Clemastinum Aflofarm

Package Leaflet: Information for the Patient

Clemastinum Aflofarm, 0.5 mg/5ml, Syrup

Clemastinum

Read the Leaflet Carefully Before Taking the Medication, 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, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 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 a syrup with antihistamine action. The active substance is clemastine. The antiallergic effect is based on blocking histamine receptors, which prevents the effects of histamine, such as vasodilation and increased permeability leading to swelling and redness.

Indications:

• treatment of symptoms associated with allergic rhinitis, such as: runny nose, sneezing, tearing, nasal itching;
• relief of symptoms of certain skin allergies, such as: urticaria, contact dermatitis, atopic dermatitis, itching, Quincke's edema (sudden swelling of the face, limbs, or joints without itching and pain).

2. Important information before taking Clemastinum Aflofarm

When not to take Clemastinum Aflofarm

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

Warnings and precautions

Before starting to take Clemastinum Aflofarm, discuss it with your doctor:

• if you have angle-closure glaucoma (eye disease caused by damage to the optic nerve);
• if you have increased intraocular pressure;
• if you have hyperthyroidism;
• if you have cardiovascular disease and hypertension;
• if you have difficulty urinating (caused by e.g., prostate enlargement, urethral stricture);
• if you have pyloric stenosis (narrowing of the pylorus, which can cause vomiting and weight loss);
• if you have a peptic ulcer that can cause obstruction of the digestive tract;
• if you have respiratory diseases (including asthma);
• if you have porphyria (a disease characterized by abnormal heme production).

In elderly patients (over 65 years), there is a greater risk of side effects, such as: tremors, dizziness, excessive sedation, and decreased blood pressure.

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 you are taking now or have taken recently, as well as any medicines you plan to take.

Clemastine enhances the effect of medicines that inhibit the activity of the central nervous system, such as:

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

Medicines that enhance the effect of clemastine:

• tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs) (medicines used in depression);
• hydroxyzine (a medicine used to treat anxiety and itching, as well as before surgery).

If you are not sure whether you are taking any of the above medicines, ask your doctor or pharmacist.

Clemastinum Aflofarm with alcohol

Do not drink alcohol while taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

This medicine may affect your ability to drive and use machines. If you experience drowsiness, coordination disorders, headaches, dizziness, fatigue, and vision disturbances (double vision and blurred vision), do 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.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate

The medicine may cause allergic reactions (possible late reactions).

Etanol

This medicine contains 240.2 mg of alcohol (ethanol) in each dose (5 ml), which is equivalent to 48 mg/ml (4.8% w/v).

Sodium

The medicine contains 11.03 mg of sodium in 5 ml of syrup.

3. How to take Clemastinum Aflofarm

Always take this medicine exactly as your doctor has told you.

Dosage is determined by the doctor individually, depending on the patient's response to treatment.

To dose the medicine, use the measuring cup provided with the packaging. This allows for accurate dosing.

Recommended doses:

Children aged 6 to 12 years:

Adults and adolescents over 12 years:

Use in children

Do not use in children under 6 years of age.

Overdose of Clemastinum Aflofarm

If you have taken more than the recommended dose, contact your doctor.

Missed dose of Clemastinum Aflofarm

Continue taking the medicine, do not increase the next dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Seek immediate medical attention if you experience any of the following symptoms, as urgent medical attention may be required:

• anaphylactic shock - the first symptoms may be: skin rash, facial swelling, difficulty breathing, wheezing, shortness of breath, unmeasurable pulse, significantly decreased blood pressure, sweating, loss of consciousness.

The following side effects may occur:

Frequent(in more than 1 in 100, but less than 1 in 10 patients):

• fatigue, drowsiness.

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

• vertigo of labyrinthine origin.

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

• urticaria (light red, itchy blisters on the skin), rash (itchy, red bumps on the skin);
• drug rash (local redness of the skin);
• photodermatosis (skin disease related to increased sensitivity to UV radiation - sunlight);
• anaphylactic shock;
• nausea, dryness of the mucous membrane of the mouth, discomfort in the upper abdomen;
• headache.

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

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

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

• excessive sweating, chills;
• thrombocytopenia (decreased platelet count - increased risk of bleeding and bruising);
• agranulocytosis (decreased granulocyte count - one of the types of white blood cells, leading to increased susceptibility to infections);
• hemolytic anemia (significant decrease in red blood cell count due to their breakdown; manifested by pallor, weakness, shortness of breath, jaundice, splenomegaly);
• menstrual disorders;
• urination disorders or urinary retention;
• hypotension (significantly decreased blood pressure);
• spasms;
• decreased production of mucus in the respiratory tract;
• feeling of a stuffy nose, dryness of the mucous membrane of the nose and throat;
• hoarseness;
• loss of appetite, vomiting, diarrhea;
• excessive sedation;
• coordination disorders (difficulty maintaining balance);
• feeling of fatigue;
• mood disorders (euphoria, excessive excitability, agitation), anxiety, insomnia, tremors;
• vision disturbances (double vision and blurred vision);
• tinnitus;
• seizures.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist.

5. How to store Clemastinum Aflofarm

Keep this medicine out of the sight and reach of children.

6. Contents of the pack 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.
• The 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), peach 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

The medicine is a syrup.

Marketing authorization holder

Aflofarm Farmacja Polska Sp. z o.o.

Manufacturer

Aflofarm Farmacja Polska Sp. z o.o.

Date of last revision of the leaflet