Dormigen 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Dormigen 25 mg film-coated tablets

Doxylamine hydrogen succinate

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Follow exactly the instructions for taking this medicine as described in this leaflet or as directed 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. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 7 days of treatment.

Contents of the leaflet

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

1. What Dormigen is and what it is used for

It is a medicine that contains 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 short-term 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 Dormigen

Do not take Dormigen:

• 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 (antiallergy medicines),
• If you are breastfeeding.
• If you suffer from respiratory disorders such as asthma, chronic bronchitis (persistent cough producing sputum and mucus), or pulmonary emphysema (difficulty breathing).
• If you have glaucoma (high pressure in the eye).
• If you have benign prostatic hyperplasia (abnormal enlargement of the prostate), bladder neck obstruction (a urinary tract condition), or difficulty urinating.
• If you have erosion of the stomach or duodenal wall, or pyloroduodenal obstruction (difficulty in food passing from the stomach to the intestine).
• If you are taking monoamine oxidase inhibitors.
• If you are taking medicines such as antidepressants, certain antibiotics, medicines affecting the heart (such as those used to treat arrhythmias), certain antivirals, drugs used to treat fungal infections, some lipid-lowering agents (drugs that reduce fat levels in the blood), or quinidine (a medicine used to treat seizures).
• If you have severe kidney or liver disease.

Warnings and precautions

Talk to your doctor or pharmacist before taking Dormigen. You should consult a doctor before taking this medicine if you have:

• Mild to moderate impairment of liver or kidney function, as dose adjustment may be necessary.
• Epilepsy (antihistamines may cause hyperexcitability and could therefore lower the seizure threshold).
• QT interval prolongation (a heart condition causing sudden changes in heart rate during exercise or stress).
• Low potassium levels in the blood or other electrolyte imbalances,
• Heart disease or high blood pressure.

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 between taking it and waking up.

• If you are taking other medicines that are ototoxic (toxic to the ears), such as carboplatin or cisplatin (cancer treatments), chloroquine (a medicine for the treatment or prevention of malaria), or certain antibiotics (medicines for infections) such as erythromycin or injected aminoglycosides, doxylamine may mask the toxic effects of these drugs; therefore, you should have your hearing checked regularly.
• Doxylamine may worsen symptoms of dehydration and heat stroke due to reduced sweating, especially in hot weather.
• Alcohol consumption must be avoided during treatment.
• If you are over 65 years old, you may be more susceptible to side effects. Therefore, pay close attention to how the treatment affects you (see section 4).
• Grapefruit consumption should be avoided while taking doxylamine.
• You should avoid taking doxylamine with medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, and vancomycin, as they may cause acute intoxication.

Doxylamine should not be administered for longer than 7 days unless your doctor considers it advisable.

Children and adolescents

The administration of Doxylamine Dormigen is not recommended for individuals under 18 years of age.

Other medicines and Dormigen

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take doxylamine together with the following medicines:

• Monoamine oxidase inhibitors (e.g., medicines used to treat depression, Parkinson's disease, or other conditions, such as moclobemide, phenelzine, tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline, and selegiline).
• Medicines with effects on the heart, such as those used to treat arrhythmias (amiodarone), certain macrolide antibiotics (clarithromycin, erythromycin, and telithromycin), certain lipid-lowering agents (gemfibrozil), some antidepressants (such as fluoxetine, fluvoxamine, paroxetine, or bupropion), protease inhibitor antivirals (indinavir, ritonavir, and telaprevir), and azole antifungals (fluconazole, ketoconazole, and itraconazol).

You should avoid taking doxylamine with the following medicines, as they may enhance its action or adverse effects:

• Adrenaline (epinephrine) (used to treat low blood pressure).
• Certain antimalarial medicines or other antihistamines.
• Certain diuretics (medicines that increase urine elimination).
• Alcohol or other central nervous system depressants, e.g., barbiturates, hypnotics, sedatives, other sleep or anxiety medicines (alprazolam, diazepam, zolpidem), opioid-type analgesics (codeine), psychiatric medicines (chlorpromazine, risperidone, amitriptyline, and trazodone), or procarbazine.
• Antihypertensives (medicines for high blood pressure) with central nervous system effects, such as guanabenz, clonidine, or methyldopa.
• Other anticholinergic drugs, such as neuroleptics (medicines for mental disorders), medicines for spasms (e.g., atropine and belladonna alkaloids), or disopyramide (used for certain heart problems).
• Topical antihistamines applied to the skin (such as diphenhydramine cream, ointment, or spray) and scopolamine.
• Medicines with a narrow therapeutic index (where the difference between therapeutic and toxic dose is small), e.g., phenytoin, digoxin, warfarin, lithium, aminoglycosides, and vancomycin.

Interference with diagnostic tests

Doxylamine may interfere with skin allergy tests using allergens. It is recommended to stop treatment with Dormigen at least 3 days before undergoing such tests.

Taking Dormigen with food, drinks, and alcohol

Alcoholic beverages must not be consumed during treatment with doxylamine. See section 3: How to take Dormigen.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no adequate data on the use of doxylamine in pregnant women; therefore, taking Dormigen during pregnancy should be avoided.

Due to the risks associated with administering antihistamines to young children, women who are breastfeeding should not take Dormigen.

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

Driving and using machines:

The effect of doxylamine 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.

Dormigen contains lactose:

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Dormigen

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.

There are other doxylamine formulations available to suit different dosage requirements.

Recommended dose:

Adults (over 18 years of age)

The recommended dose is 1 tablet (25 mg) per day, taken 30 minutes before bedtime.

If daytime drowsiness occurs, it is recommended to reduce the dose to 1 tablet of 12.5 mg per day or to take the dose earlier to ensure at least 8 hours elapse between administration and waking time.

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

Use in elderly patients

Patients over 65 years of age are more likely to have other medical conditions that may require dose reduction. The recommended initial dose is 1 tablet of 12.5 mg, taken 30 minutes before bedtime. The dose may be increased to 25 mg (1 tablet) if the initial dose does not sufficiently relieve insomnia. If undesirable adverse effects occur, the dose should be reduced to 1 tablet of 12.5 mg per day. For this reason, pay close attention to the effect of the treatment (see section 4).

Use in patients with liver or kidney disease

In patients with mild renal or hepatic impairment, dose reduction is recommended, with a maximum daily intake of 12.5 mg.

Use in children and adolescents

Doxylamine is not recommended for use in individuals under 18 years of age; therefore, the medicine should not be used in this population.

Method of administration

Oral use.

The tablets should be taken 30 minutes before going to bed with a sufficient amount of liquid (preferably water).

Doxylamine may be taken with or without food.

The tablet score line is intended solely to facilitate swallowing if the tablet is difficult to swallow whole, and not for dividing the tablet into two equal doses.

Duration of treatment

Treatment duration should be as short as possible. In general, treatment may last from a few days up to one week.

It should not be administered for longer than 7 days, unless otherwise advised by your doctor.

If you take more Dormigen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

Symptoms of poisoning 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.

Severe poisoning may lead to delirium, psychosis, low blood pressure, seizures, reduced breathing, loss of consciousness, coma, and may be life-threatening.

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 induction of vomiting, gastric lavage, or administration of medications to increase blood pressure is necessary.

If you forget to take Dormigen

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 stop taking Dormigen

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

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

Very common adverse effects (may affect more than 1 in 10 people): somnolence.

Common adverse effects (may affect up to 1 in 10 people): symptoms such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, dizziness, vertigo, headache, upper abdominal pain, 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 (decrease in blood pressure due to changes in posture), diplopia (double vision), dyspepsia (stomach discomfort), sensation of relaxation, nightmares, and dyspnea (difficulty breathing).

Rare adverse effects (may affect up to 1 in 1,000 people): agitation (especially in elderly patients), tremor, seizures, or blood disorders such as haemolytic anaemia, thrombocytopenia, leucopenia, or agranulocytosis (reduction in certain blood cells).

Adverse effects with unknown frequency (cannot be estimated from available data): general malaise.

Other adverse effects that have occurred with the use of antihistamines in general, although not observed with doxylamine, include: arrhythmia (altered heart rate), 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.

Patients over 65 years of age have a higher risk of experiencing adverse reactions, as they may suffer from 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 possible adverse effects not listed in this leaflet.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dormigen

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 unused medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and additional information

Composition of Dormigen:

• The active substance is doxylamine hydrogen succinate. Each tablet contains 25 mg of doxylamine hydrogen succinate.
• The other components (excipients) are:

Core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethyl starch type A (from potato), anhydrous colloidal silica, magnesium stearate.

Coating: hypromellose (E-464), titanium dioxide (E-171), lactose monohydrate, macrogol 4000 (E-1521).

Appearance of the product and contents of the container:

Dormigen is presented as film-coated tablets. The tablets are white, round, film-coated and scored on one side. The score line is intended solely to facilitate breaking the tablet when there are difficulties in swallowing, but not to divide the tablet into two equal doses.

Each pack contains 14 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Laboratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Date of revision of this leaflet: July 2018

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es