Doriman 500 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Doriman 500 mg film-coated tablets

ciprofloxacin

Package leaflet contents

1. What Doriman is and what it is used for
2. What you need to know before taking Doriman
3. How to take Doriman
4. Possible side effects of Doriman
5. How to store Doriman
6. Contents of the pack and other information

1. What Doriman is and what it is used for

Doriman is an antibiotic that belongs to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by eliminating the bacteria that cause infections. It only acts against specific strains of bacteria.

Adults

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

• Respiratory tract infections
• Long-lasting or recurrent ear or sinus infections
• Urinary tract infections
• Male and female genital tract infections
• Gastrointestinal and intra-abdominal infections
• Bone and joint infections
• Skin and soft tissue infections
• Prevention of infections caused by the bacterium Neisseria meningitidis
• Inhalational exposure to anthrax

If you have a severe infection or if the infection is caused by more than one type of bacteria, you may be given additional antibiotic treatment alongside Doriman.

Children and adolescents

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

• Lung and bronchial infections in children and adolescents with cystic fibrosis
• Complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)
• Inhalational exposure to anthrax

Ciprofloxacin may also be used for the treatment of serious infections in children and adolescents when considered necessary.

2. Before taking Doriman

Do not take Doriman:

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

Warnings and precautions

You should not take antibacterial medicines containing fluoroquinolones or quinolones, including ciprofloxacin, if you have previously experienced a serious adverse reaction while taking a quinolone or fluoroquinolone. If this applies to you, 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 dose adjustment
• if you suffer from epilepsy or other neurological conditions
• if you have a history of tendon problems during previous treatment with antibiotics such as 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 enlargement or a "bulge" in a large blood vessel (aortic aneurysm or peripheral large vessel aneurysm)
• if you have previously experienced an aortic dissection (tear in the wall of 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 disorders (e.g., connective tissue disorders such as Marfan syndrome or vascular Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an inflammatory autoimmune disease), or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behçet's disease, known hypertension or atherosclerosis, rheumatoid arthritis (a joint disease), or endocarditis (a heart infection)).

During treatment with this medicine

Inform your doctor immediately if any of the following occur while you are taking Doriman. Your doctor will decide whether treatment with Doriman should be discontinued.

• Sudden, severe allergic reaction (anaphylactic reaction or shock, angioedema). There is a small chance that even with the first dose, you may experience a severe allergic reaction with symptoms such as chest tightness, dizziness, nausea, or fainting, or dizziness upon standing. If this occurs, do not take any more Doriman and contact your doctor immediately.

• Serious, disabling, long-lasting, and potentially irreversible adverse effects. Antibacterial medicines containing fluoroquinolones or quinolones, including Doriman, have been associated with very rare but serious adverse effects, some of which may last for months or years, be disabling, or potentially irreversible. These include pain in tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, numbness, or burning (paresthesia), sensory disturbances such as decreased vision, taste, smell, or hearing, depression, memory impairment, severe fatigue, and serious 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 treatment, possibly considering the use of an antibiotic from another class.

• In rare cases, joint pain and swelling, or tendon inflammation or rupture may occur. The risk is higher if you are elderly (over 60 years), have had an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture may occur within the first 48 hours of treatment or even several months after stopping Doriman. At the first sign of tendon pain or inflammation (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Doriman, contact your doctor, and rest the affected area. Avoid unnecessary physical activity, as this may increase the risk of tendon rupture.

• If you suffer from epilepsy or another neurological condition, such as cerebral ischemia or stroke, you may experience adverse effects related to the central nervous system. If this occurs, stop taking Doriman and contact your doctor immediately.

• You may experience psychiatric reactions the first time you take ciprofloxacin. If you have depression or psychosis, your symptoms may worsen during treatment with Doriman. If this occurs, stop taking Doriman and contact your doctor immediately.

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

• If you feel a sudden, severe pain in the chest, abdomen, or back, which may be symptoms of aortic dissection or aneurysm, seek emergency medical attention immediately. The risk may be increased if you are receiving systemic corticosteroid treatment.

• If you suddenly develop shortness of breath, especially when lying down, or notice swelling in the ankles, feet, or abdomen, or the onset of palpitations (a sensation of rapid or irregular heartbeat), inform your doctor immediately.

• Diarrhea may develop while taking antibiotics, including ciprofloxacin, or even several weeks after stopping them. If diarrhea becomes severe or persistent, or if you notice blood or mucus in your stools, stop taking Doriman immediately, as this could be life-threatening. Do not take medications that stop or delay intestinal movements and consult your doctor.

• While taking Doriman, inform your doctor or laboratory staff if you need to undergo a blood or urine test.

• Ciprofloxacin may cause liver injury. If you notice symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or stomach pain, stop taking Doriman immediately and consult your doctor without delay.

• Ciprofloxacin may reduce white blood cell count and possibly weaken your resistance to infections. If you develop an infection with symptoms such as fever and a marked deterioration in your general condition, or fever with signs of localized infection such as sore throat/pharynx/mouth, or urinary problems, consult your doctor immediately. A blood test will be performed to check for possible reduction in white blood cells (agranulocytosis). It is important to inform your doctor about your medication.

• Your skin may become more sensitive to sunlight or ultraviolet (UV) light when taking ciprofloxacin. Avoid exposure to strong sunlight or artificial UV light, such as sunbeds.

• If you experience any changes in vision or any eye problems, consult an ophthalmologist immediately.

• Inform your doctor if you or a family member has a confirmed deficiency in glucose-6-phosphate dehydrogenase (G6PD), as this may increase the 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 or not to continue treatment, possibly considering the use of an antibiotic from another class.

Other medicines and Doriman

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicine.

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

The following medicines are known to interact with ciprofloxacin in your body. If Doriman is taken at the same time as these medicines, it may affect the therapeutic effect of these medicines. It may also increase the likelihood of experiencing 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)
• tizanidina (for muscle spasticity in multiple sclerosis)
• clozapine (an antipsychotic)
• ropinirol (for Parkinson's disease)
• phenytoin (for epilepsy)

Ciprofloxacin may increase blood levels of the following medicines:

• pentoxifylline (for circulatory disorders)
• caffeine

Some medicines decrease the effect of ciprofloxacin. Inform your doctor if you are taking or intend to take:

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

If these preparations are essential, take Doriman approximately two hours before or four hours after taking these preparations.

Taking Doriman with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Do not take Doriman while breastfeeding, as ciprofloxacin is excreted in breast milk and may cause harm to your baby.

Driving and using machines

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

3. How to take Doriman

Follow exactly the administration instructions for this medicine given by your doctor or pharmacist. If in 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 and severity of your infection.

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

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

• Swallow the tablets with plenty of liquid. Do not chew the tablets, as they have an unpleasant taste.

• Try to take the tablets at the same time each day.

• You may take the tablets with or between meals. Calcium consumed as part of a meal will not significantly affect the absorption of the medicine. However, do not take Doriman tablets with dairy products such as milk or yoghurt, or with mineral-fortified fruit juices (for example, calcium-fortified orange juice).

Remember to drink plenty of fluids while taking Doriman.

If you take more Doriman than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Doriman

Take the missed dose as soon as possible, then continue your treatment as prescribed. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed dose. Make sure you complete the full course of treatment.

If you stop taking Doriman

It is important that you complete the full course of treatment, even if you start to feel better after a few days. If you stop taking this medicine too early, your infection may not be completely cured and symptoms may worsen again. You may also develop resistance to the antibiotic.

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

4. Possible adverse effects

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

Frequent adverse effects (may affect between 1 and 10 out of 100 people):

• nausea, diarrhoea
• joint pain in children

Uncommon adverse effects (may affect between 1 and 10 out of 1,000 people):

• fungal superinfections (due to fungi)
• elevated levels of eosinophils, a type of white blood cell
• loss of appetite (anorexia)
• hyperactivity or agitation
• headache, dizziness, sleep disturbances, or taste disorders
• vomiting, abdominal pain, digestive problems such as slow digestion (indigestion/heartburn) or flatulence
• increased levels of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching, or hives
• joint pain in adults
• impaired kidney function
• muscle and bone pain, feeling of malaise (asthenia), or fever
• increased alkaline phosphatase in blood (a substance measured in blood)

Rare adverse effects (may affect between 1 and 10 out of 10,000 people):

• inflammation of the intestine (colitis) associated with antibiotic use (can be fatal in very rare cases) (see section 2)
• changes in blood cell counts (leukopenia, leukocytosis, neutropenia, anaemia), increase or decrease in levels of blood clotting factor (platelets)
• allergic reaction, swelling (edema), or rapid swelling of the skin and mucous membranes (angioedema)
• increased blood sugar (hyperglycaemia)
• confusion, disorientation, anxiety reactions, strange dreams, depression, or hallucinations
• tingling and numbness sensations, unusual sensitivity to sensory stimuli, decreased skin sensitivity, tremors, seizures (see section 2), or dizziness
• vision problems
• tinnitus (ringing in the ears), hearing loss, or hearing impairment
• increased heart rate (tachycardia)
• blood vessel dilation (vasodilation), decreased blood pressure, or fainting
• difficulty breathing, including asthma-like symptoms
• liver disorders, jaundice (cholestatic jaundice), hepatitis
• sensitivity to light (see section 2)
• muscle pain, joint inflammation, increased muscle tone, or cramps
• kidney failure, blood or crystals in urine (see section 2), inflammation of the urinary tract
• fluid retention or excessive sweating
• abnormal levels of blood clotting factor (prothrombin) or increased concentrations of the enzyme amylase

Very rare adverse effects (may affect less than 1 out of 10,000 people):

• a specific type of decreased blood cell count (haemolytic anaemia), a dangerous decrease in a type of white blood cells (agranulocytosis), a decrease in red and white blood cells and platelets (pancytopenia), with risk of death, and bone marrow suppression, also with risk of death (see section 2)
• severe allergic reactions (anaphylactic reaction or anaphylactic shock, with risk of death – serum sickness) (see section 2)
• mental disorders (psychotic reactions) (see section 2)
• migraine, coordination disorder, unsteady gait (gait disturbances), disturbances in the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure)
• visual distortions of colours
• inflammation of blood vessel walls (vasculitis)
• pancreatitis
• death of liver cells (hepatic necrosis), which very rarely leads to liver failure with risk of death
• small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems (e.g., Stevens-Johnson syndrome with 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 symptoms of myasthenia gravis (see section 2)

Frequency not known (cannot be estimated from available data):

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

The administration of antibiotics containing quinolones and fluoroquinolones has been associated with very rare cases of long-lasting (even months or years) or permanent adverse reactions, such as tendon inflammation, tendon rupture, joint pain, limb pain, difficulty walking, abnormal sensations such as pricking, tingling, pins and needles, burning, numbness, or pain (neuropathy), fatigue, memory and concentration impairment, effects on mental health (which may include sleep disorders, anxiety, panic attacks, depression, and suicidal ideation), decreased hearing, vision, taste, and smell, in some cases regardless of the presence of pre-existing risk factors.

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Doriman

No special storage conditions are required.

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging or blister, after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point in your usual pharmacy. Ask your pharmacist how to properly dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Doriman

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

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

Appearance of the product and contents of the container

Film-coated tablets, round, white and smooth.

Presented in unit-dose packaging, packs of 1 and 14 tablets. Clinical pack with 500 tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.

C/ Laguna 66-68-70. Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the most recent revision of this leaflet: June 2025

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