What it is and what it is used for

for Cefaclor Flynn prolonged-release tablets are long-acting tablets. They contain the active ingredient cefaclor, which is an antibiotic. Cefaclor Flynn prolonged-release tablets are used to treat the following infections caused by bacteria that can be killed by cefaclor:

• Bronchitis
• Infection of lung tissue (pneumonia)
• Bladder (cystitis) and kidney infections
• Throat infections including tonsillitis and pharyngitis
• Skin and soft tissue (e.g. muscle) infections 2.

What you need to know before you take it

e Cefaclor Flynn prolonged-release tablets

Do not take Cefaclor Flynn prolonged-release tablets if

• you are allergic to cefaclor, any cephalosporin (other similar antibiotics) or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue. Warnings and precautions Talk to your doctor or pharmacist before taking Cefaclor Flynn prolonged-release tablets
• if you have had an allergic reaction to penicillins or other drugs in the past
• if you have diarrhoea while taking antibiotics Other medicines and Cefaclor Flynn prolonged-release tablets Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important of the following, as they may interact with your Cefaclor Flynn prolonged-release tablets:
• warfarin (a blood thinner)

–

probenecid (a treatment for gout) antacids containing magnesium hydroxide or aluminium hydroxide, for heartburn and indigestion (these can be bought without prescription)

It may still be all right for you to be given Cefaclor Flynn prolonged-release tablets and your doctor will be able to decide what is suitable for you. Pregnancy and breast-feeding 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 Cefaclor Flynn prolonged-release tablets should not affect your ability to drive or use machines.

How to take it

Cefaclor Flynn prolonged-release tablets Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The tablets should not be cut, crushed or chewed. Dosage Adults and the elderly For pharyngitis, bronchitis, tonsillitis, lower urinary tract infections, and skin infections, the usual dose is 375 mg (one tablet) taken orally twice daily. For pneumonia, the usual dose is 750 mg (two tablets) taken orally twice daily. Patients with a severe kidney disorder or patients receiving dialysis may need a different dose. Use in Children Cefaclor Flynn prolonged-release tablets are not recommended for children. If you take more Cefaclor Flynn prolonged-release tablets than you should Go to the nearest accident and emergency department or tell your doctor straight away. If you forget to take Cefaclor Flynn prolonged-release tablets If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Cefaclor Flynn prolonged-release tablets can cause side effects, although not everybody gets them. All medicines can cause allergic reactions, although serious allergic reactions are very rare. Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body).

Serious side effects The following side effects are serious. You should stop taking this medicine and tell your doctor immediately if you experience them:

• serious peeling or blistering of the skin
• severe diarrhoea, possibly with blood or mucus. The following side effects have been reported:
• diarrhoea
• feeling sick (nausea)
• vomiting
• measles-like rash, (alone)
• itching
• red wheals on the skin (urticaria) (alone)
• rash with widespread joint pain and / or stiffness, swollen lymph glands, fever and, possibly, cloudy urine
• swollen arms or legs
• breathlessness
• changes in blood counts, which may show up as bruising or a very tired feeling. You will need a blood test to confirm this
• damage to your liver or kidneys which can only be detected by a blood and / or urine test
• jaundice (yellow skin and eyes)
• weakness
• pins and needles in the hands or feet
• fainting
• abnormally excitable behaviour
• agitation
• nervousness
• sleeplessness
• confusion
• tight muscles
• dizziness
• seeing or hearing things (hallucinations)
• encephalopathy (non-inflammatory brain disease)
• convulsions
• myoclonus (muscle-twitching)
• itching of the vagina caused by thrush (candidiasis) 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 Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

Cefaclor Flynn prolonged-release tablets Keep this medicine out of the sight and reach of children. Do not store above 25 °C. Store in the original package in order to protect from light. Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

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.

Contents of the pack and other information

What Cefaclor Flynn prolonged-release tablets contain The active substance is cefaclor. The other ingredients are: mannitol, methylhydroxypropylcellulose, hydroxypropylcellulose, methacrylic acid copolymer, stearic acid, magnesium stearate, titanium dioxide (E171), polyethylene glycol, propylene glycol, indigo carmine aluminium lake (E132) and talc. What Cefaclor Flynn prolonged-release tablets look like and contents of the pack Cefaclor Flynn prolonged-release tablets are blue, capsule-shaped film-coated tablets, marked GP5. Cefaclor Flynn prolonged-release tablets are supplied in blister packs of 2 or 14. Not all pack sizes may be marketed. Marketing Authorisation Holder Flynn Pharma Ltd 5th Floor, 40 Mespil Road, Dublin 4, IRELAND, D04 C2N4 Manufacturer ACS DOBFAR S.p.a Via Laurentina Km 24,730 00071 Pomezia Rome Italy This leaflet was last revised in March 2024