Doxylamine biofarm

Package leaflet: Information for the user

Doxylamine Biofarm
25 mg, coated tablets
Doxylamini hydrogenosuccinas
Read the entire leaflet carefully before using 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, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, 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

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

The active substance in Doxylamine Biofarm is doxylamine, which belongs to a group of medicines known as antihistamines. These medicines have sedative properties, meaning they are effective as sleep-inducing agents.
Indication:
Doxylamine Biofarm is indicated for the short-term, symptomatic treatment of occasional insomnia in adults, particularly in cases of difficulty falling asleep, frequent nocturnal awakenings, or early morning awakening.

2. Important information before using Doxylamine Biofarm

When not to use Doxylamine Biofarm

• if the patient is allergic to doxylamine succinate or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other antihistamines (antiallergic medicines);
• if insomnia has lasted longer than 3 weeks before starting treatment with this medicine;
• if the patient has a respiratory disorder, e.g. asthma, bronchitis (persistent cough producing thick mucus (sputum and phlegm)) or emphysema (inflammation of the lung alveoli causing breathing difficulties);
• if the patient has glaucoma (increased pressure in the eye);
• if the patient has benign prostatic hyperplasia (abnormal enlargement of the prostate), urinary bladder neck obstruction (a urinary tract disorder) or difficulty passing urine;
• if the patient has peptic ulcer (damage to the mucous membrane of the stomach or the initial part of the intestine) or pyloroduodenal stenosis (difficulty in food passage from the stomach to the intestine);
• if the patient has severe kidney or liver disease;
• if the patient is concurrently taking certain medicines, e.g. antidepressants (fluoxetine, fluvoxamine, paroxetine), antibiotics (clarithromycin, erythromycin, telithromycin), antiviral drugs (indinavir, ritonavir, telaprevir), antifungal medicines (fluconazole, ketoconazole, itraconazole, voriconazole), antiarrhythmic drugs (amiodarone) or calcium channel blockers (medicines used for hypertension and heart disorders), some lipid-lowering (fat-lowering) medicines (gemfibrozil), terbinafine, quinidine, nefazodone, bupropion; if the patient is concurrently taking monoamine oxidase inhibitors (medicines used for depression and Parkinson's disease) and within 2 weeks after discontinuation of such treatment;
• during pregnancy and breastfeeding.

Warnings and precautions
Before starting treatment with Doxylamine Biofarm, consult a doctor or pharmacist:

• if the patient experiences daytime drowsiness – a dose reduction or ensuring at least an 8-hour interval between taking the medicine and planned awakening is recommended (see section 3. How to take Doxylamine Biofarm);
• do not drink alcohol while taking Doxylamine Biofarm – see section below "Doxyline Biofarm with food, drink and alcohol";
• during hot weather, this medicine may increase the risk of dehydration and symptoms of heat stroke;
• if the patient has epilepsy (antihistamines may sometimes cause hyperexcitability and consequently lower the seizure threshold);
• if the patient is over 65 years of age, as they may be more susceptible to adverse effects;
• if the patient is taking other medicines that are ototoxic (toxic to the ear), such as carboplatin or cisplatin (used in cancer treatment), chloroquine (for treatment or prevention of malaria), or certain antibiotics (used to treat infections) such as erythromycin or aminoglycosides administered by injection. Doxylamine Biofarm may mask the toxic effects of these medicines, therefore periodic ear examinations are recommended;
• if the patient has liver or kidney disease – dose adjustment may be necessary (see section 3. How to take Doxylamine Biofarm);
• if the patient has heart failure, hypertension, or diagnosed pheochromocytoma (a rare tumour causing increased blood pressure);
• if the patient experiences sudden increase in heart rate in response to physical exertion or stress (so-called QT prolongation syndrome);
• if the patient has low blood potassium levels or other electrolyte imbalances;
• if the patient has previously experienced visual disturbances or seizures, as even small doses of Doxylamine Biofarm may trigger epileptic seizures;
• during treatment with doxylamine, grapefruit and grapefruit juice should be avoided;
• if the patient is taking medicines such as phenytoin, digoxin, warfarin, lithium, aminoglycosides, or vancomycin, doxylamine should be avoided as it may lead to acute poisoning.

Effect on diagnostic test results
Doxylamine Biofarm may alter the results of skin allergy tests. If the patient is referred for such tests, treatment with Doxylamine Biofarm should be discontinued 3 days before the test and the doctor should be informed.

Children and adolescents
Doxyline Biofarm is not recommended for use in children and adolescents under 18 years of age – see also section "Use in children and adolescents".

Doxyline Biofarm with other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for use.

Do not take Doxyline Biofarm while using the following medicines:

• monoamine oxidase inhibitors (e.g. medicines used to treat depression, Parkinson's disease or other conditions, such as moclobemide, phenelzine, tranylcypromine, isocarboxazid, linezolid, methylene blue, procarbazine, rasagiline and selegiline);
• medicines such as: certain antidepressants (e.g. fluoxetine, fluvoxamine, paroxetine, bupropion, nefazodone), certain macrolide antibiotics (clarithromycin, erythromycin, telithromycin), medicines used to treat heart rhythm disorders (amiodarone, quinidine), antiviral protease inhibitors (indinavir, ritonavir, telaprevir), azole antifungal agents (fluconazole, ketoconazole, itraconazole, voriconazole), other antifungal medicines (terbinafine), and certain lipid-lowering (fat-lowering) medicines (gemfibrozil).

Patients should avoid taking Doxyline Biofarm while using the following medicines, as this may intensify their effects or cause adverse reactions:

• adrenaline (used to treat low blood pressure);
• certain antimalarial medicines or certain antihistamines;
• certain diuretics (medicines increasing urine excretion);
• alcohol and other medicines that depress the central nervous system, e.g. barbiturates, sleeping pills, sedatives, other medicines used for insomnia or anxiety disorders (alprazolam, diazepam, zolpidem), anticonvulsants (e.g. carbamazepine), muscle relaxants, opioid analgesics (codeine), psychotropic medicines (chlorpromazine, risperidone, amitriptyline, trazodone) or procarbazine;
• antihypertensive medicines (medicines used to treat high blood pressure) acting on the central nervous system, such as guanabenz, clonidine or methyldopa;
• medicines known to be ototoxic (toxic to hearing), such as certain antibiotics (parenteral aminoglycosides, chloroquine, erythromycin) or medicines used in cancer treatment (carboplatin, cisplatin), as doxylamine may mask these effects;
• other medicines belonging to the anticholinergic group, such as antipsychotics (used to treat psychiatric disorders), tricyclic antidepressants (used to treat depression, e.g. amitriptyline), medicines used in Parkinson's disease (e.g. benztropine or trihexyphenidyl);
• antihistamines applied to the skin (diphenhydramine in cream, ointment, or aerosol), scopolamine, antispasmodics (e.g. atropine, belladonna alkaloids) or disopyramide (used to treat certain heart conditions);
• medicines with a narrow therapeutic index (small difference between therapeutic and toxic dose), e.g. phenytoin, digoxin, warfarin, lithium, aminoglycosides, vancomycin.

Doxyline Biofarm with food, drink and alcohol
No special instructions regarding taking this medicine before or after meals.
Do not drink grapefruit juice while taking Doxyline Biofarm.
Do not drink alcohol while taking Doxyline Biofarm.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
There are insufficient data on the use of doxylamine in pregnant women; therefore, the use of Doxyline Biofarm during pregnancy is contraindicated.
Due to the risk associated with the use of antihistamines in young children, Doxyline Biofarm must not be used by breastfeeding women.
There are no available data on the effect of Doxyline Biofarm on fertility.

Driving and using machines
Doxyline Biofarm may cause drowsiness the next day after administration, which may affect the ability to drive and operate machinery. Therefore, during treatment, driving and operating machinery should be avoided, at least during the first few days of treatment, until the effect of Doxyline Biofarm on the patient's ability to drive and operate machinery is established.

Doxyline Biofarm contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Doxyline Biofarm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Doxylamine Biofarm

This medicine should always be used exactly as directed by your doctor. If in doubt, consult your
doctor or pharmacist.

Adults (over 18 years of age)
The recommended dose is 12.5 mg (half a tablet) taken 30 minutes before bedtime.
The dose may be increased up to a maximum of 25 mg (one tablet) taken 30 minutes before bedtime, if the initial dose does not provide sufficient relief of insomnia symptoms.
The maximum daily dose is 25 mg (one tablet).
If daytime drowsiness occurs, 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 awakening.

Elderly patients (over 65 years of age)
In adults over 65 years of age, other medical conditions are more likely, which may require dose reduction. The recommended initial dose is 12.5 mg (half a tablet), taken 30 minutes before bedtime. The dose may be increased to 25 mg (one tablet) if the initial dose proves ineffective. If adverse effects occur, the dose should be reduced to 12.5 mg (half a tablet) per day. Therefore, close monitoring of treatment effects is advised (see section 4). If adverse effects occur, consult your doctor.

Patients with renal or hepatic impairment
Doxylamine Biofarm is contraindicated in patients with severe kidney and/or liver disease, as well as in patients with end-stage renal failure.
Doxylamine Biofarm should not be used in patients with moderate kidney and/or liver disease.
In patients with mild kidney or liver disease, the maximum daily dose should be reduced 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 administration.
Tablets should be taken 30 minutes before going to bed, with an adequate amount of liquid (preferably water).
Doxylamine Biofarm may be taken with or without food.
The Doxylamine Biofarm 25 mg tablet (one tablet) may 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 discontinued no later than after two weeks of daily use.

Use of a higher than recommended dose of Doxylamine Biofarm
If a higher than recommended dose is taken, contact your doctor immediately.
The doctor will decide whether and what measures should be taken.
Symptoms of overdose include: drowsiness, depression or stimulation of the central nervous system, anticholinergic effects (dilated pupils, fever, dry mouth, reduced smooth muscle tone of the intestines), increased or altered heart rate, elevated blood pressure, nausea, vomiting, agitation, disorientation, and hallucinations.
Severe poisoning may lead to delirium, psychotic disturbances, decreased blood pressure, 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 in case of 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 increase blood pressure.

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

Stopping Doxylamine Biofarm
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Doxylamine Biofarm may significantly reduce the number of white blood cells in the blood and lower resistance to infections.
If the patient develops an infection with symptoms of fever and a serious deterioration in general condition, or fever with local signs of infection such as sore throat or urinary tract pain, contact a doctor immediately.
A blood test will be performed to check for possible reduction in white blood cell count (agranulocytosis). It is important to inform the doctor about the use of Doxylamine Biofarm.
Adverse effects are listed below according to their frequency of occurrence:
Very common (more than 1 in 10 people):

• drowsiness

Common (1 to 10 in 100 people):

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

Uncommon (1 to 10 in 1,000 people):

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

Rare (1 to 10 in 10,000 people):

• tremor, convulsions
• paradoxical excitation (especially in children and elderly patients)
• reduction in the number of red blood cells, white blood cells or platelets

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

• general malaise

Other adverse effects usually associated with antihistamine medicines, which are not specifically related to doxylamine, include: heart rhythm disorders (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), depression, decreased mucus secretion in the bronchi, alopecia, allergic skin inflammation, excessive sweating, photosensitivity, or hypotension (low blood pressure).
The severity and frequency of adverse effects can be controlled by reducing the daily dose.
Adults over 65 years of age are more susceptible to adverse effects, as they may suffer from other diseases or take other medicines concurrently. These individuals are also more prone to falls.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Doxylamine Biofarm

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

6. Package Contents and Other Information

What Doxylamine Biofarm Contains

• The active substance is doxylamine hydrogen succinate. One coated tablet contains 25 mg of doxylamine hydrogen succinate.
• Other components are:
  Hydroxypropylcellulose, 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 Packaging
Doxylamine Biofarm, 25 mg:
oval, film-coated white tablets, biconvex on both sides, with a score line on one side,
allowing the tablet to be divided into two equal doses.
PVC/PVDC/Aluminum blister packs in cardboard boxes.
Pack sizes:
Doxylamine Biofarm, 25 mg: 10, 14, 20, 28 or 30 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
tel.: +48 61 66 51 500
fax: +48 61 66 51 505
e-mail: [email protected]