Doxilamina Polpharma

Leaflet attached to the packaging: patient information

Doxylamina Polpharma, 25 mg, coated tablets

Doxylamine hydrogen succinate

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Doxylamina Polpharma and what is it used for
• 2. Important information before taking Doxylamina Polpharma
• 3. How to take Doxylamina Polpharma
• 4. Possible side effects
• 5. How to store Doxylamina Polpharma
• 6. Contents of the pack and other information

1. What is Doxylamina Polpharma and what is it used for

Doxylamina Polpharma is a medicine that contains the active substance doxylamine succinate.
Doxylamine belongs to a group of antihistamine medicines with sedative and calming effects.
The medicine is indicated for short-term, symptomatic treatment of occasional insomnia
in adults, aged 18 years and older.

2. Important information before taking Doxylamina Polpharma

When not to take Doxylamina Polpharma

• -If you are allergic to doxylamine or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic to other antihistamine medicines (anti-allergic medicines).
• If you have respiratory disorders such as asthma, chronic bronchitis (persistent cough, accompanied by expectoration of mucus and sputum) or pulmonary emphysema (difficulty breathing).
• If you have glaucoma (increased eye pressure).
• If you have prostate enlargement (excessive prostate growth), difficulty urinating from the bladder (urinary tract disease) or have trouble urinating.
• If you have narrowing of the gastrointestinal tract due to stomach ulcers or pyloric stenosis (difficulty passing food from the stomach to the intestine).
• If you have severe kidney or liver dysfunction.
• If you are taking monoamine oxidase inhibitors (see section Doxylamina Polpharma and other medicines).
• If you are taking certain medicines, such as antidepressants, certain antibiotics, heart medicines, such as those used to treat arrhythmias, certain antiviral and antifungal medicines, certain medicines that affect lipid levels in the blood, or quinidine (a medicine used to treat arrhythmias) monoamine oxidase inhibitors (see section Doxylamina Polpharma and other medicines).
• If you are breastfeeding.

Warnings and precautions

Before starting treatment with Doxylamina Polpharma, discuss it with your doctor or pharmacist
in case of:

• liver or kidney dysfunction of mild or moderate severity, as this may require dose adjustment;
• epilepsy (antihistamine medicines may sometimes cause overexcitement, and as a result, lower the seizure threshold);
• prolonged QT interval on the ECG (heart disease leading to sudden changes in heart rate in response to exertion or stress);
• low potassium levels in the blood or other electrolyte disturbances;
• urinary retention;
• heart disease;
• taking other medicines that may be harmful to the ear, such as carboplatin or cisplatin (medicines used to treat cancer), chloroquine (a medicine used to treat or prevent malaria) and certain antibiotics (used to treat infections) such as erythromycin or aminoglycosides in injection form, Doxylamina Polpharma may mask the harmful effects of these medicines. Therefore, regular ear exams should be performed.

Patient over 65 years of age are more likely to experience side effects (see
section 4).
In case of drowsiness during the day, the patient is advised to reduce the dose or take the dose earlier
to ensure at least 8 hours between taking the medicine and waking up.
Doxylamina Polpharma may exacerbate dehydration and heat stroke symptoms caused by reduced sweating, especially during heatwaves. Caution should be exercised, especially in elderly patients.
Do not drink alcohol while taking Doxylamina Polpharma.

Effect on laboratory tests

Doxylamina Polpharma may affect the results of allergic skin tests. Patients are advised to stop taking Doxylamina Polpharma at least 3 days before undergoing such tests.

Children and adolescents

Doxylamina Polpharma is not indicated for use in children and adolescents under 18 years of age.

Doxylamina Polpharma and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.
Do nottake Doxylamina Polpharma if you are taking the following medicines:

• monoamine oxidase inhibitors (e.g. medicines used to treat depression, Parkinson's disease or other conditions, such as moclobemide, phenelzine and tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline and selegiline);
• medicines used to treat arrhythmias (amiodarone);
• certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin);
• certain medicines that affect lipid levels in the blood (gemfibrozil);
• certain medicines used to treat depression (such as fluoxetine, fluvoxamine, paroxetine, nefazodone, bupropion);
• protease inhibitors (indinavir, ritonavir, telaprevir);
• antifungal agents of the azole group (fluconazole, ketoconazole, itraconazole) and terbinafine;
• quinidine (an anti-arrhythmic medicine).

It is recommended to avoid taking Doxylamina Polpharma if you are taking the following medicines, as it may enhance their effects or cause side effects:

• adrenaline (used to treat low blood pressure);
• certain medicines used to treat malaria;
• certain antihistamine medicines;
• certain diuretic medicines (medicines that increase urine production);
• other medicines that have a sedative effect on the central nervous system, such as barbiturates, other sedatives, anxiolytics, or medicines used to treat insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), opioid analgesics (codeine), psychotropic medicines (chlorpromazine, risperidone, amitriptyline, trazodone) or procarbazine (an anticancer medicine);
• antihypertensive medicines that act on the central nervous system, such as guanabenz, clonidine or alpha-methyldopa;
• other medicines from the cholinolytic group, such as antipsychotic medicines (used to treat mental disorders);
• medicines used to treat spastic conditions (e.g. atropine, belladonna alkaloids, scopolamine);
• disopyramide (an anti-arrhythmic medicine);
• antihistamine medicines used on the skin (diphenhydramine in cream, ointment, or spray form) and scopolamine;
• medicines where there is a small difference between the therapeutic dose and the toxic dose (e.g. phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin).

Doxylamina Polpharma with food, drink, and alcohol

There are no special recommendations for taking this medicine before or after a meal.
It is not recommended to drink grapefruit juice while taking Doxylamina Polpharma.
Do not drink alcohol while taking Doxylamina Polpharma.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Doxylamina Polpharma should not be used during pregnancy, unless your doctor advises otherwise.
Doxylamina Polpharma passes into breast milk. Due to the risk associated with the use of antihistamine medicines in small children, Doxylamina Polpharma should not be used during breastfeeding.
There is no available data on the effect of Doxylamina Polpharma on fertility.

Driving and using machines

Doxylamina Polpharma has a significant impact on the ability to drive and operate machinery, as it causes drowsiness. During the first few days of treatment, until it is determined how the medicine affects you, do not drive or operate machinery.

Doxylamina Polpharma contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Doxylamina Polpharma

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist.

Adults (aged 18 years and over)

The recommended dose is 1 tablet (25 mg) per day, taken 30 minutes before bedtime.
In case of drowsiness during the day, it is recommended to reduce the dose to 12.5 mg (½ tablet) or take the dose earlier to ensure at least 8 hours between taking the medicine and waking up.
Do not take more than 1 tablet (25 mg) per day.

Use in elderly patients

In patients over 65 years of age, it is more likely that other diseases may occur that require dose reduction. The recommended initial dose is 12.5 mg (½ tablet), taken 30 minutes before bedtime. The dose can be increased to 25 mg (1 tablet) if the initial dose proves ineffective. If side effects occur, the dose should be reduced to 12.5 mg (½ tablet) per day. Therefore, attention should be paid to the effects of treatment (see section 4).

Use in patients with liver and/or kidney disorders

In patients with mild liver and/or kidney disorders, it is recommended to reduce the daily dose to 12.5 mg.

Use in children and adolescents

Doxylamina Polpharma is not indicated for use in children and adolescents under 18 years of age and should not be used in this patient group.

Route and method of administration

Oral administration.
Tablets should be swallowed 30 minutes before planned sleep, with a sufficient amount of liquid (e.g. a glass of water).
Doxylamina Polpharma can be taken with or after food .
The tablet can be divided into equal doses.

Duration of treatment

Treatment should be as short as possible. Treatment usually lasts from a few days to one week.
The medicine should not be used for more than 7 days, unless your doctor advises longer use.

Taking a higher dose of Doxylamina Polpharma than recommended

If you have taken more than the recommended dose of Doxylamina Polpharma, contact your doctor immediately.
Symptoms of overdose are: drowsiness, central nervous system depression or stimulation, anticholinergic effects (dilated pupils, fever, dry mouth, decreased smooth muscle tone in the intestines), heat strokes, increased or changed heart rate, elevated blood pressure, nausea, vomiting, stimulation, unsteady gait, dizziness, irritation, sedation, disorientation, and hallucinations.
Severe poisoning can cause delirium, psychotic disorders, decreased blood pressure, seizures, decreased respiratory rate, loss of consciousness, coma, and can be life-threatening.
A serious complication is rhabdomyolysis (muscle breakdown), followed by kidney failure.
There is no specific antidote in case of overdose of antihistamine medicines. If necessary, symptomatic and supportive treatment should be applied. The doctor will decide whether to induce vomiting, perform gastric lavage, or prescribe medicines to increase blood pressure.

Missing a dose of Doxylamina Polpharma

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

Stopping treatment with Doxylamina Polpharma

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects caused by doxylamine are usually mild and transient and occur more frequently during the first few days of treatment.
Very common side effects (more than 1 in 10 people):

• drowsiness.

Common side effects (less than 1 in 10 people):

• blurred vision,
• vertigo of labyrinthine origin,
• increased mucus production in the bronchi,
• dry mouth, constipation,
• urinary retention,
• insomnia, stimulation,
• vertigo, headache,
• upper abdominal pain,
• fatigue.

Uncommon side effects (less than 1 in 100 people):

• double vision,
• tinnitus (ringing in the ears),
• orthostatic hypotension (decreased blood pressure caused by changes in body position),
• nausea, vomiting, diarrhea,
• skin rash,
• weakness (feeling of fatigue), peripheral edema (hands and feet),
• nightmares,
• shortness of breath (shortness of breath),
• indigestion,
• feeling of relaxation.

Rare side effects (less than 1 in 1000 people):

• decreased red blood cell count, white blood cell count, or platelet count,
• stimulation (especially in elderly patients),
• tremors, seizures.

Frequency not known (frequency cannot be estimated from the available data):

• general malaise.

Other side effects that are usually caused by antihistamine medicines, which have not been observed with doxylamine, are: arrhythmias (changes in heart rate), palpitations, bile reflux, liver dysfunction (cholestatic jaundice), prolonged QT interval on the ECG (heart disease), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), paresthesia (sensory disturbances), psychomotor disorders (sensory or motor coordination), depression, decreased mucus production in the bronchi, hair loss, allergic skin inflammation, excessive sweating, hypersensitivity to light, hypotension (low blood pressure).
The intensity and frequency of side effects can be controlled by reducing the daily dose.
Adults over 65 years of age are more likely to experience side effects, as they may have other diseases or be taking other medicines. These patients are also more likely to fall.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Doxylamina Polpharma

Keep the medicine out of the sight and reach of children.
There are no special recommendations for storing the medicine.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP means the expiry date, and after the abbreviation Lot means the batch number.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Doxylamina Polpharma contains

• The active substance of the medicine is doxylamine succinate. Each tablet contains 25 mg of doxylamine succinate.
• The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethylcellulose (type A), colloidal anhydrous silica, magnesium stearate, hypromellose (15 mPa s), titanium dioxide (E 171), lactose monohydrate, macrogol 4000.

What Doxylamina Polpharma looks like and contents of the pack

White, round, coated tablet with a dividing line on one side, with a diameter of 7.5 mm.
The tablet can be divided into equal doses.
The medicine is available in Aluminium/PVC/PCTFE blisters containing 7 or 14 coated tablets,
in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Polpharma S.A.
Pelplińska 19, 83-200 Starogard Gdański
Phone: +48 22 364 61 01

Manufacturer

Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)
Spain

Date of last revision of the leaflet: