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Medication with sedative properties indicated in patients over 18 years old to treat occasional insomnia.
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1. What it is Normodorm and what it is used
Normodorm is a medicine that contains the active substance hidrogenosuccinato doxylamine. Doxylamine belongs to a group of medications called antihistamines with sedative properties.
This medicine is indicated for the symptomatic treatment of occasional insomnia in over 18 years.
You should consult a doctor if worsens or does not improve after 7 days.
2. What you need to know before you start taking Normodorm
♦ Do not take Normodorm if:
- If you are allergic to doxylamine or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to other antihistamines (allergy).
- If you are pregnant or lactating.
♦ Warnings and Precautions
Consult your doctor or pharmacist before you start taking Normodorm. Should consult a doctor before taking this medicine if you have:
- Impaired liver function and kidney.
- Prolongation of the QT interval (a heart problem).
- Low levels of blood potassium or other electrolyte disturbances.
- Heart disease and high blood pressure.
- Asthma, chronic bronchitis (persistent inflammation of the bronchial tubes) and emphysema (a disease that affects the lungs making breathing difficult).
- Glaucoma (elevated eye pressure).
- Urinary retention.
- Prostatic hypertrophy (abnormal enlargement of the prostate).
- Peptic ulcer (erosion of the stomach wall or bowel principle), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine) and bladder neck obstruction (urinary tract disease).
If you have daytime sleepiness may be necessary to reduce the dose or take advance to ensure a minimum interval of 8 hours until the alarm time.
intake of alcohol should be avoided during treatment.
If you are over 65 years old may be more susceptible to side effects.
Normodorm can aggravate symptoms of dehydration and heat stroke due to decreased sweating.
♦ Taking Normodorm with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Normodorm conjunction with the following medicines as they may be potentiated its effects:
- Epinephrine (for treating low blood pressure).
- Medicines acting on the heart such as those used to treat arrhythmias, some antibiotics, certain medicines for malaria, certain antihistamines, certain medicines used to lower lipids (fats) in the blood or certain neuroleptic agents (medications the treatment of mental disorders).
- Medicines that reduce the elimination of others such as azole derivatives or macrolides as they may increase the effect of Normodorm.
- Some diuretics (medicines that increase urine output).
- Inhibitors of central nervous system (eg barbiturates, hypnotics, sedatives, anxiolytics, analgesics opioid type, antipsychotics or procarbazine..).
- Anti-hypertensives (medicines for treating high blood pressure) effect on the central nervous system such as guanabenz, clonidine or alpha-methyldopa.
- Other anticholinergic medicines such as medicines for treating depression or Parkinson, monoamine oxidase inhibitors (medicines for depression), neuroleptics (medicines to treat mental disorders), atropine-like medicines to treat spasms, or disopyramide (for the treatment of certain heart problems).
- If you are taking other medications that cause toxicity in the ear, such as carboplatin or cisplatin (medication to treat cancer), chloroquine (medicine for the treatment or prevention of malaria) and certain antibiotics (medicines to treat infections) as erythromycin or aminoglycosides injected among others; Normodorm could mask the toxic effects of these medicines, so you should periodically check the status of your ears.
♦ Interference with diagnostic tests
Doxylamine may interfere with skin allergy tests using allergens. It is recommended to discontinue treatment with Normodorm at least three days before the tests.
♦ Taking Normodorm with food, drink and alcohol
Alcoholic beverages should not be consumed during treatment with Normodorm. See section 3. How to take Normodorm.
♦ Pregnancy, breast feeding and fertility
Normodorm Do not take if you are pregnant, planning to become pregnant or breast-feeding.
There is no data on possible effects on fertility Normodorm people.
♦ Driving and using machines
Normodorm influence on the ability to drive and use machines. Do not drive or use dangerous machinery while taking this medication, at least during the first days of treatment until you know how it affects you.
3. How to take Normodorm
Follow exactly the instructions of medicine administration in this leaflet or as your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Adults (over 18 years old)
The recommended dose is 1 tablet (25 mg) per day.
If drowsiness occurs during the day, it is recommended to reduce the dose to half a tablet (12.5 mg) a day, or advance decision to ensure a minimum interval of 8 hours until the alarm time.
Do not take more than 1 tablet (25 mg) per day.
Use in over 65 years
People over 65 are more likely to have other conditions that may recommend a dose reduction. In case of occurrence of unwanted side effects it is recommended to reduce the dose to half a tablet (12.5 mg) per day.
Use in patients with liver disease or kidney disease
These patients should take a different dose, adjusted to the extent of his illness, which will be determined by the physician.
Use in children and adolescents
Normodorm is not recommended for use in children under 18 years old, so the medicine should not be used in this population.
Route and method of administration
The tablet can be divided into equal doses.
The tablets should be taken 30 minutes before bedtime with a sufficient amount of liquid (preferably water).
Treatment duration should be as short as possible. In general, the duration of treatment can range from a few days to a week.
It must not be for a period longer than 7 days without consulting a doctor.
♦ If you take more than you should Normodorm
Symptoms of poisoning include drowsiness, depression or stimulation of central anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal tone), redness, or changes in heart rate, increased blood pressure nervous system, nausea, vomiting, agitation, abnormal gait, dizziness, irritability, sedation, confusion and hallucinations. They can be reached to produce delirium, psychosis, decreased blood pressure, seizures, decreased breathing, loss of consciousness, coma and death. A serious complication can be rhabdomyolysis (muscle injury), followed by kidney failure.
There is no specific antidote for overdose of antihistamines, so the treatment is symptomatic and supportive. Your doctor will assess the need to induce vomiting perform gastric lavage or prescribe medications to increase blood pressure if necessary.
In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone:
+34 91 562 04 20, indicating the medicine and the amount taken.
♦ If you forget to take Normodorm
Do not take a double dose to make up for missed doses. Take your dose at the regular time the next day.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Normodorm can cause side effects, although not everybody gets them.
The adverse effects of doxylamine are generally mild and transient, being more frequent in the first days of treatment.
Common side effects (may affect up to 1 in 10 people): sleepiness and effects such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, vertigo, dizziness, headache, pain in the upper abdomen, fatigue, insomnia and nervousness.
Uncommon side effects (may affect up to 1 in 100 people): asthenia (fatigue), peripheral edema (swelling of arms and legs), nausea, vomiting, diarrhea, rash, tinnitus (ringing in the ears), hypotension orthostatic (decrease in blood pressure due to changes in posture), diplopia (double vision), dyspepsia (stomach disorders), feeling of relaxation, nightmares and dyspnea (breathing difficulties).
Rare side effects (may affect up to 1 in 1,000 people): agitation (especially in children and the elderly), tremor, seizures, or blood problems such as hemolytic anemia, thrombocytopenia, leucopenia or agranulocytosis (decrease in certain blood cells).
Adverse effects of unknown frequency (can not be estimated from available data): malaise.
Other side effects have occurred with the use of antihistamines in general, although not observed with doxylamine, are as follows: arrhythmia (disturbance of the heart rate), palpitations, duodenal reflux, abnormal liver function (cholestatic jaundice) , prolonged QT interval electrocardiogram (heart disorder), decreased appetite, increased appetite, myalgia (muscle pain), abnormal coordination, extrapyramidal disorder (movement disorders), paresthesia (abnormal sensations), impairment of psychomotor activities (coordination senses movement), depression, decreased secretion of the bronchi, alopecia (hair loss), allergic dermatitis, hyperhidrosis (excessive sweating), photosensitivity reaction or hypotension (low blood pressure).
The frequency and magnitude of the adverse effects may be reduced by lowering the daily dose.
The over 65s are at increased risk of adverse reactions, as they may have other diseases or may be taking other medications simultaneously. These people also have a higher risk of falling.
If you experience side effects, consult your doctor or pharmacist, even if it comes to possible side effects not listed in this leaflet.
5. Conservation of Normodorm
It does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date on the carton after "EXP". The expiry date is the last day of that month.
6. Contents of the pack and other information
Composition of Normodorm
The active ingredient is doxylamine. Each tablet contains 25 mg doxylamine hidrogenosuccinato. The other ingredients are:
Tablet core: microcrystalline cellulose, calcium hydrogen phosphate dihydrate, low substituted hydroxypropylcellulose, colloidal silica and magnesium stearate.
Tablet coating: hypromellose, titanium dioxide (E171) dioxide, macrogol 6000, talc and indigo lacquer (E-132).
Authorization holder responsible for marketing and manufacturing
NORMON LABORATORIES, S.A.
Round Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)
Source: Spanish Agency for Medicines and Health Products