Puriclav

Package leaflet: Information for the patient

Puriclav 875 mg+125 mg film-coated tablets

amoxicillin + clavulanic acid
Generic medicine
Please read all of 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 (or your child) only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Puriclav is and what it is used for

Puriclav is an antibiotic that works by killing the bacteria causing infections. It contains two different active substances called amoxicillin and clavulanic acid. Amoxicillin belongs to a group of medicines known as "penicillins", whose activity can sometimes be blocked (i.e. rendered inactive). The other active component (clavulanic acid) prevents this from happening.
Puriclav 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 Puriclav

Do not take Puriclav:

• if you are allergic to amoxicillin, clavulanic acid, penicillin, or any of the other ingredients of this medicine (listed in section 6)
• if you have had a severe allergic reaction to any other antibiotic. This may include 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 Puriclav if any of these cases apply to you. If you have any doubts, speak with your doctor or
pharmacist before taking Puriclav.
Warnings and precautions
Talk to your doctor or pharmacist before taking Puriclav if you:

• have infectious mononucleosis
• 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 Puriclav.
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 Puriclav or a different medicine.
Conditions you should monitor
Puriclav 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 Puriclav, in order to reduce any risk. See “Conditions you should monitor” in Section 4.
Blood and urine tests
If you are scheduled for blood tests (such as red blood cell counts or liver function tests) or
urine tests (for glucose), inform your doctor or nurse that
you are taking Puriclav. This is because Puriclav may affect the results of these tests.
Other medicines and Puriclav
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take
any other medicines.
If you are taking allopurinol (used for gout) together with Puriclav, you are at increased risk of developing a skin allergic reaction.
If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of
Puriclav.
If you are taking medicines together with Puriclav (such as warfarin) that help prevent blood clots, additional blood tests may be required.
Puriclav may affect how methotrexate (a medicine used to treat tumors or rheumatic diseases) works.
Puriclav 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,
please consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Puriclav may cause side effects, and these symptoms may make you unfit to drive.
Do not drive or operate machinery unless you feel well.
Puriclav contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Puriclav

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Adults and children weighing 40 kg or more

• Recommended 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/clavulanic acid oral suspension or sachets.
Ask your doctor or pharmacist for advice on administering Puriclav 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 a different medicine.
• If you have liver problems, your doctor will monitor you closely and you may have more frequent blood tests to check how your liver is functioning.

How to take Puriclav

• Swallow the tablet whole with a glass of water at the beginning of a meal or just before. The tablets may be divided along the break line to make swallowing easier. Both parts of the tablet should be taken at the same time.
• Space your doses evenly throughout the day, at least 4 hours apart. Do not take 2 doses within 1 hour.
• Do not take Puriclav for longer than 2 weeks. If you still do not feel better, you should return to your doctor.

If you take more Puriclav than you should
If you take too much Puriclav, symptoms may include stomach disturbances (nausea, vomiting or
diarrhoea) or seizures. Speak to your doctor as soon as possible. Take the medicine pack with you to show the doctor.
If you forget to take Puriclav
If you forget to take a dose, take it as soon as you remember. Do not take the next dose too early, but wait approximately 4 hours.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Puriclav
Continue taking Puriclav until the treatment is complete, even if you start to feel better. You need every dose to fight the infection. If some bacteria survive, they may cause the infection to return.
If you have any questions about using 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. The following side effects may occur with this medicine.

Conditions to watch for
Allergic reactions:

• skin rashes
• inflammation of blood vessels (vasculitis), which may appear as raised 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 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 Puriclav.

Inflammation of the large intestine
Inflammation of the large intestine, causing watery diarrhoea usually accompanied by 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 you experience these symptoms.

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 affected, take Puriclav 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 through blood tests:

• increased levels of 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 look like small targets (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 through blood tests:

• low count of cells involved in blood clotting
• low white blood cell count

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 pus-filled blisters (exfoliative bullous dermatitis)
  • 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 cells (eosinophilia) and elevated liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms) (DRESS)
  • red rash commonly seen on both sides of the buttocks, upper inner thighs, armpits, and neck (Symmetrical Drug-Related Intertriginous and Flexural Erythema (SDRIFE)).

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

• rash with blisters arranged in a ring-like pattern with a central crust or resembling a string of pearls (linear IgA disease)
• liver inflammation (hepatitis)
• jaundice, caused by increased levels of bilirubin (a substance produced in the liver) in the blood, 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 Puriclav or who have kidney problems)
• black hairy tongue

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

• severe reduction in white blood cell count
• low red blood cell count (haemolytic anaemia)
• crystals in the urine leading to kidney damage

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Puriclav

Keep in the original packaging to protect the medicine from light and moisture.
Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
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 Puriclav contains

• The active substances are amoxicillin and clavulanic acid. Each tablet contains: amoxicillin trihydrate corresponding to 875 mg of amoxicillin and potassium clavulanate corresponding to 125 mg of clavulanic acid.
• The other components are: anhydrous colloidal silica, magnesium stearate, sodium starch glycolate, microcrystalline cellulose, hydroxypropylmethylcellulose, talc, titanium dioxide, diethyl phthalate, dimethicone.

Description of the appearance of Puriclav and contents of the pack
Film-coated tablets: Pack of 12 tablets
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Pharmacare S.r.l.
Via Marghera, 29
20149 Milan
Italy
Manufacturers
Elpen SA – 95 Marathonos Avenue – 19009 Pikermi Attika (Greece)
Laboratorio Reig Jofrè S.A., C/le 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 treatment. 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 antibiotic.
Bacteria become resistant to antibiotics for various reasons. By using antibiotics appropriately, you can reduce the emergence of bacterial resistance.
When your doctor prescribes you an antibiotic treatment, it is intended solely for the illness you currently have. Please pay attention to the following advice in order to avoid the emergence of bacterial resistance, which leads to the loss of antibiotic effectiveness.

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. Read the instructions in the package leaflet 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 have an infection similar to theirs.
4. Do not give to others antibiotics that have been specifically prescribed for you.
5. If you have leftover antibiotics after completing your treatment, return them to your pharmacist so they can be disposed of appropriately.