Normodorm 25 mg film-coated tablets
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
normodorm 25 mg film-coated tablets
Doxylamine, hydrogen succinate
Read the 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 or pharmacist.
- 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.
- You should consult a doctor if your condition worsens or if you do not improve after 7 days.
Contents of the leaflet:
- What normodorm is and what it is used for
- What you need to know before taking normodorm
- How to take normodorm
- Possible side effects
- How to store normodorm
- Contents of the pack and other information
1. What normodorm is and what it is used for
Normodorm is a medicine containing the active substance doxylamine hydrogen succinate. Doxylamine belongs to a group of medicines called antihistamines which have sedative properties.
This medicine is indicated for the short-term treatment of occasional insomnia in adults over 18 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 normodorm
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Do not take normodorm
- If you are allergic to doxylamine or to any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to other antihistamines (antiallergic medicines).
- If you are pregnant or breastfeeding.
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Warnings and precautions
Talk to your doctor or pharmacist before taking normodorm.
You should consult a doctor before taking this medicine if you have:
- Impaired liver or kidney function.
- Epilepsy.
- QT interval prolongation (a heart condition).
- Low blood potassium levels or other electrolyte imbalances.
- Heart disease or high blood pressure.
- Asthma, chronic bronchitis (persistent inflammation of the bronchi), or pulmonary emphysema (a lung disease that makes breathing difficult).
- Glaucoma (increased pressure in the eye).
- Urinary retention.
- Prostatic hypertrophy (abnormal enlargement of the prostate).
- Peptic ulcer (erosion of the stomach or upper intestinal wall), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), or vesical neck obstruction (a urinary tract condition).
If you experience daytime drowsiness, it may be necessary to reduce the dose or take the medicine earlier to ensure at least 8 hours pass before waking time.
Alcoholic beverages should be avoided during treatment.
If you are over 65 years of age, you may be more susceptible to side effects.
Normodorm may worsen symptoms of dehydration and heat stroke due to reduced sweating.
- Taking normodorm with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Do not take normodorm together with the following medicines, as their effects may be enhanced:
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Epinephrine (used to treat low blood pressure).
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Medicines affecting the heart, such as those used to treat arrhythmias, certain antibiotics, certain antimalarial drugs, certain antihistamines, certain lipid-lowering agents (fats in the blood), or certain neuroleptics (medicines used to treat mental disorders).
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Medicines that reduce the elimination of other drugs, such as azole derivatives or macrolides, which could increase the effect of normodorm.
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Certain diuretics (medicines that increase urine output).
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Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics,
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opioid-type analgesics, antipsychotics, or procarbazine).
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Antihypertensives (medicines for high blood pressure) with central nervous system effects, such as guanabenz, clonidine, or alpha-methyldopa.
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Other anticholinergic drugs, such as medicines used to treat depression or Parkinson’s disease, monoamine oxidase inhibitors (medicines for depression), neuroleptics (medicines for mental disorders), atropine-like medicines for treating spasms, or disopyramide (used for certain heart conditions).
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If you are taking other medicines that cause ear toxicity, such as carboplatin or cisplatin (cancer treatments), chloroquine (a medicine for treating or preventing malaria), or certain antibiotics (medicines for treating infections) such as erythromycin or injected aminoglycosides, among others; normodorm could mask the toxic effects of these medicines, so you should have your hearing checked regularly.
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Interference with diagnostic tests
Doxylamine may interfere with skin allergy tests that use allergens. It is recommended to stop treatment with normodorm at least three days before undergoing such tests.
- Taking normodorm with food, drinks, and alcohol
Do not consume alcoholic beverages during treatment with normodorm. See section 3. How to take normodorm.
- Pregnancy, breastfeeding, and fertility
Do not take normodorm if you are pregnant, planning to become pregnant, or breastfeeding.
There are no data available on the possible effects of normodorm on human fertility.
- Driving and using machines
The effect of normodorm on the ability to drive and use machines is significant. Do not drive or operate dangerous machinery while taking this medicine, at least during the first few days of treatment, until you know how it affects you.
3. How to take normodorm
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults (over 18 years of age)
The recommended dose is 1 tablet (25 mg) per day.
If daytime drowsiness occurs, it is recommended to reduce the dose to half a tablet (12.5 mg) per day, or to take the dose earlier to ensure at least 8 hours elapse before waking time.
Do not take more than 1 tablet (25 mg) per day.
Use in patients over 65 years of age
Patients over 65 years of age are more likely to have other medical conditions that may require a reduced dose. If undesirable adverse effects occur, it is recommended to reduce the dose to half a tablet (12.5 mg) per day.
Use in patients with liver or kidney disease
These patients should take a different dose, adjusted according to the severity of their condition, as determined by the physician.
Use in children and adolescents
Normodorm is not recommended for use in individuals under 18 years of age and therefore should not be used in this population.
Route and method of administration
Oral use.
The tablet may be divided into equal doses.
The tablets should be taken 30 minutes before bedtime with a sufficient amount of liquid (preferably water).
Duration of treatment
Treatment duration should be as short as possible. In general, treatment may last from a few days to one week.
Normodorm should not be used for longer than 7 days without consulting a doctor.
- If you take more normodorm than you should
Symptoms of overdose include: drowsiness, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal tone), flushing, increased or irregular heart rate, increased blood pressure, nausea, vomiting, agitation, altered gait, dizziness, irritability, sedation, confusion, and hallucinations. Delirium, psychosis, decreased blood pressure, seizures, respiratory depression, loss of consciousness, coma, and death may occur. A serious complication may be rhabdomyolysis (muscle injury), followed by kidney failure.
There is no specific antidote for antihistamine overdose; therefore, treatment is symptomatic and supportive. Your doctor will assess whether it is necessary to induce vomiting, perform gastric lavage, or prescribe medications to increase blood pressure if needed.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone: 91 562 04 20, indicating the medication and the amount ingested.
- If you forget to take normodorm
Do not take a double dose to make up for missed doses.
Take your next dose at the usual time the following day.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, normodorm may cause adverse effects, although not everyone experiences them.
The adverse effects of doxylamine are generally mild and transient, being more common during the first days of treatment.
Frequent adverse effects (may affect up to 1 in 10 people): drowsiness and effects such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, vertigo, dizziness, headache, upper abdominal pain, fatigue, insomnia, and nervousness.
Uncommon adverse effects (may affect up to 1 in 100 people): asthenia (weakness), peripheral edema (swelling of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (decrease in blood pressure due to postural changes), diplopia (double vision), dyspepsia (stomach disorders), sensation of relaxation, nightmares, and dyspnea (difficulty breathing).
Rare adverse effects (may affect up to 1 in 1,000 people): agitation (especially in children and elderly), tremor, seizures, or blood disorders such as hemolytic anemia, thrombocytopenia, leucopenia, or agranulocytosis (reduction in certain blood cells).
Adverse effects with unknown frequency (cannot be estimated from available data): general malaise.
Other adverse effects that have occurred with the use of antihistamines in general, although not observed with doxylamine, include: arrhythmia (altered heart rate), palpitations, duodenogastric reflux, abnormal liver function (cholestatic jaundice), prolonged QT interval on electrocardiogram (a cardiac abnormality), decreased appetite, increased appetite, myalgia (muscle pain), abnormal coordination, extrapyramidal disorder (movement disorders), paresthesia (abnormal sensations), impairment of psychomotor activities (coordination of senses and movement), depression, decreased bronchial secretion, alopecia (hair loss), allergic dermatitis, hyperhidrosis (excessive sweating), photosensitivity reaction, or hypotension (low blood pressure).
The frequency and severity of adverse effects may be reduced by lowering the daily dose.
People over 65 years of age have a higher risk of experiencing adverse reactions, as they may have other medical conditions or may be taking other medications simultaneously. These individuals also have an increased risk of falling.
If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.
5. Storage of Normodorm
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
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 should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at a SIGRE collection point at your pharmacy. If you are in doubt, 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 Normodorm
The active substance is doxylamine. Each tablet contains 25 mg of doxylamine hydrogen succinate.
The other components are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, low-substituted hydroxypropyl cellulose, colloidal silicon dioxide, and magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 6000, talc, and indigo carmine lake (E-132).
Appearance of the product and pack contents
Normodorm 25 mg is presented as blue, film-coated, oblong, scored tablets. Each pack contains 7 or 14 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: May 2013
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/