Cinfamar 50 mg film-coated tablets
Spain
Table of Contents
Package Leaflet: Information for the User
Introduction
Package leaflet: information for the user
cinfamar 50 mg coated tablets
dimenhydrinate
Read this 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
- What cinfamar is and what it is used for.
- What you need to know before taking cinfamar.
- How to take cinfamar.
- Possible adverse effects.
- How to store cinfamar.
- Contents of the pack and other information.
1. What cinfamar is and what it is used for
Dimenhydrinate is the active ingredient in this medicine and acts against motion sickness caused by means of transportation.
It is indicated for the prevention and treatment of symptoms of motion sickness caused by travel by land, sea, or air, such as nausea, vomiting, and/or dizziness in adults and children over 12 years of age.
You should consult a doctor if your condition worsens or does not improve after 7 days.
2. What you need to know before starting to take cinfamar
Do not take cinfamar:
- 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, in which large amounts of porphyrins are excreted in faeces and urine).
- If you have asthma attacks.
Warnings and precautions
Consult your doctor or pharmacist before starting to take cinfamar.
- 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 involving abnormally increased activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), enlarged prostate (prostatic hypertrophy), hypertension, or any condition causing obstruction of the urinary or gastrointestinal tract.
- If you have seizures involving convulsive movements, with or without loss of consciousness (epilepsy).
- If you are over 65 years of age, dry mouth, urinary retention, nausea, sedation, confusion, and low blood pressure (hypotension) may occur.
- If you are taking any medicine that causes ear toxicity, as symptoms of such toxic effects (such as ringing in the ears, 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 diseases or disorders (cardiac arrhythmia, myocardial ischaemia).
- 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 the presence of 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 and dietary measures, such as adequate ventilation and hydration.
- Avoid exposure to sunlight (even when cloudy) and ultraviolet lamps (UVA rays) while taking this medicine.
Children
Do not use this medicine in children under 2 years of age.
Taking cinfamar 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 or not to take it at all:
- Anaesthetics 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 at least 72 hours before the test to avoid interfering with test results.
Taking cinfamar with food, drinks, and alcohol
Alcohol consumption is not recommended during treatment with this medicine.
It is recommended to take this medicine with food or milk.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Taking medicines during pregnancy may be harmful to the embryo or foetus and should be supervised by your doctor.
Breastfeeding women should not take this medicine without first consulting a 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 capacity at recommended doses.
Cinfamar contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially "sodium-free".
3. How to take cinfamar
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 doses are:
- Adults and children over 12 years: 1 or 2 tablets (50 - 100 mg of dimenhydrinate) per dose. If necessary, repeat the dose every 4-6 hours. Do not administer more than 8 tablets (400 mg of dimenhydrinate) per day, divided into several doses.
- Children aged 2 to 12 years: This medicine is not suitable for children aged 2-12 years. More appropriate formulations are available for children aged 2-12 years, such as cinfamar infantil 25 mg coated tablets or cinfamar infantil 12.5 mg oral solution.
- Children under 2 years: 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 1-2 hours beforehand). If not taken previously, the first dose should be taken when symptoms appear. If dizziness persists, wait at least 4 to 6 hours between doses.
It is advisable to take the tablets 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 than you should
If you have taken more cinfamar than you should, consult your doctor or pharmacist immediately.
Symptoms of overdose include mainly: dilated pupils, flushed face, excitement, hallucinations, confusion, irritation of the stomach and intestines with nausea, vomiting and diarrhoea, movement disturbances, seizures, deep unconsciousness (coma), sudden decrease in respiratory and heart function (cardiorespiratory collapse), and death. Symptoms may take more than 2 hours to appear after overdose.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.
4. Possible adverse effects
Like all medicines, this medicine may 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, for which the frequency could not be established accurately:
- 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 following intense sunlight exposure, which may result in urticaria, itching, and skin redness.
- Decreased blood levels of red blood cells, white blood cells, leukocytes, and platelets.
- Porphyria (a rare disorder, usually hereditary, in which large amounts of porphyrins are excreted in faeces and urine).
- Hypertension or hypotension (increased or decreased 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 through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of cinfamar
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 carton and label 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 are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of cinfamar
- Each tablet contains 50 mg of dimenhydrinate as the active substance.
- The other components are:
- Core: calcium hydrogen phosphate dihydrate, corn starch, microcrystalline cellulose, sodium carboxymethyl starch (type A) (from potato), povidone, talc, and magnesium stearate.
- Coating: hypromellose 606, hypromellose 615, macrogol 6000, deionized water.
Appearance of the medicinal product and contents of the pack
White, cylindrical, biconvex coated tablets, scored on one side.
Available in packs containing 4 or 10 coated tablets.
Marketing Authorization 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 for Medicines and Health Products (AEMPS) http://www.aemps.es/