Package Insert: Information for the Patient

Doriman 500 mg Film-Coated Tablets

ciprofloxacin

Doriman is an antibiotic that belongs to the family of fluoroquinolones. The active ingredient is ciprofloxacin. Ciprofloxacin acts by eliminating the bacteria that cause infections. It only acts on specific strains of bacteria.

Adults

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

• Respiratory tract infections
• Long-term or recurrent ear or sinus infections
• Urinary tract infections
• Male and female genital tract infections
• Gastrointestinal and intrabdominal infections
• Bone and joint infections
• Skin and soft tissue infections
• Prevention of infections caused by the bacteria Neisseria meningitidis
• Exposure to anthrax by inhalation

In the event of a severe infection or if the infection is caused by more than one type of bacteria, it is possible that you will be administered an additional antibiotic treatment, in addition to Doriman.

Children and adolescents

Ciprofloxacin is used in children and adolescents, under specialized medical supervision, to treat the following bacterial infections:

• Pulmonary and bronchial infections in children and adolescents with cystic fibrosis
• Complicated urinary tract infections, including kidney infections (pyelonephritis)
• Exposure to anthrax by inhalation

Ciprofloxacin may also be used to treat severe infections in children and adolescents when necessary.

Do not take Doriman:

• If you are allergic to ciprofloxacin or other quinolones or to any of the other components of this medication (listed in section 6).
• If you are taking tizanidine (see section 2).

Warnings and precautions

Do not take antibacterial medications that contain fluoroquinolones or quinolones, including ciprofloxacin, if you have had a severe reaction to a quinolone or fluoroquinolone in the past. If this is the case, inform your doctor as soon as possible.

Consult your doctor before starting to take Doriman:

• If you have ever had kidney problems, as your treatment may need to be adjusted.
• If you have epilepsy or other neurological conditions.
• If you have a history of tendon problems during previous antibiotic treatment with Doriman.
• If you have myasthenia gravis (a type of muscle weakness).
• If you have a history of abnormal heart rhythms (arrhythmias).
• If you have been diagnosed with an aneurysm of a large artery (aortic aneurysm or aneurysm of a large peripheral artery).
• If you have had a previous episode of aortic dissection (tear in the aorta).
• If you have been diagnosed with heart valve insufficiency (regurgitation of heart valves).
• If you have a family history of aortic aneurysm or aortic dissection, congenital heart valve disease, or other risk factors or predisposing conditions (e.g., Marfan syndrome or Ehlers-Danlos vascular syndrome, Turner syndrome or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or known atherosclerosis, rheumatoid arthritis (a joint disease) or endocarditis (a heart infection)).

During treatment with this medication

Inform your doctor immediately if any of the following situations occur while taking Doriman:

• Severe and sudden allergic reaction(anaphylactic reaction or angioedema). There is a reduced possibility that, even with the first dose, you may experience a severe allergic reaction, with the following symptoms: chest tightness, dizziness, nausea, or fainting, or experiencing dizziness when standing up. If this happens, do not take any more Doriman and contact your doctor immediately.

• Severe, incapacitating, prolonged, and potentially irreversible adverse effects.Antibacterial medications that contain fluoroquinolones or quinolones, including Doriman, have been associated with rare but severe adverse effects, some of which were of long duration (persistent for months or years), incapacitating, or potentially irreversible. This includes tendon pain, muscle and joint pain in the upper and lower extremities, difficulty walking, abnormal sensations such as pins and needles, numbness, tingling, or burning (paresthesia), sensory disorders such as decreased vision, taste, smell, and hearing, depression, decreased memory, intense fatigue, and severe sleep disorders.

If you experience any of these adverse effects after taking Doriman, contact your doctor immediately, before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering the use of another class of antibiotic.

• In rare cases, you may experiencejoint pain and swelling, and inflammation or rupture of tendons. The risk is higher if you are an older adult (over 60 years), have received an organ transplant, have kidney problems, or are taking corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping Doriman. If you experience any pain or inflammation in a tendon (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Doriman, contact your doctor, and keep the affected area at rest. Avoid any unnecessary exercise, as this may increase the risk of tendon rupture.

• If you haveepilepsy or another neurological condition, such as ischemia or cerebral infarction, you may experience adverse effects associated with the central nervous system. If this occurs, stop taking Doriman and contact your doctor immediately.

• You may experiencepsychiatric reactionswhen taking ciprofloxacin for the first time. If you have depression or psychosis, your symptoms may worsen with Doriman treatment. If this occurs, stop taking Doriman and contact your doctor immediately.

In rare cases, you may experience symptoms ofnerve damage (neuropathy), such as pain, burning, numbness, tingling, and/or weakness, especially in the feet and legs or hands and arms. If this happens, stop taking Doriman and inform your doctor immediately to prevent the development of a potentially irreversible condition.

• If you experience asevere and sudden chest pain, abdominal pain, or back pain, which may be symptoms of aortic dissection or aneurysm, go to the emergency department immediately. The risk may be increased if you are taking systemic corticosteroids.

• If you start experiencing sudden shortness of breath, especially when lying down, or if you notice swelling in your ankles, feet, or abdomen, or palpitations (a rapid or irregular heartbeat), inform your doctor immediately.

• You may developdiarrheawhile taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If the diarrhea becomes intense or persistent, or if you notice blood or mucosities in your stool, stop taking Doriman immediately, as this may put your life at risk. Do not take medications that slow down or delay bowel movements and consult your doctor.

• Inform your doctor or laboratory personnel if you are taking Doriman when you need to undergoblood or urine tests.

• Ciprofloxacin may causeliver damage. If you notice symptoms such as loss of appetite, jaundice (yellow skin), dark urine, itching, or stomach pain, stop taking Doriman immediately and consult your doctor immediately.

• Ciprofloxacin may cause a decrease in white blood cell count and mayreduce your resistance to infections. If you experience an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as throat pain, or urinary problems, consult your doctor immediately. They will perform a blood test to examine the possible decrease in white blood cells (agranulocytosis). It is essential to inform your doctor about your medication.

• Your skin becomes moresensitive to sunlight or ultraviolet lightwhen taking ciprofloxacin. Avoid exposure to intense sunlight or artificial ultraviolet light, such as tanning beds.

• If you experience any visual disturbances or have any eye problems, consult an ophthalmologist immediately.

• Inform your doctor if you or a family member has a proven deficiency of glucose-6-phosphate dehydrogenase (G6PD), as you may be at risk of anemia with ciprofloxacin.

If you experience any of these adverse effects after taking Doriman, contact your doctor immediately, before continuing treatment. You and your doctor will decide whether to continue or discontinue treatment, considering the use of another class of antibiotic.

Other medications and Doriman

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not take ciprofloxacin at the same time as tizanidine, as this may cause adverse effects, such as low blood pressure and drowsiness (see section 2).

It is known that the following medications interact with ciprofloxacin in your body. If you take Doriman at the same time as these medications, this may affect the therapeutic effect of these medications. It may also increase the likelihood of adverse effects.

Inform your doctor if you are taking:

• warfarin or other oral anticoagulants (to thin the blood)
• probenecid (for gout)
• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
• theophylline (for respiratory problems)
• tizanidine (for muscle spasticity in multiple sclerosis)
• clozapine (an antipsychotic)
• ropinirole (for Parkinson's disease)
• phenytoin (for epilepsy)

Ciprofloxacin mayincreasethe blood levels of the following medications:

• pentoxifylline (for circulatory disorders)
• caffeine

Some medicationsdecreasethe effect of ciprofloxacin. Inform your doctor if you are taking or plan to take:

• antacids
• mineral supplements
• sucralfate
• a polymeric phosphate binder (e.g., sevelamer)
• medications or supplements containing calcium, magnesium, aluminum, or iron

If these preparations are essential, take Doriman approximatelytwohours before orfour hours aftertaking these preparations.

Taking Doriman with food and drinks

Although you take ciprofloxacin with meals, do not eat or drink any dairy products (such as milk or yogurt) or beverages with added calcium when taking the tablets, as they may affect the absorption of the active ingredient.

Pregnancy and lactation

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

It is preferable to avoid the use of ciprofloxacin during pregnancy. Inform your doctor if you plan to become pregnant.

Do not take Doriman during lactation, as ciprofloxacin is excreted through breast milk and may cause harm to your baby.

Driving and operating machinery

Ciprofloxacin may reduce your alertness. Some neurological effects may occur. Make sure you know how you react to Doriman before driving a vehicle or operating a machine. If in doubt, consult your doctor.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will explain exactly how much Doriman you should take, how often, and for how long. This will depend on the type of infection you have and its severity.

Inform your doctor if you have kidney problems, as your dose may need to be adjusted.

The treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Take the tablets exactly as your doctor has instructed. If you have any doubts about how many tablets of Doriman to take and how to take them, ask your doctor or pharmacist how many tablets you should take and how to take them.

a. Swallow the tablets with a large amount of liquid. Do not chew the tablets because their taste is not pleasant.

b. Try to take the tablets at the same time every day.

c. You can take the tablets with or between meals. The calcium you take as part of a meal will not seriously affect the absorption of the medication. However, do not take Doriman tablets with dairy products such as milk or yogurt, or with fruit juices enriched with minerals (for example, orange juice enriched with calcium).

Remember to drink a large amount of liquids while taking Doriman.

If you take more Doriman than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Doriman

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

If you interrupt treatment with Doriman

It is essential that you complete the full treatment , even if you start to feel better after a few days. If you stop taking this medication too soon, your infection may not be fully cured, and symptoms may worsen again. You may develop antibiotic resistance.

If you have any other questions about using this product, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Frequent side effects(it is likely that they will occur in 1 to 10 people out of every 100):

• nausea, diarrhea
• joint pain in children

Less frequent side effects(it is likely that they will occur in 1 to 10 people out of every 1,000):

• micotic superinfections (by fungi)
• a high concentration of eosinophils, a type of white blood cell
• loss of appetite (anorexia)
• hyperactivity or agitation
• headache, dizziness, sleep problems or taste disorders
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/acid reflux) or flatulence
• an increase in the amount of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching or hives
• joint pain in adults
• renal function deficiency
• muscle and bone pain, feeling unwell (asthenia) or fever
• an increase in alkaline phosphatase in the blood (a substance determined in the blood)

Rare side effects(it is likely that they will occur in 1 to 10 people out of every 10,000):

• inflammation of the intestine (colitis) linked to the use of antibiotics (may be fatal in very rare cases) (see section 2)
• changes in the count of blood cells (leucopenia, leucocytosis, neutropenia, anemia), an increase or decrease in the amounts of blood clotting factor (thrombocytes)
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema)
• an increase in blood sugar (hyperglycemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression or hallucinations
• tingling and numbness, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, convulsions (see section 2) or dizziness
• vision problems
• tinnitus (ringing in the ears), hearing loss, hearing deterioration
• an increase in heart rate (tachycardia)
• expansion of blood vessels (vasodilation), decreased blood pressure or fainting
• difficulty breathing, including asthma-like symptoms
• liver disorders, jaundice (icterus colestático), hepatitis
• light sensitivity (see section 2)
• muscle pain, joint inflammation, increased muscle tone or cramps
• renal insufficiency, blood or crystals in the urine (see section 2), urinary tract inflammation
• fluid retention or excessive sweating
• abnormal levels of blood clotting factor (prothrombin) or increased concentrations of the enzyme amylase

Very rare side effects(it is likely that they will occur in less than 1 person out of every 10,000):

• a special type of decrease in the count of blood cells (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis), a decrease in the amount of white blood cells and red blood cells and platelets (pancytopenia), with a risk of death, and bone marrow depression, also with a risk of death (see section 2)
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with a risk of death - serum disease) (see section 2)
• mental disorders (psychotic reactions) (see section 2)
• migraine, coordination disorders, gait instability (gait disorders), olfactory disorders (olfactory disorders); increased intracranial pressure
• color vision distortions
• inflammation of the blood vessel wall (vasculitis)
• pancreatitis
• liver cell death (hepatic necrosis), which very rarely leads to liver insufficiency with a risk of death
• small punctate hemorrhages under the skin (petechiae), various skin eruptions or exanthems (for example, Stevens-Johnson syndrome with a risk of death or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation, tendon rupture – especially of the long tendon at the back of the ankle (Achilles tendon) (see section 2), worsening of myasthenia gravis symptoms (see section 2)

Unknown frequency(cannot be estimated from available data)

• problems associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in the limbs
• serious anomalies of the heart rhythm, irregular heart rhythm (Torsades de Pointes)

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting or permanent adverse reactions (even months or years) such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pinching, tingling, itching, numbness or pain (neuropathy), depression, fatigue, sleep disorders, memory impairment and hearing, vision, taste and smell impairment, in some cases regardless of the presence of pre-existing risk factors.

Cases of increased size and weakening or tearing of the aortic wall (aneurysms and dissections) have been reported, which could cause rupture and be fatal, and heart valve insufficiency in patients who have received fluoroquinolones. See also section 2.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required.

Keep out of sight and reach of children.

Do not use this medication after the expiration date appearing on the packaging or blister, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point of your usual pharmacy. Ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Doriman Composition

The active ingredient is ciprofloxacin. Each tablet contains 500 mg of ciprofloxacin (as hydrochloride).

The other components are: cornstarch, microcrystalline cellulose, povidone, anhydrous colloidal silica, magnesium stearate, titanium dioxide (E-171), hypromellose, macrogol 6000.

Product appearance and packaging contents

Coated tablets, round, white, and smooth.

They are presented in single-dose packaging, 1 and 14 tablets. Clinical packaging with 500 tablets.

Only some packaging sizes may be commercially marketed.

Marketing authorization holder and manufacturer responsible

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70. Polígono Industria URTINSA II

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet:November 2020

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es