under 6 years due to a lack of data on safety and efficacy.
Hodernal is administered orally.
It is advisable to dilute the liquid paraffin in a glass of water and take in an upright position to prevent the passage of oil droplets to the respiratory tract. Do not take lying down.
During treatment, take plenty of fluids (up to two liters per day) to facilitate softening of the stool.
If symptoms worsen, if any deposition after 72 hours does not occur after the maximum daily administration, or if symptoms persist after 6 days of treatment, tell your doctor or pharmacist.

If you take more than you should Hodernal
If you take more than the recommended Hodernal anal paraffin removal may occur with electrolyte loss, cramps, muscle cramps and weakness.
In case of overdose or accidental ingestion, immediately consult your doctor or pharmacist or call poison control center, phone (+34) 915 62 04 20, indicating the medicine and the amount taken.

If you forget to take Hodernal Solution
Do not take a double dose to make up for missed doses.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


 4. Possible side effects
Like all medicines, Hodernal can cause side effects, although not everybody gets them.
Adverse effects of liquid paraffin are usually mild and transient. The following side effects are listed according to their frequency:
- Uncommon (may affect up to 1 in 100 patients): pruritus (itching) anal, anal irritation.
- Rare (may affect up to 1 in 1000 patients): deficit of fat-soluble vitamins (A, D, E and K).
- Very rare (may affect up to 1 in 10,000 patients): hypersensitivity reactions.
- Not known (can not be estimated from available data): pneumonia and pneumonitis (lung inflammation) lipoid, removal of mineral oil into the rectum, anal incontinence, watery stools, abdominal pain, worsening of constipation, reactions granulomatous (type inflammatory response caused by paraffin oil), dehydration.

Communication adverse effects:
If you experience any side effects, talk to your doctor or pharmacist, even if it comes to possible side effects not listed in this leaflet. You can also communicate directly through the Spanish Pharmacovigilance System for Medicinal Products for Human Use: https://www.notificaram.es. By communicating adverse effects you can help provide more information on the safety of this medicine.


 5. Conservation Hodernal
Keep this medicine out of the sight and reach of children. It does not require any special storage conditions.
Do not use this medicine after the expiry date on the carton after EXP. The expiry date is the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Place containers and medicines no longer required in Point SIGRE pharmacy. If in doubt, ask your pharmacist how to dispose of medicines no longer required. This way you will help to protect the environment.


 6. Contents of the pack and other information
Composition of Hodernal
- The active substance is liquid paraffin. Each ml contains 800 mg of liquid paraffin.
- The other ingredients are lemon essential oil dioleate, sorbitan (see section 2 "Hodernal contains sorbitol").

Looks like and contents of the pack
Hodernal is available in bottles of transparent PVC and aluminum cap containing 100 ml or 300 ml of clear, colorless solution with slight smell of lemon

Holder of the marketing authorization
ROTTAPHARM SL Avda. Diagonal, 67-69
08019 Barcelona - Spain
Tel .: +34 93 298 82 00
Fax: +34 93 223 16 52
E-mail: info@rottapharm.es

Responsible for manufacturing
ALCALA FARMA SL
M-300 Km 29.920 (Alcalá de Henares)
28802 - Spain


Source: Spanish Agency for Medicines and Health Products

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Hodernal jarabe 300 ml

Hodernal jarabe 300 ml

Hodernal syrup softens and lubricates the stool for easy transit and evacuation. Relieves constipation in adults and children over 6 years old

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