Package leaflet: Information for the patient

MuscoPocket 400 mg oral powder in sachet

Ibuprofen
Generic 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 of the side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice improvement or if your symptoms worsen after 3 days in case of fever, or after 5 days (3 days in adolescents) in case of pain.

Contents of this leaflet:

What MuscoPocket is and what it is used for
What you need to know before taking MuscoPocket
How to take MuscoPocket
Possible side effects
How to store MuscoPocket
Contents of the pack and other information

1. What MuscoPocket is and what it is used for

MuscoPocket contains ibuprofen as the active substance and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine can be used by adults and adolescents over 12 years of age (weighing over 40 kg) for the symptomatic relief of mild to moderate occasional pain, such as headache, toothache, menstrual pain, muscle pain (contractures), or back pain (lumbago), as well as for the treatment of fever.

2. What you need to know before taking MuscoPocket

Do not take MuscoPocket:

if you are allergic (hypersensitive) to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), to aspirin, or to any of the other components of this medicine (listed
in section 6). Signs of allergy may include: skin rash with
itching, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma
if you suffer from severe liver or kidney disease
if you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract
if you are vomiting blood
if you have black stools or diarrhoea with blood
if you have bleeding disorders or blood coagulation problems, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants at the same time, your doctor will perform blood coagulation tests
if you have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)
if you suffer from severe heart failure
if you are in the third trimester of pregnancy.

Warnings and precautions
Talk to your doctor or pharmacist before taking MuscoPocket:

if you have oedema (fluid retention)
if you suffer or have suffered from any heart condition or have high blood pressure
if you suffer from asthma or any other respiratory disorder
if you are being treated with ibuprofen, as it may mask fever, an important sign of infection, thereby making diagnosis more difficult
if you suffer from kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to carry out regular check-ups. Your doctor will advise you on how often these checks should be performed
if you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms. This risk is higher when high doses and long-term treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor will consider the possibility of adding a medicine to protect the stomach
if you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You must also inform your doctor about the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs)
if you suffer or have suffered from Crohn’s disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually leads to bloody diarrhoea) or ulcerative colitis, as medicines like MuscoPocket may worsen these conditions
if you are being treated with diuretics (medicines used to increase urine production), because your doctor needs to monitor your kidney function
if you suffer from systemic lupus erythematosus (a chronic autoimmune disease that can affect various vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis (inflammation of the meninges, the membranes protecting the brain and spinal cord, not caused by bacteria) may occur
if you suffer from acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in the urine, or liver disease); your doctor will assess whether treatment with ibuprofen is appropriate
if you suffer from headaches after prolonged treatment, do not take the medicine at higher doses
this medicine may cause allergic reactions
if you take the medicine after major surgery, your doctor will need to monitor your condition more closely
if you have chickenpox
if you have an infection, refer to the section “Infections” below.

Undesirable effects can be minimized by using the lowest effective dose for the shortest duration needed to control symptoms.
Skin reactions
Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen treatment. Stop taking MuscoPocket and consult your doctor immediately if you develop skin rashes, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.
Cardiovascular precautions
Medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke. This risk is more likely when high doses are used. Do not exceed the recommended doses or duration of treatment.
Before taking MuscoPocket, discuss the treatment with your doctor or pharmacist if:

you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including a "mini-stroke" or transient ischaemic attack "TIA")
you have high blood pressure, diabetes, or high cholesterol
there is a family history of heart disease or stroke
you are a smoker.

Children and adolescents
In dehydrated children and adolescents, there is a risk of kidney damage.
Precautions during pregnancy and in women of childbearing potential
Since administration of medicines like MuscoPocket has been associated with an increased risk of congenital abnormalities or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.
Administration of ibuprofen is contraindicated during the third trimester.
For women of childbearing potential, it should be noted that medicines like MuscoPocket have been associated with reduced fertility.
Infections
MuscoPocket may mask signs of infection such as fever and pain. Consequently, MuscoPocket may delay appropriate treatment of infection, thereby increasing the risk of complications. This has occurred in cases of bacterial pneumonia and skin infections associated with chickenpox. If you take this medicine during an infection and infection symptoms persist or worsen, consult your doctor immediately.
Elderly
Elderly patients taking NSAIDs are at greater risk of adverse effects, particularly those affecting the stomach and intestines. For further information, see section 4 “Possible side effects”.
If you have a history of gastrointestinal toxicity, especially if you are elderly, report any unusual abdominal symptoms (particularly bleeding in the stomach or intestines), especially during the initial stages of treatment.
There is a risk of kidney impairment in dehydrated elderly patients.
Other medicines and MuscoPocket
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
MuscoPocket may affect or be affected by other medicines. For example:

Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of ulcer and gastrointestinal bleeding.
Antiplatelet agents (prevent formation of blood clots or thrombi in blood vessels) such as ticlopidine.
Anticoagulants (medicines used to "thin" the blood and prevent clots, e.g. acetylsalicylic acid, warfarin, ticlopidine).
Cholestyramine (a medicine used to treat high cholesterol).
Selective serotonin reuptake inhibitors (used to treat depression).
Lithium (a medicine used to treat depression). Your doctor may need to adjust the dose of this medicine.
Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medicine.
Mifepristone (an abortion-inducing agent).
Digoxin and other cardiac glycosides (used in the treatment of heart conditions).
Hydantoins such as phenytoin (used in the treatment of epilepsy).
Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
Corticosteroids such as cortisone and prednisolone.
Diuretics (medicines used to increase urine production), as this may increase the risk of kidney toxicity.
Pentoxifylline (used to treat intermittent claudication).
Probenecid (used in patients with gout or together with penicillin for infections).
Quinolone antibiotics such as norfloxacin.
Sulfinpyrazone (for gout).
Sulfonylureas such as tolbutamide (for diabetes), as this may cause hypoglycaemia.
Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
Zidovudine (an anti-AIDS virus medicine).
Medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
Thrombolytics (medicines that dissolve clots).
Aminoglycoside antibiotics such as neomycin.
Herbal extracts: Ginkgo biloba.
CYP2C9 inhibitors (responsible for liver metabolism of many medicines), for example voriconazole and fluconazole (used to treat fungal infections).

Other medicines may also affect or be affected by treatment with MuscoPocket.
Therefore, always consult your doctor or pharmacist before using MuscoPocket together with other medicines.
Taking ibuprofen may alter the following laboratory tests:

Bleeding time (may be prolonged for 1 day after stopping treatment).
Blood glucose concentration (may decrease).
Creatinine clearance (may decrease).
Haematocrit or haemoglobin (may decrease).
Blood urea nitrogen levels and serum creatinine and potassium levels (may increase).
Liver function tests: increased transaminase values.

Inform your doctor if you are scheduled for clinical testing and are currently taking or have recently taken ibuprofen.
MuscoPocket with food, drinks and alcohol
It is recommended to take MuscoPocket during or after meals to reduce the possibility of gastrointestinal disturbances. Avoid drinking alcohol, as it may increase gastrointestinal side effects.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing potential), as it may harm the fetus or cause problems during childbirth. It may cause kidney and heart problems in the fetus. It may affect the bleeding tendency of both mother and newborn and delay or prolong labour more than expected.
MuscoPocket should not be taken during the first 6 months of pregnancy unless absolutely necessary and on medical advice. If treatment is needed during this period or while planning a pregnancy, take the lowest possible dose for the shortest time necessary to relieve symptoms. If taken for more than a few days starting from week 20 of pregnancy, MuscoPocket may cause kidney problems in the fetus, resulting in reduced levels of amniotic fluid surrounding the fetus (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the newborn’s heart. If treatment for more than a few days is required, your doctor may recommend additional monitoring.
Breastfeeding
Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.
Driving and using machines
If you experience dizziness, vertigo, visual disturbances or other symptoms while taking this medicine, do not drive or operate dangerous machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are generally not required.
Ibuprofen may delay reaction time, which should be taken into account before performing activities requiring increased alertness, such as driving vehicles and operating machinery. This is particularly relevant when combined with alcohol.
MuscoPocket contains isomaltitol (E 953)
If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take MuscoPocket

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.
This medicine is intended only for occasional use and for short-term periods.
Use the lowest effective dose for the shortest time 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).
This medicine should be taken only when pain or fever occurs. When these
symptoms subside, the medicine should be discontinued.

Method of administration
Place the oral powder on the tongue, allow it to dissolve, and then swallow; water is not required. For patients with stomach disorders, it is recommended to take MuscoPocket during or
after meals.

Recommended dose:

Adults and adolescents over 12 years of age (body weight over 40 kg): one sachet (400 mg of ibuprofen) every 6–8 hours. Do not take more than 3 sachets (1,200 mg of ibuprofen) within 24 hours.
Adults over 65 years of age: dosage should be determined by the doctor, as a reduction of the usual dose may be necessary.
Patients with renal, hepatic, or cardiac disease: reduce the dose and consult your doctor.

Duration of treatment
If symptoms worsen, if fever persists for more than 3 days, or if pain worsens or persists for
more than 5 days (3 days in adolescents), consult a doctor.
This medicine should be taken only when pain or fever occurs. When pain or fever subside, administration of the medicine should be stopped.
If you think that the effect of this medicine is too strong or too weak, inform your
doctor or pharmacist.

Use in children and adolescents
This medicine must not be given to children (under 12 years of age) or
adolescents weighing less than 40 kg.

If you take more MuscoPocket than you should
If you have taken more MuscoPocket than you should, or if a child has accidentally ingested the contents of the package, contact your doctor or the nearest hospital immediately to obtain advice regarding the risk and further actions to be taken.

Symptoms
Symptoms of overdose usually appear within 4–6 hours after taking ibuprofen.
The most common symptoms of overdose are: nausea, stomach ache, vomiting (which may
contain traces of blood), abdominal pain, diarrhoea, headache, confusion, drowsiness, involuntary eye movements, tinnitus, and lack of muscular coordination. At higher doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (especially in children), weakness, dizziness, blood in urine, low blood potassium levels, chills, and breathing difficulties have been reported. Rarely, cases of increased blood acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, temporary cessation of breathing (apnea), reduced central nervous system activity, and respiratory depression have occurred. In addition, cases of cardiovascular toxicity (low blood pressure, decreased or increased heart rate) have been reported. Furthermore, prothrombin time/INR may be prolonged, probably due to interference with circulating coagulation factors. Exacerbation of asthma is possible in asthmatic patients.
In cases of severe poisoning, kidney failure and liver damage may occur. In such cases, the doctor will take the necessary measures.

If you forget to take MuscoPocket
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. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your usual time.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.
Stop taking this medicine and contact a doctor immediately if you experience:

Allergic reactions such as skin rashes, swelling of the face, wheezing or difficulty breathing
Vomiting blood or material resembling coffee grounds
Blood in the stool or bloody diarrhoea
Severe stomach pain
Blisters or severe peeling of the skin
Severe or persistent headache
Yellowing of the skin (jaundice)
Signs of severe hypersensitivity
Swelling of the extremities or fluid accumulation in the arms or legs.

Contact your doctor if you experience any of the following adverse effects, if they worsen, or if you notice any effect not listed here.
The frequencies shown below refer to short-term use of maximum daily doses of 1,200 mg of oral ibuprofen:
Common (may affect up to 1 in 10 people):

Gastrointestinal bleeding, particularly in elderly patients
Nausea, vomiting, diarrhoea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, heartburn, abdominal pain, blood in the stool, bloody vomiting
Headache, dizziness, fatigue.

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

Sneezing, stuffy or runny nose or nasal itching (rhinitis)
Hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (possibly with low blood pressure) and photosensitivity reactions. In such cases, a doctor must be informed immediately and ibuprofen treatment must be discontinued
Tingling or pins and needles sensation, drowsiness
Difficulty sleeping, feeling anxious
Acne, urticaria, itching, small bruises on the skin or inside the mouth, nose or ears, skin sensitivity to light
Visual disturbances. In such cases, a doctor must be informed immediately and ibuprofen treatment must be discontinued.
Hearing problems
Difficulty breathing, wheezing or coughing, asthma or worsening of asthma
Inflammation of the stomach lining, gastrointestinal ulcers, sometimes with bleeding and perforation, ulcerative stomatitis
Hepatitis, yellowing of the skin or eyes, reduced liver function
Nephrotic syndrome (fluid accumulation in the body (edema) and protein accumulation in the urine); kidney inflammation (interstitial nephritis), which may be accompanied by acute kidney dysfunction. Reduced urine output, fluid accumulation in the body (edema), and general malaise may be signs of kidney disease and even kidney failure. If any of the

above symptoms occur, discontinue MuscoPocket administration and consult a doctor immediately.
Rare (may affect up to 1 in 1,000 people):

Feeling depressed or confused
During treatment with ibuprofen, symptoms of aseptic meningitis have been observed, including neck stiffness, headache, nausea, vomiting, fever, or altered consciousness. If such symptoms occur, contact a doctor immediately
Leucopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia, haemolytic anaemia (early symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe fatigue, nose and skin bleeding, unusual and unexplained bruising, and ecchymoses of unknown cause). In such cases, treatment must be stopped immediately and a doctor consulted
Reversible toxic amblyopia (reduced vision)
Dizziness, tinnitus (ringing or noises in the ear)
Liver damage
Fluid retention (edema)
Anaphylactic reaction (in case of generalized hypersensitivity reaction, swelling of the face, tongue and larynx, dyspnoea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock) may occur
Optic nerve damage.

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

High blood pressure, heart failure, heart attack
Pancreatitis
Severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and mucous membranes and purple lesions, mainly on the trunk)
Toxic epidermal necrolysis (mucosal lesions and painful lesions with necrosis and detachment of the skin)
Erythema multiforme (skin lesion)
Liver failure.

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

Worsening of colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhoea). A serious 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 cells)
Generalized red, scaly rash, with subcutaneous bumps and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (generalized pustular eruption). Discontinue MuscoPocket if these symptoms occur and contact a doctor immediately.

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

5. How to store MuscoPocket

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature. Store in the
original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the box after Exp. The
expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Dispose of packaging and
medicines no longer needed by handing them in at designated collection points at pharmacies. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. Pack contents and other information

The active substance is ibuprofen. Each sachet contains 400 mg of ibuprofen.
The other components are: Isomaltitol 720 (E 953), anhydrous citric acid, potassium acesulfame (E 950), glycerol distearate (Type I), lemon flavour 502336 TP0551 (containing maltodextrins, alpha tocopherol (E-307)).

Description of the appearance of MuscoPocket and pack contents
Oral powder in sachets.
White or almost white powder, free from foreign matter, with a characteristic lemon aroma.
Pack contents: 12 or 24 sachets in PET/Al/PE.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
DOC Generici S.r.l., Via Turati 40, 20121 Milan, Italy.

Manufacturers:
EDEFARM, S.L.
Polígono Industrial Enchilagar del Rullo, 117,
Villamarchante, 46191 Valencia, Spain.

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

This leaflet was last reviewed on

Muscopocket