Cinfamar Infantil 12.5 mg oral solution

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cinfamar infantil 12.5 mg oral solution

Dimenhydrinate

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or further information, consult your pharmacist.

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

• You should consult a doctor if you worsen or do not improve after 7 days.

Contents of the leaflet

1. What Cinfamar infantil is and what it is used for
2. What you need to know before taking Cinfamar infantil
3. How to take Cinfamar infantil
4. Possible adverse effects
5. How to store Cinfamar infantil
6. Contents of the pack and other information

1. What cinfamar infantil is and what it is used for

Dimenhydrinate is the active substance in this medicine and acts against motion sickness caused by various modes of transportation.

It is indicated for the prevention and treatment of symptoms of motion sickness caused by land, sea, or air travel, such as nausea, vomiting, and/or dizziness in children aged 2 to 12 years.

You should consult a doctor if symptoms worsen or do not improve after 7 days.

2. What you need to know before taking cinfamar infantil

Do not take cinfamar infantil

• If you are allergic to dimenhydrinate, diphenhydramine, or any of the other components of this medicine (listed in section 6).
• If you have porphyria (a rare disorder, usually hereditary, characterized by excessive excretion of porphyrins in feces and urine).
• If you are experiencing asthmatic attacks.

Warnings and precautions

Consult your doctor or pharmacist before starting to take cinfamar infantil.

• If you have asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as thickening of secretions may occur and may impair expectoration.
• If you have a condition characterized by abnormally increased activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), hypertension, or any condition causing urinary or gastrointestinal tract obstruction.
• If you suffer from seizures with or without loss of consciousness (epilepsy).
• If you are over 65 years old, dry mouth, urinary retention, nausea, sedation, confusion, and low blood pressure (hypotension) may occur.
• If you are taking any medicine that causes ototoxicity (ear toxicity), as symptoms of such toxic effects (such as tinnitus, dizziness, or vertigo) may be masked.
• If you have any liver or kidney disease, stomach or duodenal ulcer, or inflammation of the stomach (gastritis), you should consult your doctor before taking this medicine.
• You should consult your doctor before taking this medicine if you have or have had heart conditions (cardiac arrhythmia, myocardial ischemia, etc.).
• If you suspect you may have symptoms of appendicitis such as nausea, vomiting, or abdominal cramps, it is recommended to see a doctor to rule out appendicitis, as dimenhydrinate may interfere with the diagnosis of this condition.
• It is recommended to avoid exposure to high temperatures and to follow appropriate hygienic-dietary measures, such as adequate ventilation and hydration.
• Avoid exposure to sunlight (even when cloudy) and to ultraviolet radiation lamps (UV-A rays) while taking this medicine.

Children

Do not use this medicine in children under 2 years of age.

Taking cinfamar infantil with other medicines

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

In particular, if you are taking any of the following medicines, it may be necessary to adjust the dose of cinfamar infantil or avoid taking it altogether:

• Anesthetics and other substances with central nervous system depressant effects
• Antibiotics of the aminoglycoside group
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs)
• Antiparkinsonian agents
• Neuroleptics (used to calm agitation and neuromuscular hyperactivity)
• Ototoxic medicines (which may affect the ear) (see section Warnings and precautions)
• Medicines that may cause photosensitivity (skin reactions due to sensitivity to sunlight)

Interference with diagnostic tests

If you are scheduled to undergo allergy testing, including skin tests, it is recommended to discontinue treatment 72 hours before the test to avoid interference with test results.

Taking cinfamar infantil with food, drinks, and alcohol

Alcohol consumption is not recommended while taking this medicine.

Pregnancy, breastfeeding, and fertility

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

Taking medicines during pregnancy may be harmful to the embryo or fetus and should be monitored by your doctor.

Breastfeeding women should not take this medicine without first consulting their doctor or pharmacist, as this medicine passes into breast milk.

Driving and using machines

Do not drive or operate heavy machinery, as this medicine may cause drowsiness or reduced reaction ability, even at recommended doses.

cinfamar infantil contains methylparahydroxybenzoate sodium salt and propylparahydroxybenzoate sodium salt

May cause allergic reactions (possibly delayed) because it contains methylparahydroxybenzoate sodium salt and propylparahydroxybenzoate sodium salt.

cinfamar infantil contains sorbitol

This medicine contains 714.30 mg of sorbitol in each 5 ml.

Sorbitol is a source of fructose. If your doctor has diagnosed you (or your child) with intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot metabolize fructose, consult your doctor before taking this medicine.

Sorbitol may cause gastrointestinal discomfort and a mild laxative effect.

cinfamar infantil contains sodium

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

cinfamar infantil contains propylene glycol

This medicine contains 330 mg of propylene glycol in each 5 ml.

If you are pregnant or breastfeeding, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

If you have hepatic or renal insufficiency, do not take this medicine unless recommended by your doctor. Your doctor may perform additional monitoring while you are taking this medicine.

If the child is under 5 years of age, consult your doctor or pharmacist, especially if other medicines containing propylene glycol or alcohol have been administered.

3. How to take cinfamar infantil

Follow exactly the administration instructions provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended doses are:

• Children aged 7 to 12 years: 2 or 4 single-dose sachets (corresponding to 25 or 50 mg of dimenhydrinate). If necessary, repeat this dose every 6 to 8 hours. Under no circumstances should you take more than 12 single-dose sachets per day (150 mg of dimenhydrinate), divided into several doses.

• Children aged 2 to 6 years: 1 or 2 single-dose sachets (corresponding to 12.5 or 25 mg of dimenhydrinate). If necessary, repeat this dose every 6 to 8 hours. Under no circumstances should you take more than 6 single-dose sachets per day (75 mg of dimenhydrinate), divided into several doses.

• Children under 2 years: This medicine must not be used in children under 2 years of age.

• Patients with liver disease: should consult their doctor before taking this medicine, as it may be necessary to reduce the dose.

This medicine is taken orally.

It is recommended to take the first dose at least half an hour before starting the journey (preferably 1 or 2 hours beforehand). If not taken previously, the first dose should be taken when symptoms appear. If motion sickness persists, at least 6 hours should elapse between doses.

It is advisable to take this medicine with food, water, or milk to minimize gastric irritation.

If symptoms worsen or persist for more than 7 days, consult your doctor.

If you take more cinfamar infantil than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of overdose include mainly: dilated pupils, flushed face, excitement, hallucinations, confusion, stomach and intestinal irritation with nausea, vomiting and diarrhea, movement disturbances, convulsions, deep unconsciousness (coma), sudden decrease in respiratory and heart function (cardiorespiratory collapse), and death. Symptoms may take more than 2 hours to appear after the overdose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects are usually mild and transient, especially at the beginning of treatment.

During the period of use of dimenhydrinate, the following adverse reactions have been observed, although their frequency could not be accurately determined:

• Nausea, vomiting, constipation, diarrhoea, stomach pain.
• Loss of appetite and dry mouth.
• Drowsiness and sedation (drowsiness).
• Headache, dizziness, and vertigo.
• Increased mucus viscosity in the bronchi, making breathing difficult.
• Urinary retention and sexual impotence.
• Glaucoma (increased intraocular pressure of the eye).
• Pupil dilation, blurred vision, or double vision.
• Allergic skin reactions and photosensitivity after intense sun exposure, which may result in urticaria, itching, and skin redness.
• Decrease in blood levels of red blood cells, white blood cells, leucocytes, and platelets.
• Porphyria (a rare disorder, usually hereditary, in which large amounts of porphyrins are excreted in faeces and urine).
• Hypertension or hypotension (increase or decrease in blood pressure).
• Tachycardia, palpitations, and/or cardiac arrhythmias.
• Hyperexcitability may occur, especially in children, with symptoms such as insomnia, nervousness, confusion, tremor, irritability, euphoria, delirium, palpitations, and even seizures.

Reporting of 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of cinfamar infantil

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

This medicine does not require any special storage conditions.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of cinfamar infantil

• Each single-dose sachet contains 12.5 milligrams of dimenhydrinate as the active substance.

• The other components are: glycerol (E-422), propylene glycol (E-1520), raspberry flavour (glyceryl triacetate (E-1518) and natural flavouring substances), methylparaben sodium salt (E-219), propylparaben sodium salt (E-217), citric acid monohydrate (E-330), sodium chloride, sodium saccharin (E-954), acesulfame potassium (E-950), sodium citrate (E-331), sorbitol (E-420), hydroxyethylcellulose and purified water.

Appearance of the medicinal product and contents of the pack

cinfamar infantil is a clear, colourless or slightly yellowish oral solution with a raspberry odour.

It is presented in packs containing 6 or 12 single-dose sachets of 5 ml.

Marketing Authorisation Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent revision of this leaflet: December 2020

Detailed and up-to-date 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/