CROMOHEXAL 2.8 mg/nasal dose Aerosol

Contents of the leaflet

1. Patient Information Leaflet: Information for the Patient
   1. Table of Contents of the Leaflet:
2. What is CromoHEXAL and what is it used for
3. Important information before using CromoHEXAL
   1. When not to use CromoHEXAL
   2. Warnings and precautions
   3. Pregnancy and breastfeeding
   4. Driving and using machines
   5. CromoHEXAL contains benzalkonium chloride and sodium
4. How to use CromoHEXAL
   1. Using more than the recommended dose of CromoHEXAL
5. Possible side effects
   1. Reporting side effects
6. How to store CromoHEXAL
7. Contents of the pack and other information
   1. What CromoHEXAL contains
   2. What CromoHEXAL looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of last revision of the leaflet:

Patient Information Leaflet: Information for the Patient

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

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or if you feel worse, you should contact your doctor.

Table of Contents of the Leaflet:

• 1. What is CromoHEXAL and what is it used for
• 2. Important information before using CromoHEXAL
• 3. How to use CromoHEXAL
• 4. Possible side effects
• 5. How to store CromoHEXAL
• 6. Contents of the pack and other information

1. What is CromoHEXAL and what is it used for

The CromoHEXAL nasal spray contains the active substance sodium cromoglicate, an anti-allergic medication. Cromoglicate inhibits the release of histamine and other substances involved in the inflammatory process that occur as a result of contact with an allergen.
The indication for the use of CromoHEXAL nasal spray is seasonal or perennial allergic rhinitis.

2. Important information before using CromoHEXAL

When not to use CromoHEXAL

If you are allergic (hypersensitive) to sodium cromoglicate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

If you suspect that you may be allergic to CromoHEXAL nasal spray, you must avoid further contact with this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
CromoHEXAL nasal spray can be used during pregnancy or breastfeeding only if your doctor considers it necessary.

Driving and using machines

This medicine does not affect your ability to drive or use machines.

CromoHEXAL contains benzalkonium chloride and sodium

The medicine contains 0.014 mg of benzalkonium chloride (a preservative) per 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 dose, which means it is considered 'sodium-free'.

3. How to use CromoHEXAL

This medicine should be used exactly as described in the patient information leaflet or as directed by your doctor or pharmacist. If you are unsure, you should speak to your doctor or pharmacist.
Adults and children
Usually, one dose of CromoHEXAL is used for each nostril, 4 times a day.
Once an improvement is seen, the intervals between doses can be extended.
Method of administration

• 1. Remove the protective cap from the actuator.
• 2. Before using a new container for the first time, press the actuator several times to produce a fine mist of spray. For subsequent uses, the medicine is ready to use.
• 3. Insert the tip of the actuator into each nostril, press the actuator once, and inhale one dose of spray.

CromoHEXAL is used preventively. The medicine should be used regularly, even after symptoms have disappeared, but throughout the entire period of exposure to the allergen (e.g., pollen, house dust, mold spores, and food allergens).

Using more than the recommended dose of CromoHEXAL

There are no known cases of overdose with sodium cromoglicate.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rare side effects (may affect up to 1 in 1,000 people):
wheezing or feeling of tightness in the chest
Very rare side effects (may affect up to 1 in 10,000 people):
irritation of the nasal mucosa (in the first days of using the medicine)
Side effects with unknown frequency (frequency cannot be estimated from the available data):
nasal bleeding, sneezing, headache, hypersensitivity reactions (itching, shortness of breath, bronchospasm, angioedema – swelling of the skin and mucous membranes, most often affecting the face, limbs, and areas around the joints).

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Department for Monitoring of Adverse Reactions to Medicinal Products 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, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CromoHEXAL

Keep this medicine out of the sight and reach of children.
Store in 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What CromoHEXAL contains

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

What CromoHEXAL looks like and contents of the pack

CromoHEXAL nasal spray is a clear solution, presented in a plastic container and a cardboard box.
The pack contains 2 containers of 15 ml solution each.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, GermanySandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of last revision of the leaflet:

{Logo Sandoz}