Remecilox 200, 200 mg film-coated tablets

Remecilox 400 mg film-coated tablets

 

1. WHAT REMECILOX IS AND WHAT IS USED FOR

Remecilox tablets contain a medicine called ofloxacin. This belongs to a group of medicines called antibiotics. It works by killing bacteria that cause infections.

 

Remecilox tablets are used for infections of the:

• Kidneys or bladder (urinary tract).
• Chest or lungs.
• Male or female sex organs (genital tract). This includes gonorrhoea which is a sexually transmitted infection that can affect both men and women.
• Skin and soft tissue. Soft tissue is underneath the skin and includes muscle.

 

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE REMECILOX

Do not take Remecilox:

• If you are allergic (hypersensitive) to ofloxacin or to any of the other ingredients of Remecilox tablets (listed in section 6 below).  Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
• If you have ever had swelling of the tendons (called tendinitis) which can affect areas such as the wrist or the Achilles tendon.
• If you have epilepsy or are at risk of fits.
• If you have a problem with your red blood cells known as “glucose-6-dehydrogenase deficiency”.
• If you are pregnant or breast-feeding (see “Pregnancy and breast-feeding” section below).
• If you are under 18 years of age or are still growing.

Do not take this medicine if any of the above applies to you.  If you are not sure, talk to your doctor or pharmacist before taking Remecilox tablets.

 

Warnings and precautions

Take special care with Remecilox tablets.

Caution should be taken when using this kind of medicine.

Check with your doctor or pharmacist before taking your medicine if:

• You have liver or kidney problems
• You have heart disease or problems with your heartbeat
• You are taking medicines that can affect your heart (see section Taking other medicines)
• You were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart)
• You have a salt imbalance in the blood (especially low levels of potassium or magnesium in the blood)
• You have a very slow heart rhythm (called 'bradycardia')
• You have a weak heart (heart failure)
• You have a history of heart attack (myocardial infarction)
• You are female or elderly
• You are taking other medicines that result in abnormal ECG changes (see section Taking other medicines)
• You have or have ever had any mental health problems
• You suffer from a condition called ‘myasthenia gravis’ (muscle weakness)
• You have been told by your doctor that you cannot tolerate some sugars

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Remecilox tablets.

If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately.

Other medicines and Remecilox:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Remecilox tablets and some other medicines can affect the way each other work.

In particular, tell your doctor if you are taking the following medicine:

• Methotrexate used for rheumatism or cancer

Other medicines that can alter your heart rhythm:

• Medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amioderone, sotalol, dofetilide, ibutilide)
• Tricyclic antidepressants
• Some antimicrobials (that belong to the group of macrolides)
• Some antipsychotics

The following medicines can change the way Remecilox tablets work or Remecilox tablets may change the way some of these medicines work:

• Medicines used to stop your blood from clotting
• Medicines used for high blood pressure
• Medicines that contain iron (for anaemia) or zinc
• Medicines that help put you to sleep (anaesthetics)
• Water tablets (diuretics) such as furosemide
• Antacids that contain magnesium or aluminium – used for indigestion
• Glibenclamide – used for diabetes
• Probecenid – used for gout
• Cimetidine – used for stomach ulcers or indigestion
• Sucralfate – used for stomach ulcers

The following medicines, when taken with Remecilox tablets, can increase the chance of you getting side effects:

• Other antibiotics (such as erythromycin, azithromycin or clarithromycin)
• Medicines for depression (such as amitriptyline, clomipramine or imipramine)
• Theophylline – used for breathing problems
• Medicines used to control your heartbeat (such as amiodarone, quinidine, procainamide, or disopyramide)
• Non-steroidal anti-inflammatory drugs (NSAIDs) – used for pain relief and inflammation (such as ibuprofen, diclofenac or indometacin)
• Corticosteroids – used for inflammation
• Antipsychotics – used to treat psychiatric disorders such as schizophrenia and bipolar disorder

Remecilox with food and drink:

Do not drink alcohol while taking Remecilox tablets. This is because it may make you feel dizzy or sleepy.

Pregnancy and breast-feeding:

Do not take this medicine if:

• You are pregnant, might become pregnant or think you may be pregnant
• You are breast-feeding or planning to breast-feed

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines:

You may feel sleepy or dizzy or have problems with your eyesight while taking this medicine. If this happens, do not drive or use any tools or machines.

 

3. HOW TO TAKE REMECILOX

Always take Remecilox tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Taking this medicine:

• Take this medicine by mouth
• The tablet can be divided into equal doses
• When taking Remecilox tablets, avoid strong sunlight and do not use sun lamps or solaria
• Medicines containing iron (for anaemia) antacids (for indigestion or heartburn) or sucralfate (for stomach ulcers) should be avoided for two hours before or after taking Remecilox Tablets
• If you feel the effect of your medicine is too weak or strong, do not change the dose yourself, but ask your doctor

When to take your medicine:

• The length of your treatment will depend on how serious your infection is
• The medicine is usually taken for 5 to 10 days and treatment should not be longer than 2 months
• Doses up to 400 mg are taken as a single dose in the morning
• Higher doses should be taken in two doses, one in the morning and one in the evening

How much to take:

• Your doctor will decide on how many Remecilox tablets you should take
• The dose will depend on the type of infection you have

The usual dose for adults, including the elderly, is between 200 mg and 800 mg each day. The dose depends on the location and type of infection:

• Kidney or bladder infections (urinary tract):
  200 to 800 mg each day
• Chest or lung:
  400 to 800 mg each day
• Male or female sex organ infections (genital tract):
  400 mg each day
• Gonorrhoea
  a single dose of 400 mg
• Skin and soft tissue infections:
  400 to 800 mg each day

Kidney or liver problems:

If you have any kidney or liver problems you may be given a lower dose.

Children and Adolescents:

This medicine should not be given to children or adolescents.

Urine Tests:

Taking Remecilox tablets may affect the results of some urine tests. If you are going to have a urine test, it is important to tell your doctor you are taking Remecilox tablets.

If you take more Remecilox than you should:

If you take more Remecilox tablets than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following effects may happen: feeling confused or dizzy, loss of consciousness, fits, feeling sick or blood in your stools.

In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.

If you forget to take Remecilox:

If you forget a dose, take it as soon as you remember it. However, if it is nearly time for the next dose, skip the missed dose.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking Remecilox tablets:

Keep taking Remecilox tablets until your doctor tells you to stop. Do not stop taking Remecilox tablets just because you feel better. If you stop, your infection may get worse again.

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

 

4. POSSIBLE SIDE-EFFECTS

Like all medicines, Remecilox tablets can cause side effects, although not everybody gets them.

Stop taking Remecilox tablets and see a doctor or go to a hospital straight away if:

• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.

Stop taking Remecilox tablets and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

Very Rare (affects less than 1 in 10,000 people)

• An uneven or fast heartbeat, you may also feel faint
• Watery diarrhoea, which may have blood in it, possibly with stomach cramps and a high temperature
• Fits
• Hearing problems or hearing loss
• Liver problems that may cause your eyes or skin to go yellow (jaundice)
• Severe skin rashes which may include blistering or peeling of the skin around the lips, eyes, mouth, nose and genitals
• Skin rashes caused by strong sunlight
• Feeling faint, light-headed or dizzy, due to low blood pressure
• Muscle weakness, joint and muscle pains
• Feeling weak or irritable, sweating and/or trembling. This could be due to lowering of blood sugar levels
• Feeling thirsty and passing water more often than usual. This could be due to a raise in blood sugar levels
• Swelling or discomfort in your tendons, such as in the Achilles tendon
• Severe inflammation of the kidneys, which may result in your kidneys to stop working. Signs may include a rash, high temperature and general aches and pains
• Severe depression or mental illness. Some people who are depressed think of harming or killing themselves

Rare (affects less than 1 in 1000 people)

• Numbness or tingling in the hands and feet or being very sensitive to touch

Not known (frequency cannot be estimated from the available data)

• Inflammation of the eye (uveitis)
• Skin redness with extensive scaling (exfoliative dermatitis)
• Loss of appetite, skin and eyes becoming yellow in colour, dark-coloured urine, itching, or tender stomach (abdomen). These may be signs of liver problems which may include a fatal failure of the liver
• 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)

Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:

Uncommon (affects less than 1 in 100 people)

• Feeling or being sick, diarrhoea or stomach pains
• Headaches, sleeping problems, feeling dizzy or restless
• Skin rash or itching

Rare (affects less than 1 in 1000 people)

• Loss of appetite
• Feeling confused or anxious, nightmares, seeing things that are not there, depression and mental illness, feeling drowsy, trembling, problems walking due to poor muscle control
• Changes in eyesight
• Changes in or loss of your sense of taste or smell
• Changes in levels of liver enzymes shown in blood tests
• A general feeling of being unwell

Very Rare (affects less than 1 in 10,000 people)

• Feeling tired, faint, dizzy and having pale skin. These could be signs of anaemia
• You may bruise more easily than usual. This could be because of a blood problem called ‘thrombocytopenia’
• Cough or shortness of breath, caused by lung inflammation

It is possible that Remecilox may trigger an attack of porphyria (a rare illness which affects the metabolism) in some patients.

Additional undesirable effects

Metabolism and Nutrition disorders: Hyperglycaemia, Hypoglycaemic coma

Psychiatric disorders: Nervousness

Nervous system disorders: Tremor, Dyskinesia, Ageusia, Syncope

Ear and labyrinth disorders: Hearing impaired

Gastro-intestinal disorders: Dyspepsia, Flatulence, Constipation, Pancreatitis

Skin and subcutaneous tissue disorders: Stomatitis

Musculoskeletal and Connective tissue disorders: Ligament rupture, Arthritis

General disorders and administration site conditions: Asthenia, Pyrexia, Pain (including pain in back, chest and extremities), Pancytopenia

Reporting 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.

In case you have purchased or been given the product in the Republic of Cyprus you can also report side effects directly (see details below).  By reporting side effects you can help provide more information on the safety of this medicine.

Pharmaceutical Services

Ministry of Health

CY-1475

Fax: +357 22608649

Website: www.moh.gov.cy/phs

 

5. HOW TO STORE REMECILOX

Keep this medicine out of the reach and sight 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.

Keep below 25 °C, away from light and moisture.

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 protect the environment.

 

6.     CONTENTS OF THE PACK AND OTHER INFORMATION

What Remecilox contains:

Active substance: Ofloxacin

Excipients: Povidone, Microcrystalline Cellulose, Sodium Starch Glycollate, Colloidal Silicon Dioxide, Magnesium Stearate, Talc, Hypromellose, Macrogol 400, Titanium Dioxide.

What Remecilox looks like and contents of the pack:

Description of medicines:

Remecilox 200: White, oval, scored, film-coated tablets.

Remecilox: White, capsule-shaped, film-coated tablets, scored and embossed with “CLX” and Remedica’s logo on one side and embossed with “400” on the other side.

Pack-sizes:

Remecilox 200: This product is available in pack-sizes of 10, 100 and 1000 tablets.

Remecilox: This product is available in pack-sizes of 10, 100, 500 and 1000 tablets.

 

Not all pack-sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Remedica Ltd, Limassol Industrial Estate, Limassol, Cyprus, EU.

 

Name and Address of Registrationer:

Nhat Anh Pharmaceutical Co., Ltd

122/7-9 Dang Van Ngu Str., ward 14, Phu Nhuan district, HCM cit