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What Ciprinol is and what it is used for
Ciprinol is an antibiotic belonging to the group of fluoroquinolones. The active substance is ciprofloxacin. Ciprofloxacin works by destroying the bacteria that cause infections. It only works on specific types of bacteria.
Ciprinol is used to treat the following bacterial infections in adults:
respiratory tract infections;
prolonged or recurrent infections of the nose and sinuses;
urinary tract infections;
infections of female and male genital organs;
gastrointestinal and abdominal infections;
skin and subcutaneous tissue infections;
infections of bones and joints;
for inhalation exposure to anthrax.
Ciprofloxacin can be used in the treatment of patients with low white blood cell counts (neutropenia) who have a fever suspected of being caused by a bacterial infection.
If you have a severe infection or one caused by more than one type of bacteria, you may also be given another antibiotic for treatment with Ziprinol.
Children and adolescents
Ziprinol is used in children and adolescents only under medical supervision to treat the following infections:
pulmonary and bronchial infections in children and adolescents suffering from cystic fibrosis;
complicated urinary tract infections, including infections affecting the kidneys (pyelonephritis);
after inhalation exposure to anthrax.
Ziprinol can also be used to treat other specific severe infections in children and adolescents when your doctor thinks it is necessary.
2. What you need to know before using Ziprinol
Do not use Ziprinol:
if you are allergic (hypersensitive) to the active substance, other quinolone medicines or any of the other ingredients of this medicine (listed in section 6);
if you are taking tinazidine (see section 2 "Other medicines and Ziprinol").
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Ziprinol.
Before you are given Ciprinol
Tell your doctor if:
have or have had kidney problems because your treatment needs to be corrected;
you suffer from epilepsy or other neurological conditions;
you have had problems with the tendons during previous treatment with antibiotics such as Ciprinol;
you are a diabetic because you may be at risk of hypoglycaemia during treatment with ciprofloxacin;
you suffer from myasthenia gravis (a type of muscle weakness), as you may experience worsening of your symptoms;
you have heart problems. Caution should be exercised when using this type of medicine if you are born with or have a family history of QT prolongation (can be seen from ECG, electrical heart burn), have salt imbalance in the blood (especially low potassium levels or heartburn), have a very slow heartbeat (called bradycardia), have a weak heart (heart failure), a history of heart attack (myocardial infarction), are female or elderly, or are taking other medicines, which lead to abnormal changes ECG (see. Section "Other medicines and Tsiprinol");
or a member of your family is known to be deficient in glucose-6-phosphate dehydrogenase (G6PD) because there may be a risk of anemia during treatment with ciprofloxacin.
For the treatment of some infections in the genital tract, your doctor may prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in the symptoms after 3 days of treatment, please consult your doctor.
While you are being treated with Ciprinol
Tell your doctor straight away if any of the following events occur during treatment with Ziprinol. Your doctor will decide whether treatment with Ciprinol should be stopped:
Severe, suddenly occurring allergic reaction (anaphylactic reaction, shock, angioedema). Even after the first dose, there is little chance of developing a severe allergic reaction with the following symptoms: chest tightness, dizziness, exhaustion or fainting, or feeling dizzy when standing up. If this happens, tell your doctor immediately as the use of Ciprinol should be stopped;
Sometimes pain or swelling of the joints and inflammation of the tendon may occur, especially if you are elderly and if you are being treated with corticosteroids. Some symptoms may occur even within a few months after you stop taking ciprofloxacin. At the first signs of some pain or inflammation, Ciprinol should be discontinued to provide rest for the affected limb. Avoid physical stresses as they can increase the risk of tearing;
If you suffer from epilepsy or other neurological disease such as cerebral ischaemia or stroke, you may experience side effects from the central nervous system. If this happens, stop taking Ciprinol and contact your doctor immediately.
You may experience mental reactions even if you initially take Ziprinol. If you suffer from depression or psychosis, your symptoms may get worse during treatment with Ciprinol. If this happens, stop taking Ciprinol and contact your doctor immediately;
You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and / or weakness. If this happens, stop taking Ziprinol and contact your doctor immediately;
Hypoglycaemia is most commonly reported in patients with diabetes, especially in the elderly. If this happens, contact your doctor immediately.
You may get diarrhea while taking antibiotics, including Ziprinol, or even a few weeks after you stop using them. If it becomes severe or prolonged or you notice that there is blood or mucus in your stools, stop taking Cipryl immediately, as this may be life-threatening. Do not take any medicine that stops or slows down the motor cycle;
If eye damage occurs or your eyes are affected in any way, consult an ophthalmologist immediately;
Your skin becomes more sensitive to sunlight or ultraviolet rays (UVL) when taking Ziprinol. Avoid exposure to strong sunlight or artificial UV light such as, for example, solarium;
Tell your doctor or lab instructor that you are using Ciprinol if you have to have blood and urine tests;
If you suffer from kidney problems, tell your doctor as your dose may need to be adjusted;
Ciprinol may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching or stomach pain, stop taking Ziprinol and contact your doctor immediately;
Ziprinol may cause a decrease in the number of white blood cells and weaken your resistance to infections. If you develop an infection with symptoms such as fever and severe worsening of your general condition, or fever with local symptoms of infection such as throat / pharynx / mouth or urinary problems, you should consult your doctor immediately. You will be given a blood test to check for a possible decrease in the number of white blood cells (agranulocytosis). It is important to tell your doctor about the medicine you are taking.
Other medicines and Ciprinol
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not use Ciprinol at the same time as tizanidine, as this may cause side effects such as low blood pressure and drowsiness (see section 2 "Do not use Ziprinol").
It is known that the following drugs interact with Ziprinol in your body. When using Ziprinol with these medicines, it can affect their therapeutic effect. It can also increase the chance of side effects.
Tell your doctor if you are taking:
antagonists of Vitamin K (for example warfarin, acenocoumarol, phenprocoumon or fluindion) or other anticoagulants (medicines that reduce blood clotting);
probenecid (for gout);
methotrexate (for some types of cancer, psoriasis, rheumatoid arthritis);
theophylline (for breathing problems);
tizanidine (for muscular stiffness in multiple sclerosis);
clozapine, olanzapine (antipsychotic);
ropinirole (for Parkinson's disease);
phenytoin (for epilepsy);
ciclosporin (prevents rejection of organs after transplantation);
other medicines that can change heart rate: medicines that belong to the group of antiarrhythmic agents (eg quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antimicrobials (belonging to the group of macrolides ), some antipsychotics.
Ciprinol may increase your blood levels of the following medicines:
pentoxifylline (for circulatory disorders);
lidocaine (local anesthetic);
sildenafil (for erectile problems);
Ziprinol with food, beverages and alcohol
Food and beverages do not affect your treatment with Ciprinol.
Pregnancy, breastfeeding and fertility
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
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.
Common side effects (may affect up to 1 in 10 people):
nausea, diarrhea, vomiting;
joint pain in children;
local reactions at the injection site, rash;
a temporary increase in the amount of certain substances in the blood.
Uncommon side effects (may occur in up to 1 in 100 people):
fungal super infections;
increasing the concentration of eosinophils, a type of white blood cell, increasing or decreasing the amount of factors affecting blood clotting (platelet);
loss of appetite (anorexia);
hyperactivity, restlessness, confusion, disorientation, hallucinations headache, dizziness, sleep problems, taste disturbances, tingling and numbness, unusual sensitivity to stimulation of the senses, convulsions (see section 2 "Warnings and precautions"), dizziness;
visual problems (diplopia);
accelerated heart beating (tachycardia);
blood vessel enlargement (vasodilatation), lowering of blood pressure;
abdominal pain, digestive problems such as indigestion (indigestion / heartburn), liver disorders, increase in the amount of a substance in the blood (bilirubin), jaundice (cholestatic jaundice);
joint pain in adults;
impairment of renal function, renal insufficiency;
pain in muscles and bones, feeling unwell (asthenia), fever, fluid retention;
increased blood alkaline phosphatase (a substance in the blood).
Rare side effects (may occur in up to 1 in 1,000 people):
inflammation of the intestine (colitis) associated with antibiotic use (in rare cases may be fatal) (see section 2 "Warnings and Precautions");
changes in the number of blood cells (leucopenia, leukocytosis, neutropenia, anemia), a decrease in the number of red and white blood cells and platelets (pancytopenia), which may be fatal, damage to the bone marrow, which can also be fatal point 2 "Warnings and precautions");
allergic reactions, allergic edema (edema), rapid swelling of the skin and mucous membranes (angioedema), severe allergic reactions (anaphylactic shock) that may be life-threatening (see section 2 "Warnings and Precautions");
increased blood sugar (hyperglycaemia);
decreased blood sugar (hypoglycaemia) (see section 2: "Warnings and precautions");
anxiety reactions, nightmares, depression, mental disorders (psychiatric reactions) (see section 2 "Warnings and Precautions");
decreased skin sensitivity, tremor, migraine, abnormal sense of smell (olfactory disorders);
tinnitus, hearing loss;
inflammation of the blood vessels (vasculitis);
lack of air, including asthmatic symptoms;
hepatic disease, liver cell death (hepatic necrosis), which very rarely leads to life-threatening liver failure (see section 2 "Warnings and Precautions");
small, punctate skin bleeds (petechiae);
muscular pain, joint inflammation, increased muscle tone, muscle stiffness, tendon rupture - mainly the large tendon on the back of the ankle (Achilles tendon) (see section 2 "Warnings and Precautions");
blood or urine crystals (see section 2 "Warnings and Precautions"), inflammation of the urinary tract;
increased values of the amylase enzyme.
Very rare side effects (may affect up to 1 in 10,000 people):
reduction of a specific type of red blood cells (haemolytic anemia); a dangerous reduction in the number of one type of white blood cell (agranulocytosis);
severe allergic reactions (anaphylactic reactions, anaphylactic shock, serum sickness), which may be fatal (see section 2 "Warnings and Precautions");
disturbed coordination, unsteady gait (gait disturbances), pressure on the brain (intracranial pressure);
visual color change;
various skin irritations or rashes (eg, a potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis);
muscle weakness, tendon inflammation, worsening symptoms of myasthenia gravis (see section 2 "Warnings and Precautions").
Not known (can not be estimated from the available data):
problems with the nervous system such as pain, burning, numbness, numbness and / or weakness in the limbs;
abnormally fast heart rhythm, life-threatening, irregular heartbeat, change in heart rate (called "QT prolongation",
How to store ciprinol
Keep out of the reach and sight of children.
This medicinal product does not require any special storage conditions. Store in the original package in order to protect from light.
The solution should not be frozen.
Do not use this medicine after the expiry date which is stated on the pack after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines in the sewage system or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What ciprinol contains
The active substance is ciprofloxacin such as ciprofloxacin lactate (ciprofloxacin lactate).
Solution for infusion
50 ml, 100 ml and 200 ml solution for infusion (1 vial) contains 100 mg, 200 mg and 400 mg of ciprofloxacin, respectively. 1 ml infusion solution contains 2 mg of ciprofloxacin.
The other ingredients of the infusion solutions are: sodium lactate, sodium chloride, concentrated hydrochloric acid (E-507) for pH adjustment and water for injections.
What ciprinol looks like and contents of the pack
Solution for infusion
The infusion solution is a clear, yellow-green solution.
It is supplied in 1 box of 50 ml (100 mg / 50 ml), 100 ml (200 mg / 100 ml) or 200 ml of infusion solution (400 mg / 200 ml) in cartons.
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