CROMO-RATIOPHARM combination pack

Important notes (mandatory information)

Cromo-ratiopharm combination pack Active ingredient: Sodium cromoglicate. Areas of application: for hay fever, when allergic symptoms occur in the nose (e.g. runny nose) and eyes (e.g. itching, tears).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Cromo-ratiopharm combination pack
Nasal spray, solution 2.8 mg/spray and eye drops 20 mg/ml
Active ingredient: Sodium cromoglicate (Ph.Eur.)

Read the entire package leaflet carefully before you start using this medicine, as it contains important information. This medicine is available without a prescription. However, Cromo-ratiopharm must be used as directed in order to achieve the best possible treatment results.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 5 days, you must consult a doctor.
• If any of the side effects listed occur to a significant extent or if you notice any side effects not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.

This package leaflet contains

1. WHAT IS CROMO-RATIOPHARM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING CROMO-RATIOPHARM?
3. HOW SHOULD CROMO-RATIOPHARM BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD CROMO-RATIOPHARM BE STORED?
6. FURTHER INFORMATION

1. WHAT IS CROMO-RATIOPHARM AND WHAT IS IT USED FOR?

Cromo-ratiopharm is a combination of nasal spray and eye drops for allergic rhinitis, which occurs together with allergic conjunctivitis. Cromo-ratiopharm is used for hay fever, when allergic symptoms occur in the nose (e.g. runny nose) and eyes (e.g. itching, tears). Note: In some patients, the additional administration of decongestant nasal drops or systemic anti-allergic medication may be useful at the beginning of treatment. Please discuss with your doctor whether this applies to you.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CROMO-RATIOPHARM?

Cromo-ratiopharm must not be used if you are hypersensitive (allergic) to sodium cromoglicate (Ph.Eur.) or any of the other ingredients of the medicine (see also "Special care is required when using Cromo-ratiopharm"). Even if an allergic reaction is suspected, further contact should be avoided.

Special care is required when using Cromo-ratiopharm (eye drops)

In the case of inflammation, including allergic conjunctivitis, an ophthalmologist should be consulted as to whether contact lenses may continue to be worn despite the symptoms. If the ophthalmologist permits the wearing of contact lenses, the following should be noted: Benzalkonium chloride can cause irritation to the eyes. You must remove contact lenses before use and may not reinsert them until at least 15 minutes after use. Since the eye drops are preserved with benzalkonium chloride, soft contact lenses must not be worn.

When using Cromo-ratiopharm with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. Interactions with other medicines are not known.

Pregnancy and breast-feeding

There is no evidence from animal studies or from experience in humans to date to suggest that Cromo-ratiopharm is harmful to the foetus. Nevertheless, you should only use Cromo-ratiopharm during pregnancy if your doctor considers it necessary. The active ingredient of Cromo-ratiopharm passes into breast milk in small amounts. Therefore, you should only use Cromo-ratiopharm during breast-feeding if your doctor considers it necessary.

Driving and operating machinery

Cromo-ratiopharm (nasal spray)

No special precautions are required.

Cromo-ratiopharm (eye drops)

This medicine affects vision for a few minutes immediately after use. Before participating in road traffic, working without a secure hold or operating machinery, you should wait until the impairment of vision caused by blurred vision has passed.

Important information about certain other ingredients of

Cromo-ratiopharm (eye drops)

Benzalkonium chloride can cause irritation to the eyes. Due to the content of benzalkonium chloride, regular ophthalmological monitoring is indicated for long-term treatment.

3. HOW SHOULD CROMO-RATIOPHARM BE USED?

Always use Cromo-ratiopharm exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is

Cromo-ratiopharm (nasal spray)

Adults and children administer 1 spray of Cromo-ratiopharm (nasal spray) into each nostril up to 4 times a day. The daily dose can be increased if necessary, the frequency of application should not exceed 1 spray into each nostril 6 times a day. After a good response with stabilisation of the symptoms under therapy with Cromo-ratiopharm, an attempt can be made to reduce the dose.

Cromo-ratiopharm (eye drops)

Children and adults instill 1 drop of Cromo-ratiopharm (eye drops) into each eye 4 times a day. The daily dose can be increased by increasing the frequency of application to 1 drop 6 times a day and also doubled to 1 drop 8 times a day.

Method of administration

Cromo-ratiopharm (nasal spray) is intended for nasal use. When using for the first time, remove the protective cover, hold the spray bottle in your hand as shown in the diagram and press the spray mechanism until a fine mist is released. Insert the spray nozzle of the fine dosing device into one nostril at a time and press the spray mechanism firmly once. Replace the protective cover after each use. Cromo-ratiopharm (eye drops) is intended for use on the eye. Tilt your head back slightly. Pull the lower eyelid down with the index finger of one hand. Hold the bottle vertically above the eye (without touching the eye) and instill 1 drop into the lower conjunctival sac. Try to keep the eye open and move it so that the drop is distributed well.

Duration of use

Regular daily use is necessary as Cromo-ratiopharm does not have an immediate effect. Cromo-ratiopharm is only suitable for prevention. Therefore, treatment should be continued for as long as you are exposed to the allergens (pollen, house dust, mould spores, food allergens) after the symptoms have subsided. The therapeutic effect should be checked regularly. However, the dosing intervals can also be extended after the therapeutic effect has been achieved, as long as the symptoms remain free. If you want to use Cromo-ratiopharm for a longer period of time, you should have the need for treatment determined by a doctor. Do not use Cromo-ratiopharm for more than 5 days without medical advice. Please talk to your doctor or pharmacist if you have the impression that the effect of Cromo-ratiopharm is too strong or too weak.

If you have used more Cromo-ratiopharm than you should

Poisoning symptoms are not known for sodium cromoglicate.

If you forget to use Cromo-ratiopharm

Do not take a double dose if you have forgotten the previous application.

If you stop using Cromo-ratiopharm

If you stop treatment with Cromo-ratiopharm, your symptoms may worsen or recur. If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Cromo-ratiopharm can have side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Cromo-ratiopharm (nasal spray)

Respiratory tract: Irritation of the nasal mucosa, nosebleeds, sneezing, coughing, hoarseness.
Generalised disorders: Headache, hypersensitivity reactions (itching, shortness of breath, spasm of the bronchial muscles [bronchospasm], skin/mucosal swelling [angioedema], swelling of the larynx [laryngeal oedema]).
Other disorders: Temporary impairment of taste, mucosal defects, swelling of the tongue.

Cromo-ratiopharm (eye drops)

Occasionally, burning eyes, conjunctival swelling (chemosis), foreign body sensation and increased blood flow to the conjunctiva (conjunctival hyperaemia) may occur. Cromo-ratiopharm (eye drops) contains preservatives which can lead to side effects such as allergies and taste irritation.

Countermeasures

If symptoms are severe, especially if hypersensitivity to Cromo-ratiopharm is suspected, a doctor should be consulted.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly via the national reporting system: Bundesinstitut für Arzneimittel und Medizinprodukte, Abt. Pharmakovigilanz, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: http://www.bfarm.de. By reporting side effects, you can help provide more information about the safety of this medicine.

5. HOW SHOULD CROMO-RATIOPHARM BE STORED?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date stated on the container. The expiry date refers to the last day of the month.

Storage conditions

Cromo-ratiopharm (nasal spray) / Cromo-ratiopharm (eye drops)

No special storage conditions are required for this medicine.

Note on shelf life after opening

Cromo-ratiopharm (nasal spray)

Shelf life after opening: 6 months.

Cromo-ratiopharm (eye drops)

Shelf life after opening: 4 weeks.

6. FURTHER INFORMATION

What Cromo-ratiopharm contains

The active ingredient is sodium cromoglicate (Ph.Eur.). 1 ml nasal spray contains 20 mg sodium cromoglicate. 1 spray of the nasal spray at 0.14 ml contains 2.8 mg sodium cromoglicate. 1 ml eye drops contains 20 mg sodium cromoglicate. 1 drop at 0.034 ml contains 0.68 mg sodium cromoglicate. The other ingredients are:

Cromo-ratiopharm (nasal spray)

Sodium edetate (Ph.Eur.), sodium hydroxide solution (4%), water for injections. Preservative-free.

Cromo-ratiopharm (eye drops)

Benzalkonium chloride, sorbitol (Ph.Eur.), sodium edetate (Ph.Eur.), sodium hydroxide solution (4%), water for injections.

Contents of the pack

Cromo-ratiopharm is available as a combination pack with 15 ml nasal spray + 10 ml eye drops.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in June 2013.

Source: Information from the package leaflet
Status: 04/2017
Active ingredient: Sodium cromoglicate. Areas of application: for hay fever, when allergic symptoms occur in the nose (e.g. runny nose) and eyes (e.g. itching, tears).