NAPROXEN HCS 550 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Naproxen HCS 550 mg film-coated tablets EFG

naproxen sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Naproxen HCS and what is it used for
2. What you need to know before you take Naproxen HCS
3. How to take Naproxen HCS
4. Possible side effects
5. Storage of Naproxen HCS
6. Contents of the pack and other information

1. What is Naproxen HCS and what is it used for

Naproxen HCS contains the active substance naproxen, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for adults for the symptomatic treatment of pain and inflammation in:

• rheumatoid arthritis (a disease with painful and swollen joints), acute attacks of osteoarthritis, acute attacks of gout and ankylosing spondylitis (a type of arthritis that causes inflammation in the joints and ligaments of the spine),
• cramps, menstrual pain (primary dysmenorrhea) and after insertion of an intrauterine contraceptive device (IUD).

2. What you need to know before you take Naproxen HCS

Do not take Naproxen HCS

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6);
• if you have experienced difficulty breathing (bronchospasm, asthma), hives (urticaria), inflammation of the mucous membrane of the nose (rhinitis) or angioedema when taking acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs, non-steroidal anti-rheumatics);
• if you currently have or have had more than once: a stomach or duodenal ulcer or bleeding;
• if you have had a gastrointestinal bleeding or perforation while taking an NSAID;
• if you have unexplained blood formation disorders;
• if you have had a brain hemorrhage or currently have any other form of acute bleeding;
• if you have severe heart failure;
• if you are in the third trimester of pregnancy;
• if you have severe liver or kidney failure.

Warnings and precautions

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Medicines like naproxen 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 have heart problems, a history of stroke or think you may be at risk of these diseases (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker), consult your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take naproxen.

• If you have asthma, allergies (such as hay fever) or chronic obstructive pulmonary disease, or if you have had facial swelling, lips, eyes or tongue in the past.
• If you have nasal polyps or sneeze a lot or have runny, stuffy or itchy nose (rhinitis).
• If you feel weak (perhaps due to illness) or are an elderly person.
• If you have kidney or liver problems.
• If you have blood clotting problems.
• If you are taking medicines such as corticosteroids, anticoagulants, selective serotonin reuptake inhibitors (SSRIs), acetylsalicylic acid or NSAIDs, including COX-2 inhibitors.
• If you have previously had a stomach or duodenal ulcer or bleeding. You will be asked to inform your doctor of any unusual stomach symptoms.
• If you have an autoimmune disease, such as systemic lupus erythematosus (SLE, causes joint pain, skin rashes and fever) or mixed connective tissue disease and ulcerative colitis or Crohn's disease (diseases that cause intestinal inflammation, abdominal pain, diarrhea, vomiting and weight loss).
• If you have vision or hearing problems.
• If you have undergone major surgery shortly before starting treatment with naproxen.
• If you have heavy menstrual bleeding.
• If you have a disorder of the biosynthesis of the red pigment that gives color to the blood (porphyria).

This medicine should be discontinued immediately in case of gastrointestinal bleeding or visual or auditory disturbances.

In very rare cases, serious skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis or drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported in association with the administration of NSAIDs. These reactions usually occur at the start of treatment (in the first month). If you develop a skin rash (including lesions of the mucous membranes such as mouth, throat, nose, eyes, genitals) or any other sign of hypersensitivity, stop using it and contact your doctor immediately.

General information

Pain and underlying disease relief

If during treatment with naproxen you do not feel better, or if you continue to have pain, fever, fatigue or other signs of illness, consult your doctor. This is because painkillers can mask possible warning signs of an underlying disease.

Headache due to painkillers

Prolonged and high-dose use of painkillers can cause headaches that should not be treated by taking more painkillers.

Kidney damage due to painkillers

Habitual use of certain painkillers for a long period can cause permanent kidney damage with a risk of kidney failure.

If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before taking naproxen.

Laboratory test results

If your doctor recommends monitoring your blood count, blood clotting and/or liver and kidney function and/or any other test (e.g. determination of blood levels of certain medicines), it is essential that you undergo these tests. This applies especially to patients with liver function disorders, heart failure, high blood pressure or kidney damage.

If you need to have an adrenal function test, you should stop taking (temporarily) at least 3 days before the test to avoid interference with the test result.

Children and adolescents

This medicine must not be given to children under 18 years of age.

Other medicines and Naproxen HCS

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines.

In particular, tell your doctor or pharmacist if you are taking:

• other NSAIDs, including salicylates (such as acetylsalicylic acid) and COX-2 inhibitors,
• medicines used to lower cholesterol levels (cholestyramine),
• medicines used to prevent blood clotting (warfarin),
• medicines to prevent blood clots (Aspirin/acetylsalicylic acid),
• medicines for treating mental health problems, selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine or citalopram,
• medicines used to treat diabetes (sulfonylurea, metformin),
• medicines used to treat epilepsy (hydantoin derivatives),
• sulfonamide medicines, such as hydrochlorothiazide, acetazolamide, indapamide and even sulfonamide antibiotics (for infections),
• medicine used for gout (probenecid),
• medicines used to treat high blood pressure (beta-blockers, ACE inhibitors, angiotensin-II receptor antagonists and diuretics),
• medicine used for heart problems ("cardiac glycoside" such as digoxin),
• medicines used to treat mental disorders (lithium),
• medicines used to treat autoimmune diseases or malignant diseases (methotrexate),
• medicines used to treat pain and inflammation (glucocorticoids),
• medicines used after organ transplantation (cyclosporin or tacrolimus),
• medicines used to treat AIDS and HIV infections (zidovudine),
• medicines used to treat infections (a "quinolone antibiotic" such as ciprofloxacin or moxifloxacin).

Consuming alcoholic beverages during treatment with naproxen increases the risk of bleeding in the gastrointestinal tract (stomach/intestine) and should therefore be avoided.

If any of the above applies to you, or if you are not sure, consult your doctor or pharmacist before taking naproxen.

Taking Naproxen HCS with alcohol

Some side effects, such as those affecting the gastrointestinal tract or the central nervous system, may be more likely when taking alcohol at the same time as naproxen and should therefore be avoided.

Pregnancy, breastfeeding and fertility

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.

Do not take naproxen if you are in the last 3 months of pregnancy, as it may harm your baby or cause problems during delivery. It can cause kidney and heart problems in your baby. It can affect your tendency and that of your baby to bleed and make delivery delayed or longer than expected. You should not take naproxen during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, naproxen may cause kidney problems in your unborn baby that can lead to low levels of the fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Do not take naproxen after delivery because it can delay the process of the uterus returning to its normal shape and size.

Breastfeeding

You should avoid taking naproxen if you are breastfeeding, as it can pass into breast milk in small amounts.

Fertility

This medicine may make it harder to become pregnant. You should tell your doctor if you are planning to become pregnant or if you are having trouble becoming pregnant.

Driving and using machines

This medicine may cause you to feel tired, dizzy, have vision problems or other central nervous system disorders. Talk to your doctor if you experience any of these and do not drive or use tools or machines.

Naproxen HCS contains sodium

This medicine contains 50 mg of sodium (a major component of table/cooking salt) in each dose unit. This is equivalent to 2.5% of the maximum recommended daily intake of sodium for an adult.

3. How to take Naproxen HCS

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

This medicine - like all NSAIDs - should be taken at the lowest dose necessary and for the shortest duration necessary to relieve the symptoms. This precaution helps to minimize the possible side effects.

The tablet can be divided into equal doses.

Unless otherwise prescribed by your doctor, the recommended dose is:

Adults

The daily dose is usually 1 or 2 tablets. Your doctor may change this dosage regimen.

A single dose of 2 tablets must not be exceeded.

Rheumatoid arthritis, acute attacks of osteoarthritis and ankylosing spondylitis:

The daily dose is usually 1 tablet to 1.5 tablets. At the start of treatment, during acute inflammatory phases or when switching from another high-dose NSAID to naproxen, the recommended daily dose is 1.5 tablets, given in two divided doses per day (1 tablet in the morning and 0.5 tablet in the evening, or vice versa) or as a single dose (in the morning or in the evening).

In individual cases, the daily dose may be increased to 2 tablets.

The maintenance dose is 1 tablet per day, which can be given in two divided doses (0.5 tablet in the morning and 0.5 tablet in the evening) or as a single dose (in the morning or in the evening).

Acute attack of gout

The initial recommended dose is 1.5 tablets, followed by 0.5 tablet every 8 hours until the attack subsides. During acute attacks of gout, the maximum daily dose of 2 tablets may be exceeded (for a short period of time).

Primary dysmenorrhea (menstrual pain) or pain after IUD insertion

The initial recommended dose is 1 tablet, followed by 0.5 tablet every 6-8 hours if necessary.

A daily dose of 2 tablets must not be exceeded.

Use in children and adolescents

This medicine must not be used in children and adolescents under 18 years of age.

Special patient populations

Elderly patients

Close medical supervision is required. In elderly patients, it is especially important to select the lowest effective dose of naproxen for the shortest duration necessary (see section 2 "What you need to know before you take Naproxen HCS").

Patients with liver impairment

Patients with liver function disorders are at risk of overdose when taking naproxen. Therefore, the lowest effective dose of naproxen should be selected. Close medical supervision is required.

If your liver function is severely impaired, you must not take naproxen (see section 2 "What you need to know before you take Naproxen HCS").

Patients with kidney impairment

If your kidney function is impaired, your doctor may want to reduce your dose of naproxen.

If your kidney function is severely impaired, you must not take naproxen (see section 2 "What you need to know before you take Naproxen HCS").

Method of administration:

This medicine is taken orally.

Swallow the tablets whole or divided in half with a sufficient amount of liquid and preferably with or after meals.

Duration of treatment

The duration of treatment is decided by your doctor.

In the case of rheumatic diseases, it may be necessary to take naproxen for a prolonged period.

In primary dysmenorrhea and after IUD insertion, the duration of treatment depends on the respective symptoms. However, treatment with naproxen should not exceed a few days. If symptoms persist beyond this period, you should consult your doctor.

If you take more Naproxen HCS than you should

If you have taken more naproxen than you should, talk to your doctor or go to the hospital immediately. Take the medicine package with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Phone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Naproxen HCS

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them. Medicines like naproxen may be associated with a small increased risk of suffering a heart attack ('myocardial infarction') or a stroke.

Important Adverse Effects to Consider:

If you experience any of the following symptoms or combinations of symptoms, stop taking this medicine and contact a doctor immediately. You may need urgent medical treatment:

Severe Allergic Reactions(may affect up to 1 in 10,000 people), the signs include:

• Shortness of breath
• Significant drop in blood pressure
• Swelling of the face or throat, difficulty swallowing
• Skin rash (with itching), redness, small blisters

Severe Stomach and Intestinal Disorders(may affect up to 1 in 10 people), the signs include:

• Relatively severe abdominal pain (stomach), especially if it appears suddenly
• Vomiting blood or with a coffee grounds-like appearance
• Bloody or black stools
• Ulcers, perforations, and bleeding in the stomach or intestine, sometimes fatal, especially in elderly patients.

Heart Attack, the signs include:

• Chest pain that can spread to the neck and shoulders and down the left arm

Liver Disorders(may affect up to 1 in 10,000 people), the signs include:

• Severe fatigue with loss of appetite, with or without yellowing of the skin and the whites of the eyes
• Feeling or being sick, or pale-colored stools

Sensory Organ Disorders, for example

• Sudden onset visual disturbances (may affect up to 1 in 10,000 people) or hearing impairments (may affect up to 1 in 10 people)

Aseptic Meningitis(may affect up to 1 in 10,000 people), the signs include:

• Severe headache, especially if it appears suddenly
• Stiff neck, fever, feeling or being sick
• Confusion, sensitivity to bright light

Patients with autoimmune diseases (SLE, mixed connective tissue diseases) have a higher risk of developing meningitis.

Blood and Lymphatic System Disorders(may affect up to 1 in 10,000 people), the signs include:

• Flu-like symptoms, mouth ulcers, sore throat, and nosebleeds

Skin and subcutaneous tissue disorders (frequency not known, cannot be estimated from available data), the signs include:

• Widespread skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.
• A characteristic allergic skin reaction known as fixed drug eruption, which usually recurs in the same location when re-exposed to the medicine and may appear as red, round, or oval patches and skin swelling, blisters (urticaria), and itching.

Naproxen may cause the following adverse effects:

Very Common (may affect more than 1 in 10 patients):

• Feeling sick
• Being sick
• Heartburn
• Stomach pain
• Feeling bloated
• Constipation or diarrhea and small amounts of blood in the gastrointestinal tract, which in exceptional cases can cause anemia

Common (may affect up to 1 in 10 patients):

• Bleeding from the skin and mucous membranes
• Depression
• Abnormal dreams
• Difficulty falling asleep or staying asleep (insomnia)
• Headache
• Dizziness
• Agitation
• Irritability
• Sleep disturbances
• Fatigue
• Disorders of perception and cognitive dysfunction
• Ringing in the ears
• Dizziness (vertigo)
• Sweating
• Fluid deposits in the body (edema), especially in patients with high blood pressure
• Thirst

Uncommon (may affect up to 1 in 100 patients):

• Changes in blood count
• Increased count of certain types of white blood cells (eosinophilia)
• Asthma attacks (with and without a drop in blood pressure)
• Lung inflammation (eosinophilic pneumonia)
• Symptoms in the lower abdomen (e.g., inflammation of the large intestine with bleeding or worsening of Crohn's disease/ulcerative colitis)
• Inflammation of the lining of the mouth (oral cavity)
• Lesions of the digestive tract
• Liver function disorders with elevated transaminases
• Hair loss (usually temporary)
• Skin inflammation caused by light (sunlight) (which may include blisters)
• Muscle pain
• Muscle weakness
• Acute kidney failure
• Renal function disorder (nephrotic syndrome)
• Kidney inflammation (interstitial nephritis)
• Fever and chills, general malaise
• Inflammation of the stomach lining
• Gas

Rare (may affect up to 1 in 1,000 patients):

• Blisters on the skin (reactions similar to epidermolysis bullosa)

Very Rare (may affect up to 1 in 10,000 patients):

• Decreased count of red and/or white blood cells and/or platelets (aplastic or hemolytic anemia, thrombocytopenia, leucopenia, pancytopenia, agranulocytosis).
• Seizures (attacks)
• Nerve inflammation
• High blood pressure
• Increased heart rate
• Palpitations
• Heart failure
• Inflammation of blood vessels
• Worsening of inflammation related to infection (e.g., development of necrotizing fasciitis, i.e., acute and necrotic inflammation of the tissue under the skin and muscles)
• Anaphylactic or anaphylactoid systemic reactions
• Liver inflammation (hepatitis), liver damage, especially after prolonged treatment
• Hypersensitivity reactions such as skin rash, erythema multiforme, in isolated cases manifesting as severe skin adverse reactions (including Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Kidney damage (papillary renal necrosis) (especially during long-term treatment)
• Increased blood uric acid levels

Unknown (frequency cannot be estimated from available data):

• Increased potassium levels
• Decreased white blood cell count (neutropenia)
• Inflammation of the lens and the head of the optic nerve
• Corneal opacity
• Inflammation of the head of the optic nerve
• Feeling of tingling or numbness in hands and feet
• Pulmonary edema
• Inflammation of the pancreas (a large gland located behind the stomach)
• Erythema nodosum (skin inflammation with painful red lumps)
• Lichen planus (a non-infectious skin rash with itching that can affect many areas of the body)
• Systemic lupus erythematosus (SLE, an autoimmune disease that causes an inflammatory process that can affect various parts of the body)
• Pustular reaction
• Localized skin rash caused by medication (EFF, allergic skin rash with spots that recur in the same place each time a specific medication is taken)
• Blood in the urine (hematuria)
• Inflammation of certain parts of the kidneys (glomerulonephritis)
• Female infertility
• Edema

Naproxen may interfere with laboratory test results; therefore, you should inform all your doctors (if applicable) that you are taking naproxen (see section 2 "What you need to know before taking Naproxen HCS").

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Naproxen HCS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Store the blister pack in the outer packaging to protect it from light.

This medicine does not require any special storage temperature.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Naproxen HCS Composition

• The active ingredient is naproxen. Each film-coated tablet contains 550 mg of naproxen sodium, equivalent to 500 mg of naproxen.
• The other ingredients (excipients) are: povidone K30, microcrystalline cellulose, talc, and magnesium stearate in the tablet core. The film coating contains hypromellose, titanium dioxide (E171), macrogol 8000, and indigo carmine (E132). See section 2 "Naproxen HCS contains sodium".

Product Appearance and Package Contents

The tablets are oval, slightly biconvex, scored on one side, blue, and film-coated. Dimensions 18 x 8 mm.

The film-coated tablets are available in packages of 10x1, 16x1, 30x1, 40x1, and 60x1 tablets in single-dose precut blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

HCS BV

Hendrik Kennisstraat 53

Edegem. Antwerp B-2650

Belgium

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

You can request more information about this medicine by contacting the local representative of the Marketing Authorization Holder:

KRKA Farmacéutica, S.L., Calle de Anabel Segura 10, Pta. Baja, Oficina 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the Last Revision of this Leaflet:

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).