Ketoprofen lysine salt Ratiopharm: detailed information

Package leaflet: Information for the patient

Ketoprofen lysine salt ratiopharm 80 mg granules for oral solution

Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ketoprofene Lysine Salt ratiopharm is and what it is used for

Ketoprofene Lysine Salt ratiopharm contains ketoprofen, a substance belonging to a group of medicines called NSAIDs (non-steroidal anti-inflammatory drugs), used for its analgesic and anti-inflammatory properties.
Ketoprofene Lysine Salt ratiopharm is indicated for the treatment of:
in adults
inflammatory conditions associated with pain, including:

rheumatoid arthritis (an autoimmune disease);
ankylosing spondylitis (a chronic inflammatory disease);
painful osteoarthritis (a disease affecting the joints);
extra-articular rheumatism (rheumatic disease);
post-traumatic inflammation (inflammation following trauma);
painful inflammatory conditions in dentistry, otorhinolaryngology, urology and pneumology;

in children

short-term inflammatory conditions associated with pain, sometimes accompanied by fever, such as those affecting bones and joints;
painful conditions following surgical procedures;
ear inflammations (otitis).

Consult your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking Ketoprofen lysine salt ratiopharm

Do not take Ketoprofen lysine salt ratiopharm

if you are allergic to ketoprofen, to other non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the other ingredients of this medicine (listed in section 6);
if you have previously experienced hypersensitivity reactions (allergy) such as bronchospasm (difficulty breathing), asthma attacks, acute rhinitis, nasal polyps, angioedema (swelling of the face, hands and feet, eyes, lips, tongue and/or face), or other allergic-type reactions following intake of ketoprofen or other substances with similar action such as acetylsalicylic acid or other NSAIDs;
if you have suffered from bronchial asthma;
if you have severe heart problems (severe heart failure);
if you currently have or have previously had peptic ulcer (lesions in the stomach lining);
if you have previously experienced gastrointestinal bleeding or perforation, gastrointestinal ulceration (in the stomach or intestine), or chronic dyspepsia (difficult digestion);
if you have had gastrointestinal bleeding or perforation after taking NSAIDs;
in case of leucopenia (reduced number of white blood cells) or thrombocytopenia (reduced number of platelets);
if you suffer from blood coagulation disorders;
if you suffer from Crohn's disease or ulcerative colitis;
in case of severe impairment of liver or kidney function such as hepatic cirrhosis, severe hepatitis, severe hepatic or renal insufficiency;
if you are taking high-dose diuretics;
during the third trimester of pregnancy;
to treat a child under 6 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Ketoprofen lysine salt ratiopharm.
To reduce the risk of adverse effects associated with the use of this medicine, it is recommended to use the lowest effective dose for the shortest possible duration. Always follow your doctor's instructions.
Avoid taking other NSAIDs (including COX-2 inhibitors) during treatment with Ketoprofen lysine salt ratiopharm, as this may increase the risk of serious adverse reactions.
You must stop treatment and contact your doctor immediately if you experience:

skin rashes, mucosal or skin lesions, or any other sign of allergic nature (hypersensitivity);
any unusual abdominal symptoms, especially if you have previously suffered from gastrointestinal problems or if you are elderly;
a significant worsening or persistent abnormality in blood tests assessing liver function (SGOT and SGPT);
blurred vision or other visual disturbances.

Exercise particular caution and consult your doctor before taking Ketoprofen lysine salt ratiopharm if:

you are elderly;
you are already taking medications that could increase the risk of gastrointestinal ulceration or bleeding (e.g. oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors, or antiplatelet agents such as acetylsalicylic acid);
you suffer from ulcerative colitis or have Crohn's disease;
your liver or kidney function is impaired;
your heart function is impaired, for example if you suffer from heart failure or congestive heart failure, confirmed ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
you are being treated with diuretic medications;
you are exposed to multiple risk factors for cardiovascular events, such as smoking, elevated blood sugar levels (diabetes mellitus), high blood pressure (hypertension), or elevated blood lipid levels (hyperlipidemia);
you suffer from disorders in blood cell production (hematopoietic disorders);
you suffer from an autoimmune disease known as systemic lupus erythematosus;
you suffer from connective tissue disorders;
you suffer from bronchial asthma associated with chronic rhinitis, chronic sinusitis and/or nasal polyps;
you are allergic or predisposed to allergies (allergic diathesis);
you have an infection – see section “Infections” below.

Infections
Ketoprofen lysine salt ratiopharm may mask symptoms of infections such as fever and pain. Therefore, Ketoprofen lysine salt ratiopharm could delay appropriate treatment of the infection, potentially increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, contact your doctor immediately.
Gastrointestinal effects
The risk of gastrointestinal bleeding and gastrointestinal lesions (ulceration and perforation), which may be fatal, is higher in elderly patients and in patients who have previously suffered from gastric problems (ulcer, especially if complicated by bleeding or perforation) when taking high doses of NSAIDs.
Depending on your health status and your response to the drug, your doctor may decide to perform regular check-ups and blood tests at the beginning and during treatment to monitor potassium levels and assess the function of your heart, liver, and kidneys (especially if you are expected to take ketoprofen for a prolonged period).
Children and adolescents
Ketoprofen lysine salt ratiopharm is contraindicated in children under 6 years of age and should be administered with caution and under strict medical supervision in children over 6 years of age and in adolescents due to the risk of gastrointestinal bleeding, even severe, and ulcers.
Your doctor will determine the most appropriate dose for your case.
Other medicines and Ketoprofen lysine salt ratiopharm
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pay special attention and inform your doctor if you are taking any of the following medicines:

other anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors, and high doses of salicylates);
medicines that delay blood coagulation (anticoagulants), such as heparin and warfarin;
medicines that reduce platelet aggregation (antiplatelet agents), such as ticlopidine and clopidogrel;
lithium, used to treat certain mental disorders;
methotrexate, used to treat certain cancers and autoimmune diseases;
hydantoins and sulfonamides, used respectively to treat epileptic seizures and certain bacterial infections;
medicines that may increase blood potassium levels (potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (ACE inhibitors), angiotensin II receptor blockers, NSAIDs, heparin, and trimethoprim);
tenofovir, used in the treatment of AIDS;
diuretics, used to treat high blood pressure;
other antihypertensives such as ACE inhibitors and angiotensin II receptor antagonists;
corticosteroids, used to treat certain allergic conditions;
pentoxifylline, used to prevent blood clot (thrombus) formation;
zidovudine, used in the treatment of AIDS;
sulfonylureas, used in the treatment of diabetes;
cardiac glycosides, used to treat heart failure;
beta-blockers, used to treat high blood pressure and other heart conditions;
mifepristone, used for medical abortion;
intrauterine contraceptive devices (IUDs);
probenecid, used to treat gout;
cyclosporine and tacrolimus, used to prevent transplant rejection;
selective serotonin reuptake inhibitors (SSRIs), used to treat depression;
quinolone and sulfonamide antibiotics, used to treat infections;
gemeprost, used in obstetrics;
phenytoin, used to treat epilepsy.

Ketoprofen lysine salt ratiopharm and alcohol
The intake of ketoprofen lysine salt together with alcohol should be avoided.
Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Pregnancy
Do not take Ketoprofen lysine salt ratiopharm during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labor more than expected.
You should not take Ketoprofen lysine salt during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is required during this period or during attempts to conceive, the lowest possible dose for the shortest possible time should be used.
From the 20th week of pregnancy, Ketoprofen lysine salt ratiopharm may cause kidney problems in the fetus if taken for more than a few days, thereby reducing the levels of amniotic fluid surrounding the baby (oligohydramnios), or cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for more than a few days, your doctor may recommend additional monitoring.
Breastfeeding
Taking this medicine during breastfeeding is not recommended.
Fertility
This medicine may affect female fertility. Therefore, it is recommended to discontinue treatment in women who are trying to conceive, in those experiencing difficulty conceiving, or in those undergoing fertility investigations.
Driving and using machines
Ketoprofen lysine salt ratiopharm may affect your ability to drive or use machinery. Indeed, during treatment with ketoprofen, drowsiness, dizziness, or convulsions may occur; therefore, avoid driving, operating machinery, or performing activities requiring special alertness.
Ketoprofen lysine salt ratiopharm contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per 80 mg sachet, i.e. essentially "sodium-free". However, note that 3 sachets of 80 mg contain approximately 29 mg of sodium. This corresponds to about 1.45% of the maximum recommended daily dietary intake for an adult.

3. How to take Ketoprofen lysine salt ratiopharm

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
Dosage
Adults
The recommended dose is one sachet (80 mg) three times daily during meals.
The maximum daily dose must not exceed 320 mg.
Children aged 6 to 14 years
The recommended dose is half a sachet (40 mg) three times daily during meals.
Administration of Ketoprofen lysine salt ratiopharm is contraindicated in children under 6 years of age.
Elderly patients and patients with liver or kidney problems
The recommended dose must be carefully determined by the doctor, who will consider reducing the dose compared to the doses indicated above. The lowest daily dose is recommended.
Your doctor will monitor your health status during treatment with this medicine.
Administration of ketoprofen lysine salt is contraindicated in patients with severe impairment of liver or kidney function.
Instructions for use
To take the full dose (80 mg), open the sachet along the line marked “full dose”, while to obtain a half dose (40 mg), open the sachet along the line marked “half dose”. Pour the contents of a full sachet or half sachet into half a glass of water and mix.
The lowest effective dose for the shortest duration necessary to relieve symptoms should be used.
If you have an infection, consult your doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).
If you take more Ketoprofen lysine salt ratiopharm than you should
In case of accidental ingestion/overdose of this medicine, contact your doctor immediately or go to the nearest hospital.
Symptoms of overdose may include deep sleep (lethargy), drowsiness, nausea, vomiting, stomach or chest pain (epigastric pain), abdominal pain, headache (cephalalgia), dizziness and diarrhoea.
In case of accidental ingestion or overdose of this medicine, low blood pressure (hypotension), slowed breathing (respiratory depression) and gastrointestinal bleeding may occur.
If you forget to use Ketoprofen lysine salt ratiopharm
Do not take a double dose to make up for the missed dose.
If you stop treatment with Ketoprofen lysine salt ratiopharm
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most frequent adverse events involve the stomach and intestines.
You must stop treatment and contact your doctor immediately if you experience:

skin rashes, itching, difficulty breathing (bronchospasm) or swallowing (laryngeal oedema, which may occur very rarely, and laryngospasm), swelling of the face, hands and feet, eyes, lips (oral oedema), tongue (lingual oedema) and/or face (angioedema). These may be signs of allergic reactions, even severe ones (anaphylactic shock);
abdominal symptoms and disorders (e.g. digestive disturbances), especially at the beginning of treatment, particularly if you are elderly or have previously experienced stomach or intestinal side effects from medications (gastrointestinal toxicity). These could be symptoms of bleeding, perforations or ulcerations in the stomach or intestines;
worsening or persistent abnormalities in liver function blood tests (SGOT and SGPT). These could be signs of liver inflammation, even severe;
blurred vision or other visual disturbances;
excessive fluid accumulation in the body (oedema); this condition is reversible upon discontinuation of treatment.

Possible side effects include:
Common (may affect up to 1 in 10 people)

indigestion (dyspepsia);
nausea;
abdominal pain;
vomiting.

Uncommon (may affect up to 1 in 100 people)

headache (cephalalgia);
dizziness;
vertigo;
somnolence;
abdominal discomfort;
constipation;
diarrhoea;
gas in the stomach (flatulence);
inflammation of the stomach (gastritis);
rash;
itching;
fluid retention (oedema and peripheral oedema);
fatigue;
chills.

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

excessive reduction in red blood cells due to blood loss (anaemia due to blood loss);
altered sensation in limbs or other body parts (paraesthesia);
ringing in the ears (tinnitus);
blurred vision;
asthma;
inflammation of the mouth mucosa (stomatitis);
inflammation of the intestine (colitis);
lesions in the stomach lining (peptic ulcer);
inflammation of the liver (hepatitis);
yellowing of the skin and eyes (jaundice);
weight gain;
increased levels of certain liver enzymes (transaminases);
increased levels of bilirubin in the blood.

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

abnormal and uncoordinated muscle movements (dyskinesia);
fainting (syncope);
decreased blood pressure (hypotension);
blood in the urine (haematuria);
weakness (asthenia);
laryngeal oedema;
facial swelling (facial oedema).

Not known (frequency cannot be estimated from the available data)

non-infectious inflammation of the meninges (aseptic meningitis);
inflammation of the lymphatic vessels (lymphangitis);
inflammation of the nasal mucosa (rhinitis);
reduced number of white blood cells (leucopenia, neutropenia, agranulocytosis);
increased number of white blood cells (leukocytosis);
reduced number of blood cells called platelets (thrombocytopenia);
inadequate production of blood cells by the bone marrow (bone marrow failure, aplastic anaemia);
reduced number of red blood cells due to their destruction (haemolytic anaemia);
autoimmune disease affecting blood platelets (thrombocytopenic purpura);
allergic-type reactions (anaphylactic reaction, including shock, hypersensitivity);
increased potassium levels in the blood (hyperkalaemia);
reduced sodium levels in the blood (hyponatraemia);
altered mood;
depression;
agitation;
hallucinations;
confusion;
insomnia;
anxiety and behavioural disorders occurred in a child who had taken a double dose compared to the recommended dose;
seizures;
altered taste perception (dysgeusia);
tremor;
excessive muscle movements (hyperkinesia);
swelling of the eyes due to fluid accumulation (periorbital oedema);
impaired heart function (heart failure);
changes in heart rhythm (atrial fibrillation and tachycardia);
awareness of heartbeat (palpitations);
increased blood pressure (hypertension);
increased blood vessel volume (vasodilation);
inflammation of blood vessels (vasculitis, including cutaneous vasculitis);
bronchial constriction (bronchospasm);
difficulty breathing (dyspnoea);
laryngeal constriction (laryngospasm);
severe breathing difficulty (acute respiratory failure);
stomach pain (gastric pain, upper abdominal pain);
heartburn (gastric pyrosis);
erosion of the stomach lining, leading to bleeding (erosive gastritis);
lesions of the stomach and intestine (gastric ulcer, duodenal ulcer, gastrointestinal perforation);
swelling of the mouth and tongue (oral oedema, lingual oedema);
inflammation of the pancreas (pancreatitis);
blood in the stools (melena);
vomiting blood (haematemesis);
excess hydrochloric acid in gastric juices (hyperchlorhydria);
worsening of a chronic intestinal inflammation called Crohn's disease;
bleeding from the stomach and intestine (gastrointestinal haemorrhage);
light sensitivity (photosensitivity reaction);
hair loss (alopecia);
urticaria;
excessive fluid accumulation in subcutaneous tissues and submucosa (angioedema);
bullous dermatitis;
severe skin diseases such as Stevens-Johnson syndrome, Lyell's syndrome, and toxic epidermal necrolysis;
skin redness (erythema);
skin rash (rash, maculopapular exanthema);
severe and widespread body rash (generalized pustular exanthema);
red spots on the skin (purpura);
skin inflammation (dermatitis);
kidney problems (acute renal failure, tubulointerstitial nephritis, nephritis or nephritic syndrome, nephrotic syndrome, glomerulonephritis, fluid/sodium retention with possible oedema, renal tubular necrosis, renal papillary necrosis);
abnormal kidney function test results;
reduced urine production (oliguria).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ketoprofen lysine salt ratiopharm

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ketoprofene Lysine Salt ratiopharm contains

The active substance is ketoprofen lysine salt. Each bipartite sachet contains 80 mg of ketoprofen lysine salt (equivalent to 50 mg of ketoprofen).
The other components are: mannitol, povidone, colloidal silicon dioxide, sodium chloride, sodium saccharin, mint flavour (maltodextrin, gum arabic, sulfur dioxide, pulegone).

Description of the appearance of Ketoprofene Lysine Salt ratiopharm and package contents
Ketoprofene Lysine Salt ratiopharm is presented in a box containing 30 bipartite sachets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ratiopharm GmbH - Graf-Arco Strasse n. 3 - Ulm (Germany)
Manufacturer
Fine Foods & Pharmaceuticals NTM S.p.A. - Via Grignano, 43 - 24041, Brembate (BG) - Italy