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Cefaclor 500mg Capsules

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Package leaflet: Information for the user

Distaclor Capsules 500mg

Cefaclor

The name of your medicine is Distaclor Capsules 500mg, which will be referred to as Distaclor capsules throughout this document.

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 Distaclor capsules are and what they are used for

2.    What you need to know before you take Distaclor capsules

3.    How to take Distaclor capsules

4.    Possible side effects

5.    How to store Distaclor capsules

6.    Contents of the pack and other information

1    What Distaclor capsules are and what they are used for

Distaclor capsules contain the active ingredient cefaclor, which is an antibiotic.

Distaclor capsules 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

■    Middle ear infections (otitis media)

■    Skin and soft tissue (e.g. muscle) infections

■    Infection of the sinuses (sinusitis).

2    What you need to know before you take Distaclor capsules

Do not take Distaclor capsules:

■    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 Distaclor capsules

■    If you have had an allergic reaction to penicillins or other drugs in the past

■    If you have a history of gastrointestinal disease, especially inflammation of the colon (colitis)

■    If you have severe kidney problems

Tell your doctor if you are having blood or urine tests. Distaclor capsules may interfere with these tests.

Other medicines and Distaclor capsules

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 Distaclor capsules:

■    warfarin (a blood thinner)

■    probenecid (a treatment for gout).

It may still be all right for you to be given Distaclor capsules 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

Distaclor capsules should not affect your ability to drive or use machines.

3 How to take Distaclor capsules

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

Dosage

Adults and the elderly:

The usual dose is one capsule taken orally three times a day. Your doctor will tell you if you need a different dose.

Patients with a severe kidney disorder or patients receiving dialysis may need a reduced dose.

Use in Children

Cefaclor capsules are not recommended for children.

This leaflet was last revised in

August 2015


If you take more Distaclor capsules than you should

Go to the nearest accident and emergency department or tell your doctor straight away.

If you forget to take Distaclor capsules

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.

4 Possible side effects

Like all medicines, Distaclor capsules 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, lips or limbs, rash or itching (especially affecting your whole body).

Serious side effects

The following side effects are serious. You should stop taking this medicine and contact 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

■    measle-like rash, (alone)

■    itching

■    red wheals on the skin (urticaria) (alone)

■    rash with wide spread 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)

■    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.

By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Distaclor capsules

Keep this medicine out of the sight and reach of children. Do not store above 2 5°C.

Store in the original packaging 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.

6 Contents of the pack and other information

What Distaclor capsules contain

The active substance is cefaclor.

The other ingredients are: magnesium stearate, dimeticone, starch flowable, erythrosine, patent blue V, black iron oxide, titanium dioxide and gelatin.

What Distaclor capsules look like and contents of the pack

Distaclor capsules are purple and grey capsules.

Distaclor capsules come in plastic bottles with screw caps containing 20, 50 and 100 capsules or foil blister packs containing 14 or 21 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Flynn Pharma Ltd

Alton House

4 Herbert Street

Dublin 2

Ireland.

Manufacturer

Facta Farmaceutici SpA Via Laurentina Km 24,730 Pomezia 00040 Rome Italy.

FLYNN

PHARMA

LTD

Artwork for:

Flynn Pharma Limited

Product name:

Distaclor Capsules 500mg

Size:

PL/PA no:

Type:

Leaflet

Artwork dimensions:

160mm x 260mm

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Assumed

Date of first artwork:

27 May 2010

Reason for request:

Revision date edit

Version no:

5 DB

Date of revision:

30 July 2015

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Artwork software:

InDesign CS5.5

BAC ref:

S803