Ibuprofen CINFA 40 mg/ml oral suspension EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

ibuprofeno cinfa 40 mg/ml oral suspension EFG

Read this entire leaflet carefully before you start taking this medicine, because it contains important information for you.

Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What ibuprofen cinfa is and what it is used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines work by altering the body's response to pain and elevated body temperature. Ibuprofen cinfa is used for the short-term symptomatic treatment of:

fever,
mild to moderate pain.

2. What you need to know before taking ibuprofen cinfa

Do not take ibuprofen cinfa

if you are allergic to ibuprofen, to other similar painkillers (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6).
if you have experienced breathlessness, asthma, runny nose, swelling of the face and/or hands, or hives after taking acetylsalicylic acid or other similar painkillers (NSAIDs).
if you have had gastrointestinal bleeding or perforation related to previous use of NSAIDs.
if you currently have or have had recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (two or more episodes of ulcer or confirmed bleeding).
if you have severe liver or kidney failure.
if you have severe heart failure.
if you have cerebral haemorrhage (cerebrovascular haemorrhage) or any other active bleeding.
if you have blood coagulation disorders, since ibuprofen may increase bleeding time.
if you have undetermined disorders in blood cell formation.
if you have severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).

You must not take this medicine if you are in the last trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before taking ibuprofen cinfa

if you have a hereditary disorder affecting blood cell production (e.g. acute intermittent porphyria).
if you have coagulation disorders.
if you have certain skin diseases (systemic lupus erythematosus [SLE] or mixed connective tissue disease).
if you currently have or have had intestinal disease (ulcerative colitis or Crohn’s disease), as these conditions may worsen (see section 4 ‘Possible side effects’).
if you have had or currently have hypertension or heart failure.
if you have reduced kidney function.
if you have liver disorders. When taking ibuprofen for a prolonged period, liver function, kidney function, and blood tests should be performed regularly.
caution is advised if you are taking other medicines that may increase the risk of ulcer or bleeding, such as oral corticosteroids (e.g. prednisolone), anticoagulants (e.g. warfarin), selective serotonin reuptake inhibitors (a medicine used for depression), or antiplatelet agents (e.g. acetylsalicylic acid).
if you are taking another NSAID (including COX-2 inhibitors such as celecoxib or etoricoxib), as they should not be taken together (see section “Use of other medicines”).
unwanted effects can be minimized by using the lowest effective dose for the shortest possible duration.
in general, regular use of (various types of) painkillers may lead to serious and prolonged kidney problems. This risk may increase during physical exertion associated with loss of electrolytes and dehydration. Therefore, it should be avoided.
prolonged use of any type of painkiller for headaches may worsen them. If this occurs or is suspected, medical advice should be sought and treatment discontinued. Medication-overuse headache should be suspected in patients who experience frequent or daily headaches despite (or due to) regular use of headache medications.
if you currently have or have had asthma or an allergic disease, as breathing difficulties may occur.
if you have allergic rhinitis, nasal polyps, or chronic obstructive pulmonary disease, as there is an increased risk of allergic reactions. Allergic reactions may present as asthma attacks, angioedema, or urticaria.
severe skin reactions (such as Stevens-Johnson syndrome) have been very rarely reported in connection with the use of NSAIDs. Ibuprofen treatment must be stopped immediately upon the first signs of skin rash, mucosal lesions, or any other signs of allergic reactions.
if you are advised not to use ibuprofen during chickenpox.
if you have recently undergone major surgery, as special medical monitoring is required.
if you are dehydrated, as there is an increased risk of kidney problems in dehydrated children.
NSAIDs may mask symptoms of infections and fever.
if you have an infection; see the “Infections” heading below.
Allergic reactions to this medicine, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop using ibuprofen cinfa immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Special caution with ibuprofen cinfa is recommended.

Skin reactions

Severe 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 in association with ibuprofen treatment. Discontinue treatment with ibuprofen cinfa and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Stop taking ibuprofen and consult your doctor immediately if you develop any 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.

Infections

Ibuprofen may mask signs of infection such as fever and pain. Consequently, ibuprofen may delay appropriate treatment of the infection, 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 a doctor without delay.

Cases of gastrointestinal bleeding, ulceration, or perforation, which may be fatal, have been reported with all NSAIDs at any time during treatment, with or without previous symptoms or history of serious gastrointestinal events. If gastrointestinal bleeding or ulceration occurs, treatment must be stopped immediately. The risk of gastrointestinal bleeding, ulceration, or perforation is higher with increased doses of NSAIDs in patients with a history of ulcers, especially complicated by bleeding or perforation (see section 2 ‘Do not take ibuprofen cinfa’) and in elderly patients. In these patients, treatment should be initiated at the lowest available dose. Combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered for these patients, as well as for those requiring concomitant administration of low-dose acetylsalicylic acid or other medicines likely to increase gastrointestinal risk.

Anti-inflammatory/pain-relieving medicines 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.

Discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

you have heart problems, including heart failure, angina (chest pain), or if you 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, high cholesterol, a family history of heart disease or stroke, or if you smoke.

Consult your doctor before using ibuprofen if your child has any of the above conditions.

Elderly patients

Elderly patients have a higher risk of adverse events when taking NSAIDs, especially gastrointestinal and intestinal events. See section 4 ‘Possible side effects’ for more information.

Patients with a history of gastrointestinal toxicity, particularly elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), particularly during the initial stages of treatment.

Taking ibuprofen cinfa with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Ibuprofen may affect or be affected by other medicines. For example:

anticoagulant medicines (e.g. to treat or prevent clotting problems, e.g. acetylsalicylic acid, warfarin, ticlopidine)
medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin-II receptor antagonists such as losartan)

Other medicines may also affect or be affected by treatment with ibuprofen. Therefore, you should always consult your doctor or pharmacist before using ibuprofen with other medicines.

Please inform your doctor or pharmacist if you are taking, or have recently taken any other medicines, including those obtained without a prescription. In particular, inform them if you are taking:

Other NSAIDs including COX-2 inhibitors	Because it may increase the risk of side effects
Digoxin (for heart failure)	Because the effect of digoxin may be potentiated
Glucocorticoids (medications containing cortisone or cortisone-like substances)	Because they may increase the risk of gastrointestinal ulcers or bleeding
Antiplatelet agents	Because they may increase the risk of bleeding
Acetylsalicylic acid (low dose)	Because the anticoagulant effect may be affected
Medications to thin the blood (such as warfarin)	Because ibuprofen may enhance the effects of these medications
Phenytoin (for epilepsy)	Because the effect of phenytoin may be potentiated
Selective serotonin reuptake inhibitors (medications used for depression)	Because they may increase the risk of gastrointestinal bleeding
Lithium (medication for manic-depressive illness and depression)	Because the effect of lithium may be potentiated
Probenecid and sulfinpyrazone (medications for gout)	Because they may delay the excretion of ibuprofen
Medications for high blood pressure and diuretics	Because ibuprofen may reduce the effects of these medications and there may be an increased risk to the kidney
Potassium-sparing diuretics e.g. amiloride, potassium canrenoate, spironolactone, triamterene	Because it may lead to hyperkalemia
Methotrexate (medication for cancer or rheumatoid arthritis)	Because the effect of methotrexate may be potentiated
Tacrolimus and cyclosporine (immunosuppressive medications)	Because kidney damage may occur
Zidovudine (medication for the treatment of HIV/AIDS)	Because the use of ibuprofen may increase the risk of intra-articular bleeding or bleeding causing inflammation in HIV-positive hemophiliacs
Sulfonylureas (medications for diabetes)	Because blood sugar levels may be affected
Quinolone antibiotics	Because it may increase the risk of seizures (fits)
Voriconazole and fluconazole (CYP2C9 inhibitors used for fungal infections)	Because the effect of ibuprofen may be increased. A reduction in the dose of ibuprofen should be considered, especially when high doses of ibuprofen are administered together with voriconazole or fluconazole.
Baclofen	Baclofen toxicity may develop after starting treatment with ibuprofen.
Ritonavir	Ritonavir may increase plasma concentrations of NSAIDs
Aminoglycosides	NSAIDs may reduce the excretion of aminoglycosides

Taking ibuprofeno cinfa with alcohol

You should not consume alcohol while using ibuprofeno. The risk of experiencing certain adverse effects, such as those affecting the gastrointestinal tract or the central nervous system, may be increased when alcohol is consumed during treatment with ibuprofeno.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not use this medicine during the last trimester of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labor beyond the expected duration. You should not take ibuprofeno during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible dose for the shortest possible time. From week 20 of pregnancy, ibuprofeno may cause kidney problems in your fetus if taken for more than a few days, which could lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is required, your doctor may recommend additional monitoring.

Breastfeeding

Only small amounts of ibuprofeno and its breakdown products pass into breast milk. Ibuprofeno may be taken during breastfeeding if used at the recommended dose and for the shortest possible duration.

Fertility

Ibuprofeno belongs to a group of medicines (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuation of the medicine.

Driving and use of machinery

When used short-term, this medicine has no or negligible influence on the ability to drive and use machines.

ibuprofeno cinfa contains sodium benzoate (E-211). This medicine contains 1 mg of sodium benzoate per ml.

ibuprofeno cinfa contains maltitol (E-965). This medicine contains liquid maltitol. If your doctor has informed you of an intolerance to certain sugars, consult with them before taking this medicine.

ibuprofeno cinfa contains sodium. This medicine contains 5.79 mg of sodium (the main component of table/cooking salt) per ml. This corresponds to 0.28% of the maximum daily recommended sodium intake for an adult.

ibuprofeno cinfa contains benzyl alcohol. This medicine contains 0.00016 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems ("gasping syndrome"), in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless specifically advised by your doctor.

This medicine should not be used for more than one week in children under 3 years of age unless directed by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

3. How to take ibuprofen cinfa

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Recommended dose for pain and fever:

Child's weight (age)	What amount?	How many times in 24 h?*
From 5 kg (3-5 months)	1.25 ml (equivalent to 50 mg of ibuprofen)	3 times
7 - 9 kg (6-11 months)	1.25 ml (equivalent to 50 mg of ibuprofen)	3 to 4 times
10 - 15 kg (1-3 years)	2.5 ml (equivalent to 100 mg of ibuprofen)	3 times
16 - 19 kg (4-5 years)	3.75 ml (equivalent to 150 mg of ibuprofen)	3 times
20 - 29 kg (6-9 years)	5 ml (equivalent to 200 mg of ibuprofen)	3 times
30 - 40 kg (10-12 years)	7.5 ml (equivalent to 300 mg of ibuprofen) (use the syringe twice: 5 ml + 2.5 ml)	3 times

*Doses should be administered approximately every 6 to 8 hours.

Use is not recommended in children under 3 months of age or weighing less than 5 kg.

In patients with sensitive stomachs, it is recommended to take ibuprofen during meals.

WARNING: Do not administer a dose higher than indicated.

Administration method using the syringe

For oral use.

Shake the bottle well.
Remove the cap by pressing down and turning counterclockwise.
Insert the syringe firmly into the port (opening) located in the neck of the bottle.
To fill the syringe, invert the bottle. While holding the syringe, gently pull the plunger down until the suspension reaches the appropriate mark on the syringe.
Return the bottle to its upright position and remove the syringe from the port by gently twisting it.
Place the tip of the syringe into the child's mouth. Slowly press the plunger to gently dispense the suspension. Replace the cap after use. Wash the syringe with lukewarm water and allow it to dry. Store it out of the reach and sight of children.

Duration of treatment

This medicine should only be used short-term. If in children aged 6 months and older this medicine is required for more than 3 days, or if symptoms worsen, consult a doctor.

If symptoms in infants aged 3–5 months (weighing at least 5 kg) persist, consult a doctor within 24 hours of use.

Consult your doctor if symptoms worsen.

If you take more ibuprofen cinfa than you should

If you have taken more ibuprofen cinfa than you should, or if a child has accidentally ingested the medicine, consult a doctor immediately or go to the nearest hospital to assess the risk and receive advice on necessary measures.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see section 4), diarrhea, headache, tinnitus, confusion, and involuntary eye movements. Agitation, disorientation, or coma may also occur. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported.

Additionally, prothrombin time/INR may be prolonged, likely due to interference with the actions of circulating coagulation factors.

Acute renal failure and liver damage may occur.

Asthma exacerbation is possible in asthmatic patients. In addition, low blood pressure and reduced breathing may occur.

If you forget to take ibuprofen cinfa

Do not take a double dose to make up for missed doses. If you forget to take or administer a dose, take it as soon as you remember, then continue with the next dose at the previously indicated dosing interval.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them. Adverse effects can be minimized by taking the lowest effective dose for the shortest time necessary to relieve symptoms. You or your child may experience one of the known adverse effects of NSAIDs. If so, or if you have any concerns, stop taking this medicine and consult your doctor as soon as possible. Elderly patients using this medicine are at higher risk of developing problems associated with adverse effects.

STOP TAKING this medicine and seek immediate medical attention if you or your child develops:

Signs of gastrointestinal bleeding such as severe abdominal pain, black stools, vomiting blood or dark particles resembling coffee grounds.
Signs of a rare but serious allergic reaction such as worsening asthma, wheezing or unexplained shortness of breath, swelling of the face, tongue or throat, difficulty breathing, rapid heartbeat, or drop in blood pressure leading to shock. These reactions may occur even when using this medicine for the first time. If you notice any of these symptoms, consult a doctor immediately.
Serious skin reactions such as a rash covering the entire body, skin exfoliation, blisters or skin peeling.
Flat, non-elevated red spots, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
Generalized rash, high body temperature, and enlarged 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).

If you or your child experiences any of the following adverse effects, if they worsen, or if you notice any unlisted effect, inform your doctor.

Common (may affect up to 1 in 10 people)

Gastrointestinal problems such as heartburn, stomach pain, nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation, and minor gastrointestinal bleeding which may rarely lead to anemia

Uncommon (may affect up to 1 in 100 people)

Gastrointestinal ulcers, perforation or bleeding, inflammation of the mucous membrane of the mouth with ulceration, worsening of pre-existing bowel disease (colitis or Crohn's disease), gastritis
Central nervous system disorders such as headache, dizziness, insomnia, restlessness, irritability, or fatigue
Visual disturbances
Various skin rashes
Hypersensitivity reactions with hives and itching

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

Tinnitus (ringing in the ears)
Increased blood urea levels, pain in the sides and/or abdomen, blood in the urine, and fever may be signs of kidney damage (papillary necrosis)
Increased blood uric acid levels
Decreased hemoglobin levels

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

Esophagitis, pancreatitis, and development of diaphragm-type intestinal strictures
Heart failure, heart attack, and swelling of the face and hands (edema)
Reduced urine output and swelling (especially in patients with hypertension or reduced kidney function), edema, cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute kidney failure. If you experience any of the symptoms listed above, or if you feel depressed, stop taking ibuprofen and consult your doctor immediately, as these may be early signs of kidney damage or failure
Psychotic-type reactions, depression
Elevated blood pressure, vasculitis
Palpitations
Liver dysfunction, liver damage (early signs may include skin discoloration), especially during long-term treatment, liver failure, acute inflammation of the liver (hepatitis)
Problems with blood cell production – early symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds and skin bleeding, and unexplained bruising. In such cases, treatment must be stopped immediately and a doctor consulted. Do not self-medicate with painkillers or fever-reducing medicines (antipyretics)
Severe skin infections and soft tissue complications during chickenpox infection
Worsening of inflammation associated with infection (e.g., necrotizing fasciitis) has been reported in association with the use of some painkillers (NSAIDs). If signs of infection appear or worsen, seek medical attention immediately. Antibiotic therapy should be evaluated
Symptoms of aseptic meningitis such as neck stiffness, headache, nausea, vomiting, fever, or altered consciousness have been observed during treatment with ibuprofen. This is more likely to affect patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately
Severe forms of skin reactions such as rashes with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis / Lyell's syndrome), hair loss (alopecia)

Frequency not known (cannot be estimated from available data)

Respiratory tract reactivity including asthma, bronchospasm, or dyspnea.
A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).
Widespread red, scaly rash with bumps under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno Cinfa if you experience these symptoms and seek medical attention immediately. See also section 2.
Skin becomes sensitive to light.
Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Medicines of this type may be associated with a slight increase in the risk of myocardial infarction or stroke.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage instructions for ibuprofen cinfa

Keep this medicine out of sight and reach of children.

This medicine does not require any special storage conditions.

After opening the container, store below 30°C and use within a maximum of 6 months.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at a SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the container and other information

Composition of ibuprofen cinfa

The active substance is ibuprofen. Each ml of oral suspension contains 40 mg of ibuprofen.
The other components are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), thaumatin (E-957), strawberry flavour (natural flavouring preparations, corn maltodextrin, triethyl citrate (E-1505), propylene glycol (E-1520) and benzyl alcohol), glycerol (E-422) and purified water.

Appearance of the product and contents of the container

Ibuprofeno Cinfa is an oral, viscous suspension, white or almost white in colour, with a strawberry flavour. It is supplied in a topaz-coloured PET bottle with a child-resistant closure, made of polyethylene. It includes a 5 ml graduated oral syringe with a polypropylene cylinder and a polyethylene plunger.

It is available in 30, 100, 150 and 200 ml container sizes.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Laboratorios Farmasierra Manufacturing, S.L.

Ctra. Irún, Km 26,200

San Sebastián de los Reyes (Madrid)

Spain

FARMALIDER, S.A.

C/ Aragoneses 2

28108 Alcobendas, Madrid

Spain

ZINEREO PHARMA, S.L.U

A Relva, S.N

O Porriño 36410 Pontevedra (Spain)

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

DELPHARM BLADEL BV

Industrieweg 1

5531 AD Bladel

The Netherlands

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117

Villamarchante, Valencia, 46191, Spain

LABORATORIOS BASI INDUSTRIA FARMACEUTICA S.A.

Parque Industrial Manuel Lourenco Ferreira Lote 8 15 E 16,

Mortagua, 3450-232, Portugal

Date of the most recent review of this summary: November 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77857/P_77857.html

QR code link: https://cima.aemps.es/cima/dochtml/p/77857/P_77857.html