Doxidina 25 mg comprimidos recubiertos con pelicula

Label: information for the user

Doxidina 25 mg film-coated tablets

Hidrogenosuccinato de doxilamina

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

Follow exactly the administration instructions for the medicine contained in this label or those indicated by your doctor or pharmacist.

-Keep this label, as you may need to refer to 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 not listed in this label (see section 4).

-You should consult a doctor if your condition worsens or does not improve after 7 days.

5Storage of Doxidina.

6.Contents of the package and additional information.

Doxidina is a medication that contains the active ingredient doxilamine hydrogenosuccinate.

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

Patients with persistent sleep problems should consult their doctor.

They should consult a doctor if their condition worsens or does not improve after 7 days.

Do not take Doxidina

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6).
• If you are allergic to other antihistamines.
• If you are breastfeeding.
• If you suffer from respiratory problems such as asthma, chronic bronchitis (persistent cough accompanied by mucus and phlegm) or pulmonary emphysema (respiratory difficulties).
• If you have glaucoma (increased eye pressure).
• If the patient has benign prostatic hyperplasia (abnormal enlargement of the prostate), urinary tract problems, or difficulty urinating.
• If you have a stomach ulcer or initial section of the small intestine narrowing 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, for example, for the treatment of cardiac 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 Doxidina.

• 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 up.
• Alcohol consumption should be avoided during treatment.
• If you are over 65 years old, you may be more susceptible to experiencing side effects.
• Doxidina may exacerbate dehydration and heatstroke symptoms due to decreased sweating.
• If you have prolonged QT interval (cardiac rhythm disorder)
• Do not administer for more than 7 days without consulting a doctor. If symptoms persist, consult your doctor.

Taking Doxidina with other medications

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

• Epinephrine (for treating low blood pressure).
• Medications affecting the heart, such as those used to treat arrhythmias, some antibiotics, certain medications for malaria, certain antihistamines, certain medications used to reduce lipid levels (fats) in the blood, or certain neuroléptics (medications for mental disorders).
• Medications that decrease the elimination of others, such as azole derivatives or macrolides, which may increase the effect of Doxidina.
• Some diuretics (medications that increase urine elimination).
• Central nervous system inhibitors (e.g. barbiturates, hypnotics, sedatives, anxiolytics, opioid analgesics, antipsychotics, or procarbazine).
• Antihypertensive medications with central nervous system effects, such as guanabenz, clonidine, or alpha-methyldopa.
• Other anticholinergic medications, such as medications for depression or Parkinson's disease, monoamine oxidase inhibitors (medications for depression), neuroléptics (medications for mental disorders), atropinic medications for spasms, or disopyramide (for certain heart problems).
• If you are taking other medications that cause ototoxicity, such as carboplatin or cisplatin (medications for cancer), chloroquine (medication for malaria treatment or prevention), and some antibiotics (medications for infections) such as erythromycin or injected aminoglycosides; Doxidina may mask the toxic effects of these medications, so you should regularly check your ear status.

Interference with diagnostic tests

Doxilamine may interfere with skin allergy tests that use allergens. It is recommended to suspend Doxidina treatment at least three days before starting these tests.

Taking Doxidina with food, drink, and alcohol

Alcoholic beverages should not be consumed during Doxidina treatment.

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.

Due to the placental transfer of doxilamine, as a precaution, it is recommended to avoid the use of Doxilamine during pregnancy, unless the potential benefits of treating the mother outweigh the possible risks to the fetus.

Due to the excretion of succinate doxilamine in breast milk and the risk of antihistamine use in young children, Doxidina should not be used during breastfeeding.

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

Driving and operating machinery

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

Doxidina contains sodium

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

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

Adults (18 years and older)

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 the medication earlier to ensure at least 8 hours pass before waking up.

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

Use in patients 65 years and older

Patients 65 years and older are more prone to other conditions 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 for insomnia elimination. In case of undesirable 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

Doxidina is not recommended for use in patients under 18 years, so the 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).

Doxidina can be taken before or after meals.

The groove is only for breaking and facilitating swallowing.

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.

Do not administer for a period exceeding 7 days without consulting the doctor.

If you take more Doxidina 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), redness, increased or altered heart rate, increased blood pressure, nausea, vomiting, agitation, altered gait, dizziness, irritability, sedation, confusion, and hallucinations. Delirium, psychosis, decreased blood pressure, seizures, decreased respiration, loss of consciousness, coma, and death can occur. A serious complication can be rhabdomyolysis (muscle injury), followed by renal 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.

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 Doxidina

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

If you interrupt treatment with Doxidina

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

Like all medications, Doxidina may produce adverse effects, although not all people will experience them.

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

Frequent Adverse Effects (may affect up to 1 in 10 people):drowsiness and effects such as dry mouth, constipation, blurred vision, urinary retention, increased bronchial secretion, dizziness, vertigo, headache, upper abdominal pain, fatigue, insomnia, and nervousness.

Less Frequent Adverse 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 changes in posture), diplopia (double vision), dyspepsia (stomach disorders), feeling of relaxation, nightmares, and dyspnea (respiratory difficulties).

Rare Adverse Effects (may affect up to 1 in 1,000 people):agitation (especially in children and people over 65 years old), tremor, seizures, or blood-related problems such as hemolytic anemia, thrombocytopenia, leucopenia, or agranulocytosis (decrease in certain blood cells).

Adverse Effects of Unknown Frequency (cannot be estimated from available data): general malaise.

Reporting Suspected Adverse Reactions

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

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Conserve the medication in its original packaging.

Content of Doxidina 25 mg

Each tablet contains 25 mg of doxilamine hydrochloride.

The other components are:

Core excipients:

Manitol

Microcrystalline cellulose

Sodium starch glycolate (type A)

Anhydrous colloidal silica

Magnesium stearate

Coating excipients:

Hypromellose

Titanium dioxide (E-171)

Macrogol 400

Indigotin (E-132)

Appearance of the product and content of the packaging

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

Only some packaging sizes may be commercially available.

Marketing authorization holder

Teva B.V.

Swensweg, 5

2031GA Haarlem, Netherlands

Responsible for manufacturing

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

Last review date of this leaflet: October 2022

The detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es/