IBUPROFENE 400 mg Film-Coated Tablets

Зміст інструкції

1. Ibuprofene Laboratori Alter 400 mg tablets
2. Ibuprofene Laboratori Alter 600 mg tablets
   1. What is Ibuprofene Laboratori Alter and what it is used for
   2. What you need to know before taking Ibuprofene Laboratori Alter
   3. How to take Ibuprofene Laboratori Alter
   4. Possible side effects
   5. How to store Ibuprofene Laboratori Alter
   6. Contents of the pack and other information

Ibuprofene Laboratori Alter 400 mg tablets

film-coated

Ibuprofene Laboratori Alter 600 mg tablets

film-coated
Generic medicine

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 for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could 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 Ibuprofene Laboratori Alter is and what it is used for
• 2. What you need to know before you take Ibuprofene Laboratori Alter
• 3. How to take Ibuprofene Laboratori Alter
• 4. Possible side effects
• 5. How to store Ibuprofene Laboratori Alter
• 6. Contents of the pack and other information

1. What is Ibuprofene Laboratori Alter and what it is used for

Ibuprofene Laboratori Alter contains ibuprofen, an active ingredient belonging to a group of medicines
called NSAIDs (non-steroidal anti-inflammatory drugs). NSAIDs are drugs against pain and
inflammation. Ibuprofene Laboratori Alter is used to treat pain due to, for example:

• trauma (for example caused by sport), toothache (for example after extraction or dental and oral surgery), pain after childbirth, menstrual pain, eye pain (for example caused by eye surgery), headache, pain after surgery;
• rheumatic diseases such as: inflammation of muscles, tendons, nerves and joints (scapulo-humeral periarthritis, radiculo-neuritis, tenosynovitis, myositis, fibrosis), back pain (lumbago), leg pain due to inflammation of the sciatic nerve (sciatica), degenerative diseases affecting the joints (osteoarthritis), such as cervical, dorsal, lumbar osteoarthritis, shoulder, hip, knee or widespread osteoarthritis, an autoimmune progressive and chronic disease that mainly affects the joints (rheumatoid arthritis), a rare inflammatory disease called Still's disease.

2. What you need to know before taking Ibuprofene Laboratori Alter

Do not take Ibuprofene Laboratori Alter

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6);
• if you have had allergic reactions after taking aspirin (acetylsalicylic acid), other medicines

for pain, fever, or other non-steroidal anti-inflammatory drugs (NSAIDs), especially if
associated with nasal polyps, facial swelling (angioedema) and/or asthma;

• if you have a lesion of the wall of the stomach or intestine (severe or active peptic ulcer);
• if you have had an episode of perforation or bleeding in the stomach or intestine caused by taking medicines;
• if you have had two or more distinct episodes of bleeding or lesion of the wall of the stomach or intestine (recurrent peptic ulcer);
• if you have serious problems with the liver or kidneys;
• if you suffer from serious heart problems (severe heart failure);
• if you have any disease that increases the risk of bleeding;
• if you are in a severe state of dehydration, for example, you have had severe episodes of vomiting, diarrhea or drink very little;
• after the sixth month of pregnancy.

Do not use Ibuprofene Laboratori Alter in children under 12 years of age.

Warnings and precautions
Consult your doctor before taking Ibuprofene Laboratori Alter if:

• you suffer from systemic lupus erythematosus (SLE) or mixed connective tissue disease, diseases that affect connective tissue causing joint or muscle pain, skin changes and problems with other organs;
• you have had problems with the stomach or intestine, such as ulcers, Crohn's disease, ulcerative colitis (see the section below “PAY ATTENTION” on gastrointestinal risks and “Do not take Ibuprofene Laboratori Alter”);
• you have reduced kidney function;
• you have liver problems;
• you have blood coagulation problems;
• you have or have had allergies (e.g. hay fever);
• you have inflammation of the nose (chronic rhinitis) or nasal polyps;
• you suffer from asthma or long-lasting respiratory diseases (chronic);
• you have had facial, throat, lip or other body swelling (angioedema) in the past;
• you are elderly, as you are more likely to develop adverse events with this medicine, in particular bleeding and perforation of the stomach and intestine which can be life-threatening (see the section below PAY ATTENTION on gastrointestinal risks);
• you have chickenpox, as pain and inflammation medications (NSAIDs) may worsen the severity of skin lesions caused by it. In such cases, your doctor may advise you not to use this medicine;
• if you are a dehydrated adolescent or an elderly person as you are more likely to have kidney problems.
• you have an infection - see paragraph “Infections” below.

Signs of an allergic reaction to this medicine, including breathing problems, facial and neck swelling (angioedema) and chest pain, have been reported with ibuprofen. Immediately stop treatment with Ibuprofene Laboratori Alter and contact your doctor or emergency health service immediately if you notice any of these signs.

Heart attack and stroke
Anti-inflammatory/pain relievers such as ibuprofen may be associated with a modest increase in the
risk of heart attack or stroke, especially when administered at high doses. Do not exceed the recommended
dose or duration of treatment.
You should discuss the therapy with your doctor or pharmacist before taking Ibuprofene Laboratori Alter 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, family history of heart disease or stroke, or if you are a smoker.

Skin reactions
Serious skin reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP) have been reported in association with ibuprofen treatment. Stop using Ibuprofene Laboratori Alter and contact your doctor immediately if you notice any of the symptoms related to these serious skin reactions described in paragraph 4.
Infections
Ibuprofene Laboratori Alter can mask the symptoms of infections such as fever and pain. Therefore, it is possible that
Ibuprofene Laboratori Alter may delay adequate treatment of the infection, which could increase
the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections
related to chickenpox. If you are taking this medicine while you have an infection and the symptoms of the infection persist or
worsen, consult your doctor immediately.

PAY ATTENTION, as during treatment with all non-steroidal anti-inflammatory drugs
for pain and inflammation (NSAIDs):

• at any time, with or without warning symptoms, even in patients without a history of serious stomach or intestinal (gastrointestinal) problems, bleeding, ulceration or perforation of the stomach or intestine have been reported, which can be life-threatening (see paragraph “Do not take Ibuprofene Laboratori Alter”). If you are elderly or have had these problems in the past, the risk of developing these events will be greater if you take higher doses of the medicine. In this case, your doctor will tell you to start treatment with the lowest available dose, and may also prescribe you a medicine to protect your stomach (gastroprotectors such as misoprostol or proton pump inhibitors) to take together with Ibuprofene Laboratori Alter;
• even though very rarely, serious skin reactions (aphylattoid reactions, up to anaphylactic shock) have been reported;
• serious eye reactions may occur if you use Ibuprofene Laboratori Alter. Periodic eye checks are necessary during therapy, especially for prolonged treatments;
• especially if used for prolonged periods and at high doses, headache may occur; in this case, do not increase the dose of Ibuprofene Laboratori Alter to relieve the pain.

If you have reduced heart, liver or kidney function (especially if you suffer from systemic lupus erythematosus), your doctor will prescribe you periodic specific tests, particularly in the case of prolonged treatments, and will prescribe you the lowest effective dose and for the shortest possible duration of treatment needed to control the symptoms.
The risk of having adverse effects can be reduced by using the lowest effective dose and for the shortest
duration of treatment needed to control the symptoms. Do not exceed the dose of Ibuprofene
Laboratori Alter and do not take it for long periods; always carefully follow your doctor's instructions.

STOPtreatment and contact your doctor if:

• you notice any symptoms affecting the stomach and intestine (gastrointestinal), especially if it is

bleeding, especially if this occurs in the early stages of treatment, if you are an elderly patient
or if you have had gastrointestinal problems in the past;

• a rash, mucosal lesions or any other sign of an allergic reaction (e.g. redness, itching, swelling of the face and throat, sudden drop in blood pressure) appears.
• you experience vision problems;
• you experience liver problems.

Children
Do not use Ibuprofene Laboratori Alter in children under 12 years of age. If necessary, ask your doctor for advice, as specific (lower) dosages are available for these patients.

Other medicines and Ibuprofene Laboratori Alter
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Ibuprofene Laboratori Alter can affect or be affected by other medicines. For example:

• other medicines that reduce pain and inflammation (NSAIDs) including medicines called COX-2 selective inhibitors, as this may increase the risk of ulcers or gastrointestinal bleeding;
• cardiac glycosides (e.g. digoxin), medicines used for heart disease; sulfonylureas, medicines used for diabetes; medicines that have an anticoagulant effect (i.e. substances that thin the blood preventing the formation of clots, e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine);
• cyclosporine and tacrolimus, medicines that reduce the immune defenses;
• medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan, diuretics);
• medicines that contain cortisone or substances similar to cortisone, used for the treatment of inflammation (corticosteroids);
• medicines called ‘selective serotonin reuptake inhibitors’ (SSRIs), used as antidepressants;
• aminoglycoside and quinolone antibiotics, a type of antibiotic;
• zidovudine and ritonavir, medicines used for HIV infections;
• methotrexate, used in cancer treatment and for some types of autoimmune diseases,

e.g. rheumatoid arthritis;

• cholestyramine, a medicine used to lower cholesterol levels in the blood;
• lithium, used for depression;
• medicines that inhibit CYP2C9, such as voriconazole and fluconazole, medicines used for fungal infections;
• Ginkgo Biloba, a plant extract used to improve circulation;
• probenecid, a medicine used for gout;
• phenytoin, a medicine used for epilepsy;
• bisphosphonates, medicines used to treat osteoporosis;
• oxpentifylline, a medicine used for blood vessel problems;
• baclofen, a medicine used to relax muscles;
• mifepristone, a medicine used for medical abortion;
• moclobemide, a medicine used for the treatment of depression.

Some other medicines may also affect or be affected by treatment with Ibuprofene Laboratori
Alter. Therefore, always consult your doctor or pharmacist before taking Ibuprofene Laboratori Alter with
other medicines.

Ibuprofene Laboratori Alter with alcohol
Some side effects, such as those affecting the stomach and intestine or the nervous system, may
be more likely when you drink alcohol during treatment with Ibuprofene Laboratori Alter.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not use Ibuprofene Laboratori Alter in the last 3 months of pregnancy, as such treatment may cause
problems with the heart, lungs or kidneys of the fetus and complications during childbirth (see paragraph 2 “Do
not take Ibuprofene Laboratori Alter”). It may affect your and your baby's tendency to bleed and
delay or prolong labor more than expected.
During the first 6 months of pregnancy, take this medicine only if necessary and under
direct medical supervision, as treatment may negatively affect pregnancy and fetal development.
If you need treatment 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, Ibuprofene
Laboratori Alter can cause kidney problems in the fetus, if taken for more than a few days, leading to a
reduction of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel
(ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor
may recommend additional monitoring.
Breastfeeding
Avoid taking Ibuprofene Laboratori Alter if you are breastfeeding as the medicine may pass into
breast milk in small amounts.
Fertility
If you want to become pregnant or have difficulty conceiving, consult your doctor, as
this medicine may impair fertility. This effect is reversible upon discontinuation of the drug.

Driving and using machines
Ibuprofene Laboratori Alter can cause side effects that may worsen your reactivity to
stimuli, such as headache, drowsiness, dizziness, vertigo, fatigue and visual disturbances. Make sure you do not suffer from any of these side effects before driving vehicles or using machinery or
doing anything that requires attention. This is particularly important when you drink alcohol during
treatment with Ibuprofene Laboratori Alter.

Ibuprofene Laboratori Alter contains lactose.
If your doctor has diagnosed you with intolerance to some sugars, contact them before taking this
medicine.

Ibuprofene Laboratori Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.

3. How to take Ibuprofene Laboratori Alter

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your doctor
or pharmacist.
The lowest effective dose should be used for the shortest period necessary to relieve symptoms. If you have
an infection, consult your doctor immediately if symptoms (such as fever and pain) persist
or worsen (see section 2).

Adults and children over 12 years of age
IbuprofeneLaboratori Alter 400 mg- The recommended dose is 2-4 tablets per day as directed by your
doctor. The maximum dose is 4 tablets per day.

IbuprofeneLaboratori Alter 600 mg- The recommended dose is 1-3 tablets per day as directed by your
doctor. The maximum dose is 3 tablets (1800 mg) per day.

Patients with kidney or liver problems
If you have kidney or liver problems, your doctor will decide on the most appropriate dose for you, possibly reducing the
dosages indicated above. If you have severe kidney or liver problems, you should not take this medicine (see
“Do not take Ibuprofene Laboratori Alter”).

Elderly
If you are elderly, your doctor will decide on the most appropriate dose for you, possibly reducing the dosages indicated above.
Method of administration
Ibuprofene Laboratori Alter must be taken orally (oral use) with plenty of water. Take the
tablets whole, without chewing, breaking, crushing or sucking them.
If you are using Ibuprofene Laboratori Alter for rheumatic diseases, take the first dose in the
morning upon waking and subsequent doses with meals.

If you take more IbuprofeneLaboratori Alter than you shouldor if your child has taken this medicine
by mistake, always contact your doctor or go to the nearest hospital to get advice on
the risk and recommendations on what actions to take.
Symptoms of overdose may include: nausea, stomach pain, vomiting (possibly with
traces of blood), blood in the urine, diarrhea, pain in the abdomen or chest, bleeding in the stomach or
intestine, heart problems such as low blood pressure or changes in heart rate (bradycardia,
tachycardia) and blood circulation, liver or kidney problems, headache, ringing in the ears (tinnitus),
confusion and oscillating and uncontrolled eye movements (nystagmus), decreased blood pH (metabolic acidosis,
weakness and dizziness, low potassium levels in the blood, fainting, seizures (especially in
children), disorientation, excited state, breathing problems (including severe ones) including apnea, symptoms
of central nervous system depression such as drowsiness, feeling of coldness to the body (hypothermia), loss
of consciousness, deep sleep (lethargy), coma.

If you forget to take Ibuprofene Laboratori Alter
Do not take a double dose to make up for a missed dose.
If you have any questions about 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.

Serious side effects
Stop taking IbuprofeneLaboratori Alter and contact your doctor immediately if any of the
following occur:

• serious stomach problems, burning or abdominal pain due to damage to the stomach or intestinal wall (peptic ulcer), severe and sudden pain in the upper abdomen or stomach (gastrointestinal perforation). These side effects are uncommon;
• vomiting blood (hematemesis) or black stools (melena), bleeding from the stomach or intestines (gastrointestinal bleeding). These conditions are common side effects;
• allergic reactions, even severe, manifesting with the more or less sudden appearance of skin lesions, for example with widespread or patchy redness (rash, purpura), hives, itching, swelling of the face, eyes, lips, swelling of the throat with possible difficulty breathing and swallowing (angioedema). These conditions occur infrequently. Rarely, a severe allergic reaction may also occur, which can be life-threatening, characterized by

an increased heart rate and a sudden drop in blood pressure (anaphylactic reactions,
anaphylaxis);

• reddish, non-raised patches, target-shaped or circular on the trunk, often with central blisters, skin exfoliation, ulcers of 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].
• difficulty breathing (asthma even severe, bronchospasm or dyspnea). These conditions are uncommon side effects;
• systemic lupus erythematosus (SLE), a disease that affects connective tissue causing pain in the joints or muscles, skin changes and problems with other organs. This condition occurs rarely.
• worsening of infections such as the onset of necrotizing fasciitis, which manifests with fever, chills, weakness, sweating, diarrhea, vomiting, redness, pain, swelling, bruising in an area of the body due to tissue necrosis (death of tissue cells);
• inflammation of the meninges (aseptic meningitis) which manifests with: very high fever, sudden headache, inability to flex the head, nausea, vomiting, confusion, drowsiness and sensitivity to light. This condition occurs rarely.
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome).
• Widespread, red and scaly rash with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Stop using Ibuprofene Laboratori Alter if you develop these symptoms and contact your doctor immediately.
See also paragraph 2.

Other side effects
Tell your doctor if you notice:

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

• nausea, vomiting, diarrhea, flatulence, difficulty evacuating (constipation), indigestion (dyspepsia), abdominal pain;
• headache, dizziness;
• fatigue.

Uncommon side effects(may affect up to 1 in 100 people)

• inflammation of the nose (rhinitis);
• inflammation of the stomach (gastritis), mouth ulcers;
• dizziness, drowsiness, difficulty falling asleep (insomnia), anxiety, altered sensitivity (paresthesia);
• impaired hearing, ringing in the ears (tinnitus), visual disturbances;
• skin reaction following exposure to the sun (photosensitivity);
• alterations in liver function, yellowish discoloration of the eyes or skin (jaundice), dark urine, pale stools, itching or abdominal pain, inflammation of the liver (hepatitis);
• kidney problems such as nephrotic syndrome, kidney inflammation (tubulointerstitial nephritis), altered function (renal insufficiency).

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

• decreased number of white blood cells (leukopenia) or certain types of white blood cells (neutropenia, agranulocytosis), decreased number of platelets (thrombocytopenia), decreased number of red blood cells due to destruction (hemolytic anemia) or bone marrow problems (aplastic anemia);
• depression, confusion;
• altered vision due to, for example, inflammation of the optic nerve (optic neuritis) or toxic optic neuropathy;
• swelling (edema).

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

• reduced liver function, inflammation of the pancreas (pancreatitis);
• feeling of heart in the throat (palpitations), heart attack (myocardial infarction), reduced heart function (heart failure), high blood pressure (hypertension);
• breathing problems due to fluid in the lungs.

Other side effects

• pain or burning (pyrosis) in the upper abdomen, inflammation of the oral mucosa with ulcers (ulcerative stomatitis),
• worsening of inflammation in the colon (colitis) or Crohn's disease (frequency not known: frequency cannot be defined based on available data);
• worsening of skin infections caused by chickenpox;
• stroke;
• hallucinations, malaise
• chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Ibuprofene Laboratori Alter

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. The expiry date refers to the last day of that month.
Do not store at a temperature above 30°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 Ibuprofene Laboratori Alter contains
The active ingredient is: ibuprofen.
One coated tablet of Ibuprofene Laboratori Alter contains: 400 mg of ibuprofen.
Tablet core: microcrystalline cellulose, sodium croscarmellose, hypromellose, lactose monohydrate,
pregelatinized corn starch, magnesium stearate, anhydrous colloidal silica.
Film coating: hypromellose, titanium dioxide (E-171), talc, propylene glycol (E 1520).
One coated tablet of Ibuprofene Laboratori Alter contains: 600 mg of ibuprofen.
Tablet core: microcrystalline cellulose, sodium croscarmellose, hypromellose, lactose monohydrate,
pregelatinized corn starch, magnesium stearate, anhydrous colloidal silica.
Film coating: hypromellose, titanium dioxide (E-171), talc, propylene glycol (E 1520).

Description of the appearance of Ibuprofene Laboratori Alter and contents of the pack
Ibuprofene Laboratori Alter 400 mg
This medicine is available in packs of 30 tablets in Al/PVC/PVDC blisters.
Ibuprofene Laboratori Alter 600 mg
This medicine is available in packs of 30 tablets in Al/PVC/PVDC blisters.

Marketing Authorisation Holder and Manufacturer
LABORATORI ALTER S.r.l.,
Via Egadi, 7
20144 Milano

Producer:

ROVI PHARMA INDUSTRIAL SERVICES, S.A.
Vía Complutense 140,
E-28805 Alcalá de Henares (Madrid) Spain

TOLL MANUFACTURING SERVICES S.L.
C/ Aragoneses, 2
28108 (Alcobendas-Madrid) Spain

FARMALIDER, S.A.
C/ Aragoneses, 2
28108 Alcobendas (Madrid) Spain