50 mg / ml, granules and liquid for oral suspension . ciprofloxacin

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

  • Save this leaflet, 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, see section 4.

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

1. What Ciproxin is and what it is used for

Ciproxin contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic in the group of fluoroquinolones. Ciprofloxacin works by killing bacteria that cause infections. It only acts on specific strains of bacteria.

Adults

Ciproxin is used in adults to treat the following bacterial infections:

  • respiratory infections
  • prolonged or recurrent ear or sinus infections
  • urinary tract infections
  • infection in the genitals of men and women
  • infection in the gastrointestinal tract and infection in the abdomen
  • skin and soft tissue infections
  • the infection you in the skeleton and joints
  • to prevent infection caused by Neisseria meningitidis
  • exposure to anthrax bacteria via the respiratory tract

Ciprofloxacin can be used in the treatment of patients with low white blood cell count( neutropenia ) who have a fever suspected of being due to a bacterial infection.

If you have a serious infection or one that is caused by more than one type of bacterium, you may be prescribed additional antibiotic treatment in addition to Ciproxin.

Children and young people

Ciproxin is used in children and adolescents, at the discretion of a medical specialist, to treat the following bacterial infections:

  • lung and bronchial infections in children and adolescents suffering from cystic fibrosis
  • complicated urinary tract infections, including infection that has reached the kidneys ( pyelonephritis )
  • exposure to anthrax bacteria via the respiratory tract (suspected or confirmed)

Ciproxin can also be used to treat other particularly serious infections in children and adolescents when your doctor deems it necessary.

2. What you need to know before you use Ciproxin

Do not take Ciproxin:

  • if you are allergic to the active substance or to other quinolone medicines or any of the other ingredients of this medicine (see section 6)
  • if you are being treated with tizanidine (see section 2: Other medicines and Ciproxin)

Warnings and cautions

Before taking this medicine

You should not take antibacterial fluoroquinolone/quinolone medicines, including Ciproxin, if you have previously had any serious side effects from taking any quinolone or fluoroquinolone medicines. If this is the case, contact your doctor as soon as possible.

Talk to your doctor or pharmacist before taking Ciproxin

  • if you have ever had kidney problems because your treatment may need to be adjusted
  • if you suffer from epilepsy or other neurological diseases
  • if you have experienced tendon problems during previous treatment with an antibiotic similar to Ciproxin
  • if you are diabetic because there is a risk of you getting hypoglycemia from ciprofloxacin
  • if you have myasthenia gravis (a type of muscle weakness), as the symptoms may worsen
  • if you have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or peripheral aneurysm in a large blood vessel)
  • if you have had an aortic dissection (a rupture in the aortic wall)
  • if someone in your family has or has had an aortic aneurysm or aortic dissection or has other risk factors or conditions that increase the risk of this (eg connective tissue diseases such as Marfan’s syndrome, or vascular Ehlers-Danlos syndrome, or vascular diseases such as Takayasu’s arteritis, giant cell arteritis, Behçet’s disease, high blood pressure, or known atherosclerosis)
  • if you have heart problems. Caution should be exercised when using ciprofloxacin, if you were born with or previously had problems with prolonged QT interval(seen on ECG, the electrical activity of the heart), have an imbalance of salts in the blood (especially low levels of potassium or magnesium ), have a very slow heart rhythm (so-called bradycardia ), have a weak heart ( heart failure ), have had a heart attack (heart attack), if you are a woman or elderly or if you are taking other medicines that cause abnormal ECG changes (see section 2: Other medicines and Ciproxin)
  • if you or a family member are deficient in glucose -6-phosphate dehydrogenase (G6PD) because you are at risk of developing ciprofloxacin anemia.

To treat certain genital infections, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, you should consult a doctor.

During treatment with Ciproxin

Tell your doctor immediately if any of the following occur during treatment with Ciproxin. Your doctor will decide if you need to stop taking Ciproxin.

  • Severe, sudden allergic reaction (anaphylactic reaction / shock, angioedema ). Even with the first dose, there is a small risk that you will experience a severe allergic reaction with the following symptoms: chest tightness, dizziness, or fainting, or dizziness when you get up. If this happens, stop taking Ciproxin and contact your doctor immediately.
  • Long-term, debilitating, and potentially lasting serious side effects antibacterial fluoroquinolone/quinolone drugs, including Ciproxin, have been linked to very rare but serious side effects. Some of these have been long-lasting (up to months or years), disabling, and possibly permanent. This includes pain in tendons, muscles, and joints in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, numbness or a burning sensation ( paresthesia ), sensory disturbances in the form of impaired vision, taste, smell and hearing, depression, impaired memory, extreme fatigue, and severe sleep problems. If you suffer from any of these side effects after taking Ciproxin, you should contact your doctor immediately before continuing treatment. You and your doctor will decide if you should continue treatment or consider using another type of antibiotic.
  • In rare cases, pain and swelling in the joints and inflammation or rupture of tendons can occur. The risk is greater if you are older (over 60 years), have undergone an organ transplant, have kidney problems, or if you are being treated with cortisone ( corticosteroids ). Inflammation and tendon rupture can occur within the first 48 hours after starting treatment but also up to several months after stopping treatment with Ciproxin. At the first sign of pain or inflammation of a tendon (eg in the ankle, wrist, elbow, shoulder, or knee), stop taking Ciproxin, consult a doctor, and rest the painful area. Avoid unnecessary effort as it may increase the risk of a tendon rupture.
  • If you feel a sudden, severe pain in your stomach, chest, or back, you should immediately go to an emergency room.
  • If you suffer from epilepsy or other neurological diseases such as decreased blood flow to the brain or stroke, you may experience side effects related to the central nervous system. If you get seizures, stop taking Ciproxin and contact your doctor immediately.
  • In rare cases, you may experience symptoms of nerve damage ( neuropathy )such as pain, a burning sensation, tingling, numbness, and/or weakness, especially in the feet and legs or in the hands and arms. If this happens, stop taking Ciproxin and contact your doctor immediately to prevent the development of a possible permanent condition.
  • You may experience mental reactions the first time you take it
  • antibiotics belonging to the quinolone group, this also applies to Ciproxin. If you suffer from depression or psychosis, your symptoms may get worse during treatment with Ciproxin. In rare cases, depression or psychosis can lead to suicidal ideation and self-harming behavior such as suicide attempts or completed suicide (see section 4, Possible side effects ). Contact your doctor immediately for depression, psychosis, suicidal thoughts, or suicidal behavior.
  • Antibiotics quinolone can cause disturbances in blood sugar level, both a reduction in normal blood sugar (hypoglycemia) and an increase of the normal blood sugar level ( hyperglycemia ) (see section 4. Possible adverse s ). Disorders of blood sugar levels occur mainly in elderly diabetic patients who are on concomitant treatment with oral diabetes medicines that lower blood sugar levels (eg glibenclamide) or insulin . Loss of consciousness due to severe hypoglycemia (hypoglycaemic coma ) has been reported. If you have diabetes, your blood sugar should be monitored carefully.
  • Diarrhea can occur while you are taking antibiotics , including Ciproxin, or even several weeks after you stop taking them. If this becomes severe or persistent or if you notice blood or mucus in your stool, stop taking Ciproxin and contact your doctor immediately as this can be life-threatening. Do not take medicines that stop or reduce bowel movements.
  • If your vision becomes worse, or if your eyes are affected in any other way, contact an ophthalmologist immediately.
  • Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when you take Ciproxin. Avoid exposure to strong sunlight or artificial UV light such as tanning beds.
  • Tell your doctor or laboratory staff that you are taking Ciproxin if you are going to have a blood or urine sample.
  • Tell your doctor if you suffer from kidney problems as the dose may need to be adjusted.
  • Ciproxin can cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowish skin), dark urine, itching, or soreness in the stomach, you should contact your doctor immediately.
  • Ciproxin can cause a decrease in the number of white blood cells and your resistance to infection may be reduced. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with local symptoms of infection such as sore throat / pharynx / mouth or urinary incontinence, contact your doctor immediately. A blood sample will be taken to check for a possible decline in white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

Other medicines and Ciproxin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Do not take Ciproxin with tizanidine as it may cause side effects such as low blood pressure and fatigue (see section 2: “Do not take Ciproxin”).

It is known that the following drugs interact with Ciproxin in your body. Taking Ciproxin with these medicines may affect the therapeutic effect of these medicines. It can also increase the risk of experiencing side effects.

Tell your doctor if you are taking:

  • Vitamin K antagonist (eg warfarin, acenocoumarin, phenprocoumon or fluindione) or other anticoagulants (dilutes the blood)
  • probenecid (for gout )
  • methotrexate (for special types of cancer, psoriasis, rheumatoid arthritis )
  • theophylline (for respiratory problems)
  • tizanidine (for muscle spasticity in multiple sclerosis )
  • olanzapine (an antipsychotic )
  • clozapine (an antipsychotic )
  • ropinirole (for Parkinson’s disease )
  • phenytoin (for epilepsy )
  • metoclopramide (for nausea and vomiting)
  • ciclosporin (for skin conditions, rheumatoid arthritis, and for organ transplantation)
  • other medicines that can change your heart rhythm: medicines belonging to the antiarrhythmic group (eg quinidine, hydroquinone, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), certain antidepressants, certain bactericidal medicines (belonging to the macrolide group ), certain medicines against mental illness
  • zolpidem (for insomnia)

Ciproxin may increase the levels of the following substances in your blood:

  • pentoxifylline (for circulatory disorders)
  • caffeine
  • duloxetine (for depression, diabetic nerve disease, or incontinence )
  • lidocaine (for heart problems or anesthesia)
  • sildenafil (eg for erection problems)
  • agomelatine (for depression)

Some medicines may reduce the effect of Ciproxin. Tell your doctor if you are taking or want to take:

  • antacids
  • omeprazole
  • mineral supplements
  • sucralfate
  • phosphate-bound polymers (eg sevelamer or Tantum carbonate)
  • medicines or supplements containing calcium, magnesium, aluminum, or iron.

If these medicines are important to you, take Ciproxin about 2 hours before or no earlier than 4 hours after them.

Ciproxin with food, drink, and alcohol

Unless you are taking Ciproxin during a meal, do not eat or drink any dairy product (such as milk or yogurt) or drinks with calcium supplements when taking suspension one as it may affect the uptake of the active substance.

Pregnancy, breastfeeding, and fertility

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.

It is best to avoid taking Ciproxin during pregnancy.

Do not take Ciproxin while breast-feeding as Ciproxin is excreted in human milk and may be harmful to your baby.

Driving and using machines

Ciproxin may make you feel less alert. Some neurological side effects may occur. Do not drive or use machines until you know how you react to Ciproxin. If you are not sure, talk to your doctor. 
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.

Ciproxin contains sucrose

This medicine contains sucrose. If you are intolerant to sucrose, consult your doctor before taking Ciproxin 50 mg/ml granules and liquid for oral suspension.

As Ciproxin 50 mg/ml contains 1.4 g of sucrose per 5 ml dosing spoon, this should be taken into account when calculating daily intake. This is especially true if you are eating a diet adapted for diabetics to control your blood sugar level. This medicine can damage the teeth.

3. How to take Ciproxin

Your doctor will explain to you exactly how much Ciproxin to take as well as how often and for how long. The dosage depends on the type of infection and the severity of the infection.

Always take this medicine exactly as your doctor has told you. If you are not sure how to take Ciproxin, talk to your doctor, or pharmacist.

  • To prepare the oral suspension one (see section “Preparation and treatment with the suspension”);
  • Use the dosing spoon that comes with the bottle.

Dosage

Adults

The recommended dose of Ciproxin is usually 250 mg to 750 mg twice daily (every 12 hours) depending on the severity and type of infection:

50 mg / ml oral suspension

  • 1 dosing spoon is equal to 250 mg
  • 2 dosing spoons is equal to 500 mg
  • 3 dosing doses are equal to 750 mg (maximum dose per administration ).

Children and young people

Your doctor will calculate the appropriate dose for your child based on body weight, severity, and type of infection.

Dose one is calculated based on the child’s body weight in kilograms (kg).

The recommended dose is usually 10 to 20 mg for each kilogram of body weight per dose and each dose should be taken twice daily (every 12 hours). The highest recommended dose is 750 mg per dose.

A practical guide with the number of dosing spoons for each individual dose at each of the two daily doses of Ciproxin oral suspension per recommended dose in mg / kg body weight is given in the table below:

50 mg / ml oral suspension½ spoon = 125 mg, 1 spoon = 250 mg, 1½ spoon = 375 mg, 2 spoons = 500 mg, 2½ spoons = 625 mg, 3 spoons = 750 mg (highest dose )

Bodyweight (kg) Practical guidance for each of the two daily doses of Ciproxin oral suspension per recommended dose in mg/kg body weight

10 mg / kg 20 mg / kg
9-15 kg ½ spoon 1 spoon
16-20 kg 1 spoon 1½ spoon
21-25 kg 1 spoon 2 spoons
26-28 kg 1 spoon 2½ spoons
29-31 kg 1½ spoon 2½ spoons
32-40 kg 1½ spoon 3 spoons
41-51 kg 2 spoons 3 spoons
52-61 kg 2½ spoons 3 spoons
62 kg or more 3 spoons 3 spoons

Kidney problems

Tell your doctor if you suffer from kidney problems as your dose may need to be adjusted.

Preparation and treatment with suspension one

Use only after reconstitution: the small brown bottle contains ciproxin granules. Pour the granules into the liquid in the larger white bottle.

  1. The drug comes in 2 bottles, a small brown bottle, and a larger white bottle. The small brown bottle contains granules that should be added to the solution in the larger white bottle.
  2. Open both bottles. Press down on the childproof cap and turn left.
  3. Empty the small brown bottle containing granules into the opening of the larger white bottle of liquid. Do not add any water to the liquid. Discard the empty small brown bottle.
  4. Seal the white bottle with the liquid and the added granules, turn it aside, and shake vigorously for about 15 seconds.
  5. Shake vigorously for about 15 seconds before each dose.
  6. Enter the expiry date after reconstitution (= reconstitution date + 14 days) in the relevant area on the white bottle. The reconstituted suspension is not stable for more than 14 days even if it is stored in the refrigerator.
  7. Try to take suspension one at about the same time each day.
  8. Always use the dosing spoon provided. The full dose of Ciproxin 50 mg/ml gives you a dose of 250 mg ciprofloxacin.
  9. Do not chew the grains contained in suspension one, simply swallow them.
  10. It is okay to take a glass of water after taking a dose.
  11. You can take suspension one at meals or between meals. Taking calcium as part of a meal does not affect your uptake. However, Ciproxin suspension should not be taken with dairy products such as milk or yogurt or with fortified fruit juice (eg calcium-fortified orange juice).

Remember to drink plenty of fluids while taking this medicine.

After use, the graduated dosing spoon should be cleaned with detergent under running water, rinsed with water, and dried thoroughly with a clean paper towel. The spoon should be stored in the outer carton together with the bottle of Ciproxin oral suspension.

If you forget to take Ciproxin

  • Take the usual dose as soon as possible and then continue as prescribed. However, if it is soon time for your next dose, do not take the missed dose but continue as usual. Do not take a double dose to make up for a forgotten dose. Make sure to complete your cure.

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

If you stop taking Ciproxin

  • It is important that you complete the treatment regimen even if you start to feel better after a few days. If you stop taking this medicine too soon, your infection may be inadequately treated and the symptoms of infection may return or get worse. You may also develop resistance to the antibiotic.

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.

The following sections list the most serious side effects that you may recognize yourself:

Stop taking Ciproxin and contact your doctor immediately if you experience any of the following serious side effects so that other antibiotic treatments can be considered:

Rare (may affect up to 1 in 1,000 people):

  • Seizures (see section 2: Warnings and precautions)

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

  • Severe, sudden allergic reaction with symptoms such as pressure over the chest, dizziness, nausea, fainting, or if you feel dizzy when you get up (anaphylactic reaction/shock) (see section 2: Warnings and precautions).
  • Muscle weakness, inflammation of the tendons can lead to tendon rupture, especially in the large tendon on the back of the heel (heel tendon) (see section 2: Warnings and caution)
  • Severe life-threatening skin rash, usually in the form of blisters or sores in the mouth, pharynx, nose, eyes, and other mucous membranes such as. genitals, which can develop into widespread blistering or skin loosening (Stevens-Johnson syndrome, toxic epidermal necrolysis ).

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

  • Abnormal pain, burning sensation, tingling, numbness, or muscle weakness in the arms and legs ( neuropathy ) (see section 2: Warnings and caution)
  • A drug reaction that causes skin rash, fever, inflammation of the internal organs, altered blood count, and systemic disease (DRESS, drug reaction with eosinophilia and systemic symptoms, AGEP, acute generalized exanthematous pustulosis ).

Other side effects that have been observed during treatment with Ciproxin are listed below according to the frequency with which they occur:

Common (may affect up to 1 in 10 people):

  • nausea, diarrhea
  • joint pain and joint inflammation in children

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

  • joint pain in adults
  • fungal infections
  • a high concentration of eosinophils, a type of white blood cell
  • decreased appetite
  • hyperactivity or agitation
  • headache, dizziness, sleep problems, or taste changes
  • vomiting, abdominal pain, indigestion such as upset stomach (indigestion/heartburn) or gas in the stomach
  • increased amounts of certain substances in the blood ( transaminases and / or bilirubin )
  • rash, itching, or hives
  • poor kidney function
  • pain in muscles and bones, feeling sick ( asthenia ) or fever
  • increase in alkaline phosphatases in the blood (a special substance in the blood)

Rare (may affect up to 1 in 1,000 users):

  • muscle pain, inflammation in the joints, increased muscle tension or cramping
  • inflammation of the intestine ( colitis ) associated with antibiotic use (maybe fatal in very rare cases) (see section 2: Warnings and precautions)
  • changes in blood value ( leukopenia, leukocytosis, neutropenia, anemia ), increased or decreased amount of a blood coagulation factor ( platelets )
  • allergic reaction, swelling ( edema ), or rapid swelling of the skin and mucous membranes ( angioedema ) (see section 2: Warnings and precautions)
  • elevated blood sugar (hyperglycemia)
  • decreased blood sugar ( hypoglycemia ) (see Section 2: Precautions)
  • confusion, disorientation, anxiety, strange dreams, depression (which can lead to suicidal thoughts, suicide attempts, or completed suicide) (see section 2: Warnings and caution) or hallucinations
  • ant crawling, unusual sensation, decreased sensitivity of the skin, tremors or dizziness
  • vision problems including double vision (see section 2: Warnings and precautions)
  • tinnitus, hearing loss, hearing loss
  • palpitations, ( tachycardia )
  • dilated blood vessels ( vasodilation ), low blood pressure, or fainting
  • shortness of breath including asthmatic symptoms
  • hepatic impairment, jaundice (cholestatic jaundice), or hepatitis
  • photosensitivity (see section 2: Warnings and precautions)
  • kidney failure, blood or crystals in the urine, inflammation of the urinary tract
  • fluid retention or pronounced sweating
  • elevated levels of enzyme et amylase

Very rare

 (may affect up to 1 in 10,000 users):

  • decreased number of a special type of red blood cells ( hemolytic anemia ); a severe decline in a type of white blood cell ( agranulocytosis ) (see section 2: Warnings and precautions); decrease in the number of red and white blood cells and platelets (pancytopenia), which can be fatal, and bone marrow depression which can also be fatal
  • an allergic reaction called serum sickness reaction (see section 2: Warnings and precautions)
  • mental disorder (the psychotic reaction that can lead to suicidal ideation, suicide attempt, or completed suicide) (see section 2: Warning and caution)
  • migraine, altered coordination, unsteady gait (gait disturbance), altered sense of smell (olfactory disorder), pressure on the brain ( intracranial pressure and benign intracranial pressure increase)
  • distortion of color vision
  • inflammation of the walls of blood vessels ( vasculitis )
  • pancreatitis ( inflammation of the pancreas)
  • Liver cell death (liver necrosis) can in very rare cases lead to life-threatening liver failure (see section 2: Warnings and precautions)
  • small punctate hemorrhages under the skin ( petechiae ); various skin conditions or rashes
  • worsening of myasthenia gravis symptoms (see section 2: Warnings and precautions)

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

  • condition of decreased water excretion and low sodium levels (SIADH)
  • very excited mood (mania) or feeling of great optimism and overactivity ( hypomania )
  • abnormally fast heartbeat, life-threatening irregular heartbeat, change of heart rhythm (called “prolonged QT interval”, seen on ECG, the electrical activity of the heart)
  • effects on blood clotting ability (in patients treated with vitamin K antagonists )

In very rare cases, long-term (up to several months or years) or lasting side effects, such as tendinitis, tendonitis, joint pain, pain in arms and legs, difficulty walking, abnormal sensations such as ant crawling, tingling, tingling, a burning sensation, numbness or pain ( neuropathy ), depression, fatigue, sleep disturbances, impaired memory and impaired hearing, vision and taste and odor associated with treatment with quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors.

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 the information about the safety of the medicine.

The Medical Products Agency

Box 26

751 03 Uppsala

Website: 

5. How to store Ciproxin

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 and bottle after “EXP”. The expiration date is the last day of the specified month.

Granules: 
Do not store above 25 ° C.

Solution: 
Do not store above 25 ° C. Do not freeze. Avoid upside-down storage.

The reconstituted oral suspension is stable only for 14 days when stored in either temperature up to 30 ° C, or in a refrigerator (2 ° C-8 ° C). After this time, the reconstituted suspension should not be used. The reconstituted suspension must not be frozen.

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.


1 dosing spoon (approximately 5 ml suspension ) contains approximately 250 mg ciprofloxacin. 
½ dosing spoon (approximately 2.5 ml suspension ) contains approximately 125 mg ciprofloxacin.

The other ingredients are: 
Granules: hypromellose, magnesium stearate, polyacrylate dispersion 30%, polysorbate 20, povidone. 
Solution: Soy lecithin, triglycerides, medium chain, strawberry flavor, sucrose, purified water.

What the medicine looks like and the contents of the pack

Pack of 1 brown glass bottle containing granules and 1 white HDPE bottle containing solution, which gives 100 ml of oral suspension. 1 blue graduated dosing spoon in plastic is in the package.

Pack of 2 brown glass bottles containing granules and 2 white HDPE bottles containing solution, giving 100 ml oral suspension each. 2 blue graduated dosing spoons are in the package.

Pack of 5 brown glass vials containing granules and 5 white HDPE vials containing solution, giving 100 ml of oral suspension each. 5 blue graduated dosing spoons in plastic are in the package.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Bayer AB

Box 606

SE-169 26 Solna

Manufacturer

Bayer AG 
51368 Leverkusen 
Germany

or

Bayer HealthCare Manufacturing Srl 
Via Delle Groaned, 126 
20024 Garbagnate Milanese 
Italy

This medicinal product is authorized under the European Economic Area under the names:

Austria: Ciproxin
Belgium: Ciproxine
France: Ciflox
Germany: Ciprobay
Italy: Ciproxin
Luxembourg: Ciproxine
Netherlands: Ciproxin
UK: Ciproxin

Muhammad Nadeem

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