NEWCLAV

NEWCLAV 400mg/57 mg/5ml powder for oral suspension

Amoxicillin/clavulanic acid

Package leaflet: Information for the user

Read all of this leaflet carefully before you start giving your child this medicine because it contains important information for them.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for a baby or child Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
• If your child gets any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What NEWCLAV is and what it is used for
2. What you need to know before you give NEWCLAV
3. How to give NEWCLAV
4. Possible side effects
5. How to store NEWCLAV
6. Contents of the pack and other information

1. What NEWCLAV is and what it is used for

NEWCLAV 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). The other active component (clavulanic acid) stops this from happening.

NEWCLAV is used in babies and children to treat the following infections:

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

2. What you need to know before you give NEWCLAV

Do not give your child NEWCLAV:

• if they are allergic to amoxicillin, clavulanic acid or any of the other ingredients of NEWCLAV (listed in section 6)
• if they have ever had a severe allergic (hypersensitive) reaction to any other antibiotic. This can include a skin rash or swelling of the face or neck
• if they have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not give NEWCLAV to your child if any of the above apply to your child. If you are not sure, talk to their doctor or pharmacist before giving NEWCLAV.

Warnings and precautions

Check with their doctor,  pharmacist or nurse before giving your child this medicine if they:

• have glandular fever
• are being treated for liver or kidney problems
• are not passing water regularly.

If you are not sure if any of the above apply to your child, talk to their doctor or pharmacist before giving NEWCLAV.

In some cases, your doctor may investigate the type of bacteria that is causing your child’s infection. Depending on the results, your child may be given a different strength of NEWCLAV or a different medicine.

Conditions you need to look out for

NEWCLAV can make some existing conditions worse, or cause serious side effects. These include allergic reactions, convulsions (fits) and inflammation of the large intestine. You must look out for certain symptoms while your child is taking NEWCLAV, to reduce the risk of any problems. See ‘Conditions you need to look out for’ in Section 4.

Blood or urine tests

If your child is having blood tests (such as red blood cell status tests or liver function tests) or urine tests (for glucose), let the doctor or nurse know that they are taking NEWCLAV. This is because NEWCLAV can affect the results of these types of tests.

Other medicines and NEWCLAV

Tell your doctor or pharmacist if your child is taking or has recently taken or might take any other medicines.

If your child is taking allopurinol (used for gout) with NEWCLAV, it may be more likely that they will have an allergic skin reaction.

If your child is taking probenecid (used for gout), your doctor may decide to adjust the dose of NEWCLAV.

If medicines to help stop blood clots (such as warfarin) are taken with NEWCLAV then extra blood tests may be needed.

NEWCLAV can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works.

NEWCLAV can affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works.

Pregnancy, breast-feeding and fertility

If your child who is about to take this medicine is pregnant or breast-feeding, thinks they 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

NEWCLAV can have side effects and the symptoms may make you unfit to drive.

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

3. How to give NEWCLAV

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

Adults and children weighing 40 kg or over

• This suspension is not usually recommended for adults and children weighing 40 kg and over. Ask your doctor or pharmacist for advice.

Children weighing less than 40 kg

All doses are worked out depending on the child’s bodyweight in kilograms.

• Your doctor will advise you how much NEWCLAV you should give to your baby or child.

• You may be provided with a plastic measuring spoon or plastic measuring cup or dosing syringe. You should use this to give the correct dose to your baby or child.
  • Recommended dose – 25 mg/3.6 mg to 45 mg/6.4 mg for each kilogram of body weight a day, given in two divided doses.
  • Higher dose – up to 70 mg/10 mg for each kilogram of body weight a day, given in two divided doses.

Patients with kidney and liver problems

• If your child has kidney problems the dose might be lowered. A different strength or a different medicine may be chosen by your doctor.
• If your child has liver problems they may have more frequent blood tests to see how their liver is working.

How to give NEWCLAV

• Always shake the bottle well before each dose
• Give at the start of a meal or slightly before
• Space the doses evenly during the day, at least 4 hours apart. Do not give 2 doses in 1 hour.
• Do not give your child NEWCLAV for more than 2 weeks. If your child still feels unwell they should go back to see the doctor.

If you give more NEWCLAV than you should

If you give your child too much NEWCLAV, signs might include an upset stomach (feeling sick, being sick or diarrhoea) or convulsions. Talk to their doctor as soon as possible. Take the medicine bottle to show the doctor.

If you forget to give NEWCLAV

If you forget to give your child a dose, give it as soon as you remember. You should not give your child the next dose too soon, but wait about 4 hours before giving the next dose.

If your child stops taking NEWCLAV

Keep giving your child NEWCLAV until the treatment is finished, even if they feel better. Your child needs every dose to help fight the infection. If some bacteria survive they can cause the infection to come back.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.

Conditions you need to look out for

Allergic reactions:

• skin rash
• 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
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• acute circulatory failure (collapse).

Contact a doctor immediately if your child gets any of these symptoms. Stop taking NEWCLAV.

Inflammation of large intestine

Inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever.

Contact your doctor as soon as possible for advice if your child gets these symptoms.

Common side effects

These may affect up to 1 in 10 people

• thrush (candida – a yeast infection of the vagina, mouth or skin folds)
• feeling sick (nausea), especially when taking high doses – if affected give NEWCLAV before food
• vomiting
• diarrhorea (in children).

Uncommon side effects

These may affect up to 1 in 100 people

• skin rash, itching
• raised itchy rash (hives)
• indigestion
• dizziness

Uncommon side effects that may show up in blood tests:

• increase in some substances (enzymes) produced by the liver

Rare side effects

These may affect up to 1 in 1000 people

• skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge – erythema multiforme)

If you notice any of these symptoms contact your docotor urgently

Rare side effects that may show up in blood tests:

• low number of cells involved in blood clotting
• low number of white blood cells

Other side effects

Other side effects have occurred in a very small number of people but their exact frequency is unknown.

• Allergic reactions (see above)
• Inflammation of the large intestine (see above)
• Inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• Serious skin reactions:
• a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome), and 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))

Contact a doctor immediately if your child gets any of these symptoms.

• inflammation of the liver (hepatitis)
• jaundice, caused by increases in the blood of bilirubin (a substance produced in the liver) which may make your child’s skin and whites of the eyes appear yellow
• inflammation of tubes in the kidney
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of NEWCLAV or who have kidney problems)
• black tongue which looks hairy
• stained teeth (in children), usually removed by brushing.

Side effects that may show up in blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells (haemollytic anaemia).
• cristals in urine

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 national reporting system. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store NEWCLAV

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

Store below 25°C.

Do not use this medicineafter the expiry date which is stated on the carton. The expiry date refers to the last day of that month. The expiry date which is stated on the bottle label is for the unopened bottle.

Following reconstitution your medicine should be stored in the fridge and should be used within 7 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 NEWCLAV contains

• The active substances are 400 mg amoxicillin and 57 mg clavulanic acid (present as potassium clavulanate) in every 5 ml of suspension.
• The other ingredients are xanthan gum, hydroxypropylmethyl cellulose, saccharin sodium, colloidal anhydrous silica (aerosil), colloidal anhydrous silica (Syloid al-1), strawberry flavor, peach flavor, lemon flavor, succinic acid.

What NEWCLAV looks like and contents of the pack

White to off-white free flowing powder for reconstitution in water, at time of dispensing, to form an oral suspension.

Brown semitransparent glass bottles, TYPE III (with aluminium white caps).

Bottles of 150 ml bottle size for 70 ml suspension.

Bottles of 200 ml bottle size for 140 ml suspension.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Medochemie Ltd, 1-10 Constantinopeoleus street, 3011, Limassol, Cyprus

Manufacturer

MEDOCHEMIE LTD (FACTORY B), 48 Iapetou street, Agios Athanassios Industrial Area, 4101 Agios Athanassios, Limassol, Cyprus

Organization which receives claims from consumers on product quality in the territory of Georgia:

“NEW PHARMA” LTD

Legal address: Georgia, Gori, st. Tsabadze, Bldg. No. 5, sq. 32.

Actual address: Evdoshvili str.18, 0154 Tbilisi, Georgia.

Tel / Fax: +995 (32) 210 88 18.

For any information about this medicine, please contact “NEW PHARMA” LTD

This leaflet was last revised in September 2017

Advice/medical education

Antibiotics are used to treat infections caused by bacteria. They have no effect against infections caused by viruses.

Sometimes an infection caused by bacteria does not respond to a course of an antibiotic. One of the commonest reasons for this to occur is because the bacteria causing the infection are resistant to the antibiotic that is being taken. This means that they can survive and even multiply despite the antibiotic.

Bacteria can become resistant to antibiotics for many reasons. Using antibiotics carefully can help to reduce the chance of bacteria becoming resistant to them.

When your doctor prescribes a course of an antibiotic it is intended to treat only your current illness. Paying attention to the following advice will help prevent the emergence of resistant bacteria that could stop the antibiotic working.

1. It is very important that you take the antibiotic at the right dose, at the right times and for the right number of days. Read the instructions on the label and if you do not understand anything ask your doctor or pharmacist to explain.
2. You should not take an antibiotic unless it has been prescribed specifically for you and you should use it only to treat the infection for which it was prescribed.
3. You should not take antibiotics that have been prescribed for other people even if they had an infection that was similar to yours.
4. You should not give antibiotics that were prescribed for you to other people.
5. If you have any antibiotic left over when you have taken the course as directed by your doctor you should take the remainder to a pharmacy for appropriate disposal.

—————————————————————————————————————————

Instructions for reconstitution

Check cap seal is intact before using. Shake bottle to loosen powder. Add volume of water (as indicated below) invert and shake well. Alternatively fill the bottle with water to just below the mark on bottle label, invert and shake well, then top up with water exactly to the mark, invert and again shake well.

Shake the bottle well before each dose.