PROSPECTO : INFORMATION FOR THE USER

Chiclida 25 mg chewable tablets

Meclozine hydrochloride

Meclozine hydrochloride, the active ingredient of Chiclida, belongs to the group of medications called antihistamines, used against motion sickness caused by transportation means.

Chiclida is indicated for the prevention and treatment of symptoms of motion sickness caused by land, sea, or air transportation, such as nausea, vomiting, and/or dizziness in adults and adolescents over 12 years old.

You should consult a doctor if it worsens or does not improve after 7 days.

Do not take Chiclida

• If you are allergic to Meclozine hydrochloride or any of the other components of this medication (listed in section 6).
• If you have increased intraocular pressure (glaucoma).
• If you have an enlarged prostate (Prostatic Hypertrophy).
• If you have a disease that causes obstruction of the gastrointestinal tract or urinary system.
• If you have asthma.
• If you have diabetes.
• Children under 6 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Chiclida:

• If you have seizures with or without loss of consciousness (epilepsy).
• If you are over 65 years old, it may cause dry mouth, urinary retention, glaucoma, nausea, dizziness, sedation, confusion, low blood pressure (hypotension), or hyperexcitability.
• If you are using a medication that causes ear toxicity, as symptoms of these effects may be masked, such as ringing in the ears, dizziness, or vertigo.
• If you have any liver or kidney disease, as it may increase the concentration of the active principle.
• If you have or have had heart diseases or disorders such as cardiac arrhythmia, high blood pressure, severe muscle weakness (myasthenia gravis), stomach or intestinal ulcers.
• If you suspect you have symptoms of appendicitis such as nausea, vomiting, or abdominal cramps. It is recommended to consult a doctor to rule out the presence or absence of appendicitis.

Avoid exposure to the sun while taking this medication.

If you are allergic to any other antihistamine, it is not recommended to take this

medication.

Interference with analytical tests

If you are going to undergo a skin test that uses allergens, inform your doctor that you are taking this medication, as it may alter the results.

It is recommended to suspend the administration of this medication at least 72 hours before the test.

Children

Do not use this medication in children under 12 years old.

Use of Chiclida with other medications

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

It is contraindicated to use it together with:

• Central nervous system depressants such as anesthetics, opioid analgesics, barbiturates (used as sedatives, anticonvulsants, and for sleep problems), benzodiazepines (for sleep), antipsychotics.
• Antiparkinsonian drugs.
• Antidepressants.
• Neuroleptics (used to calm excitement and hyperactivity of the neuromuscular system).

Chiclida intake with food, drinks, and alcohol

Alcoholic beverages may potentiate the action of Meclozine, so it is not recommended to use them simultaneously.

Pregnancy and lactation

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

Do not use it during pregnancy, except in cases where it is strictly necessary. Do not administer during lactation.

Driving and operating machines

Chiclida may cause drowsiness, which may affect your ability to drive and/or operate machines. Patients should avoid operating hazardous machinery, including cars, until they know how they tolerate the medication.

Chiclida contains Glucose and Sucrose

This medication contains Glucose and Sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

It may cause tooth decay.

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

Adults and adolescents (over 12 years):1 or 2 Chiclida tablets (25 mg- 50 mg meclozine hydrochloride) approximately one hour before starting the trip. If necessary, repeat the dose every 24 hours. Do not exceed the dose of 2 Chiclida tablets (50 mg meclozine hydrochloride) per day.

Patients with renal and/or hepatic insufficiency:It may be necessary to reduce the dose (see section 2 Adverse reactions and precautions).

Chew the tablet. Do not swallow.

Administer at least one hour before starting the trip.

If symptoms worsen, or if they persist for more than 7 days, you must consult your doctor.

Use in children

Chiclida is contraindicated in children under 6 years.

This medication is not recommended for children aged 6 to 12 years.

If you take more Chiclida than you should

You must consult your doctor or pharmacist immediately.

The symptoms of an overdose may vary, from sedation, difficulty breathing, loss of consciousness to insomnia, hallucinations, tremors, or seizures.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone 91 562 04 20 indicating the medication and the amount ingested.

If you forgot to take Chiclida

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 medicines, this medicine can cause side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

If you suffer a severe allergic reaction (anaphylactic shock) with rash, itching, difficulty breathing, stop taking the medicine and seek immediate medical help.

The most frequent adverse reactions are the appearance of drowsiness and sedation. Dry mouth, blurred vision, nausea, vomiting, and joint pain occur rarely (can affect up to 1 in 1,000 patients).

Other adverse reactions of unknown frequency (cannot be estimated from available data) are:

• Abdominal pain, diarrhea, and constipation.
• Sleep and sedation.
• Increased secretion of the bronchi.
• Increased appetite, anorexia.
• Anxiety, euphoria, irritability, hallucinations, insomnia, memory disorders, psychotic disorders, confusion, and paranoia.
• Dizziness, headache, movement disorders (e.g. Parkinson's), paresthesia (tingling and numbness).
• Diplopia (double vision).
• Vertigo, tinnitus (internal sounds in the ear).
• Throat and nasal dryness, bronchospasm (contraction of the bronchi), epistaxis (nasal hemorrhage).
• Difficulty, painful, and incomplete urination, polyuria (excretion of a large amount of urine), urinary retention.
• Fatigue, weakness.
• Tachycardia, palpitations, and/or arrhythmias.
• Hypotension (decreased blood pressure).
• May cause hyperexcitability, especially in children.
• Decreased blood count of red blood cells, white blood cells, leukocytes, and platelets.
• Allergic reactions on the skin and sensitivity to sunlight, after intense exposure, which may cause itching and redness of the skin.
• Weight gain.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.

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

No special conservation conditions are required.

Keep out of sight and reach of children.

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.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the designated point of the Pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Chiclida

The active principle is Meclozine hydrochloride. Each lozenge contains 25 mg of meclozine hydrochloride.

The other components are: Glucose monohydrate, Sucrose, Peppermint essence and Magnesium stearate. See section 2 “Chiclida contains glucose and sucrose”.

Appearance of the product and contents of the packaging

Oval-shaped lozenges with a white color.

Each package contains 6 lozenges.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Name: Fleer Española, S.L.

Address: Rambla Catalunya Nº. 53 ático

City: 08007-Barcelona

Responsible for manufacturing:

Name: Fleer Española, S.L.

Address: 08795 – Olesa de Bonesvalls (Barcelona)Phone: 93 898 40 11Fax: 93 898 41 76

Date of the last review of this leaflet: January 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://aemps.gob.es