Normostop 50 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Normostop 50 mg tablets

dimenhydrinate

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

Follow exactly the instructions for use provided 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 effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 7 days.

Contents of the leaflet:

1. What Normostop is and what it is used for
2. What you need to know before taking Normostop
3. How to take Normostop
4. Possible adverse effects
5. How to store Normostop
6. Contents of the pack and other information

1. What normostop is and what it is used for

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

Normostop 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 from 2 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

Do not take normostop

• If you are allergic to dimenhydrinate or diphenhydramine or to any of the other ingredients of this medicine (listed in section 6).
• If you have porphyria (a rare disorder, usually hereditary, in which large amounts of porphyrins are excreted in urine and feces).

Warnings and precautions

Consult your doctor or pharmacist before taking normostop:

• If you are allergic to any antihistamine medicine, you may also be allergic to dimenhydrinate.
• If you have asthma or severe respiratory diseases (chronic obstructive pulmonary disease, emphysema, chronic bronchitis), as thickening of secretions may occur and affect expectoration.
• If you have a condition characterized by abnormally increased activity of the thyroid gland (hyperthyroidism), increased intraocular pressure (glaucoma), prostate enlargement (prostatic hypertrophy), or any condition causing urinary or gastrointestinal obstruction.
• If you have seizures involving convulsive movements, with or without loss of consciousness (epilepsy).
• If you are over 65 years of age, dry mouth, urinary retention, nausea, sedation, confusion, and low blood pressure (hypotension) may occur.
• If you are taking any medicine that causes ear toxicity, as symptoms of such toxic effects (such as ringing in the ears, dizziness, or vertigo) may be masked.
• If you have any liver or kidney disease, stomach or duodenal ulcer, or inflammation of the stomach (gastritis).
• If you have or have had heart diseases or disorders (cardiac arrhythmia, myocardial ischemia, etc.).
• If you suspect you might have symptoms of appendicitis such as nausea, vomiting, or abdominal cramps, it is recommended to see a doctor to rule out the presence of appendicitis, as dimenhydrinate may make diagnosis of this condition more difficult.
• 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 UV-A lamps while taking this medicine.

Children

Children under 2 years of age must not take this medicine.

Taking normostop 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, as it may be necessary to adjust the dose of normostop or avoid taking it altogether:

• Anesthetics, opioid 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 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).

Interference with diagnostic tests

If you are scheduled to undergo allergy testing, including skin tests, it is recommended to stop treatment 72 hours before the test to avoid interfering with test results.

Taking normostop with food, drinks, and alcohol

Alcohol consumption is not recommended during treatment with 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 are planning 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 their doctor or pharmacist, as this medicine passes into breast milk and may also cause inhibition of lactation.

Driving and using machines

While taking this medicine, do not drive or operate heavy machinery, as this medicine may cause drowsiness or reduced reaction time even at recommended doses.

Normostop contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take normostop

Follow exactly the instructions for using this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult 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 1.5 tablets per day (equivalent to 75 mg of dimenhydrinate), 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 (equivalent to 150 mg of dimenhydrinate).

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 (equivalent to 400 mg of dimenhydrinate).

Patients with liver disease:

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

Oral use.

The first dose should be taken at least half an hour before starting the journey (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.

If your condition worsens or if symptoms persist for more than 7 days, you should 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.

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, convulsions, deep unconsciousness (coma), sudden decrease in respiratory and heart function (cardiorespiratory collapse), and death. Symptoms may take more than 2 hours to appear after overdose.

In case of overdose or accidental ingestion, go immediately to a medical centre or call the Toxicology Information Service (telephone: 915620420), indicating the medicine and the amount ingested.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

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

• Nausea, vomiting, constipation, diarrhoea, stomach pain.
• Loss of appetite and dry mouth.
• Drowsiness and sedation (drowsiness).
• Headache, dizziness, and vertigo.
• Increased mucus viscosity in the bronchi, making breathing difficult.
• Urinary retention and sexual impotence.
• Glaucoma (increased intraocular pressure of the eye).
• Pupil dilation, blurred vision or double vision.
• Allergic skin reactions and sensitivity to sunlight, following intense exposure, which may result in urticaria, itching, and redness of the skin.
• Decrease in blood levels of red blood cells, white blood cells, leucocytes, and platelets.
• Porphyria (a rare disorder, usually hereditary, characterized by excessive excretion of porphyrins in faeces 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 seizures.

Reporting of adverse effects

If you experience any type of adverse effect, 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 Medicinal Products Website: www.notificaram.es.

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

5. Storage of normostop

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

<Store below 25 ºC.>

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Normostop

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

Appearance of the product and contents of the container

Normostop tablets are yellow, round, flat, and have a break line on one side. The tablet can be divided into equal doses.

It is available in packaging 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: July 2014

Detailed 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/