DEXKETOPROFEN PENSAVITAL

Do not take DEXKETOPROFEN PENSAVITAL:

• if you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• non-steroidal anti-inflammatory drugs;
• if you have asthma or have suffered asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal mucosa), nasal polyps (lumps within the nose due to allergy), urticaria (skin rash), angioedema (swollen face, eyes, lips, or tongue, or respiratory distress) or wheezing in the chest after taking aspirin or other non-steroidal anti-inflammatory drugs;
• if you have suffered from photoallergic or phototoxic reactions (a particular form of reddening and/or blistering of the skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower the level of fats in the blood);
• if you have, or if you have suffered in the past from, a peptic ulcer, stomach or bowel bleeding or if you have chronic digestive problems (e.g. indigestion, heartburn);
• if you have suffered in the past from stomach or bowel bleeding or perforation, due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;
• if you have bowel disease with chronic inflammation (Crohn’s disease or ulcerative colitis);
• if you have serious heart failure, moderate or serious kidney problems or serious liver problems;
• if you have a bleeding disorder or a blood clotting disorder;
• if you are severely dehydrated (have lost a lot of bodily fluids) due to vomiting, diarrhoea or insufficient intake of fluids;
• if you are in the third trimester of pregnancy or breastfeeding.

Warnings and precautions:

Talk to your doctor or pharmacist before taking DEXKETOPROFEN PENSAVITAL

• if you suffer from allergies, or if you have had any allergies in the past;
• if you have kidney, liver or heart problems (hypertension and/or heart failure) as well as fluid retention, or have suffered from any of these problems in the past;
• if you are taking diuretics or you suffer from very poor hydration and reduced blood volume due to an excessive loss of fluids (e.g. from excessive urination, diarrhoea or vomiting);
• if you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist; medicines such as DEXKETOPROFEN PENSAVITAL may be associated with a small increased risk of heart attack («myocardial infarction») or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
• if you are elderly: you may be more likely to suffer from side effects (see section 4). If any of these occur, consult your doctor immediately;
• if you are a woman with fertility problems (DEXKETOPROFEN PENSAVITAL may impair your fertility, therefore you should not take it if you are planning to become pregnant or you are doing fertility tests);
• if you suffer from a disorder in the formation of blood and blood cells;
• if you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect connective tissue);
• if you have suffered in the past from a chronic inflammatory disease of the bowel (ulcerative colitis, Crohn’s disease);
• if you have or have suffered in the past from other stomach or bowel problems;
• if you are taking other medicines that increase the risk of peptic ulcer or bleeding, e.g. oral steroids, some antidepressants (those of the SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), agents that prevent blood clots such as aspirin or anticoagulants such as warfarin. In such cases, consult your doctor before taking DEXKETOPROFEN PENSAVITAL: they may prescribe you an additional medicine to protect your stomach (e.g. misoprostol or medicines that block the production of stomach acid);
• if you suffer from asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicine can cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Children and adolescents

DEXKETOPROFEN PENSAVITAL has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the product should not be used in children and adolescents.

Other medicines and DEXKETOPROFEN PENSAVITAL

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. There are some medicines that should not be taken together and others that may need their doses to be altered when taken together.

Always inform your doctor, dentist or pharmacist if you are using or receiving any of the following medicines in addition to DEXKETOPROFEN PENSAVITAL:

Inadvisable combinations:

• Acetylsalicylic acid, corticosteroids or other anti-inflammatory drugs
• Warfarin, heparin or other medicines used to prevent blood clots
• Lithium, used to treat certain mood disorders
• Methotrexate, used to treat rheumatoid arthritis and cancer
• Hydantoins and phenytoin, used to treat epilepsy
• Sulfamethoxazole, used to treat bacterial infections

Combinations requiring precautions:

• ACE inhibitors, diuretics and angiotensin II antagonists, used to treat high blood pressure and heart problems
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
• Zidovudine, used to treat viral infections
• Aminoglycosides antibiotics, used to treat bacterial infections
• Chlorpropamide and glibenclamide, used to treat diabetes

Associations to be considered carefully:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin), used to treat bacterial infections
• Cyclosporine or tacrolimus, used to treat immune system diseases and in organ transplants
• Streptokinase and other thrombolytic or fibrinolytic medicines, i.e. medicines used to break up blood clots
• Probenecid, used to treat gout
• Digoxin, used to treat chronic heart failure
• Mifepristone, used as an abortifacient (to terminate a pregnancy)
• Antidepressants of the selective serotonin reuptake inhibitors type (SSRIs)
• Antiplatelet agents used to reduce platelet aggregation and the formation of blood clots
• Tenofovir, deferasirox, pemetrexed.

If you have any doubts about taking other medicines with DEXKETOPROFEN PENSAVITAL, consult your doctor or pharmacist.

DEXKETOPROFEN PENSAVITAL with food and drink

Take the tablets with an adequate amount of water. Take your tablets with food, as it helps to decrease the risk of stomach or bowel side effects. However, if you have acute pain, take the tablets on an empty stomach, i.e. at least 30 minutes before meals, as this helps the medicine start working a little faster.

Pregnancy, breastfeeding and fertility

Do not take DEXKETOPROFEN PENSAVITAL if you are in the final 3 months of pregnancy as it could harm your unborn child or cause problems at delivery. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You should not take DEXKETOPROFEN PENSAVITAL during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more than a few days from 20 weeks of pregnancy onward, DEXKETOPROFEN PENSAVITAL can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine as DEXKETOPROFEN PENSAVITAL may not be suitable for you.

The use of DEXKETOPROFEN PENSAVITAL should be avoided by women planning to have a baby or who are pregnant. Treatment at any time during pregnancy should only take place as instructed by a doctor.

The use of DEXKETOPROFEN PENSAVITAL is not recommended while attempting to conceive or during investigation of infertility.

Driving and using machines

DEXKETOPROFEN PENSAVITAL may slightly affect your ability to drive and handle machines, due to the possibility of dizziness or drowsiness as side effects of treatment. If you notice such effects, do not drive or use machines until the symptoms wear off. Ask your doctor for advice.

DEXKETOPROFEN PENSAVITAL contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet; this means that it is essentially “sodium free”.