3mg / ml + 0.25mg / ml ear drops , solution 
ciprofloxacin / fluocinolone acetonide

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 can harm them, even if they show signs of illness 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.

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

1. What Cetraxal Comp is and what it is used for

Cetraxal Comp is a solution intended for use in the ears. It contains:

  • ciprofloxacin, an antibiotic belonging to the group fluoroquinolones. Ciprofloxacin works by killing bacteria that cause you infections
  • fluocinolone acetonide, a corticosteroid with anti-inflammatory and analgesic properties for the treatment of swelling and pain.

Cetraxal Comp is ear drops, solution. They are used in adults and children from 6 months and older for the treatment of bacterial acute external otitis ( inflammation of the outer ear) and media otitis ( inflammation of the middle ear) with ear drainage tubes (tympanostomy tubes).

You must talk to a doctor if you do not feel better or if you feel worse after treatment.

2. What you need to know before using Cetraxal Comp

Do not use Cetraxal Comp

  • if you are allergic (hypersensitive) to ciprofloxacin, other quinolones, fluocinolone acetonide, or any of the other ingredients of this medicine (listed in section 6).
  • if you have an ear infection caused by a virus or fungus.

Warnings and cautions

  • 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.
  • if you get hives, skin rash, or other allergy 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
  • Talk to your doctor if your symptoms do not improve before it is time to stop 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.Contact a doctor if you experience blurred vision or other visual disturbances.

Children and young people

There is only limited experience with the use of Cetraxal Comp in children under 6 months. Therefore, consult a doctor before giving the medicine to children at this age.

Other medicines and Cetraxal Comp

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription.

Concomitant use with other ear medicines is not recommended.

Pregnancy, breastfeeding, and fertility

There are no adequate and well-controlled studies with Cetraxal Comp in pregnant women. 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.

Caution should be exercised when using Cetraxal Comp during breast-feeding, as it is not known whether Cetraxal Comp is excreted in human milk.

Driving and using machines

Due to its properties and method of administration, Cetraxal Comp does not affect its ability to drive or use dangerous machines.

Cetraxal Comp contains methyl parahydroxybenzoate and propyl parahydroxybenzoate and may cause allergic reactions (possibly delayed).

3. How to use Cetraxal Comp

Cetraxal Comp is for ear use only.

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

The recommended dose for adults and children is 6 to 8 drops in the ear to be treated twice a day for 7 days.

Use Cetraxal Comp in both ears only if your doctor tells you to.

Your doctor will tell you how long your treatment with Cetraxal Comp should continue. To prevent an infection from returning, it is important that you do not end the treatment prematurely, even if the ear/ears feel better.

Instructions for use

The person giving Cetraxal Comp should wash their hands.

1. Heat the drops by holding the bottle in your hand for several minutes, as applying a cold solution in the ear canal can cause dizziness.

Instructions for use

2. Tilt your head so that the ear to be treated is facing upwards.

Instructions for use

3. Apply the drops in the ear using the drip tip. To avoid contamination, make sure that the drip tip does not come into contact with the ear or fingers.

Instructions for use

4. Follow the instructions below for specific patient ear infection, after the drops given: For patients with infection of the middle ear with öronrör Drain: While the patient is lying on the side, should be the person who gives Cetraxal Comp pressing gently on the skin flap at the entrance to the ear canal of a (picture 4a) 4 times with a pumping motion. This causes the droplets to pass through the tube into the eardrum and into the middle ear.

Instructions for use

For patients with an outer ear infection: While the patient is lying on his or her side, the person giving Cetraxal Comp should gently pull the outer earlobe up and back (Figure 4b). This allows the ear drops to drain into the ear canal.

Instructions for use

5. Continue to tilt your head with your ear pointing upwards for about 1 minute to give the medicine time to reach deep into the ear.

6. Repeat on the other ear if your doctor prescribes it.

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.

Save the bottle until the treatment is completed. Do not save it for further use.

If you forget to use Cetraxal Comp

Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.

If you stop using Cetraxal Comp

Do not stop using Cetraxal Comp without consulting your doctor or pharmacist. Even if the symptoms go away, it is very important that you use the drops for as long as your doctor prescribes them. If you stop treatment prematurely, it is possible that the infection will not go away and that the symptoms will return or even worsen. This can also lead to antibiotic resistance.

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.

If you get a severe allergic reaction and any of the following, stop taking this medicine and contact a doctor immediately: swelling of the hands, feet, ankles, face, lips, mouth or throat, difficulty swallowing or breathing, skin rash or hives, ulcers, stomach ulcers. 

Common (may affect up to 1 in 10 people)

Symptoms in the ear: discomfort, pain, itching

General symptoms: change in taste

Uncommon (may affect up to 1 in 100 people)

Symptoms in the ear: ringing, drug residues, blockage of drainage in the ear, tingling, pressure, hearing loss, rash, redness, fungal infection of the outer ear, discharge, swelling, eardrum, granulation tissue (lumpy and pink tissue ), contralateralmediaotitis ( inflammation of the middle ear on the opposite side).

Common symptoms: fungal ( candida ) infection, irritation, crying, dizziness, redness of the skin, headache, vomiting, fatigue.

Has been reported (occurs in an unknown number of users)

Symptoms in the eye: blurred vision.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. 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.

Läkemedelsverket 
Box 26 
751 03 Uppsala

5. How to store Cetraxal Comp

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

Do not store above 30 ° C.

Do not use this medicine after the expiry date which is stated on the label after EXP. date. or EXP.

The expiration date is the last day of the specified month.

Opened packaging must be used within one month. When opened, do not store above 25 ° C.

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 substances are ciprofloxacin in the form of ciprofloxacin hydrochloride monohydrate and fluocinolone acetonide. One milliliter of Cetraxal Comp contains 3 mg ciprofloxacin (as hydrochloride monohydrate) and 0.25 mg fluocinolone acetonide.

The other ingredients are methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), Povidone, diethylene glycol monoethyl ether, glycerin-26 (a mixture of glycerin and ethylene oxide), hydrochloric acid (E507), sodium hydroxide, and water (E524).

What the medicine looks like and the contents of the pack

Cetraxal Comp ear drops are a colorless or slightly yellow, clear aqueous solution. The ear drops are packed in white opaque plastic bottles with a drip tip.

One bottle contains 10 ml of solution.

Advice/drug information

Antibiotics are used to cure bacterial infections. They are not effective against infection caused by viruses. The antibiotic prescribed by your doctor is explicitly intended for the treatment of your current illness. Some bacteria can survive or multiply despite antibiotic treatment. This phenomenon is called resistance: some antibiotic treatments lose their effect.

Improper use of antibiotics increases the development of resistance. If you do not follow the correct dosage, treatment schedule, and duration of treatment, you can even help bacteria to become resistant, which can delay your recovery or reduce the effect of antibiotics.

Thus, follow the following instructions to preserve the effect of the medicine:

  • Use antibiotics only as prescribed by a doctor.
  • Follow the prescription carefully.
  • Do not use the antibiotic again without a doctor’s prescription even if you want to treat a similar disease.
  • Never give your antibiotic to another person. It may not be appropriate for the treatment of his / her illness.
  • After finishing treatment, you should return unused medicine to the pharmacy for proper disposal.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

POA Pharma Scandinavia AB

Box 24026

Ebbe Lieberathsgatan 21

400 22 Gothenburg


Manufacturer

Salvat Laboratories, SA

Gall, 30 – 36 – Esplugues de Llobregat

Barcelona (Spain)

Muhammad Nadeem

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