Cefalexin 125mg/5ml Powder For Oral Suspension

Document: leaflet MAH GENERIC_PL 16363-0122 change

PACKAGE LEAFLET: INFORMATION FOR THE USER Cefalexin 125mg/5ml Powder for Oral Suspension Cefalexin 250mg/5ml Powder for Oral Suspension

(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 Oral Suspension is and what it is used for

2. What you need to know before you take Cefalexin Oral Suspension

3. How to take Cefalexin Oral Suspension

4. Possible side effects

5. How to store Cefalexin Oral Suspension

6. Contents of the pack and other information

1. WAT CEFALEXIN ORAL SUSPENSION IS AND WHAT IT IS USED FOR

Cefalexin Oral Suspension contain cefalexin as the active ingredient, which belongs to a class of antibiotics called 'cephalosporins'.

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

• Respiratory tract (lung and airways) e.g. tonsillitis, pharyngitis and bronchitis

• Middle ear infections (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 gland (prostatitis)

• Dental infections.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CEFALEXIN ORAL SUSPENSION

Do not take Cefalexin Oral Suspension if you:

• Are allergic (hypersensitive) to cefalexin, other cephalosporins (similar antibiotics) or penicillin group of antibiotics, or to any of the ingredients in the product (see Section 6 and end of Section 2). An allergic reaction may include rash, itching, difficulty breathing or swelling of the face, lips, throat or tongue.

• Have porphyria; a hereditary metabolic disorder.

Warnings and precautions

Talk to your doctor or pharmacist before taking Cefalexin Oral Suspension if you:

• Have had allergic reaction to cefalexin, cephalosporins, penicillins or other drugs in the past

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

• Develop diarrhoea. This could be symptom of the inflammation of the large intestine. Other symptoms include pain and fever.

Tell your doctor if you are having blood and urine tests. Cefalexin Oral Suspension may

interfere with these tests.

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Other medicines and Cefalexin Oral Suspension

Please tell your doctor or pharmacist if you are taking or have recently taken, or might take any other medicines. This includes medicines you buy without a prescription.

In particular, tell your doctor if you are taking any of the following

• other antibiotics, especially amphotericin, capreomycin, vancomycin, gentamicin or neomycin

• diuretics (water tablets) such as furosemide, bumetanide

• probenecid for a treatment of gout

• metformin for treatment of diabetes

• drugs used to treat leukemia

It may be still be all right for you to be given Cefalexin Capsules and your doctor will be able to decide what is suitable for you.

Cefalexin Oral Suspension with food and drink

This suspension may be taken before, during or after your meals.

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 Oral Suspension is not expected to affect your ability to drive or operate machinery. Cefalexin Oral Suspension contains Sorbitol and Sodium

Sorbitol - If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Sorbitol may have a mild laxative effect Calorific value of sorbitol is2.6 kcal/g. One dose of the Cefalexin suspension contains 900mg of sorbitol

Sodium - This medicinal product contains 3.38 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet

3. HOW TO TAKE CEFALEXIN ORAL SUSPENSION

The doctor will decide on the most appropriate dose for you, based on the nature and severity of your infection. Always take Cefalexin Oral Suspension exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

For oral use only.

Dosage:

Adults: The usual total daily dose is 1g to 4g a day in divided doses.

Most infections can be treated by 500mg every 8 hours. For skin and soft tissue infections, sore throat (Streptococcal pharyngitis), and mild, uncomplicated urinary tract infections, the usual dose is 250mg every 6 hours or 500mg every 12 hours. For more severe infections, larger doses may be needed

Elderly: You should take the normal adult dose, unless you have severe kidney problems when the maximum daily dose will be 500mg.

Children: The doctor will calculate the correct dose for your child depending on his or her body weight. The usual daily dose for children is 25mg to 50mg for each kilogram of their weight, split into smaller amounts and taken every 8 or 12 hours.

For most infections the following is recommended:

Children under 5 years: 125mg every 8 hours.

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

If your child is taking Cefalexin Oral Suspension for an ear infection, he or she may have to take 75mg to 100mg for each kilogram of their weight, split into smaller doses throughout the day.

Take all the suspension your doctor has given you. Do not stop taking them, even if you feel better

If you take more Cefalexin Oral Suspension than you should

Contact your doctor or nearest hospital casualty department if you or a child have swallowed too much medicine. Take this leaflet and any remaining suspension with you, if possible. Symptoms of overdose include nausea, vomiting, stomach upset, appearance of blood in the urine.

If you forget to take Cefalexin Oral Suspension

If you miss a dose, take the suspension as soon as you remember. If it is almost time to take the next dose, wait until then and then carry on as before. Do not take a double dose to make up for the forgotten dose.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Cefalexin Oral Suspension can cause side effects, although not everyone gets them.

Tell your doctor immediately if you get any of these side effects:

• rash

• fever

• itchy skin

• swelling of the lips, eye lids, tongue

• difficulty in breathing, sudden wheeziness.

These are the signs of an allergic reaction. Stop taking the oral suspension immediately. 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

The following side effects have been reported

• Diarrhoea, stomach pain, heartburn, indigestion

• Lower gut pain, inflammation of colon (colitis), severe diarrhoea containing mucus or blood

• Feeling sick (nausea) or being sick (vomiting)

• Measle like rash

• Itching

• Red wheals on the skin (urticaria)

• Pus in the eyes

• Blisters in the nose or mouth

• Rash with wide spread joint pain and/ or stiffness, swollen lymph glands, fever and, possibly, cloudy urine

• Changes in blood counts, witch may show up as bruising ir a very tired feeling. You will need a blood test to confirm this

• Damage to your liver or kidneys which can be detected by a blood and/ or urine test

• Yellow skin and eye whites (jaunudice)

• Weakness, fainting

• Feeling confused or agitated, seeing or hearing things that are not there (hallucinations), extreme restlessness

• Dizziness, tiredness, headache, sleep disorders, nervousness

• itching around the anus or genitals, inflamed vagina, discharge from the vagina caused by thrush (candidasis)

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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 CEFALEXIN ORAL SUSPENSION

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

Dry powder: Store below 25°C, tightly closed in the container.

Made-up suspension: Store at 2 - 8°C. Discard any unused medicine after 14 days.

Do not use Cefalexin Oral Suspension after the expiry date stated on the pack.

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. CONTENTS OF THE PACK AND OTHER INFORMATION

What Cefalexin Oral Suspension contains

The active substance is cefalexin monohydrate, 125mg or 250mg in a 5ml spoonful.

The other ingredients are sodium benzoate (E211). Disodium edetate, citric acid, sodium citrate, sorbitol powder, saccharin sodium, colloidal silicon dioxide, monoammonium glycerrhizinate, and xanthan gum.

The 125mg/5ml suspension contains colour E127 (erythrosine) and strawberry flavour. The 250mg/5ml suspension contains colour 104 (quinoline yellow) and orange flavour.

What Cefalexin Oral Solution looks like and contents of the pack

125mg/5ml powder - pale pink, free flowing granular powder, which readily mixes in water to give a pink suspension with a flavour of strawberry.

250mg/5ml powder - pale yellow, free flowing granular powder, which readily mixes in water to give a yellow suspension with a flavour of orange.

Both suspensions are supplied in plastic bottles of 100ml.

Marketing Authorisation Holder

Marketing Authorisation Holder:

Milpharm Limited

Ares, Odyssey Business Park,

West End Road, South Ruislip HA4 6QD,

United Kingdom.

Manufacturers: