Abidol

PACKAGE LEAFLET: INFORMATION FOR THE USER

ABIDOL 200 mg film-coated tablets

For adolescents from the age of 12 years and adults
Ibuprofen
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• If your symptoms worsen or do not improve after 3 days in adolescents or after 4 days in adults, you must inform your doctor.

Contents of this leaflet:

1. What ABIDOL 200 mg is and what it is used for
2. What you need to know before taking ABIDOL 200 mg
3. How to take ABIDOL 200 mg
4. Possible side effects
5. How to store ABIDOL 200 mg
6. Contents of the pack and other information

1. What ABIDOL 200 mg is and what it is used for

ABIDOL 200 mg is a medicine that reduces pain (non-steroidal anti-inflammatory drug [NSAID]).
ABIDOL 200 mg is used for the short-term symptomatic treatment of:

• mild to moderate pain

2. What you should know before taking ABIDOL 200 mg

Do not take ABIDOL 200 mg
in the following circumstances:

• if you are allergic to ibuprofen or to any of the other ingredients of this medicine (listed in section 6).
• if you previously experienced reactions such as shortness of breath, asthma attacks, nasal mucosa swelling, angioedema, or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs)
• unspecified blood formation disorders
• if you currently have or have had in the past a stomach/duodenal ulcer (peptic ulcers) or recurrent bleeding (at least two confirmed episodes of ulcer or bleeding)
• if you have previously suffered gastrointestinal bleeding or perforation related to NSAID therapy
• cerebrovascular haemorrhage or other types of active bleeding
• if you have severe impairment of liver or kidney function
• during the last 3 months of pregnancy
• if you suffer from severe heart failure
• if you are severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake)
• if you are under 12 years of age, as this dosage is not suitable due to the high amount of active substance

Warnings and precautions
Talk to your doctor or pharmacist before taking ABIDOL 200 mg.
Be especially careful with ABIDOL 200 mg in the following circumstances:

• inherited blood formation disorders (e.g. acute intermittent porphyria)
• certain immune system disorders (systemic lupus erythematosus and mixed connective tissue disease, immune system conditions affecting connective tissue leading to joint pain, skin changes, and disorders of other organs), as there may be an increased risk of aseptic meningitis.
• gastrointestinal disorders or chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease)
• impaired kidney or liver function
• if you are dehydrated (e.g. due to vomiting or diarrhoea)
• high blood pressure or heart failure
• if you suffer from allergies (e.g. skin reactions to other medicines, asthma, hay fever), chronic mucosal swelling, or chronic obstructive airway disease, as you may be at higher risk of hypersensitivity reactions
• immediately after major surgery
• if you have an infection – see the “Infections” section below.

The concomitant use of ABIDOL 200 mg and other NSAIDs, including selective cyclooxygenase-2 inhibitors,
should be avoided.
Elderly patients
Elderly patients are at increased risk of adverse reactions to NSAIDs, particularly
gastrointestinal bleeding and perforation, which may be fatal.
Gastrointestinal bleeding, ulceration or perforation
Gastrointestinal bleeding, ulceration, and perforation: during treatment with all NSAIDs, at any
time during therapy, with or without warning symptoms or previous history of serious gastrointestinal events,
gastrointestinal bleeding, ulceration, or perforation have been reported, which may be fatal.
The risk of gastrointestinal bleeding, ulceration, or perforation is higher with increasing doses of
NSAIDs, if you have previously suffered from ulcers, especially if complicated by bleeding or perforation, and in
elderly patients. Treatment should be started at the lowest available dose. Consult your doctor, as protective
medication may be considered. This also applies if you are taking low-dose acetylsalicylic acid or other
medicines that may increase the risk of gastrointestinal events.
If you have previously experienced gastrointestinal toxicity, especially if you are elderly, inform your doctor
about any unusual gastrointestinal symptoms (particularly gastrointestinal bleeding), especially
in the early stages of treatment. Caution is required if you are taking concomitant medicines that may
increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants like warfarin,
selective serotonin reuptake inhibitors, or antiplatelet agents like acetylsalicylic acid.
If you develop bleeding or ulcers during treatment with this medicine, stop treatment immediately.
Skin reactions
Serious skin reactions have been reported in association with ibuprofen treatment. Discontinue
taking ABIDOL 200 mg and consult your doctor immediately if you develop a skin rash,
mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a very
serious skin reaction. See section 4.
Serious skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis,
erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP).
Stop using ABIDOL 200 mg and contact your doctor immediately if you notice any of the symptoms
related to these serious skin reactions described in section 4.
Infections
ABIDOL 200 mg may mask symptoms of infections such as fever and pain. Therefore, ABIDOL 200 mg
may delay appropriate treatment of the infection, potentially increasing the risk of
complications. This has been observed in bacterial pneumonia and bacterial skin infections
associated with chickenpox. If you take this medicine while having an infection and infection
symptoms persist or worsen, consult your doctor immediately.
During chickenpox, it is advisable to avoid using this medicine.
Ibuprofen, the active substance in ABIDOL 200 mg, may temporarily inhibit platelet function (platelet aggregation). Patients with coagulation disorders should therefore be closely monitored.
If your doctor considers long-term ibuprofen therapy necessary, regular monitoring of liver function, kidney function, and blood cell counts should be performed.
During treatment with this medicine, consult/inform your doctor or dentist before undergoing surgery.
In very rare cases, severe acute hypersensitivity reactions (e.g. anaphylactic shock) have been observed. Treatment must be discontinued at the first signs of a hypersensitivity reaction after taking ABIDOL 200 mg. Depending on the symptoms, necessary medical procedures should be carried out by trained medical personnel.
You should drink sufficient fluids during treatment, especially in case of fever, diarrhoea, or vomiting.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration needed to control symptoms.
Prolonged use of any painkiller for headache may worsen it. If this occurs or is suspected, consult your doctor and treatment should be discontinued. Medication-overuse headache (MOH) should be suspected in patients with frequent or daily headaches despite (or because of) regular use of headache medicines.
In general, habitual use of painkillers, particularly a combination of different analgesic substances, may cause permanent kidney damage with risk of kidney failure (analgesic nephropathy).
Effect on the cardiovascular system
Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended dose or duration of treatment (3 days in adolescents and 4 days in adults).
You should discuss treatment with your doctor or pharmacist before taking ABIDOL 200 mg if you have:

• heart problems including heart attack, angina (chest pain), or history of heart attack, coronary bypass surgery, peripheral arterial disease (poor circulation to legs or feet due to narrowed or blocked arteries), or any type of stroke (including “mini-stroke” or “TIA”, transient ischaemic attack).
• high blood pressure, diabetes, high cholesterol, family history of heart disease or stroke, or if you are a smoker.

Signs of an allergic reaction to this medicine, including breathing problems, swelling of the face and neck (angioedema), and chest pain, have been reported with ibuprofen. Stop ABIDOL 200 mg immediately and contact your doctor or emergency medical services if you notice any of these signs.
Children and adolescents
In dehydrated adolescents, there is a risk of kidney impairment.
Do not administer this medicine to children under 12 years of age.
Other medicines and ABIDOL 200 mg
Do not use different types of painkillers simultaneously unless directed by a doctor.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
ABIDOL 200 mg may affect or be affected by treatment with other medicines, including those used to treat/prevent:

• tumours and immune system disorders (methotrexate),
• bipolar disorder (lithium),
• irregular heartbeat (digoxin),
• epilepsy or neuropathic pain (phenytoin),
• pain (acetylsalicylic acid),
• thromboembolic disorders (medicines that are antiplatelet agents or anticoagulants, i.e. substances that thin the blood and prevent clot formation, e.g. aspirin/acetylsalicylic acid, dicoumarol, warfarin, ticlopidine),
• depression (medicines called SSRIs – selective serotonin reuptake inhibitors),
• high blood pressure (medicines that lower blood pressure such as ACE inhibitors like captopril, beta-blockers like atenolol, angiotensin II receptor antagonists like losartan, diuretics),
• organ transplant rejection (immunosuppressive medicines such as cyclosporine and tacrolimus),
• inflammation (corticosteroids),
• bacterial infections (some antibiotics including aminoglycosides and quinolone antibiotics),
• fungal infections (antimycotics, particularly voriconazole or fluconazole),
• type 2 diabetes mellitus (sulfonylureas),
• high cholesterol (cholestyramine),
• human immunodeficiency virus (HIV) infection (zidovudine),
• gout (probenecid and sulfinpyrazone).

Other medicines may also affect or be affected by treatment with ABIDOL 200 mg.
Therefore, always consult your doctor or pharmacist before using ABIDOL 200 mg with other medicines.
ABIDOL 200 mg with food, drinks, and alcohol
ABIDOL 200 mg can be taken with food and drinks. ABIDOL 200 mg may be taken on an
empty stomach for faster relief. If ABIDOL 200 mg is taken with alcohol, side effects may increase.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take ABIDOL 200 mg during the last 3 months of pregnancy, as it may harm the fetus or cause
problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your
and your baby’s tendency to bleed and delay or prolong labour beyond normal. You should not take
ABIDOL 200 mg during the first 6 months of pregnancy unless absolutely necessary and under medical advice.
If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used. From week 20 of pregnancy, ABIDOL 200 mg
may cause kidney problems in the fetus if taken for more than a few days, reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing narrowing of a blood vessel (ductus arteriosus)
in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring. If pregnancy occurs during use of ABIDOL 200 mg, you must inform your doctor.
Breastfeeding
Only small amounts of ibuprofen and its metabolites pass into breast milk. As no adverse effects in infants are known, breastfeeding does not generally need to be discontinued during short-term use and at recommended doses for the treatment of mild to moderate pain.
However, if the medicine is prescribed for long-term treatment or at high doses, early weaning should be considered.
Fertility
This product belongs to a group of medicines (NSAIDs) that may impair fertility in women. This
effect is reversible upon discontinuation of treatment.
Driving and using machines
Since undesirable effects such as fatigue, dizziness, and visual disturbances may occur during use of ABIDOL 200 mg, your ability to react and your active vigilance while driving or operating machinery may occasionally be impaired. These effects may be enhanced if alcohol is consumed concurrently.
ABIDOL 200 mg contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e.
essentially ‘sodium-free’.

3. How to take ABIDOL 200 mg

Take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, contact your doctor immediately if symptoms (for example fever and pain) persist or worsen (see section 2).
Recommended dose:
Age Single dose Maximum daily dose
12-15 years 1 tablet 3 tablets
(equivalent to 200 mg of (equivalent to 600 mg of
ibuprofen) ibuprofen)
over 15 years 1-2 tablets 6 tablets
(equivalent to 200-400 mg of (equivalent to 1200 mg of
ibuprofen) ibuprofen)
If you have taken the maximum single dose, you must wait at least 6 hours before taking the next dose.
The recommended dose must not be exceeded.
If you feel that the effect of ABIDOL 200 mg is too strong or too weak, talk to your doctor or pharmacist.
Method of administration
For oral use
Film-coated tablets should be swallowed whole with water.
Patients with gastric sensitivity are advised to take ABIDOL 200 mg during meals.
Duration of treatment
For short-term use only.
If use of the medicine is required for more than 3 days in adolescents, or if symptoms worsen, consult a doctor.
If use of the medicine is required for more than 4 days in adults, or if symptoms worsen, consult a doctor.
If you take more ABIDOL 200 mg than you should
If you have taken more ABIDOL 200 mg than you should, or if your child has accidentally taken this medicine, always contact a doctor or the nearest hospital for advice on the risk and recommendations on what actions to take.
Symptoms of overdose may include nausea, stomach ache, vomiting (possibly with traces of blood), headache, ringing in the ears, confusion, and uncontrolled eye movements. At high doses, drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and dizziness, blood in the urine, low blood potassium levels, feeling cold, and breathing problems have been reported.
If you forget to take ABIDOL 200 mg
Do not take a double dose to make up for a forgotten dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking ABIDOL 200 mg and contact a doctor immediately if you experience any of the
following symptoms:

• Angioedema (an uncommon side effect) with symptoms such as:
  • swelling of the face, tongue or throat,
  • difficulty swallowing,
  • urticaria and breathing difficulties.
• An infection with symptoms such as fever and severe worsening of your general condition, or fever with signs of a local infection such as sore throat/pharynx/mouth or urinary problems. ABIDOL 200 mg may cause a reduction in the number of white blood cells (agranulocytosis), resulting in reduced resistance to infections (an uncommon side effect). It is important to inform your doctor that you are taking this medicine.
• Serious skin and mucous membrane reactions have been reported, such as epidermal necrolysis and/or erythema multiforme (a very rare side effect). Additionally, a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell). Stop taking ABIDOL 200 mg and contact a doctor if you develop a skin rash or mucosal lesions. Severe rashes may include blisters on the skin, especially on the legs, arms, hands and feet, which may also involve the face and lips. This may become even more serious when blisters grow larger and spread, and parts of the skin may peel off (toxic epidermal necrolysis). There may also be a severe infection with destruction (necrosis) of the skin, subcutaneous tissue and muscles.

Reddish, flat spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome).
• Widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Other side effects that may occur:
Common (may affect up to 1 in 10 people):

• Headache, dizziness
• Gastrointestinal side effects (dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, black stools, stomach and intestinal bleeding, blood in vomit)
• Skin rash
• Fatigue

Uncommon (may affect up to 1 in 100 people):

• Rhinitis
• Hypersensitivity
• Insomnia, anxiety
• Visual disturbances, hearing damage
• Bronchospasm, asthma
• Mouth ulcers
• Gastric ulcer, intestinal ulcer, perforation of gastric ulcer, inflammation of the stomach lining
• Hepatitis, jaundice, abnormal liver function
• Itching, small bruises on the skin and mucous membranes
• Increased skin sensitivity to light
• Impaired kidney function
• Changes in blood count
• Anaemia (reduction in red blood cells or haemoglobin, which may cause paleness of the skin and lead to weakness)
• Drowsiness
• Tingling sensation
• Hearing loss

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

• Aseptic meningitis
• Allergic reaction
• Depression, confusion
• Blurred vision, tinnitus (ringing in the ears), dizziness
• Liver damage and fluid retention in the body

Very rare (may affect up to 1 in 10,000 people):

• Pancreatitis, liver failure

Not known (frequency cannot be estimated from the available data):

• Worsening of ulcers in the large intestine (colitis) and Crohn’s disease (intestinal disorder)
• Heart failure, heart attack, hypertension
• Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome
• Drug-induced fixed eruption

Please note that ABIDOL 200 mg may prolong bleeding time.
Very rarely, it may cause severe skin infections in case of chickenpox. When using an NSAID, skin inflammation related to infection may develop or worsen (e.g. conditions such as necrotizing fasciitis, characterized by severe pain, high fever, swollen and hot skin, blister formation, necrosis). If signs of skin infection occur or worsen during treatment with ABIDOL 200 mg, immediate medical advice is recommended.
Medicines such as ABIDOL 200 mg may slightly increase the risk of heart attack or stroke.
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 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 ABIDOL 200 mg

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and on the carton after EXP. The
expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines 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 ABIDOL 200 mg contains
The active substance is ibuprofen.
Each film-coated tablet contains 200 mg of ibuprofen.
The other components are:
Tablet core
Modified maize starch, croscarmellose sodium, hypromellose, stearic acid, anhydrous colloidal silica.
Coating
Hypromellose, macrogol 8000, titanium dioxide.

Description of the appearance of ABIDOL 200 mg and pack sizes
Film-coated tablets, white in colour, round and biconvex.
ABIDOL 200 mg is available in packs containing 6, 10, 12, 20, 24, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurora Licensing s.r.l.
Via del Milliario 32 – 40133 Bologna
Italy

Manufacturer
Merckle GmbH
Ludwig – Merckle Strasse 3
89143 Blaubeuren - Germany

This medicinal product is authorized in the European Economic Area countries under the following
names:
Denmark Ibuprofen Teva
Germany Ibuprofen – ratio 200 mg Filmtabletten
Italy ABIDOL