DORMIGEN 25 mg FILM-COATED TABLETS

2. What you need to know before taking Dormigen

Do not take Dormigen:

• If you are allergic to doxylamine or any of the other components of this medicine (listed in section 6),
• If you are allergic to other antihistamines (antiallergics),
• If you are breastfeeding.
• If you have respiratory disorders such as asthma, chronic bronchitis (persistent cough that produces sputum and mucus) or pulmonary emphysema (difficulty breathing).
• If you have glaucoma (high eye pressure).
• If you have prostatic hypertrophy (abnormal enlargement of the prostate), obstruction of the neck of the bladder (disease of the urinary tract) or difficulty urinating.
• If you have erosion of the stomach wall or the beginning of the intestinal wall or pyloroduodenal obstruction (difficulty passing food from the stomach to the intestine).
• If you are taking monoamine oxidase inhibitors.
• If you are taking medicines such as antidepressants, certain antibiotics, heart medications, such as those used to treat arrhythmias, certain antivirals, and medications intended to treat fungal infections, some medications that reduce lipid (fat) content in the blood, or quinidine (a medication used to treat convulsions).
• If you have severe kidney or liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Dormigen. You should consult a doctor before starting to take this medicine if you have:

• mild to moderate liver and kidney function impairment, as it may be necessary to adjust the dose.
• epilepsy (sometimes antihistamines cause hyperexcitability and may therefore reduce the convulsive threshold)
• prolongation of the QT interval (a heart problem that causes a sudden change in heart rate when exercising or in stressful situations).
• low potassium levels in the blood or other electrolyte disturbances,
• heart disease and high blood pressure

If you experience daytime drowsiness, it may be necessary to reduce the dose or take it earlier to ensure that at least 8 hours pass until waking time.

• If you are taking other medications that produce ear toxicity, such as carboplatin or cisplatin (cancer medications), chloroquine (malaria treatment or prevention medication) and some antibiotics (infection medications) such as erythromycin or injected aminoglycosides, among others, doxylamine may mask the toxic effects of these medications, so you should periodically review the condition of your ears.
• Doxylamine may worsen dehydration and heat stroke symptoms due to decreased sweating, especially in hot weather.
• Alcohol consumption should be avoided during treatment.
• If you are over 65 years old, you may be more susceptible to side effects. For this reason, pay attention to the effects of treatment (see section 4).
• Grapefruit consumption should be avoided while taking doxylamine.
• Medications such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, and vancomycin should be avoided when taking doxylamine, as they may cause acute intoxication.

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

Children and adolescents

Doxylamine is not recommended for use in children under 18 years of age, so this medicine should not be used in this population.

Other medicines and Dormigen

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicine.

Do not take doxylamine with the following medications:

• Monoamine oxidase inhibitors (e.g., medications used to treat depression, Parkinson's disease, or other conditions, such as moclobemide, phenelzine, and tranylcypromine, isocarboxazid, linezolid, methyl blue, procarbazine, rasagiline, and selegiline.
• Medications that affect the heart, such as those used to treat arrhythmias (amiodarone), some macrolide antibiotics (clarithromycin, erythromycin, and telithromycin), certain medications used to reduce lipids (fat) in the blood (gemfibrozil), some medications used to treat depression (antidepressants such as fluoxetine, fluvoxamine, paroxetine, or bupropion), protease inhibitor antivirals (indinavir, ritonavir, and telaprevir), and azole antimycotics (fluconazole, ketoconazole, and itraconazole).

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

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

Interference with diagnostic tests

Doxylamine may interfere with skin allergy tests that use allergens. It is recommended to discontinue treatment with Dormigen at least 3 days before starting such tests.

Taking Dormigen with food, drinks, and alcohol

Alcoholic beverages should 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 plan 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, so Dormigen should be avoided during pregnancy.

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

There is no data on the possible effects of Dormigen on fertility.

Driving and using machines:

Doxylamine'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.

Dormigen contains lactose:

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

3. How to take Dormigen

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

There are other presentations of doxylamine to adapt to all doses.

The recommended dose is:

Adults (over 18 years old)

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 take it earlier to ensure that at least 8 hours pass until waking time.

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

Use in elderly patients

People over 65 years old are more likely to suffer from other conditions that may recommend a dose reduction. The initial recommended dose is 1 tablet of 12.5 mg, taken 30 minutes before bedtime. The dose can be increased to 25 mg (1 tablet) if the initial dose does not sufficiently relieve insomnia. In case of unwanted side effects, it is recommended to reduce the dose to 1 tablet of 12.5 mg per day. For this reason, pay attention to the effect of the treatment (see section 4).

Use in patients with liver or kidney disease

In patients with mild or moderate renal or hepatic insufficiency, it is recommended to reduce the dose to a maximum daily intake of 12.5 mg.

Use in children and adolescents

Doxylamine is not recommended for use in children under 18 years of age, so this medicine should not be used in this population.

Method of administration

Oral route.

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

Doxylamine can be taken before or after meals.

The score line on the tablets is only for breaking the tablet if you have difficulty swallowing it whole, but not for dividing it into 2 equal doses.

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 more than 7 days, unless your doctor advises you to take it for a longer period.

If you take more Dormigen than you should

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

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, alteration of gait, dizziness, irritability, sedation, confusion, and hallucinations.

Severe overdose can cause delirium, psychosis, decreased blood pressure, convulsions, decreased respiration, loss of consciousness, and coma, and can be life-threatening.

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 gastric lavage, or prescribe medications to increase blood pressure if necessary.

If you forget to take Dormigen

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

Take your dose at the usual time the next day.

If you stop taking Dormigen

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects of doxylamine are generally mild and transient, being more frequent in the first days of treatment.

Very common side effects (may affect more than 1 in 10 people): drowsiness.

Common side effects (may affect up to 1 in 10 people): symptoms such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, vertigo, dizziness, headache, pain in the upper abdominal area, 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 (decrease in 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 elderly patients), tremors, 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 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 (alteration of heart rate), palpitations, duodenogastric reflux, abnormal liver function (cholestatic jaundice), prolonged QT interval on the electrocardiogram (a cardiac alteration), 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.

People over 65 years old have a higher risk of experiencing adverse reactions, as they may have other conditions or be taking other medications 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.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing 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 expiration date stated on the packaging, after EXP. The expiration date is the last day of the month indicated.

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

6. Package contents and additional information

Dormigen composition:

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

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

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

Appearance of the product and package contents:

Dormigen is presented in the form of film-coated tablets. The tablets are white, round, film-coated, and scored on one side. The score line is only for breaking the tablet if you have difficulty swallowing it whole, but not for dividing it into 2 equal doses.

Each package contains 14 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avenida de Bruselas, 13, 3º D.

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Laoratorios Alcalá Farma, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

Spain

Date of revision of this leaflet: July 2018

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