DOXIDINA 25 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Doxidine 25 mg film-coated tablets

Doxylamine hydrogen succinate

Read this leaflet carefully before starting to take this medicine, as it contains important information for you.

Follow the administration instructions of the medicine contained in this leaflet or as indicated 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4).
• You should consult a doctor if it worsens or does not improve after 7 days.

Contents of the leaflet

1. What Doxidine is and what it is used for.
2. What you need to know before taking Doxidine.
3. How to take Doxidine.
4. Possible side effects.

5 Conservation of Doxidine.

1. Package contents and additional information.

1. What Doxidine is and what it is used for

Doxidine is a medicine that contains the active ingredient doxylamine hydrogen succinate.

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

Patient with persistent sleep problems should consult their doctor.

You should consult a doctor if it worsens or does not improve after 7 days.

2. What you need to know before taking Doxidine

Do not take Doxidine

• 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 coughing with phlegm and mucus) or pulmonary emphysema (breathing difficulties).
• If you have glaucoma (increased eye pressure).
• If the patient has prostatic hyperplasia (abnormal increase in the size of the prostate), which prevents urine from leaving the bladder (urinary tract disease) or has difficulty urinating.
• If you have stomach or duodenal ulcers or duodenal stenosis (difficulty passing food from the stomach to the intestines).
• If you are taking monoamine oxidase inhibitors.
• If you are taking certain medications, such as antidepressants, antibiotics, heart medications, e.g. for the treatment of heart rhythm disorders, antivirals, antifungals, some medications that affect the reduction of lipid levels (fats) 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 Doxidine.

• If you have epilepsy
• 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.
• Alcohol consumption should be avoided during treatment.
• If you are over 65 years old, you may be more susceptible to experiencing side effects.
• Doxidine may worsen dehydration and heat stroke symptoms due to decreased sweating.
• If you have a prolonged QT interval (heart rhythm disorder)
• It should not be administered for a period exceeding 7 days without consulting a doctor. If symptoms persist, consult your doctor.

Taking Doxidine with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. In particular, inform your doctor if you are taking:

• Epinephrine (for low blood pressure).
• Medications that act on the heart, such as those used to treat arrhythmias, some antibiotics, certain antimalarial medications, certain antihistamines, certain medications used to reduce lipids (fats) in the blood, or certain neuroleptic agents (medications for treating mental disorders).
• Medications that decrease the elimination of others, such as azole derivatives or macrolides, as they may increase the effect of Doxidine.
• Any diuretic (medications that increase urine elimination).
• Central nervous system depressants (e.g., barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).
• Antihypertensives (medications for high blood pressure) with an effect on the central nervous system, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic medications, such as medications for treating depression or Parkinson's disease, monoamine oxidase inhibitors (medications for depression), neuroleptics (medications for treating mental disorders), antispasmodic medications, or disopyramide (for treating certain heart problems).
• If you are taking other medications that produce ear toxicity, such as carboplatin or cisplatin (medications for treating cancer), chloroquine (medication for treating or preventing malaria), and some antibiotics (medications for treating infections) such as erythromycin or injectable aminoglycosides, among others; Doxidine may mask the toxic effects of these medications, so you should periodically review the condition of your ears.

Interference with diagnostic tests

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

Taking Doxidine with food, drink, and alcohol

Alcoholic beverages should not be consumed during treatment with Doxidine.

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 taking this medication.

Because doxylamine crosses the placenta, as a precaution, it is preferable to avoid the use of Doxylamine during pregnancy, unless the potential benefit of treating the mother outweighs the possible risks to the developing fetus.

Because of the excretion of doxylamine succinate in breast milk and the risk of using antihistamines in young children, Doxidine should not be used during breastfeeding.

No data are available on the possible effects of Doxidine on fertility.

Driving and using machines

The influence of Doxidine on the ability to drive and use machines is significant. Do not drive or use hazardous machinery while taking this medication, at least during the first days of treatment, until you know how it affects you.

Doxidine contains sodium

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

3. How to take Doxidine

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

Adults (over 18 years old)

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

If daytime drowsiness occurs, it is recommended to reduce the dose from 25 to 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 patients over 65 years old

People over 65 years old are more likely to suffer from other pathologies that may recommend 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 can be increased to 25 mg (1 tablet) if the 12.5 mg dose is ineffective in eliminating insomnia. In case of unwanted side effects, it is recommended to reduce the dose to 12.5 mg per day.

Use in patients with liver or kidney disease

These patients should take a different dose, adjusted to the degree of their disease, which will be determined by the doctor.

Use in children and adolescents

Doxidine is not recommended for use in children under 18 years old, so this medication should not be used in this population.

Route and method of administration

Oral route.

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

Doxidine can be taken before or after meals.

The score line is only for breaking and facilitating swallowing.

Duration of treatment

The duration of treatment should be as short as possible. In general, the duration of treatment can range from a few days to a week.

It should not be administered for a period exceeding 7 days without consulting a doctor.

If you take more Doxidine than you should

The symptoms of an overdose include: 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. Delirium, psychosis, decreased blood pressure, seizures, decreased respiration, loss of consciousness, coma, and death may occur. 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 stomach lavage, or prescribe medications to increase blood pressure if necessary.

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 medication and the amount ingested.

If you forget to take Doxidine

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 Doxidine

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

4. Possible side effects

Like all medications, Doxidine can cause side effects, although not everyone will experience them.

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

Common side effects (may affect up to 1 in 10 people):drowsiness and effects 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 (decreased blood pressure due to postural 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 children and people over 65 years old), tremors, seizures, 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.

Reporting suspected adverse reactions

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines (www.notificaram.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Doxidine

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the box or blister after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Keep the medication in its original packaging.

6. Package contents and information

Doxidine 25 mg content

Each tablet contains 25 mg of doxylamine hydrogen succinate.

The other components are:

Core excipients:

Mannitol

Microcrystalline cellulose

Sodium starch glycolate (type A)

Anhydrous colloidal silica

Magnesium stearate

Coating excipients:

Hypromellose

Titanium dioxide (E-171)

Macrogol 400

Indigotine (E-132)

Appearance of the product and package contents

Doxidine is presented in oval, biconvex, film-coated tablets, scored and blue in color, in aluminum blisters containing 7, 10, 14, or 20 tablets.

Only some package sizes may be marketed.

Marketing authorization holder

Teva B.V.

Swensweg, 5

2031GA Haarlem, 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 1ªplanta

28108 Alcobendas, Madrid

Spain

Date of the last revision of this leaflet: October 2022

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