Clemastinum aflofarm

Patient Information Leaflet

Clemastinum Aflofarm, 0.5 mg/5 ml, syrup
Clemastinum
Please read the entire leaflet before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What is Clemastinum Aflofarm and what is it used for

Clemastinum Aflofarm is an antihistamine syrup. The active substance in this medicine is clemastine. Its antiallergic action results from blocking histamine H\textsubscript{1} receptors, thus preventing the effects of histamine, such as blood vessel dilation and increased permeability leading to swelling and redness.
Clemastine is rapidly absorbed from the gastrointestinal tract. Food intake does not affect absorption. Maximum blood concentration is reached within 4–6 hours.
Indications:

• Treatment of symptoms associated with allergic rhinitis, such as watery nasal discharge, sneezing, tearing, and nasal itching;
• Relief of symptoms in certain skin allergies, such as urticaria, contact dermatitis, atopic eczema, itching, and Quincke's edema (sudden swelling of the face, limbs, or joints without itching or pain).

2. Important information before taking Clemastinum Aflofarm

When not to take Clemastinum Aflofarm

• if the patient is allergic to clemastine or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to other medicines with a chemical structure similar to clemastine (e.g. chlorpheniramine, diphenhydramine);
• if the patient is simultaneously taking medicines called monoamine oxidase inhibitors (see section: Clemastinum Aflofarm and other medicines).

Warnings and precautions
Before starting to take Clemastinum Aflofarm, consult a doctor:

• if the patient has closed-angle glaucoma (an eye disease caused by damage to the optic nerve);
• if the patient has increased intraocular pressure;
• if the patient has hyperthyroidism;
• if the patient has circulatory system disorders and arterial hypertension;
• if the patient has difficulty urinating (e.g. due to benign prostatic hyperplasia, bladder neck obstruction);
• if the patient has pyloric stenosis (impairing the passage of food from the stomach to the duodenum);
• if the patient has peptic ulcer impairing the passage of food through the gastrointestinal tract;
• if the patient has respiratory system disorders (including asthma);
• if the patient has porphyria (a disorder characterized by abnormal heme production – a component of hemoglobin).

In elderly patients (over 65 years of age), there is an increased risk of adverse effects,
such as tremors, dizziness, excessive sedation, and decreased arterial blood pressure.
Clemastine should not be used simultaneously with medicines that depress the central nervous system, tricyclic antidepressants, or hydroxyzine (see section:
Clemastinum Aflofarm and other medicines).
The medicine may affect the results of allergy tests; the medicine should not be taken at least 3 days
before undergoing such tests.
Children
Clemastinum Aflofarm should not be given to children under 6 years of age.
Clemastinum Aflofarm and other medicines
Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
If the patient is taking any of the medicines listed below, they should inform their doctor.
Clemastine enhances the effects of medicines that depress central nervous system function,
such as:

• barbiturates (medicines used to treat insomnia and epilepsy, e.g. phenobarbital);
• neuroleptics (medicines used to treat psychiatric disorders, e.g. promazine, chlorpromazine, perazine);
• anxiolytic medicines.

Medicines that enhance the effects of clemastine:

• tricyclic antidepressants and monoamine oxidase inhibitors (MAO inhibitors) (medicines used in depression);
• hydroxyzine (a medicine used to treat anxiety, itching, and before surgical procedures).

If the patient is unsure whether they are taking any of the above-mentioned medicines, they should
consult their doctor or pharmacist.
Clemastinum Aflofarm and alcohol
Do not drink alcohol while taking this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult a doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if the doctor considers it absolutely necessary.
Clemastinum Aflofarm should not be used during breastfeeding, as the medicine passes into breast milk and may cause adverse effects in the infant.
Driving and operating machinery
This medicine may affect the ability to drive and operate machinery. If drowsiness,
coordination disturbances, headaches and dizziness, feelings of fatigue and tiredness, or visual disturbances (double or blurred vision) occur, the patient should not drive or operate machinery.
The medicine contains sorbitol liquid non-crystallizing, methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol, propylene glycol, and sodium
Sorbitol liquid non-crystallizing
The medicine contains 2150 mg of sorbitol in 5 ml of syrup.
Sorbitol is a source of fructose. If fructose intolerance has previously been diagnosed in the patient (or their child), or hereditary fructose intolerance – a rare genetic disorder in which the patient's body cannot break down fructose – the patient should contact a doctor before taking the medicine or giving it to the child.
Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medicine may cause allergic reactions (delayed-type reactions are possible).
Ethanol
This medicine contains 240.2 mg of alcohol (ethanol) per dose (5 ml), equivalent to 48 mg/ml (4.8% w/v). The amount of alcohol in 5 ml of this medicine is equivalent to less than 6 ml of beer or 3 ml of wine.
The amount of alcohol in this medicine is unlikely to affect adults and adolescents, and its effect in children is likely to be unnoticeable. It may cause some effects in younger children, for example drowsiness.
Alcohol in this medicine may alter the effects of other medicines. If the patient is taking other medicines, they should consult a doctor or pharmacist.
If the patient is pregnant or breastfeeding, she should consult a doctor or pharmacist before using this medicine.
If the patient is alcohol-dependent, they should consult a doctor or pharmacist before using this medicine.
Propylene glycol (E 1520)
The medicine contains 752.43 mg of propylene glycol in 5 ml of syrup.
Pregnant or breastfeeding women should not take this medicine without medical advice.
The doctor may decide to perform additional tests in such patients.
Patients with liver or kidney function disorders should not take this medicine without medical advice. The doctor may decide to perform additional tests in such patients.
Sodium
The medicine contains 11.03 mg of sodium in 5 ml of syrup.
The medicine contains 132.36 mg of sodium (the main component of table salt) in 60 ml of syrup.
This corresponds to 6.62% of the maximum recommended daily sodium intake in the adult diet.

3. How to take Clemastinum Aflofarm

This medicine should always be taken according to the doctor's instructions. If you have any doubts,
consult your doctor or pharmacist.
This is an oral medicine.
The dosage is determined individually by the doctor, depending on the patient's response to treatment.
The measuring device provided with the package should be used for dosing. This ensures accurate
measurement of the dose.
Recommended doses:
Children aged 6 to 12 years:

Adults and adolescents over 12 years of age:

Use in children
Do not use in children under 6 years of age.

Taking more medicine than recommended – Clemastinum Aflofarm
If you take more medicine than recommended, contact your doctor immediately.
Overdose of clemastine may cause inhibition or stimulation of the central nervous system (CNS).

In children, overdose initially leads to CNS stimulation, manifested by:
agitation, hallucinations (perceiving non-existent objects or people), convulsions followed by cardiorespiratory depression (slowed heart rate, slowed and shallow breathing, apnea, and death due to suffocation), impaired motor coordination, ataxia (lack of voluntary movement control), muscle tremors, athetosis (a neurological disorder characterized by involuntary, slow, irregular movements of the hands), elevated body temperature, and cyanosis (bluish discoloration of the skin and mucous membranes).
Other symptoms may include dryness of the oral mucosa, dilated pupils, and facial flushing.

In adults, CNS depression is more commonly observed, presenting as drowsiness or even coma.

In both children and adults, overdose may lead to coma and circulatory collapse (sudden cardiac arrest).

If a dose of Clemastinum Aflofarm is missed
Continue taking the medicine as prescribed without increasing the next dose.
Do not take a double dose to make up for a missed dose.

If you have any further questions regarding 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.
You should contact a doctor immediately if any of the following symptoms occur,
as urgent medical care may be required:

• anaphylactic shock – early symptoms may include: skin rash, swelling of the face, lips or throat, difficulty breathing, wheezing, shortness of breath, undetectable pulse, significantly lowered blood pressure, sweating, loss of consciousness.

The following adverse reactions may occur:
Common (affects more than 1 in 100 but less than 1 in 10 patients):

• fatigue, drowsiness.

Uncommon (affects more than 1 in 1,000 but less than 1 in 100 patients):

• vertigo of labyrinthine origin.

Rare (affects more than 1 in 10,000 but less than 1 in 1,000 patients):

• urticaria (pinkish, itchy blisters on the skin), rash (itchy, red bumps on the skin);
• drug erythema (localized redness of the skin);
• photodermatosis (skin disorder associated with hypersensitivity to UV radiation – sunlight);
• anaphylactic shock;
• nausea, dryness of the oral mucosa, epigastric discomfort;
• headache.

Very rare (affects less than 1 in 10,000 patients):

• palpitations (irregular heartbeat);
• tachycardia (rapid heartbeat);
• constipation.

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

• excessive sweating, chills;
• thrombocytopenia (reduced number of blood platelets – increased risk of bleeding and bruising);
• agranulocytosis (reduced number of granulocytes – a type of white blood cells, leading to increased susceptibility to infections);
• haemolytic anaemia (significant reduction in red blood cells due to their destruction; symptoms include pallor, weakness, shortness of breath, jaundice, enlarged spleen);
• menstrual disorders;
• difficulty in urination or urinary retention;
• hypotension (significant decrease in blood pressure);
• additional contractions;
• reduced mucus production in the respiratory tract;
• sensation of nasal congestion, dryness of nasal and pharyngeal mucosa;
• hoarseness;
• loss of appetite, vomiting, diarrhoea;
• excessive sedation;
• coordination disturbances (difficulty maintaining balance);
• feeling of fatigue;
• mood disturbances (euphoria, excessive excitability, agitation), anxiety, insomnia, tremors;
• visual disturbances (double vision, blurred vision);
• tinnitus;
• seizures.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be
reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: + 48 22 49 21 301
Faks: + 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 Clemastinum Aflofarm

Keep this medicine out of sight and reach of children.
Store below 25°C. Keep in the original packaging. Do not store in the refrigerator. Do not freeze.
Do not use this medicine after the expiry date stated on the label and carton.
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 in use. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Clemastinum Aflofarm contains

• The active substance is clemastine in the form of clemastine fumarate. 5 ml of syrup contains 0.5 mg of clemastine.
• Other ingredients are: sorbitol liquid non-crystallizing, propylene glycol (E 1520), ethanol 96%, sodium saccharin, methyl parahydroxybenzoate, propyl parahydroxybenzoate, lemon flavor AR 0886A (contains ethanol, citral), apricot flavor AR 0059 (contains ethanol, propylene glycol (E 1520)), sodium dihydrogen phosphate monohydrate, disodium phosphate dodecahydrate, purified water.

What Clemastinum Aflofarm looks like and contents of the pack
Clemastinum Aflofarm is a syrup.
The packaging consists of a brown glass bottle with a white aluminum cap and a measuring cup,
in a cardboard box.
The pack contains 100 ml of syrup.
Marketing Authorization Holder
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
tel. (42) 22-53-100
Manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Krzywa 2
95-030 Rzgów