Dormidina doxylamine 12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dormidina doxylamine 12.5 mg film-coated tablets

doxylamine, succinate

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

Follow exactly the instructions for use of this medicine 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 more information, consult your pharmacist.

• If you experience adverse effects, consult your doctor or pharmacist, even if these are effects not listed in this leaflet. See section 4.

• You should consult a doctor if you worsen or do not improve after 7 days.

Contents of the leaflet

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

1. What Dormidina doxylamine is and what it is used for

Dormidina doxylamine is a medicine containing the active substance doxylamine hydrogen succinate. Doxylamine belongs to a group of medicines called antihistamines, which have sedative properties.

Dormidina doxylamine is indicated for the short-term symptomatic treatment of occasional insomnia in individuals 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 Dormidina doxylamine

Do not take Dormidina doxylamine

• If you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• If you are allergic to other antihistamines (antiallergy medicines).
• If you are breastfeeding.
• If you have 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), vesical neck obstruction (urinary tract disorder), or difficulty urinating.
• If you have gastric or duodenal ulcer or pyloroduodenal obstruction (difficulty passing food from the stomach into the intestine).
• If you are taking monoamine oxidase inhibitors (MAOIs).
• If you are taking medicines such as antidepressants, certain antibiotics, medicines affecting the heart (such as those used to treat arrhythmias), certain antivirals, antifungal agents, some lipid-lowering (fat-reducing) medicines, or quinidine (a medicine used to treat seizures).
• If you have severe kidney or liver disease.

Warnings and precautions

Consult your doctor or pharmacist before taking Dormidina doxylamine.

• If you have:

• Mild to moderate impairment of liver or kidney function, as dose adjustment may be necessary,

• Epilepsy (antihistamines may cause hyperexcitability and thereby potentially lower the seizure threshold),

• QT interval prolongation (a heart condition causing sudden changes in heartbeat rate during exercise or stress),

• Low blood potassium levels 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 before waking time.

• If you are taking other medicines that are ototoxic (toxic to the ears), such as carboplatin or cisplatin (cancer treatments), chloroquine (for treatment or prevention of malaria), or certain antibiotics (for treating infections) such as erythromycin or injectable aminoglycosides, among others, Dormidina doxylamine may mask the toxic effects of these drugs; therefore, regular monitoring of your hearing is recommended.

• Dormidina 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 of age, you may be more susceptible to side effects. Therefore, pay close attention to the effects of treatment (see section 4).

• Grapefruit consumption should be avoided while taking doxylamine.

• Concomitant use of doxylamine with phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin should be avoided, as this may lead to acute intoxication.

Dormidina doxylamine should not be used for longer than 7 days unless otherwise advised by your doctor.

Children and adolescents

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

Other medicines and Dormidina doxylamine

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

Do not take Dormidina doxylamine together with the following medicines:

• Monoamine oxidase inhibitors (MAOIs) (e.g., medicines used to treat depression, Parkinson's disease, or other conditions, such as moclobemide, phenelzine, tranilcypramine, 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, telithromycin), certain lipid-lowering (fat-reducing) medicines (gemfibrozil), some antidepressants (fluoxetine, fluvoxetine, paroxetine, or bupropion), protease inhibitor antivirals (indinavir, ritonavir, telaprevir), and azole antifungals (fluconazole, ketoconazole, itraconazole).

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

• Epinephrine (used to treat low blood pressure).
• Certain medicines used to treat malaria or other antihistamines.
• Some 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, 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 (for treating certain heart problems).
• Topical antihistamines applied to the skin (such as diphenhydramine cream, ointment, or spray) and scopolamine.
• Medicines with a narrow therapeutic index (i.e., where the difference between therapeutic and toxic dose is small), such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, and vancomycin.

Interference with diagnostic tests

Doxylamine may interfere with skin allergy tests using allergens. It is recommended to discontinue treatment with Dormidina doxylamine at least three days before such tests.

Taking Dormidina doxylamine with food, drinks, and alcohol

Alcoholic beverages must not be consumed during treatment with Dormidina doxylamine.

See section 3. How to take Dormidina doxylamine.

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; therefore, taking Dormidina doxylamine during pregnancy should be avoided.

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

There are no data available on the potential effects of Dormidina doxylamine on human fertility.

Driving and using machines

Dormidina doxylamine may significantly impair your ability to drive or operate machinery due to drowsiness. 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.

Dormidina doxylamine contains carmine (cochineal red A) and sodium

This medicine may cause allergic reactions as it contains carmine (cochineal red A). It may trigger asthma, especially in patients allergic to acetylsalicylic acid.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially "sodium-free".

3. How to take Dormidina doxylamine

Follow exactly the dosing instructions for this medicine provided in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

Adults (over 18 years of age)

The recommended dose is 1 to 2 tablets (12.5 mg to 25 mg) daily, taken 30 minutes before going to bed.

If daytime drowsiness occurs, it is recommended to reduce the dose to 1 tablet (12.5 mg) or take the medicine earlier to ensure at least 8 hours elapse before waking time.

Do not take more than 2 tablets (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 a dose reduction. The recommended initial dose is 12.5 mg (1 tablet), taken 30 minutes before bedtime. The dose may be increased to 25 mg (2 tablets) if the initial dose does not sufficiently relieve insomnia. If unwanted adverse effects occur, it is advisable to reduce the dose to 1 tablet (12.5 mg) daily. For this reason, pay close attention to how the treatment affects you (see section 4).

Patients with liver or kidney disease

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

Use in children and adolescents

Dormidina doxylamine 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

Oral use.

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

Dormidina doxylamine may be taken before or after meals.

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 your doctor advises you to take it for a longer period.

If you take more Dormidina doxylamine than you should

If you take more Dormidina doxylamine than you should, consult your doctor or pharmacist immediately. 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.

Severe poisoning may result in delirium, psychosis, low blood pressure, seizures, reduced respiration, 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 the need to induce vomiting, perform gastric lavage, or prescribe medications to increase blood pressure if necessary.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91.562.04.20.

If you forget to take Dormidina doxylamine

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, ask your doctor or pharmacist.

4. Possible adverse effects

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

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

Very common (may affect more than 1 in 10 people):

• somnolence

Common (may affect up to 1 in 10 people):

• dry mouth
• constipation
• blurred vision
• urinary retention
• increased bronchial secretion
• dizziness
• vertigo
• headache
• pain in the upper part of the abdomen
• fatigue
• insomnia and nervousness

Uncommon (may affect up to 1 in 100 people):

• asthenia (weakness)
• 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 disturbances)
• sensation of relaxation
• nightmares
• dyspnea (breathing difficulties)

Rare (may affect up to 1 in 1,000 people):

• agitation (especially in the elderly)
• tremor
• seizures
• blood disorders such as hemolytic anemia, thrombocytopenia, leucopenia, or agranulocytosis (reduction in certain blood cells)

Not known (cannot be estimated from available data):

• general malaise
• hypersensitivity

Other adverse effects that have occurred with the use of antihistamines in general, although not observed with doxylamine, include the following: 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 disorders (movement disorders), paraesthesia (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 aged 65 years and older have an increased risk of experiencing adverse reactions, as they may have other medical conditions or may be taking other medications simultaneously. These individuals also have a higher 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.

Reporting of adverse effects:

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect 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 Dormidina Doxylamine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dormidina Doxylamine

• The active substance is doxylamine succinate. Each tablet contains 12.5 mg of doxylamine succinate.
• The other components are:

Tablet core excipients:

Calcium hydrogen phosphate dihydrate (E-341)
Microcrystalline cellulose (E-460)
Sodium carboxymethyl starch (type A) from potato
Colloidal anhydrous silica (E-551)
Magnesium stearate (E-572)

Coating excipients:

Microcrystalline cellulose (E-460)
Macrogol 40 stearate type I (E-431)
Propylene glycol (E-1520)
Hypromellose (E-464)
Titanium dioxide (E-171)
Carmoisine (E-124) (see section 2 "Dormidina doxylamine contains carmoisine")
Macrogol 400
Macrogol 6000

Appearance of the medicine and contents of the pack

Dormidina doxylamine is presented as pink, elongated, film-coated tablets, in packs containing 7 or 14 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Esteve Pharmaceuticals, S.A.
Passeig de la Zona Franca, 109
08038 Barcelona
Spain

Manufacturer

TOWA Pharmaceutical Europe, S.L.
Carrer de Sant Martí, 75-97
08107 Martorelles (Barcelona), Spain

Date of the most recent revision of this leaflet: September 2021

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