Aklav

Patient Information Leaflet: Information for the User

AKLAV

875 mg + 125 mg film-coated tablets
Amoxicillin + Clavulanic acid
Generic medicine
Please read this leaflet carefully before taking this medicine because 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 give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact 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 taking 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 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 known as "penicillins", whose activity can sometimes
be blocked (rendered inactive). The other active component (clavulanic acid) prevents this from occurring.
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 to any of the other ingredients of this medicine (listed in section 6)
• if you have previously 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 liver problems or jaundice (yellowing of the skin) when taking an antibiotic.

Do not take Aklav if any of the above apply to you. If you have any doubts, speak with 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 “kissing disease”, characterized by fever and swollen glands (lymph nodes) in the neck)
• have previously been treated for liver or kidney problems
• do not urinate regularly.

If you are unsure whether any of the conditions listed above apply to you, discuss them with your doctor or pharmacist before taking Aklav.
In some cases, your doctor may carry out tests to identify the type of bacteria causing your infection.
Based on the results, your doctor may prescribe a different dose of Aklav or a different medicine.
Conditions to which you should pay attention
Aklav may worsen certain pre-existing conditions or cause serious side effects. These may include allergic reactions, seizures, and inflammation of the intestine. You should be aware of certain symptoms while taking Aklav in order to minimize any risks.
See “Conditions to which you should pay attention ” in section 4.
Blood and urine tests
If you are scheduled for blood tests (such as checks for red blood cells or liver function tests) or urine tests (for glucose), inform your doctor or nurse that you are taking Aklav. This is because Aklav may affect the results of these types of tests.
Other medicines and Aklav
Inform 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) together with Aklav, you are very likely to develop 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 (which help prevent blood clots) together with Aklav, additional blood tests may be required.
Aklav may affect how methotrexate (a medicine used to treat cancers or rheumatic diseases) works.
Aklav may affect the action of mycophenolate mofetil (a medicine used to prevent rejection of transplanted organs).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Aklav may cause side effects, and symptoms may affect your ability to drive or operate machinery. Do not drive or operate machinery unless you feel well.
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 exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Adults and children weighing 40 kg or more

• Usual dose: 1 tablet twice daily
• Higher dose: 1 tablet three times daily

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 pediatric 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 or liver problems

• If you have kidney problems, your dose may need to be adjusted. Your doctor may choose a different dosage or an alternative medicine.
• If you have liver problems, your doctor will monitor you closely and you may require more frequent liver function tests.

How to take Aklav

• Take with food
• The tablets may be divided along the break line to make swallowing easier. Both tablet parts should be taken together.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour. Do not take Aklav for longer than 2 weeks. If you continue to feel unwell, you should see your doctor.

If you take more Aklav than you should
If you take too much Aklav, symptoms may include stomach disturbances (nausea, vomiting or diarrhoea) or seizures. Inform your doctor as soon as possible. Take the medicine pack with you to show your doctor.

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

If you stop taking Aklav
Continue taking Aklav for the full duration of treatment, even if you feel better. You need every dose to help fight the infection. If some bacteria survive, they may cause the infection to return.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Conditions to which you should pay attention:
Allergic reactions:

• skin rashes
• inflammation of blood vessels ( vasculitis ), which may appear as red or purple spots on the skin, but may also affect other parts of the body
• fever, joint pain, swelling of the glands in the neck, armpits or groin
• swelling, sometimes of the face or throat ( angioedema ), causing difficulty in breathing
• collapse
• chest pain occurring during allergic reactions, which may be a symptom of an allergy-triggered heart attack (Kounis syndrome)

➔ Contact your doctor immediately if you experience any of these symptoms. Stop taking Aklav.
Intestinal inflammation
Intestinal inflammation, causing watery diarrhoea usually 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 stomach area, this could be a sign of acute pancreatitis.
Drug-induced enterocolitis syndrome (DIES):
DIES has been reported mainly in children treated with amoxicillin/clavulanate. It is a type of allergic reaction with the main symptom being repeated 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 ( candidiasis – a fungal infection of the vagina, mouth or skin folds)
• nausea, especially when high doses are taken: if affected, take Aklav with meals
• vomiting
• diarrhoea (in children).

Uncommon side effects
May affect up to 1 in 100 people

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

Uncommon side effects may be detected in blood tests:
increase in certain 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 resemble small targets (a dark central spot 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 may be detected in blood tests:

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

Frequency not known ( 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:
  • widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), and a more severe form causing extensive skin detachment (more than 30% of body surface – toxic epidermal necrolysis )
  • widespread red rash with small blisters containing pus ( exfoliative bullous dermatitis )
  • a red rash with crusts, swellings under the skin and blisters ( pustular exanthema )
  • flu-like symptoms with rash, fever, swollen glands and abnormal blood test results (including increased white blood cell count (eosinophilia) and elevated liver enzymes) ( Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) )
  • a red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck ( Symmetrical Drug-Related Intertriginous and Flexural Erythema (SDRIFE) ).
• Skin rash with blistering arranged in a ring-shaped pattern with a central crust or resembling a string of pearls (linear IgA disease)
• Crystals in 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 increased blood levels of bilirubin (a substance produced in the liver), which may make the skin and whites of the eyes appear yellow
• inflammation of the kidney tubules
• blood takes longer to clot
• hyperactivity
• seizures (in people taking high doses of Aklav or who have kidney problems)
• black hairy tongue

Side effects that may be detected in blood or urine tests:

• severe reduction in white blood cell count
• low number of red blood cells ( haemolytic anaemia )

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via
By reporting side effects, you 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 packaging after "Exp." The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light and moisture.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

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

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

The other components 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 package contents
Film-coated tablets: Carton containing 12 tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 against viral infections.
Sometimes a bacterial infection does not respond to antibiotic therapy. The most common reason for this is that the bacteria causing the infection are resistant to the antibiotic being used. This means that the bacteria survive and multiply despite the presence of the antibiotic.
Bacteria become resistant to antibiotics for several reasons. Using antibiotics appropriately can reduce the development of bacterial resistance.
When your doctor prescribes an antibiotic treatment, it is intended solely for the illness you currently have. Please follow the advice below to help prevent the emergence of bacterial resistance, which can lead to failure of antibiotic therapy.

1. It is very important that you take the antibiotic at the correct dose, at the prescribed times, and for the exact number of days indicated. Read the instructions in this leaflet carefully, and if anything is unclear, ask your doctor or pharmacist for clarification.
2. Do not take antibiotics unless they have been specifically prescribed for you, and use them only for the infection for which they were prescribed.
3. Do not use antibiotics that have been prescribed for other people, even if you believe your infection is similar.
4. Do not give your prescribed antibiotics to other people.
5. If you have leftover antibiotics after completing your course of treatment, return them to your pharmacist for proper disposal.