NORMOSTOP CAFEINE 50 MG/50 MG FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Normostop Caffeine 50 mg/50 mg Film-Coated Tablets

Dimenhydrinate/Caffeine

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 7 days.

Package Leaflet Contents

1. What Normostop Caffeine is and what it is used for
2. What you need to know before taking Normostop Caffeine
3. How to take Normostop Caffeine
4. Possible side effects
5. Storage of Normostop Caffeine
6. Package Contents and Additional Information

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

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

Caffeine has a stimulating effect on the nervous system, which counteracts the drowsiness that dimenhydrinate may cause.

Normostop Caffeine is a medication indicated for the prevention and treatment of symptoms of motion sickness caused by land, sea, or air travel, such as nausea, vomiting, and/or vertigo in adults and children over 12 years old.

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

2. What you need to know before taking Normostop Caffeine

Do not take Normostop Caffeine

• If you are allergic to dimenhydrinate, diphenhydramine, caffeine (or its derivatives, such as aminophylline, theophylline, etc.) or any other component of this medication (listed in section 6).
• If you have porphyria (a rare, usually hereditary 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 convulsive crises 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 Caffeine:

• If you are allergic to any medication for treating allergies, 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 thyroid gland activity (hyperthyroidism), increased intraocular pressure (glaucoma), enlarged prostate (prostatic hypertrophy), or any disease that causes obstruction of the urinary or gastrointestinal tract.
• If you are over 65 years old, dry mouth, urinary retention, nausea, sedation, confusion, and hypotension may occur.
• If you are using any medication that produces ototoxicity (which can affect the ear), which manifests with symptoms such as ringing in the ears, dizziness, or vertigo, as this medication may mask the symptoms of those toxic effects.
• If you are diabetic, you should be aware that caffeine can raise blood sugar levels.
• If you have any liver, kidney, stomach, or duodenal disease, or 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 engaging in physical exercise or being in high-altitude areas.
• 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 consult a doctor to rule out the presence or absence of appendicitis, as dimenhydrinate may hinder the diagnosis of this disease.
• It is recommended to avoid exposure to very high temperatures and follow adequate hygienic-dietary measures, such as proper ventilation and hydration.
• Avoid exposure to the sun (even on cloudy days) and UVA 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 Caffeine with other medications

Inform your doctor or pharmacist that you are taking, have recently taken, 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 Caffeine or not take it:

Medications that primarily interact with dimenhydrinate:

• Anesthetics and other substances with a depressant effect on the Central Nervous System
• Antibiotics from the aminoglycoside group.
• Antidepressants, such as monoamine oxidase inhibitors (MAOIs).
• Antiparkinsonian medications.
• Neuroleptics (used to calm agitation and neuromuscular hyperactivity).
• Ototoxic medications (which can affect the ear) (see Warnings and Precautions section).
• Medications that can cause photosensitivity (skin reactions due to sensitivity to sunlight).

Medications that primarily interact with caffeine:

• Oral contraceptives.
• Anti-infective medications from the quinolone group (e.g., pipemidic acid, ciprofloxacin), linezolid, and erythromycin.

• Barbiturates (used as anticonvulsants)
• Adrenergic bronchodilators and theophylline (used to combat bronchial asthma).
• Calcium.
• Cimetidine (used to treat excessive gastric secretion and stomach ulcers).
• Disulfiram (used in alcohol detoxification treatments).
• Phenytoin (used to treat epilepsy).
• Iron (used to treat anemia) (caffeine decreases 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 going to undergo any analytical tests (blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results of these tests.

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

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

Taking Normostop Caffeine with food, beverages, and alcohol

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

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

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

Pregnancy and breastfeeding

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

Breastfeeding

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

Driving and using machines

While being treated with this medication, do not drive or operate hazardous machinery, as this medication can cause drowsiness or decreased reaction capacity at the recommended doses.

3. How to take Normostop Caffeine

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist. In case of 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 take more than 8 tablets per day (corresponding to 400 mg of dimenhydrinate and 400 mg of caffeine)

Patient with liver disease

They should 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 route.

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 doses. It is recommended to take the tablets with food, water, or milk to minimize gastric irritation. The last dose should not be taken in the 6 hours prior to bedtime to avoid possible insomnia, especially in patients with difficulty sleeping.

If your condition worsens or if the symptoms persist for more than 7 days, you should consult your 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 disorders, convulsions, deep loss of consciousness (coma), sudden decrease in respiratory and cardiac function (cardiorespiratory collapse), and death. The 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 Toxicology Information Service (phone: 915620420), indicating the medication and the amount ingested.

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

4. Possible side effects

Like all medications, Normostop Caffeine can cause side effects, although not everyone will experience them.

Side effects usually occur at the beginning of treatment.

During the use of dimenhydrinate, the following adverse reactions have been observed, whose frequency could not be established with accuracy:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Lack of appetite and dry mouth.
• Sleepiness and sedation (drowsiness).
• Headache, dizziness, and vertigo.
• Increased viscosity of mucus in the bronchi, making breathing difficult.
• Urinary retention and impotence.
• Glaucoma (increased intraocular pressure).
• Dilated pupils, blurred vision, or double vision.
• Allergic reactions on the skin and sensitivity to sunlight, after intense exposure, which can cause hives, itching, and skin redness.
• Decrease in the number of red blood cells, white blood cells, leukocytes, and platelets in the blood.
• Porphyria (a rare, usually hereditary disorder in which a large amount of porphyrin is eliminated in feces and urine).
• Hypotension (decreased blood pressure).
• Tachycardia, palpitations, and/or cardiac arrhythmias.
• Hyperexcitability may occur, 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 occur:

• Excitement, agitation, and/or difficulty sleeping.
• Ringing in the ears.
• Disorientation.
• Rapid breathing.
• Hot flashes.
• Excessive urination.
• Hyperglycemia or hypoglycemia (increased or decreased glucose in the blood).

Reporting side effects

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

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

5. Storage of Normostop Caffeine

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

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

Aluminum/PVC-PVDC and Aluminum/PVC blister packs: Store below 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.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Normostop Caffeine

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

Appearance of the product and package contents

Normostop Caffeine are white or almost white, round, biconvex tablets with a break line and markings.

They are available in packages containing 4 or 12 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this package leaflet:October 2018

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/