CEFALEXIN 500 MG CAPSULES, KEFLEX CAPSULES 500 MG - patient leaflet, side effects, dosage

Cefalexin Capsules 250 mg

Cefalexin

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 Cefalexin is and what it is used for

2. What you need to know before you take Cefalexin

3. How to take Cefalexin

4. Possible side effects

5. How to store Cefalexin

6. Contents of the pack and other information

1 What Cefalexin is and what it is used for

Cefalexin contains the active ingredient cefalexin monohydrate, which is an antibiotic.

Cefalexin is used to treat the following infections caused by bacteria that can be killed by cefalexin:

• ■ Respiratory tract (lung and airways) infections

e.g. tonsillitis, pharyngitis and bronchitis

• ■ Middle ear infection (otitis media)

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

• ■ Bone and joint infections

• ■ Infections of the reproductive organs and urinary tract (e.g. cystitis), including acute inflammation of the prostate (prostatitis)

• ■ Dental infections.

2 What you need to know before you take Cefalexin

Do not take Cefalexin:

• ■ If you are allergic to cefalexin, other cephalosporins (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 Cefalexin if you:

• ■ have had an allergic reaction to cefalexin, cephalosporins, penicillins, or other drugs in the past

• ■ develop severe or prolonged diarrhoea during or after taking cefalexin

• ■ have a severe kidney disorder (you may need a reduced dose)

• ■ have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking cefalexin or other antibacterials.

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

Acute generalised exanthematous pustulosis (AGEP) has been reported with the use of cefalexin. AGEP appears at the initiation of treatment as a red, scaly widespread rash with bumps under the skin and blisters accompanied by fever. The most common location: mainly localized on the skin folds, trunk, and upper extremities. The highest risk for occurrence of this serious skin reaction is within the first week of treatment. If you develop a serious rash or another of these skin symptoms, stop taking cefalexin and contact your doctor or seek medical attention immediately.

Other medicines and Cefalexin

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 Cefalexin:

• ■ Any other antibiotics (e.g. gentamicin, tobramycin, cefuroxime)

• ■ Potent diuretics e.g. furosemide (water tablets used to treat high blood pressure or water retention)

• ■ Probenecid (a treatment for gout)

• ■ Metformin (a treatment for diabetes)

• ■ Drugs used to treat leukaemia.

It may still be all right for you to be given Cefalexin 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

Cefalexin should not affect your ability to drive or use machines.

Cefalexin Capsules contain sodium

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

3 how to take cefalexin

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 total daily dose is 1–4 g orally, in divided doses.

• ■ Most infections can be treated by 500 mg every

8 hours. For skin and soft tissue infections, sore throat (streptococcal pharyngitis), and mild, uncomplicated urinary tract infections, the usual dose is 250 mg every 6 hours, or 500 mg every 12 hours.

• ■ For more severe infections, larger doses may be needed. A reduced dose is needed for patients with severe kidney disorders.

Use in children

The usual total daily dose for children is 25–50 mg/kg (body weight) in divided doses.

• ■ For skin and soft tissue infections, streptococcal pharyngitis, and mild, uncomplicated urinary tract infections, the total daily dose may be divided and administered every 12 hours.

For most infections the following schedule is suggested: Children under 5 years: 125 mg every 8 hours.

Children 5 years and over: 250 mg every 8 hours.

In severe infections, the dose may be doubled. In the treatment of middle ear infections, a total daily dose of 75 to 100 mg/kg in 4 doses is required.

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

4 Possible side effects

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

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 contact your doctor immediately if you experience them:

• ■ Serious peeling or blistering of the skin

• ■ Severe diarrhoea

• ■ A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using cefalexin if you develop these symptoms and contact your doctor or seek medical attention immediately.

See also section 2.

The following side effects have been reported

• ■ Diarrhoea

• ■ Feeling sick (nausea)

• ■ Vomiting

• ■ Indigestion

• ■ Stomach pains

• ■ 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

• ■ 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

• ■ Fainting

• ■ Abnormally excitable behaviour

• ■ Agitation

• ■ Tiredness

• ■ Headache

• ■ Confusion

• ■ Dizziness

• ■ Seeing or hearing things (hallucinations)

• ■ Itching of the vagina or anus caused by thrush (candidiasis).

5 how to store cefalexin

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiry date refers to the last day of that month.

Do not store above 30°C.

Keep containers tightly closed.

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 Cefalexin contains

The active substance is cefalexin monohydrate.

The other ingredients are:

Cellulose with sodium carboxymethyl cellulose, dimeticone, magnesium stearate, paten blue V (E131), quinoline yellow (E104), titanium dioxide (E171) and gelatin.

What Cefalexin looks like and contents of the pack

250 mg Capsules: Green and white and marked ‘GP1’. Available in Plastic bottles of 20, 100 and 500 capsules, or blisters of 28 capsules.

500 mg Capsules: Pale green and dark green and marked ‘GP2’. Available in plastic bottles of 20, 100 and 500 capsules or blisters of 21 or 28 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Flynn Pharma Ltd

Marine House

Clanwilliam Place

Dublin 2

Ireland.

Manufacturer

ACS DOBFAR S.p.a

Via Laurentina,

Km 24,730 Pomezia

00071 Rome

Italy

This leaflet was last revised in

January 2021