What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 13621/0010 .


Distaclor granules for suspension 125mg/5ml & 250mg/5ml

Package leaflet: Information for the user

Distaclor granules for suspension 125 mg/5 ml & 250 mg/5 ml

Cefaclor

The name of your medicine is Distaclor Granules for Suspension 125 mg/5 ml & 250 mg/5 ml, which will be referred to as Distaclor suspension 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 suspension is and what it is used for
2. What you need to know before you take Distaclor suspension
3. How to take Distaclor suspension
4. Possible side effects
5. How to store Distaclor suspension
6. Contents of the pack and other information

1 What Distaclor suspension is and what it is used for

Distaclor suspension is made from granules of the active ingredient cefaclor, which is an antibiotic. Your pharmacist will add fresh clean drinking water to the bottle containing the granules, to make up the suspension, before you are given it. Distaclor suspension 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
  • 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 suspension

Do not take Distaclor suspension:

  • if you are allergic (hypersensitive) 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 suspension 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 suspension may interfere with these tests.

Other medicines and Distaclor suspension

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 suspension:

  • warfarin (a blood thinner)
  • probenecid (a treatment for gout).

It may still be all right for you to be given Distaclor suspension 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 before taking this medicine.

Driving and using machines

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

Distaclor suspension contains sucrose

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

Distaclor suspension contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 5ml, that is to say essentially ‘sodium free’.

3 How to take Distaclor suspension

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

Dosage

For adults and the elderly the usual dose is 250 mg three times daily. For more severe infections the dose may be doubled. The maximum daily dose is 4 g.

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

Use in children

For children, and babies over the age of one month, the usual total daily dosage is 20 mg/kg (body weight). This total daily dose is usually divided into three and given eight hours apart. For throat and middle ear infections the total daily dose can be divided into two and given twelve hours apart. For more severe infections the dose may be doubled. The maximum daily dose is 1 g.

If you take more Distaclor suspension than you should

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

If you forget to take Distaclor suspension

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 medicine, ask your doctor or pharmacist.

4 Possible side effects

Like all medicines, this medicine 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
  • measles-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 suspension

Keep this medicine out of the sight and reach of children.

Store at room temperature (15-25°C).

Keep containers tightly closed and protect from light.

Do not use this medicine after the expiry date which is stated on the bottle. The expiry date refers to the last day of that month.

After it is made up, the suspension should be stored in a refrigerator (2-8°C) and be used within 14 days.

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 protect the environment.

6 Contents of the pack and other information

What Distaclor suspension contains

  • The active substance is cefaclor 125 or 250 mg/5 ml
  • The other ingredients are: sucrose, erythrosine aluminium lake, methylcellulose 15, sodium lauryl sulphate, artificial strawberry flavour, dimeticone, xanthan gum F and modified starch.

What Distaclor suspension looks like and contents of the pack

The product is filled into plastic bottles with screw caps containing 30 or 100 ml of strawberry coloured cefaclor suspension. The granules may also be filled into individual laminated sachets.

Not all pack sizes may be marketed.

Manufacturer

ACS DOBFAR S.p.a.
Via Laurentina
Km 24,730
00071 Pomezia
Rome
Italy.

Marketing Authorisation Holder

Flynn Pharma Ltd
Marine House
Clanwilliam Place
Dublin 2
Ireland

This leaflet was last revised in January 2021