Coliprid 250 mg/500 mg/750 mg Tablets

The active substance is ciprofloxacin hydrochloride. COLIPRID 250 mg TABLETS: Each film-coated tablet contains ciprofloxacin hydrochloride equivalent to 250 mg ciprofloxacin. COLIPRID 500 mg TABLETS: Each film-coated tablet contains ciprofloxacin hydrochloride equivalent to 500 mg ciprofloxacin. COLIPRID 750 mg TABLETS: Each film-coated tablet contains ciprofloxacin hydrochloride equivalent to 750 mg ciprofloxacin. The other ingredients are cellulose, microcrystalline; sodium starch glycollate; povidone; silica, colloidal anhydrous and magnesium stearate and opadry white. Opadry white contains hypromellose, macrogol and titanium dioxide (C.I. No: 77891).

COLIPRID TABLETS is used for the treatment of the following infections due to sensitive micro-organisms:

• Lower respiratory tract infections
• Urinary tract infections
• Skin and soft tissue infections
• Gastro-intestinal infections such as infective diarrhoea
• Bone Infections
• Gonorrhoea

Do not take COLIPRID TABLETS:

• If you are hypersensitive (allergic) to ciprofloxacin hydrochloride or to other quinolones or to any of the other ingredients of COLIPRID TABLETS.
• If you are pregnant or breast-feeding.
• If you are under the age of 18 years.

Take special care with COLIPRID TABLETS:

• If you have a history of fits.
• If you experience crystals in your urine which causes kidney pain or discomfort when passing urine. You should be well hydrated and avoid excessive alkalinity of the urine when taking COLIPRID TABLETS.
• Long-term or repeated use of COLIPRID TABLETS can lead to superinfections with resistant bacteria or fungi.
• If you have a heart condition and/or are taking medicines for your heart, you will have to be closely monitored by your doctor.
• If you have a serious allergic reaction when taking COLIPRID TABLETS you should report to your doctor immediately.
• If you experience severe and persistent diarrhoea during or after your treatment, you should consult your doctor as soon as possible.
• If you experience painful swelling of your tendons, you should avoid any physical exercise and your doctor should be consulted.
• You should avoid direct exposure to excessive sunlight and UV-light.
• You should inform your doctor if you are taking any other medicines.

COLIPRID TABLETS should be swallowed whole with plenty of liquid and can be taken with or without food.

Pregnancy and Breast-feeding: Safety of COLIPRID TABLETS in pregnant and breast-feeding women has not been established. If you are pregnant or breast-feeding your baby while taking COLIPRID TABLETS, please consult your doctor, pharmacist or healthcare professional for advice. You should not use COLIPRID TABLETS if you are pregnant, trying to become pregnant or breast-feeding your baby.

Driving and using machinery: The ability to drive a motor vehicle or operate machinery may be affected by COLIPRID TABLETS. This applies particularly in combination with alcohol.

Taking other medicines with COLIPRID TABLETS: If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of COLIPRID TABLETS with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice. COLIPRID TABLETS interacts with theophylline typically used in the treatment of asthma, NSAIDs (e.g. ibuprofen), the immune suppressant agent cyclosporin, warfarin used as a blood thinning agent, the antidiabetic medicine glibenclamide, probenecid used for treating gout and metoclopramide used for treating nausea.

COLIPRID TABLETS should be administered 1 - 2 hours before, or at least 4 hours after taking iron preparations, antacids containing magnesium, aluminium, calcium or sucralfate, as interference with absorption may occur.

Always take COLIPRID TABLETS exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that the effect of COLIPRID TABLETS is too strong or too weak, talk to your doctor or pharmacist.

Dosage and Duration of Treatment: The dosage range is 250 - 750 mg twice daily. The duration of treatment depends upon the severity of the infection, clinical response and bacteriological cultures.

If you take more COLIPRID TABLETS than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control centre.

If you forget to take COLIPRID TABLETS: If you forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

COLIPRID TABLETS can have side effects. If any of the following symptoms occur, stop taking the COLIPRID TABLETS and tell your doctor immediately.

• Tendon rupture or swelling of the tendon (tendinitis) - Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: Pain, swelling, tears and inflammation of tendons including the back of the ankle (achilles), shoulder, hand, or other tendon sites.
• Myasthenia gravis (a type of muscle weakness) - COLIPRID TABLETS may cause worsening of myasthenia gravis symptoms, including muscle weakness, joint pain, joint swelling and general feeling of weakness.
• Severe diarrhoea with bleeding or mucus. And also the following symptoms need urgent medical attention:
• Serious skin allergic reactions including rashes, itching skin, hives and sensitivity to sunlight (blisters, sensation of skin burning), small, pin-point bleeding under the skin, redness of the skin due to allergic reactions and a red rash caused by hypersensitivity to a medicine, disease or other allergen.
• Increased risk of sunburn.
• Severe heart rhythm abnormalities, irregular heart beat.
• Troubles associated with the nervous system such as dizziness, seizures, sense things that are not there (hallucinations), restlessness, tremors, feel anxious or nervous, confusion, depression, trouble sleeping, nightmares, suicidal thoughts or acts.
• Other side effects that you may experience include:
• double vision, colour disturbances.
• ringing sound in the ears, loss of hearing, impaired hearing, vertigo, feeling of constant movement of self or surroundings; sensation of spinning.
• Bruising, nose-bleeds, bleeding gums.
• Frequent infections of the nose, throat, skin and other organs.
• Pale skin, mucosal linings and nail bed, feelings of weakness and fatigue.
• Headache, taste disorders.
• Kidney problems such blood in the urine, crystals in the urine causing pain during urination.
• Pancreatitis (swelling and inflammation of the pancreas) causing severe upper abdominal burning pain that spreads to your back, nausea and vomiting.

Not all side effects reported for COLIPRID TABLETS are included in this leaflet. Should your general health worsen while taking COLIPRID TABLETS, please consult your doctor, pharmacist or other health care professional for advice.

Keep all medicines out of reach of children. Store at or below 30 °C. Keep bottle tightly closed. Keep blisters in outer carton until required for use. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).