Patient Information Leaflet

Normostop Caffeine 50 mg/50 mg Film-Coated Tablets

Dimenhidrinato/Caffeine

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

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist, or nurse.

• 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

1. What is Normostop Caffeine and what it is used for

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

3. How to take Normostop Caffeine

4. Possible side effects

5. Storage of Normostop Caffeine

6. Contents of the pack and additional information

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

Caffeine has a stimulating effect on the nervous system, so it counteracts the drowsiness that dimenhidrinato may cause.

Normostop caffeine 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 over 12 years old.

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

Do not take Normostop with caffeine

• If you are allergic to dimenhydrinate, diphenhydramine, caffeine (or derivatives such as aminophylline, theophylline, etc.) 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).
• If you have asthma attacks.
• If you have mental disorders that cause nervous excitement or seizures with or without loss of consciousness (epilepsy).
• If you have anxiety or insomnia (difficulty sleeping).
• If you have severe liver or heart disorders.
• If you have stomach or duodenal ulcers.
• If you have high blood pressure.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Normostop with caffeine:

- If you are allergic to any allergy medication, you may also be allergic to dimenhydrinate.

- 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 that causes 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 are over 65 years old, it may cause dry mouth, urinary retention, nausea, sedation, confusion and low blood pressure (hypotension).

- If you are using a medication that causes ototoxicity, which manifests with symptoms such as ringing in the ears, dizziness or vertigo, as this medication may mask the symptoms of these toxic effects.

- If you are diabetic, you should be aware that caffeine may raise blood sugar levels.

- If you have any liver or kidney disease, stomach or duodenal ulcers, or stomach inflammation (gastritis), you should consult your doctor before taking this medication.

- You should consult your doctor before taking this medication if you have or have had heart diseases (cardiac arrhythmia, myocardial ischemia, etc.), especially when exercising or being in high-altitude places.

- If you are sensitive to caffeine or other xanthines, such as theophylline, aminophylline or others, you should consult your doctor before taking this medication.

- 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 dimenhydrinate 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 UV-A lamps (ultraviolet rays) while taking this medication.

- The simultaneous use of tobacco with the caffeine contained in this medication may increase the degradation of caffeine.

Children

Children under 12 years old should not take this medication.

Taking Normostop with other medications

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

Particularly, if you are using any of the following medications, as it may be necessary to modify the dose of Normostop with caffeine or not be able to take it:

Medications that primarily interfere with dimenhydrinate:

• Depressants of the Central Nervous System (CNS) such as anesthetics and other substances.
• Aminoglycoside antibiotics.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs).
• Antiparkinsonian medications.
• Neuroleptics (used to calm agitation and hyperactivity of the neuromuscular system).
• Ototoxic medications (that can affect the ear) (see Warnings and Precautions section).
• Medications that may cause photosensitivity (skin reactions due to sensitivity to sunlight).

Medications that primarily interfere with caffeine:

• Oral contraceptives.
• Quinolone antibiotics (such as pipemidic acid, ciprofloxacin), linezolid and erythromycin.
• Barbiturates (used as anticonvulsants).
• Adrenergic bronchodilators and theophylline (used to combat asthma).
• Calcium.
• Cimetidine (used to treat excessive stomach secretion and stomach ulcers).
• Disulfiram (used in alcohol withdrawal treatments).
• Fenitoin (used to treat epilepsy).
• Iron (used to treat anemia) (caffeine reduces iron absorption, so it should be taken at least 2 hours apart).
• Lithium (antidepressant).
• Mexiletine used for heart rhythm disorders (cardiac arrhythmias).
• Procarbazine (anticancer medication).
• Selegiline (used to treat Parkinson's disease).
• Thyroxine (used to treat thyroid diseases).

Interference with diagnostic tests

If you are to undergo any analytical test (blood, urine, etc.), inform your doctor that you are taking this medication, as it may alter the results of these 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 results of the test.

Additionally, diabetic patients should be aware that caffeine may increase blood glucose levels.

Taking Normostop with food, drinks and alcohol

It is not recommended to consume alcohol while taking this medication.

Limit the consumption of drinks that contain caffeine (coffee, tea, chocolate and cola drinks) while taking this medication.

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

Pregnancy and lactation

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

Lactation

Women who are breastfeeding should not take this medication without consulting their doctor or pharmacist, as this medication passes into breast milk.

Driving and operating machinery

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

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

The recommended dose is:

Adults and children over 12 years old

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 and 400 mg of caffeine)

Patients with liver disease

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

Use in children

Children under 12 years old should not take this medication.

Oral administration.

The first dose should be taken at least 30 minutes 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. Do not take the last dose within 6 hours of going to bed, to avoid possible insomnia, especially in patients with difficulty sleeping.

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

If you take more Normostop Caffeine than you should

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

The symptoms of overdose include mainly: dilated pupils, flushed face, excitement, hallucinations, confusion, stomach and intestinal irritation 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.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Normostop caffeine can produce adverse effects, although not everyone may experience them.

Adverse effects usually occur at the beginning of treatment.

During the period of use of dimenhidrinato, 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.
• Urinary 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 urticaria, itching, and skin redness.
• Decrease in 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 arrhythmias.
• It may cause hyperexcitability, especially in children, with symptoms such as insomnia, nervousness, confusion, tremors, irritability, euphoria, delirium, palpitations, and even convulsions.

In addition, due to caffeine, the following may appear:

• Excitement, agitation, and/or difficulty sleeping.
• Tinnitus.
• Disorientation.
• Accelerated breathing.
• Hot flashes.
• Abundant urine elimination.
• Hypoglycemia or hyperglycemia (increase or decrease in blood glucose).

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.

Aluminum/Polyamide-Aluminum-PVC blister packs: no special storage conditions required

Aluminum/PVC-PVDC blister packs and Aluminum/PVC blister packs: Store below 86°F (30°C).

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

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

Composition of normostop caffeine

• The active principles are dimenhidrinato and caffeine. Each tablet contains 50 mg of dimenhidrinato and 50 mg of caffeine.
• The other components (excipients) are: Microcrystalline cellulose (E-460), Crospovidona, Povidona, Anhydrous colloidal silica, Magnesium stearate, Hypromellose, Titanium dioxide (E-171), Macrogol 6000 and Talc (E-553b).

Appearance of the product and content of the packaging

Normostop caffeine are white or almost white, round, biconvex, breakable tablets with a bar and marked.

They are presented in packaging that contains 4 or 12 tablets.

Title of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet:October 2018

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