EPROMUL 220MG TBL N10

ATC code: M01AE02 

Active substances: Naproxenum Natricum

Vendor, principal: Pharmaswiss Ceska Republika S.r.o. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

EPROMUL 220MG N10

Package leaflet: Information for the user Epromul 220 mg, film-coated tablets

Naproxen sodium

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   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.
-   You must talk to a doctor if you do not feel better or if you feel worse after three days (if you use this medicine for relief of fever) or after seven days (if you use this medicine for the treatment of pain).

What is in this leaflet

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

1. What Epromul is and what it is used for

Epromul contains naproxen, which belongs to a group of medicines called non-steroidal antiinflammatory drugs (NSAIDs). This medicine reduces inflammation, pain and fever.
Epromul is used :
■   for the short term treatment of mild to moderate pain of different origin, such as: headache, toothache, muscular pain, joint pain, back pain and period pain (also called menstrual pain or dysmenorrhea);
■   for relief of fever and symptomatic treatment of pain associated with common cold or influenza.
You must talk to your doctor if you do not feel better or if you feel worse after three days (if you use this medicine for relief of fever) or after seven days (if you use this medicine for the treatment of pain).

2. What you need to know before you take Epromul Do not take Epromul :

■   if you are allergic to naproxen or to any of the other ingredients of this medicine (listed in section 6);
■   if you have ever developed signs of asthma, hives (urticaria) or any other allergic reactions after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs;
■   if you previously experienced bleeding or perforation in your stomach or gut (intestine) while taking non-steroidal anti-inflammatory drugs;
■   if you have or have ever had any problems with your stomach or gut such as ulcer or bleeding;
■   if you have severe heart problems;
■   if you have severe kidney or liver problems;
■   if you are in the last three months of pregnancy.
Do not take Epromul if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Epromul.

Warnings and precautions

Undesirable effects may be minimized by using the minimum effective dose for the shortest possible duration necessary to control symptoms.
Naproxen is not recommended for the treatment of pain with GI origin.
Talk to your doctor or pharmacist before taking Epromul:
■   If you have a history of gastrointestinal disease e.g. ulcerative colitis, Crohn’s disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss)
■   If you use other non-steroidal anti-inflammatory drugs, including medicines called cyclooxygenase-2 selective inhibitors (COX 2 inhibitors) or any medication which may cause bleeding or ulcers in the stomach, such as corticosteroids, medicines which prevent blood clotting (e.g. warfarin), certain antidepressants called selective serotonin reuptake inhibitors (see below: “Other medicines and Epromul”)
■   If you are elderly, because you have a higher risk of getting side effects, especially from the stomach.
■   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)
■   If you have or have had problems with the blood vessels (arteries) anywhere in your body
■   If you have or had have kidney or liver problems
■   If you drink alcohol, especially often and in large amounts
■   If you have problems with the way that your blood clots
■   If you have or have had bronchial asthma
■   If you have ever experienced allergic reactions, such as e.g. angioedema (swelling of the face, lips, eyes or tongue), skin rashes, mucosal lesions in the past
■   If you have lumps in your nose (polyps) or if you sneeze a lot or have a runny, blocked, or itchy nose (rhinitis)
■   If you have systemic lupus erythematosus (SLE, causes joint pain, skin rashes and fever) or other connective tissue disorders e.g. rheumatoid arthritis (RA)
■   If you are a women trying to become pregnant or undergoing investigation of infertility (see below: “Pregnancy, breast-feeding and fertility”)
■   If you need to carry out any blood or urine tests tell your doctor or pharmacist that you are taking Epromul. The tablets may need to be stopped 48 hours before a test as they may interfere with the results.
Other warnings
Medicines such as 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.
Due to the anti-inflammatory and antipyretic activities, Epromul may hide the symptoms of another disease and hinder its diagnosis.

Children and adolescents

Epromul is not recommended for use in children under 16 years of age.

Other medicines and Epromul

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Check with your doctor or pharmacist if you are taking any of the following medicines:
■   Other painkillers such as ibuprofen, acetylsalicylic acid (aspirin) or COX 2 inhibitors, e.g. celecoxib
■   Medicines used to treat high blood pressure, including medicines called ACE-inhibitors
■   Diuretics (water tablets), like furosemide
■   Cardiac glycosides (used to treat heart failure), like digoxin
■   Lithium (used for mental problems)
■   Methotrexate (used to treat skin problems, arthritis or cancer)
■   Ciclosporin or tacrolimus (used for skin problems or after an organ transplant)
■   Mifepristone (used to end pregnancy or to bring on labour if the baby has died)
■   Steroids, also called corticosteroids
■   Anticoagulants (medicines which thin the blood or which prevent blood clotting) such as warfarin, acenocoumarol or heparin
■   Sulphonyloureas (used to treat diabetes)
■   Medicines for “thinning the blood”, such as clopidogrel or acetylsalicylic acid (aspirin) in low dose
■   Medicines used to treat depression called selective serotonin reuptake inhibitors, e.g. paroxetine, citalopram
■   Quinolones(used for bacterial infections), e.g. ciprofloxacin
■   Probenecid (used for gout)
■   Zidovudine (used to treat AIDS and HIV infections)
■   Bisphosphonates (used for the prevention and treatment of osteoporosis)
■   Antacids (used to treat heartburn)
■   Colestyramine (used to lower cholesterol in blood)
■   Hydantoins like phenytoin ( for epilepsy)
■   Sulphonamide medicines, including medicines used for bacterial infections.

Epromul with food and drink

This medicine can be taken with or after a meal.
Epromul should be swallowed with a glass of water.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You must not take Epromul in the last three months of pregnancy.
During the first six months of pregnancy, you should only use Epromul if your doctor says it is necessary.
Breast-feeding
If you are breast-feeding, you should not take Epromul.
Fertility
Epromul may make it more difficult to become pregnant. You should tell your doctor or pharmacist if you are planning to become pregnant or if you have problems with becoming pregnant.

Driving and using machines

Epromul may make you feel dizzy, drowsy or tired and may cause problems with your eyesight and balance, depressed or have difficulty with sleeping. Make sure you are not affected before you drive or operate machinery.

3. How to take Epromul

Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure.
Epromul is intended for oral administration.
Swallow the tablets with a glass of water.
Do not take more than the recommended dose of up to three tablets in a day.
If you use Epromul for the treatment of pain, do not take it for longer than seven days.
If you use Epromul for relief of fever, do not take it for longer than three days.
You must talk to a doctor if you do not feel better or if you feel worse after seven days (if you use this medicine for the treatment fo pain) or after three days (if you use this medicine for relief of fever).
Adults and adolescents aged 16 years and above The recommended dose is one tablet every 8 to 12 hours.
The starting dose of two tablets followed by one tablet after 12 hours can be used.
Do not take more than three tablets each day.
Elderly and patients with liver, kidney and (or) cardiac problems The dose is usually lower than that recommended for other adults.
Elderly patients should consult the dose with their doctor.

Use in children and adolescents

Epromul is not recommended for use in children under 16 years of age.

If you take more Epromul than you should

Contact your doctor or pharmacist if you have taken more tablets than you should.

If you forget to take Epromul

If you forget to take your tablets, take your next dose as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for a forgotten dose.

If you stop taking Epromul

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking Epromul and contact your doctor immediately if you:

■   have indigestion, heartburn, pains in your stomach or other abnormal stomach symptoms, feeling or being sick (you may have an ulcer or inflammation in the stomach or gut);
■   pass blood in your faeces (stools/motions) or black tarry looking stools (signs of bleeding and perforation of the stomach and intestines);
■   vomit any blood or dark particles that look like coffee grounds;
■   have hives, also called urticaria (uncommon side effect);
■   have difficulty breathing, including wheezing, shortness of breath, or coughing (frequency not known);
■   have rhinitis (frequency not known);
■   have swelling of the face, hands and feet, eyes, lips and/or tongue, which may cause difficulties in breathing or swallowing (angioedema) - frequency not known;
■   anaphylaxis (life-threatening allergic reaction, which symptoms may include: low blood pressure, breathing problems and skin symptoms such as rash and swelling) - rare side effect;
■   any other allergic reactions (rare side effects);
■   severe skin reactions (side effects occurs very rare or which frequency is not known): skin shedding, itching, swelling, raised purple rashes, red skin patches, reddening of the skin with painful red areas, blisters or peeling. There may also be severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.

Other possible side effects:

The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Feeling sick, being sick, diarrhoea, wind, constipation, indigestion, stomach pain, blood in the stools, vomiting of blood, ulcerative stomatitis and worsening of colitis and Crohn’s disease have been reported following administration. Less frequency, gastritis (inflammation of the lining of the stomach) has been observed.
Water retention (may cause swelling in the limbs), high blood pressure and heart failure have been reported in association with non-steroidal anti-inflammatory drugs therapy.

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

■   Confusion, feeling dizzy or sleepy, headache
■   Changes to vision (you should go for an eye test if you notice changes in your vision)
■   Ringing in the ears (tinnitus)
■   Skin rash, itchiness, red spots on the skin
■   Feeling tired

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

■   Depression
■   Difficulty sleeping
■   Abnormal dreams
■   Difficulty with your memory or concentration
■   Palpitations (feeling like your heart is fluttering, racing)
■   Sensitivity of the skin to light (photosensitivity)

Rare (may affect up to 1 in 1000 people):

■   Low red blood cells count (haemolitic anaemia)
■   High blood potassium level (causing irregular heartbeat, feeling sick)
■   Hearing difficulties
■   Inflammation of blood vessels (causing fever, swelling and general unwellness)
■   Worsening of asthma, pneumonia
■   inflammation of the liver - sometimes fatal (symptoms include feeling tired, loss of appetite, feeling or being sick and pale coloured stools)
■   Jaundice (yellow skin or eyes)
■   Hair loss
■   Blistering of skin when exposed to sunlight seen most on arms, face and hands (pseudoporphyria)
■   Muscle pain or weakness

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

■   Changes in white blood cells count
■   Low platelet count
■   Low white blood cells count
■   Sleep disturbances, concentration disturbance
■   Fits or seizures
■   Elevated blood pressure
■   Heart attack* (chest pain which may spread to your neck and shoulders and down your left arm) and stroke* (symptoms may include muscle weakness and numbness. This may only be on one side of your body or a suddenly altered sense of smell, taste, hearing or vision, confusion)
■   Inflamation of the the membranes around the brain and spinal cord that is not caused by bacteria (aseptic meningitis). Symptoms include: fever, feeling or being sick, disorientation, headache, neck stiffness and sensitivity to light
■   Inflammation of the pancreas (causing fever, stomach pain, sickness)
■   Kidney damage or inflammation (may cause blood in the urine, decrease in amount of urine passed, feeling or being sick)

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

■   Low amounts of some white blood cells, which may cause fever or frequent infections (neutropenia)
■   Low red blood cells count (aplastic anaemia)
■   Seeing and possibly hearing things that are not there (hallucinations)
■   Dizziness that causes problems with your balance
■   Pins and needles or numbness of your hands and feet
■   Feeling generally unwell
■   Visual disturbances
■   Thirst
■   Liver problems: found through abnormal blood test results
■   Severe kidney problems, such as kidney failure, nephropathy
■   High level of serum creatinine
■   Problems for women in getting pregnant
■   Swelling of your hands, feet or legs (peripheral oedema)
■   Fever
*Medicines such as Epromul may be associated with a small increased risk of heart attack or stroke.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Epromul

Keep this medicine out of the sight and reach of children.
Store below 25C.
Store in the original package in order to protect from light and moisture.
Do not use Epromul after the expiry date which is stated on the carton and foil. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

6. Contents of the pack and other information What Epromul contains

-   The active substance is naproxen. Each film-coated tablet contains 220 mg naproxen sodium (corresponding to 200 mg naproxen).
-   The other ingredients are:
Tablet core: celulose microcrystaline, povidon K30, talc, magnesium stearate, water purified. Tablet coating: Opadry Blue YS-1R-4216: hypromellose 2910, titanium dioxide (E171), indigotine, lake (E132), macrogol 6000.

What Epromul looks like and contents of the pack

Epromul 220 mg film-coated tablets are blue, oval and biconvex with length of 13 mm and width of 7.1 mm.
Epromul is available in blisters made from PVC/PVDC/Al foil packed in cartons containing 10, 20 or 30 film-coated tablets.
Not all the packs are marketed.

Marketing Authorisation Holder

PharmaSwiss Ceska republika s.r.o.
Jankovcova 1569/2c 170 00 Praha 7 Czech Republic

Manufacturer

ICN Polfa Rzeszow S.A. ul. Przemyslowa 2 35-959 Rzeszow Poland

This medicinal product is authorised in the Member States of the EEA under the following names:

Croatia   Emoxen 220 mg filmom obložene tablete
Latvia   Epromul 220 mg apvalkotās tabletes
Lithuania   Epromul 220 mg plevele dengtos tabletes
Slovenia   Emoxen 220 mg filmsko obložene tablete
Czech Republic   Emoxen 220 mg potahovane tablety
Hungary   Apranax Dolo 220 mg filmtabletta

This leaflet was last revised in September 2016.