Doxilamine Biofarm

Package Leaflet: Information for the User

Doxylamine Biofarm

25 mg, coated tablets

Doxylamine hydrogen succinate

Read the package 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 inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Doxylamine Biofarm and what is it used for

The active substance in Doxylamine Biofarm is doxylamine, which belongs to the group of antihistamine medicines. These medicines are characterized by a sedative effect, which means they are effective as aids to sleep.

Indications:

Doxylamine Biofarm is indicated for short-term, symptomatic treatment of occasional insomnia in adults, especially when there are difficulties falling asleep, frequent nocturnal awakenings, or early morning awakenings.

2. Important information before taking Doxylamine Biofarm

When not to take Doxylamine Biofarm

• if you are allergic to doxylamine succinate or any of the other ingredients of this medicine (listed in section 6);
• if you are allergic to other antihistamine medicines (anti-allergic);
• if insomnia lasts longer than 3 weeks before starting treatment with this medicine;
• if you have a respiratory disease, such as asthma, chronic bronchitis (persistent cough producing thick mucus and phlegm) or chronic obstructive pulmonary disease (inflammation of the air sacs in the lungs causing breathing difficulties);
• if you have glaucoma (increased pressure in the eye);
• if you have prostate enlargement (abnormal enlargement of the prostate), urethral stricture (a condition affecting the urinary system) or difficulty urinating;
• if you have a stomach ulcer (damage to the stomach lining) or pyloric stenosis (difficulty moving food from the stomach to the intestine);
• if you have severe kidney or liver disease;
• if you are taking certain medicines, such as antidepressants (e.g., fluoxetine, fluvoxamine, paroxetine), antibiotics (e.g., clarithromycin, erythromycin, telithromycin), antiviral medicines (e.g., indinavir, ritonavir, telaprevir), antifungal medicines (e.g., fluconazole, ketoconazole, itraconazole, voriconazole), anti-arrhythmic medicines (e.g., amiodarone), or calcium channel blockers (medicines used to treat high blood pressure and heart rhythm disorders), certain medicines that lower blood lipid levels (e.g., gemfibrozil), terbinafine, quinidine, nefazodone, bupropion; if you are taking monoamine oxidase inhibitors (medicines used to treat depression and Parkinson's disease) and for up to 2 weeks after stopping them;
• in pregnancy and breastfeeding.

Warnings and precautions

Before taking Doxylamine Biofarm, discuss with your doctor or pharmacist:

• if you experience daytime sleepiness - it is recommended to reduce the dose or ensure at least an 8-hour interval between taking the medicine and planned wake-up time (see section 3. How to take Doxylamine Biofarm);
• do not drink alcohol while taking Doxylamine Biofarm - see below "Doxylamine Biofarm with food, drink, and alcohol";
• in hot weather, this medicine may increase the risk of dehydration and heat stroke;
• if you have epilepsy (antihistamines may sometimes cause overexcitement and thus lower the seizure threshold);
• if you are over 65 years old, as you may be more prone to side effects;
• if you are taking other medicines that are toxic to the ear, such as carboplatin or cisplatin (used to treat cancer), chloroquine (for malaria treatment or prevention), or certain antibiotics (e.g., erythromycin or aminoglycosides given by injection). Doxylamine Biofarm may mask the toxic effects of these medicines, so it is recommended to periodically check your hearing.
• if you have liver or kidney disease - dose adjustment may be necessary (see section 3. How to take Doxylamine Biofarm);
• if you have heart failure, high blood pressure, or have been diagnosed with a pheochromocytoma (a rare type of tumor that causes high blood pressure);
• if you experience a sudden increase in heart rate in response to physical exertion or stress (so-called QT interval prolongation);
• if you have low potassium levels in the blood or other electrolyte disturbances;
• if you have had vision disturbances or seizures, as even small doses of Doxylamine Biofarm may cause seizures;
• while taking doxylamine, avoid consuming grapefruits and grapefruit juice;
• if you are taking medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin, you should avoid taking doxylamine, as it may cause acute poisoning.

Effect on diagnostic tests
Doxylamine Biofarm may alter the results of skin allergy tests. If you are referred for such tests, you should stop taking Doxylamine Biofarm 3 days before the tests and inform your doctor.

Children and adolescents

Doxylamine Biofarm is not recommended for use in children and adolescents under 18 years of age - see also "Use in children and adolescents".

Doxylamine Biofarm with other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have recently taken, as well as any medicines you plan to take.
Do not take Doxylamine Biofarm while 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 such as certain antidepressants (e.g., fluoxetine, fluvoxamine, paroxetine, bupropion, nefazodone), certain macrolide antibiotics (e.g., clarithromycin, erythromycin, telithromycin), medicines used to treat heart rhythm disorders (e.g., amiodarone, quinidine), protease inhibitors (e.g., indinavir, ritonavir, telaprevir), azole antifungals (e.g., fluconazole, ketoconazole, itraconazole, voriconazole), other antifungal medicines (e.g., terbinafine), and certain medicines that lower blood lipid levels (e.g., gemfibrozil).

Patients should avoid taking Doxylamine Biofarm while taking the following medicines, as it may increase their effect or cause side effects:

• adrenaline (used to treat low blood pressure);
• certain medicines used to treat malaria or certain antihistamines;
• certain diuretics (medicines that increase urine production);
• alcohol and other medicines that act on the central nervous system, such as barbiturates, sleeping pills, sedatives, other medicines used to treat insomnia or anxiety disorders (e.g., alprazolam, diazepam, zolpidem), anticonvulsants (e.g., carbamazepine), muscle relaxants, opioid painkillers (e.g., codeine), or psychotropic medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone);
• medicines used to treat high blood pressure that act on the central nervous system, such as guanabenz, clonidine, or methyldopa;
• medicines known to have toxic effects on hearing, such as certain antibiotics (e.g., aminoglycosides given by injection, chloroquine, erythromycin) or cancer medicines (e.g., carboplatin, cisplatin), as doxylamine may mask these effects;
• other medicines from the cholinolytic group, such as antipsychotic medicines (used to treat mental disorders), tricyclic antidepressants (used to treat depression, e.g., amitriptyline), medicines used to treat Parkinson's disease (e.g., benzatropine or trihexyphenidyl);
• antihistamines used on the skin (e.g., diphenhydramine cream, ointment, spray), scopolamine, antispasmodic medicines (e.g., atropine, belladonna alkaloids), or dyssopyramide (used to treat certain heart conditions);
• medicines where there is a small difference between the therapeutic dose and the toxic dose (e.g., phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin).

Doxylamine Biofarm with food, drink, and alcohol

There are no special recommendations for taking this medicine with or without food.
It is not recommended to drink grapefruit juice while taking Doxylamine Biofarm.
Do not drink alcohol while taking Doxylamine Biofarm.

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.
There is not enough data on the use of doxylamine in pregnant women, so the use of Doxylamine Biofarm in pregnant women is contraindicated.
Due to the risk associated with the use of antihistamines in small children, Doxylamine Biofarm should not be used in breastfeeding women.
There is no available data on the effect of Doxylamine Biofarm on fertility.

Driving and using machines

Doxylamine Biofarm may cause drowsiness the next day after taking it, which may affect your ability to drive and use machines. Therefore, during the treatment period, you should avoid driving and using machines, at least for the first few days of treatment, until you determine how Doxylamine Biofarm affects your ability to drive vehicles and operate machinery.

Doxylamine Biofarm contains lactose

If you have been told that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.

Doxylamine Biofarm contains sodium

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

3. How to take Doxylamine Biofarm

This medicine should always be taken exactly as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Adults (over 18 years old)
The recommended dose is 12.5 mg (half a tablet) taken 30 minutes before bedtime.
The dose may be increased to a maximum of 25 mg (one tablet) taken 30 minutes before bedtime if the initial dose does not provide sufficient relief from insomnia symptoms.
The maximum daily dose is 25 mg (one tablet).
If you experience daytime sleepiness, it is recommended to reduce the dose to 12.5 mg (half a tablet) or ensure at least an 8-hour interval between taking the medicine and planned wake-up time.
Elderly (over 65 years old)
In adults over 65 years old, it is more likely that other conditions may require dose reduction. The recommended initial dose is 12.5 mg (half a tablet), given 30 minutes before bedtime. The dose can be increased to 25 mg (one tablet) if the initial dose is ineffective. If side effects occur, the dose should be reduced to 12.5 mg (half a tablet) per day. Therefore, attention should be paid to the effects of treatment (see section 4). If side effects occur, consult your doctor.
Patient with kidney or liver impairment
Doxylamine Biofarm is contraindicated in patients with severe kidney or liver disease, as well as in patients with end-stage renal failure.
Doxylamine Biofarm should not be used in patients with moderate kidney or liver disease.
In patients with mild kidney or liver disease, it is recommended to reduce the maximum daily dose to 12.5 mg (half a tablet).

Use in children and adolescents

Doxylamine Biofarm 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 use.
Tablets should be taken 30 minutes before bedtime, with an appropriate amount of liquid (preferably water).
Doxylamine Biofarm can be taken with or without food.
The 25 mg (one tablet) Doxylamine Biofarm tablet can be divided into two equal doses.

Duration of treatment

Treatment should be as short as possible. Treatment usually lasts from a few days to one week. Treatment should be stopped after a maximum of two weeks of daily use.

Overdose of Doxylamine Biofarm

If you have taken more than the recommended dose, contact your doctor immediately.
Your doctor will decide what measures should be taken.
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), increased or changed heart rate, increased blood pressure, nausea, vomiting, stimulation, disorientation, and hallucinations.
Severe poisonings 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 antihistamines. 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.

Missed dose of Doxylamine Biofarm

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

Stopping treatment with Doxylamine Biofarm

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

4. Possible side effects

Like all medicines, Doxylamine Biofarm can cause side effects, although not everybody gets them.
Doxylamine Biofarm may cause a significant decrease in the number of white blood cells in the blood and lower resistance to infections.
If you experience an infection with symptoms of fever and a serious deterioration in general condition or fever with local symptoms of infection, such as sore throat or urinary tract pain, contact your doctor immediately.
A blood test will be performed to check for a possible decrease in the number of white blood cells (agranulocytosis). It is important to inform your doctor that you are taking Doxylamine Biofarm.
Side effects are ranked according to frequency:

• very common (more than 1 in 10):

Very common(more than 1 in 10):

• drowsiness

Common(between 1 in 10 and 1 in 100):

• dry mouth, constipation, upper abdominal pain
• blurred vision
• dizziness, headache
• fatigue,
• difficulty urinating (urinary retention)
• increased mucus production in the bronchi

Uncommon(between 1 in 100 and 1 in 1,000):

• weakness, peripheral edema
• nausea, vomiting, diarrhea, indigestion
• rash
• feeling of relaxation
• nightmares
• shortness of breath
• double vision
• sudden drop in blood pressure, especially when changing position from lying down to standing (orthostatic hypotension)
• ringing in the ears

Rare(between 1 in 1,000 and 1 in 10,000):

• tremors, seizures
• paradoxical excitement (especially in children and the elderly)
• decreased number of red blood cells, white blood cells, or platelets

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

• general malaise

Other side effects usually caused by antihistamines, which do not have specific relevance to doxylamine, include: heart rhythm disorders (changes in heart rate), palpitations, bile reflux, liver function disorders (cholestatic jaundice), QT interval prolongation in the ECG (heart disease), loss of appetite, increased appetite, muscle pain, coordination disorders, extrapyramidal disorders (movement disorders), depression, decreased mucus production in the bronchi, hair loss, allergic skin inflammation, excessive sweating, hypersensitivity to light, or hypotension (low blood pressure).
The severity and frequency of side effects can be controlled by reducing the daily dose.
Adults over 65 years old are more prone to side effects, as they may have other conditions or be taking other medicines. These individuals are also more prone to falls.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform 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:
Jerozolimskie Avenue 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 Doxylamine Biofarm

Keep this medicine out of the sight and reach of children.
Store in a temperature below 30°C.
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.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Doxylamine Biofarm contains

• The active substance is doxylamine succinate. One coated tablet contains 25 mg of doxylamine succinate.
• The other ingredients are: Excipients: hydroxypropyl cellulose, lactose monohydrate, crospovidone (type A), microcrystalline cellulose (type 102), colloidal anhydrous silica, talc, sodium stearyl fumarate. Tablet coating: hypromellose 6 mPa·s, titanium dioxide (E171), macrogol 400.

What Doxylamine Biofarm looks like and contents of the pack

Doxylamine Biofarm, 25 mg:
oval, coated tablets, white, convex on both sides with a transverse score line on one side, allowing the tablet to be divided into two equal doses.
PVC/PVDC/Aluminum blister pack in a cardboard box.
Pack sizes:
Doxylamine Biofarm, 25 mg: 10, 14, 20, 28, or 30 coated tablets

Marketing authorization holder and manufacturer

Biofarm Sp. z o.o.
Wałbrzyska Street 13
60-198 Poznań
phone: +48 61 66 51 500
fax: +48 61 66 51 505
email: biofarm@biofarm.pl

Date of last revision of the leaflet: