Doxidina 25 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Doxidina 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 instructions for use 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse 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.

Contents of this leaflet

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

1. What Doxidina is and what it is used for

Doxidina is a medicine containing the active substance doxylamine hydrogen succinate.

Doxidina is indicated for the symptomatic treatment of occasional insomnia in adults over 18 years of age.

Patients with persistent sleep problems should consult their doctor.

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

2. What you need to know before starting to take Doxidina

Do not take Doxidina

• 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.
• If you are breastfeeding.
• If you have respiratory problems such as asthma, chronic bronchitis (persistent cough, accompanied by cough with phlegm and mucus), or pulmonary emphysema (breathing difficulties).
• If you have glaucoma (increased eye pressure).
• If the patient has prostatic hyperplasia (abnormal enlargement of the prostate), which obstructs the outflow of urine from the bladder (urinary tract disorder), or has difficulty urinating.
• If you have a stomach ulcer or duodenal ulcer, or duodenal stenosis (difficulty passing food from the stomach into the intestines).
• If you are taking monoamine oxidase inhibitors.
• If you are taking certain medications, such as antidepressants, antibiotics, cardiac medications, e.g., for the treatment of cardiac rhythm disorders, antifungal antivirals, some medications affecting the reduction of lipid (fat) levels in the blood, or quinidine (a medication used to treat seizures).
• If you have severe kidney or liver disease.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Doxidina.

• If you have epilepsy
• If you experience daytime drowsiness, it may be necessary to reduce the dose or take it earlier to ensure at least 8 hours pass before waking time.
• Consumption of alcoholic beverages should be avoided during treatment.
• If you are over 65 years of age, you may be more susceptible to experiencing side effects.
• Doxidina may worsen symptoms of dehydration and heat stroke due to decreased sweating.
• If you have QT interval prolongation (a heart rhythm disorder)
• It should not be administered for longer than 7 days without consulting a doctor. If symptoms persist, consult your doctor.

Taking Doxidina with other medicines

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

• Epinephrine (to treat low blood pressure).
• Medicines that affect the heart, such as those used to treat arrhythmias, certain antibiotics, certain antimalarial drugs, certain antihistamines, certain medicines used to lower lipids (fats) in the blood, or certain neuroleptic agents (medicines used to treat mental disorders).
• Medicines that reduce the elimination of other drugs, such as azole derivatives or macrolides, as they may increase the effect of Doxidina.
• Any diuretics (medicines that increase urine elimination).
• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid-type analgesics, antipsychotics, or procarbazine).
• Antihypertensives (medicines to treat high blood pressure) with central nervous system effects, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic drugs, such as medicines used to treat depression or Parkinson's disease, monoamine oxidase inhibitors (medicines for depression), neuroleptics (medicines for mental disorders), antispasmodic atropine-like drugs, or disopyramide (used to treat certain heart problems).
• Any other medicines that may cause ear toxicity, such as carboplatin or cisplatin (medicines used to treat cancer), chloroquine (a medicine used to treat or prevent malaria), and certain antibiotics (medicines used to treat infections) such as erythromycin or injected aminoglycosides, among others; Doxidina may mask the toxic effects of these medicines, so you should have your hearing checked regularly.

Interference with diagnostic tests

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

Taking Doxidina with food, drink, and alcohol

Alcoholic beverages should not be consumed during treatment with Doxidina.

Pregnancy, lactation 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 taking this medicine.

Since doxylamine crosses the placenta, as a precautionary measure, it is preferable to avoid the use of doxylamine during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus.

Due to the excretion of doxylamine succinate in breast milk and the risk associated with the use of antihistamines in young children, Doxidina should not be used during breastfeeding.

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

Driving and operating machinery

The effect of Doxidina on the ability to drive and operate machinery is important. 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.

Doxidina contains sodium

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

3. How to take Doxidina

Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Adults (over 18 years of age)

The recommended dose is 1 tablet (25 mg) per day.

If daytime drowsiness occurs, it is recommended to reduce the dose from 25 mg to 12.5 mg per day or to take the dose earlier to ensure at least 8 hours elapse before waking time.

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

Use in patients over 65 years of age

Elderly patients over 65 years of age are more likely to have comorbid conditions that may require a dose reduction (see section 4.4). It is recommended to start with a dose of 12.5 mg (1 tablet of 12.5 mg), administered 30 minutes before bedtime. The dose may be increased to 25 mg (1 tablet) if the 12.5 mg dose is ineffective in relieving insomnia. If undesirable adverse effects occur, dose reduction to 12.5 mg daily is recommended.

Use in patients with liver or kidney disease

These patients should take a different dose, adjusted according to the severity of their condition, as determined by the physician.

Use in children and adolescents

Doxidina is not recommended for use in individuals under 18 years of age; therefore, the medication 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).

Doxidina may be taken before or after meals.

The score line is intended solely for ease of splitting and to facilitate swallowing.

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 one week.

It should not be administered for longer than 7 days without consulting a doctor.

If you take more Doxidina than you should

Symptoms of poisoning include: drowsiness, central nervous system depression or stimulation, 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. Delirium, psychosis, decreased blood pressure, seizures, reduced respiration, loss of consciousness, coma, and death may occur. A serious complication may be rhabdomyolysis (muscle injury), followed by renal 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 needed.

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 medication and the amount ingested.

If you forget to take Doxidina

Do not take a double dose to make up for missed doses. Take your dose at the usual time the next day.

If treatment with Doxidina is interrupted

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

4. Possible adverse effects

Like all medicines, Doxidina may cause adverse effects, although not everyone experiences them.

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

Frequent adverse effects (may affect up to 1 in 10 people): somnolence and effects such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, vertigo, dizziness, 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 (drop in blood pressure due to postural change), diplopia (double vision), dyspepsia (indigestion), feeling of relaxation, nightmares, and dyspnea (breathing difficulties).

Rare adverse effects (may affect up to 1 in 1,000 people): agitation (especially in children and in individuals over 65 years of age), 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.

Reporting of suspected adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if these adverse reactions are not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products (www.notificaram.es). By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Doxidina

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

Do not use this medicine after the expiry date which is stated on the carton or blister 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 unused medicines and their containers at the SIGRE Point located 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.

Store the medicine in its original packaging.

6. Contents of the container and information

Doxidina 25 mg Composition

Each tablet contains 25 mg of doxylamine hydrogen succinate.

Other components are:

Core excipients:

Manitol
Microcrystalline cellulose
Sodium starch glycolate (type A)
Colloidal anhydrous silica
Magnesium stearate

Coating excipients:

Hypromellose
Titanium dioxide (E-171)
Macrogol 400
Indigotine (E-132)

Appearance of the product and contents of the container

Doxidina is presented as oval, biconvex, film-coated, blue tablets, with a score line, contained in aluminum blisters with 7, 10, 14 or 20 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Teva B.V.

Swensweg, 5

2031GA Haarlem, The Netherlands

Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna, 66-68-70. Pol. Industrial Urtinsa II

28923 Alcorcón, Madrid

Spain

Local Representative

Teva Pharma S.L.U.

C/Anabel Segura 11,

Edificio Albatros B 1st floor

28108 Alcobendas, Madrid

Spain

Date of the most recent review of this leaflet: October 2022

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