RUPALYN 400 mg, 10 film-coated tablets, Medochemie

Rupalyn, 10 tablets, Medochemie

Indications:

• Rupalyn 400 mg film-coated tablets is used by adults.
• Rupalyn 400 mg is indicated for the symptomatic treatment of mild to moderate pain such as headache, migraine, toothache, menstrual pain, muscle pain, rheumatic pain, back pain, neuralgia and to treat cold symptoms and flu.
• It is also used for the symptomatic treatment of fever.

Composition:
- The active substance is ibuprofen. Each film-coated tablet contains 400 mg ibuprofen (equivalent to 684 mg ibuprofen lysinate).
- The other ingredients are: - tablet core: microristalin cellulose PH102, crospovidone (type A), copovidone
(Plasdone S-630), purified talc, magnesium stearate; - tablet film: Opadry II Alb 85F18422 (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol 4000, purified talc)

Administration method:
The recommended dose is:
Grown ups:
- The initial dose is 1 film-coated tablet (400 mg), after which it is repeated every 6 hours if necessary. Do not exceed 3 film-coated tablets in 24 hours (1200 mg).

• Children and adolescents:- Rupalyn 400 mg is not intended for use by children and adolescents.
• Rupalyn 400 mg film-coated tablets can be used by adolescents weighing more than 40 kg (aged 12 years and over).
• Do not use a higher dose than recommended or for a period longer than 3 consecutive days for fever, unless the doctor recommends otherwise.

Contraindications:
Do not take Rupalyn 400 mg:
- if you are allergic to ibuprofen or any of the other components of this medicine;
- if you have ever had gastrointestinal bleeding or perforation, related to the previous use of NSAIDs;
- if you have an ulcer (in the stomach or duodenum) or active bleeding or have had an ulcer in the past or recurrent bleeding;
- if you have had allergic reactions in the past (such as asthma, rhinitis, angioedema or urticaria) associated with the use of acetylsalicylic acid or other NSAIDs;
- if you have serious liver, kidney or heart problems;
- if you have blood coagulation disorders (tendency to increase bleeding), brain bleeding or other active bleeding;
- if you are severely dehydrated (due to vomiting, diarrhea or insufficient fluid intake);
- if you are in the third trimester of pregnancy (see "Pregnancy, breastfeeding and fertility");

Precautions:
Before taking Rupalyn 400 mg talk to your doctor or pharmacist if:
- you have heart problems including heart failure, angina pectoris (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (reduced blood flow to the legs or soles due to narrowing or blockage arteries) or any other type of stroke (including "minor stroke" or transient ischemic attack "TIA").
- you have high blood pressure, diabetes, high blood cholesterol, a family history of heart disease or stroke, or if you are a smoker.

Pregnancy, breast-feeding and fertility:

• If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
• Do not take this medicine during the first 6 months of pregnancy unless absolutely necessary.
• Do not take this medicine during the last 3 months of pregnancy.
• Ibuprofen is found in breast milk in very low concentrations and is unlikely to affect the breastfed child. It is not absolutely necessary to interrupt breastfeeding for the short-term administration of ibuprofen, at the recommended doses, because there are no studies on the negative effect on the breastfed child.
• Administration of ibuprofen leads to decreased fertility in women and therefore it is not recommended to use it if you intend to become pregnant. If you have problems conceiving or if you are considering the possibility of infertility, you should stop taking ibuprofen.

Driving and using machines:
When used for short periods of time and at the recommended dose, ibuprofen does not affect the ability to drive or use machines.

Presentation:
10 film-coated tablets

Warning:
Read the leaflet carefully and completely before you start using this medicine, because it contains important information for you. Always use this medicine as directed in this leaflet or as directed by your doctor or pharmacist.