AKLAV 875 mg/125 mg Film-Coated Tablets

Зміст інструкції

1. AKLAV
   1. WHAT AKLAV IS AND WHAT IT IS USED FOR
   2. What you need to know before taking Aklav
   3. How to take Aklav
   4. Possible side effects
   5. How to store Aklav
   6. Contents of the pack and other information

AKLAV

875 mg + 125 mg film-coated tablets
Amoxicillin + Clavulanic acid
Generic medicine

Read this leaflet carefully before you start taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT AKLAV IS AND WHAT IT IS USED FOR

Aklav is an antibiotic that works by killing the bacteria that cause infections.
It contains two different active ingredients called amoxicillin and clavulanic acid. Amoxicillin is an
antibiotic belonging to the group of medicines called “penicillins” whose activity can sometimes
be blocked (they are inactivated). The other active component (clavulanic acid) prevents this from
happening.
Aklav is used in adults and children to treat the following infections:

• 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 taking Aklav

Do not take Aklav:

• if you are allergic to amoxicillin, clavulanic acid, penicillins or any of the other ingredients of this medicine (listed in section 6)
• if you have had a severe allergic reaction (hypersensitivity) to any other antibiotic. This may include skin rash or swelling of the face or throat
• if you have had problems with your liver or jaundice (yellowing of the skin) when you have taken an antibiotic.

Do not take Aklav if any of these apply to you.If you are unsure, talk to your doctor or pharmacist
before taking Aklav.

Warnings and precautions
Talk to your doctor or pharmacist before taking AKLAV if you:

• have infectious mononucleosis (commonly known as “glandular fever”, which manifests with fever and swollen glands (lymph nodes) in the neck)
• have been treated for liver or kidney problems
• do not urinate regularly.

If you are not sure whether any of the above applies to you, talk to your doctor or pharmacist before
taking Aklav.
In some cases, your doctor may perform a test to assess the type of bacteria that caused your
infection.
Based on the results, they may prescribe a different dose of Aklav or a different medicine.

Conditions you should pay attention to
Aklav can worsen certain existing conditions, or cause serious side effects.
These may include allergic reactions, convulsions and inflammation of the intestines. You should
pay attention to certain symptoms while taking Aklav, in order to reduce any risk.
See “ Conditions you should pay attention to”in section 4.

Blood and urine tests
If you are about to have blood tests (such as tests related to red blood cells or
liver function tests) or urine tests (for glucose), tell your doctor or nurse
that you are taking Aklav. This is because Aklav can affect the results of these types of tests.

Other medicines and Aklav
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
If you are taking allopurinol (used for gout) with Aklav, you are very likely to have
a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of
Aklav.
If you are taking medicines (such as warfarin) that help prevent
blood clots together with Aklav, you may need to have additional blood tests.
Aklav can affect the way methotrexate (a medicine used to treat cancer
or rheumatic diseases) works.
Aklav can affect the functioning of mycophenolate mofetil (a drug used to prevent
organ rejection after transplantation).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
Aklav may have side effects and symptoms may affect your ability to drive
vehicles and use machines. Do not drive vehicles or use machines unless you feel
better.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

3. How to take Aklav

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

Adults and children weighing 40 kg or more

• Usual dose: 1 tablet twice a day
• Highest dose: 1 tablet three times a day.

Children weighing less than 40 kg
Children up to 6 years of age should preferably be treated with amoxicillin and clavulanic acid oral
suspension in paediatric sachets.
Ask your doctor or pharmacist for advice on administering Aklav film-coated tablets to
children weighing less than 40 kg. The tablets are not suitable for children weighing less than
25 kg.

Patients with kidney and liver problems

• If you have kidney problems, the dose may be adjusted. Your doctor may choose a different dosage or a different medicine.
• If you have liver problems, your doctor will closely monitor you and you may be subjected to more regular liver tests.

How to take Aklav

• Take with meals
• The tablets can be divided along the fracture line to make them easier to swallow. Both halves of the tablet should be taken at the same time.
• Space the doses regularly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour. Do not take Aklav for more than 2 weeks. If you continue to feel unwell, you should return to your doctor.

If you take more Aklav than you should
If you take too much Aklav, symptoms may include stomach upset (nausea, vomiting or
diarrhoea) or convulsions. Tell your doctor as soon as possible. Bring the medicine packaging
with you to show the doctor.

If you forget to take Aklav
If you forget to take a dose, take it as soon as you remember. You should not take the next dose
too soon, but should wait about four hours. Do not take a double dose to make up for a forgotten dose.

If you stop taking Aklav
Continue to take Aklav until the treatment is finished, even if you feel better. You
need every dose to help you fight the infection. If some bacteria survive, they can
cause the infection to return.
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.

Conditions you should pay attention to:
Allergic reactions:

• skin rashes
• inflammation of the blood vessels ( vasculitis) which can be visible as red or purple spots on the skin, but which can affect other parts of the body
• fever, joint pain, swelling of the lymph nodes in the neck, armpits or groin
• swelling, sometimes of the face or throat ( angioedema), which causes difficulty breathing
• collapse
• chest pain in the context of allergic reactions, which may be a symptom of a heart attack triggered by allergy (Kounis syndrome)

➔ Contact your doctor immediatelyif you experience any of these symptoms. Stop taking
Aklav.
Intestinal inflammation
Intestinal inflammation, which causes watery diarrhoea generally with blood and mucus, stomach pain and/or fever.

Acute inflammation of the pancreas (acute pancreatitis)
If you have severe and persistent pain in the area of the stomach, this could be a sign of
acute pancreatitis.

Drug-induced enterocolitic syndrome (DIES):
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a certain type of
allergic reaction with the main symptom of repetitive vomiting (1-4 hours after taking the medicine).
Further symptoms may include abdominal pain, lethargy, diarrhoea and low blood pressure.
➔ Contact your doctor as soon as possible for advice if these symptoms occur
Very common side effects
May affect more than 1 in 10 people

• diarrhoea (in adults).

Common side effects
May affect up to 1 in 10 people

• thrush ( candida- a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when taking high doses: if you suffer from this, take Aklav with meals
• vomiting
• diarrhoea (in children).

Uncommon side effects
May affect up to 1 in 100 people

• skin rashes, itching
• raised rash, with itching ( urticaria)
• indigestion
• dizziness
• headache.

Uncommon side effects can be visible from blood tests:
increase of some proteins ( enzymes) produced by the liver.

Rare side effects
May affect up to 1 in 1,000 people

• skin rashes, which may appear as blisters and look like small targets (dark central area surrounded by a paler area, with a dark ring around the edge - erythema multiforme) ➔ If you notice any of these symptoms, contact your doctor urgently.

Rare side effects can be visible from blood tests:

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

Frequency not known (the frequency cannot be estimated from the available data) .

• allergic reactions (see above)
• intestinal inflammation (see above)
• Inflammation of the membranes surrounding the brain and spinal cord (aseptic meningitis)
• severe skin reactions:
• a widespread rash with blisters and detachment of the skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome), and a more severe form, causing extensive detachment of the skin (more than 30% of the body surface area - toxic epidermal necrolysis)
• widespread red rash with small blisters containing pus ( exfoliative bullous dermatitis)
• a rash, red, with scabs and swellings under the skin and blisters (pustulous exanthema)
• flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased number of white blood cells (eosinophilia) and elevated liver enzymes) ( Drug Reaction with Eosinophilia and Systemic Symptoms(DRESS))
• a red rash commonly observed on both sides of the buttocks, on the upper inner thighs, in the armpits, on the neck ( drug-related flexural symmetric intertriginous exanthema (SDRIFE)).
• Rash with blisters arranged in a circle with a crusty central or like a string of pearls (linear IgA disease)
• Crystals in the urine leading to acute kidney damage

➔ If you experience any of these symptoms, contact your doctor immediately.

• inflammation of the liver ( hepatitis)
• jaundice, caused by an increase in bilirubin in the blood (a substance produced by the liver) which can make the skin and whites of the eyes appear yellow
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• convulsions (in people taking high doses of Aklav or who have kidney problems)
• black tongue that appears covered in hair

Side effects that can be visible from blood or urine tests:

• severe reduction in the number of white blood cells
• low number of red blood cells ( hemolytic anemia)

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not
listed in this leaflet. You can also report side effects directly through
Reporting side effects can help provide more information on the safety of
this medicine.

5. How to store Aklav

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 pack after Exp. The date
of expiry refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not store at a temperature above 25°C.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Aklav contains
Aklav 875 mg + 125 mg film-coated tablets

• The active ingredients are amoxicillin trihydrate corresponding to amoxicillin 875 mg and potassium clavulanate corresponding to clavulanic acid 125 mg.

The other ingredients are Colloidal silicon dioxide, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, titanium dioxide, macrogol 4000, macrogol 6000, dimethicone

Description of the appearance of Aklav and contents of the pack
Film-coated tablets: Blister pack of 12 tablets

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Konpharma srl - Via Pietro Della Valle, 1 – 00193 ROMA

Manufacturer
Laboratorio Reig Jofré, S.A. - C/Jarama s/n, Poligono Industrial - 45007 Toledo - Spain

Behavioural hygiene
Antibiotics are used to treat bacterial infections. They are not effective for viral infections.
Sometimes an infection caused by bacteria does not respond to antibiotic therapy. The most common reason this happens is that the bacteria causing the infection are resistant to the antibiotic being used. This means that the bacteria survive and multiply despite the antibiotic.
Bacteria become resistant to antibiotics for various reasons. Using antibiotics appropriately can reduce the emergence of bacterial resistance.
When your doctor prescribes antibiotic therapy, it is only indicated for the current illness. Pay attention to the following advice, in order to avoid the emergence of bacterial resistance which causes the blocking of antibiotic activity.

• 1. It is very important that you take the antibiotic at the correct dose, at the scheduled times and for

ask your doctor or pharmacist for explanations.

• 2. Do not take antibiotics if they have not been expressly prescribed for you and use them only for the infection for which they have been prescribed.
• 3. Do not use antibiotics that have been prescribed to other people, even if you have a similar infection to theirs.
• 4. Do not give antibiotics to others that have been expressly prescribed for you.
• 5. If you have any antibiotic left over at the end of the treatment, return it to the pharmacist so that it can be disposed of appropriately.