Package leaflet: Information for the patient

Doxylamina Polpharma, 25 mg, coated tablets
Doxylamini hydrogenosuccinas
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What Doxylamina Polpharma is and what it is used for
Important information before taking Doxylamina Polpharma
How to take Doxylamina Polpharma
Possible side effects
How to store Doxylamina Polpharma
Contents of the pack and other information

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

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

2. Important information before using Doxylamina Polpharma

When Doxylamina Polpharma must not be used

If the patient is allergic to doxylamine or any of the other ingredients of this medicine (listed in section 6).
If the patient is allergic to other antihistamines (antiallergic drugs).
If the patient has respiratory disorders such as asthma, chronic bronchitis (persistent cough associated with expectoration of mucus and phlegm), or pulmonary emphysema (difficulty breathing).
If the patient has glaucoma (increased pressure in the eye).
If the patient has benign prostatic hyperplasia (enlarged prostate gland), difficulty in urination due to urinary retention (urinary tract disorder), or experiences difficulty passing urine.
If the patient has gastrointestinal obstruction due to peptic ulcer or pyloroduodenal stenosis (difficulty in food passage from the stomach to the intestine).
If the patient has severe impairment of kidney or liver function.
If the patient is taking monoamine oxidase inhibitors (see section Doxylamina Polpharma and other medicines).
If the patient is taking certain medicines, e.g. antidepressants, certain antibiotics, cardiac medications such as those used to treat cardiac arrhythmias, certain antiviral and antifungal drugs, certain lipid-lowering agents, or quinidine (a drug used in the treatment of seizures) monoamine oxidase inhibitors (see section Doxylamina Polpharma and other medicines).
If the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Doxylamina Polpharma, consult a doctor or pharmacist if:

The patient has mild or moderate impairment of liver or kidney function, as this may require dose adjustment;
The patient has epilepsy (antihistamines may occasionally cause hyperexcitability and consequently lower the seizure threshold);
The patient has QT interval prolongation on ECG (a heart condition leading to sudden changes in heart rate in response to exertion or stress);
The patient has low blood potassium levels or other electrolyte imbalances;
The patient has urinary retention;
The patient has heart disease;
The patient is taking other medicines that may be harmful to the ear, such as carboplatin or cisplatin (drugs used in cancer treatment), chloroquine (a drug used to treat or prevent malaria), or certain antibiotics (used to treat infections) such as erythromycin or parenteral aminoglycosides; Doxylamina Polpharma may mask the harmful effects of these drugs. Therefore, regular ear examinations should be performed.

Patients over 65 years of age are more susceptible to adverse effects (see section 4).
If daytime drowsiness occurs, patients are advised to reduce the dose or take the dose earlier, ensuring at least an 8-hour interval between taking the medicine and waking up.
Doxylamina Polpharma may increase the risk of dehydration and heat stroke due to reduced sweating, especially during hot weather. Particular caution is advised in elderly patients.
Alcohol must not be consumed during treatment with this medicine (see section Doxylamina Polpharma with food, drink and alcohol).

Effect on laboratory tests
Doxylamina Polpharma may affect the results of allergic skin tests. Patients are advised to discontinue Doxylamina Polpharma at least 3 days before undergoing such tests.
Doxylamina Polpharma should not be used for longer than 7 days unless otherwise recommended by a physician.

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

Doxylamina Polpharma and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently taken, or planned to be taken.

Do not use Doxylamina Polpharma if the patient is taking the following medicines:

Monoamine oxidase inhibitors (e.g. drugs used to treat depression, Parkinson's disease or other conditions, such as moclobemide, phenelzine, tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline, and selegiline);
Medicines used to treat cardiac arrhythmias (amiodarone);
Certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin);
Certain lipid-lowering agents (gemfibrozil);
Certain antidepressants (such as fluoxetine, fluvoxamine, paroxetine, nefazodone, bupropion);
Antiviral protease inhibitors (indinavir, ritonavir, telaprevir);
Antifungal azole compounds (fluconazole, ketoconazole, itraconazole) and terbinafine;
Quinidine (an antiarrhythmic drug).

Avoid using Doxylamina Polpharma if the patient is taking any of the following medicines, as this may enhance their effects or lead to adverse reactions:

Adrenaline (used to treat low blood pressure);
Certain antimalarial drugs;
Certain antihistamines;
Certain diuretics (drugs that increase urine excretion);
Other medicines with central nervous system depressant effects, e.g. barbiturates, other hypnotics, sedatives, other medicines used for insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), opioid analgesics (codeine), psychotropic drugs (chlorpromazine, risperidone, amitriptyline, trazodone), or procarbazine (an anticancer drug);
Antihypertensive drugs (medicines used to treat high blood pressure) acting on the central nervous system, such as guanabenz, clonidine, or methyldopa;
Other anticholinergic drugs, such as antipsychotics (used to treat psychiatric disorders);
Medicines used to treat spastic conditions (e.g. atropine, belladonna alkaloids, scopolamine);
Disopyramide (an antiarrhythmic drug);
Topical antihistamines (diphenhydramine in cream, ointment, or aerosol form) and scopolamine;
Medicines with a narrow therapeutic index (i.e. small difference between therapeutic and toxic dose), such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin.

Doxylamina Polpharma with food, drink and alcohol
No special instructions regarding administration before or after meals are required.
Grapefruit juice should not be consumed during treatment with Doxylamina Polpharma.
Alcohol must not be consumed during treatment with Doxylamina Polpharma.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Doxylamina Polpharma must not be used during pregnancy unless otherwise advised by a physician.
Doxylamina Polpharma passes into breast milk. Due to the risk associated with the use of antihistamines in infants, Doxylamina Polpharma must not be used in breastfeeding women.
There are no available data on the effect of Doxylamina Polpharma on fertility.

Driving and operating machinery
Doxylamina Polpharma has a major influence on the ability to drive and operate machinery due to its sedative effect. During the first few days of treatment, until it is established how the medicine affects the patient, driving and operating machinery should be avoided.

Doxylamina Polpharma contains lactose and sodium
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Doxylamina Polpharma

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist.
Adults (aged 18 years and older)
The recommended dose is 1 tablet (25 mg) per day, taken 30 minutes before bedtime.
If daytime drowsiness occurs, it is recommended to reduce the dose to 12.5 mg (½ tablet) or to take the
dose earlier, ensuring at least an 8-hour interval 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, other medical conditions are more likely, which may require dose adjustment.
The recommended initial dose is 12.5 mg (½ tablet), taken 30 minutes before bedtime. The dose may be
increased to 25 mg (1 tablet) if the initial dose proves ineffective. If adverse effects occur, the dose should
be reduced to 12.5 mg (½ tablet) per day. Therefore, the effects of treatment should be carefully monitored
(see section 4).
Use in patients with liver and/or kidney impairment
In patients with mild impairment of liver and/or kidney function, the daily dose should be reduced 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.
The tablets should be swallowed 30 minutes before planned sleep, with an adequate amount of liquid
(e.g. a glass of water).
Doxylamina Polpharma may be taken with or after food.
The tablet may be divided into equal doses.
Duration of treatment
Treatment should be as short as possible. Treatment usually lasts from several days to one week.
Do not use the medicine for longer than 7 days unless otherwise directed by your doctor.
Taking more Doxylamina Polpharma than recommended
If you take more Doxylamina Polpharma than recommended, contact your doctor immediately.
Symptoms of overdose include: drowsiness, central nervous system depression or stimulation,
anticholinergic effects (dilated pupils, fever, dry mouth, reduced smooth muscle tone in the intestines),
hot flushes, increased or altered heart rate, elevated blood pressure, nausea, vomiting, restlessness,
ataxia, dizziness, irritability, sedation, disorientation, and hallucinations.
Severe poisoning may cause delirium, psychotic disturbances, hypotension, seizures, reduced respiratory
rate, loss of consciousness, coma, and may be life-threatening.
Severe complications include rhabdomyolysis (muscle breakdown), leading to kidney failure.
There is no specific antidote for antihistamine overdose. If necessary, symptomatic and supportive
treatment should be administered. The doctor will decide whether to induce vomiting, perform gastric
lavage, or prescribe medications to raise blood pressure.
Missed 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 Doxylamina Polpharma
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions caused by doxylamine are generally mild and transient, and occur more frequently
during the first few days of treatment.

Very common adverse reactions (occurring in more than 1 in 10 people):

drowsiness.

Common adverse reactions (occurring in less than 1 in 10 people):

blurred vision,
vertigo (dizziness of labyrinthine origin),
increased mucus secretion in the bronchi,
dry mouth, constipation,
urinary retention,
insomnia, restlessness,
dizziness, headache,
abdominal pain in the upper part of the abdomen,
fatigue.

Uncommon adverse reactions (occurring in less than 1 in 100 people):

double vision,
tinnitus (ringing in the ears),
orthostatic hypotension (low blood pressure caused by changes in body position),
nausea, vomiting, diarrhoea,
skin rash,
asthenia (feeling of weakness), peripheral oedema (swelling of hands and feet),
nightmares,
dyspnoea (shortness of breath),
dyspepsia,
feeling of relaxation.

Rare adverse reactions (occurring in less than 1 in 1000 people):

decreased number of red blood cells, white blood cells or platelets,
restlessness (especially in elderly people),
tremor, convulsions.

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

malaise (general feeling of discomfort).

Other adverse reactions usually associated with antihistamine medicines, which have not been observed with doxylamine, include: cardiac arrhythmias (changes in heart rate), palpitations, biliary reflux, liver function disorders (cholestatic jaundice), QT interval prolongation in ECG (heart disease), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), paresthesia (sensory disturbances), psychomotor disturbances (sensory or motor coordination), depression, decreased mucus secretion in the bronchi, alopecia, allergic dermatitis, excessive sweating, photosensitivity, hypotension (low blood pressure).
The intensity and frequency of adverse reactions can be controlled by reducing the daily dose.
Adults aged over 65 are more susceptible to adverse reactions, as they may suffer from other diseases or take other medicines concurrently. These individuals are also at higher risk of falls.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Doxylamina Polpharma

Keep this medicine out of sight and reach of children.
No special storage instructions are required for this medicine.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
The label on the packaging shows EXP followed by the expiry date, and Lot followed by the batch number.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such practices will help protect the environment.

6. Contents of the pack and other information

What Doxylamina Polpharma contains

The active substance is doxylamine hydrogen succinate. Each film-coated tablet contains 25 mg of doxylamine hydrogen succinate.
The other ingredients are: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethyl starch (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, film-coated tablet with a score line on one side, 7.5 mm in diameter.
The tablet can be divided into equal doses.
The medicine is available in aluminium/PVC/PCTFE blisters containing 7 or 14 film-coated tablets,
packaged in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01
Manufacturer
Laboratorios Alcalá Farma, S.L.
Avenida de Madrid, 82
28802 Alcalá de Henares (Madrid)
Spain