Hydropolyvit oral solution drops

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Hidropolivit oral drops in solution

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

Follow exactly the instructions for use of this medicine as described in this leaflet or as 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 any 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 15-30 days.

Contents of the 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 adverse effects
5. How to store Hidropolivit oral drops
6. Contents of the pack and other information

1. What Hidropolivit oral drops is and what it is used for

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

It is indicated for: Vitamin deficiencies, such as those occurring in situations of inadequate diets, weight-loss diets, vegetarian diets or other dietary regimens; loss of appetite and convalescence.

Hidropolivit oral drops is indicated in adults and children over 2 years of age.

2. What you need to know before starting to take Hidropolivit oral drops

Do not take Hidropolivit oral drops

• if you are allergic to the vitamins it contains, to vitamin D derivatives, or to any of the other components of this medicine (listed in section 6)
• if you have severe kidney or liver disease
• if you have high levels of calcium or of vitamins A or D in blood or urine
• if you have a severe bone disease (renal osteodystrophy)
• if you suffer from calcium kidney stones (kidney stones).

Warnings and precautions

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

• Do not use this medicine as a substitute for a balanced diet, and take into account any other sources of vitamin intake.

• You may notice a more pronounced yellowish color of the urine, without interference in any bodily function.

• You should consult your doctor before taking this medicine if you have any of the following conditions: kidney disease, heart disease, predisposition to kidney stones, arteriosclerosis, high blood phosphate levels, or a granulomatous disease such as sarcoidosis (with nodules, usually in the skin).

• You should also consult your doctor if you are taking any of the following medications: heart medications or anticoagulants (for circulation), among others (see section Other medicines and Hidropolivit oral drops).

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

Children Do not use in children under 2 years of age.

Other medicines and Hidropolivit oral drops

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

The active ingredients in this medicine interact with the following medicines:

• Oral anticoagulants (such as warfarin or dicoumarol)
• Cholestyramine, colestipol (for cholesterol), mineral oil (laxative), orlistat (for obesity)
• Medicines for the heart or arteries (thiazide diuretics, cardiac glycosides such as digoxin, etc.)
• Antacids containing aluminium or magnesium

Additionally, other specific interactions may occur due to individual active ingredients:

Other interactions due to retinol (vitamin A):

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

Other interactions due to colecalciferol (vitamin D):

• Cimetidine (for digestive ulcers)
• Calcium-containing preparations in high doses

Other interactions due to ascorbic acid (vitamin C):

• Deferoxamine (for iron intoxication or overload)
• Iron
• Indinavir (for AIDS)

Other interactions due to pyridoxine (vitamin B6):

• Levodopa (Parkinson's treatment)
• Altretamine (for cancer)
• Amiodarone (for the heart)

Patients treated with certain medicines may have lower than normal levels of some vitamins. For example: patients treated with antiepileptic drugs may have low vitamin D levels, and patients treated with antituberculosis drugs (isoniazid, cycloserine, etc.), penicillamine (for arthritis or other conditions), or oral contraceptives may have low levels of vitamin B6 (pyridoxine).

You should separate the administration of Hidropolivit oral drops by at least 2 to 3 hours from the following medicines:

• Cholesterol-lowering medicines (cholestyramine or colestipol), obesity treatment (orlistat), laxatives (mineral oil).
• Antacids containing aluminium or magnesium.

Taking Hidropolivit oral drops with alcohol

Alcoholic patients generally may have vitamin deficiencies.

Pregnancy and breastfeeding

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

Pregnancy

Some of the active ingredients in this medicine, when taken at high doses, could cause abnormalities in the newborn.

The use of Hidropolivit oral drops during pregnancy is not recommended.

Breastfeeding

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

Consult your doctor before taking this medicine, to consider whether you need to discontinue treatment or breastfeeding, weighing the benefits of breastfeeding for the baby and of treatment for the mother.

Driving and using machines

The effect of Hidropolivit oral drops on the ability to drive and use machines is negligible.

Hidropolivit oral drops contains sorbitol (E-420), methylparaben (E-218), benzyl alcohol, propylene glycol (E-1520), and sodium

This medicine contains 124 mg of sorbitol in each 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 have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child's doctor) before taking this medicine.

This medicine contains 209.51 mg of propylene glycol in each ml.

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

It may cause allergic reactions (possibly delayed) because it contains methylparaben (E-218).

This medicine contains 0.14 mg of benzyl alcohol in each ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome"), in infants. Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has specifically recommended it.

This product should not be used for more than one week in children under 3 years of age unless directed 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 high amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

This medicine contains less than 1 mmol of sodium (23 mg) per ml; hence, it is essentially “sodium-free”.

3. How to take Hidropolivit oral drops

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 is:

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

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

For oral use.

The drops, measured with the dropper, may be taken directly or mixed with a small amount of water.

Do not take continuously for longer 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

Ingestion of large amounts 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; prolonged treatment may lead to liver abnormalities, kidney stones; soft tissue calcifications and other disorders may also appear.

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

If you forget to take Hidropolivit oral drops

Do not take a double dose to make up for forgotten 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 cause adverse effects, although not everyone will experience them.

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

Gastrointestinal reactions (such as nausea and vomiting).

Allergic reactions.

Itching and skin irritation.

In predisposed individuals, there is a risk of developing calculi (kidney stones).

Reporting of adverse effects

If you experience any 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 Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Hidropolivit oral drops

Keep this medicine out of the sight and reach of children.

Store below 25 ºC.

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

After opening, when closed with the cap, this medicine can be used for 6 months if stored under the conditions specified above.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Hidropolivit oral drops solution

Each ml (approximately 28 drops) contains:

• The active substances: 1,500 IU of Retinol palmitate (vitamin A), 600 IU 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, polysorbate 80, sorbitol 70% (E-420), glycerol (E-422), sodium saccharin, disodium edetate, monotioglycerol, methyl p-hydroxybenzoate (E-218), butylhydroxyanisole (E-320), banana flavour (contains benzyl alcohol and propylene glycol [E-1520]), vanilla flavour (contains propylene glycol [E-1520]), sodium hydroxide, and purified water.

Appearance of the product and contents of the container

Hidropolivit oral drops is a clear, golden-coloured solution with a banana odour, which may slightly darken over time.

It is an oral solution dosed in drops, supplied 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 most recent revision of this leaflet: June 2024

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.