Label: information for the user

Hidropolivit oral drops in solution

Read this label carefully before starting to take this medication, as it contains important information for you.

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

- Keep this label, 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 label. See section 4.

- You should consult a doctor if your condition worsens or does not improve after 15-30 days.

The active principles it contains are fat-soluble vitamins (vitamins A, D, and E) and water-soluble vitamins (group B and vitamin C).

It is indicated for: Vitamin deficiencies, such as in situations of inadequate diets, weight loss, vegetarian diets, or others; loss of appetite and convalescence.

Hidropolivit gotas orales is indicated for adults and children over 2 years old.

Do not take Hidropolivit oral drops

• if you are allergic to the vitamins it contains, to vitamin D products or to any of the other components of this medication (listed in section 6)
• if you have severe kidney or liver disease
• if you have high levels of calcium or vitamins A or D in your blood or urine
• if you have a severe bone disease (renal osteodystrophy)
• if you have a condition of calcium stone formation in the kidney

Warnings and precautions

Consult your doctor or pharmacist before starting to take Hidropolivit oral drops.

• Do not take this medication as a substitute for a balanced diet and you should take into account other vitamin sources.
• A yellowish tone of the urine may appear, without interfering with any bodily function
• You should consult your doctor before taking this medication if you have any of the following conditions: kidney disease, heart disease, predisposition to stone formation, arteriosclerosis or high levels of phosphate in the blood, or any granulomatous disease such as sarcoidosis (with nodules, usually on the skin).
• You should also consult your doctor if you are taking: heart medications or anticoagulants (for circulation), among others (see sectionOther medications and Hidropolivit oral drops).

• Interference with diagnostic tests: If you are to undergo any diagnostic test (including blood, urine, etc... tests) inform your doctor that you are taking this medication, as it may alter the results.

ChildrenNo use in children under 2 years.

Other medications and Hidropolivit oral drops

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

The active principles of this medication interact with the following medications:

- Oral anticoagulants (such as warfarin or dicumarol)

- Cholestyramine, colestipol (for cholesterol), mineral oil (laxative), orlistat (for obesity)

- Heart medications or artery medications (diuretics, cardiac glycosides such as digoxin, etc.)

- Antacids containing aluminum or magnesium

Additionally, other specific interactions may occur due to retinol (vitamin A):

Other interactions, due to retinol (vitamin A):

- Similar medications to vitamin A and derivatives, such as retinoids

- Minocycline (antibiotic)

Other interactions, due to colecalciferol (vitamin D):

- Cimetidine (for digestive ulcers)

- Preparations with high doses of calcium

Other interactions, due to ascorbic acid (vitamin C):

- Deferoxamine (for iron poisoning or overload)

- Iron

- Indinavir (for AIDS)

Other interactions, due to pyridoxine (vitamin B6):

- Levodopa (Parkinson's disease treatment)

- Altretamine (for cancer)

- Amiodarone (for heart disease).

Patients treated with certain medications may have lower than normal levels of certain vitamins, such as: patients treated with antiepileptic medications may have lower levels of vitamin D, and patients treated with antitubercular medications (isoniazid, cycloserine, etc.), penicillamine (for arthritis or other conditions) or oral contraceptives may have lower levels of vitamin B6 (pyridoxine).

You should space the intake of Hidropolivit oral drops at least 2 or 3 hours from the following medications:

- Cholesterol medications (cholestyramine or colestipol), obesity medications (orlistat), laxatives (mineral oil)

- Antacids containing aluminum or magnesium

Hidropolivit oral drops and alcohol

Alcoholic patients in general may have vitamin deficiencies.

Pregnancy and breastfeeding

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

Pregnancy

Some of the active principles of this medication in high doses may cause alterations in the newborn.

This medication is not recommended during pregnancy.

Breastfeeding

Vitamins are excreted in breast milk in amounts that may affect the baby.

Consult your doctor before taking this medication if you need to interrupt treatment or breastfeeding, considering the benefits of breastfeeding for the baby and treatment for the mother.

Driving and operating machinery

The influence of Hidropolivit oral drops on the ability to drive and operate machinery is insignificant.

Hidropolivit oral drops contain sorbitol (E-420), methyl parahydroxybenzoate (E-218), benzyl alcohol, propylene glycol (E-1520) and sodium

This medication contains 124 mg of sorbitol per ml.

Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have a condition of intolerance to certain sugars, or if you have been diagnosed with hereditary fructose intolerance (IHF), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medication.

This medication contains 209.51 mg of propylene glycol per ml.

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate.

This medication contains 0.14 mg of benzyl alcohol per ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of severe adverse effects that include respiratory problems ("breathing difficulty") in children. Do not administer this medication to your newborn (up to 4 weeks old) unless your doctor recommends it.

This product should not be used for more than a week in children under 3 years of age unless your doctor or pharmacist advises it.

Consult your doctor or pharmacist if you are pregnant or breastfeeding or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

This medication contains less than 1 mmol of sodium (23 mg) per ml; it is essentially "sodium-free".

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

The recommended dose is:

N Children aged 2 to 6 years : 10 drops per day, which may be divided into two doses, preferably one in the morning with breakfast and the other during lunch.

Children over 6 years and adults : 18 drops per day, preferably in the morning with breakfast.

Oral administration.

The drops, measured with the dropper, can be taken directly or mixed with a little water.

Do not take continuously for more than 15 days or up to a month.

If symptoms worsen or persist after 15-30 days of treatment, consult your doctor.

Use in children

Do not administer to children under 2 years.

If you take more Hidropolivit oral drops than you should

The ingestion of large quantities and/or over several days may cause gastrointestinal disturbances (vomiting, diarrhea, or abdominal cramps), irritability, drowsiness; hypercalcemia (elevated calcium levels in the blood) may occur; other symptoms may include skin disorders; in prolonged treatment, liver disturbances, kidney stones may occur; soft tissue calcifications may appear, among other disorders.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or go to a medical center, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Hidropolivit oral drops

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 following adverse effects have been described, whose frequency cannot be estimated from the available data:

Digestive reactions (such as nausea and vomiting).

Allergic reactions.

Itching and skin irritation.

In predisposed individuals, there is a risk of stone formation (kidney stones).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is about possible adverse effects that do not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: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 below 25 °C.

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

Once opened, covered with the cap, this medication can be used for 6 months if stored in the same conditions indicated.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Hidropolivit oral drops in solution

Each ml (approximately 28 drops) contains:

• The active principles: 1,500 UI of Retinol palmitate (Vitamin A), 600 UI of Colecalciferol (Vitamin D), 10 mg of Alfa-tocoferol acetate (Vitamin E), 2 mg of Riboflavin (Vitamin B2), 1.6 mg of Pyridoxine (hydrochloride) (Vitamin B6), 50 mg of Ascorbic acid (Vitamin C), 0.125 mg of Biotin, and 12.5 mg of Nicotinamide.
• The other components (excipients) are: propylene glycol, polisorbate 80, sorbitol 70% (E-420), glycerol (E-422), sodium saccharin, disodium edetate, monothioglycerol, methyl parahydroxybenzoate (E-218), butylhydroxyanisole (E-320), banana essence (contains benzyl alcohol and propylene glycol [E-1520]), vanilla essence (contains propylene glycol [E-1520]), sodium hydroxide, and purified water.

Appearance of the product and content of the packaging

Hidropolivit oral drops is a transparent, golden-colored solution with a banana-like odor that darkens slightly over time.

It is an oral solution dosed in drops and presented in a dropper bottle with a cap, containing 20 ml.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

Date of the last review of this leaflet: June 2024

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