Dormikern 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

DormiKern 25 mg film-coated tablets

Doxylamine, succinate

Read the entire leaflet carefully before you start taking this medicine, as 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 further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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

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

1. What DormiKern is and what it is used for

DormiKern 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 symptomatic 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 DormiKern

• Do not take DormiKern

• 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 agents).

• 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:

• 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 eyes).
• Urinary retention.
• Prostatic hypertrophy (abnormal enlargement of the prostate).
• Peptic ulcer (erosion of the stomach or beginning of the intestine), pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine), or vesical neck obstruction (a urinary tract disorder).

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.

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

• Taking DormiKern 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 DormiKern together with the following medicines, as their effects may be enhanced:

• Epinephrine (used to treat low blood pressure).

• Medicines acting on the heart, such as those used to treat arrhythmias, certain antibiotics, certain antimalarial drugs, certain antihistamines, certain medicines used to lower blood lipids (fats), or certain neuroleptics (medicines used to treat mental disorders).

• Medicines that reduce the elimination of other drugs, such as azole derivatives or macrolides, which could increase the effect of DormiKern.

• Certain diuretics (medicines that increase urine output).

• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid-type analgesics, antipsychotics, or procarbazine).

• Antihypertensives (medicines for treating high blood pressure) with central nervous system effects, such as guanabenz, clonidine, or alpha-methyldopa.

• 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 to treat certain heart problems).

• If you are taking other medicines that cause ototoxicity (ear toxicity), such as carboplatin or cisplatin (cancer medicines), chloroquine (a medicine for treating or preventing malaria), or certain antibiotics (medicines for treating infections) such as erythromycin or injected aminoglycosides, among others; DormiKern could mask the toxic effects of these medicines, so you should have your hearing 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 three days before undergoing such tests.

• Taking DormiKern with food, drinks, and alcohol

Alcoholic beverages must 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, planning to become pregnant, or breastfeeding.

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

• Driving and using machines

The effect of DormiKern on the ability to drive and operate machinery 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 DormiKern

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 dose reduction. 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 receive a different dose, adjusted according to the severity of their condition, as determined by the physician.

Use in children and adolescents

DormiKern is not recommended for use in individuals under 18 years of age and should not be used in this population.

Route and method of administration

For oral use.

The tablet may be divided into equal doses.

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.

Do not take for longer than 7 days without consulting your doctor.

• If you take more DormiKern 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, elevated blood pressure, nausea, vomiting, agitation, impaired gait, dizziness, irritability, sedation, confusion, and hallucinations. Delirium, psychosis, low blood pressure, seizures, reduced breathing, loss of consciousness, coma, and death may occur. A serious complication may be rhabdomyolysis (muscle damage), 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 DormiKern

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, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, DormiKern may cause adverse effects, although not everyone gets them.

The adverse effects of doxylamine are generally mild and transient, being more common during the first days of treatment.

Common 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, dizziness, vertigo, headache, abdominal pain in the upper part of the stomach, fatigue, insomnia, and nervousness.

Uncommon adverse effects (may affect up to 1 in 100 people): asthenia (weakness, fatigue), peripheral edema (swelling of arms and legs), nausea, vomiting, diarrhea, skin rash, tinnitus (ringing in the ears), orthostatic hypotension (low blood pressure due to postural changes), diplopia (double vision), dyspepsia (stomach discomfort), feeling 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 people), 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): malaise.

Other adverse effects that have occurred with the use of antihistamines in general, although not observed with doxylamine, include: arrhythmia (irregular heartbeat), 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 performance (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 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 refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and any unused medicines at the SIGRE collection point at your pharmacy. If in doubt, please ask your pharmacist how to dispose of containers and unused medicines. This way, you will help protect the environment.

6. Package contents and other information

Composition of DormiKern

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 hydroxypropylcellulose, 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 medicinal product and contents of the package

DormiKern 25 mg is presented as blue, film-coated, oblong, scored tablets. Each pack contains 7 or 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 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 Health Products (AEMPS) http://www.aemps.gob.es/