Tarivid 200

Leaflet accompanying the packaging: information for the user

Tarivid 200

200 mg, film-coated tablets

Ofloxacin

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What Tarivid 200 is and what it is used for
• 2. Important information before taking Tarivid 200
• 3. How to take Tarivid 200
• 4. Possible side effects
• 5. How to store Tarivid 200
• 6. Contents of the packaging and other information

1. What Tarivid 200 is and what it is used for

Tarivid 200 contains the active substance ofloxacin, a medicine belonging to the group of fluoroquinolones, which acts bactericidally on bacteria causing infections.
Tarivid 200 is indicated in adults for the treatment of the following bacterial infections:

• acute pyelonephritis and complicated urinary tract infections,
• bacterial prostatitis, epididymitis and orchitis,
• pelvic inflammatory disease, in combination with other antibacterial medicines.

For the following indications, Tarivid 200 should only be used when the use of other commonly recommended antibacterial medicines for the treatment of these infections is considered inappropriate:

• uncomplicated urinary tract infections,
• urethritis,
• complicated skin and soft tissue infections,
• acute bacterial sinusitis,
• acute exacerbation of chronic obstructive pulmonary disease, including bronchitis,
• community-acquired pneumonia.

2. Important information before taking Tarivid 200

When not to take Tarivid 200 and consult a doctor

• If the patient is allergic to ofloxacin or any of the other ingredients of the tablets (listed in section 6). Symptoms of an allergic reaction include: rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• If the patient has ever had tendon swelling (tendinitis), including, for example, the wrist or Achilles tendon.
• If the patient has epilepsy or an increased risk of seizures, e.g. after a head injury, stroke or inflammatory process in the central nervous system (increased risk of seizures).
• If the patient is pregnant or breastfeeding (see "Pregnancy and breastfeeding" below).
• If the patient is under 18 years old or still growing.

Warnings and precautions

Before taking Tarivid 200

Before starting treatment with Tarivid 200, the patient should discuss with their doctor or pharmacist if they:

• have a history of seizures,
• have had a transplant,
• have had tendon disorders in their medical history, related to the administration of fluoroquinolones,
• have liver or kidney problems,
• have heart disease or arrhythmias,
• suffer from myasthenia gravis,
• suffer from diabetes and are taking oral hypoglycemic agents,
• have a blood disorder known as "glucose-6-phosphate dehydrogenase deficiency",
• are taking anticoagulant medicines,
• have currently or have had mental health problems in the past,
• have been diagnosed with a large blood vessel aneurysm or a large peripheral artery aneurysm,
• have had aortic dissection (tear in the aortic wall) in the past,
• have been diagnosed with heart valve problems,
• have a family history of aortic aneurysm or aortic dissection or congenital heart valve disease, or other risk factors or conditions (e.g. Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Sjögren's syndrome [autoimmune inflammatory disease] or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension or confirmed atherosclerosis, rheumatoid arthritis [joint disease] or endocarditis [heart infection]).

Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Tarivid 200, if the patient has experienced any severe side effects while taking a quinolone or fluoroquinolone in the past. In such a situation, the doctor should be informed as soon as possible.
In the event of sudden severe abdominal, back or chest pain, the patient should immediately go to the emergency department. The risk of these changes may be higher in patients treated with systemic corticosteroids.
If the patient experiences sudden shortness of breath, especially when lying down, or notices swelling of the ankles, feet or abdomen, or palpitations (feeling of rapid or irregular heartbeat), they should immediately consult a doctor.
Especially in the case of severe infections or lack of response to treatment, due to the risk of resistance, the doctor will recommend a microbiological examination of the isolated bacterial strain and determine its sensitivity.
In patients taking fluoroquinolones, including ofloxacin, there have been reports of excessive or low blood sugar levels. In diabetic patients taking oral hypoglycemic agents (e.g. glibenclamide) or insulin, cases of hypoglycemic coma have been reported. In diabetic patients, the doctor will recommend close monitoring of blood sugar levels.
Rarely, joint or muscle pain and tendon inflammation or rupture may occur. The risk is increased in elderly patients (over 60 years old), after organ transplantation, in the presence of kidney problems or corticosteroid treatment. Tendon inflammation and rupture can occur within 48 hours of starting treatment and may occur up to several months after stopping treatment with Tarivid 200. After the first symptoms of pain or tendon inflammation appear (e.g. in the ankle, wrist, elbow, shoulder or knee), the patient should stop taking Tarivid 200, consult a doctor and rest the affected area. The patient should avoid excessive strain, as this may increase the risk of tendon rupture.
The patient may rarely experience symptoms of nerve damage (neuropathy), such as pain, burning, tingling, numbness or weakness, especially in the feet and legs and hands and arms. In such a case, the patient should stop taking Tarivid 200 and immediately inform their doctor to prevent the development of potentially irreversible disease.
Long-term, debilitating and potentially irreversible severe side effects
Antibacterial medicines containing fluoroquinolones and/or quinolones, including Tarivid 200, have been associated with very rare but severe side effects. Some of these have been long-term (lasting for months or years), debilitating or potentially irreversible.
These include: tendon pain, muscle pain and joint pain in the upper and lower limbs, walking difficulties, abnormal sensations such as tingling, burning, itching, numbness or pain (paresthesia), fatigue, memory and concentration disorders, mental health effects (which can include sleep disorders, anxiety, panic attacks, depression and suicidal thoughts) and sensory disorders, including vision, taste and smell and hearing disorders.
If any of these side effects occur after taking Tarivid 200, the patient should immediately consult their doctor before continuing treatment. The patient and doctor will decide whether to continue treatment, also taking into account antibiotics from another group.

Effect on laboratory test results

If the patient is to have a urine test, they should inform their doctor that they are taking Tarivid 200. Tarivid 200 may affect the results of some urine tests (e.g. false positive result for opioids and porphyrin).
If the patient is to have tuberculosis tests, they should inform their doctor that they are taking Tarivid 200. Tarivid 200 may inhibit the growth of Mycobacterium tuberculosis and therefore the result of the bacteriological test for tuberculosis may be false negative.

Tarivid 200 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Tarivid 200 and some other medicines may interact with each other.
If the patient is taking other medicines that may affect heart rhythm, such as anti-arrhythmic medicines (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, certain antibacterial medicines (belonging to the macrolide group) or certain antipsychotic medicines, they should inform their doctor.

The following medicines may change the way Tarivid 200 works or Tarivid 200 may change the way some of the following medicines work:

• methotrexate, used in rheumatic or cancerous diseases,
• anticoagulant medicines,
• iron-containing medicines (used for anemia) or zinc,
• medicines used to treat mental disorders,
• diuretic medicines, such as furosemide,
• antacids containing magnesium or aluminum (used for indigestion),
• glibenclamide (used in diabetes),
• probenecid (used in gout),
• cimetidine (used in stomach ulcers or indigestion),
• sucralfate (used in stomach ulcers).

The following medicines, taken at the same time as Tarivid 200, may increase the risk of side effects:

• other antibiotics (such as: erythromycin, azithromycin or clarithromycin),
• medicines used in depression (such as: amitriptyline, clomipramine or imipramine),
• theophylline (used in respiratory disorders),
• medicines used to regulate heart rhythm (such as: amiodarone, quinidine, procainamide or disopyramide),
• medicines used in the treatment of mental disorders,
• fenbufen or non-steroidal anti-inflammatory drugs (NSAIDs) used to relieve pain and inflammation (such as: ibuprofen, diclofenac or indomethacin).

Taking Tarivid 200 with food and drink

The tablets can be taken on an empty stomach or after a meal. A 2-hour interval should be maintained between taking Tarivid 200 and antacids.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The patient should not take Tarivid 200 if:

• they are pregnant, plan to become pregnant or think they may be pregnant
• they are breastfeeding or plan to breastfeed.

Driving and using machines

While taking Tarivid 200, the patient may feel drowsy, have balance disorders or dizziness or may have vision disturbances. If the patient experiences such symptoms, they should not drive a car, operate any tools or machines.

Tarivid 200 contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Tarivid 200.

3. How to take Tarivid 200

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.

How and when to take Tarivid 200

• The medicine should be taken orally.
• The tablets should be swallowed whole, with a glass of water.
• During treatment with Tarivid 200, the patient should avoid strong sunlight and not use sunlamps or solarium.
• Medicines containing iron (for anemia), antacids (for indigestion or heartburn) or sucralfate (used in stomach ulcers) should not be taken within 2 hours before and after taking Tarivid 200.
• If the patient feels that the effect of the medicine is too strong or too weak, they should consult their doctor. The patient should not change the dosage of the medicine themselves.
• The duration of treatment depends on the severity of the infection.
• In severe infections, usually 7 to 10 days are sufficient. Treatment should not last longer than 2 months.
• Daily doses are usually divided into two equal doses (morning and evening). Equal intervals (12 hours) should be maintained between doses taken during the day.
• Doses up to 400 mg can be taken as a single dose, in the morning. Higher doses should be taken as two separate doses, in the morning and evening, approximately every 12 hours.

What dose of Tarivid 200 to take

• The doctor will decide how many Tarivid 200 tablets the patient should take and how often, as well as how long the treatment should last.
• The dose of the medicine depends on the type of infection and its severity.

Usually, the dose for adults, including elderly patients, is from 200 mg to 400 mg per day. The dose depends on the location and type of infection.

In some cases, the doctor may recommend a higher daily dose of the medicine (600 mg or even 800 mg).

Elderly patients

In elderly patients, special attention should be paid to kidney function. The doctor will adjust the dosage accordingly. See also section 2 "Heart disorders".

Kidney disorders

If the patient has any kidney problems, the doctor may recommend a lower dose of Tarivid 200.

Liver function disorders

In patients with severe liver function disorders (such as liver cirrhosis with ascites), the elimination may be reduced, so it is not recommended to administer a higher daily dose than 400 mg.

Use in children and adolescents

Tarivid 200 should not be used in children and adolescents.

Taking a higher dose of Tarivid 200 than recommended

In the event of taking a higher dose of Tarivid 200 than recommended, the patient should immediately consult a doctor or go to the nearest hospital emergency department, as specialized medical help may be necessary. The patient should take the medicine packaging with them, so that the doctor knows what medicine was taken. Symptoms may include: feeling disoriented, dizziness, loss of consciousness, seizures, nausea or blood in the stool. After the medicine was introduced to the market, the following neurological symptoms have been observed: feeling disoriented, seizures, seeing, feeling or hearing things that do not exist (hallucinations) and tremors.

Missing a dose of Tarivid 200

If the patient forgets to take a dose of Tarivid 200, they should take it as soon as they remember. However, if it is almost time for the next dose, the patient should skip the missed dose. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Tarivid 200

Tarivid 200 should be taken for as long as the doctor has prescribed. The patient should not stop taking Tarivid 200 even if they feel better. If the patient stops taking the medicine, the infection may recur.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

If any of the following side effects occur, the patient should stop taking Tarivid 200 and immediately consult their doctor or go to the nearest hospital emergency department (see also "Warnings and precautions" in section 2)

• Severe allergic reaction, manifested by rash, difficulty breathing, swelling of the lips, face, throat or tongue (anaphylactic shock).
• Very severe allergic reaction, called "anaphylactic shock", manifested by weakness, fainting, difficulty breathing or swelling of the face.
• Severe skin reaction with blistering of the skin, peeling of the skin around the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), widespread peeling of the skin (toxic epidermal necrolysis), painful redness of the skin with blisters and rash (erythema multiforme).
• Heart rhythm disorders (irregular heartbeat), which can be life-threatening (ventricular arrhythmia).
• Muscle breakdown (rhabdomyolysis): widespread muscle pain, muscle sensitivity to touch, which may be accompanied by fever, fatigue and worsening of kidney function.
• Hepatitis: yellowing of the skin and whites of the eyes, dark urine, itching, pain or tenderness in the abdomen.
• Diarrhea, especially severe, watery, with blood or mucus, abdominal pain and/or fever (pseudomembranous colitis).
• Sudden severe abdominal, back or chest pain.
• Coma caused by low blood sugar (hypoglycemic coma). This is important in diabetic patients.
• Low blood sugar (hypoglycemia) in diabetic patients taking oral hypoglycemic agents; symptoms may include: weakness, irritability, sweating and/or tremors.

In patients receiving fluoroquinolones, cases of aortic aneurysm or aortic dissection (a tear in the aortic wall) have been reported, which can be fatal, as well as cases of heart valve problems. See also section 2.
The administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors, has very rarely caused long-term (lasting for months or years) or permanent side effects, such as tendonitis, tendon rupture, joint pain, limb pain, walking difficulties, abnormal sensations such as tingling, burning, itching, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory and concentration disorders, as well as hearing, vision, taste and smell disorders (see "Warnings and precautions" in section 2).

The patient should consult their doctor if any of the following side effects worsen or persist for more than a few days:

Uncommon (occurring in less than 1 in 100 patients)

• Fungal infections, secondary infections with resistant microorganisms
• Agitation, sleep disorders, sleep problems
• Dizziness, headache
• Eye irritation
• Balance disorders
• Cough, inflammation of the nose and throat
• Abdominal pain, diarrhea, nausea, vomiting
• Itching, rash

Rare (occurring in less than 1 in 1,000 patients)

• Anaphylactic reaction - a very severe allergic reaction, manifested by weakness, fainting, difficulty breathing or swelling of the face
• Anaphylactoid reaction - an immediate reaction affecting the whole body, similar to anaphylaxis
• Anaphylactic shock - a severe allergic reaction, manifested by rash, difficulty breathing, swelling of the lips, face, throat or tongue
• Lack of appetite
• Feeling of confusion or anxiety, nightmares, psychotic disorders, e.g. seeing, feeling or hearing things that do not exist (hallucinations), depression
• Drowsiness
• Numbness or tingling of hands and feet
• Change or loss of taste and smell
• Vision disorders
• Fast heartbeat (tachycardia)
• Fainting, confusion or dizziness caused by low blood pressure
• Shortness of breath, bronchospasm
• Colitis [symptoms include: watery diarrhea with blood or mucus, abdominal pain and/or fever]
• Increased liver enzyme activity and/or bilirubin levels, as shown in blood tests
• Hives, hot flashes, excessive sweating, pustular rash
• Swelling and pain in the tendon area due to inflammation
• Increased creatinine levels in the blood
• Memory disorders
• Acute confusion (delirium)
• Seeing or hearing things that do not exist (hallucinations, paranoia), changes in opinion and thought (psychotic reactions) with a risk of suicidal thoughts or attempts.

Very rare (occurring in less than 1 in 10,000 patients)

• Feeling of fatigue, fainting, dizziness and paleness; these may be symptoms of anemia (red blood cell deficiency)
• Blood disorders, such as decreased white blood cell count (leukopenia) or platelet count (thrombocytopenia); this may lead to weakness, easy bruising or increased susceptibility to infections
• Increased number of a certain type of white blood cells called eosinophils (eosinophilia)
• Anaphylactic shock - a rapid-onset, life-threatening allergic reaction
• Anaphylactoid shock - a rapid-onset, life-threatening reaction affecting the whole body, similar to anaphylaxis
• Nervous system disorders (weakness, numbness or tingling)
• Tremors and increased or decreased muscle tone, slow movement, reduced movement and other muscle coordination disorders
• Seizures
• Tinnitus, hearing loss
• Diarrhea, especially severe, watery, with blood or mucus, abdominal pain and/or fever (pseudomembranous colitis)
• Jaundice (yellowing of the skin and whites of the eyes)
• Painful redness of the skin with blisters and rash (erythema multiforme)
• Widespread peeling of the skin (toxic epidermal necrolysis)
• Photosensitivity reactions (allergic reactions to sunlight)
• Vasculitis, often with red or purple raised spots on the skin, which can lead to skin necrosis
• Joint and muscle pain
• Tendon rupture, e.g. Achilles tendon rupture, which can occur within 48 hours of starting treatment and may be bilateral
• Acute kidney failure, which can cause kidney failure; symptoms may include rash, high fever and generalized pain

Frequency not known (frequency cannot be estimated from the available data)

• Complete or almost complete disappearance of granulocytes from the blood (agranulocytosis), which can lead to increased susceptibility to infections
• Feeling of weakness, easy bruising and increased susceptibility to infections; this may be due to a decrease in the number of all blood cells, inhibition of bone marrow function
• Increased blood sugar levels (hyperglycemia)
• Severe depression or psychotic disorders; in some patients with depression, suicidal thoughts or attempts may occur
• Nervousness
• Tremors, uncontrolled and involuntary movements of the limbs or whole body (dyskinesia)
• Lack of taste, fainting
• Eye inflammation (uveitis)
• Hearing disorders
• Heart disorders
• very fast heartbeat,
• life-threatening irregular heartbeat,
• heart rhythm disorder (called "QT interval prolongation", visible in ECG - a test of heart electrical activity)
• Increased shortness of breath, allergic pneumonia causing shortness of breath, cough and fever
• Nausea, bloating, constipation
• Pancreatitis
• Hepatitis, sometimes severe
• Lack of appetite, yellowing of the skin and whites of the eyes, dark urine, itching, abdominal pain. These may be symptoms of liver function disorders, which can lead to liver failure and death
• Severe skin reaction with blistering of the skin, peeling of the skin around the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome)
• Red, scaly rash with thickening under the skin and blisters, drug rash
• Oral inflammation
• Redness of the skin with intense peeling (exfoliative dermatitis)
• Widespread muscle pain, muscle sensitivity to touch, which may be accompanied by fever, fatigue and worsening of kidney function - muscle breakdown (rhabdomyolysis)
• Pain or weakness of the muscles, which may be particularly important in patients with myasthenia gravis (see "Warnings and precautions")
• Muscle rupture
• Ligament rupture
• Arthritis
• Acute interstitial nephritis, which can cause swelling of the ankles or high blood pressure
• Porphyria attacks (a rare disease affecting metabolism) in patients with porphyria
• Weakness, fever, pain (including back, chest and limb pain)
• Persistent headache with blurred vision (benign intracranial hypertension).

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder or its representative in Poland.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tarivid 200

Store at a temperature below 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Tarivid 200 contains

• Each tablet contains 200 mg of ofloxacin as the active substance.
• The other ingredients of the tablets are: cornstarch, lactose monohydrate, hydroxypropylcellulose, carmellose, magnesium stearate, methylhydroxypropylcellulose, macrogol 8000, talc, titanium dioxide (E 171).

What Tarivid 200 looks like and what the packaging contains

Tarivid 200 is a white to yellowish, biconvex, oblong film-coated tablet with a dividing line on both sides and the inscription "MXI" and the Hoechst logo on both sides.
It is packaged in PVC/Aluminum blisters. Each package contains 10 tablets (1 blister of 10 tablets) or 20 tablets (2 blisters of 10 tablets), in a cardboard box.

Marketing authorization holder and manufacturer

Marketing authorization holder
Sanofi-Aventis Deutschland GmbH
Brüningstrasse 50
D-65926 Frankfurt am Main, Germany
Manufacturer
Opella Healthcare International SAS
56, Route de Choisy
60200 Compiègne
France
The leaflet does not contain all the information about the medicine. In case of any questions or doubts, the patient should consult their doctor or pharmacist.
To obtain more detailed information about this medicine, the patient should contact the local representative of the marketing authorization holder in Poland:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Phone: +48 22 280 00 00
Date of last revision of the leaflet:April 2025