Package Insert: Information for the Patient

Normostop 50 mg Tablets

Dimenhydrinate

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor, pharmacist, or nurse.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

1. What is Normostop and what is it used for

2. What you need to know before starting to take Normostop

3. How to take Normostop

4. Possible adverse effects

5. Storage of Normostop

6. Contents of the package and additional information

Dimenhydrinate is an active ingredient that acts against motion sickness caused by means of transportation.

Normostop is a medication 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 children 2 years of age and older.

Consult a doctor if symptoms worsen or do not improve after 7 days.

Do not take Normostop

• If you are allergic to dimenhidrinato or difenhidramina or any of the other components of this medication (listed in section 6).
• If you have porphyria (a rare, usually inherited disorder in which a large amount of porphyrin is eliminated in urine and feces).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Normostop:

• If you are allergic to any medication for treating allergies, you may also be allergic to dimenhidrinato.
• If you have asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as it may cause thickening of secretions and alter expectoration.
• If you have a disease in which there is an abnormal increase in the activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), or any disease that causes obstruction of the urinary or gastrointestinal tract.
• If you have seizures in which convulsive movements appear, with or without loss of consciousness (epilepsy).
• If you are over 65 years old, you may experience dry mouth, urinary retention, nausea, sedation, confusion, and hypotension.
• If you are using any medication that causes ototoxicity, as symptoms of these effects may be masked, such as ringing in the ears, dizziness, or vertigo.
• If you have any liver disease, kidney disease, stomach ulcer, or duodenal ulcer, or stomach inflammation (gastritis).
• If you have or have had heart disease (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 the presence or absence of appendicitis, as dimenhidrinato may make it difficult to diagnose this disease.
• It is recommended to avoid exposure to very high temperatures and follow adequate hygiene and dietary measures, such as proper ventilation and hydration.
• Avoid exposure to the sun (even on cloudy days), and UVA lamps while taking this medication.

Children

Children under 2 years old should not take this medication.

Taking Normostop with other medications

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

In particular, if you are using any of the following medications, it may be necessary to modify the dose of Normostop or not take it:

• Anesthetics, analgesics, and other substances with central nervous system depressant effects, such as alcohol, barbiturates, benzodiazepines.
• Aminoglycoside antibiotics.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs).
• Antiparkinsonian medications.
• Neuroleptics (used to calm agitation and hyperactivity).
• Ototoxic medications (that can affect the ear) (see Warnings and Precautions section).
• Medications that may cause photosensitivity (skin reactions due to sensitivity to sunlight).

Interference with diagnostic tests

If you are to undergo any allergy test, including skin tests, it is recommended to suspend treatment 72 hours before starting the test to avoid altering the test results.

Taking Normostop with food, drinks, and alcohol

It is not recommended to consume alcohol during the time you are taking this medication.

It is recommended to take this medication with food or milk.

Pregnancy and breastfeeding

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

Breastfeeding

Women who are breastfeeding should not take this medication without consulting their doctor or pharmacist, as this medication passes into breast milk and may also cause inhibition of lactation.

Driving and operating machinery

While taking this medication, do not drive or operate hazardous machinery as it may cause drowsiness or decreased reaction time.

Normostop contains sodium

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

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

The recommended dose is:

Children aged 2 to 6 years:

Half a tablet per dose. If necessary, repeat the dose every 8 hours.

Do not administer more than 1 and a half tablets per day (corresponding to 75 mg of dimenhidrinato) divided into several doses.

Children aged 7 to 12 years:

Half or 1 tablet per dose. If necessary, repeat the dose every 6 - 8 hours.

Do not administer more than 3 tablets per day (corresponding to 150 mg of dimenhidrinato)

Adults and adolescents over 12 years:

1 or 2 tablets per dose. If necessary, repeat the dose every 4 - 6 hours.

Do not administer more than 8 tablets per day (corresponding to 400 mg of dimenhidrinato)

Patients with liver diseases:

They must consult their doctor before taking this medication, as it may be necessary to adjust the dose.

Oral administration.

The first dose should be taken at least half an hour before starting the trip (preferably 1 or 2 hours before), leaving at least 4 hours between one dose and the next. It is recommended to take the tablets with food, water, or milk to minimize gastric irritation.

If it worsens, or if the symptoms persist for more than 7 days, consult your doctor.

If you take more Normostop than you should

If you have taken more Normostop than you should, consult your doctor or pharmacist immediately.

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

In case of overdose or accidental ingestion, go immediately to a medical center or call the Toxicological Information Service (phone: 915620420), indicating the medication and the amount ingested.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

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

During the period of use of dimenhidrinate, the following adverse reactions have been observed, whose frequency has not been established with precision:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Loss of appetite and dry mouth.
• Drowsiness and sedation (drowsiness).
• Headache, dizziness, and dizziness.
• Increased mucus viscosity in the bronchi, making breathing difficult.
• Urination retention and impotence.
• Glaucoma (increase in intraocular pressure of the eye).
• Pupil dilation, blurred vision, or double vision.
• Allergic reactions on the skin and sensitivity to sunlight, after intense exposure, which may appear as urticaria, itching, and skin redness.
• Decrease in the blood of red blood cells, white blood cells, leukocytes, and platelets.
• Porphyria (rare disorder, usually inherited, in which a large amount of porphyrin is eliminated in feces and urine).
• Hypotension (decrease in blood pressure).
• Tachycardia, palpitations, and/or cardiac arrhythmias.
• It may cause hyperexcitability, especially in children, with symptoms such as insomnia, nervousness, confusion, tremors, irritability, euphoria, delirium, palpitations, and even convulsions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use Website:www.notificaram.es.

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

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

Do not use this medication after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of normostop

• The active principle is dimenhidrinato, each tablet contains 50 mg of dimenhidrinato.
• The other components (excipients) are: microcrystalline cellulose, dihydrate calcium hydrogen phosphate, carboxymethylstarch sodium potato (type A), hydroxypropylcellulose, quinoline yellow, sodium saccharin, anhydrous colloidal silica, magnesium stearate.

Appearance of the product and contents of the packaging

Normostop are yellow, round, flat, and scored tablets. The tablet can be divided into equal doses.

It is presented in packaging containing 4 or 12 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the last review of this leaflet: July 2014

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