Cromohexal 10ml eye drops + 15 ml nasal spray combination pack, 1 p

Instructions for use for Cromohexal 10ml eye drops + 15 ml nasal spray combination pack, 1 p

Important notes (compulsory information):

Cromohexal® combi 20 mg / ml eye drops and nasal spray. Active substance: sodiumcromoglicat. Areas of application: for symptomatic treatment at all-year allergic runs (Rhinitis) or hay fever (seasonal allergic rhinitis) Connected with allergic conditional, acute or chronic conjunctivitis (conjunctivitis), z. B. Hay fever-conjunctivitis, Spring Katarrh (Kerato conjunctivitis vernalis). Note: Eye drops contain benzalkonium chloride.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


LEAFLET: INFORMATION FOR THE USER

Cromohexal® combination
20 mg / ml eye drops and nasal spray, solution

Active ingredient: sodiumcromoglicat (ph.eur.)

Read the entire leaflet carefully because it contains important information for you. This medicine is available without prescription. In order to achieve the best possible treatment success, however, Cromohexal Combi must be applied correctly.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If your symptoms get worse or no improvement occurs, you must definitely visit a doctor.
• If one of the listed side effects you significantly affect it or notice side effects that are not specified in this information information, please inform your doctor or pharmacist.

This leaflet contains:

1. What is Cromohexal Combi and what is it used for?
2. What do you need to know before using Cromohexal Combi?
3. How to use Cromohexal Combi?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How is Cromohexal Kombi Store?
6. ADDITIONAL INFORMATION

1. What is Cromohexal Combi and what is it used for?

Cromohexal Combi is a medicament against allergic conjunctivations in conjunction with allergic runs.

Cromohexal Combi is applied to symptomatic treatment at all-year allergic runny nose (rhinitis) or hay fever (seasonal allergic rhinitis) combined with allergic, acute or chronic conjunctivitis (Conjunctivitis), eg. B. Hay fever-conjunctivitis, spring catarrh (kerato-conjunctivitis vernalis).

2. What do you need to know before using Cromohexal Combi?

Cromohexal Combi must not be used if they are hypersensitive (allergic) against sodium scrimoglicat or any of the other ingredients of Cromohexal Combi. Even if there is a suspicion of an allergic reaction situation, a renewed contact must be avoided.

Take special care with the application of Cromohexal Kombi is required:
In inflammation, even with allergic conjunctivitis, the ophthalmologist must be questioned whether contact lenses may continue to be worn despite the complaints. If the ophthalmologist allows the wearing of contact lenses, the following must be observed: Take out the contact lenses before the dropping out, and set it back at the earliest 15 minutes after dropwise.

When using Cromo-Hexal combination with other medicines:
Please inform your doctor or pharmacist if you take / use other medicines or recently taken / applied, even if it is non-prescription medicines. Interactions with other medicines are unknown.

pregnancy and breast feeding period
Ask your doctor or pharmacist for advice before taking / application of all medicines.

pregnancy
Indications for a frustrated effect of sodium scrimoglicat are not available from animal studies as well as from the previous experience in humans. Nevertheless, they should only use Cromohexal Combi from fundamental considerations during pregnancyn, if the doctor keeps it necessary.

Lactation
It is not known if sodiumcromoglicat goes into breast milk. Therefore, you should only apply Cromohexal Combi during breastfeeding when the doctor is required for it.

Driveion and use of machines:
The eye drops immediately after use for a few minutes influence the vision. Before you participate in road traffic, without working hard or use machines, should be removed until the impairment of vision is passed through foggy.

Important information about certain other ingredients of Cromohexal Combi
Benzalkonium chloride can cause irritation to the eye. Avoid contact with soft contact lenses. Benzalkonium chloride can lead to discoloration of soft contact lenses. Contact lenses must be removed before use and allowed to be 15 at the earliest Using minutes after the application.

3. How is Cromohexal Combi to apply?

Always use Cromohexal Combi exactly as directed in this leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by the doctor, the usual dose is:

Eye drop:
Children and adult drops 2 times a daily 1 drops in the lower tethering bag of the affected eye. The daily dose can be made by increasing the frequency of application for 4 times a day 1 drops are doubled.

Nasal Spray:
Adults and children give up to 4 times a day each 1 spray in each nasal opening. The daily dose can be increased if necessary, the application frequency should not exceed 1 spray nasal spray in each nose opening 6 times a day.

Type of application:

Eye drop:
Drop the eye drops in the hangout of the eye. To do this, get the head slightly backwards, look upwards and pull the lower lid away from the eye. By pressing on the vial, drop a drop in the lower tethering bag. Do not bring the drip opening into contact with the eye. After dropping, slowly close the eye. Close the vial after use immediately.

Nasal Spray:
The nasal spray is only intended for local use in the nose. Remove the protective cap.

Important:
Before the first application, you must operate the spray mechanism several times until a fine, uniform spray from the spray opening exits. To do this, hold the spray bottle as shown in the sketch and remove the spray stroke by thumbning pressure on the bottom of the bottle. The nasal spray is ready to use for each other application.

Insert the spray opening into the nostril and spray once each nostril. After use, clean the spray opening and restart the protective cap.

Duration of the application
The regular daily application is required because Cromohexal Combi has no immediate effect. You should continue the treatment with Cromohexal Combi after the decay of complaints as long as they are exposed to the allergy substances (house dust, fungal pens, pollen, etc.). The therapy effect must be checked regularly. However, the dosage intervals can also be extended after reaching the therapeutic effect as long as reflection is maintained. If you want to apply Cromohexal Combi over a longer period of time, you should find the need for treatment by the doctor.

Please talk to your doctor or pharmacist if you have the impression that the effect of Cromohexal Combi is too strong or too weak.

If you have used a larger amount of Cromohexal Combi than you should not know poisoning phenomena for sodium scrimoglicat.

If you forget the application of Cromohexal Combi:
Do not apply twice the dose if you forget the previous application.

If you cancel the application of Cromohexal Combi:
If you cancel the treatment with Cromohexal Combi, your complaints can reinforce or occur again.

If you have further questions about the application of the medicine, ask your doctor or pharmacist.

4. Which side effects are possible?

Like all medicines, Cromohexal Combi can have side effects, but they do not have to occur each other. The assessment of side effects is based on the following frequency information:

Very common: More than 1 treated from 10
Frequently: 1 to 10 treated from 100
Occasionally: 1 to 10 treated from 1,000
Rarely: 1 to 10 treated from 10,000
Very rare: less than 1 treated from 10,000
Unknown: Frequency on the basis of the available data is not estimable

Eye drop:
Occasionally it can be eyes, conjunctivation (Chemosis), external body feel and an increased blood circulation of the conjunctival (conjunctive hyperemia) come.

Nasal Spray:

Respiratory tract:
Occasionally: irritation of the nasal mucosa, sneezing
Very rare: nosebleed, cough, hoarseness

Generalized disruptions:
Rare: Headache, Very rare: Hypersensitivity reactions, partly heavy generalized anaphylactic reactions itching, shortness of breath, bronchial muscle spasm (bronchospasms), Skin / mucous membrane threshold (angioedema, larynx edema)

Other disorders
Rare: flavoring disorders
Very rare: mucosal ulcerations, tongue swelling

For stronger discomfort, especially if suspected of hypersensitivity to Cromohexal Combi, a doctor is to visit.

Please inform your doctor or pharmacist if one of the listed side effects will significantly affect it or notice side effects that are not specified in this document formation.

5. How is Cromohexal Combi Storage?

Store drug out of reach of children! You may be the medicine after the on the folding box and the label "Usable until" specified expiration date no longer use. The expiration date refers to the last day of the month.

Storage conditions:
This medicinal product does not require special storage conditions.

Note on durability after a break:
The eye drops can be used after a break 6 weeks.

The nasal spray can be used after a break 6 weeks.

6. Further information

What CROMohexal Combi contains:
The active ingredient is sodiumcromoglicat (ph.eur.).

eye drop
1 ml eye drops contains 20 mg of sodium scrimoglicat (ph.eur.).

The other ingredients are:
Benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium diet (ph.eur.), Sodium monohydrogen phosphate dodecahydrate (Ph.eur.), Sorbitol (Ph.eur.), Water for injection purposes.

Nasal spray
1 spray to 0.14 ml contains 2.8 mg of sodiumcromoglicat (Ph.eur.).

The other ingredients are:
Hyetlosis, sodium chloride, sodium dihydrogen phosphate dihydrate, sodium edetate (ph.eur.), Sodium hydroxide solution 10%, Sodium monohydrogen phosphate dodecahydrate (ph.eur.), Sorbitol Solution 70% (not crystallizing) (ph.eur.), Water for injection purposes.

How to look for Cromohexal Combi and content of the pack:
Cromohexal Combi is available in packs with 10 ml eye drops and 15 ml nasal spray, solution.

Pharmaceutic entrepreneur:
Hexal AG
Industriestraße 25
83607 Holzkirchen
Telephone: (08024) 908-0
Fax: (08024) 908-1290
E-mail: [email protected]

Manufacturer:
Salutas pharma GmbH,
A company of Hexal AG
Otto-von-Guericke-Allee 1
39179 Bar life

This information information was last revised in April 2013.

Source: Information of the leaflet
Status: 04/2014