Licensed Products - Distaclor® [PIL]

Patient Information Leaflets for Distaclor 375mg Tablets & 500mg Capsules

Distaclor MR tablets 375mg Cefaclor

The name of your medicine is Distaclor MR Tablets 375mg, which will be referred to as Distaclor MR tablets throughout this document.

Read all of this leaflet carefully before you start taking this medicine.

* 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.What Distaclor MR tablets are andwhat they are used for
2.Before you take Distaclor MR tablets
3.How to take Distaclor MR tablets
4.Possible side effects
5.How to store Distaclor MR tablets
6.Further information

1 What Distaclor MR tablets are and what they are used for:

Distaclor MR tablets are a long acting tablet. They contain the active ingredient cefaclor, which is an antibiotic. Distaclor MR is 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.

2 Before you take Distaclor MR tablets

Do not take Distaclor MR tablets if

* you are allergic (hypersensitive) to cefaclor, any cephalosporin (other similar antibiotics) or any of the other ingredients of Distaclor MR tablets (these are listed in Section 6 of this leaflet). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Take special care with Distaclor MR

* if you have had an allergic reaction to penicillins or other drugs in the past
* or have diarrhoea while taking antibiotics.

Taking other medicines.

Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription. This is especially important of the following, as they may interact with your Distaclor MR tablets:

* warfarin (a blood thinner)
* 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 Distaclor MR tablets and your doctor will be able to decide what is suitable for you.

Pregnancy and breast-feeding

You should tell your doctor if you are pregnant or breastfeeding. Ask your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Important information about the ingredients of Distaclor MR tablets

Distaclor MR tablets contain mannitol, which may have a mild laxative effect.

3 How to take Distaclor MR tablets

Always take Distaclor MR tablets exactly as your doctor has told you. You should 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 375mg (one tablet) taken orally twice daily.
For pneumonia, the usual dose is 750mg (two tablets) taken orally twice daily.

Patients with a severe kidney disorder or patients recieving dialysis may need a different dose.

Children:
Distaclor MR tablets are not recommended for children.

If you take more Distaclor MR tablets than you should

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

If you forget to take Distaclor MR tablets

If you miss a dose, take one as soon as you can. If you have missed several doses, tell your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, Distaclor MR 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, 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).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5 How to store Distaclor MR tablets

Distaclor MR tablets should be kept out of the sight and reach of children.
Store between 15°C and 25°C.
Store in the original container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Further information

What Distaclor MR 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 Distaclor MR tablets look like and contents of the pack

Distaclor MR is packaged in foil blister packs of 2 or 14.
Not all pack sizes may be marketed.
Distaclor MR is a blue, capsule-shaped, film-coated tablet marked GP5.

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

Marketing Authorisation Holder
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
Ireland.
This leaflet was last revised in
December 2007

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.

* 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
* If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.What Distaclor capsules are and what they are used for
2.Before you take Distaclor capsules
3.How to take Distaclor capsules
4.Possible side effects
5.How to store Distaclor capsules
6.Further 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 Before you take Distaclor capsules

Do not take Distaclor capsules if

* you are allergic (hypersensitive) to cefaclor, any cephalosporin (other similar antibiotics) or any of the other ingredients of Distaclor capsules (these are listed in Section 6 of this leaflet). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

Take special care with Distaclor capsules if you

* have had an allergic reaction to penicillins or other drugs in the past
* have a history of gastrointestinal disease, especially inflammation of the colon (colitis)
* have severe kidney problems

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

Taking other medicines

Please tell your doctor or pharmacist if you are taking, or have recently taken, 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

You should tell your doctor if you are pregnant or breastfeeding. Ask your doctor or pharmacist before taking any medication.

Driving and using machines

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

3 How to take Distaclor capsules

Always take Distaclor capsules exactly as your doctor has told you. You should 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.

Children:
Distaclor capsules are not recommended for children.

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. If you have any further questions on the use of this product, 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 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).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5 How to store Distaclor capsules
Distaclor capsules should be kept out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging and protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6 Further 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.

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

Marketing Authorisation Holder
Flynn Pharma Ltd
Alton House
4 Herbert Street
Dublin 2
Ireland.

This leaflet was last revised in December 2007