Package leaflet: Information for the patient

CromoHEXAL, 2.8 mg/nasal dose, nasal spray, solution
Sodium cromoglicate
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if you feel worse, you should contact your doctor.

Leaflet contents:

What CromoHEXAL is and what it is used for
Important information before using CromoHEXAL
How to use CromoHEXAL
Possible side effects
How to store CromoHEXAL
Contents of the pack and other information

1. What CromoHEXAL is and what it is used for

CromoHEXAL nasal spray contains the active substance sodium cromoglicate, an anti-allergic agent. Cromoglicate inhibits the release of histamine and other inflammatory mediators that are released upon exposure to an allergen.
CromoHEXAL nasal spray is indicated for the treatment of seasonal or perennial allergic rhinitis.

2. Information before using CromoHEXAL

When not to use CromoHEXAL
If the patient is allergic (hypersensitive) to sodium cromoglicate or to any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
If the patient suspects they may be allergic to the CromoHEXAL nasal aerosol, they must avoid
further contact with this medicine.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant or is planning to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
The CromoHEXAL nasal aerosol may be used during pregnancy or breastfeeding only if the doctor
considers it necessary.
Driving and operating machinery
This medicine does not affect the ability to drive or operate machinery.
CromoHEXAL contains benzalkonium chloride and sodium
The medicine contains 0.014 mg of benzalkonium chloride (a preservative) per nasal dose.
Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a long time.
The medicine contains less than 1 mmol (23 mg) of sodium per nasal dose, which means the medicine is considered "sodium-free".

3. How to use CromoHEXAL

This medicine should be used exactly as described in this patient leaflet or as directed by a
doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and children
Usually, one dose of CromoHEXAL is administered into each nostril four times daily.
Once improvement has been achieved, the intervals between doses may be extended.
Method of administration

Remove the protective cap from the spray nozzle.
Before first use of a new container, press the pump several times until a fine aerosol mist is obtained. For subsequent uses, the medicine is ready to use.
Insert the nozzle into each nostril, press the pump once, and release one dose of the aerosol.

CromoHEXAL is used preventively. The medicine should be used regularly, even after symptoms
have subsided, throughout the entire period of exposure to the allergen (e.g. pollen, house dust,
fungal spores, and food allergens).
Use of more than the recommended dose of CromoHEXAL
Cases of overdose with sodium cromoglicate are not known.
If you have any further doubts concerning 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.
Rare adverse reactions (may occur in less than 1 in 1,000 people):
wheezing or feeling of tightness in the chest
Very rare adverse reactions (may occur in less than 1 in 10,000 people):
nasal mucosa irritation (during the first days of treatment)
Adverse reactions occurring with unknown frequency (frequency cannot be estimated from the available data):
nosebleed, sneezing, headache, hypersensitivity reactions (itching, shortness of breath, bronchospasm, angioedema – swelling of the skin and mucous membranes, most commonly affecting the face, limbs and joint areas).
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 at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw,
tel.: + 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 provide more information on the safety of this medicine.

5. How to store CromoHexal

Keep the medicine out of the sight and reach of children.
Store at a temperature not exceeding 25°C. Protect from light.
The shelf life after first opening the container is 6 weeks.
Do not use after the expiry date stated on the packaging after EXP. 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 properly dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What CromoHEXAL contains

The active substance is sodium cromoglicate. One nasal dose (0.14 ml) contains 2.8 mg of sodium cromoglicate.
Other ingredients are: benzalkonium chloride, sodium chloride, disodium edetate, sorbitol, disodium dihydrogen phosphate dihydrate, disodium dihydrogen phosphate dodecahydrate, purified water.

What CromoHEXAL looks like and contents of the pack
CromoHEXAL nasal spray is a clear solution contained in a plastic bottle and placed in a cardboard box.
The pack contains 2 bottles, each with 15 ml of solution.

Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany

For further information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00