Normostop Caffeine 50 mg/50 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Normostop caffeine 50 mg/50 mg film-coated tablets

Dimenhydrinate/Caffeine

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

Always follow exactly the instructions for use of this medicine contained in this leaflet or those given 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 adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

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. How to store Normostop caffeine
6. Contents of the pack and other information

1. What normostop caffeine is and what it is used for

Dimenhydrinate is an active substance that acts against motion sickness caused by various modes of transportation.

Caffeine has a stimulating effect on the central nervous system and therefore counteracts the drowsiness that dimenhydrinate may cause.

Normostop caffeine is a medicine indicated for the prevention and treatment of symptoms of motion sickness caused by land, sea, or air travel, 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 taking normostop caffeine

Do not take normostop caffeine

• If you are allergic to dimenhydrinate, diphenhydramine, caffeine (or derivatives thereof, such as aminophylline, theophylline, etc.), or to any of the other components of this medicine (listed in section 6).
• If you have porphyria (a rare disorder, usually hereditary, characterized by excessive excretion of porphyrins in urine and feces).
• If you are experiencing asthma attacks.
• If you have mental disorders causing nervous excitement or seizures with or without loss of consciousness (epilepsy).
• If you suffer from anxiety states or insomnia (difficulty sleeping).
• If you have severe liver or heart disorders.
• If you have gastric or duodenal ulcers.
• If you have high blood pressure (hypertension).

Warnings and precautions

Consult your doctor or pharmacist before taking normostop caffeine:

• If you are allergic to any antihistamine medication, you may also be allergic to dimenhydrinate.
• If you have asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as this may cause thickening of secretions and impair expectoration.
• If you have a condition involving abnormal overactivity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), or any condition causing urinary or gastrointestinal obstruction.
• If you are over 65 years old, dry mouth, urinary retention, nausea, sedation, confusion, and low blood pressure (hypotension) may occur.
• If you are taking any medication that causes ear toxicity, manifested by symptoms such as tinnitus, dizziness, or vertigo, since this medicine may mask the symptoms of such toxic effects.
• Diabetic patients should be aware that caffeine may increase blood glucose levels.
• If you have any liver, kidney, gastric or duodenal ulcer disease, or stomach inflammation (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 conditions (cardiac arrhythmia, myocardial ischemia, etc.), especially when exercising or in high-altitude environments.
• If you are sensitive to caffeine or other xanthines such as theophylline, aminophylline, or others, you should consult your doctor before taking this medicine.
• 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 appendicitis, as dimenhydrinate may interfere with the diagnosis of this condition.
• It is recommended to avoid exposure to high temperatures and to follow appropriate hygiene and dietary measures, such as adequate ventilation and hydration.
• Avoid exposure to sunlight (even when cloudy) and to UVA lamps (ultraviolet rays) while taking this medicine.
• Simultaneous use of tobacco with the caffeine contained in this medicine may increase the degradation of caffeine.

Children

Children under 12 years of age must not take this medicine.

Taking normostop caffeine 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, a dose adjustment of normostop caffeine may be necessary or concomitant use may not be recommended:

Medicines that primarily interact with dimenhydrinate:

• Anesthetics and other substances with central nervous system depressant effects
• Aminoglycoside antibiotics
• 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)

Medicines that primarily interact with caffeine:

• Oral contraceptives
• Anti-infective agents of the quinolone group (e.g., pipemidic acid, ciprofloxacin), linezolid, and erythromycin
• Barbiturates (used as anticonvulsants)
• Adrenergic bronchodilators and theophylline (used to treat bronchial asthma)
• Calcium
• Cimetidine (used to treat excessive gastric secretion and gastric ulcers)
• Disulfiram (used in alcohol deterrent therapy)
• Phenytoin (used to treat epilepsy)
• Iron (used to treat anemia) (caffeine reduces iron absorption; therefore, administration should be separated by at least 2 hours)
• Lithium (antidepressant)
• Mexiletine (used for cardiac rhythm disorders—cardiac arrhythmias)
• Procarbazine (anticancer agent)
• Selegiline (used to treat Parkinson's disease)
• Thyroxine (used to treat thyroid disorders)

Interference with diagnostic tests

If you are scheduled to undergo any laboratory tests (blood, urine, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

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 interference with test results.

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

Taking normostop caffeine with food, drinks, and alcohol

Alcohol consumption is not recommended during treatment with this medicine.

Limit intake of beverages containing caffeine (coffee, tea, chocolate, and cola drinks) while taking 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding

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

Driving and use of machines

While being treated with this medicine, do not drive or operate dangerous machinery, as this medicine may cause drowsiness or reduced reaction capacity at recommended doses.

3. How to take normostop caffeine

Follow exactly the dosing instructions provided in this leaflet or those given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Recommended dose:

Adults and children over 12 years of age

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

Do not exceed 8 tablets per day (equivalent to 400 mg of dimenhydrinate and 400 mg of caffeine).

Patients with liver disease

Should consult their doctor before taking this medicine, as a dose adjustment may be necessary.

Use in children

Children under 12 years of age must not take this medicine.

Oral use.

The first dose should be taken at least half an hour before starting the journey (preferably 1 or 2 hours beforehand), 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 within the 6 hours before going to bed, to avoid possible insomnia, especially in patients with difficulty sleeping.

If your condition worsens or 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, contact 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 reduction in respiratory and heart function (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 Toxicology Information Service (telephone: 915620420), indicating the medicine and the amount ingested.

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

4. Possible adverse effects

Like all medicines, normostop caffeine may produce adverse effects, although not everyone experiences them.

Adverse effects usually occur at the beginning of treatment.

During the period of use of dimenhydrinate, the following adverse reactions have been observed, although their frequency could not be established accurately:

• Nausea, vomiting, constipation, diarrhea, stomach pain.
• Loss of appetite and dry mouth.
• Drowsiness and sedation.
• Headache, dizziness, and vertigo.
• Increased viscosity of mucus in the bronchi, making breathing difficult.
• Urinary retention and sexual impotence.
• Glaucoma (increased intraocular pressure of the eye).
• Dilatation of the pupils, blurred vision, or double vision.
• Allergic skin reactions and sensitivity to sunlight, following intense exposure, possibly resulting in urticaria, itching, and redness of the skin.
• Decrease in blood levels of red blood cells, white blood cells, leukocytes, and platelets.
• Porphyria (a rare disorder, usually hereditary, characterized by excessive excretion of porphyrins in feces and urine).
• Hypotension (decrease in 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 convulsions.

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

• Excitement, restlessness, and/or difficulty sleeping.
• Ringing in the ears.
• Disorientation.
• Rapid breathing.
• Hot flushes.
• Excessive urination.
• Hyperglycemia or hypoglycemia (increase or decrease of blood glucose).

Reporting of adverse effects

If you experience any type of adverse effect, please consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines Website: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Normostop Caffeine

Keep this medicine out of sight and reach of children.

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

Aluminum/PVC-PVDC and Aluminum/PVC blister packs: Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Normostop Caffeine

• The active substances 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, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide (E-171), macrogol 6000 and talc (E-553b).

Appearance of the product and contents of the pack

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

It is available in packs 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 most recent review of this leaflet: October 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/