DORMÍKERN 25 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

DormiKern 25 mg Film-Coated Tablets

Doxylamine, Hydrogen Succinate

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What is DormiKern and what is it used for
2. What you need to know before taking DormiKern
3. How to take DormiKern
4. Possible side effects
5. Storage of DormiKern
6. Contents of the pack and further information

1. What is DormiKern and what is it used for

DormiKern is a medicine that contains the active ingredient doxylamine hydrogen succinate. Doxylamine belongs to a group of medicines called antihistamines with sedative properties.

This medicine is indicated for the symptomatic treatment of occasional insomnia in adults over 18 years of age.

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

2. What you need to know before taking DormiKern

• Do not take DormiKern

• 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 (antiallergics).
• If you are pregnant or breastfeeding.

• Warnings and precautions

Consult your doctor or pharmacist before taking DormiKern.

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

• Liver or kidney function disorders.
• Epilepsy.
• QT interval prolongation (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, making breathing difficult).
• Glaucoma (increased eye pressure).
• Urinary retention.
• Prostatic hypertrophy (abnormal enlargement of the prostate).
• Peptic ulcer (erosion of the stomach or duodenum wall), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), and vesical neck obstruction (a disease of the urinary tract).

If you experience drowsiness during the day, it may be necessary to reduce the dose or take it earlier to ensure that at least 8 hours pass until wake-up time.

Alcohol consumption should be avoided during treatment.

If you are over 65 years old, you may be more susceptible to experiencing side effects.

DormiKern may worsen dehydration and heat stroke symptoms due to decreased sweating.

• Taking DormiKern with other medicines

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

Do not take DormiKern with the following medicines, as their effects may be increased:

• Epinephrine (for low blood pressure treatment).
• Medicines that act on the heart, such as those used for arrhythmia treatment, some antibiotics, certain antimalarial drugs, certain antihistamines, certain lipid-lowering agents, or certain neuroleptics.
• Medicines that decrease the elimination of other medicines, such as azole derivatives or macrolides, as they may increase the effect of DormiKern.
• Certain diuretics (medicines that increase urine elimination).
• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).
• Antihypertensive agents with central nervous system effects, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic agents, such as medicines for depression or Parkinson's disease treatment, monoamine oxidase inhibitors (antidepressants), neuroleptics (medicines for mental disorder treatment), atropine-like medicines for spasm treatment, or disopyramide (for certain heart problems).
• If you are taking other medicines that can cause ear toxicity, such as carboplatin or cisplatin (cancer medicines), chloroquine (a medicine for malaria treatment or prevention), or certain antibiotics (infection medicines) like erythromycin or injectable aminoglycosides; DormiKern may mask the toxic effects of these medicines, so you should have your ears checked regularly.

• Interference with diagnostic tests

Doxylamine may interfere with skin allergy tests that use allergens. It is recommended to stop treatment with DormiKern at least 3 days before starting such 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, plan to become pregnant, or are breastfeeding.

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

• Driving and using machines

DormiKern's influence on the ability to drive and use machines is significant. Do not drive or use hazardous machinery while taking this medicine, at least during the first days of treatment, until you know how it affects you.

3. How to take DormiKern

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Adults (over 18 years of age)

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) per day or take it earlier to ensure that at least 8 hours pass until wake-up time.

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

Use in adults over 65 years of age

Adults over 65 years of age are more prone to suffering from other diseases that may recommend a dose reduction. In case 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 or kidney disease

These patients should 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 children under 18 years of age, so the medicine should not be used in this population.

Route and method of administration

Oral route.

The tablet can be divided into equal doses.

Tablets should be taken 30 minutes before bedtime with a sufficient amount of liquid (preferably water).

Duration of treatment

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

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

• If you take more DormiKern than you should

Symptoms of 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. Delirium, psychosis, decreased blood pressure, convulsions, decreased respiration, loss of consciousness, coma, and death may occur. A serious complication can be rhabdomyolysis (muscle damage), followed by kidney 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 stomach lavage, or prescribe medicines 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 medicine and the amount taken.

• If you forget to take DormiKern

Do not take a double dose to make up for forgotten doses.

Take your dose at the usual 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, DormiKern can cause side effects, although not everybody gets them.

The side effects of doxylamine are, in general, mild and transient, being more frequent in the first 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, vertigo, dizziness, headache, abdominal pain, fatigue, insomnia, and nervousness.

Uncommon 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 (decreased blood pressure due to posture changes), 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, convulsions, or blood disorders such as hemolytic anemia, thrombocytopenia, leukopenia, or agranulocytosis (decrease in certain blood cells).

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

Other side effects that have occurred with the use of antihistamines in general, although not observed with doxylamine, are the following: arrhythmia (heart rate alteration), palpitations, duodenogastric reflux, abnormal liver function (cholestatic jaundice), prolonged QT interval on the electrocardiogram (a cardiac disorder), decreased appetite, increased appetite, myalgia (muscle pain), abnormal coordination, extrapyramidal disorder (movement disorders), paresthesia (abnormal sensations), psychomotor activity impairment (senses-movement 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 can be reduced by decreasing the daily dose.

Adults over 65 years of age have a higher risk of experiencing adverse reactions, as they may have other diseases or be taking other medicines simultaneously. These people also have a higher risk of falls.

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

5. Storage of DormiKern

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 is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of DormiKern

The active ingredient is doxylamine. Each tablet contains 25 mg of doxylamine hydrogen succinate.

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 (E-171), macrogol 6000, talc, and indigo carmine lake (E-132).

Appearance of the product and pack contents

DormiKern 25 mg is presented in the form of film-coated tablets of blue color, oblong shape, and scored. Each pack contains 7 and 14 tablets.

Marketing authorization holder

KERN PHARMA, S.L.

Venus, 72. Poligono Industrial Colon II.

08228- Tarrasa, Barcelona

Spain

Manufacturer

LABORATORIOS NORMON, S.A.

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

Date of last revision of this leaflet: May 2013

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/