Doxylamine Esteve 12.5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Doxilamina Esteve 12.5 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 instructions for taking this medicine provided in this leaflet or those given to you 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 side effects, talk to your doctor or pharmacist, including any side 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 this leaflet:

1. What Doxilamina Esteve is and what it is used for

2. What you need to know before taking Doxilamina Esteve

3. How to take Doxilamina Esteve

4. Possible side effects

5. How to store Doxilamina Esteve

6. Contents of the pack and other information

1. What Doxilamina Esteve is and what it is used for

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

It 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 Doxilamina Esteve

Do not take Doxilamina Esteve

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other antihistamines (antiallergy drugs).
• 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 prostate hypertrophy (abnormal enlargement of the prostate), vesical neck obstruction (urinary tract disorder), or difficulty urinating.
• If you have gastric or duodenal erosion 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, drugs affecting the heart (such as those used to treat arrhythmias), certain antivirals, drugs used to treat fungal infections, some lipid-lowering (fat-reducing) drugs, 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 starting to take Doxilamina Esteve.

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 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 cause ear toxicity, such as carboplatin or cisplatin (cancer treatments), chloroquine (used to treat or prevent malaria), or certain antibiotics (e.g., erythromycin or injected aminoglycosides), Doxilamina Esteve may mask the toxic effects of these drugs; therefore, periodic ear examinations are recommended.

• Doxilamina Esteve may worsen symptoms of dehydration and heat stroke due to reduced 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. 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, and vancomycin should be avoided, as it may lead to acute intoxication.

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

Children and adolescents

The administration of Doxilamina Esteve is not recommended in individuals under 18 years of age.

Taking Doxilamina Esteve 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 Doxilamina Esteve 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, tranilcypramine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline, and selegiline).
• Medicines with action on the heart such as those used to treat arrhythmias (amiodarone), certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin), certain lipid-lowering (fat-reducing) drugs (gemfibrozil), some antidepressants (fluoxetine, fluvoxamine, paroxetine, or bupropion), protease inhibitor antivirals (indinavir, ritonavir, telaprevir), and azole antifungals (fluconazole, ketoconazole, itraconazole).

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

• Epinephrine (used to treat low blood pressure).
• Certain antimalarial drugs 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 (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 (i.e., small difference between therapeutic and toxic dose), 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 Doxilamina Esteve at least three days before undergoing such tests.

Taking Doxilamina Esteve with food, drink, and alcohol

Alcoholic beverages must not be consumed during treatment with Doxilamina Esteve.

See section 3. How to take Doxilamina Esteve.

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 insufficient data on the use of doxylamine in pregnant women; therefore, taking Doxilamina Esteve during pregnancy should be avoided.

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

There are no data available on the potential effects of Doxilamina Esteve on human fertility.

Driving and use of machines

The effect of Doxilamina Esteve on the ability to drive and operate machinery is significant because it causes 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.

Doxilamina Esteve contains carmine (cochineal red A).

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

Doxilamina Esteve contains sodium

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

3. How to take Doxilamina Esteve

Follow exactly the dosing instructions 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 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 to take the dose 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

Individuals 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 going to bed. The dose may be increased to 25 mg (2 tablets) if the initial dose does not sufficiently relieve insomnia. If unwanted adverse effects occur, the dose should be reduced to 1 tablet (12.5 mg) daily. For this reason, pay close attention to how the treatment affects you (see section 4).

Use in patients with liver or kidney disease

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

Use in children and adolescents

Doxilamina Esteve 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 going to bed with a sufficient amount of liquid (preferably water).

Doxilamina Esteve 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 to one week.

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

If you take more Doxilamina Esteve than you should

If you take more Doxilamina Esteve than prescribed, 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, increased blood pressure, nausea, vomiting, agitation, impaired gait, dizziness, irritability, sedation, confusion, and hallucinations.

Severe intoxication may lead to delirium, psychosis, decreased blood pressure, seizures, respiratory depression, loss of consciousness, coma, and may be life-threatening.

A serious complication may be rhabdomyolysis (muscle injury), 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 required.

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

If you forget to take Doxilamina Esteve

Do not take a double dose to make up for a missed dose.

Take your next dose at the usual time the following day.

If you stop treatment with Doxilamina Esteve

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 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), 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 postural changes), 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 hemolytic anemia, 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 (changes in 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 activities (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 are at greater 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 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 via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Doxilamina Esteve

Keep this medicine out of sight and reach of children.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Doxilamina Esteve

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

Excipients of the core:

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)

Excipients of the coating:

Microcrystalline cellulose (E-460)
Macrogol stearyl ether type I (E-431)
Propylene glycol (E-1520)
Hypromellose (E-464)
Titanium dioxide (E-171)
Carmoisine A (E-124)
Macrogol 400
Macrogol 6000

Appearance of the product and contents of the pack

Doxilamina Esteve is presented as elongated pink 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

Manufacturer

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

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Finland: Dormix
Norway: Zonat
Sweden: Zovin

Date of the most recent review of this leaflet: December 2020.

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/