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Document: Ciprofloxacin Amneal film-coated tablet ENG PL change

• Ciprofloxacin Amneal film-coated tablet PL
• Ciprofloxacin Amneal film-coated tablet ENG PL

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Package leaflet: Information for the user

Ciprofloxacin Amneal 250 mg film-coated tablets

Ciprofloxacin Amneal 500 mg film-coated tablets

Ciprofloxacin Amneal 750 mg film-coated tablets

Ciprofloxacin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Ciprofloxacin Amneal is and what it is used for

2. What you need to know before you take Ciprofloxacin Amneal

3. How to take Ciprofloxacin Amneal

4. Possible side effects

5. How to store Ciprofloxacin Amneal

6. Contents of the pack and other information

1. What Ciprofloxacin Amneal is and what it is used for

Ciprofloxacin Amneal is an antibiotic belonging to the fluoroquinolone family. The active substance is ciprofloxacin. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria.

Adults

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

• respiratory tract infections

• long lasting or recurring ear or sinus infections

• urinary tract infections

• infections of the testicles

• genital organ infections in women

• gastro-intestinal tract infections and intra-abdominal infections

• skin and soft tissue infections

• bone and joint infections

• to treat infections in patients with a very low white blood cell count (neutropenia)

• to prevent infections in patients with a very low white blood cell count (neutropenia)

• to prevent infections due to the bacterium Neisseria meningitidis

• anthrax inhalation exposure

If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin Amneal.

Children and adolescents

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

• lung and bronchial infections in children and adolescents suffering from cystic fibrosis

• complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis)

• anthrax inhalation exposure

Ciprofloxacin Amneal may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary.

2. What you need to know before you take Ciprofloxacin Amneal

Do not take Ciprofloxacin Amneal if you are:

• allergic to Ciprofloxacin, to other quinolone drugs or to any of the other ingredients of this medicine (listed in section 6)

• taking tizanidine (see Section 2: Other medicines and Ciprofloxacin Amneal)

Warnings and precautions

Talk to your doctor, nurse or pharmacist before taking Ciprofloxacin Amneal if you:

• have ever had kidney problems because your treatment may need to be adjusted

• suffer from epilepsy or other neurological conditions

• have a history of tendon problems during previous treatment with antibiotics such as Ciprofloxacin Amneal

While taking Ciprofloxacin Amneal

Tell your doctor immediately, if any of the following occurs while taking Ciprofloxacin Amneal. Your doctor will decide whether treatment with Ciprofloxacin Amneal needs to be stopped.

• Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema). Even with the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up. If this happens, stop taking Ciprofloxacin Amneal and contact your doctor immediately.

• Pain and swelling in the joints and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids. At the first sign of any pain or inflammation stop taking Ciprofloxacin Amneal and rest the painful area. Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture. Tendon inflammation and ruptures may occur even up to several months after you stop taking Ciprofloxacin Amneal.

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

• You may experience psychiatric reactions the first time you take Ciprofloxacin Amneal. If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin Amneal. If this happens, stop taking Ciprofloxacin Amneal 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 Ciprofloxacin Amneal and contact your doctor immediately.

• Diarrhoea may develop while you are taking antibiotics, including Ciprofloxacin Amneal, or even several weeks after you have stopped taking them. If it becomes severe or persistent or you notice that your stool contains blood or mucus, stop taking Ciprofloxacin Amneal immediately, as this can be life-threatening. Do not take medicines that stop or slow down bowel movements and contact your doctor.

• Tell the doctor or laboratory staff that you are taking Ciprofloxacin Amneal if you have to provide a blood or urine sample.

• Ciprofloxacin Amneal may cause liver damage. If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, stop taking Ciprofloxacin Amneal and contact your doctor immediately.

• Ciprofloxacin Amneal may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine.

• Tell your doctor if you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anaemia with ciprofloxacin.

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

Other medicines and Ciprofloxacin Amneal

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Ciprofloxacin Amneal together with tizanidine, because this may cause side effects such as low blood pressure and sleepiness (see Section 2: "Do not take Ciprofloxacin Amneal").

You must tell your doctor if you are taking other medicines that can alter your heart rhythm: medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), tricyclic antidepressants, some antimicrobials (that belong to the group of macrolides), some antipsychotics.

The following medicines are known to interact with Ciprofloxacin Amneal in your body. Taking Ciprofloxacin Amneal together with these medicines can influence the therapeutic effect of those medicines. It can also increase the probability of experiencing side effects.

Tell your doctor if you are taking:

• warfarin, acenocoumarol, phenprocoumon, fluindione or other oral anti-coagulants (to thin the blood)

• probenecid (for gout)

• metoclopramide (for nausea and migraines)

• omeprazole (for stomach ulcers, indigestion, heartburn and Zollinger–Ellison syndrome)

• cyclosporin (an immunosuppressant)

• methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)

• theophylline (for breathing problems)

• tizanidine (for muscle spasticity in multiple sclerosis)

• clozapine (an antipsychotic)

• ropinirole (for Parkinson’s disease)

• phenytoin (for epilepsy)

• olanzapine (an antipsychotic)

• glibenclamide (for diabetes)

Ciprofloxacin Amneal may increase the levels of the following medicines in your blood:

• pentoxifylline (for circulatory disorders)

• caffeine

• lidocaine (an anesthetic)

• sildenafil (for erectile dysfunction)

• duloxetine (for depression, anxiety, pain and stress incontinence)

Some medicines reduce the effect of Ciprofloxacin Amneal. Tell your doctor if you take or wish 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 Ciprofloxacin Amneal about two hours before or no sooner than four hours after them.

Ciprofloxacin Amneal with food and drink

Unless you take Ciprofloxacin Amneal during meals, do not eat or drink any dairy products (such as milk or yoghurt) or drinks with added calcium when you take the tablets, as they may affect the absorption of the active substance.

Pregnancy and breast-feeding

It is preferable to avoid the use of Ciprofloxacin Amneal during pregnancy.

Do not take Ciprofloxacin Amneal during breast-feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Ciprofloxacin Amneal may make you feel less alert. Some neurological adverse events can occur. Therefore, make sure you know how you react to Ciprofloxacin Amneal before driving a vehicle or operating machinery. If in doubt, talk to your doctor.

3. How to take Ciprofloxacin Amneal

Your doctor will explain to you exactly how much Ciprofloxacin Amneal you will have to take as well as how often and for how long. This will depend on the type of infection you have and how bad it is.

Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.

The treatment usually lasts from 5 to 21 days, but may take longer for severe infections.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

a. Swallow the tablets with plenty of fluid. Do not chew the tablets because they do not taste nice.

b. Do try to take the tablets at around the same time every day.

c. You can take the tablets at mealtimes or between meals. Any calcium you take as part of a meal will not seriously affect uptake. However, do not take Ciprofloxacin Amneal tablets with dairy products such as milk or yoghurt or with fortified fruit juices (e.g. calcium-fortified orange juice).

Remember to drink plenty of fluids while you are taking Ciprofloxacin Amneal.

If you take more Ciprofloxacin Amneal than you should

If you forget to take Ciprofloxacin Amneal

If you stop taking Ciprofloxacin Amneal

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 everybody gets them.

Common side effects (may affect up to 1 in 10 people):

- nausea, diarrhoea

- joint pains in children

Uncommon side effects (may affect up to 1 in 100 people):

- fungal superinfections

- a high concentration of eosinophils, a type of white blood cell

- loss of appetite (anorexia)

- hyperactivity or agitation

- headache, dizziness, sleeping problems, or taste disorders

- vomiting, abdominal pain, digestive problems such as stomach upset (indigestion/heartburn), or wind

- increased amounts of certain substances in the blood (transaminases and/or bilirubin)

- rash, itching, or hives

- joint pain in adults

- poor kidney function

- pains in your muscles and bones, feeling unwell (asthenia), or fever

- increase in blood alkaline phosphatase (a certain substance in the blood)

Rare side effects (may affect up to 1 in 1,000 people):

- inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in very rare cases) (see Section 2: Warnings and precautions)

- changes to the blood count (leukopenia, leukocytosis, neutropenia, anaemia), increased or decreased amounts of a blood clotting factor (thrombocytes)

- allergic reaction, swelling (oedema), or rapid swelling of the skin and mucous membranes (angio-oedema)

- increased blood sugar (hyperglycaemia)

- confusion, disorientation, anxiety reactions, strange dreams, depression which in rare cases may lead to thoughts of suicide or suicidal behaviour, or hallucinations

- pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors, seizures (see Section 2: Warnings and precautions), or giddiness

- eyesight problems

- tinnitus, loss of hearing, impaired hearing

- rapid heartbeat (tachycardia)

- expansion of blood vessels (vasodilation), low blood pressure, or fainting

- shortness of breath, including asthmatic symptoms

- liver disorders, jaundice (cholestatic icterus), or hepatitis

- sensitivity to light (see Section 2: Warnings and precautions)

- muscle pain, inflammation of the joints, increased muscle tone, or cramp

- kidney failure, blood or crystals in the urine (see Section 2: Warnings and precautions), urinary tract inflammation

- fluid retention or excessive sweating

- increased levels of the enzyme amylase

Very rare side effects (may affect up to 1 in 10,000 people):

- a special type of reduced red blood cell count (haemolytic anaemia); a dangerous drop in a type of white blood cells (agranulocytosis); a drop in the number of red and white blood cells and platelets (pancytopenia), which may be fatal; and bone marrow depression, which may also be fatal (see Section 2: Warnings and precautions)

- severe allergic reactions (anaphylactic reaction or anaphylactic shock, which can be fatal - serum sickness) (see Section 2: Warnings and precautions)

- mental disturbances (psychotic reactions) which in rare cases may lead to thoughts of suicide or suicidal behaviour (see Section 2: Warnings and precautions)

- migraine, disturbed coordination, unsteady walk (gait disturbance), disorder of sense of smell (olfactory disorders), pressure on the brain (intracranial pressure)

- visual colour distortions

- inflammation of the wall of the blood vessels (vasculitis)

- pancreatitis

- death of liver cells (liver necrosis) very rarely leading to life-threatening liver failure

- small, pin-point bleeding under the skin (petechiae); various skin eruptions or rashes (for example, the potentially fatal Stevens-Johnson syndrome or toxic epidermal necrolysis)

- muscle weakness, tendon inflammation, tendon rupture – especially of the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Warnings and precautions); worsening of the symptoms of myasthenia gravis (see Section 2: Warnings and precautions)

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

- troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities

- heart problems; abnormal fast heart rhythm, life-threatening irregular heart rhythm, alteration of the heart rhythm (called ‘prolongation of QT interval’, seen on ECG, electrical activity of the heart)

- acute generalised exanthematous pustulosis (AGEP) – type of skin disease with red blistered skin

- blood thinning increases if taken with an anti-coagulant such as warfarin

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ciprofloxacin Amneal

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date, which is stated on the blister or carton after “EXP”: The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Ciprofloxacin Amneal contains

- The active substance is ciprofloxacin (as ciprofloxacin hydrochloride).

Each film-coated tablet contains 250 mg ciprofloxacin (as ciprofloxacin hydrochloride).

Each film-coated tablet contains 500 mg ciprofloxacin (as ciprofloxacin hydrochloride).

Each film-coated tablet contains 750 mg ciprofloxacin (as ciprofloxacin hydrochloride).

- The otheringredients are

Tablet core: Cellulose microcrystalline, Sodium starch glycolate (Type A), Povidone (K 30),

Silica (Colloidal anhydrous), Magnesium stearate

Film coating:Hypromellose, Macrogol (400), Titanium dioxide

What Ciprofloxacin Amneal looks like and contents of the pack

Film-coated tablet

Ciprofloxacin Amneal 250 mg

White to off white, round, film-coated tablets, with a score line on one side and debossed with ‘F’, ‘23’ on either side of a score line on the other side.

The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

Ciprofloxacin Amneal 500 mg

White to off white, capsule shaped, film coated tablets, with a score line on one side and debossed with ‘F 22’ on the other side.

The tablet can be divided into equal halves.

Ciprofloxacin Amneal 750 mg

White to off white, capsule shaped, film coated tablets, debossed with ‘C’ on one side and ‘93’ on the other side.

PVC/PVdC-Aluminium foil blisters packed in carton.

Pack sizes:

250 mg & 750 mg:6, 10, 12, 14, 16, 20, 28, 50, 100 and 120 film-coated tablets

500 mg: 1, 6, 10, 12, 14, 16, 20, 28, 50, 100 and 120 film-coated tablets

Not all pack sizes may be marked.

Marketing Authorisation Holder andManufacturer

Marketing Authorisation Holder

[To be completed nationally]

Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Norway: Ciprofloxacin Amneal

Spain: CIPROFLOXACINO Amneal250 mg/ 500 mg/ 750 mg comprimidos recubiertos con pelicula

Sweden: Ciprofloxacin Amneal

United Kingdom: Ciprofloxacin 250 mg/ 500 mg/ 750 mg film-coated tablets

This leaflet was last revised in 2015-05-21

Advice/medical education

Antibiotics are used to cure bacterial infections. They are ineffective against viral infections.

If your doctor has prescribed antibiotics, you need them precisely for your current illness.

Despite antibiotics, some bacteria may survive or grow. This phenomenon is called resistance: some antibiotic treatments become ineffective.

Misuse of antibiotics increases resistance. You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate:

- dosages

- schedules

- duration of treatment

Consequently, to preserve the efficacy of this drug:

1 - Use antibiotics only when prescribed.

2 - Strictly follow the prescription.

3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.

4 - Never give your antibiotic to another person; maybe it is not adapted to her/his illness.

5 - After completion of treatment, return all unused drugs to your chemist’s shop to ensure they will be disposed of correctly.