AFACLAV® ( Co-Amoxiclav ) Tablet 625 mg

AFACLAV®

Co-Amoxiclav

Tablet 375 mg & 625 mg

Powder for oral suspension 156mg/5mL, 312mg/5mL, 228mg/5mL, 457mg/5mL, 643mg/5mL

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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.
• If you have any further questions, ask your doctor or pharmacist.t

it is used f

What Co-amoxiclav is and what it is used for

Co-amoxiclav is an antibiotic and works by killing bacteria that cause infections. It contains two different medicines called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines called “penicillins” that can sometimes be stopped from working (made inactive). Clavulanic acid stops this from happening.

Co-amoxiclav is used in adults and children to treat the following infections:

• respiratory infections
• middle ear and sinus infections
• urinary tract and kidney infections
• skin and soft tissue infections including animal bites and dental infections
• bone and joint infections

 

You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

 

Before use this drug, ask your doctor:

• If you are allergic to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of this medicine.
• If you have ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face, lips, tongue, throat or neck.
• If you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.
• If you have phenylketonuria. (The suspensions contains phenylalanine, don’t be used by phenylketonurics)

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.

You should only use Co-amoxiclav whilst pregnant if your doctor tells you to. This medicine may be harmful to the baby.

Amoxicillin and clavulanic acid can pass into breast milk. If you breast-feed while taking this medicine, your baby may be more likely to get diarrhoea or an infection. You should only use Co-amoxiclav whilst breastfeeding if your doctor tells you to.

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Co-amoxiclav if you:

• have glandular fever
• have liver or kidney problems
• are not passing water regularly

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Co-amoxiclav.

 

In some cases, your doctor may investigate the type of bacteria that is causing your infection. Depending on the results, you may be given a different strength of Co-amoxiclav or a different medicine.

 

Driving and using machines

Co-amoxiclav can have side effects such as allergic reactions, dizziness or fits that may make you unfit to drive.

Do not drive or use machinery unless you are feeling well.

Method of administration

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• Take this medicine by mouth.
• Swallow the tablets whole with a glass of water at the start of a meal or slightly before.
• Space the doses evenly during the day, at least 4 hours apart. Do not take 2 doses in 1 hour.
• Do not take Co-Amoxiclav for more than 2 weeks. If you still feel unwell you should go back to see the doctor.

 

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

For adults and children ≥ 40 kg, this formulation of Co-Amoxiclav provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below.

For children < 40 kg, this formulation of Co-Amoxiclav provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended below. If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Co-Amoxiclav is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid.

The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment. Treatment should not be extended beyond 14 days without review.

Adults and children ≥ 40 kg

One 500 mg/125 mg dose taken three times a day.

Children < 40 kg

20 mg/5 mg/kg/day to 60 mg/15 mg/kg/day given in three divided doses.

Children may be treated with Co-Amoxiclav tablets, suspensions.

As the tablets cannot be divided, children weighing less than 25 kg must not be treated with Augmentin tablets.

People with kidney problems

If you have kidney problems the dose might be changed. A different strength or a different medicine may be chosen by your doctor.

• CrCl <30 mL/min: Do not use 875/125 mg tablet or extended-release tablets
• CrCl 10-30 mL/min: 250-500/125 mg PO q12hr
• CrCl <10 mL/min: 250-500/125 mg PO q24hr
• Hemodialysis: 250-500/125 mg PO q24hr; administer additional dose both during and at end of dialysis

People with liver problems

If you have liver problems you may have more frequent blood tests to check how your liver is working.

• Dose with caution; monitor hepatic function regularly

 

Reconstitution Directions for Oral Suspension

• Tap the bottle several times to loosen powder contents, then add fresh drinking water in two portions up to the filling mark and shake well after each addition.
• Keep tightly closed.
• Shake well before using.
• Do not freeze.
• Discard unused portion after 7 days (susp 156mg/5mL, 312mg/5mL) and 10 days (susp 228mg/5mL, 457mg/5mL and 643mg/5mL)

 

 

If you take more Afamox® than you should

If you take too much Co-amoxiclav, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions (fits). Talk to your doctor as soon as possible. Take the medicine carton to show the doctor.

 

If you forget to take Afamox®

If you forget to take a dose, take it as soon as you remember. You should then wait 4 hours before taking the next dose.

Do not take a double dose to make up for a forgotten dose.

 

Adverse reactions

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

Stop taking Co-amoxiclav, contact a doctor immediately or go directly to your nearest hospital emergency department if you get any of the following:

Rare (may affect up to 1 in 1,000 people)

• Frequent infections causing fever, severe chills, sore throat or mouth ulcers (these may be signs of a low number of white blood cells).

Frequency Not known (cannot be estimated from the available data)

• signs of a serious allergic reaction which can include:
  • Sudden itching, red skin rash or swelling of the face, lips, tongue, throat or neck, difficulty breathing or swallowing. Inflammation of blood vessels (vasculitis) which may be visible as red or purple raised spots on the skin, but can affect other parts of the body.
  • Fever, joint pain, swollen glands in the neck, armpit or groin.
• Tiredness, headaches, shortness of breath when exercising, dizziness, pale or yellowing of the skin or eyes (these may be signs of a low number of red blood cells).
• Sensitivity to light, stiff neck, body aches, sore throat, severe headache, flu-like symptoms (these may indicate you have a type of meningitis that cannot be passed on to others).
• Diarrhoea, possibly with blood or mucus, stomach pain or fever.
• Yellowing of the skin or whites of the eyes, dark urine, pale stools, tiredness, fever, nausea, weakness, drowsiness and abdominal pain, with blood test results showing abnormal liver function (These may be signs of serious problems with your liver).
• Serious skin reactions:
  • A widespread rash with blisters, bleeding and peeling skin, particularly around the mouth, nose, eyes or genitals (Steven’s-Johnson syndrome) or a more severe form, causing extensive peeling of the skin (more than 30% of the body surface – toxic epidermal necrolysis).
  • Widespread red skin rash with small pus-containing blisters (bullous exfoliative dermatitis).
  • A red, scaly rash with bumps under the skin and blisters (exanthemous pustulosis).
  • Flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS))
• Pain passing urine, lower back pain or fever. These may be signs of a serious kidney problem (interstitial nephritis).
• Fits (especially if you take high doses of Co-amoxiclav or if you have kidney problems).

Other side effects

Common (may affect up to 1 in 10 people)

• Thrush (candida – a yeast infection of the vagina, mouth or skin folds).
• Feeling sick (nausea), especially if you take high doses. If affected take Co-amoxiclav before food.
• Being sick (vomiting).

Uncommon (may affect up to 1 in 100 people)

• Increase in some substances (enzymes) produced by the liver that may show up in blood tests.

Rare (may affect up to 1 in 1,000 people)

• Unexplained bruising or bleeding more easily or for longer than normal. (These may be signs of a low number of cells involved in blood clotting).

Frequency Not known (cannot be estimated from the available data)

• Black tongue which looks hairy.
• Other infections that is difficult to treat (over growth of non-susceptible organisms).
• Crystals in urine (seen as cloudy urine or in a urine test).

Special precautions for storage

• Keep this medicine in room temperature, out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the label and blister pack after EXP:.
• After reconstitution, the suspension may be kept for 7-10 days either at room temperature, or under refrigeration, without significant loss of potency.
• Do not freeze.
• Discard unused portion after 7 to 10 days.
• Store dry powder below 25°C, protect from light and moisture.
• Do not throw away 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.

 

AFACLAV®

Each tablet contains:

250 mg + 125 mg Amoxicillin (as trihydrate) + Clavulanic acid (as potassium)

500 mg + 125 mg Amoxicillin (as trihydrate) + Clavulanic acid (as potassium)

Each 5 mL of Suspension contains:

200 mg + 28 mg Amoxicillin (as trihydrate) + Clavulanic acid (as potassium)

600 mg + 42.5 mg Amoxicillin (as trihydrate) + Clavulanic acid (as potassium)

400 mg + 57 mg Amoxicillin (as trihydrate) + Clavulanic acid (as potassium)

125 mg +31.25 mg Amoxicillin (as trihydrate) + Clavulanic acid (as potassium)

250 mg + 625.5 mg Amoxicillin (as trihydrate) + Clavulanic acid (as potassium)

 

Manufacture by Afa chemi pharmaceutical co. Tehran-Iran.