HIDROPOLIVIT ORAL SOLUTION DROPS

Introduction

Package Leaflet: Information for the User

Hidropolivit Oral Drops in Solution

Read the entire package leaflet carefully before starting to take 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.

• 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 15-30 days.

Contents of the Package Leaflet

1. What Hidropolivit Oral Drops are and what they are used for
2. What you need to know before taking Hidropolivit Oral Drops
3. How to take Hidropolivit Oral Drops
4. Possible side effects
5. Storage of Hidropolivit Oral Drops
6. Package Contents and Additional Information

1. What Hidropolivit Oral Drops are and what they are used for

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

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

Hidropolivit Oral Drops are indicated for adults and children over 2 years of age.

2. What you need to know before taking Hidropolivit Oral Drops

Do not take Hidropolivit Oral Drops

• if you are allergic to the vitamins it contains, to products derived from vitamin D, 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 kidney stone formation.

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 consider other sources of vitamins.
• A greater yellowish tone of the urine may appear, without interfering with any function of the body
• You should consult your doctor before taking this medication if you have kidney disease, heart disease, are prone to kidney stones, arteriosclerosis, or have high phosphate levels in your blood, or have a granulomatous disease such as sarcoidosis (with nodules, usually on the skin).
• You should also consult your doctor if you are being treated with: heart medications or anticoagulants (for circulation), among others (see section "Other Medications and Hidropolivit Oral Drops").

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

ChildrenDo not use in children under 2 years of age.

Other Medications and Hidropolivit Oral Drops

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

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

• Oral anticoagulants (such as warfarin or dicumarol)
• Colestyramine, colestipol (for cholesterol), mineral oil (laxative), orlistat (for obesity)
• Heart or artery medications (thiazide diuretics, cardiac glycosides such as digoxin, etc.)
• Antacids containing aluminum or magnesium

Additionally, other specific interactions may occur with some active ingredients:

Other interactions due to retinol (vitamin A):

• Medications similar to vitamin A and derivatives, such as retinoids
• Minocycline (antibiotic)

Other interactions due to colecalciferol (vitamin D):

• Cimetidine (for digestive ulcers)
• High-dose calcium preparations

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 (for Parkinson's disease)
• Altretamine (for cancer)
• Amiodarone (for heart conditions)

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

You should take Hidropolivit Oral Drops at least 2 or 3 hours apart from the following medications:

• Cholesterol medications (colestyramine or colestipol), obesity medications (orlistat), laxatives (mineral oil).
• Antacids containing aluminum or magnesium.

Taking Hidropolivit Oral Drops with Alcohol

Alcoholic patients may generally have vitamin deficiencies.

Pregnancy and Breastfeeding

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.

Pregnancy

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

Hidropolivit Oral Drops are not recommended during pregnancy.

Breastfeeding

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

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

Driving and Using Machines

The influence of Hidropolivit Oral Drops on the ability to drive and use machines is insignificant.

Hidropolivit Oral Drops contain sorbitol (E-420), methylparaben (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 told you (or your child) that you have an intolerance to certain sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), 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 methylparaben.

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 serious side effects, including respiratory problems ("gasping syndrome") 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 one week in children under 3 years of age unless indicated by your doctor or pharmacist.

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 can accumulate in the body and cause side effects (metabolic acidosis).

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

3. How to take Hidropolivit Oral Drops

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

The recommended dose is:

Children from 2 to 6 years: 10 drops per day, which can be divided into two doses, one preferably 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 route.

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 one 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 of age.

If you take more Hidropolivit Oral Drops than you should

Taking large amounts and/or for several days may cause digestive disorders (vomiting, diarrhea, or abdominal cramps), irritability, drowsiness; hypercalcemia (high calcium levels in the blood) may occur; other symptoms may include skin disorders; in prolonged treatment, liver disorders, kidney stones, or calcifications in soft tissues may occur, 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Hidropolivit Oral Drops

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

If you have any other questions 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 will experience them.

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

Digestive reactions (such as nausea and vomiting).

Allergic reactions.

Itching and irritation of the skin.

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

Reporting Side Effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Hidropolivit Oral Drops

Keep this medication out of sight and reach of children.

Store below 25°C.

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection 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

Composition of Hidropolivit Oral Drops in Solution

Each ml (approximately 28 drops) contains:

• The active ingredients: 1,500 IU of Retinol palmitate (vitamin A), 600 IU of Colecalciferol (vitamin D), 10 mg of Alpha-tocopherol 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, polysorbate 80, sorbitol 70% (E-420), glycerol (E-422), sodium saccharin, disodium edetate, monothioglycerol, methylparaben (E-218), butylhydroxyanisole (E-320), banana flavor (contains benzyl alcohol and propylene glycol [E-1520]), vanilla flavor (contains propylene glycol [E-1520]), sodium hydroxide, and purified water.

Appearance of the Product and Package Contents

Hidropolivit Oral Drops are a clear, golden-colored solution with a banana flavor that becomes slightly darker over time.

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

Marketing Authorization Holder and Manufacturer

Laboratorios Menarini, S.A.

Alfons XII, 587

08918 Badalona (Barcelona) Spain

Date of the Last Revision of this Package Leaflet:June 2024

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