TABUMOL 200 mg/500 mg Film-Coated Tablets

Зміст інструкції

1. Tabumol 200 mg/500 mg film-coated tablets
   1. What is Tabumol and what is it used for
   2. What you need to know before taking Tabumol
   3. How to take Tabumol
   4. Possible side effects
   5. How to store Tabumol
   6. Contents of the pack and other information

Tabumol 200 mg/500 mg film-coated tablets

Ibuprofen/paracetamol

Read this leaflet carefully before 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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Read this leaflet carefully before taking this medicine as it contains important
information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any of the side effects occur, including effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after 3 days.

Contents of this leaflet

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

1. What is Tabumol and what is it used for

Tabumol contains two active ingredients (which make the medicine work). These are ibuprofen and
paracetamol.
Paracetamol Ibuprofen belongs to a group of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by reducing pain, swelling and lowering high temperatures.
Paracetamol is an analgesic that works differently from ibuprofen to provide relief from pain and
fever. This medicine is especially suitable for pain that requires stronger analgesia than that of
ibuprofen or paracetamol alone.
Tabumol is used for the temporary relief of mild to moderate pain associated with migraine, headache, back pain, menstrual pain, toothache, rheumatic and muscle pain, pain from mild arthritis, flu and cold symptoms, sore throat and fever.
Tabumol is indicated for adults aged 18 years and over.
See a doctor if you do not feel better or if you feel worse after 3 days.

2. What you need to know before taking Tabumol

Do not take Tabumol:

• if you are already taking other medicines containing paracetamol
• if you are taking other medicines for pain relief including ibuprofen, acetylsalicylic acidat high doses (more than 75 mg per day) or other non-steroidal anti-inflammatory drugs(NSAIDs) including specific cyclooxygenase 2 (COX-2) inhibitors
• if you are allergic to ibuprofen, paracetamolor any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to acetylsalicylic acid or other pain-relieving NSAIDs
• if you have or have had in the past an ulcer or bleeding in the stomach or duodenum(small intestine)
• if you have a blood clotting disorder
• if you suffer from heart, liver or kidney failure
• if you are in the last 3 months of pregnancy

Warnings and precautions
Talk to your doctor or pharmacist before taking Tabumol.

• if you are elderly
• if you have asthmaor have suffered from asthma
• if you have problems with your kidneys, heart, liveror intestines
• have an infection - see section «Infections» below.
• if you have Systemic Lupus Erythematosus(SLE) - a condition of the immune system that affects connective tissue and causes joint pain, skin changes and disorders of other organs or mixed connective tissue disease
• if you have gastrointestinal disorders or chronic inflammatory bowel disease(e.g. ulcerative colitis, Crohn's disease)
• if you are in the first six months of pregnancyor if you are breastfeeding
• are planning a pregnancy

Anti-inflammatory pain relievers such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.
Infections
Tabumol can mask the symptoms of infections such as fever and pain. Therefore, Tabumol may delay adequate treatment of the infection, which could increase the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox.
If you take this medicine while you have an infection and the symptoms of the infection persist or worsen, see your doctor immediately.
Skin reactions
Serious skin reactions have been reported in association with treatment with Tabumol. You must stop taking Tabumol and seek immediate medical attention if you develop any rash, mucous membrane lesions, blisters or other signs of allergy as these may be the first signs of a very serious skin reaction. See section 4.
You should discuss the treatment with your doctor or pharmacist before taking Tabumol if you have:

• heart problems including heart attack, angina (chest pain) or if you have a history of heart attack, coronary bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) or any type of stroke (including ‘mini-stroke’ or “TIA”, transient ischemic attack);
• high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker. Other medicines and TabumolTell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Do not take Tabumol with:

• other medicines containing paracetamol
• other medicines containing NSAIDssuch as acetylsalicylic acid, ibuprofen.

Particular caution is required as some medicines can interact with Tabumol:

• corticosteroidtablets
• antibiotics(e.g. chloramphenicol or quinolones)
• flucloxacillin (antibiotic), due to a serious risk of blood and fluid alterations (metabolic acidosis with high anion gap) which must be treated urgently and which can occur particularly in case of severe renal impairment, sepsis (when bacteria and their toxins circulate in the blood leading to organ damage), malnutrition, chronic alcoholism and if the maximum daily doses of paracetamol are used .
• medicines for nausea(e.g. metoclopramide, domperidone)
• heart stimulants(e.g. glycosides)
• medicines for high cholesterol(e.g. colestyramine)
• diuretics(to help you urinate)
• medicines for suppression of the immune system(e.g. methotrexate, cyclosporine, tacrolimus)
• medicines for maniaor depression(e.g. lithium or SSRIs)
• mifepristone(for termination of pregnancy)
• medicines for HIV(e.g. zidovudine).

Tabumol can affect or be affected by other medicines.
For example:

• medicines that are anticoagulants (i.e. substances that thin the blood/prevent clotting, e.g. acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan);

Even some other medicines can affect or be affected by treatment with Tabumol.
Therefore, always consult your doctor or pharmacist before using Tabumol with other medicines.
Tabumol with food
To reduce the likelihood of side effects, take Tabumol with food.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Tabumol in the last 3 months of pregnancy as it may harm the fetus or cause problems during childbirth. It may cause problems with the kidneys and heart of the fetus. It may affect your and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take Tabumol in the first 6 months of pregnancy unless absolutely necessary and under the advice of a doctor.
If treatment is necessary during this period or during attempts to conceive, the minimum dose should be used for the shortest possible time. From the 20th week of pregnancy, Tabumol 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 narrowing a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few days, your doctor may advise additional monitoring.
Ibuprofen belongs to a group of medicines that can impair fertility in women. This is reversible on stopping the medicine. Tell your doctor if you are planning a pregnancy or have problems getting pregnant.

Driving and using machines
Tabumol can cause dizziness, impaired concentration and drowsiness.
If this affects you, do not drive and do not use tools or machines.

3. How to take Tabumol

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

Adults: the recommended dose is1 tablet with water and food, up to 3 times a day.
Leave at least 6 hours between doses.
If one tablet does not control the symptoms, then a maximum of 2 tablets can be taken up to 3 times
a day.

Do not take more than 6 tablets within 24 hours(equivalent to 1200 mg of ibuprofen and 3000 mg of
paracetamol per day).

Use in children and adolescents
Not recommended for use in children and adolescents under 18 years of age.
For oral use and for short-term use only.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. Do
not take Tabumol for more than 3 days.If you have an infection, consult your doctor immediately if
symptoms (e.g. fever and pain) persist or worsen (see section 2).

If you take more Tabumol than you should
If you have taken more Tabumol than you should, or if children have taken Tabumol accidentally, always contact
a doctor or the nearest hospital for advice on the risk and what action to take.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood),
headache, ringing in the ears, confusion and uncontrolled eye movements. At high doses, are
reported drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in
children), weakness and dizziness, blood in the urine, feeling cold to the body and breathing problems.

Seek immediate medical attention if you have taken too much of this medicine even if you feel well, as
too much paracetamol can cause serious and delayed liver damage.
If you forget to take Tabumol
Do not take a double dose to make up for a missed dose. If you forget to take a dose,
take it as soon as you remember and then take the next dose at least 6 hours later.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

STOP TAKING the medicine and tell your doctor if you experience:

• heartburn, indigestion
• signs of intestinal bleeding(severe stomach pain, vomiting blood or material that looks like coffee grounds, blood in the stools/faeces, black stools)
• signs of inflammation of the lining of the brainsuch as: stiff neck, headache, feeling sick or being sick, fever or feeling disoriented
• signs of a severe allergic reaction(swelling of the face, tongue or throat, difficulty breathing, worsening of asthma)
• severe skin reactionknown as DRESS syndrome (frequency not known). Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cell).

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

• stomach pain or discomfort, feeling sick and being sick, diarrhoea
• high levels of liver enzymes (shown by blood tests)

Uncommon(may affect up to 1 in 100 people)

• headache and dizziness, wind and constipation, skin rashes, swelling of the face
• reduction in the number of red blood cells and increase in platelets (cells for blood clotting)

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

• reduction in blood cells (causing sore throat, mouth ulcers, flu-like symptoms, severe tiredness, unexplained bleeding, bruising and nosebleeds)
• vision problems, ringing in the ears, feeling dizzy
• confusion, depression, hallucinations
• tiredness, general feeling of being unwell
• high blood pressure, fluid retention
• liver problems (causing yellowing of the skin and whites of the eyes)
• kidney problems (causing increased or decreased urination, swelling of the legs)
• heart failure (causing shortness of breath, swelling)

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

• a red and scaly rash with bumps under the skin and blisters mainly located in the skin folds, on the trunk and upper extremities accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If you develop these symptoms, stop using Tabumol and seek immediate medical attention. See also section 2.

Medicines like Tabumol may be associated with a slight increase in the risk of heart attack
(“myocardial infarction”) or stroke (see section 2).

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 through 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 Tabumol

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 package and on the blister after “EXP”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 Tabumol contains

• The active ingredients are paracetamol and ibuprofen. Each film-coated tablet contains 200 mg of ibuprofen and 500 mg of paracetamol. The other ingredients are: tablet core: corn starch, crospovidone (Type A) (E1202), anhydrous colloidal silica (E551), povidone K-30 (E1201), pregelatinized corn starch, talc (E553b), stearic acid (50).

Coating: polyvinyl alcohol (E1203), talc (E553b), macrogol 3350 (E1521), titanium dioxide (E171).

Description of the appearance of Tabumol and contents of the pack
Tabumol tablets are white to almost white, capsule-shaped, film-coated tablets
with dimensions 19.7 mm x 9.2 mm.
They are available in blisters in packs of 16 or 20 film-coated tablets.
They are available in blisters in packs of 10 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Sandoz S.p.A.,
L.go U. Boccioni 1,
21040 Origgio (VA),
Italy

Manufacturer
Rontis Hellas Medical and Pharmaceutical Products S.A.
P.O. Box 3012 Larisa Industrial Area
41004 Larisa,
Greece
Lek Pharmaceuticals d.d.,
Verovškova ulica 57,
1526 Ljubljana,
Slovenia

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Italy Tabumol