Package leaflet: Information for the patient

Histin, 20 mg, tablets
Bilastinum
Please read all of this leaflet carefully before taking this medicine, because 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. 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:

What Histin is and what it is used for
What you need to know before taking Histin
How to take Histin
Possible side effects
How to store Histin
Contents of the pack and other information

1. What Histin is and what it is used for

Histin contains the active substance bilastin, which has antihistaminic
(antiallergic) properties. Histin is used to relieve symptoms of seasonal allergic rhinitis
(sneezing, itching, runny nose, nasal congestion, and red, watery eyes) as well as other forms
of allergic rhinitis. Histin may also be used to treat itchy skin rashes (blisters or hives).
Histin is indicated for use in adults and adolescents aged 12 years and older.

2. Important information before using Histin

When not to use Histin

if the patient is allergic to bilastine or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Histin, consult a doctor or pharmacist if the patient has
moderate to severe kidney function impairment, low blood levels of potassium, magnesium,
or calcium, if the patient has or has had heart rhythm disorders or very slow heart rate, if the
patient is taking medicines that may affect heart rhythm, or if the patient has or has had an
abnormal heart rhythm pattern (known as QTc prolongation on electrocardiogram), which
may occur in certain types of heart disease. Additionally, consult a doctor if the patient is
taking other medicines (see "Histin and other medicines").
Children
This medicine should not be given to children under 12 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.
Histin and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has
recently taken, including those obtained without a prescription, as well as any medicines the
patient plans to take.
In particular, inform the doctor if the patient is taking any of the following medicines:

ketoconazole (an antifungal medicine)
erythromycin (an antibiotic)
diltiazem (a medicine used for coronary artery disease)
cyclosporine (an immunosuppressive medicine used to prevent organ transplant rejection and in autoimmune and allergic disorders such as psoriasis, atopic dermatitis, and rheumatoid arthritis)
ritonavir (used in the treatment of AIDS)
rifampicin (an antibiotic)

Histin with food, drink, and alcohol
Do not take this medicine together with food or grapefruit juice or other fruit juices, as this may reduce the effectiveness of Histin. To avoid reduced effectiveness of the medicine:

swallow the tablet and wait one hour before eating a meal or drinking fruit juice, or
wait two hours after eating or drinking fruit juice before taking the tablet.

Bilastine at the recommended dose (20 mg) does not increase drowsiness caused by alcohol consumption.

Pregnancy, breastfeeding, and fertility
There are no data or limited data on the use of bilastine during pregnancy, breastfeeding, or its effect on fertility.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine. Always consult a doctor or pharmacist before taking any medicine.
Driving and operating machinery
It has been shown that taking bilastine at a dose of 20 mg does not affect the ability to drive in adults. However, individual patient response to treatment may vary. Therefore, before driving or operating machinery, the patient should assess how this medicine affects them.
Histin 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 take Histin

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The recommended dose for adults, including elderly people, and adolescents aged 12 years and older is: 1 tablet (20 mg) once daily.

Tablet for oral administration.
The tablet should be taken one hour before or two hours after any meal or fruit juice (see section 2. "Histin with food, drink and alcohol").
Swallow the tablet with a glass of water.
The break line on the tablet is only intended to facilitate splitting for easier swallowing.

Regarding the duration of treatment, your doctor will determine the type of illness and decide how long you should take Histin.

Use in children
Histin must not be given to children under 12 years of age.
Other pediatric formulations of this medicine – orodispersible tablet containing bilastine 10 mg or bilastine 2.5 mg/ml oral solution – are more suitable for children aged 6 to 11 years with body weight at least 20 kg – consult your doctor or pharmacist.
Pediatric formulations of this medicine must not be given to children under 6 years of age
or with body weight below 20 kg, due to insufficient data on use.

Taking more Histin than recommended
If you take more Histin than recommended, you should immediately contact your doctor or pharmacist or go to the nearest hospital emergency department.
Take the medicine pack or leaflet with you.

If you miss a dose of Histin
Do not take a double dose to make up for a missed dose.
If you miss a dose, take it as soon as possible, then return to taking your regular dose at the usual time.
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 they do not occur in everyone.
If a patient experiences hypersensitivity reactions (frequency not known), including: breathing difficulties, dizziness, collapse or loss of consciousness, swelling of the face, lips, tongue or throat and (or) skin swelling and redness, the medicine should be discontinued immediately and medical advice should be sought without delay.

Other adverse reactions that may occur in adults and adolescents include:

Common: occurring in less than 1 in 10 treated patients

Headache
Drowsiness

Uncommon: occurring in less than 1 in 100 treated patients

Abnormal electrocardiogram (ECG) readings
Blood test abnormalities indicating liver function disorders
Dizziness
Stomach pain
Fatigue
Increased appetite
Heart rhythm disturbances
Weight gain
Nausea
Anxiety
Sensation of dryness or discomfort in the nose
Abdominal pain
Diarrhoea
Gastritis
Dizziness (spinning sensation)
Weakness
Increased thirst
Dyspnoea (breathing difficulties)
Dry mouth
Indigestion
Itching
Facial rash
Fever
Tinnitus (ringing in the ears)
Sleep disturbances
Blood test abnormalities indicating kidney function disorders
Increased blood lipid levels

Frequency not known: cannot be estimated from available data

Palpitations (awareness of heartbeat)
Tachycardia (rapid heartbeat)
Vomiting

Adverse reactions that may occur in children include:

Common: occurring in less than 1 in 10 treated patients

Rhinitis (nasal irritation)
Allergic conjunctivitis (eye irritation)
Headache
Stomach pain (abdominal pain, epigastric pain)

Uncommon: occurring in less than 1 in 100 treated patients

Eye irritation
Dizziness
Loss of consciousness
Diarrhoea
Nausea
Swelling of the lips
Rash
Urticaria (hives)
Fatigue

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Histin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after
"EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Histin contains

The active substance is bilastine. Each tablet contains 20 mg of bilastine.
The other ingredients are: microcrystalline cellulose, sodium carboxymethyl starch (type A), colloidal anhydrous silica, magnesium stearate.

What Histin looks like and contents of the pack
Histin tablets are oval, white or almost white, with a score line on one side,
with the number "2" embossed above the line and "0" below the line.
Tablets are packed in blisters.
Pack size: 30 tablets.
Marketing Authorisation Holder
{Logo of the marketing authorisation holder}
Solinea Sp. z o.o.
Elizówka, ul. Szafranowa 6
21-003 Ciecierzyn
e-mail: [email protected]
Manufacturer
Mako Pharma Sp. z o.o.
ul. Władysława Reymonta 2
05-092 Dziekanów Leśny