Patient Information Leaflet

Ketesse 25 25 mg film-coated tablets
Dexketoprofen
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

Keep this leaflet. You may need to read it again.
If you need advice or further information, please consult your doctor or pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 to 4 days, or if you feel worse, you should contact your doctor.

Leaflet Contents:

What Ketesse 25 is and what it is used for
What you need to know before taking Ketesse 25
How to take Ketesse 25
Possible side effects
How to store Ketesse 25
Contents of the pack and other information

1. What Ketesse 25 is and what it is used for

Ketesse 25 is an analgesic medicine belonging to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
It is used for symptomatic treatment of mild to moderate pain, such as muscle pain, painful menstruation (dysmenorrhoea), or toothache.
If there is no improvement after 3 to 4 days, or if you feel worse, you should contact your doctor.

2. Important information before using Ketesse 25

When not to use Ketesse 25:

If the patient is allergic to dexketoprofen or to any of the other ingredients of this medicine (listed in section 6);
If the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
If the patient has asthma or has previously experienced asthma attacks, acute allergic rhinitis (a short period of inflammation of the nasal lining), nasal polyps (nodules inside the nose caused by allergy), urticaria (blistering rash), angioedema (swelling of the face, eyes, lips, tongue or a combination of respiratory disorders), or wheezing after taking acetylsalicylic acid or another NSAID;
If the patient has previously experienced photosensitivity reactions: photoallergic or phototoxic reactions (particularly as redness and/or blisters on skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (medicines used to lower blood lipid levels);
If the patient has gastric or duodenal ulcer disease or bleeding from the stomach or intestines, or if there has been previous gastrointestinal bleeding, ulceration, or perforation;
If the patient has chronic digestive problems (e.g. indigestion, heartburn);
If the patient has previously experienced gastrointestinal bleeding or perforation due to prior use of NSAIDs used to treat pain;
If the patient has inflammatory bowel diseases (Crohn's disease or ulcerative colitis);
If the patient has severe heart failure, moderate or severe renal impairment, or severe hepatic impairment;
If the patient has a tendency to excessive bleeding or coagulation disorders;
If the patient is severely dehydrated (excessive fluid loss from the body) due to vomiting, diarrhoea, or inadequate fluid intake;
If the patient is in the third trimester of pregnancy or breastfeeding.

Warnings and precautions
Before starting to take Ketesse, discuss this with your doctor or pharmacist:

If the patient has an allergy or has previously had allergy-related problems;
If the patient has impaired kidney, liver, or heart function (hypertension and/or heart failure), fluid retention, or if any of these conditions occurred previously;
In patients receiving diuretics or in patients with reduced hydration and decreased blood volume due to excessive fluid loss (e.g. frequent urination, diarrhoea, or vomiting);
If the patient has heart problems, has had a stroke, or is suspected of being at risk for these conditions (e.g. due to high blood pressure, diabetes, elevated cholesterol levels, or smoking). In such cases, consult your doctor before using Ketesse 25. Use of medicines such as Ketesse 25 may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. This risk increases with long-term use of high doses. Do not use higher doses or longer treatment duration than recommended;
If the patient is elderly: there is an increased risk of adverse effects (see section 4). In such cases, contact your doctor immediately;
In women experiencing difficulty becoming pregnant or undergoing fertility investigations (this medicine may impair female fertility and is not recommended for women planning pregnancy or undergoing fertility treatment);
If the patient has blood or blood cell formation disorders;
If the patient has systemic lupus erythematosus or mixed connective tissue disease (immune system disorders affecting connective tissue);
If the patient has previously had chronic inflammatory bowel diseases (ulcerative colitis, Crohn's disease);
If the patient has or has previously had other stomach or intestinal disorders;
If the patient has an infection – see below, section titled "Infections";
If the patient is taking other medicines that increase the risk of gastric or duodenal ulcer disease or bleeding, e.g. oral corticosteroids, certain antidepressants (SSRI-class drugs, e.g. serotonin reuptake inhibitors), anticoagulants such as acetylsalicylic acid, or antithrombotic drugs such as warfarin. In such cases, consult your doctor before taking this medicine, who may decide to prescribe an additional protective medicine (e.g. misoprostol or drugs inhibiting gastric acid production).
If the patient has asthma, chronic rhinitis, chronic sinusitis, and/or nasal polyps, the risk of allergy to acetylsalicylic acid and/or NSAIDs is higher than in the general population. Administration of this medicine may trigger asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid and/or NSAIDs.

Infections
Dexketoprofen may mask symptoms of infection such as fever and pain. Therefore, this medicine may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient takes this medicine during an infection and symptoms persist or worsen, consult a doctor immediately.
Avoid using this medicine during chickenpox.
Allergic reactions to dexketoprofen have been reported during its use, including breathing difficulties, facial and neck swelling (angioedema), and chest pain. If any of these symptoms occur, stop using Ketesse 25 immediately and contact a doctor or emergency services without delay.

Children and adolescents
The use of this medicine has not been studied in children and adolescents. Safety and efficacy have not been established, and therefore Ketesse 25 should not be used in children and adolescents.

Ketesse 25 and other medicines
Inform your doctor about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. Some medicines should not be used together with Ketesse 25, while for others, dosage adjustments may be necessary when used concurrently.
Always inform your doctor, dentist, or pharmacist if you are taking any of the following medicines together with this medicine:

Concomitant use not recommended:

Acetylsalicylic acid, corticosteroids, or other anti-inflammatory drugs
Warfarin, heparin, or other anticoagulant drugs
Lithium used to treat certain mood disorders
High-dose methotrexate (15 mg per week) used as an anticancer or immunosuppressive agent
Hydantoin derivatives and phenytoin used to treat epilepsy
Sulfamethoxazole used to treat bacterial infections

Concomitant use requiring caution:

ACE inhibitors, diuretics, and angiotensin II antagonists used to treat high blood pressure and heart disease
Pentoxifylline and oxpentifylline used to treat ulcers in chronic venous insufficiency
Zidovudine used to treat viral infections
Aminoglycoside antibiotics used to treat bacterial infections
Sulfonylurea derivatives (chlorpropamide and glibenclamide) used to treat diabetes
Low-dose methotrexate, below 15 mg per week

Concomitant use requiring special consideration:

Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used to treat bacterial infections
Cyclosporine and tacrolimus used to treat immune system disorders and in transplant patients
Streptokinase and other thrombolytic or fibrinolytic drugs, i.e. drugs used to dissolve clots
Probenecid used to treat gout
Digoxin used to treat chronic heart failure
Mifepristone used as an abortion-inducing agent (to terminate pregnancy)
Selective serotonin reuptake inhibitors (SSRIs) used as antidepressants
Antiplatelet drugs used to reduce platelet aggregation and blood clot formation
Beta-blockers used to treat high blood pressure and heart disease
Tenofovir, deferasirox, pemetrexed.

If you have any doubts regarding the use of Ketesse 25, consult your doctor or pharmacist.

Use with food and drink
Ketesse 25 tablets should be swallowed with sufficient water. Taking the tablets with food may reduce the risk of gastrointestinal adverse effects.
However, in the case of acute pain, it is recommended to take the medicine on an empty stomach, e.g. at least 30 minutes before a meal, to allow faster onset of action.

Pregnancy, breastfeeding, and effects on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Do not use this medicine during the last three months of pregnancy or while breastfeeding. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. During the first six months of pregnancy, do not use this medicine unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time.
From the 20th week of pregnancy, Ketesse 25, if taken for longer than a few days, may cause:
renal dysfunction in the unborn child – this may lead to reduced amniotic fluid volume surrounding the child (oligohydramnios) or constriction of blood vessels (ductus arteriosus) in the child's heart. If treatment for longer than a few days is necessary, the doctor may recommend additional monitoring.
This medicine is not recommended for women planning pregnancy or undergoing fertility investigations.
Information on potential effects on fertility is provided in section 2, "Warnings and precautions".

Driving and operating machinery
This medicine may cause dizziness and fatigue and therefore may have a minor or moderate effect on the ability to drive and operate machinery. If such symptoms occur, do not drive or operate machinery until symptoms resolve.
If in doubt, consult your doctor.

Ketesse 25 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Ketesse 25

This medicine should always be taken exactly as described in the patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If, during an infection, symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
The tablets may be divided into equal doses by breaking along the division line.
The recommended daily dose is 1 coated tablet (25 mg) every 8 hours. The total daily dose should not exceed 3 coated tablets (75 mg).
If there is no improvement after 3 to 4 days, or if the patient feels worse, a doctor should be contacted. The doctor will inform the patient how many tablets to take per day and for how long. The dose of this medicine will depend on the type, severity, and duration of pain in the patient.
For elderly patients or those with kidney or liver disease, treatment should be initiated with a lower total daily dose corresponding to no more than 2 coated tablets (50 mg).
If this medicine is well tolerated in elderly patients, the initial dose may subsequently be increased to the dose recommended for the general population (75 mg).
In cases of acute pain requiring faster relief, it is recommended to take the medicine on an empty stomach (at least 30 minutes before a meal), which will result in faster absorption of the medicine (see section 2, "Taking this medicine with food and drink").
Use in children and adolescents
This medicine must not be used in individuals under 18 years of age.
Taking more Ketesse 25 than recommended
In case of suspected overdose, a doctor or pharmacist should be contacted immediately or the nearest hospital emergency department should be visited. Remember to bring the medicine packaging or patient leaflet with you.
Missing a dose of Ketesse 25
Do not take a double dose to make up for a missed dose. The next dose should be taken according to the prescribed dosing schedule (see section 3, "How to use Ketesse 25").
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The possible side effects are listed below, grouped according to their frequency of occurrence.

Common side effects (may affect up to 1 in 10 people):
Nausea and/or vomiting, abdominal pain, mainly in the upper quadrants, diarrhoea, indigestion (dyspepsia).

Uncommon side effects (may affect up to 1 in 100 people):
Vertigo (of labyrinthine origin), drowsiness, sleep disturbances, nervousness, headache, palpitations, facial flushing, inflammation of the gastric mucosa (gastritis), constipation, dryness of the oral mucosa, flatulence, rash, fatigue, pain, feeling of fever and chills, malaise.

Rare side effects (may affect up to 1 in 1,000 people):
Peptic ulcer disease, gastrointestinal bleeding or perforation (which may present as bloody vomit or black stools), fainting, hypertension, respiratory depression, fluid retention and peripheral oedema (e.g. swollen ankles), throat swelling, loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, increased urination, menstrual disorders, prostate disorders, abnormal liver function tests (blood tests), liver cell damage (hepatitis), acute kidney failure.

Very rare side effects (may affect up to 1 in 10,000 people):
Anaphylactic reactions (acute hypersensitivity reactions which may lead to anaphylactic shock), skin, lip, eye and genital ulceration (Stevens-Johnson syndrome and Lyell's syndrome), facial swelling or swelling of lips and throat (angioedema), shortness of breath due to respiratory muscle spasm (bronchospasm), shortness of breath, rapid heartbeat, low blood pressure, pancreatitis, blurred vision, tinnitus, skin hypersensitivity reactions and photosensitivity, itching, kidney damage, decreased white blood cell count (neutrop游戏副本

5. How to store Ketesse 25

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the
blister. The expiry date refers to the last day of the stated month.
[PVC/Aluminium blister:]
Do not store above 30°C. Keep the blisters in the outer packaging to protect from light.
[Aclar/Aluminium blister or Aluminium/Aluminium blister:]
No special requirements for storage temperature. Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Ketesse 25 contains

The active substance is dexketoprofen (as dexketoprofen trometamol). One coated tablet contains 25 mg of dexketoprofen.
Other components are:
Tablet core: maize starch, microcrystalline cellulose, sodium carboxymethyl starch, glycerol distearate.
Coating: dry coat (composition: hypromellose, titanium dioxide, macrogol 6000), propylene glycol.

What Ketesse 25 looks like and contents of the pack
White, round, biconvex coated tablets with a dividing score line.
The medicine is available in blister packs containing: 10, 20 or 30 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611 Luxembourg
Luxembourg

Manufacturer
A. Menarini Manufacturing Logistics and Services s.r.l.
Campo di Pile, L’Aquila, Italy
or
Laboratorios Menarini S.A.
C/Alfonso XII, 587 E–08918-Badalona (Barcelona), Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Spain (RMS), Hungary, Italy: Enantyum
Estonia, Latvia, Lithuania, Poland: Ketesse
Greece: Viaxal

For further information, please contact the representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel. (22) 566 21 00
Fax. (22) 566 21 01