Package Insert: Information for the User

DormiKern 25 mg Film-Coated Tablets

Doxilamine, Hydrogen Succinate

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

Follow exactly the administration instructions for the medicine 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.

DormiKern 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.

Consult a doctor if symptoms worsen or do not improve after 7 days.

• Do not take DormiKern

• If you are allergic to doxilamina 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 DormiKern.

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

• Liver and kidney function impairment.
• Epilepsy.
• Prolongation of the QT interval (a heart problem).
• Low potassium levels in the blood or other electrolyte imbalances.
• 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.

Consumption of alcoholic beverages should be avoided during treatment.

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

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

• Taking DormiKern 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 DormiKern with the following medications, as they may potentiate its effects:

• Epinephrine (for treating low blood pressure).
• Medications affecting the heart, such as those used to treat arrhythmias, some antibiotics, certain antimalarial drugs, certain antihistamines, certain lipid-lowering medications, or certain neuroléptics (medications for mental health disorders).
• Medications that decrease the elimination of other medications, such as azole derivatives or macrolides, which may increase the effect of DormiKern.
• Some diuretics (medications that increase urine elimination).
• Central nervous system inhibitors (e.g. barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).
• Antihypertensive medications with central nervous system effects, such as guanabenzo, clonidina, or alpha-metildopa.
• Other anticholinergic medications, such as medications for depression or Parkinson's disease, monoamine oxidase inhibitors (medications for depression), neuroléptics (medications for mental health disorders), atropinic medications for spasms, or disopiramida (for certain heart problems).
• If you are taking other medications that cause ototoxicity, such as carboplatino or cisplatino (cancer medications), cloroquina (malaria medication), and some antibiotics (infection medications) like eritromicina or aminoglucósidos inyectados, among others; DormiKern may mask the toxic effects of these medications, so you should regularly check your ear status.

• Interference with diagnostic tests

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

• Taking DormiKern with food, drinks, and alcohol

Alcoholic beverages should not be consumed during treatment with DormiKern. See section 3. How to take DormiKern.

• Pregnancy, breastfeeding, and fertility

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

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

• Driving and operating machinery

The influence of DormiKern 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 will take a different dose, adjusted to the degree of their disease, which will be determined by the doctor.

Use in children and adolescents

DormiKern 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 DormiKern 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 evaluate 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, phone: 91 562 04 20, indicating the medication and the amount ingested.

• If you forgot to take DormiKern

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 questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, DormiKern 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.

Frequent 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, vertigo, 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 (respiratory 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, leukopenia, 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, duodenogastric 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 experiencing a fall.

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

No special conservation conditions are required.

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.

Medications should not be disposed of through drains or in the trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of DormiKern

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

The other components are: Tablet core: microcrystalline cellulose, dihydrate calcium hydrogen phosphate, low-substitution 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 contents of the packaging

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

Holder of the marketing authorization

KERN PHARMA, S.L.

Venus, 72. Poligono Industrial Colon II.

08228- Tarrasa, Barcelona

Spain

Responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Last review date of this leaflet: May 2013

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