IBU-LYSIN-

IBU-LYSIN-ratiopharm 400 mg film-coated tablets

Important information (mandatory details)

Ibu-Lysin-ratiopharm 400 mg film-coated tablets. Active ingredient: Ibuprofen (as Ibuprofen-dl-Lysine (1:1)). Areas of application: for the short-term symptomatic treatment of mild to moderately severe pain such as headaches, toothaches, menstrual pain, as well as fever and pain associated with colds and/or the acute headache phase in migraines with or without aura.

For risks and side effects, read the package leaflet and ask your doctor, pharmacist, or at your pharmacy.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibu-Lysin-ratiopharm 400 mg film-coated tablets, for children from 20 kg body weight (from 6 years), adolescents and adults
Active ingredient: Ibuprofen (as Ibuprofen-dl-Lysine (1:1))

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take this medicine exactly as described in this package leaflet or exactly as instructed by your doctor or pharmacist.

• Keep this package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If, after 3 days, migraine headaches or fever, or in children and adolescents, or after 4 days of pain treatment in adults, there is no improvement or the symptoms worsen, consult your doctor.

What is in this package leaflet

1. WHAT IS Ibu-Lysin-ratiopharm AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Ibu-Lysin-ratiopharm?
3. HOW TO TAKE Ibu-Lysin-ratiopharm?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO STORE Ibu-Lysin-ratiopharm?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS Ibu-Lysin-ratiopharm AND WHAT IS IT USED FOR?

Ibu-Lysin-ratiopharm is a pain-relieving and fever-reducing medicine (non-steroidal anti-inflammatory drug [NSAID]). Ibu-Lysin-ratiopharm is used for the short-term symptomatic treatment of:

• mild to moderately severe pain such as headaches, toothaches, menstrual pain, as well as fever and pain associated with colds.
• the acute headache phase in migraines with or without aura.

Ibu-Lysin-ratiopharm is used in children from 20 kg body weight (from 6 years), adolescents and adults.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE Ibu-Lysin-ratiopharm?

Do not take Ibu-Lysin-ratiopharm:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine listed in section 6.
• if you have previously reacted with shortness of breath, asthma, nasal mucosal swelling, angioedema or skin reactions after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs/antiphlogistics (NSAIDs).
• if you have unexplained blood formation disorders.
• if you have existing or recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least two distinct episodes of proven ulcers or bleeding) in the past.
• if you have a history of gastrointestinal bleeding or perforation associated with previous NSAID therapy.
• in case of cerebral haemorrhages (cerebrovascular bleeding) or other active bleeding.
• if you suffer from severe liver or kidney dysfunction.
• in the last 3 months of pregnancy.
• if you suffer from severe heart muscle weakness (heart failure).
• if you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).
• in children under 20 kg body weight or under 6 years of age, as this dosage strength is not suitable due to the higher amount of active ingredient.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Ibu-Lysin-ratiopharm:

• if you suffer from certain congenital blood formation disorders (e.g. acute intermittent porphyria).
• if you have certain autoimmune diseases (systemic lupus erythematosus and mixed connective tissue disease).
• if you have gastrointestinal disorders or chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease).
• if you suffer from impaired kidney or liver function.
• in case of dehydration.
• if you suffer or have ever suffered from high blood pressure and/or heart muscle weakness (heart failure).
• if you suffer from allergies (e.g. skin reactions to other medicines, asthma, hay fever), chronic mucosal swelling or chronic respiratory diseases that narrow the airways, as you then have an increased risk of hypersensitivity reactions.
• in case of blood clotting disorders.
• immediately after major surgical procedures.
• if you have an infection - see "Infections" below.

Side effects can be reduced by using the lowest effective dose for the shortest period necessary to control symptoms. For prolonged use of Ibu-Lysin-ratiopharm, regular monitoring of your liver values, kidney function and blood count is required.

Safety in the gastrointestinal tract

The concomitant use of Ibu-Lysin-ratiopharm with other non-steroidal anti-inflammatory drugs (NSAIDs), including so-called cyclooxygenase-2 inhibitors, should be avoided.

Elderly patients

Elderly patients experience side effects more frequently after NSAID use, particularly gastrointestinal bleeding and perforations, which can be fatal.

Bleeding, ulcers and perforations in the gastrointestinal tract

Bleeding, ulcers or perforations in the gastrointestinal tract, which can be fatal, have been reported during treatment with all NSAIDs. They occurred with or without prior warning signs or severe gastrointestinal events in the history at any time during treatment. The risk of bleeding, ulcers or perforations in the gastrointestinal tract is higher with increasing NSAID dose, if you have had an ulcer before, especially if bleeding or perforations occurred as complications, and in elderly patients. You should start treatment with the lowest available dose. Please talk to your doctor, as combination therapy with protective medicines (e.g. misoprostol or proton pump inhibitors) may be considered. This also applies if you are taking low-dose acetylsalicylic acid or other active substances at the same time that are likely to increase the risk of gastrointestinal diseases. If you have experienced gastrointestinal side effects in the past, especially in old age, you should report any unusual abdominal symptoms (especially gastrointestinal bleeding) to your doctor, especially at the beginning of treatment.

Caution is advised if you are taking medicines at the same time that may increase the risk of ulcers or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid. If bleeding or ulcers occur in the gastrointestinal tract during treatment with Ibu-Lysin-ratiopharm, treatment must be stopped and a doctor consulted.

Effects on the blood vessels of the heart and brain (cardiovascular and cerebrovascular effects)

Anti-inflammatory drugs/painkillers such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.

You should discuss your treatment with your doctor or pharmacist before taking Ibu-Lysin-ratiopharm if you:

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

Skin reactions

Serious skin reactions have been reported in association with ibuprofen treatment. If a rash, mucosal lesions, blisters or other signs of allergy occur, you should stop treatment with Ibu-Lysin-ratiopharm and seek immediate medical attention, as these may be the first signs of a very serious skin reaction. See section 4. During a chickenpox infection, it is advisable to avoid the use