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DORMÍKERN 25 mg FILM-COATED TABLETS

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About the medicine

How to use DORMÍKERN 25 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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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.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

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.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

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/

Online doctors for DORMÍKERN 25 mg FILM-COATED TABLETS

Discuss questions about DORMÍKERN 25 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
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If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

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  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
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Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
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  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
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  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
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Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
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  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
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  • Chronic conditions: diabetes, thyroid disorders.
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Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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Doctor

Alexander Nazarchuk

Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

You can consult Dr. Nazarchuk for:

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  • Allergen-specific immunotherapy (AIT) – initiation and ongoing management.
  • Abdominal pain, bloating, changes in bowel habits, nausea, heartburn.
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Doctor

Marta Reguero Capilla

Allergology 8 years exp.

Dr Marta Reguero Capilla is an allergist and immunologist who works with both adults and children. She specialises in the diagnosis, treatment, and ongoing management of allergic and immune-related conditions through online consultations.

In her practice, Dr Reguero Capilla helps patients understand the causes of their symptoms, review test results, and choose appropriate treatment or monitoring strategies. Her consultations are suitable both for first-time assessments and for follow-up care over time.

Patients commonly consult Dr Marta Reguero Capilla for:

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Dr Reguero Capilla works in a structured and attentive manner, explaining medical decisions clearly and helping patients make informed choices about their own health or their child’s care.

When clinically appropriate, she may provide recommendations for further tests or referrals that patients can use within Spanish medical networks, including Sanitas and DKV, in accordance with the terms and conditions of those services.

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Frequently Asked Questions

Is a prescription required for DORMÍKERN 25 mg FILM-COATED TABLETS?
DORMÍKERN 25 mg FILM-COATED TABLETS does not require a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in DORMÍKERN 25 mg FILM-COATED TABLETS?
The active ingredient in DORMÍKERN 25 mg FILM-COATED TABLETS is doxylamine. This information helps identify medicines with the same composition but different brand names.
Who manufactures DORMÍKERN 25 mg FILM-COATED TABLETS?
DORMÍKERN 25 mg FILM-COATED TABLETS is manufactured by Kern Pharma S.L.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DORMÍKERN 25 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether DORMÍKERN 25 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to DORMÍKERN 25 mg FILM-COATED TABLETS?
Other medicines with the same active substance (doxylamine) include DORMIDINA DOXILAMINE 12.5 mg FILM-COATED TABLETS, DORMIDINA DOXILAMINE 25 mg FILM-COATED TABLETS, DORMIGEN 25 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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