Package Insert: Information for the User

Normodorm 25 mg Film-Coated Tablets

Doxilamine Hydrogen Succinate

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

Follow exactly the administration instructions for the medication contained in this package insert or those indicated by your doctor or pharmacist.

- Keep this package insert, as you may need to refer to 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 not listed in this package insert.

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

1. What is Normodorm and what is it used for

2. What you need to know before starting to take Normodorm

3. How to take Normodorm

4. Possible adverse effects

5. Storage of Normodorm

6. Contents of the package and additional information

Normodorm is a medication that contains the active ingredient doxylamine hydrogenosuccinate. Doxylamine belongs to a group of medications called antihistamines that have sedative properties.

This medication is indicated for the symptomatic treatment of occasional insomnia in individuals over 18 years old.

You should consult a doctor if symptoms worsen or do not improve after 7 days.

• Do not take Normodorm
• • If you are allergic to doxilamine or any of the other components of this medication (listed in section 6).
  • If you are allergic to other antihistamines (antiallergics).
  • If you are pregnant or breastfeeding.

• Warnings and precautions

Consult your doctor or pharmacist before starting to take Normodorm.

You should consult a doctor before taking this medication if you have:

• Liver and kidney function disorders.
• Epilepsy.
• Prolongation of the QT interval (a heart problem).
• Low potassium levels in the blood or other electrolyte disorders.
• Heart disease and high blood pressure.
• Asthma, chronic bronchitis (persistent inflammation of the bronchi) and pulmonary emphysema (a disease that affects the lungs and makes breathing difficult).
• Glaucoma (elevated eye pressure).
• Urinary retention.
• Prostatic hypertrophy (abnormal enlargement of the prostate).
• Peptic ulcer (erosion of the stomach wall or beginning of the intestine), pyloric obstruction (difficulty passing food from the stomach to the intestine) and urethral stricture (disease of the urinary tract).

If you experience daytime somnolence, it may be necessary to reduce the dose or take it earlier to ensure that at least 8 hours pass before waking up.

It is recommended to avoid consuming alcoholic beverages during treatment.

People over 65 years old may be more susceptible to experiencing side effects.

Normodorm may exacerbate dehydration and heatstroke symptoms due to decreased sweating.

• Taking Normodorm with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Do not take Normodorm with the following medications, as they may potentiate its effects:

• Epinephrine (for treating low blood pressure).
• Medications that affect the heart, such as those used to treat arrhythmias, some antibiotics, certain antimalarial medications, certain antihistamines, certain lipid-lowering medications, or certain neuroleptics (medications for treating mental disorders).
• Medications that decrease the elimination of other substances, such as azole derivatives or macrolides, which may increase the effect of Normodorm.
• Some diuretics (medications that increase urine elimination).
• Inhibitors of the central nervous system (e.g. barbiturates, hypnotics, sedatives, anxiolytics,

• opioid analgesics, antipsychotics, or procarbazine).

• Anti-hypertensive medications with central nervous system effects, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic medications, such as medications for treating depression or Parkinson's disease, monoamine oxidase inhibitors (medications for depression), neuroleptics (medications for treating mental disorders), atropine medications for treating spasms, or disopyramide (for treating certain heart problems).
• If you are taking other medications that cause ototoxicity, such as carboplatin or cisplatin (medications for treating cancer), chloroquine (medication for treating or preventing malaria), and some antibiotics (medications for treating infections) such as erythromycin or injected aminoglycosides, Normodorm may mask the toxic effects of these medications, so you should regularly check your ear status.

• Interference with diagnostic tests

Doxilamine may interfere with skin allergy tests that use allergens. It is recommended to suspend Normodorm treatment at least three days before starting these tests.

• Taking Normodorm with food, drinks, and alcohol

Do not consume alcoholic beverages during Normodorm treatment. See section 3. How to take Normodorm.

• Pregnancy, breastfeeding, and fertility

Do not take Normodorm if you are pregnant, intend to become pregnant, or are breastfeeding.

No data are available on the possible effects of Normodorm on human fertility.

• Driving and operating machinery

The influence of Normodorm on the ability to drive and operate machinery is important. Do not drive or operate hazardous machinery while taking this medication, at least during the first few days of treatment until you know how it affects you.

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

Adults (18 years and older)

The recommended dose is 1 tablet (25 mg) per day.

If daytime drowsiness appears, it is recommended to reduce the dose to half a tablet (12.5 mg) per day, or take it earlier to ensure that at least 8 hours pass until waking up.

Do not take more than 1 tablet (25 mg) per day.

Use in patients 65 years and older

Patients 65 years and older are more prone to suffering from other pathologies that may recommend a dose reduction. In case of appearance of undesirable side effects, 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 must take a different dose, adjusted to the degree of their disease, which will be determined by the doctor.

Use in children and adolescents

Normodorm is not recommended for use in patients under 18 years, so the medication should not be used in this population.

Route and method of administration

Oral route.

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

The treatment duration should be as short as possible. In general, the treatment duration can range from a few days to a week.

It should not be administered for a period exceeding 7 days without consulting the doctor.

• If you take more Normodorm than you should

The symptoms of an overdose are: drowsiness, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, decreased intestinal tone), flushing, increased or altered heart rate, increased blood pressure, nausea, vomiting, agitation, altered gait, dizziness, irritability, sedation, confusion, and hallucinations. Severe complications may include rhabdomyolysis (muscle injury), followed by renal failure.

There is no specific antidote for antihistamine overdose, so 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

• If you forgot to take Normodorm

Do not take a double dose to compensate for the missed doses.

Take your dose at the usual time the next day.

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

Like all medications, Normodorm may cause side effects, although not everyone will experience them.

The side effects of doxilamine are generally mild and transient, and are more frequent in the first few days of treatment.

Common side effects (may affect up to 1 in 10 people): drowsiness and effects such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, dizziness, nausea, headache, upper abdominal pain, fatigue, insomnia, and nervousness.

Rare side effects (may affect up to 1 in 100 people): asthenia (fatigue), peripheral edema (inflammation of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (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), tremors, convulsions, or blood-related problems such as hemolytic anemia, thrombocytopenia, leucopenia, or agranulocytosis (decrease in certain blood cells).

Side effects of unknown frequency (cannot be estimated from available data): general discomfort.

Other side effects that have occurred with the use of antihistamines in general, although not observed with doxilamine, are the following: arrhythmia (heart rate alteration), palpitations, duodenogastroesophageal reflux, abnormal liver function (cholestatic jaundice), prolonged QT interval on the electrocardiogram (cardiac alteration), decreased appetite, increased appetite, myalgia (muscle pain), abnormal coordination, extrapyramidal disorder (movement disorders), paresthesia (abnormal sensations), impairment of psychomotor activities (sensory-motor coordination), depression, decreased bronchial secretion, alopecia (hair loss), allergic dermatitis, hyperhidrosis (excessive sweating), photosensitivity reaction, or hypotension (low blood pressure).

The frequency and magnitude of side effects may be reduced by decreasing the daily dose.

People over 65 years old have a higher risk of experiencing adverse reactions, as they may have other underlying conditions or be taking other medications simultaneously. These individuals also have a higher risk of falls.

If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this prospectus.

This product does not require special storage conditions.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains or trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of normodorm

The active ingredient is doxilamina. Each tablet contains 25 mg of doxilamina hydrogenosuccinate.

The other components are:

Tablet core: microcrystalline cellulose, dihydrogen phosphate of calcium dihydrate, low-substituted hydroxypropyl cellulose, colloidal silica, and magnesium stearate.

Tablet coating: hypromellose, titanium dioxide (E-171), macrogol 6000, talc, and indigotin lake (E-132).

Appearance of the product and content of the packaging

Normodorm 25 mg is presented in the form of coated tablets with a blue film coating, oval and scored. Each package contains 7 and 14 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Date of the last review of this leaflet: May 2013

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/