2 mg / ml ear drops solution in a single-dose ciprofloxacin container

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information.

In this leaflet: 
1. What Cetraxal is and what it is used for 
2. What you need to know before you use Cetraxal 
3. How to use Cetraxal 
4. Possible side effects 
5. How to store Cetraxal 
6. Contents of the packaging and other information 

What Cetraxal is and what it is used for

Cetraxal is a solution that is intended for use in the ears. The active substance is ciprofloxacin, an antibiotic belonging to the group fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections. Cetraxal is indicated for the treatment of acute bacterial infection of the outer ear (external otitis ) in adults and children over 1 year of age with intact eardrum (see section 2, What you need to know before using Cetraxal ).

What you need to know before you use Cetraxal

Do not use Cetraxal

  • if you are allergic to ciprofloxacin, antibiotics from the quinolone, or any other ingredients of this medicine (listed in section 6).

Warnings and cautions

  • If you get hives, skin rashes, or other allergic symptoms (eg sudden swelling of the face, neck, or eyelids, difficulty breathing) during treatment, you must stop treatment immediately and contact a doctor. Severe hypersensitivity reactions may require immediate emergency treatment.
  • This medicine should only be applied to the ear. It must not be swallowed, injected, or inhaled. It must not be used in the eye.
  • Tell your doctor if your symptoms do not improve within a week of starting treatment
  • As with other antibiotics, additional infections caused by non-ciprofloxacin-sensitive bacteria can sometimes occur. If such an infection occurs, the doctor will start appropriate treatment.
  • Caution should be exercised when using Cetraxal in patients who have or are suspected of having a ruptured eardrum, or when there is a risk of rupture of the eardrum.

Other medicines and Cetraxal

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Concomitant use of other drugs applied to the ear is not recommended.

Pregnancy, breastfeeding, and fertility

Cetraxal can be used during pregnancy and lactation.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Cetraxal does not affect the ability to drive or use dangerous machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Cetraxal

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

This medicine is intended for use in the ear. This medicine must not be swallowed, injected, or inhaled.

Dosage

The recommended dose for children (1 year or older) and adults: the contents of a single-dose container are applied to the ear twice daily for 7 days.

Instructions for use

Heat the solution by holding the single-dose container in your hand for several minutes, as applying a cold solution in the ear canal can cause dizziness.

Lie with the ear to be treated facing upwards and then apply the drops while pulling repeatedly in the outer ear. Remain in this position for about 5 minutes for the drug to reach deep into the ear canal. When you lift your head up again, a few drops may drain away. You can wipe them off with a non-sterile absorbent paper. Repeat if necessary in the other ear.

If your ear canal is narrow, you should pull your ear up to get the medicine to reach the eardrum.

For the drug to be effective, it is extremely important that you follow these instructions. If you keep your head upright while applying the drops or touch your head too quickly, some of the medicine will be lost, as the drops run on your face and do not reach deep into the ear canal.

Dispose of the single-dose container after use. Do not save it for later use.

If you use more Cetraxal than you should  

Because the preparation is packaged in a single-dose container, accidental overdose is unlikely. If an overdose occurs, you should contact your doctor or pharmacist.

If you forget to use Cetraxal

Do not take a double dose to make up for a forgotten dose.

If you forget to apply the drops, apply the correct dose as soon as you remember. If it is soon time for your next application, skip the missed dose.

If you stop using Cetraxal

It is very important that you continue to use the ear drops for as long as your doctor prescribes them, even if your symptoms have disappeared. Do not stop treatment too soon, as infection may return.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

  • ear itching, tinnitus
  • headache
  • dizziness
  • local reactions or skin irritation ( dermatitis )
  • pain at the site of application of the drug.

Very rare (may affect up to 1 in 10,000 people):

  • rash
  • blistering and tissue degradation (toxic epidermolysis)
  • redness and flaking of the skin (exfoliative dermatitis )
  • severe allergic reaction with fever, red spots, joint pain and/or eye problems ( Stevens-Johnson syndrome )
  • skin allergy with itching and hives ( urticaria ).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects ar

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase drug safety information.

The Medical Products Agency

Box 26

751 03 Uppsala

5. How to store Cetraxal

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Store in the original package. Sensitive to light.

The contents of the single-dose container should be used immediately after opening. Any unused content must be discarded.

The opened bag should be used within 8 days.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substance is ciprofloxacin (as hydrochloride).

1 ml solution contains 2 mg ciprofloxacin as hydrochloride. A single-dose container provides 0.25 ml of a solution containing 0.58 mg of ciprofloxacin hydrochloride equivalent to 0.50 mg of ciprofloxacin.

The other ingredients are povidone-K-90-F (E1201), glycerol (E422), purified water and sodium hydroxide (E524), and/or lactic acid (E270) (for pH adjustment ).

What the medicine looks like and the contents of the pack

Cetraxal is clear ear drops (solution) packaged in single-dose containers. These are packed in a protective outer bag of aluminum foil. One pack contains 15 single-dose containers.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

POA Pharma Scandinavia AB

Box 24026

Ebbe Lieberathsgatan 21

400 22 Gothenburg


Manufacturer

LLaboratorios Salvat, SA

Gall, 30 – 36 – Esplugues de Llobregat

Barcelona (Spain)

Muhammad Nadeem

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