DORIMAN 500 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Doriman 500 mg Film-Coated Tablets

ciprofloxacin

Contents of the Package Leaflet

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

1. What is Doriman and what is it used for

Doriman is an antibiotic that belongs to the family of fluoroquinolones. The active substance is ciprofloxacin. Ciprofloxacin works by killing the bacteria that cause infections. It only works with 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 intra-abdominal infections
• Bone and joint infections
• Skin and soft tissue infections
• Prevention of infections caused by the bacteria Neisseria meningitidis
• Inhalation exposure to anthrax

In the event that you suffer from a severe infection or if the infection is caused by more than one type of bacteria, you may be given 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:

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

Ciprofloxacin may also be used to treat severe infections in children and adolescents when deemed 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 medications that contain fluoroquinolones or quinolones, including ciprofloxacin, if you have experienced a severe adverse reaction in the past when taking a quinolone or fluoroquinolone. If this is the case, you should inform your doctor as soon as possible.

Consult your doctor before starting to take Doriman:

• if you have ever had kidney problems because your treatment needs to be adjusted
• if you suffer from epilepsy or other neurological conditions
• if you have a history of tendon problems during previous treatment with antibiotics like Doriman
• if you suffer from severe myasthenia (a type of muscle weakness)
• if you have a history of abnormal heart rhythms (arrhythmias)
• if you have been diagnosed with an enlarged or "bulging" of a large blood vessel (aortic aneurysm or large peripheral vessel aneurysm).
• if you have had a previous episode of aortic dissection (tear in the aortic wall).
• if you have been diagnosed with a heart valve problem (regurgitation of the heart valves).
• if you have a family history of aortic aneurysm or aortic dissection, congenital heart valve problems, or other risk factors or predisposing conditions (e.g., connective tissue disorders such as 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, high blood pressure, 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 situations occur while taking Doriman. Your doctor will decide whether it is necessary to interrupt treatment with Doriman.

• Severe and sudden allergic reaction(anaphylactic reaction or shock, 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 experience dizziness when standing up. If this happens, do not take any more Doriman and contact your doctor immediately.

• Severe, disabling, and potentially irreversible side effects.Antibacterial medications that contain fluoroquinolones or quinolones, including Doriman, have been associated with very rare but severe side effects, some of which were long-lasting (persistent for months or years), disabling, or potentially irreversible. This includes pain in the tendons, muscles, and joints of the upper and lower limbs, difficulty walking, abnormal sensations such as pinching, burning, tingling, numbness, or burning, 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 side effects after taking Doriman, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of an antibiotic of another class.

• If you experience joint pain and swelling and tendon inflammation or rupture, stop taking Doriman, contact your doctor, and rest the affected area. Avoid any unnecessary exercise, as this could increase the risk of tendon rupture. The risk is higher if you are an older adult (over 60 years), have received an organ transplant, have kidney problems, or are being treated with corticosteroids. Tendon inflammation and rupture can occur within the first 48 hours of treatment and even several months after stopping treatment with Doriman.

• If you suffer from epilepsy or other neurological conditions, such as cerebral ischemia or infarction, you may experience side effects associated with the central nervous system. If this occurs, stop taking Doriman and contact your doctor immediately.

• You may experience psychiatric reactionsthe first time you take ciprofloxacin. If you suffer from depression or psychosis, your symptoms may worsen with 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 happens, stop taking Doriman and inform your doctor immediately to prevent the development of a potentially irreversible disorder.

• If you feel a strong and sudden pain in the chest, abdomen, or back, which can be symptoms of aortic dissection or aneurysm, go to the emergency room immediately. The risk may increase if you are receiving systemic corticosteroid treatment.

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

• Diarrheamay develop while you are taking antibiotics, including ciprofloxacin, or even several weeks after you have stopped taking them. If the diarrhea becomes severe or persistent, or if you notice that the stool contains blood or mucus, stop taking Doriman immediately, as this can be life-threatening. Do not take medications that stop or slow down bowel movements, and consult your doctor.

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

• Ciprofloxacin can cause liver damage. 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 immediately.

• Ciprofloxacin can cause a decrease in the white blood cell count and may decrease your resistance to infections. If you suffer from an infection with symptoms such as fever and severe deterioration of your general condition, or fever with symptoms of local infection such as sore throat/pharynx/mouth, 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 that you inform your doctor about your medication.

• Your skin becomes more sensitive to sunlight or ultraviolet (UV) lightwhen taking ciprofloxacin. Avoid exposure to intense sunlight or artificial ultraviolet light, such as tanning booths.

• If you experience any vision changes 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 side effects after taking Doriman, contact your doctor immediately before continuing treatment. You and your doctor will decide whether to continue or not with the treatment, also considering the use of an antibiotic of another class.

Other Medicines and Doriman

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

Do not take ciprofloxacin at the same time as tizanidine, as this may cause side 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 experiencing side 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 may increaseblood levels of the following medications:

• pentoxifylline (for circulatory disorders)
• caffeine

Some medications decreasethe 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 that contain calcium, magnesium, aluminum, or iron

If these preparations are essential, take Doriman approximately twohours before or fourhours after taking these preparations.

Taking Doriman with Food and Drinks

Although you can 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 substance.

Pregnancy and Breastfeeding

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

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 breastfeeding, as ciprofloxacin is excreted in breast milk and may harm your baby.

Driving and Using Machines

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

3. How to Take Doriman

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, 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.

Treatment usually lasts from 5 to 21 days, but may last longer for severe infections. Take the tablets exactly as your doctor has indicated. If you are unsure about how many Doriman tablets to take or how to take them, ask your doctor or pharmacist how many tablets you should take and how to take them.

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

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

• 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 (e.g., calcium-enriched 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, consult your doctor or pharmacist immediately or call the Toxicology 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 missed doses. Make sure to complete the treatment cycle.

If you stop 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 completely cured, and your symptoms may worsen. You may 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 all people suffer from them.

Frequent Adverse Effects(it is likely that they will affect between 1 and 10 out of every 100 people):

• nausea, diarrhea
• joint pain in children

Infrequent Adverse Effects(it is likely that they will affect between 1 and 10 out of every 1,000 people):

• fungal superinfections
• 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/heartburn) or flatulence
• increase in the amount of certain substances in the blood (transaminases and/or bilirubin)
• skin rash, itching or hives
• joint pain in adults
• poor kidney function
• muscle and bone pain, feeling of discomfort (asthenia) or fever
• increase in alkaline phosphatase in the blood (a blood-determined substance)

Rare Adverse Effects(it is likely that they will affect between 1 and 10 out of every 10,000 people):

• inflammation of the intestine (colitis) related to the use of antibiotics (can be fatal in very rare cases) (see section 2)
• changes in blood cell count (leukopenia, leukocytosis, neutropenia, anemia), increase or decrease in blood coagulation factor quantities (thrombocytes)
• allergic reaction, swelling (edema) or rapid swelling of the skin and mucous membranes (angioedema)
• increase in blood sugar (hyperglycemia)
• confusion, disorientation, anxiety reactions, unusual dreams, depression or hallucinations
• tingling and numbness sensation, 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 impairment
• increased heart rate (tachycardia)
• expansion of blood vessels (vasodilation), decrease in blood pressure or fainting
• difficulty breathing, including asthmatic 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 the urine (see section 2), inflammation of the urinary tract
• fluid retention or excessive sweating
• abnormal levels of coagulation factor (prothrombin) or increased concentrations of the amylase enzyme

Very Rare Adverse Effects(it is likely that they will affect less than 1 out of every 10,000 people):

• a special type of decrease in blood cell count (hemolytic anemia), a dangerous decrease in a type of white blood cell (agranulocytosis), a decrease in the amount of white 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 sickness) (see section 2)
• mental disorders (psychotic reactions) (see section 2)
• migraine, coordination disorder, instability when walking (gait disorders), disorders in the sense of smell (olfactory disorders); pressure in the brain (intracranial pressure)
• visual distortions of colors
• inflammation of the blood vessel wall (vasculitis)
• pancreatitis
• death of liver cells (necrosis), which very rarely leads to liver failure with a risk of death
• small pinpoint bleeding under the skin (petechiae), various skin rashes or exanthems (e.g., Stevens-Johnson syndrome with a risk of death or toxic epidermal necrolysis)
• muscle weakness, tendon inflammation, tendon rupture - especially the long tendon in the back of the ankle (Achilles tendon) (see section 2), worsening of myasthenia gravis symptoms (see section 2)

Unknown Frequency(cannot be estimated from the available data)

• nervous system problems such as pain, burning, tingling, numbness, and/or weakness in the limbs
• serious heart rhythm disorders, irregular heart rhythm (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 pinching, tingling, tickling, burning, numbness or pain (neuropathy), fatigue, decreased memory and concentration, 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.

There have been reports of increased size and weakening or tearing of the aortic wall (aneurysms and dissections), which could lead to rupture and be fatal, and cardiac 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 is not listed in this prospectus. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) http://www.aemps.gob.es.

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

5. Storage of Doriman

It does not require special storage conditions.

Keep out of sight and reach of children.

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

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of your usual pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

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 Package 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 package sizes may be marketed.

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 Last Revision of this Prospectus:June 2025

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