IBUPROFENE 400 mg Soft Capsule

Зміст інструкції

1. Ibuprofene Strides 400 mg soft capsules
   1. What is Ibuprofene Strides and what is it used for
   2. What you need to know before taking Ibuprofene Strides
   3. How to take Ibuprofene Strides
   4. Possible side effects
   5. How to store Ibuprofene Strides
   6. Package contents and other information

Ibuprofene Strides 400 mg soft capsules

Ibuprofen

Generic medicine

Read this leaflet carefully before you start 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.
• Ask your pharmacist if you need further information or advice.
• If any side effects occur, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. See section 4.
• You should consult a doctor if you do not feel better or if you feel worse after 3 days in adolescents and in the treatment of migraine or fever in adults or after 4 days in the treatment of pain in adults. Contents of this leaflet
• 1. What is Ibuprofene Strides and what it is used for
• 2. What you need to know before you take Ibuprofene Strides
• 3. How to take Ibuprofene Strides
• 4. Possible side effects
• 5. How to store Ibuprofene Strides
• 6. Contents of the pack and other information

1. What is Ibuprofene Strides and what is it used for

Ibuprofene Strides belongs to a group of medicines called NSAIDs and contains ibuprofen.
Ibuprofen reduces pain and fever.
Ibuprofene Strides is used for the short-term symptomatic treatment of:

• mild to moderate pain such as headache, menstrual pain, toothache,
• acute migraine with or without aura,
• fever.

Ibuprofene Strides is indicated in adults and adolescents starting from 40 kg of body weight (12
years and over).

2. What you need to know before taking Ibuprofene Strides

Do not take Ibuprofene Strides if:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine listed in section 6;
• if you have suffered from allergic reactions such as shortness of breath, asthma, angioedema, urticaria or runny nose after taking acetylsalicylic acid or similar painkillers (NSAIDs);
• if you suffer from severe liver failure, severe kidney failure or severe heart failure;
• if you are in the last three months of pregnancy (see the paragraphs "Pregnancy" and "Breastfeeding");
• if you have a history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least 2 different episodes of ulcers or confirmed bleeding);
• if you have a history of bleeding or perforation of the gastrointestinal tract associated with a

previous treatment with NSAIDs;

• if you have bleeding in the brain (cerebrovascular hemorrhage) or other active bleeding;
• in case of severe ongoing dehydration (e.g. caused by vomiting, diarrhea or insufficient fluid intake);
• if you have unexplained blood clotting disorders.

Warnings and precautions
Anti-inflammatory/pain-relieving medicines such as ibuprofen may be associated with a
slight increase in the risk of heart attack or stroke, especially if used at high doses. Do not exceed
the recommended dose and duration of treatment.
Consult your doctor or pharmacist before taking Ibuprofene Strides if:
You have heart problems including heart failure or angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowed or
blocked arteries) or any type of stroke (including "mini-stroke" or transient ischemic attack,
"TIA").
You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke
or if you are a smoker.
You have problems with liver or kidney function. In general, regular use of (various types
of) painkillers can lead to long-lasting kidney problems. This risk may increase
under physical exertion associated with salt loss and dehydration (e.g. caused by vomiting,
diarrhea or insufficient fluid intake).
You have or have had problems with the digestive system or chronic inflammatory bowel
disease that is inflammation of the colon (ulcerative colitis) or Crohn's disease.
Use caution if you are taking other medicines that may increase the risk of
ulceration or bleeding, such as oral corticosteroids (like prednisolone), medicines
to thin the blood (like warfarin), selective serotonin reuptake inhibitors (a medicine for depression) or antiplatelet agents (like acetylsalicylic acid).
You are taking another NSAID medicine (including COX-2 inhibitors such as celecoxib
or etoricoxib): taking it in combination with these drugs should be avoided (see the
section "Other medicines and Ibuprofene Strides ").
Mixed connective tissue disease (an autoimmune disease) or systemic lupus erythematosus (an autoimmune disease).
You suffer from some inherited blood formation disorders (e.g. acute intermittent porphyria).
You suffer from blood clotting disorders.
You have recently undergone major surgery.
You are dehydrated.
You suffer or have suffered from asthma or allergic diseases, as shortness of breath may occur.
You suffer from hay fever, nasal polyps or chronic obstructive respiratory diseases: there is
an increased risk of allergic reactions. Allergic reactions can manifest
as asthma attacks (so-called analgesic asthma), angioedema or urticaria.
You have an infection – see the paragraph "Infections" below.
Prolonged use of any type of painkiller for headache can worsen the
symptoms. If this occurs or is suspected, you should consult a doctor and
treatment should be discontinued.
Skin reactions
Serious skin reactions have been reported in association with treatment with Ibuprofene Strides.
Stop taking Ibuprofene Strides and consult a doctor immediately if you experience
any type of 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.
The risk of side effects is minimized by using the lowest effective dose for the shortest
possible time. Elderly patients are subject to an increased risk of side effects to
NSAIDs, especially bleeding and gastrointestinal perforation, which can be fatal. Do not
use several painkillers at the same time unless your doctor has told you to do so.
Bleeding, ulceration or perforation of the gastrointestinal tract, potentially fatal, have been
reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. When bleeding or
an ulceration of the gastrointestinal tract occurs, treatment should be discontinued immediately. The risk of
bleeding, ulceration or perforation of the gastrointestinal tract is greater with increasing doses of
NSAIDs, in patients with a history of ulcer, especially if complicated by bleeding or
perforation (see paragraph 2 "Do not take Ibuprofene Strides if") and in the elderly. These
patients should start treatment with the lowest available dose. For these patients, and for
patients who require concomitant intake of acetylsalicylic acid at low doses or other
drugs that may increase the risk of gastrointestinal problems, combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered.
Patients with a history of gastrointestinal toxicity, especially if elderly, should report any
unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the early
stages of treatment.
Infections
Ibuprofene Strides can mask signs of infections such as fever and pain. It is therefore possible that
Ibuprofene Strides delays appropriate treatment of the infection, which may lead to an increased
risk of complications. This has been observed in pneumonia caused by bacteria and skin infections
caused by bacteria related to varicella. If you take this medicine while you have an infection and the
symptoms of the infection persist or worsen, consult a doctor immediately. During
varicella it is advisable to avoid taking this medicine.
Consult a doctor if any of the above conditions concern you.

Children and adolescents
There is a risk of impaired kidney function in dehydrated adolescents.
This medicine is not indicated for adolescents weighing less than 40 kg or children under the age of
12 years.

Other medicines and Ibuprofene Strides
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicines.
Ibuprofene Strides can affect or be affected by some other medicines.
For example:
anticoagulants (i.e. medicines used to 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).
Other medicines can also affect or be affected by treatment with Ibuprofene Strides
capsules.
Therefore, you should always ask your doctor or pharmacist for advice before using Ibuprofene
Strides with other medicines.
Especially if it concerns any of the following medicines:

Ibuprofene Strides with alcohol
Do not drink alcohol while using Ibuprofene Strides. Some side effects, such as those
affecting the gastrointestinal tract or the central nervous system, may become more likely
when alcohol is taken at the same time as Ibuprofene Strides.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy

During the first 6 months of pregnancy, due to the possible risk of miscarriage and
birth defects, the doctor will prescribe this medicine only if it is clearly necessary. In
this case, the dose should be kept as low as possible and the duration of treatment
as short as possible.

During the last 3 months of pregnancy, this medicine is contraindicated: NEVER take
this medicine, as it can have serious or even fatal consequences for the baby, in
particular on its heart, lungs and/or kidneys, even with a single dose.
If you have taken this medicine during pregnancy, tell your
doctor/midwife immediately so that appropriate monitoring can be considered.
Breastfeeding
Ibuprofen passes into breast milk but is unlikely to have effects on the baby.
The use of this medicine is permitted during breastfeeding for a short period at the recommended
dose. Consult your doctor if you need to use this medicine for a prolonged period
during breastfeeding.
Fertility
This medicine belongs to a group of medicines called NSAIDs that can impair
fertility in women. This effect is reversible upon discontinuation of the medicine.
Consult a doctor if any of the above conditions concern you.

Driving and operating machinery
Ibuprofen generally does not alter or negligibly alters the ability to drive vehicles and to
use machinery.
However, as undesirable effects on the central nervous system such as fatigue and dizziness may occur at higher doses, the ability to react and the ability to actively participate
in road traffic and operate machinery may be impaired in individual cases.
This applies to a greater extent in combination with alcohol.

Ibuprofene Strides contains soya
Ibuprofene Strides contains soya lecithin. Do not use this medicine if you are allergic to peanuts or
soya.

Ibuprofene Strides contains potassium
This medicine contains 28 mg of potassium per capsule. This should be taken into consideration in patients
with reduced renal function or in patients following a low-potassium diet.

Ibuprofene Strides contains sorbitol
Contains Sorbitol (E 420). Sorbitol is a source of fructose. If your doctor has told you that you (or the
child) are intolerant to some sugars or if you have a diagnosis of hereditary fructose intolerance
(HFI), a rare genetic disease in which patients are unable to convert fructose, consult your
doctor before you (or the child) take or receive this medicine.

3. How to take Ibuprofene Strides

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

Adults and adolescents weighing 40 kg or more (aged 12 years or older):
The recommended single dose is 1 Ibuprofene capsule (400 mg). If necessary, an additional dose of 1 Ibuprofene capsule (400 mg) can be taken. The respective dosing interval should be chosen based on the observed symptoms and the recommended maximum daily dose
and should not be less than 6 hours. Do not take more than 3 Ibuprofene capsules (1200
mg) in 24 hours.
This medicine is intended for short-term use only.
Method of administration
The capsules should be swallowed whole with plenty of water. It is recommended that people with a
sensitive stomach take Ibuprofene Strides with food.
Consult a doctor:
In adults, if treatment for migraine or fever is required for more than 3 days, if treatment for pain is required for more than 4 days, or if symptoms worsen.
In adolescents between 12 and 17 years of age, if treatment is necessary for more than 3 days or if
symptoms worsen.

Use in children and adolescents
This medicine is not intended for use in children under 12 years of age and adolescents
weighing less than 40 kg.

If you take more Ibuprofene Strides than you should
If you have taken more capsules than you should, or if children have accidentally taken this medicine,
always contact your doctor or the nearest hospital immediately for an opinion on the risk and
advice on what action to take.
Symptoms may include nausea, stomach pain, vomiting (possibly with traces of blood), or more
rarely diarrhea. Also, headache, gastrointestinal bleeding, blurred vision, ringing in the
ears, confusion and uncontrolled eye movements, and worsening of asthma in asthmatic patients. In case of high doses, the onset of drowsiness, disorientation, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness and
dizziness, blood in the urine, low blood pressure, increased potassium levels in the blood,
increased prothrombin time/INR, acute renal failure, liver damage, respiratory depression, cyanosis, feeling of coldness in the body and breathing problems have been reported.

If you forget to takeIbuprofene Strides
Do not take a double dose to make up for a missed dose.
If you have any further questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ibuprofene Strides can cause side effects, although not everybody gets them.
In association with treatment with NSAIDs, fluid retention in the tissues (edema),
hypertension and heart failure have been reported.
The most commonly observed side effects relate to the digestive system. Gastric/duodenal ulcers (peptic ulcers), perforation or bleeding,
occasionally fatal, especially in elderly patients (section 2 “Warnings and precautions”) can occur.
Nausea, vomiting, diarrhoea, flatulence, constipation, digestive disorders, abdominal pain, tarry stools,
vomiting blood, sores (ulcers) in the mouth and throat (ulcerative stomatitis), worsening of colitis and Crohn's disease (see section 2 “Warnings and
precautions”) have been reported after use. Less commonly, inflammation
of the stomach lining (gastritis) has been observed. In particular, the risk of developing gastrointestinal
bleeding depends on the dose and duration of treatment.

Stop taking Ibuprofene Strides and contact your doctor immediately if you develop any of the
following symptoms:

• Severe stomach pain, especially when starting to take Ibuprofene Strides (uncommon: may affect up to 1 in 100 people).
• Black stools, diarrhoea or vomiting blood (uncommon: may affect up to 1 in 100 people).
• Skin rash, severe blistering or peeling of the skin, lesions of the mucous membranes (very rare: may affect up to 1 in 10,000 people) or any signs of hypersensitivity (uncommon: may affect up to 1 in 100 people).
• Fever, sore throat and mouth, flu-like symptoms, feeling tired, nosebleeds and skin bleeding. These symptoms may be caused by a reduction in white blood cells in your body (agranulocytosis) (very rare: may affect up to 1 in 10,000 people).
• Severe or persistent headache (very rare: may affect up to 1 in 10,000 people).
• Blisters on the hands and feet (Stevens-Johnson syndrome) (very rare: may affect up to 1 in 10,000 people);
• A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swollen lymph nodes and increased eosinophils (a type of white blood cells) (frequency not known: the frequency cannot be estimated based on available data).
• Widespread red and scaly skin rash with bumps under the skin and blisters mainly located in skin folds, on the trunk and upper extremities accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop using Ibuprofene Strides if these symptoms develop and seek immediate medical attention. See also section 2 (frequency not known: the frequency cannot be estimated based on available data).

Other side effects that may occur

• Common: may affect up to 1 in 10 people Gastrointestinal disorders such as heartburn, stomach pain and nausea, diarrhoea, vomiting, flatulence (wind) and constipation.

Minor gastrointestinal bleeding which, in exceptional cases, can cause anaemia.

• Uncommon: may affect up to 1 in 100 people Gastrointestinal ulcer, potentially with bleeding and perforation, ulcerative stomatitis, worsening of existing intestinal diseases (colitis or Crohn's disease), gastritis. Hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with a drop in blood pressure). Central nervous system disorders, such as headache, dizziness, insomnia, agitation, irritability and fatigue. Visual disturbances.
• Rare: may affect up to 1 in 1,000 Tinnitus (ringing in the ears), hearing loss. Pain in the flanks and/or abdomen, blood in the urine and fever may be signs of kidney damage (papillary necrosis). Elevated uric acid concentrations in the blood, elevated urea concentrations in the blood.
• Very rare: may affect up to 1 in 10,000 If signs of an infection appear or worsen during the use of Ibuprofene Strides, you should see a doctor immediately. It must be verified whether there is an indication for an anti-infective/antibiotic therapy. Symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or blurred consciousness have been observed with ibuprofen. Patients with autoimmune diseases (systemic lupus erythematosus (SLE), mixed connective tissue disease) appear to be predisposed. Problems in the production of blood cells (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis) - the first signs are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe exhaustion, nosebleeds and skin bleeding. In these cases, therapy must be stopped immediately and a doctor must be consulted. Do not use any self-medication with painkillers or medicines that reduce fever (antipyretic medicines). Severe generalized allergic reactions - the signs can be: swelling of the face, tongue and throat, shortness of breath, rapid heartbeat, drop in blood pressure, up to a life-threatening shock. If one of these symptoms occurs, which can also occur with the first use, immediate medical assistance is necessary. Psychotic reactions, depression. Palpitations, heart failure, myocardial infarction, swelling (edema), high blood pressure and heart failure have been reported in association with treatment with high doses of NSAIDs. Arterial hypertension, inflammation of blood vessels (vasculitis). Asthma, dyspnoea, bronchospasm. Esophagitis, pancreatitis, formation of intestinal stenoses similar to the diaphragm. If you experience relatively severe pain in the upper abdomen, vomiting blood or black stools, you should stop treatment and consult a doctor. Liver damage (the first signs may be yellowing of the skin), especially with long-term therapy, liver failure, acute hepatitis, impaired liver function. Lower urine than normal and swelling (especially in patients with high or low blood pressure or impaired kidney function); swelling (edema) and cloudy urine (nephrotic syndrome); inflammatory kidney disease (interstitial nephritis) which can lead to acute renal failure. If one of the above symptoms occurs or if you have a general feeling of unwellness, stop taking Ibuprofene Strides and consult your doctor immediately as these may be the first signs of kidney damage or renal failure. Severe forms of skin reactions including rash with redness and blisters, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), hair loss (alopecia).
• Not known: the frequency cannot be estimated based on available data The skin becomes sensitive to light.

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

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at 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 Strides

Keep the medicine out of sight and reach of children.
Do not use Ibuprofene Strides after the expiry date which is stated on the box and blister.
The expiry date refers to the last day of the month indicated.
Do not store at temperatures above 25°C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to
dispose of unused medicines. These measures will help protect the environment.

6. Package contents and other information

What Ibuprofene Strides contains

• The active ingredient of this medicine is ibuprofen. Each capsule contains 400 mg of ibuprofen
• The other ingredients are listed below. Capsule content: Macrogol 600 Purified water Potassium hydroxide Capsule shell: Gelatin Sorbitol, liquid, partially dehydrated (E420) Erythrosine (E127), Purified water Soybean lecithin Medium chain triglycerides Macrogol 600

Description of the appearance of Ibuprofene Strides and the package contents
Ibuprofene Strides 400 mg soft capsules
A clear light reddish-pink oval soft gelatin capsule containing a viscous liquid of
color from transparent to light pink.
Packaging: Aluminum/PVC/PVDC blisters of 2, 4, 10, 12, 16, 20, 50 soft capsules. The blisters
are packaged in cardboard boxes.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
MAH
Strides Pharma (Cyprus) Limited
Themistokli Dervi, 3
Julia House, 1st Floor
Nicosia 1066
Cyprus

Manufacturer
Fairmed Healthcare GmbH
Maria-Goeppert-Straße 3
23562 Lübeck
Germany

This medicine is authorised in the Member States of the EEA under the following denominations:
Netherlands Ibuprofen Strides 400 mg soft capsules
Czech Republic Ibuprofen Strides
France Ibuprofene Strides 400 mg capsules molle
Italy Ibuprofene Strides
Poland Ibuprofen Strides
Spain Ibuprofeno Strides 400 mg capsulais blanda EFG
Romania Ibuprofen Strides 400 mg capsule moale
Austria Ibu-Fairmed Liquid 400 mg Weichkapseln
Germany Ibu-Fairmed Healthcare 400 mg Weichkapseln