PACKAGE LEAFLET: INFORMATION FOR THE LEAFLET

Cefaclor 125mg/5ml and 250mg/5ml Suspension (Cefaclor Monohydrate)

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

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

•    If you have any further questions, please 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 Cefaclor is and what it is used for

2.    What you need to know before you take Cefaclor

3.    How to take Cefaclor

4.    Possible side effects

5.    How to store Cefaclor

6.    Contents of the pack and other information

1.    What Cefaclor is and what it is used for

Cefaclor belongs to a group of antibiotic medicines called cephalosporins and works by killing bacteria that cause infections.

Cefaclor is used to treat the following:

•    A range of infections including throat, nose and ear infections, infections of skin and soft tissue

•    Urinary tract infections, including inflammation of the bladder (cystitis) and kidney infections (pyelonephritis)

•    Respiratory tract infections, including inflammation of the lungs (pneumonia, bronchitis), inflammation of the tonsils (tonsillitis), sore throat (pharyngitis) and swelling of the lining of the sinuses (sinusitis).

2.    What you need to know before you take Cefaclor Do not take Cefaclor if:

•    You are allergic to Cefaclor, cephalosporins, penicillin or other antibiotics or any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions

Talk to your doctor before taking Cefaclor if:

•    You have ever suffered from colitis (inflammation which causes abdominal pain or diarrhoea)

•    You suffer from kidney problems

•    You are due to have a Coombs test or a urine sugar test as Cefaclor can cause a false-positive reading

Other medicines and Cefaclor

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines which may interact with or be affected by Cefaclor:

•    Warfarin, used to prevent blood clots (anticoagulant)

•    Probenecid, used to treat gout

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 for advice before taking this medicine.

Pregnancy

Care should be taken when prescribing Cefaclor to pregnant women.

Breast-feeding

Cefaclor is passed into breast milk and therefore it is advisable to avoid taking Cefaclor whilst breastfeeding.

Driving and using machines

Cefaclor does not affect the ability to drive or operate machinery.

Cefaclor contains sucrose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Cefaclor

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

•    This suspension is to be taken orally.

Adults and elderly

•    The usual recommended dose is 250mg every eight hours.

•    For severe infections this may be doubled to 500mg every eight hours.

•    The total daily dose should not exceed 4g.

•    The normal adult dose is appropriate for patients with kidney problems (not including dialysis -see below).

Patients undergoing dialysis

Before dialysis, a dose of 250mg - lg is recommended, with a maintenance dose (between dialysis sessions) of 250mg - 500mg every 6-8 hours.

Use in children

•    The usual recommended dose is 20mg per kg of body weight daily. This is to be given in divided doses every 8 hours.

•    Doses may generally be administered every 8 hours as follows:

o 1 month to 1 year old (9kg) - 2.5mls (62.5mg) of 125mg/5ml suspension 3 times daily o    1-5 years old (9-18kg) - 5mls (125mg) of 125mg/5ml suspension 3 times daily

o Over 5 years of age - 5mls (250mg) of 250mg/5ml suspension 3 times daily

•    For the treatment of bronchitis and pneumonia (inflammation of the lungs), the recommended dose is 20mg per kg of body weight daily. This is to be given in divided doses 3 times daily.

•    For the treatment of ear infections or sore throat (pharyngitis), the total daily dose should be given in divided doses every 12 hours.

•    Doses may be increased to 40mg per kg of body weight daily, given in divided doses for more severe infections.

•    The total daily dose should not exceed 1g.

•    In the treatment of streptococcal infections, treatment should be continued for at least 10 days.

•    Do not give Cefaclor to babies who are less than one month old.

If you take more Cefaclor than you should

If you accidentally take too much suspension, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining suspension with you.

Symptoms of overdose include: feeling (nausea) or being sick (vomiting), diarrhoea, stomach upsets.

If you forget to take your Cefaclor

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Cefaclor

It is important that you keep taking Cefaclor for as long as your doctor has told you to.

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

4. Possible side effects

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

Serious Side Effects

Seek medical advice immediately if you develop the following symptoms:

•    Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness (anaphylaxis)

•    Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)

•    Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)

•    Severe blistering of the skin, mouth, eyes and genitals (Steven-Johnson syndrome, toxic epidermal necrolysis)

•    Frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an increase in certain white blood cells (eosinophilia)

Other Side Effects

•    Diarrhoea

•    Inflammation which causes abdominal pain or diarrhoea (colitis)

•    Feeling (nausea) or being sick (vomiting)

•    Sever itching (pruritus)

•    Skin rashes with the formation of wheals (urticaria)

•    Pain and inflammation in the joint (arthritis)

•    Pain or selling in the joints (arthralgia)

•    Fever

•    Swollen/enlarged lymph nodes (lymphadenopathy)

•    Protein in the urine (proteinuria)

• General weakness (asthenia)

•    Difficulty in breathing/shortness of breath (dysponea)

•    Tingling or numbness in the hands or feet (paraesthesia)

•    Fainting (syncope)

•    Widening of blood vessels (vasodilation)

•    An increase in blood platelets (thrombocytopenia)

•    Increase in the number of lymphocytes in the blood (lymphocytosis)

•    A reduction in white blood cells (leucopenia, neutropenia)

•    Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)

•    Severe reduction in blood cells which can cause weakness, bruising or make infections more likely (aplastic anaemia)

•    More prone to infections due to a severe reduction in number of white blood cells (agranulocytosis)

•    Inflammation of the liver (hepatitis)

•    Yellowing of the skin or whites of the eyes (cholestatic jaundice)

•    Inflammation of the kidney (interstitial nephritis - reversible)

•    Slight elevations in blood urea or serum creatinine or abnormal urine tests

•    Unusually or abnormally active (hyperactivity - reversible)

•    Agitation

•    Nervousness

•    Difficulty in sleeping (insomnia)

•    Confusion

•    Increased tightness of muscle tone reducing the ability of the muscle to stretch (hypertonia)

•    Dizziness

•    Seeing or hearing things that are not real (hallucinations)

•    Sleepiness or drowsiness (somnolence)

•    Itching of the genital area (genital pruritus)

•    Inflammation of the vagina (vaginitis)

•    Vaginal yeast infection such as thrush (vaginal moniliasis)

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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Cefaclor

•    Keep all medicines out of the sight and reach of children.

•    Do not use Cefaclor after the expiry date is stated on the carton/label after EXP. The expiry date refers to the last day of that month.

•    Dry Powder: Store below 25°C, in a dry place, protected from light. Reconstituted Suspension: Store at 2-8°C.

•    After 14 days, throw away any unused suspension

•    Medicines should not be disposed of 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 Cefaclor contains:

Each 5ml of reconstituted suspension contains Cefaclor Monohydrate equivalent to either 125mg or 250mg of Cefaclor

The other ingredients are: antischaumemulsion SE2, xanthan gum, sodium starch glycollate, strawberry flavour, raspberry flavour, sodium lauryl sulfate, methylhydroxyethylcellulose and sucrose

What Cefaclor looks like and the contents of the pack:

Cefaclor is a homogenous, white to slightly yellow coloured granule powder mixture. When dispersed in water (prepared by Pharmacist), it is white to slightly yellow in colour with a taste and odour of fruit.

Cefaclor is available in:

Cefaclor is available as a powder for the preparation of a fruit-flavoured suspension.

When prepared by the pharmacist, each bottle of suspension contains 100mls.

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St. Neots Cambridgeshire PE198ET UK

Manufacturer:

Allphamed Pharbil Pharma Gmbh Hildebrand Strasse 12 37023 Gottingen Germany

Product Licence Numbers:

PL 11311/0119 - 125mg/5ml PL 11311/0120 - 250mg/5ml

This leaflet was last revised in May 2016

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