Polcrom 2%

Patient Information Leaflet

POLCROM 2%, 20 mg/ml (2.8 mg per nasal dose), nasal spray, solution
Sodium cromoglicate
Please read all of this leaflet carefully before using this medicine, because it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any side effects, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your symptoms do not improve or if you feel worse, contact your doctor.

Table of contents

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

1. What Polcrom 2% is and what it is used for

Polcrom 2% is an anti-allergic medicine containing sodium cromoglicate. It inhibits the release of histamine and other cellular mediators involved in allergic reactions. As a result, allergic symptoms do not occur.
This medicine is used preventively in the treatment of seasonal and perennial allergic rhinitis.
Treatment should be started before exposure to the allergen.

2. Important information before using Polcrom 2%

When not to use Polcrom 2%:

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

Warnings and precautions
Before starting to use Polcrom 2%, discuss it with your doctor or pharmacist.
Children and adolescents
The medicine can be used in children over 3 years of age.
Polcrom 2% and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using, has recently used, or plans to use.
No interactions between sodium cromoglicate and other medicines administered intranasally have been observed.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
The medicine may be used during pregnancy only if clearly necessary.
It is not known whether sodium cromoglicate passes into human milk. However, caution should be exercised when administering the medicine to breastfeeding women, although it is unlikely that the drug would pass into breast milk and cause adverse effects in the breastfed infant.
Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.
Polcrom 2% contains benzalkonium chloride
The medicine contains 0.1 mg of benzalkonium chloride per ml of solution. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for a prolonged period.

3. How to use Polcrom 2%

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
One dose contains 2.8 mg of sodium cromoglicate.
Adults, adolescents and children over 3 years of age:
1 dose into each nostril 4 to 6 times daily.
Treatment should be started at least one week before exposure to the allergen and continued throughout the period of allergen exposure.
Sodium cromoglicate is a preventive treatment. The medicine should be used regularly.

Method of administration
For hygienic reasons, the medicine container should be used by only one patient.
The medicine is intended for external use only – locally in the nose.
Each time before use, remove the protective cap.
Before first use of a new bottle, after removing the cap, press the pump 3–5 times until a fine mist appears. Insert the nozzle into the nostril. While holding the bottle upright, press the pump to release a dose of the medicine into the nose.

Use of a higher than recommended dose of Polcrom 2%
No cases of sodium cromoglicate poisoning or symptoms of overdose have been reported, regardless of the route of administration.

Missed dose of Polcrom 2%
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue with the next scheduled dose. Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Transient irritation of the nasal mucosa, nasal mucosal congestion and swelling, sneezing, and rarely nosebleeds may occur.
Wheezing, sensation of chest tightness, cough, taste disturbances, headache, rash, and hypersensitivity reactions including severe anaphylactic reactions may also occur.

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
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 enables better assessment of the benefit-risk balance of the medicine.

5. How to store Polcrom 2% medicine

Store at a temperature not exceeding 25°C.
Keep the medicine in a place out of sight and out of reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Polcrom 2% contains

• The active substance is sodium cromoglicate. Each ml of solution contains 20 mg of sodium cromoglicate. One dose contains 2.8 mg of sodium cromoglicate.
• The other ingredients are: sorbitol, disodium phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, disodium edetate, sodium chloride, polysorbate 80, benzalkonium chloride solution, purified water.

What Polcrom 2% looks like and contents of the pack
HDPE bottle closed with a metering pump in a cardboard box.
1 bottle of 15 ml
Marketing Authorisation Holder
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. + 48 22 364 61 01
Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
Medana Plant in Sieradz
ul. Władysława Łokietka 10, 98-200 Sieradz